2009 GMP Form w Elements and Guidance (Final 1-8-09)

SILLIKER, Inc. 900 Maple Road * Homewood, IL 60430 * Tel 1+(708)957-7878 * Fax 1+(708)957-8405

rev 7 01/08/2009

AUDIT REPORT

Company:

Audit Date:

Auditor Name:

By: Silliker, Inc.

This audit report sets forth Silliker, Inc. (“Silliker”) findings and recommendations as of the date herein. Silliker shall not assume any responsibility for the programs and/or facility being audited nor for events or actions occurring prior or subsequent to this audit. Silliker shall not endorse, and hereby expressly disclaims, any liability related to the client carrying out Silliker’s recommendations, if any, contained in this report. This report is furnished solely for the benefit of the above named client in connection with the auditing services indicated above and provided in accordance with “Silliker, Inc. Terms and Conditions for Technical Services”. This audit report may not be reproduced or published in full or in part, altered, amended, made available to or relied upon by any other person, firm or entity without the prior written consent of Silliker. The name of Silliker or its affiliates or any of its employees may not be used in connection with any marketing or promotion or in any publication concerning or relating to the client or its products and services without the prior written consent of Silliker. The entire content of this audit report is subject to copyright protection. Copyright © 2009 Silliker, Inc. All rights reserved. The content of this audit report may not be copied, reproduced or otherwise redistributed other than for use by the client with appropriate reference to all copyright notices stated. Except as expressly provided above, copying, displaying, downloading, distributing, modifying, reproducing, republishing or retransmitting any information, text or documents contained in this audit report or any portion thereof in any electronic medium or in hard copy, or creating any derivative work based on such documents, is prohibited without the express written consent of Silliker. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any copyright of Silliker, or any party affiliated with Silliker.

Items in CAPS and bold are automatic failure questions if a “1” is scored by auditor. SILLIKER, Inc.

900 Maple Road * Homewood, IL 60430 * Tel 1+(708)957-7878 * Fax 1+(708)957-8405 rev 7 01/08/2009

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Company: Parent Company:

Audit date: Start / End Time:

Plant address:

Plant phone & fax numbers

Silliker Auditor: (name & contact info):

Company Associate(s) accompanying auditor: (name & contact info)

Products produced by plant:

Facility meets Bio-terrorism requirement:

Yes – No – N/A

Audit score: Rating:

Last Audit Date: Last Audit Score:

Follow-up audit required: Reason for follow-up audit:

Pass/Fail:

Company associate(s) with whom audit findings were reviewed:

Auditor Signature:



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Critical or Major Areas (Questions scoring a 1 or 2):



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#Points # Possible Percentage Category Received Points (%)

I FOOD SAFETY SYSTEMS 135

II QUALITY SYSTEMS 200

III GROUNDS, BUILDING, AND EQUIPMENT 100

IV PEST CONTROL 55

V EMPLOYEE PRACTICES 30

VI RECEIVING, STORAGE, AND SHIPPING 85

VII PLANT SANITATION 45

VIII PROCESSING 80

IX FOOD DEFENSE 55



5

(Program and Records)

Audit Form Question Question Elements Further Guidance

1. A HACCP team, comprised of members from across the plant, has been established and meets on a routine basis. The team includes a person trained in a formal, external HACCP course. (5 pts)

• A HACCP team is listed • Team meets at least annually and

meeting minutes are kept as proof of meeting

• At least one person is formally trained in HACCP

A HACCP team is defined as 2 or more people, is ideally multidisciplinary and includes individuals from all responsible areas of the plant. The HACCP team must meet at least annually and keep minutes of the meetings. At least one person on the HACCP team must be trained in a formal HACCP course. This course does not need to be certified or accredited but must produce a certificate of completion.

2. Each product has been described, and current process flow diagrams are available. (5 pts)

• Product description is available • Flow chart of the process is

available and is updated annually

Each specific product should be described, with product name, how it is to be used, shelf life, (with temperature parameters if applicable) type of packaging, intended customer use, (where it will be sold), and distribution parameters. Flow diagrams should have every process step, all major holding or manipulation of the product including rework, returns and waste described. Multiple flow charts/per product (modular flow charts) are acceptable. Listing of control points (cps) or process control points is allowed, but not recommended. The chart should be reviewed and verified annually or when changes occur in ingredients, packaging or equipment.

3. A documented HACCP program, including all 7 principles, has been established and is in use. A hazard analysis has been completed and it evaluates each step of the process. (5 pts)

• Hazard analysis is present,

process specific and evaluates each step of the process

• A documented HACCP program, including all 7 principles is established and in use

The HACCP program would include the hazard analysis, the product description and the flow chart. A hazard analysis is a step-by-step evaluation of each step in the process for all types of hazards (physical, chemical and biological risks to the product that can be introduced both within and outside the processing plant environment. It is to be process specific, not product specific. If a hazard analysis is conducted, and no hazards were found, no plan will be present. The auditor will comment in the audit report that the hazard analysis has shown that no critical control points have been identified. For USDA plants FSIS notice 45-05, “verification of activities related to an establishment’s controls for the use of ingredients of public health concern”, the facility has to address such ingredients including allergens in its hazard analysis. The auditor shall list the products/process names for the HACCP plans or Hazard analysis evaluated as part of the audit.

4. The critical control points are identified on the process flow chart as well as in the documented HACCP plan. (5 pts)

• Critical control points have been identified

• They are identified on the process

The Critical Control points shall be listed separately in the HACCP plan and identified on the process flow diagram. The auditor will list the number and name of Critical Control Points evaluated in the audit.



6flow diagram

5. Critical limits have been scientifically established and are documented. (5 pts)

• The critical limits are specifically listed

• There is a food safety justification available for the establishment of the limits

Scientifically established means having a reference. This reference can be a regulation, a specification, industry practice, research, or company history. It should be documented to Justify the critical limit. The critical limit is an absolute number, the absolute tolerance for safety. If a schedule or a matrix is used to determine the critical limit, it must be attached to the HACCP plan, as well as available to the monitor. The Critical Control Points must be specifically identified. There should not be a range listed. If an identified Critical Control point is a quality based issue, where there is no food safety justification for the CCP then the auditor will document as such that “the critical limit is not the tolerance for safety.”

6. Critical Control Points are monitored at regularly scheduled intervals. Monitoring procedures are documented and monitoring records are maintained. The person monitoring the Critical Control Point understands the procedures. (5 pts)

• Critical Control Points are being monitored per the frequency described in the plan

• Monitoring records are maintained per the record retention policy

• Written procedures are available that describe the monitoring task

• Monitor performs monitoring procedures according to the plan

Monitoring procedures should indicate who is responsible, what is being monitored, how it is being monitored, and when it will it be monitored. Auditor will review 3 randomly selected records from three months spaced evenly throughout the year with additional sampling if necessary. Auditor shall list in the comments the time period of records reviewed. Additionally, the auditor will question monitor during the physical plant evaluation to verify that the monitor performs the monitoring procedure as written and according to the plan. This would include corrective actions to take if critical limits are not met. Score Deviation: If the auditor finds through record review or observation that a critical control point is not being monitored per the frequency described in the plan this question is to be scored a 1.

7. Employees who are involved in the HACCP plan have been trained in the HACCP-related activities in their immediate work areas. This training is documented as to date(s) given and is a part of the employee’s records. The training should be conducted annually. (5 pts)

• Employees responsible for HACCP have the training and are aware of basic HACCP elements in their area

• Training occurs at least annually • Records of the training are kept

This training is required for employees who have HACCP responsibility as described in the plan and/or in their immediate work area. The training will occur at least annually and records of the training are kept and include the name and signature of the employee, who conducted the training, dates of the training and topics covered. Auditor will verify the training through record review and onsite verification. This will include asking employees with HACCP related responsibility (monitors) about the CCP in their area, the critical limit, and corrective action.

8. Corrective action procedures have been identified and corrective action records are maintained. Product disposition is documented. (5 pts)

• The corrective action section in

the plan is complete with specific tasks described

• Corrective actions are documented and maintained per record retention policy

• Product dispositions are documented

Corrective actions should be listed in the HACCP plan and include specific tasks for product isolation. Corrective action records can be attached to monitoring records, or kept separate. Corrective action records must describe the deviation, identify the product, list the short-term corrective action to the process, and describe the final disposition of the product. They also should address any long- term corrections that are required.

9. CORRECTIVE ACTION PROCEDURES ARE TAKEN WHEN CRITICAL LIMITS ARE NOT MET. (5 pts)

• Monitoring record review shows that corrective action was taken when critical limits were not met

If a documented corrective action is not taken after a Critical Limit has not been met it is an auto failure and the auditor will score this question a 1. This will be determined through record review and observation during the physical verification portion of the audit. If the auditor finds the Critical Limit is not being met, and the facility does not



7pts) immediately follow their corrective action plan, it would be documented here as an

auto-failure. THIS IS AN AUTOMATIC FAILURE QUESTION.

10. Appropriate verification procedures have been identified and are documented, including the frequency for each verification step. Calibration tasks are documented and records of the calibration are maintained. (5 pts)

• The appropriate verification activities with frequency have been identified

• The procedures for the calibration tasks have been developed

• Records of the calibration are kept per the record retention policy

Verification activities must be included in HACCP plan. Verification means those activities, other than monitoring, that establish the validity of the HACCP plan and that the system is operating according to the plan. These would include but are not limited to: record review and equipment calibration. If calibration of equipment is included then the frequency and responsibility of the calibration must be included in the HACCP plan. They must include data showing that the plan has been validated upon development and after any process or product changes.

11. All records related to performing HACCP tasks and reviewing HACCP records are appropriately signed/initialed and dated. (5 pts)

• All HACCP documents are signed/initialed by the individual performing the task

• All HACCP documents are signed initialed by the individual reviewing the records

HACCP monitoring records, deviation records, verification records all must have 2 signatures, one of the person who completed the task, the other of the person who reviewed the task. They cannot be the same person. The auditor shall define in comments the time period of records reviewed.

12. The HACCP plans must be verified through an annual reassessment. The reassessment team can be internal or external to the operation. This verification is independent of other routine verification procedures and must be documented by a report that is maintained in the HACCP plan’s historical records. The reassessment must be performed to ensure the HACCP plan results in the control of the hazards. (5 pts)

• Assessments of the HACCP plan are conducted at least annually by an internal or external reassessment team that includes at least one person trained in HACCP

• The verification is independent of other routine verification procedures and a documented report is maintained in the HACCP plan’s historical record

• The reassessment is performed to ensure the HACCP plan results in the control of the hazards

Regulatory and/or corporate audits of the HACCP plan are acceptable as verification audits, provided a report is generated and the results are available for review. The re-assessments shall be performed annually and at least one person on the re-assessment team must be trained in HACCP. The report generated must show that the plan results in the control of the hazards and is maintained in the HACCP

(Observation)

Audit Form Question Question Elements Further Guidance 1. Proper employee and equipment traffic flows are used to minimize contamination between raw products and finished products. Food processing areas are organized to minimize the risk of cross-contamination through adequate separation of raw materials, finished

• Employee and equipment traffic flows are used to minimize contamination

• Food processing areas and welfare facilities are organized to minimize the risk of cross-contamination

The potential for cross contamination will be evaluated in all processing environments including raw plants. The auditor will evaluate the flow of equipment and personnel. Scoring is based on risk, with cross contamination potential much higher in a ready to eat facility. Organization and control of the potential cross contamination risk is also evaluated and would include employee traffic flow patterns and use of hand wash sinks, the presence of footbaths, utensil dips, hand dips and change of production smocks in ready to eat or raw facilities. Auditor must verify that the hand dips and footbaths are being properly used in the



8separation of raw materials, finished product, and storage and distribution areas. (5 pts)

facilities. Auditor must verify that the hand dips and footbaths are being properly used in the plant and that their locations are in the correct areas for traffic flow. Best practices show the flow patterns of employees, equipment and products be from dirty to clean in both raw and ready to eat production facilities. Scoring here can be based on risk to the product and the process.

2. EMPLOYEES WITH OBVIOUS SORES, INFECTED WOUNDS, OR OTHER INFECTIOUS ILLNESSES SHALL NOT BE ALLOWED TO HAVE DIRECT CONTACT WITH EXPOSED FOOD PRODUCTS OR PRODUCTION / STORAGE AREAS. (5 pts)

• Employees with obvious sores, infected wounds, or other infectious illnesses shall not be allowed to have direct contact with exposed food products or production/storage areas

If an employee is observed to be showing obvious signs of illness and is touching exposed food, or food contact surfaces this is an automatic failure and the question is scored a 1. The scoring in this question will also be based on the site’s control of employees with obvious sores, infected wounds or wearing of bandages. Employees with any bandage must also be wearing a glove if they are in a processing room even if they are not directly handling product. Employees sneezing, constantly wiping their nose or showing obvious signs of illness would be assessed and scored in this question. THIS IS AN AUTOMATIC FAILURE QUESTION.

3. Employees are observed washing their hands after activities that may have contaminated them. Activities can include, but are not limited to: using the restrooms; after breaks; prior to entering production and product packaging areas; prior to handling product; prior to touching product contact and non-food contact surfaces or after handling garbage. When disposable gloves are being used they must be changed when they are damaged, after any absence from the workstation, or when potential contaminates are handled. Procedures for the proper handling and usage of gloves are established and implemented. Gloves must be worn when there is direct hand contact with ready-to-eat products. Non-disposable rubber gloves must be washed and sanitized frequently, after breaks, and/or after handling potential contaminates. (5 pts)

• Employees are observed washing their hands after activities that may have contaminated them

• There are procedures for proper handling and usage of gloves and they are observed as being maintained intact and clean so they are not a source of contamination

• Gloves are worn when there is direct hand contact with RTE products

Auditor will observe employees during production, at the beginning of the shift or at return to production areas to assess hand-washing practices. Hands shall be washed after the handling of trash, pallets or any other activity that could contaminate them. Best practices indicate hand sanitizers alone do not replace the requirement for hand washing. If employees are observed using only hand sanitizer after breaks, using restroom, or handling trash, etc. points will be deducted. When disposable gloves are being used replacement gloves should be accessible to the employee. When non-disposable rubber gloves are being used, wash and sanitize facilities must be available (note: hand wash sinks are acceptable). The auditor will verify the company’s policy on gloves however gloves are required when handling ready to eat products. Companies that require gloves should have a glove policy in place directing employees when glove changes need to occur these could include after breaks, using the restroom, handling trash or inedible product, etc. Hand washing must always take place prior to putting new gloves on. Single use gloves should never be re-worn. Latex gloves can be washed; therefore, they can be reused. Scoring here would be based on risk to the product and the process with ready to eat products at a greater risk than raw product processing facility.



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4. Only approved food-grade lubricants are used in product contact zones and they are appropriately stored and labeled. (5 pts)

• Only food grade lubricants are used in product zones

• Food grade lubricants, including grease guns, are properly stored and labeled

Only food grade lubricants in properly labeled grease guns should be used or stored in food processing areas. Auditor will assess the use of food grade and non -food grade grease by asking maintenance personnel or line operator personnel where food grade lubricants are used in the facility. Non-food grade grease is acceptable in non-product processing areas. Food grade and non-food grade items should not be stored together, and food grade grease guns should be color-coded or labeled as food grade.

(Observation)


1. NO ACTUAL PRODUCT CONTAMINATION IS OBSERVED. (5 pts)

• NO ACTUAL PRODUCT CONTAMINATION IS OBSERVED

Instances of actual contamination can include but are not limited to: condensation dripping into open product; wood, metal, or plastic fragments in the product; paint flakes, insects, dirty fans blowing on product, roof leak leaking water directly on ingredients or finished products. Observation of a cross-contact of allergen ingredient with a non-allergen product or ingredient would be considered product contamination. Any instance of product contamination will result in a score of 1 and an automatic failure rating. The instance that allowed the contamination (peeling paint) would still be addressed in that specific question of the audit. This comment would be specific to the contamination; the other comment within the audit about the instance would be specific to the cause. THIS IS AN AUTOMATIC FAILURE QUESTION.

2. No condition or practice exists that may potentially contaminate product, or could lead to product contamination. (5 pts)

• No condition or practice exists that may potentially contaminate product, or could lead to product contamination.

Any potential contamination of product or food contact surfaces within a product zone and directly associated with product will be addressed in this question. The issue causing the contamination threat may also be included later in the audit report. For example chipping paint above an open hopper would be addressed and scored in this question and in section 3, where construction issues are addressed. Other examples of potential contamination could be but are not limited to: a dirty fan blowing over exposed product, condensation above product zones, ice build up on boxes in a freezer etc. Scoring is based on risk. The potential of contamination to RTE products or ready to eat equipment food contact surfaces would be much more severe than a practice or condition that could potentially lead to contamination of raw product. The instance that allowed the potential contamination (peeling paint) would still be addressed in the corresponding question in the audit. The finding/comment in this question relates to the potential contamination. The finding/comment within the other area of the audit would address the specific cause.

3. A written glass control and brittle plastic, program has been established. The program addresses all glass that is to be shielded within the facility, handling of glass and brittle plastic packaging, and clean-up procedures for glass and brittle

• Program is developed that includes glass to be shielded within the facility

• Program includes glass packaging for finished products or raw materials.

The written glass and brittle plastic control program should contain the following areas: What glass needs to be shielded within the facility, what to do if glass or brittle plastic breaks within the facility and how to address the storage and use of glass or brittle plastic packaging. A glass and brittle plastic breakage clean up procedure shall be included in the written program describing how broken glass and brittle plastic will be discarded. The auditor will verify compliance to the written program during the facility observation part of the



10clean-up procedures for glass and brittle plastic breakage. (5 pts)

• Program includes glass and brittle plastic breakage cleanup procedure

auditor will verify compliance to the written program during the facility observation part of the audit.

Audit Form Question Question Elements Further Guidance 1. THE FACILITY USES INGREDIENTS THAT ARE FOOD ALLERGENS AND HAS DEVELOPED AN ALLERGEN CONTROL PROGRAM TO PREVENT CROSS-CONTACT WITH ALLERGENS. (5 pts)

• The facility has developed an allergen control program

If the facility has allergens and has no allergen program this is an auto-failure and the question is scored a 1. If during the course of the audit, the auditor discovers undeclared allergens in use at the facility, there is no control of those allergens and the situation results in an auto-failure and the question is scored a 1. THIS IS AN AUTOMATIC FAILURE QUESTION.

2. A master listing of ingredients that are food allergens that are present in the plant has been developed and is documented. Ingredients that are allergens are identified as allergens on all formulation, batch, or raw material production records. Allergens are properly labeled when not in original container. (5 pts)

• There is a master list of all food allergens used in the facility

• Production records have allergens properly identified

• Allergen containing ingredients and products are properly labeled to indicate they are an allergen

The auditor will list in the comments section of the audit the allergens present in the facility. The recognized eight allergens are: shellfish, eggs, wheat, soy, tree nuts, (including coconuts) peanuts, fish and milk (includes goat milk, and buffalo milk.) For audits in Canadian facilities sesame seeds and sulfites would be included in this list of allergens. A master list of ingredients that are or contain allergenic ingredients must be developed. Additionally, the facility must identify the finished products that the allergenic ingredients go into. If an ingredient like lecithin that is considered to contain an allergen is used, it must be addressed in the allergen program or the facility must have verification that it was manufactured by a process that removed the allergenic protein. Batch sheets, production records, or whatever is used to manage production of finished products must contain the ingredient identified as an allergen so that all employees are aware that it is an allergen. Allergens must be properly labeled on all ingredient bins and buckets. Totes, hoppers, or any product carrying device must be properly labeled as containing an allergen. If the ingredient has had the protein removed (some peanut oils) it is not considered an allergen and the site shall have definitive documentation to provide direct evidence that the allergenic protein has been removed.

3. The allergen program includes documented procedures for control of allergens in the following areas: allergen separation in storage, clean up procedures for allergenic ingredient spills, controls of utensils and storage containers that come into contact with allergens. (5 pts)

• There are documented procedures for storage controls and for clean up of accidental spills of allergen containing materials

• There must be a documented schedule/procedure for utensil and product storage containing devices, if they are not allergen

Allergen storage separation would include separation of allergens from non-allergens. If more than one allergen is present, there should be separation between the allergens as well to prevent contamination. In spice rooms and formulation areas, dedicated utensils are required for dispensing each allergen type. If a site weighs out the ingredient, a dedicated container for each allergen type is needed. Facilities that store pre- packaged ingredients that contain allergens that are to be part of a finished product package must have procedures for storage and accidental spillage to prevent cross contamination with packaging or other non-allergen ingredients.



11allergens. (5 pts) dedicated The auditor will assess product containers, totes, hoppers, and buckets that are used in

process to assess how allergens are restricted from cross contact. If a color- coding system is utilized, it must be posted for view in use areas of the facility. An SSOP must be present to address tote and product carrying devices that are not dedicated to allergens so that it is assured that allergen protein is properly removed prior to use of non-allergen containing products.

4. Production scheduling is done to ensure allergens are run prior to change-over and that specific change-over procedures are developed for allergen removal. Verification of change-over activity is conducted. Records of change-over and verification activities are maintained. (5 pts)

• Allergens are controlled through production schedules

• There are process change-over SSOPs

• There are records of changeover and all tasks related to verifying allergen removal

Allergen control in processing would be a management of production schedule to have allergens run last, dedicated lines for allergens, or matrix of allergen production to ensure that allergens are segregated. Written procedures should include alerting of sanitation if an allergen is added to production schedule so that process change over can occur. SSOPs are developed to specifically deal with allergen removal. Wet sanitation is currently not required to adequately remove allergen protein. The SSOP can be a full wet sanitation process and not unique for allergens. When a change over to allergens from non-allergens occurs, a SSOP must be developed to define actions taken. The verification of the process changeover must occur, even if change-over is in middle of production run. Verification standard for allergen removal is currently visibly clean. A pre-op inspection to assure equipment is visibly clean must be documented prior to the running of non-allergens or non-like allergens. Points will not be deducted if a testing program is not being used. Test kits are currently available for peanuts, tree nuts, milk, eggs, and soy.

5. Facility has a written label reconciliation program in place. It includes regular review of product labels versus product being packaged, inspection of labels at receipt to ensure accuracy, and removal and destruction of obsolete labels. Records of allergenic containing label inspection at receipt and review of label vs. product are maintained. (5 pts)

• Documented label reconciliation program of product labels vs. product being packaged

• Documented label inspection program of allergenic containing labels at receipt

• Obsolete label disposal / segregation program is in place

The facility shall have a procedure and records that show verification of product labels when allergenic product is running. Verification shall occur a minimum of one time per shift. The facility must verify that the product being produced is going into the correct product package. The product being produced should be verified against the ingredient statement on product film or container. At a minimum of one unit per shift is to be checked. Records of these checks are maintained. A documented label inspection program is in place that includes inspection of labels that contain allergenic ingredients at receipt for accuracy. Specification sheets should be used as a reference to ensure accuracy of label. Old and/or obsolete labels for finished products that contain allergens or finished products that did not contain allergens and now do are disposed of in a timely manner, or segregated so that they are not accessible to production or packaging personnel.

6. Facility has a written procedure on handling the rework of allergens. It includes proper labeling of rework to identify the product and allergen present and control of rework back into process and/or product. (5 pts)

• Allergen program addresses handling and labeling of rework of allergen containing product

• Allergen containing rework is only used in like allergen containing product

The allergen program must address rework. If no rework is utilized by the facility, the allergen program must state that. The definition of rework is required. The auditor should audit against the plant’s definition of rework. Rework is generally defined as product that has been recovered or rejected from normal production, and has been reprocessed, re-blended, or reformatted into the finished product. Work in process or work carried over from a previous day’s shift must also be considered and labeled. Controls for rework include proper labeling, protection of product, and the description of what product that rework can be used in. Only like allergen protein rework can be used in like allergen product. Auditor will review the procedures that should state “like into like” or an equivalent statement.

7. Facility complies with US FDA Food Allergen Labeling and Protection Act of 2004 (effective January 2006), which identifies allergens on product labels using common terms. (This is only

• Facility complies with US FDA Food Allergen Labeling and Protection Act of 2004

Beginning in 2006, major food allergens must be identified by the name of the food source from which they were derived, such as milk, eggs, wheat, peanut, soybean, tree nuts (e.g., almonds, pecans, walnuts), crustacean shellfish (e.g., crab, lobster, shrimp), fish (bass, flounder, cod). The regulation has 2 labeling options: (1) parenthetical description of allergen source in plain English following the name of the allergen in the ingredient



12using common terms. (This is only applicable to facilities governed by FDA regulations). (Yes/No)

statement – e.g., albumen (egg); (2) add information in a “contains” statement immediately adjacent to the ingredient statement. There are some exceptions and exemptions in the regulation, so the auditor will ask the site for evidence that they are in compliance with labeling regulations if their labels contain these predetermined exceptions or exemptions.

8. Facility is using testing to verify effectiveness of allergen removal in changeover procedures. Auditor is to list the method being used. (Yes/No)

• Facility is using testing to verify effectiveness of allergen removal in changeover procedures

The auditor is to indicate if the plant is using a test method to verify the effectiveness of allergen cleaning and sanitation procedures. Auditor will list the type of method being used. ATP is not considered an effective method to verify allergen residue. If ATP is used the answer to this question would be no. The plant should have data verifying the methodology in use.

Audit Form Question Question Elements Further Guidance 1. A program for conducting food safety, food defense, GMP, and allergen training for all employees, including new employees, has been established. Completion of this training is documented as to date(s) given, what topics were covered, and who conducted the training and is a part of the employee’s records. The training should be conducted annually. Provisions for temporary employees are included in the training program. (5 pts)

• Orientation training occurs for all new employees

• Annual training exists for all employees

• Temporary employees are included in the training

• Records of the training are kept

The facility’s training program shall include training in food safety, food defense, GMP and allergens. Training occurs at orientation, includes temporary employees and is conducted on an annual basis. The training must be scheduled, not a part of a regular staff meeting in response to issues seen in the plant. Documentation of training must include the employee’s name, the topic covered, and the name of the person who conducted the training. The facility shall have a tracking method for ensuring that all employees have attended all training as required. Silliker does not determine the minimum requirements for training, however food safety, food defense, GMP and allergens must be covered in the training program.


1. FACILITY HAS COMPLETED THE REQUIRED REGISTRATION FOR THE BIO-TERRORISM REGULATION. THE AUDITOR CAN VERIFY THAT THE FACILITY HAS GONE THROUGH THE REGISTRATION PROCESS. (Not required if facility is under USDA FSIS inspection) (5,1, N/A pt(s))

• FACILITY HAS COMPLETED THE REQUIRED REGISTRATION FOR THE BIO-TERRORISM REGULATION

The auditor will verify that the facility has registered with FDA per the regulation. Facilities do not have to show the specific registration number. In order to maintain confidentially the auditor does not record the facility registration number. Registration verification can be done by viewing fax confirmation of registration, email confirmation of registration, or corporate/location registration programs. If the facility has been sold, the new ownership must register the facility within 60 days of change of ownership. If the facility is under USDA FSIS inspection the auditor will document the USDA establishment number in the comments box. The scoring here is: 5 = registered, 1 = not registered and auto failure or n/a, does not apply (i.e. the facility is a USDA facility).



13The scoring here is: 5 = registered, 1 = not registered and auto failure or n/a, does not apply (i.e. the facility is a USDA facility). THIS IS AN AUTOMATIC FAILURE QUESTION.

2. Facility has completed corrective action from previous third party audits for designated audit defects. Auditor will randomly select 3 corrective actions listed from previous audits and verify that designated audit defects were not observed as being out of compliance in this audit. (Yes/No)

• Facility has completed corrective action from previous third party audits for designated audit defects.

The auditor will review the corrective action plan created from last third party audit. The corrective action plan shall contain who is responsible, what is to be done, and timeline for completion. This will be reviewed and compared to the results of the facility verification audit results. If similar audit defects are observed, the auditor is to note these issues in the comments as recurring. At a minimum, corrective actions will have addressed lowest scoring items and show what actions were taken, by whom, when they were completed or current status, and who verified that action was taken. The auditor shall physically verify three randomly selected deviations to see if they were completed and indicate this in the comments of the report. The 3 deviations will be a combination of system and physical types of deviations. If the previous audit was not done by Silliker, other audits can be reviewed.


1. A written quality management program, which identifies and defines the policies and procedures for the operation and control of the site’s food safety and quality programs, is established, organized, and current. There is an approval process for the program and its procedures, including changes. The program identifies an individual whose job description includes responsibility for managing the overall program. (5 pts)

• A defined quality program exists

in a printed or electronic format • It is managed by an individual

whose job description includes responsibility for overall program management

• The programs are current and dated and there is an approval process for changes

• The program is well organized and records can be easily located during the audit

The quality management program can be in printed or electronic format. It shall contain at a minimum the programs included in the quality systems section of this audit and those programs that guide the site’s food safety programs. The program will be assessed for organization and completeness. The program must be managed by an individual whose job description includes the responsibility for quality systems management. Documents and records should be easily located. Programs should be current and dated. There should be an approval process for changes to all programs and documents.

2. There are written standards and specifications for raw and finished food products and packaging materials that come in contact with food. How any

• Packaging specifications are available

• Raw material specifications are available

All raw materials (food ingredients and primary packaging) should have a current, written specification. Specifications for packaging material that come in contact with food (primary packaging) can be the supplier’s specifications.



14rework is used in products must be defined. (5 pts)

• Finished product specifications are available

• Procedures for how rework is used in the process and finished products, including allowable amounts, is clearly defined in finished product specifications or other documents

All finished product specifications should include a description of the product, physical parameters that are required for the product (cut size, weight, age, color, etc), microbiological or chemical analyses that are required, if applicable, and condition of distribution (fresh, frozen, vacuum packaged, etc). Any rework used in final product should be defined as well. Rework is defined as product that has been recovered or rejected from normal production, and has been reprocessed, re-blended, or reformatted in to the finished product. A customer specification would satisfy as a finished product specification. Rework can also be product carried over to another day or lot code of in process or finished goods.

3. Procedures and criteria have been established for all hold and release programs. Documentation and records are maintained. The procedures shall include a method of identification for held products, a log of holds with descriptions of the holds and reconciliation of open holds. (5 pts)

• A procedure describes the method of identification of held product

• Log of holds with a description of the hold listed

• Reconciliation of open holds to ensure that all holds are closed in a timely manner and none are missing

The hold procedures shall insure that non- conforming products, packaging or raw material is identified and segregated. This should include a method of identifying the product (i.e. tag), a log of the holds that includes the hold identity, the product description, reason for the hold, the date, and the final product disposition. There must be a system or frequency for review of the hold log to ensure that all holds are closed in a timely manner.

4. There is a written record retention program for all quality and food safety records, including electronic documents. The program describes what records are included, how long they are maintained and where the records will be kept. There are secure back-up procedures for electronically retained records. (5 pts)

• There is a written record retention program for all quality and food safety records

• The program describes what records are included, how long they are maintained and where the records will be kept

• There are secure back-up procedures for electronically retained records

The facility shall have a written program for how long Quality Control/Quality Assurance and food safety records will be kept. The program shall describe what records are included, how long they will be maintained and where they will be maintained. A general guideline would be 2 times the shelf life of the product or 1 year for perishable and 2 years for frozen or cured product. If electronic records are used the retention information for this process should also be documented in the record retention program including secure back up procedures for electronically retained records. USDA regulations require SSOP records to be maintained for 6 months. The USDA also has a directive (fsis directive 8080.1 – recall of meat and poultry products) that states “ records should be maintained for a period of time that exceeds the shelf-life and expected use of the product and at least the length of time specified in 9 CFR 320; 381.175. sec 320.3 which states that records should be retained for a period of 2 years after December 31 of the year in which the record was recorded. FDA in its guidance to inspections of acidified food manufacturers states all records of processing and deviations in processing must be kept for 3 years. A printed document is an acceptable form of back-up, as long as it is kept secured, accessible, and current.

5. Self-audits are performed at least monthly. Copies are maintained for at least 12 months. Self-audits must include physical inspections of all areas and equipment of the facility and grounds, evaluating maintenance, sanitation, food security, and GMP compliance. Personnel from all departments participate. Corrective

• Audit of the entire facility and equipment is completed at least monthly

• Copies are maintained for at least 12 months

• A team is involved, not the same person every month

• Corrective Actions are completed

Procedures for monthly self-audit inspections shall be developed. These shall include but are not limited to all areas of the facility including equipment, maintenance issues, sanitation, food security, outside grounds (within 20 feet of the building) and GMP compliance. The facility daily walk around is not a self-assessment unless the entire facility is completed within a month and corrective action is written for all observations. These audits should be completed by a team and not by the same individual each month. Corrective actions developed from these audits should include what is to be done, when and by whom. Follow-up to the corrective action could be the next monthly audit or a check list showing close out of the corrective action.



15actions include what is to be done, when, and by whom. (5 pts)

6. There is a defined program to review existing product labels and the development of new product labels for information accuracy, and regulatory compliance. The program identifies the frequency of review, responsible function for completing it, and the approval process for new label development and label changes. The auditor will verify compliance to the process by reviewing a minimum of one label against specification and include the label name and compliance level in the comments. (5 pts)

• There is a defined program to review existing product labels and the development of new product labels for information accuracy and regulatory compliance

• The program identifies the frequency of review, responsible, function for completing review and the approval process for new label development and label changes

• Compliance to the process will be verified by the auditor by reviewing a minimum of one label against specification and regulatory requirements

Auditor will assess the label review program. The program must include the following: who is responsible for development of new labels and/or review of established labels, procedures for approval of new labels and frequency of label review, and procedures to ensure regulatory compliance. The label review results can be kept on a database or in paper form. The finished product specification if available should have labeling guidelines if supplied by the customer. The auditor will choose a label to review and evaluate it against the specification and any applicable regulatory guidelines. Auditor will also verify the label that is reviewed and approved is the one currently being put on the product. If the site has any granted exceptions by USDA or FDA that state the site can run out the labels they have, the auditor will make note of this variance in the comments. Auditor will pay particular attention to allergen labeling, nutritional labeling and country of origin labeling. The following products are required to contain Country of Origin labeling as of September 30, 2008: a meat product from beef (including veal), pork, lamb, chicken or goat must bear a COOL label or is subject to labeling providing COOL information if it is sold at retail and it is a muscle cut or is a ground product. Processed meats are exempt from the COOL labeling for example hot dogs and sausages. Products sold at the food service level are also exempt. All whole seafood must bear the Country of Origin labeling and include whether fish or shellfish were farm raised or wild caught. Produce, juices and peanut products must also be evaluated for compliance to the COOL regulation.


1. A DOCUMENTED GMP PROGRAM HAS BEEN ESTABLISHED. IT COMPLIES WITH ALL APPLICABLE REGULATIONS. (5 pts)

• FACILITY HAS DEVELOPED

BASIC GMP REQUIREMENTS FOR EMPLOYEE HYGIENE, PEST CONTROL, SANITATION, AND FACILITY MANAGEMENT

If the facility has not developed basic GMP programs that at a minimum must include employee hygiene/GMPs, pest control, sanitation and building condition management then this question scores a 1 and it is an auto-failure. GMP programs should be in compliance with the FDA CFR 21 part 110 and USDA/FSIS guidelines. These programs should include but are not limited to: personal hygiene, dress code, hand washing requirements, hand wash requirement signage, traffic control, building issues would be addressed in the GMP programs. This program should not include only the hygiene requirements for the employees. THIS IS AN AUTOMATIC FAILURE QUESTION.



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2. Signage that identifies applicable employee hygiene requirements in languages appropriate for employees to understand is present at all entrances to GMP zones. GMPs are posted for employees and visitors and/or they are given a copy of the facility’s GMPs. The GMPs or company policy should specify that lack of compliance with the standards might result in disciplinary action. Corrective action procedures must be established for deviations to employee hygiene practices, and records are maintained. (5 pts)

• Employee hygiene rules are posted or given to visitors

• All entrances to production areas (GMP zones) have appropriate signage in languages appropriate for employees to understand about the hygiene practices

• Facility has a discipline policy for infractions to the GMPs

• Corrective action procedures must be established for deviations to employee hygiene practices

Employees should be given a copy of the employee hygiene practices when they begin their employment with the company. The GMP policy should be in a language understood by all employees. All entrances into production areas should have GMP signage alerting employees to GMP zones. Deviations from the employee hygiene practices should be described (i.e. all employees but maintenance need gloves in processing room) at a minimum they should describe jewelry, hair, clothes, food, and drink in processing and storage areas. Moustache and beard program should be specific. Moustache should be covered if it extends below the lip. Visitors should be given a copy or card with the company hygiene GMPs or have them posted in plain view. Auditor will read the company’s GMP policy and will use these to audit against when conducting the physical verification portion of the audit. The GMPs or company policy should specify that the lack of compliance with the standards may result in disciplinary action. Corrective action procedures must be established for deviations to employee hygiene practices, and appropriate records must be maintained. Ideally, there should be some form of tracking and monitoring of employees who continually fail to adhere to GMPs.


1. A WRITTEN PEST CONTROL PROGRAM HAS BEEN ESTABLISHED. IT MUST INCLUDE A DESIGNATED PEST CONTROL OPERATOR (INTERNAL OR AN OUTSIDE SERVICE), SCHEDULED FREQUENCY OF SERVICE AND A CURRENT MAP, UPDATED ANNUALLY, SHOWING THE LOCATION AND TYPE OF ALL PEST CONTROL DEVICES (INTERNAL AND EXTERNAL). (5 pts)

• THE SITE HAS A PEST

CONTROL MANAGEMENT PROGRAM WITH A DESIGNATED PCO AND ESTABLISHED INSPECTION FREQUENCIES (The frequencies can be established from risk studies done in accordance with NPMA standards)

• There is a map of all pest control devices utilized within the facility that is updated annually

There must be an established schedule or frequency of service for the management of the pest control program. This can be in the form of a contract or a written internal program. If the facility has conducted a study with the pest control company in accordance with the national pest management association standards (2007 or 2008 edition) and has the results of a “depth matrix” study included with the program, then frequency of service can be adjusted for both interior and exterior. The study must be present in the pest control binder and signed by the facility and the PCO representative. The device map should be current, updated annually and include all devices including bait stations, mechanical traps, glue boards, insect light traps, pheromone traps, and any external bird bait devices used. If the facility does not have a pest control program this is an auto-failure and the question will score a 1. THIS IS AN AUTOMATIC FAILURE QUESTION.

2. The pest control files include documentation of all business licenses, proof of indemnity insurance and certification for all PCOs in accordance with state requirements. The files also include a current list of approved pesticides to be used in the facility.

• The pest control documentation includes a current business license and insurance

• The PCOs are current with their certifications, and the site has this documentation

• There is a list of approved

If an outside pest control service is used, there should be a current business license (if required by state or local law) and proof of indemnity insurance present in the pest control documentation. Pest Control Operator certifications must be present and current for all technicians who service the facility. The auditor will verify that the initials on the stations, and signatures on the service report match those of the certification license. Some states do not require a business license, and others allow many pest technicians to operate under an individual certification. The site should have documentation that supports these situations. There should be provisions in the program to allow for vacations for the Pest



17pesticides to be used in the facility. MSDS and sample labels for products used. All pesticides, chemicals and compounds used meet applicable regulations and approvals (EPA, USDA, OSHA, etc.). The files are accurate, up-to-date and complete. (5 pts)

pesticides and documentation is current for MSDS information and sample labels

situations. There should be provisions in the program to allow for vacations for the Pest Control Operators. The EPA is the only agency in the United States that certifies pesticides. All pesticides in the facility should be approved by EPA and have an EPA number on the label. The MSDS must be for the specific chemical used in the facility. EPA numbers are listed as such 12345-12. The first part is the chemical, the second part “-12” is how it is packaged. The site must have the proper MSDS for the product used. The EPA numbers on the chemical used (documented on the service report or usage log and on the facility’s approved pesticide list) and the sample label must match exactly. The auditor will verify that chemicals used have the appropriate MSDS and sample labels.

3. Service reports, at the frequency described in the contract or in the program, must be up-to-date and available for review. They must show the service performed, types and amounts of chemicals used, EPA or other applicable regulatory registration numbers, the location treated, targeted pests, signs of activity and applicable follow-up actions. Trends in activity must be assessed by the PCO or plant to identify areas of improvement in the pest control program. (5 pts)

• Service reports are available for review and meet the contract/program requirements

• Pesticide usage is recorded and includes all necessary elements.

• Signs of activity are tracked and trended to identify areas of improvement

• Follow-up actions are documented

Service reports must be available for review and up-to-date. Pesticide usage can be tracked on the service report or a separate usage log. It should contain the chemical used, the concentration and amount, the method of application, location of application and targeted pests. Trend reports should include all pest control devices inside and outside the facility. The facility can trend the information in the form of a chart or list. Follow up actions should be listed on the service report.


1. A written master cleaning/sanitation schedule lists all areas and equipment in the plant that require cleaning (including processing and non-processing areas and equipment) and provides the frequency of cleaning. Documentation of the person who completed the task and the verification that they were completed are available for review. (5 pts)

• A master cleaning/sanitation

schedule of cleaning and sanitation duties exists. It lists all areas and all equipment to be cleaned and the frequency of cleaning

• There are records available that show the tasks were completed and by whom

• Verification that the tasks have been completed exists

The master sanitation schedule should include all tasks performed inside and outside of the facility except the daily production areas. The daily production pre-operational checklist will be used to assess the daily requirements for those areas or equipment that are cleaned daily or at the end of shifts of production in those areas. The schedule should identify the person or position who is responsible for the task. There shall be a master sign-off by the person who verified that all tasks were completed. The auditor will review records and verify a number of the tasks during the physical verification part of the audit.



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2. Written sanitation SOPs are established and implemented for all cleaning tasks that involve chemicals or water including tear down procedures if required. They include all necessary and/or regulatory content, such as responsibility, task to be performed, chemicals and equipment to be used. Sanitation SOPs in wet processing environments detail how equipment is to be cleaned and sanitized after being out of service, including the time element for being out of service. Facility maintains current MSDS and labels for all cleaners and sanitizers being used in an organized, accessible and easy-to-use system. (5 pts)

• Sanitation SOPs for all tasks that involve chemicals or water are written, in use, and include all necessary tear down procedures, responsibility for the task to be performed and/or regulatory content to perform the cleaning and sanitizing

• Sanitation SOPs in wet processing environments detail how equipment is to be cleaned and sanitized after being out of service, including the time element for being out of service

• MSDS system is organized and accessible. Auditor will randomly verify a minimum of 3 cleaning and/or sanitation chemicals

The sanitation employees with chemical handling responsibilities must have accessibility to the MSDS/Sample label file and it must be close to the chemical handling areas. Sanitizers will have an EPA registration number. All chemicals should describe they are approved for use in a food manufacturing facility; otherwise the chemical is illegal. Some bleach sold at retail is not approved for use in a food manufacturing facility. The label must include directions for use in food manufacturing facilities. Bleaches with added scents should not be used. The auditor will verify the approval for use, presence of MSDS and sample labels for 3 chemicals from the Sanitation SOPs or from stored chemicals in the facility. New technologies that are accessible and store MSDS and sample label information on secured internet sites are acceptable as long as the employees know how to and can access them. Ideally each task on the master sanitation schedule (MSS) should be numbered and reference the sanitation SOP that describes the task. The auditor will review the cleaning procedures for tasks on the Master Sanitation Schedule and processing equipment from the Pre-operational inspection list. Sanitation SOPs should be written specific enough to be of value to the individual performing the task, including tear down procedures where required, the chemicals to be used, the concentration of the chemical to be used, and the methods of use for each task. They must be available to the sanitation personnel, who should have been trained on them. USDA plants that have a generic SSOP to satisfy regulations still should have specific sanitation SOPs to describe the cleaning of equipment and facilities. Even cleaning tasks that involve only water should have a Sanitation SOP. There shall be a sanitation SOP in place in wet processing environments that details how equipment is to be cleaned and sanitized after being out of service, including the time element for being out of service.

3. A program for conducting ongoing training on cleaning and sanitation procedures and safe chemical handling for sanitation employees, including new sanitation employees and employees who have emergency sanitation responsibility, has been established. Contract production cleaning and sanitizing companies must maintain SSOP and safe chemical training records at the facility. Completion of this sanitation training is documented as to date(s) given, what topics were covered, and who conducted the training and is a part of the employee’s records. The training should be conducted annually. (5 pts)

• All employees with sanitation responsibility undergo sanitation training

• Training occurs at least annually and at hire

• Records are kept of the training

Sanitation training should include training on sanitation SOPs and chemical safety training. Any training conducted by the chemical company should be documented. If production cleaning & sanitation is conducted by an outside company, their employee training records must be kept available at the facility for review. All personnel who perform sanitation must go through the training, even if it is only for emergency repairs. This training shall occur upon hire and annually. Records of the training shall contain the employee’s name, topics covered, and the name of the person who conducted the training.



194. A pre-operational sanitation inspection program, with pass/fail criteria is established and includes all production related areas of the facility. Visual inspection is used to assess sanitation prior to the start of production. Pass/ fail criteria are established and corrective actions are written and implemented when results of visual inspection show failure. Records of all pre –operational sanitation checks and corrective actions are maintained. (5 pts)

• A pre-operational sanitation inspection program is established and includes a visual inspection with pass/fail criteria of all production related areas of the facility to assess sanitation prior to the start of production

• Corrective actions are written and implemented when visual inspection indicates failure.

• Records of the pre-operational sanitation inspection program are maintained

A checklist should be used to perform the visual pre-op so that all production related areas of the facility are covered. All equipment in the facility that will be used should be visually assessed. Pre-op should include all areas of production including but not limited to: floors, walls and ceilings. There shall be pass/fail limits for visual inspection with the corresponding corrective actions required and these should at a minimum include a re-clean on failing food contact surfaces before the start of production. Corrective actions taken when results of visual inspections show failure shall be recorded. The auditor will review pre-op records of visual inspection.

5. An environmental monitoring program using rapid methods and /or microbiological swabbing for pathogens and indicator organisms unique to the product being manufactured should be in place and used to verify sanitation on a pre-defined basis. Pass/fail criteria have been identified. Corrective action procedures are written and implemented when results show failure. Records are maintained and results are reviewed and trended on a routine basis to identify areas for continuous improvement. (5 pts)

• Environmental monitoring using rapid methods and/or microbiological swabbing for pathogens and indicator organisms unique to the product being manufactured are in place

• Pass/fail criteria have been established

• Corrective action procedures are written and implemented when results show failure

• Records are maintained, results reviewed and trended on a routine basis to identify areas for continuous improvment

Environmental monitoring should be done to verify the effectiveness of the sanitation program and to monitor for pathogens and indicator organisms unique to the product being manufactured. Program should include swabbing/sponging and/or use of rapid methods for monitoring. Environmental monitoring programs must be applied/related to the production of products at that plant. Regulatory guidelines must be followed where applicable. The facility shall have written procedures that define the sample locations for swabbing, including a procedure describing how to take the swabs and a schedule of sampling. These procedures must include: the sanitizing of food contact surfaces after swabbing. Pass/fail criteria must be included in the plan. The plan shall also describe what trouble-shooting and investigative actions are taken when positives are found. The facility plan should show how the plant insures compliance with any regulations and/or customer requirements pertaining to sampling and frequency of testing. Any deviations found in the swabbing must have corrective actions documented. Results shall be reviewed and trended to identity areas of continuous improvement. In ready to eat facilities using only Listeria testing as verification, the swabbing procedure should state that the minimum swabbing area is 1ft x 1ft. Rapid monitoring failures should show that re-cleaning has taken place, and that the site was rechecked using the same rapid method prior to being released to production. Microbiological failures shall have predetermined corrective actions that can include but are not limited to: retraining of employees, investigation of site, review of cleaning procedures and at a minimum the placing the location that failed microbiological testing on an accelerated monitoring schedule. Score Deviation: If there is no program in place in facilities where regulatory guidelines require specific testing this question will be scored a 1. In facilities where there are no regulatory requirements for testing and there is no pathogen testing done the auditor will comment what method is being used.

6. THE FACILITY WATER IS FROM A POTABLE SOURCE. (5 pts)

• THE FACILITY WATER IS FROM A POTABLE SOURCE

If the facility water is not from a potable source and it is not being tested then this question scores a 1 and it is an auto failure. to failure if the water is not from a potable source and not being tested (non-potable includes wells, etc. City water is



20assumed to be a potable source). If the most recent water test shows coliforms in the water, then it is an auto failure potability is defined as negative (<1.1 coliforms / 100 ml of water). The water sample must be taken from the site. A certified laboratory must perform the test; even facilities with municipal water must have the test done. THIS IS AN AUTOMATIC FAILURE QUESTION.

7. Water potability is tested annually by a certified laboratory. The sample should be taken from a different location in the facility, each year. Records are maintained. (5 pts)

• Water is tested annually by a certified laboratory and records are maintained.

• The sample should be taken from a different location in the facility, each year

Water potability is defined as negative (<1.1 Coliforms / 100 ml of water). The water sample must be taken from the site. A certified laboratory must perform the test. Facilities with municipal water must still test the water from locations within the facility. The most common standard test for potability is via membrane filtration of 100ml of water. Silliker does not mandate which method is used, but it does require that the lab be certified to do water testing. The certifications for water testing in the United States are given by the EPA.


1. A documented program has been established for approving domestic and international suppliers of raw materials, ingredients and packaging. Facility should have a master list of approved suppliers. (5 pts)

• Facility has a procedure for the

approval of suppliers • A master list of suppliers exists

and is used

There shall be a supplier approval process in place. These procedures shall include the method for granting approved supplier status. If the approval is managed by a corporate function or if deliveries from approved suppliers are developed by purchasing, auditor will ask the receiving supervisor how they know that suppliers are approved. The auditor will place a comment in the comment box that describes the how the receiving employees know that received raw materials are from an approved supplier. The facility shall have a master list of approved suppliers. This list can be in an electronic format or hard copy list.

2. An inbound delivery inspection program is required for the ongoing monitoring of all ingredients and materials. Appropriate procedures or monitoring methods are used to document load conditions, including cleanliness of the delivery containers or trailers. They include the examination of incoming materials for evidence of contamination (pest, microbiological, chemical and physical), temperature abuse, damage, quality and condition. Inspection records are documented and filed, including disposition of any rejected product. (5 pts)

• There is an inspection program for ongoing monitoring of inbound deliveries of materials

• The procedures to be used for this monitoring are identified and at a minimum include monitoring load conditions and inspection for evidence of contamination, damage and temperature abuse

• Inspection records for the monitoring programs are documented, filed, and include actions and disposition of rejected products

There shall be written procedures for the inspection and monitoring of incoming ingredients and packaging. At a minimum the receiving procedures should define the cleanliness of the trailer (swept or freshly washed), how to assess a load, and what are acceptable receiving temperatures for any perishable products. The checks of the incoming loads can be recorded receiving worksheets or on separate forms, as long as they include the condition of the trailer, the temperature (if applicable), and the condition of the load. Disposition of any partial, rejected or complete loads of product should be documented. Where applicable a statistically based sampling program of the deliveries is acceptable.



213. A written, ongoing monitoring QA program is established to evaluate ingredients, raw materials, and packaging for compliance to specifications. Packaging includes product labels. When letters of guarantee are used to assure compliance, the plant has identified the frequency for their renewal and verification. Ingredients, raw materials and packaging that are monitored via a certificate of analysis upon receipt must be identified on a master list, and the site must have a predefined system for verifying the accuracy of the COA results against the specification. (5 pts)

• Facility has a documented ongoing monitoring QA program to evaluate ingredient, raw materials, and packaging compliance to specification

• When letters of guarantee are used, the frequencies for renewal and verification must be identified

• Ingredients monitored via a certificate of analysis must be identified on a master list, and there must be a predefined system to verify accuracy of the COA

Raw materials and packaging can be evaluated internally for compliance to specification by inspection or testing. There shall be procedures for conducting inspections and records are kept of inspections. If ingredients are not evaluated by the facility, there must be a program that includes letters of guarantee from suppliers or certificates of analysis. Letters of guarantee would need to be renewed on a regular basis (annually not required, but a timeline must be established) A master list of ingredients, raw materials, and packaging that require a COA must exist, and the COAs must be reviewed against specification to ensure compliance. The process of assessing raw materials against specifications must be defined. Ingredients originating from high-risk regions should be addressed in the ingredient evaluation process with particular attention placed on monitoring and verification procedures of these ingredients.

4. A system for identifying and labeling all incoming packaged and bulk ingredients and packaging materials has been established for traceability. The system must include lot and date code identification. (5 pts)

• Incoming packaged and bulk raw materials have code date / lot number recorded, or facility assigns code date / lot number to the raw material

• Incoming packaging materials have code date / lot number recorded, or facility assigns code date / lot number to the raw material

The facility shall have a program for labeling all raw materials. This program must include but is not limited to: labeling all raw materials and packaging with the date of receipt. For traceability, the vendor code date or lot number can be used, or the facility can issue the material with a new code date or lot number. A log can be kept with the materials received that day and their code date as long as they can be linked to the finished products.

5. A documented program has been established for verifying that finished products are ready for shipping and distribution. The procedures meet any applicable regulatory requirements and include trailer inspection and load condition. Outside storage facilities (company or independently owned) are identified, and there are defined procedures for verifying the condition and practices used at these facilities. (5 pts)

• Auditors are to verify that products being loaded are intact, packaged properly and labeled

• There is no evidence of temperature abuse, excessively leaning product on pallets

• There are no products ready for shipment that are expired

• Requirements for trailer condition must be documented in the program, however the results are reviewed in section VI A 5

Auditor is to review procedures that indicate the products being loaded are intact, properly labeled and packaged properly. Product on outbound pallets should show no signs of temperature abuse and are centered on the pallet. Products on outbound pallets shall not be expired. If the facility uses outside storage facilities, the monitoring of these facilities shall be in a documented program that includes self or third party inspections. The facility will demonstrate that the outside storage facilities have, or are provided with the same requirements that the facility is required to follow. Records of outside storage facility audits can be reviewed by the auditor or records provided by the outside storage facility that show the facility follows the required shipping and receiving procedures. This can be similar to a vendor approval process. If for example, all outside storages are required to have a third party Distribution Center audit, this would be objective evidence that they are required to meet appropriate requirements.



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6. FINISHED PRODUCTS CAN BE TRACED TO THE CODE DATES OF ANY INGREDIENTS, RAW MATERIALS AND REWORKED USED. (5 pts)

• Finished products can be traced back through their manufacturing process to the ingredients, raw materials and any rework used

Auditor is to verify that the site has documented traceability procedures and records for linking the lot or batch numbers of all raw materials, ingredients, and any reworked product. Auditor is to indicate the type of finished product coding system used in the comment section of the audit form. THIS IS AN AUTOMATIC FAILURE QUESTION.

7. Finished products can be traced to the food contact/primary packaging materials used. (5 pts)

• Finished products can be traced back through their manufacturing process to the food contact/primary packaging used

Auditor is to verify that the site has documented traceability procedures and records for linking the food contact/primary packaging to finished products.

8. Written procedures are established to determine the safety and security of returned goods. Procedures must define how returned products are to be segregated and evaluated for food safety and food security concerns when received. If there is a policy to use returned goods, there must be defined procedures on the controls to be used to insure safety. If the returned goods are to be destroyed, there must be procedures on what methods of disposal will be used. Code dates of all returned goods and all actions taken on the returned goods must be recorded and tracked from receipt to use or disposal. (5 pts)

• Written procedures for product returns must be established to determine the food safety and security of the products.

• Procedures must define how returned products are to be segregated and evaluated for use or disposal

• Code dates of all returned goods and all actions taken on the returned goods must be recorded and tracked from receipt to use or disposal

There must be a written procedure that defines how product returns will be evaluated for use from a food safety and food security perspective from receiving through use or disposal. Procedures must describe segregation and evaluation of returned goods. All products that are destroyed must have their code dates recorded. Methods of disposal shall also be defined. There must be procedures that describe how returned goods will be reused or redistributed. The auditor will verify these procedures by checking the logs for returned goods and tracing the actions taken by the plant.

9. Does this plant buy imported ingredients, raw materials and packaging? Are controls in place to approve and monitor foreign suppliers? (Yes/No)

• Does this plant buy imported ingredients, raw materials and packaging? Are controls in place to approve and monitor foreign suppliers?

This question will be answered yes or no. International suppliers should be included in the supplier approval program in question 2 E 1. Auditors will ask about ingredients from high - risk regions. If through investigation of this question differences in the controls used for foreign suppliers are found, the auditor must clearly indicate this in the audit comments. If there are ingredients that are purchased through distributors the auditor will verify that the facility can identify the point of origin of those products.

10. Does this plant use co-manufacturers for any of the products it sells under its labels? Are controls in place to approve and monitor the co-manufacturers? (Yes/No)

• 10. Does this plant use co-manufacturers for any of the products it sells under its labels? Are controls in place to approve and monitor the co-manufacturers?

This question will be answered yes or no. The auditor will not be expected to assess a co-manufacturer. This question is for the informational purposes of the entity using the information contained in this audit. If co-manufacturing of products is managed by a corporate function this question should be scored as N/A.



23manufacturers?


1. Process control points and applicable limits have been identified for all production lines. There are written procedures for monitoring the control points and the corrective actions to be taken when deviations occur. Records of all process control point monitoring and corrective actions are kept. (5 pts)

• Facility has identified process control points with appropriate criteria

• There are written procedures and records for monitoring process control points

• There are written procedures and records for all corrective actions

Key process control points should be identified by the facility. These can include but are not limited to: weight (when an automatic filler is used), moisture, fat, color, taste, size, % acid, salt, etc. The monitoring program does not have to be as formal as HACCP as long as there are written procedures for monitoring the process control point. Criteria for applicable limits shall be established and quality records are kept for verification. These points may be listed in a finished product specification along with the criteria and monitoring frequency. Process control points may also be required by a customer. There shall be written procedures for the corrective actions that will be taken, and who is responsible for those actions. Records of all corrective actions must include product disposition. Auditor will review records of process control point monitoring. The auditor will also verify this program is in place during the on site walk-through and record results of the verification in section VIII.

2. All measurement equipment for monitoring process control points (e.g., thermometers, scales, pH meters, refractometers) is calibrated according to a defined schedule. The calibration results and any corrective actions are documented. (5 pts)

• There is a set schedule for calibrating equipment

• Records of the calibration results and corrective actions are maintained

There should be a schedule for calibration of key equipment. Records that the calibration occurred must be maintained. Thermometers that are used to check cold temperatures should be calibrated by a cold standard (ice bath). Thermometers that are used to check hot temperatures (cooking) should be calibrated against a hot standard. (hot water bath and a certified thermometer). Any certified thermometer must be recertified annually. Thermometers should be calibrated at least weekly. Corrective actions should occur if temperature is plus or minus 2 degrees from standard. Criteria must be established for when corrective actions are to occur. Scales should be monitored at some set schedule with a set of standard weights. If the scale is measuring small items, small weights should be used, if large, large weights. Scales should be calibrated at least annually, usually by an outside service.

3. There are written procedures on how to calibrate and maintain all metal detectors or other automated foreign material detection equipment systems. There are written procedures on how to handle product rejected by the detection systems. Records of all calibration checks are maintained. Auditor is to list the type(s) of foreign material detection systems being used by the facility. (5 pts)

• There are written procedures on how to calibrate and maintain all metal detectors or other foreign material detection equipment

• There are written procedures on how to handle product rejected by the detection systems

• Records of the calibration checks must be maintained

The procedure for testing the metal detector/foreign detection equipment must be written. It must include the number of checks needed, the placement of the standards and corrective actions if the detector fails the calibration. The corrective actions should address the handling of product since last good check, and how to handle product that is rejected by the detector. The auditor will verify that procedure is being followed during verification plant walk-through in section VIII. Auditor will document what type of foreign material detection system is being used and rejection method.



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Audit Form Question Question Elements Further Guidance 1. A written program exists for the proper preventive maintenance of all equipment and appropriate areas of the facility. There is an established schedule and a system for verifying that the PM tasks have been completed. (5 pts)

• A written schedule of tasks to be completed for PM exists

• Verification that the tasks are being completed is available

A schedule of activities for routine preventive maintenance needs to be kept. It can be in a database or posted on a wall. However the schedule must be written and exists. Verification that tasks are completed must be able to be verified by the auditor through objective evidence (records.) This program shall focus on preventative maintenance activities only. Fixing equipment when it is broken would not be considered a preventative maintenance activity.

2. A documented program exists for employees to identify items in the facility needing maintenance. A system for reconciliation that maintenance has been completed is in place. (5 pts)

• A system is in place that allows employees to inform maintenance about work requests

• A documented process is present that allows the tracking completion of work requests for maintenance to verify that they have been completed

This program can be in the form of a work order system. Identified repairs can be fed into the Preventative Maintenance system if necessary or kept separate. At a minimum the program must contain a written method for employees to get information to maintenance about a repair being needed, then maintenance completing the task, and verification that it was completed. A log, numbered work orders, or a computer database tracking system is required to reconcile any open work orders. Emergency repairs should be written up in the work order system.

3. There is a written program to address the cleaning and sanitizing of equipment that has undergone repairs, maintenance or re-assembly before being used in processing. Responsibility for completing and verifying completion of this process is assigned. Documentation of this sanitation is required. (5 pts)

• Procedures are established that describe the sanitation activities that are to occur after equipment has undergone repairs

• The procedures identify who is responsible for conducting the sanitation and who verifies its completion

• Records are maintained that show sanitation was completed, as required by procedure

There must be a written procedure that describes when sanitation must follow repairs, who performs these tasks, and how completion is verified. Auditor will ask maintenance personnel what is done when a repair is made to a product zone. Records are required that show that sanitation has taken place when repairs of equipment in a product contact zone have taken place prior to releasing the equipment back to production. The personnel who conduct the sanitation must have been properly trained. In some cases spraying the equipment with sanitizer may be acceptable, in others full cleaning and sanitizing would be required.

4. Written guidelines are in place to insure product is protected during all maintenance activities including actions required to protect exposed and non-exposed product. Guidelines must be in place to ensure product disposition when product has been affected by maintenance activities. (5 pts)

• Guidelines address how the facility will protect product when breakdowns occur and/or repairs are made in product zones

• The guidelines describe product disposition when affected by maintenance activities

When repairs within a product zone take place, there should be specific guidelines on how to handle the product (i.e. if equipment is down more than 15 minutes, product is destroyed; if the product is exposed to maintenance activity, what is done with it; when equipment is being repaired prior to sanitation, what is done with the product. The auditor will evaluate areas of risk generally the biggest risk would be equipment like a filling machine. If repairs are made to product zones and product is exposed, the procedures must describe product disposition when affected by maintenance activities. For example how is product handled that is used to test a machine once it has been fixed and is being tested for functionality.



25

5. Written guidelines are established to insure tool and parts control when repairs are taking place during production. The guidelines should include proper placement of tools and parts and should address tools used in raw areas versus finished product areas. (5 pts)

• Guidelines should be in place that describes how maintenance will handle tools and equipment when repairs are being made

• Guidelines should exist that describe how tools are to be handled in raw vs. finished areas to protect products and avoid potential cross contamination from maintenance activities

This is not a part or tool inventory system. While this is not a part and tool inventory system, tools and parts should be removed from the work zone when repairs are completed. This is simply how are mechanics trained to place tools or parts on food processing machinery. Ideally no tools or parts should be placed on a product contact zone. Tools should not be carried in pockets or placed directly on the floor. Facilities should have separate tools for raw vs. RTE product repairs, or have guidelines on how to clean and sanitize tools prior to repairs in RTE areas.


1. A documented GLP program has been established. It includes steps for the handling and storage of reagents and samples, the test methods to be used, and written SOPs for internal calibration and control procedures for all tests or analyses performed. Lab results are documented and initialed. There is a documented verification program for internal laboratory proficiency for chemical and microbiological testing, and records are available for review. (5 pts)

• Facility has a documented GLP program that includes handling and storage of reagents and samples, established methods for the analyses being conducted, and internal calibration and control procedures. All laboratory media must be dated and not out of date range for reliability

• Facility participates in a laboratory proficiency program to assure accuracy of its chemical and microbiological results

• All results are documented and initialed

Methods of analysis should be documented, and reference a recognized standard (AOAC, BAM, etc.). The facility can have their own methods, as long as they are shown to be as good as the national standard. Some type of check sample or split sample program should be used to verify lab performance. This is when a sample is spiked, sent to many labs that analyze it. The results of each lab are then compared. National programs include AOAC, and AACC. Taking a sample, splitting it, analyzing half and sending half to a certified laboratory on a routine basis would also satisfy the criteria. Rapid micro methods do not require participation in a check sample program, as long as any confirmations are sent to an outside laboratory for analysis. Recommended frequency for participation in proficiency programs is minimum of 3 to 4 times per year and include chemical and microbiological testing. Facility should be dating media and PH buffers and other reagents/chemicals when they come in. Auditor will verify that none are outdated.

2. All appropriate laboratory equipment is calibrated as scheduled or as necessary and is functioning properly on a continuing basis. The calibration results are documented. (5 pts)

• An established schedule is used for the calibration of appropriate laboratory equipment.

• Records of the calibration activities are maintained and are current

Procedures for the calibration of laboratory equipment must be in place. Examples of equipment that should be calibrated include PH meters (using buffers that are near the PH being measured, 4,7and 10), scales, incubators (log of temps), and autoclaves (autoclave tape is not verification of autoclave calibration). Schedules of calibration shall be established with records maintained. Auditor will review records and procedures.

3. The on site laboratory is testing for pathogens and has a program in place for running positive controls. Auditor will comment whether the laboratory is in a separate building or located under the

• The on site laboratory is testing for pathogens and has a program in place for running positive controls

This question is a yes/no question. The auditor will ask if the facility laboratory is testing for pathogens and if a positive control program is in place. Pathogens can include Listeria Monocytogenes, Salmonella, and E coli 0157:H7. Note: Generic E.Coli, Listeria species, and Coliforms are not pathogens.



26separate building or located under the same roof as the production facility. (Yes/No)

If yes the auditor will comment as to the location of the laboratory either under the same roof as the production facility or in a separate building.

Audit Form Question Question Elements Further Guidance 1. A documented, product recovery program that can trace the distribution of specific production lots and the source of all primary packaging and ingredients used therein has been established and is maintained. The program must comply with FDA/USDA or equivalent guidelines for conducting a product recovery. The program must define procedures for contacting customers. Contact lists for responsible employees and customers are updated annually. Responsibility for managing the recovery program is assigned. (5 pts)

• An established, and documented product recovery program that complies with governmental guidelines is in place and describes how customers affected by the recovery are to be contacted

• The contact lists are updated annually and are available for all internal and external contacts necessary to conduct the recovery

• Responsibility for managing the recovery program is assigned

The procedures for product recovery must outline the complete program, all steps to be taken and the documentation needed to complete the recall. There should be contact lists for all employees on the recall team with 24/7 access and for all applicable customers these must be updated annually. The customer list can be kept electronically but must be available for review by the auditor. The program shall include procedures that reference FDA/USDA guidelines for level of recall and actions to be taken.

2. Mock recalls are conducted at least every 12 months to assess the effectiveness of the program. The results of the mock recall are on file, available for review, and must include a summary page and copies of all supporting documents. The mock recall should account for 100% of the ingredient, product, or primary packaging tested within 2 hours. Auditor will list the date of the last mock recall, the item tested, and the percentage of product recovered in the comments. (5 pts)

• A mock recall has been conducted within the last 12 months

• All supporting documentation necessary to complete the recall is maintained and available for review

• Mock recall recovered 100% of product within 2 hours

Auditor will review, verify and record date of last mock recall. A real recall does not take the place of a mock recall. The required timeline for recovery is 100% of product within 2 hours. All supporting documentation from the mock recall must accompany the recall. The recall should include a summary page that summarizes the recall. As a part of the exercise, the facility does not have to actually bring the product back to the facility. Only a finished product recall once per year is required to meet the requirements of this audit. Auditor should assess the mock recall and follow the flow of the process. The following steps will be taken by the auditor to verify the success of the mock recall. First, determine the product identification and the amount of the product produced. This could be from batch sheets, production documents, or pallet tags. There must be some documentation listing the product identification, the date of production, and the amount of product produced. Secondly, the auditor will determine if any of the product is still in the facility. Thirdly, the auditor will verify where the product was shipped? This would be determined by reviewing the recording of the product code dates on shipping manifests. The facility must be able to verify what product was shipped where. The fourth step will be to reconcile the product using the following formula: amount of product produced =amount of product still on site + amount of product shipped + amount of product destroyed = 100%. Recovery of < 99% or > 101% will have points deducted. Best practices indicate that any issues found with the recall should result in the recall procedure being retested. Score deviation: If a mock recall has not been conducted within the last 12 months, but



27within 24 months, the score will be a 2. If a mock recall has not been conducted in 24 months, the score will be a 1.

3. Auditor is to conduct a traceability exercise on one item during the audit to verify that the facility can identify, track and locate 100% of finished product lots, raw materials or packaging to first external customer or first level of external distribution within 2 hours. Auditor will list the item tested and summarize results in the comments. (5 pts)

• Results of the auditor-initiated mock recall meet the program guidelines

A traceability exercise will be conducted on a finished product, raw material or packaging item related to the customer for whom you are conducting the audit. If all items are bulk, or large quantity, then confine your trace to a certain time period or other limit. The procedures and time requirements will be the same as in question II.I.2 in this section. Silliker audit program guidelines require that mock recalls must recover 100% of product within 2 hours. Score deviation: For full points the facility must be able to trace 100% of the finished product, raw material or packaging with in 2 hours or the time listed in the facility’s procedure. (Auditor to note the time frame in the facility’s procedure if different than two hours) If the facility can trace 100% within 4 hours or twice the time listed in the site’s procedure score a 3. If 100% of the product cannot be traced score a 1. Auditor will use caution when choosing an item to run a mock recall on. Raw materials, packaging or finished products should be chosen in a way that does not cause an undue time element burden to the site.

4. A documented program on how to collect and evaluate customer complaints, especially those related to food safety and quality, has been established. There is a system for notifying food safety/QA personnel of applicable customer complaints and for investigation to identify a probable cause and resolution. Customer complaints are summarized on a routine basis to identify areas for continuous improvement. (5 pts)

• There is a mechanism for the collection and evaluation of complaints

• Each valid complaint is investigated to determine a cause and resolution

• Complaints are summarized to conduct trend analysis and identify areas for improvement

Customer complaint programs should have 3 parts. Collection of the complaint, which could be documented on a worksheet or some type of log filled out by the person who takes the complaint and is a guide to obtain information. Individual investigation of complaints to identify a probable cause as to the validity of the complaint and the reason for it in the facility shall be documented. A summary of all complaints on a predefined schedule to look for trends and identify possible improvement areas shall also be included in the customer complaint program. If complaints are handled off site (corporate or 800 number) the site should still be given information to investigate the complaint, when complaints are of a food safety or quality nature. However, if the program is handled by a corporate function and the auditor does not have direct objective evidence to verify the program, the question should be marked N/A and the auditor should comment on how complaints at the plant are investigated and results are sent back to the corporate entity.



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1. Roads, yards, grounds, and parking lots are maintained in neat and good condition, and free of trash and litter. Grass and weeds are cut to minimize harborage areas for pests and are not within 20 feet of the building. Ornamental landscaping must not provide harborage next to the building. (5 pts)

• Roads, yards and parking lots

are maintained and clean • Grass and weeds are cut to

minimize harborage areas for pests and are not within 20 feet of the building

• Ornamental landscaping must not provide harborage next to the building

Weeds are defined as anything over 12 inches high. A very dusty parking lot and a gravel parking lots will be addressed by the auditor in this question. Anything outside of the 20 foot perimeter should not be scored as points lost but in potential harborage situations, the auditor may place a “ comment only” in the report describing the potential harborage situation.

2. Plant grounds have adequate drainage to prevent pooling water that can serve as a source of contamination by seepage, foot-borne filth, or provide a breeding place for pests. There should be no evidence of pooled water and no standing water should be observed. (5 pts)

• No standing water or pot holes are observed

• No signs or evidence of previous inadequate drainage

Potholes will be the determining factor for documentation of standing water. The auditor will be mindful of recent rains and assess the outside areas for the potential for pooling of water. Roof drains that are not protected properly will cause holes in ground and drainage issues. The auditor will look for signs of dried algae or dried water ring stains as signs of potential pooled water evidence. Large potholes will be addressed in this question.

3. Equipment and pipes stored on plant grounds are at least 20 feet away from the buildings or at least 6 inches above the ground and in an organized manner to prevent breeding areas and harborage for pests. Any pipes within 20 feet of the building must have closed ends. (5 pts)

• Equipment within 20 feet of building does not create a source of potential harborage

• Pipes within 20 feet of building are capped

Inside 20 feet of the perimeter of the building all equipment must be on pallets or 6 inches off ground. Even equipment that is on pallets if there is a harborage potential, points would be deducted. Areas outside of the 20 foot perimeter will not be included in the report. Any pipes over 1 inch in diameter within 20 feet of building must be sealed. Sealed with tape meets the criteria. Equipment with feet does not have to be stored up off the ground if no harborage area exists.

4. Litter and waste are properly stored in enclosed containers. All waste is removed from the premises at appropriate intervals and in such a manner to prevent spillage and litter. The dumpster is on a rigid cleanable surface. The dumpster areas are

• All trash containers are covered • The frequency of service is

sufficient to manage waste • The dumpster is on a rigid,

cleanable surface and/or the dumpster area is maintained clean

All dumpsters and trash containers within 20 feet must be enclosed with tight-fitting lids to prevent pest entry. Large dumpsters are difficult to cover, but still an attractant. Ideally trash cans should be more than 20 ft. away from food handling areas. Point adjustments should be made, if trash containers are covered but they are overflowing and not dumped in a timely manner. Dumpsters should be located on a rigid, cleanable surface and if not the grounds around the dumpster should be maintained clean and neat.



29surface. The dumpster areas are cleaned on a regularly scheduled basis, and/or are clear of debris and spilled product. (5 pts)

5. The loading dock areas are clear of debris and spilled products. Equipment or items stored on the dock should be clean and organized. All bumpers, levelers, and shelters are in good repair and clean. (5 pts)

• Loading dock areas are clear of debris and spilled products

• Equipment or items stored on the dock should be clean and organized

• Bumpers, levelers, and shelters are in good repair and clean

Any spilled product or litter on loading area will be addressed here. Equipment (load bars, bulkheads, etc.) should not be stored in the perimeter clearance or in disarray. Normal wear on bumpers is allowed, large gaps or pieces missing would be an issue. Bumpers: usually two hard rubber pads that the trailer rests against. Dock shelter/cushion: canopy and sides that the trailer sits in, that prevent rain, dust, pests from entering the dock door. They must provide a tight seal around the back of the trailer. If no shelters/cushions are in place or are poorly maintained, points will be deducted. If ill-fitting shelters or cushions with gaps are observed this will be addressed in question 3 B 3. The auditor will look under dock levelers with flashlight to assess sanitation. Brushes on levelers should be in good repair. Shelters around docks should not be torn or have exposed insulation. When a trailer is present, very little outside light should be visible from the inside of facility.

(Observation)


1. Plant buildings and roofs are suitable in construction and designed to facilitate maintenance and sanitary operations. There are no roof leaks. (5 pts)

• Roof is in good condition. There

are no roof leaks • Exterior walls of facility, including

troughs and down spouts, are in good condition

Roofs shall be in good condition, without leaks, and made of a suitable design to be maintained and cleaned. Exterior walls of the facility shall be in good condition, without peeling or flaking paint, and show no signs of leaks from troughs and down spouts. Score deviation: roof leaks in storage areas for packaged product or in other areas of the facility away from exposed product will score a 3. Roof leaks that result in damage to raw materials or finished product packaging will score a 1. Roof leaks that result in finished product contamination will score a 1 and will result in an additional score of 1 in question 1 C 1 and result in an automatic failure.

2. Interior floors, walls, and ceilings are constructed of materials that can be adequately cleaned and maintained in good repair. (5 pts)

• Floors in all areas are constructed with materials that can be cleaned and are in good condition

• Walls in all areas are constructed with materials that can be cleaned and are in good condition

• Ceilings in all areas are constructed with materials that can be cleaned and are in good condition

The auditor will look at all areas and comment on issues observed. The auditor will look for holes, cracks, soft/weak spots, damage to walls, ceilings, or floors where absorbed or held moisture could lead to problems. The auditor will comment in detail and describe the location and deviation found. If there are floor issues in RTE areas, the auditor will rate this more severely than floor issues observed elsewhere. Walls of all storage and processing areas should be non-absorbent and easily cleaned. Dry storage walls made of wood should be sealed, with the exception of dedicated corrugated storage areas. Any drop ceilings must have non-absorbent ceiling tiles. Score deviation: this question will be scored in accordance with the severity, location and number of instances of damaged floors, walls or ceilings.



303. Adequate screening or other protection is provided for defense against pests. Doors and windows should be closed or screened with no gaps greater than 0.25 inch. Cracks and crevices have been sealed to prevent entrance or harborage of pests. Drains protruding from outer building walls must be screened. (5 pts)

• All outer openings of doors and windows are protected from pest entry

• No cracks are present in walls to exterior of facility

• All drains protruding on exterior of the buildings are protected

Dock doors or pedestrian doors left open would be addressed here, including ill- fitting dock shelters. Torn screens into the facility would be addressed here. Fan intakes or outputs do not have to have to be screened providing the louvers seal properly when fan is off. Only roof drains do not have to be screened. Air curtains or strip curtains cannot take the place of a door that leads to the outside, as they do not deter rodents.

4. Aisles and workspaces between processing equipment and walls are unobstructed and of adequate width to permit employees to perform their duties and protect against contamination. There is adequate lighting in all areas of the facility, including processing, storage, receiving, shipping, locker rooms, restrooms and break areas. (5 pts)

• Aisles and workspaces are unobstructed and have adequate width

• The lighting is adequate for the intended purpose

Adequate space for movement is 18 inches. Equipment should be 18 inches from walls and other equipment to allow adequate access for cleaning, preoperational inspection and repair. Adequate lighting is necessary to enable employees to conduct inspection or cleaning tasks. Lighting in warehouse or storage areas should be adequate to allow for cleaning and monitoring of stored product and pest activity. If bulbs are out or more are needed, the auditor would document and points would be deducted. Score deviation: scoring is based on frequency and severity of observed issue. This will not be scored as one bulb found = 4, 2 = 3. etc. The auditor will comment clearly and support the score with the comment.

5. All glass and brittle plastic in receiving, shipping, production, and storage areas of the facility are to be shielded or protected against breakage. (5 pts)

• All glass and brittle plastic are protected from shattering and breakage

Glass and brittle plastic to be addressed includes, lights, windows, computer screens, gauges, laboratory glassware, etc. Examples of lights that would need to be shielded include overhead processing lights, overhead storage lights, trailer lights, emergency lights, forklift lights, trailer inspection lights, overhead loading dock lights and insect lights. Shielding can be plastic covering or teflon coating. If overhead lights are claimed to be teflon safety coated, auditor will verify coating from bulb inventory. Score deviation: frequency/severity and each area should be considered separately. For example, uncovered or damaged glass/brittle plastic in the shipping area away from product storage areas would score a 4. One instance of damaged or uncovered glass/brittle plastic in the production area will score a 3. If there are more than two instances in any area the question will score a 1.

6. Adequate ventilation or control equipment is in place to minimize odors and vapors. Fans and other air-blowing equipment are operated and maintained in a manner that minimizes the potential for contaminating food, equipment or packaging materials. (5 pts)

• No odors or ventilation issues are present

• Fans and other air-blowing equipment are operated and maintained to minimize the potential for contamination

Cleanliness of fans would be addressed in this question. Air deflection shields should be clean and in good repair. If heavy fumes are present in storage, maintenance or processing areas, deduct points in this question. If there are strong ammonia smells in boiler rooms points will be deducted here.

7. Water lines and hoses are protected against backflow or cross-connections between potable and non- potable water systems in areas where potential

• Water lines and hoses are protected against back flow or cross connections to prevent contamination of potable water

Most municipal building codes require a main back flow device into the building. There must not be cross-flow, a cross-connection (a pipe, hose or conduit) between a potable water system or water line and a non-potable water line or a water line of unknown quality or unknown potential contamination. Best practices indicate that the piping of all non-potable



31systems in areas where potential backflow conditions exist. (5 pts)

water should be durably and conspicuously identified so that it is readily distinguishable from piping that carries potable water. Backflow prevention devices must be located so that they may be readily serviced and maintained. They must be located immediately before or in the close proximity of the location where backflow prevention is required. If a backflow prevention device is not readily identifiable at the point of potential backflow, it will be a “note” in the comments, at least, and it may be a deduction if the auditor has to leave the area to verify the presence of the device or there is a possibility of cross-connection between the device and the point of potential backflow. Any faucets or water spouts that are threaded and could have a hose attached to them should be fitted with a backflow prevention device whether inside or outside the facility. Best practices indicate that a facility should have a plan for inspection frequency of their backflow devices. Score deviation: this question will be scored in accordance with the severity, location and number of instances.

8. Hand wash stations are appropriately located in the processing areas. Hand washing stations have hands-free water and towel operations and are provided with antibacterial soaps, warm water and single use towels or a suitable drying device at all times. Signs in the appropriate languages direct employees to wash and sanitize their hands before they start work, after each absence from their workstation, and at any time their hands may become soiled or contaminated. (5 pts)

• Hand sinks are convenient to processing areas

• Processing area hand sinks are hands-free, including water and paper towels

• Hand sinks have warm water, antibacterial soap, and single use towels or suitable drying devices

• Signs for washing and sanitizing hands in languages appropriate for workers to understand are posted near hand wash stations

Hand wash facilities should be located in processing rooms and accessible to employees. Water should be warm within 30 seconds to meet the criteria. Continuous roll hand drying devices are not acceptable. Hands free drying devices are required. If towels are used, a waste receptacle must be located near by. Hands-free is foot operated or electric eye motion sensor. If the plant uses covered trashcans at hand wash stations and in areas where employees must return to the line after disposing of waste, these trashcans must be hands-free, have either foot operated covers or have electronic sensors to open the covers. Signs that direct employees to wash their hands must be posted at hand wash stations and when applicable be in languages appropriate for workers to understand.

9. Break areas, locker rooms, and restrooms are maintained in a clean and sanitary condition. They are equipped with proper ventilation and self-closing doors. Drains function properly and are free of standing water. Break areas are separated from the food processing areas and are free of plant garments, aprons, etc. Employee lunches should not be stored in lockers. Ladies restrooms must have covered trash receptacles. Hand wash signage is posted in all of these areas. (5 pts)

• Break areas, locker rooms, and restrooms are clean and well maintained. Equipment, ventilation and drains are functioning properly

• Women’s and unisex restrooms have covered waste containers

• Signs for washing and sanitizing hands in languages appropriate for workers to understand are posted

• Employee lunches should not be stored in lockers

Break areas, locker rooms, and restrooms shall be maintained clean and in sanitary condition. There should be adequate ventilation with no obvious odors. There should not be standing water in floor drains. Break areas must be away from food processing areas. Restrooms do not need a door, if a zig zag entrance is in place, as long as there is not a direct line of site into the restroom, it is acceptable (fly control). If doors are used they should be self-closing. Covered waste containers in women’s restroom can be in each stall, or there can be just one main waste container that is covered. If the restroom is unisex, this rule applies and must be followed. Ideally, there should be separate break areas for raw and RTE areas of the facility. If the plant uses covered trashcans in rest rooms, these trashcans must be hands-free, have either foot- operated covers or have electronic sensors to open the covers. If in a small facility, the break room and the locker room are the same room, the auditor is to comment that there is a common locker room, break room area and evaluate the area for cleanliness. In all cases employee lunches should be stored in designated areas or refrigerators not in employee lockers.



3210. Ladders and walkways over exposed product lines are protected to prevent potential contamination. Appropriate kick plates are installed as necessary. (5 pts)

• Exposed product is protected from potential contamination under ladders and walkways

On average four-inches is an adequate kick plate height. There should be no gap under the kick plate. Any open grating over exposed product or packaging must also have protection under it. If stairs are open over product, they must be protected. Score deviation: this question will be scored in accordance with the severity, location and number of instances.

(Observation)

Audit Form Question Question Elements Further Guidance 1. All plant equipment and utensils are designed and constructed to prevent contamination to food products. Food contact surfaces and seams are smoothly bonded. Wooden equipment and / or wooden food surfaces are not used in food processing areas. (5 pts)

• There are no equipment design

issues that would prevent proper cleaning

• No equipment or surfaces are made from wood

There should not be any wooden utensils or tables in use in the facility. One exception would be in some industries (bakeries) would use wooden tables in the process. These should be of hard maple and only used if in good repair. If these tables contain any grooves or cracks they would be found to be unacceptable and points deducted. Hollow leg tables, or utensils, voids, niches, and holes that allow excess product accumulation or are inaccessible for cleaning would result in point deductions here.

2. Equipment is maintained in good repair and is being used for the task for which it was intended. Contact surfaces are corrosion resistant and able to withstand the processing environment. No mold or rust is observed on equipment. (5 pts)

• All equipment is observed to be in good repair and used for its intended operations

• No mold or rust is observed on product zone equipment

Equipment shall not contain rough welds. Any flaking paint, fraying conveyor belts, or unsanitary welds on the insides of product contact piping or piping used for CIP purposes will be addressed in this question. Excess lubricant on grease zerks, and rusty gear boxes will be considered a non-conformance for this question. Mold or rust must not be observed on equipment located in a product zone.

3. Temporary repairs of equipment will not inhibit proper sanitation or be made with materials that contribute in any way to the contamination of the product or environment. (5 pts)

• Temporary repairs will not inhibit sanitation

• Materials used for temporary repairs cannot cause contamination issues to products or the environment

Examples of temporary repairs would be plastic taped to ceiling or equipment, cardboard, or duct tape used on anything except ducts, tape, paper, rubber bands, etc. Electrical tape used on wires is allowed, but should be avoided near product zones. Dating of temporary repairs would still be an issue, and points would be deducted here.

4. Soiled or broken pallets are not used. Empty pallets are not stored near raw material, in food processing, or food storage areas. (5 pts)

• Soiled or broken pallets are not used in the facility

• Multiple pallets or excess pallets should not be stored near raw material, in food processing or food storage areas

A broken pallet is defined as a pallet with broken slates and exposed nails. Empty pallets stored in processing, raw material or food storage areas should only be those needed for immediate use. The auditor will verify through observation that these areas are not used as general pallet storage or overflow area. Excess damaged pallets should not be stored next to finished products, raw materials or packaging.

5. Vehicles and equipment used for moving raw materials, finished products and packaging throughout the facility are cleaned and maintained in good condition. Fork truck or hand truck batteries are stored segregated from food products and packaging materials. (5 pts)

• Transportation vehicles are in good repair and not a source of potential contamination

• Vehicles and batteries are stored separated from food stuffs

There should not be any oil or other leaking fluid from fork trucks or pallet jacks. There should not be any excess trash on forklifts. Temporary repairs of forklifts like plastic tape on cracked seats would be addressed in this question. Any condition that would prevent the adequate cleaning of a fork truck or pallet jack will be addressed in this question. Fork trucks and pallet jacks should be clean, in good condition and controlled as to not introduce contamination from raw to cooked production areas. Tires on fork trucks should be in good repair, without cracks and free of product waste and dirt build up. Battery and vehicle segregation from food products and packaging materials would be a minimum of 4 feet.



33segregation from food products and packaging materials would be a minimum of 4 feet.


1. The plant has an adequate number of interior pest control devices. The spacing is at consistent intervals (typically 20-40ft.) around the inside of any exterior wall. Mechanical stations should be within 10 ft. of both sides of doors leading to the exterior, including dock doors. Pest control devices must also be used in dry storage areas, coolers, locker rooms, and break areas. These devices must be located so that they do not contaminate product, packaging or equipment. A number and/or color code must correspond with the master identification map. (5 pts)

• The plant has an adequate

number of interior pest control devices. The spacing is at consistent intervals (typically 20-40ft.) around the inside of any exterior wall. Mechanical stations should be within 10 ft. of both sides of doors leading to the exterior, including dock doors

• Devices are used in dry storage areas, coolers, locker rooms, & lunchrooms

• Proper number/ color code corresponding with map should be used

Mechanical traps or glue boards can be used in the facility. Recommended distances between interior devices are 20 to 40 feet with the devices located on the interior perimeter of the facility, and additionally in coolers, dry storage areas, locker rooms, and lunchrooms. For small break rooms, only 1 trap placed in the room is sufficient. Interior rodent devices shall be used on upper floors that are used for the storage of finished product, packaging and raw materials or employee amenities. Interior pest control devices should not be on ledges or raised from the floor. In areas where it is very wet (for example processing rooms) devices are not required, as long as they are used elsewhere in the facility. On shipping docks or loading docks, traps must be located between each dock door, and must be mechanical to prevent any pest from moving from one trailer to another. One mechanical station between each dock door meets this criteria. If the facility has conducted a study with the pest control company in accordance with the National Pest Management Association Standards (2007 or 2008 edition) and has the results of a depth matrix (history and potential for infestation) study included with the program, then some aspects of control device placement can be adjusted on the interior. The study must be present in the pest control binder and signed by the facility and the PCO representative.

2. The plant has an adequate number of tamper-resistant exterior pest control stations spaced at appropriate intervals (usually 25-50 ft.) around the building’s exterior perimeter. (If the plant has conducted a risk study with its pest control service within the past 6 to 12 months using the National Pest

• The plant has an adequate number of secured, tamper-resistant exterior pest control stations spaced at appropriate intervals around the building’s exterior perimeter.

• Bait is anchored within the device

On the exterior, doors do not have to determine the placement of traps. They do not need to be on each side of the door on the exterior. A device must be required to get into the traps; this will ensure the stations are secured. The trap is considered secured in place if it is attached to a concrete patio block, anchored to the ground, or chained to the building. If the facility has conducted a study with the pest control company in accordance with the national pest management association standards (2007 or 2008 edition) and has the results of a “depth matrix” study included with the program, then the number of stations can be adjusted for both interior and exterior. The study must be present in the pest control binder and signed by the facility and the PCO representative. Silliker recommends that bait stations



34months using the National Pest Management Association standards and the study is available for review, spacing of the exterior stations can be adjusted based on the study results.) Stations are secured in place next to the building, closed, and a key or a tool (e.g., Allen wrench) is required to open. Bait must be anchored inside the stations to avoid being removed by a rodent or floating away during heavy rains. These devices must be located so that they do not contaminate product, packaging or equipment. The number and location code must correspond with the master identification map. (5 pts)

• Proper number/ color code corresponding with map should be used

and signed by the facility and the PCO representative. Silliker recommends that bait stations should be present on the outside of the facility for monitoring purposes. If the facility has public access (sidewalk) it would be illegal to place bait stations there, so they are not required, as long as they are used where it is legal to do so. Scoring deviation: if a facility only has mechanical ketchalls and no bait stations, this question will be scored a 4.

3. Live catch devices and glue boards are checked at least twice monthly. Exterior bait stations are checked at least monthly. The PCO must initial and date the labels and initial punch cards on all devices. These labels should be on the inside of the devices, unless they are mechanical devices with a clear window. (5 pts)

• Live catch devices and glue boards are checked at least twice monthly

• Exterior bait stations are checked at least monthly

• PCO must initial and date labels, scan the barcode, or use punch cards on all devices

• Labels must be on the inside of devices, unless there is a clear window on top

The interior traps can be checked by the facility once per month and the PCO once per month, as long as the facility has a schedule and policy for checking the devices. The person checking the traps dates and signs the labels inside the device or uses a punch card. The person from the facility does not apply any pesticides unless they are properly certified. Mechanical devices that have a clear window on top do not have to have a service label placed on the inside of the device. Bar coding may also be used. When bar coding is used initials would not be required on service labels. On exterior stations, if a punch card is to be used, the PCO must initial the card when placed in service. The card would be punched for each service with a “unique” punch or if not unique, punched and initialed at each service. The service report would need to be signed after completion of each service. The auditor will match the initials (when used) on the traps, with the signature on the report, to the license in the pest control documentation. If exterior devices are not checked in the winter months due to snow, they should be removed or they could provide a harborage area. Score deviation: if the bait stations cannot be checked by the auditor due to a padlock and the site does not have the key, the question will be scored a 1.

4. All pest control devices must be appropriately positioned and located so that they do not contaminate product, packaging or equipment. Bait must not be used in interior areas. All pest control devices are clean and functioning properly. Bait in the stations has a fresh

• Traps must be properly positioned and located to prevent contamination of products, packaging or equipment

Bait is not used inside the facility (Note: presence of bait in interior results in a score = 1 for

Traps must be properly located and positioned. Traps shall not be placed on perimeter ledges or elevated from the floor. Traps should be located next to the wall with the openings parallel to the wall. Interior traps must not be placed on food product or packaging. All pest control devices are functioning properly, properly wound and are of sound construction.



35appearance. (5 pts) interior results in a score = 1 for

this question.) All pest control devices are

functioning properly (i.e., are properly wound, have bait as appropriate, are of sound construction and working as intended) and bait in the stations has a fresh appearance

• Pest control devices are clean

Any damaged device would be addressed here and points deducted. Bait should not contain mold or damaged. The use of bait is not acceptable inside the facility. If bait is observed within the facility, this will result in a Score deviation: and the question is scored 1.

5. The site is controlling external pest activity, based on the pest control reports and observations during the audit. (5 pts)

• Pests, pets, or pest activity are not observed around the exterior perimeter of the facility.

• No decomposed rodents are found in exterior pest control devices.

Burrowing on the exterior, signs of bird droppings or nesting activity would be indicators of external pest activity. Heavy droppings and feeding activity in the bait stations would indicate high rodent or other pest pressure. Decomposed rodents should not be found in exterior pest control devices. Pest activity from wildlife or domestic animals if present, can be a source of potential contamination and the site should have documentation or evidence that there are corrective actions are in place to eliminate this activity.

6. The site is controlling internal pest activity, based on the pest control reports and observations during the audit. (5 pts)

• Internal pest activity includes significant presence of webbing and/or live insects and/or sightings of rodents or rodent activity in the facility

Internal pest activity would be numerous sightings of webbing (3 or more) or live insects (such as ants, crickets, roaches), or sightings of rodents or rodent activity like urine tracks, pellets. The number of sightings listed in the audit report and the severity of the infestation will determine the score. Score deviation: this question will be scored in accordance with the severity, location and number of instances.

7. THERE IS NO EVIDENCE OF DECOMPOSED PESTS ANYWHERE IN THE INTERIOR OF THE FACILITY, INCLUDING IN PEST CONTROL DEVICES. (5 pts)

• NO DECOMPOSED PESTS ARE FOUND ANYWHERE IN INTERIOR OF THE FACILITY

A dead pest in a pest control device is not an automatic failure, unless it is clear that the traps have not been serviced for quite a while and a badly decomposed pest is found in the device. Decomposed pests for this question do not include insects. If a decomposed rodent is found in a trap then the question scores a 1 and it is an automatic failure. THIS IS AN AUTOMATIC FAILURE QUESTION.

8. THERE IS NO EVIDENCE OF INSECTS, SPIDERS, RODENTS OR BIRDS ON OR IN ANY FOOD INGREDIENTS, PRODUCTS OR PACKAGING MATERIALS. (5 pts)

• NO PEST INFESTATION IS FOUND IN OR ON ANY INGREDIENTS, FOOD PRODUCTS OR PACKAGING MATERIALS

Any evidence of any pest activity found in products or in ingredients is an auto failure. Invading pests on products, such as spiders, house flies, the occasional bee or hornet, would be graded as internal pest activity and scored in question #7. Pest attracted as a result of decomposition of the food, and this may be a swarm of fruit flies, house fly maggots, is pest activity that will be documented in this question and scored a 1 and is an auto failure. Pests in food that are present as a result of prior infestation or storage practices, this could be stored product pests (grain, flour, cereal beetles) and would be scored here as a 1 and is an auto-failure. Rodent dropping, rodent nests, evidence of cockroaches would be reported and



36scored here as a 1 and is an auto failure. THIS IS AN AUTOMATIC FAILURE QUESTION.

9. Insect light traps (ILTs) (both low and high voltage) and flying insect traps may be used. Placement must be according to manufacturer instructions and comply with applicable regulations. If instructions are not available, ILTs must be between 2 and 5 feet off the ground. High voltage ILTs should be at least 10 ft. from covered/protected products or packaging and at least 30 ft. from exposed product, packaging, or equipment. Low voltage ILTs must not be above covered/protected or exposed product, packaging or equipment. Low voltage ILTs must also include sticky boards. They must be cleaned and maintained on a scheduled basis. Bulbs must be changed at least annually, and shatter protection must be in place. There must be a schedule for replacing the sticky boards in sticky-type ILTs. (5 pts)

• High and low voltage insect control devices are located appropriately, so they will not contaminate exposed product, packaging, or equipment or interfere with plant operations

• Devices must be cleaned and maintained on a scheduled basis

• There must be a schedule for replacing the sticky boards in sticky-type ILTs

• Bulbs must be changed at least annually, and shatter protection must be in place

All ILTs must be between 2 and 5 feet off the ground, unless specified differently by the manufacturer or due to special circumstances such as targeting high flying insects. If instructions are not available, high voltage insect light traps are required to be 30 ft. from exposed product and 10 ft. from packaged product. Low voltage light traps are the types with glue boards. The only placement issue for these is that they cannot be placed directly over exposed product and must contain glue boards. Both types require annual replacement of bulbs. A record of this replacement should be maintained. The traps should also be kept clean to aid in monitoring of activity. The insect light traps should not be placed where they can attract insects from the outside. Many facilities will service and monitor devices on their own. They should be cleaned regularly. Findings and seasonal requirements dictate inspection frequency. Pheromone traps may be used in some facilities. They should be placed on the pest control map, be monitored monthly and changed frequently. These devices may be removed during non- insect seasons, and should not be stored near product or packaging materials. If no insect devices are used, this question should be marked N/A with a comment by the auditor indicating no insect control devices are used.

10. Avicides are prohibited inside the facility. If used on the exterior, avicides must be used according to program and label requirements. (5 pts)

• Avicides are prohibited inside the plant’s facilities and are used appropriately

If bait for birds is used, it should be properly enclosed in a bait device like all other types of pest control bait. These stations should also be located on the pest control map. If no anti-bird chemicals are used this question should be marked N/A with a comment by the auditor that avicides are not used by the facility.

11. All pesticides, chemicals and other compounds stored on site for pest control are properly labeled and kept in locked, secured areas away from any food storage or processing areas. (5 pts)

• All pesticides and chemicals for pest control are labeled properly and kept in secured areas away from food processing and storage

If facility is storing pesticides on site, the chemicals need to be segregated and secured. Glue boards and tin cats do not need to be segregated and secured. If no pesticides are stored on site, this question should be marked N/A with a comment by the auditor that states that pesticide chemicals are not stored at the facility.



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1. Employees follow written programs on employee hygiene practices, store personal items appropriately, maintain personal cleanliness, and use hygienic practices at all times. (5 pts)

• Employees follow written

programs on employee hygiene practices and store personal items appropriately

• Employees maintain personal cleanliness and use hygienic practices at all times

The auditor will review the company’s employee hygiene practice and GMP policy to verify that employees adhere to the company GMP policies. All deviations from the company’s GMP policy will be documented here Any observed violations to the facility GMP policy or CGMPs will be documented here. Employees violating hand washing policies or not washing their hands after handling items that may have contaminated them would be addressed in question 1 B 3. Proper hand washing before use of gloves and the facility glove policy will be addressed in question 5 of this section. Employees should have areas for storing personal items and no personal items should be observed stored on food products or packaging.

2. Exposed jewelry, other than a plain wedding band, and other objects that might contaminate products, such as artificial nails and body piercings, are not worn. Objects, such as pens, thermometers, etc. that could fall into food, equipment or containers, are not carried in above the waist pockets. (5 pts)

• Exposed jewelry is not worn • Objects are not carried in

above-the-waist pockets

Exposed jewelry would include watches, chains, earrings, bracelets, rings with stones, nose rings, eyebrow ring, etc. Medic alert bracelets should not be worn. Medic alert chains are the only exception and should be worn under clothing. If the facility has special provisions for tours or office workers it should be specifically listed in the visitor GMP policy. Frocks should not have open pockets above the waist. Pockets on the inside of frocks are allowed.

3. Hairnets or other appropriate restraints are properly worn in food processing areas and in other areas of the facility as designated by facility’s employee hygiene practices. All employees with facial hair, working in production areas, must wear beard covers. The facility’s employee hygiene policy must address all facial hair, including definition for acceptable appearance and when coverage of facial hair such as moustaches is required. (5pts)

• Hairnets or other appropriate restraints are properly worn in food processing and other designated areas

• Facial hair is covered with beard covers

• The facility’s employee hygiene policy must address all facial hair, including definition for acceptable appearance and when coverage of the moustache is required

Auditor shall review the facility hair restraint policy. Hairnets must be worn in food processing areas and other facility designated areas. The auditor will refer to the company hair restraint policy, as many facilities will allow ball caps as hair restraints in dry storage and warehouse areas. If the company’s policy calls for hairnets for all employees in all areas of the plant, then auditor will audit to that policy and document any deviations. Even employees that are bald would need to wear a hairnet. The moustache policy must address appearance (i.e. neatly trimmed, not below the corner of the mouth) Goatees are covered by sentence two in the question and must be covered by a beard cover. Note: this question is scored at the auditor’s assessment of number of violations of this requirement.

4. Garments worn in the facility (uniforms, aprons, frocks, lab coats, etc.) are clean and appropriate for the operation and do not contribute to potential product contamination. All

• Garments are clean, appropriate for the operation and do not have snaps not buttons

• Outer garments are not worn in restrooms, lunchrooms or

Garments worn in the facility should be clean with in the parameters of the process, for example raw meat operations. Auditor will observe and evaluate the level of cleanliness of the outer garments. Frocks should not show signs of becoming soiled, hung back up and used by another person. Frocks should be clean for each shift. Frocks and uniforms should have snaps, not buttons. Any raw to finished area employee traffic flows require a



38potential product contamination. All garments should have snaps not buttons. Outer garments like frocks and aprons are not worn in restrooms, break areas or outside of the facility. Employees adhere to traffic flows when moving through the facility by changing frocks, aprons or uniforms to minimize cross-contamination. (5 pts)

outside the facility • Employees change frocks or

uniforms as necessary to minimize cross-contamination

should have snaps, not buttons. Any raw to finished area employee traffic flows require a change of frock, apron, or uniform as necessary to minimize cross- contamination. Frocks and aprons should not be worn in restrooms, lunchrooms or outside of the facility.

5. Gloves worn in the food processing areas are maintained in intact, clean and good condition. Gloves must be used where there is direct hand contact with ready-to-eat products. Procedures for the proper handling and usage of gloves are established, implemented, and verified where required. (5 pts)

• Gloves worn in processing areas are maintained intact, clean & in good condition

• Gloves are worn when there is direct hand contact with RTE products

• Procedures for the proper handling & usage of gloves are established, implemented, and verified, where required

The auditor shall review the company’s policy on gloves with the exception of RTE products. Employees handling RTE products should be wearing gloves. Companies that require gloves should have a glove policy in place directing employees when glove changes need to occur. These could include after breaks, using the restroom, handling trash or inedible product, etc. Hand washing must always take place prior to putting new gloves on. Single use gloves should never be re-worn. Heavy latex gloves can be washed; therefore, they can be reused.

6. Eating, chewing gum, drinking and use of tobacco are confined to designated areas outside of the processing and storage areas. (5 pts)

• Eating and chewing gum are confined to designated areas outside of the processing areas

• Drinking is confined to designated areas outside of the processing areas

• Use of tobacco is confined to designated areas outside of the processing areas

Per CFR part 110. 10 b “drinking of beverages and usage of tobacco products must be confined to areas other than where food is handled or where food handling equipment or utensils are washed. The consumption of potable water in warehouse areas and in certain types of processes that are very warm in the summer months would be allowed, if the company has a policy that includes where in the facility water is allowed. This must be a very specific designated area, must not be near products, storage of products or areas where food handling equipment or utensils are washed and it must be clearly marked. The auditor will observe trash containers outside of the designated area. If used cups are seen outside of the designated area, or water bottles are found on fork trucks in production areas, then a failure to follow the policy is observed, and will be documented here with points deducted. Beverages other than potable water are not allowed. In facilities where the locker room and the break room are separate areas, there should not be evidence of food storage or consumption in the locker room. Tasting of product required for organoleptic analysis, should be done in a lab or test kitchen setting, and should not be done in the processing area. Hand washing must always follow tasting of product. Score deviation: One or two instances of eating or drinking a personal food item, score 4. Three or four instances the score would be a 3 and if 5 or more instances are found the question will score a 1.



39


1. All ingredients and materials should be properly identified and labeled. They should include the date of receipt or a verifiable system for first in/first out (FIFO) or first expired/first out (FEFO) product rotation. Ingredients and primary packaging in storage must be traceable into the production system by the vendor’s lot number or the processing facility’s assigned system. (5 pts)

• All ingredients and materials are

labeled with date of receipt or there is a verifiable product rotation system

• Ingredients and primary packaging can be identified by lot number or code date, either assigned by the supplier or the site

During the audit the auditor will observed pallets of raw materials, including ingredients and all packaging materials, to verify that the date of receipt is placed on the pallets. The date of receipt should be placed on the lower edge of the pallet to ensure that it remains with the pallet until the product is used. If the facility chooses to use a system other than FIFO (first-in first-out) or FEFO (first-expired first out), the auditor will verify that the system is acceptable and verify that it is being followed. There are some computer generated inventory control programs that may not require a date of receipt on the pallets. As long as the proper product rotation is being followed, and this can be verified using records, it is acceptable. The facility can be using the vendor code date for traceability, or they can use their own assigned lot code. The key is that there is a documented system in place to record the lot codes of all ingredients and primary packaging materials. A log of raw materials received may be kept for traceability, but this does not override the need to date the pallets with the date of receipt or use another verifiable means of product rotation.

2. Products must be maintained in their appropriate temperature ranges. Products are not stored in the shipping and receiving areas, unless proper controls are used to prevent quality, food safety, and/or temperature degradation. Perishable product should not be stored on the cool dock. (5 pts)

• Products must be stored in their proper temperature range in shipping and receiving areas to prevent quality, food safety, and/or temperature degradation

• Perishable products should not be stored on the cool dock

The refrigerated cool dock areas should not be used to store perishable products. The area above the dock door is especially at risk as this area is very difficult to keep cool during the summer time. Product is allowed to be staged on the cool dock, however, the product must not be staged for more than 1 hour. During the audit the auditor will take the temperature of perishable product that is observed on the cool dock to determine if it meets the company’s written temperature policy for raw materials or finished product. It is acceptable to store non-perishable products in the cool dock areas.

3. Shipping and receiving areas are clean, organized, and free of debris and spilled products. Equipment stored on the dock (load bars, bulkheads, etc.) should be organized and in good repair. (5 pts)

• Shipping and receiving docks are clean, organized, and free of debris and spilled products

• Equipment stored on the docks should be organized and in good repair

The shipping and receiving docks, including cool docks, should be clean, organized, and free of debris. The area should be routinely cleaned to remove broken pallets, spilled product, used pallet wrap. These materials should be promptly and properly disposed of. The trash containers in the shipping/receiving areas should be frequently emptied to prevent overflowing. Transportation equipment, including bulkheads, load bars, and freezer blankets, should not be stored in the perimeter of the dock areas. Broken pallets and non-functional equipment should be properly disposed of and should not be stored in the dock areas

4. Temperatures of refrigerated and frozen products are documented at the time of receipt. The temperature monitoring devices being used are

• Temperatures of refrigerated and frozen products are documented at the time of receipt

The auditor will verify the raw material and finished product specifications to ensure these temperature requirements are being met. Using a calibrated thermometer, the auditor will take the temperature of products that are being shipped, received and compare these results to the facility’s temperature requirements. In addition, the auditor will review inbound



40monitoring devices being used are available and in good repair. Auditor is to verify that devices cover the temperature ranges of the products being monitored and indicate this in the comment section. (5 pts)

• Devices to monitor the temperature of products are available, in good repair, and cover the range

inspection documents to insure that the temperature of perishable products are recorded. Employees responsible for monitoring the temperature of inbound materials will be questioned to insure they understand the product temperature requirements, as well as the proper methods for taking product temperature. The methods for taking product temperatures must not contribute to possible product contamination. The temperature taking devices must be capable of covering the range of the product temperatures that are being taken. If frozen materials are received, the temperature device should be capable of temperatures less than zero. The receiving employees must have access to the temperature monitoring device and be able to locate it as needed. Infrared (IR) thermometers are allowed, as long as they are calibrated according to the manufacturers recommendations. The temperatures of outbound finished product do not need to be documented, however, all product that is in the storage and shipping areas must be within the temperature requirements that are listed in the product specifications.

5. Transport vehicles used (incoming or shipping) are clean and free of any pest contamination. They are in sound condition and capable of maintaining proper product temperatures and preventing any product contamination. Perishable product transport vehicles must be pre-cooled prior to loading, and documentation of the pre-cooling must be maintained. (5 pts)

• Transport vehicles are clean, free of pest contamination and in sound condition

• Conditions in the trailers should be able to be maintained at product temperatures and not be a potential source of contamination

• Perishable product transport vehicles must be pre-cooled prior to loading, and documentation of the pre-cooling should be maintained

All transport vehicles must be clean, free of pest contamination, and maintained in good condition. The vehicles must be capable of protecting product from the elements and other sources of product contamination. All perishable products must be shipped on transport vehicles that are equipped with the means to keep product cool. This would generally require a reefer or condenser unit. The cooling equipment in the vehicles must be in good condition and maintained in a manner that does not create a potential source of contamination (i.e. condensation dripping on product). If perishable product is being shipped, the trailer must be pre-cooled, to a specified temperature, prior to loading. The pre-cooling temperature requirements must be defined and the employee responsible for loading the trailer must be aware of the temperature requirements. The auditor will question the loader on the proper trailer temperature and method for monitoring the temperature. It is expected that the reefer will be turned off once the doors have been open for loading. Records must be maintained to verify that the trailers are properly pre-cooled prior to loading.

6. If ingredients are received in bulk (tanker, rail, etc.), transfer procedures must protect the product from contamination. Hoses must be clean, capped and stored off the ground, and connection ports into the building must be capped when not in use. (5 pts)

• Transfer procedures must protect the product from contamination

• Hoses must be clean, capped and stored off the ground

• Connection ports into the building must be capped and locked when not in use

The receiving of all bulk raw materials must be done in a manner that protects the material from intentional or unintentional contamination. Any receiving ports that are used for receiving ingredients, raw materials, or chemicals must be capped and locked when they are not in use. Any hoses that are stored outside of the facility must be secured and stored in a manner that prevents contamination. All hoses that are used for transferring product must be stored off the ground. These requirements do not apply to non-product hoses that are used for steam to melt product prior to unloading.



41

Audit Form Question Question Elements Further Guidance 1. Sufficient space (typically 18 inches) is maintained along all walls to permit proper cleaning and inspection for pest activity. No materials are stored within this space. All materials are stored at an adequate height (6” or pallet height) above the floor. Easy access to all areas around the walls for cleaning and inspections is provided. (5 pts)

• Sufficient space is maintained

along all walls for cleaning and pest activity inspection

• All materials are stored at an adequate height above the floor

An inspection perimeter is required to be maintained in the dry storage areas, warehouse areas, packaging material storage areas, freezers, coolers, and dock areas. If an inspection perimeter is not possible due to racking, the bottom rack must be 18 inches off the ground the meet the requirement. This requirement is based upon 21 CFR sec.110.20 plants and grounds (b) (1) provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food. A white line is not required to be in place, however, if it is, it must be clean and properly maintained.

2. FIFO or FEFO rotation practices are used for all raw materials, in-process materials, finished products and packaging. (5 pts)

• FIFO or FEFO rotation practices are used for all raw materials

• FIFO or FEFO rotation practices are used for all finished products

• FIFO or FEFO rotation practices are used for all packaging

The auditor will verify that FIFO/FEFO practices are being followed by observing the dates on the pallets that are in the active “pick” locations and then observing the same product in the non-pick slots. The product in the active pick slot should be older than the product not being selected, based upon the use by date or the date of receipt of the product. This requirement applies to all ingredients, packaging materials (including corrugate), and finished product.

3. All stored ingredients and packaging materials are clean, dry, intact, in good condition, and free from contamination or spoilage. They are properly packaged or covered to prevent contamination of other products. They are stored under appropriate conditions (e.g., dry, cooler and freezer). (5 pts)

• All ingredients, materials and packaging are stored properly packaged or covered to prevent contamination of other products

• They are in good condition clean, dry, intact, and free from contamination and spoilage

• They are stored under appropriate conditions

All ingredients and packaging materials must be properly packaged and stored to prevent contamination or spoilage. Any stored ingredients must be covered or stored in properly closed containers. All raw materials must be stored according to the product specification or label instructions. Refrigerated items must be stored under refrigeration and frozen items must be stored under frozen conditions. Partially consumed rolls and boxes of primary packaging materials should be covered or protected from contamination.

4. Any damaged cases or packages are immediately segregated and repackaged or properly discarded. All materials rejected or on hold are properly identified, adequately segregated, and protected from contamination. Product on hold is clearly identified and held under appropriate conditions. (5 pts)

• Damaged cases are segregated and repacked or discarded

• On hold materials are identified, segregated, and protected from contamination

• Product on hold is clearly identified and held under appropriate conditions

The auditor will observe product, both raw materials and finished goods, to ensure all damaged items have been properly handled. When the facility observes damaged product, they should act immediately to correct the problem and not wait until the product is ready to be used or shipped. Any damaged items must be properly identified through tagging or an inventory control system. If an inventory control system is used the auditor will compare the product that is observed to the inventory system to ensure the product and count is accurate. Damaged and/or non-conforming product should be clearly identified and segregated to reduce the likelihood of accidental use. Product that has been placed on hold should be held under the appropriate conditions to prevent spoilage or contamination. This includes keeping perishable product in refrigerated or frozen areas. Finished ready-to-eat product should not be stored in a raw cooler, even if it is going to be reprocessed.



425. Ingredient containers are not reused, unless they are adequately sanitized or have protective liners. Single-use containers from microbiologically sensitive products must not be reused. (5 pts)

• Ingredient containers are not reused without being sanitized or without a protective liner

• Single-use containers from microbiologically sensitive products must not be reused

Cardboard boxes should not be used as trashcans. Ingredient containers should not be re-used unless they have been properly cleaned and sanitized. Container liners should only be used once and then discarded. Any ingredient containers that are being reused should be properly labeled and/or identified through a color-coding system.

6. Dry storage areas are maintained in a clean and sanitary manner. All spills are immediately cleaned up; i.e., the floors and racks are not dirty and there is no evidence of spills, trash or other litter. (5 pts)

• Dry storage areas are maintained in a clean and sanitary manner

• Spills are cleaned up immediately

The dry storage areas should be maintained in a clean sanitary manner. Product spills should be cleaned up immediately, or at least within the shift. Rack footings should be free from excess build up or aged product spills. The racking, walls, ceiling, equipment and product should be free from cobwebs and excess dust.

7. Restricted chemicals for use in processing or as an ingredient are stored in separate, locked areas away from food and packaging supplies. (5 pts)

• Restricted chemicals for use in processing or as an ingredient are stored in separate, locked areas away from food and packaging supplies

Restricted chemicals are primarily used in the meat industry and include sodium nitrite, sodium nitrate, and sodium etherothorbate. When the facilities purchase the chemicals alone (solid, in solution, or in pre-measured forms) and are mixing or weighing the chemicals, they are required to have a segregated, secured storage area. If the facility purchases the restricted chemicals already mixed with spice mixes, they do not have to keep these mixes in restricted, separate, locked storage areas. If the facility does not used these chemicals or they are pre-mixed, this question will be scored not applicable (N/A).

8. Racks, floors, walls and ceilings of coolers are in good repair and maintained in a clean and sanitary condition. There is no evidence of spills, trash or clutter. Floors are kept dry. (5 pts)

• Cooler racks, floors, walls, and ceilings are in good repair

• Coolers are clean with no aged spills

• Cooler floors are kept dry

The racks, floors, walls, and ceilings of the cooler areas should be maintained in good condition. The racks should be in good condition and free from excess rust or peeling paint. The walls, floors, and ceilings should be in good repair and made of easily cleanable materials. No wood should be used for walls or shelves in the cooler area. Any spills in the cooler area should be promptly cleaned. The floors in the cooler areas should be kept dry. An exception to this would be with product that is packed in ice (i.e. some produce or raw poultry). However, even with this product, the facility should have procedures in place to deal with the excess water. If no cooler areas are used in the facility, this question should be scored not applicable.

9. Coolers show no sign of condensation. Products stored in coolers should be free from condensation and ice. Cooler temperatures are maintained within the allowable ranges. Monitoring occurs either by checking temperatures manually at least twice a day or via continuous recording systems. (5 pts)

• There is no condensation in coolers

• No product shows signs of having condensation on it from the storage in coolers

• Temperatures of coolers are maintained within the allowable ranges

• Temperatures are checked manually at least twice a day or via continuous recording devices

The facility should have pre-determined limits for the cooler areas. The auditor will review the limits and verify that the limits are being followed by reviewing records and taking the actual cooler temperatures. The temperature of the cooler areas should be less than 40 degrees F, unless otherwise noted. The thermometer that is used to take cooler temperatures must be able to be calibrated. Plastic dial thermometers are not able to be calibrated and should not be used to record and verify cooler temperatures. If a continuous monitoring system is used, it should be serviced and calibrated at least annually. The cooling units should be properly maintained to prevent condensation. All condensation in the cooler areas should be controlled. Score deviation: If any condensation is observed on product in a cooler, this question should be scored a 1. If no coolers are used at this facility, this question should be scored not applicable.



4310. Racks, floors, walls and ceilings of freezers are in good repair and maintained in a clean and sanitary condition. There is no evidence of spills, trash or clutter. Floors are kept dry. (5 pts)

• Freezer racks, floors, walls, and ceilings are in good repair

• Freezer is clean with no aged spills

• Freezer floors are kept dry.

The racks, floors, walls, and ceilings of the freezer areas should be maintained in good condition. The racks should be in good condition and free from excess rust or peeling paint. The walls, floors, and ceilings should be in good repair and made of easily cleanable materials. No wood should be used for walls or shelves in the freezer area. Any spills in the freezer area should be promptly cleaned. The floors in the freezer areas should be kept dry and free from ice build up. If no freezer areas are used in the facility, this question should be scored not applicable.

11. Freezers show no sign of aged frozen condensation or aged ice. Products stored in freezers are free from ice and show no signs of freeze/thaw conditions. Temperatures of freezers are maintained below the maximum allowable temperatures. Monitoring occurs either by checking temperatures manually twice a day or via continuous recording systems. (5 pts)

• There is no frozen condensation or ice in freezers

• No product shows signs of ice on it or freeze/thaw conditions

• Temperatures of freezers are below the maximum allowable temperatures

• Temperatures are checked manually at least twice a day or via continuous recording devices

The facility should have pre-determined limits for the freezer areas. The auditor will review the limits and verify that the limits are being followed by reviewing records and taking the actual freezer temperatures. The temperature of the freezer areas should be less than 0 degrees F, unless otherwise noted. The thermometer that is used to take freezer temperatures must be able to be calibrated. Plastic dial thermometers are not able to be calibrated and should not be used to record and verify freezer temperatures. If a continuous monitoring system is used, it should be serviced and calibrated at least annually. The cooling units and doors should be properly maintained to prevent excess frost and aged ice build up. Score deviation: If any aged ice is observed on product in a freezer, this question should be scored a 1. If no freezers are used at this facility, this question should be scored not applicable.



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1. All chemicals used for cleaning, sanitizing, and processing must be approved for use in a food handling facility and are properly labeled. They are used for their intended purposes and they are stored in secure, locked areas away from any food processing or storage. Chemicals that are connected to dilution devices do not have to be in a locked area, if their location does not pose a contamination risk to food, packaging, or equipment. (5 pts)

• Chemicals observed being used

are approved for use in a food handling facility and are properly labeled

• Chemicals are used for their intended purposes

• They are stored in secure, locked areas away from processing or storage areas

All chemical containers whether primary and/or secondary, must be properly and legibly labeled, even water and mineral oil. The label must at least include the common name of the chemical. Chemicals not in use must be properly stored away from food products and be properly secured to prevent unauthorized use by unauthorized and non-trained personnel. Bulk chemicals such as 55-gallon drums, with the original seals, do not need to be secured but must be stored separate from food storage areas. Chemicals attached to mixing devices do not need to be secured. Open 55-gallon drums, including those with hand pumps or other syphoning devices, must be stored in a way to prevent unauthorized use. All chemicals must state on their label that they are approved for use in a food processing facility. Letters of guarantee or product description from the chemical supplier are acceptable for proof of approval for use in a food processing facility. All sanitizers must have an epa number on their label. Bleaches (with color or scents added to please the user) are not industry grade and are not approved for use in a food processing facility as the color and scent may not be readily rinsed from equipment surfaces. Bleaches with an EPA number are usually found to be acceptable.

2. Test kits or sanitizer test strips are routinely used and observed being used to monitor chemical concentration in sanitizing hand dips, foot baths, and sanitizing solutions. Procedures for these checks have been established and are accessible to the employees doing the checks. Records of the checks are documented. (5 pts)

• Test kits or strips are observed being used to monitor chemical concentration

• Procedures for these checks are established and are accessible to the employees doing the checks

• Records of the checks are documented

Auditor will verify strengths of sanitizers in footbaths, hand dips, and central systems with test strips to verify compliance to label instructions or written sanitation SOPs. Records of a chemical representative checking a central sanitizer system on a regular basis will be considered documentation that the sanitizer is properly mixed. The auditor is to view those records if site does not record chemical concentration checks. The foot bath and hand dip concentrations should be changed on a regularly scheduled basis to maintain effectiveness and proper strengths. If a central chemical mixing system is not used, each batch of sanitizer that is made must be checked with test strips with results recorded. Federal guidelines for sanitizers are maximum 200 PPM for chlorine and quaternary ammonia and 25 PPM for iodine. Higher concentrations would require a fresh water rinse after sanitizing. Iodine would also require a ph of less than 5.5 to be effective. Any chemical that is used as a processing aid (chlorine) should also be verified by the auditor. The auditor is to document any sanitizer concentration checks in the comments section listing area checked and the results of the test and compliance level to facility program.

3. Containers, brushes and applicators used for cleaning and sanitizing are color coded or labeled to properly identify them for their intended use. If a color-coding system is used, appropriate signage describing the system in languages

• Equipment for cleaning and sanitizing are color coded/ labeled

• For color-coding systems, appropriate signage describing the system is posted

Equipment used for cleaning and sanitizing should be color- coded or labeled and identify raw product brushes and cleaning utensils from finished product area brushes and cleaning utensils. All non-food contact brushes should be identified. If a color- coded system is used it should be posted in appropriate areas and in a language understood by all employees.



45describing the system in languages appropriate for employees to understand is posted. (5 pts) 4. Cleaning equipment is properly stored (when not in use) and is not stored in food processing areas. Cleaning equipment is non-porous and in good repair. (5 pts)

• Cleaning equipment is properly stored (when not in use) and is not stored in food processing areas

• Cleaning equipment is non-porous and in good repair

Cleaning equipment includes but is not limited to mops, brooms, mop buckets, squeegees, floor scrubbers, etc. Cleaning equipment should be stored in designated areas and off the floor to prevent the trapping of debris and potential pest harborage. Broom handles and mop handles should not be made of wood. Any mops or utensils that are used to wipe condensation must be stored in a way that does not contaminate the mops or utensils and ensures they are maintained in good repair.

(Observation)


1. Cleanliness is maintained in all non-processing and non-food contact areas. The cleanup of spills and accumulation of materials is conducted on a continuing basis during production. (5 pts)

• Cleanliness is maintained in all

non-processing and non-food contact areas

• Spills are continually cleaned up during production

All areas of the facility should be maintained clean including, maintenance areas, the laboratory, sample retention areas, boiler rooms areas, etc. For each separate area cluttered and unclean one point would be deducted. Trash cans inside the plant may or may not be covered, depending upon plant rules. Auditor will observe the normal processing conditions and evaluate the frequency and processes for removal of bulk residue. Removal of residue from spills should be removed at breaks and shift changes. The spills from equipment malfunctions (filling machines) should be promptly cleaned.

2. Cleanliness is maintained on all food contact surfaces. Significant accumulations of product build-up are not observed during production. (5 pts)

• Cleanliness is maintained on all food contact surfaces

• No accumulation of gross product build-up is observed during production

If equipment has been cleaned and the auditor views the equipment prior to use and finds the equipment visibly dirty then it would be scored in this question. Food contact surfaces and product zones will be the focus of observation. If the auditor observes the pre-op conditions in a facility and finds a dirty food contact surface or product zone points would be deducted in the question. Auditor will assess the process to determine if product is aged or newly deposited. Aged product residue and excess product reside should be removed. Product residue will be removed at changeover or shift change. If excess product residue is seen after a shift change or changeover, then points will be deducted in this question.

3. Excess moisture and pools of water are removed from equipment and the processing environment. (5 pts)

• Excess moisture and pools of water are removed from equipment and the processing environment

This question is to be assessed after the end of wet clean up sanitation activities. Excess water on the floor or pooled water in cleaned equipment can be a source of contamination. If the end of wet sanitation activities are not viewed by the auditor this question is to be marked N/A with comments by the auditor indicating that post sanitation conditions were not observed.

4. Knives, saws, trimmers, and other tools used in processing and for opening ingredient bags and packaging are properly stored, cleaned and sanitized as necessary throughout the production shifts and at the end of the production period. (5pts)

• Knives, saws, trimmers, and other tools used in processing are properly stored, cleaned and sanitized

• Knives and blades used for opening bags of ingredients are properly stored, cleaned, sanitized, and in good condition

Knives used in any product trimming process should be placed in sanitizer at each break. Knives, scrapers, and hand tools used in processing should be stored in scabards or devices that can be maintained cleaned and sanitized. Knives and tools for processing should be controlled, stored appropriately and cleaned and sanitized. Knives and blades used for opening dry ingredient bags must be clean and in good condition. (intact, no broken handles, etc.)



46

5. Proper cleaning and sanitizing procedures are followed and are accessible to employees needing them. Equipment is disassembled as necessary to insure thorough cleaning. Equipment in wet processing environments that has been out of service is cleaned and sanitized prior to use per written sanitation SOPs. Results are being documented to verify cleaning and sanitation was completed per procedure. (5 pts)

• Proper cleaning and sanitizing procedures are followed and are accessible to employees needing them

• Equipment is disassembled as necessary to insure thorough cleaning

• Equipment in wet processing environments that has been out of service is cleaned and sanitized prior to use per written sanitation SOPs

• Results are being documented to verify cleaning and sanitation was completed

Auditor will evaluate compliance to the elements in this question through observation, review of records and Sanitation SOPs. The proper sanitation method for each piece of equipment must be used. When possible the auditor will observe some sanitation activities in progress to determine if proper sanitation is being conducted. Under most circumstances, wash, rinse, sanitizer is the proper procedure that needs to be followed when wet sanitation is being performed. An exception may be a highly sugary or oil type product, where plain hot water is sufficient to remove the soil. In dry clean up operations, check for dry product residue that could possibly contain contaminants from previous runs of unlike product or the dry product (such as salt) that is used as a “run” powder to clean the processing lines. The auditor is to observe equipment and mixing platforms (less than 18" off the ground), pasteurizers or ovens (with low clearance) placed so close to walls that it is impossible for anyone to get between the wall and the equipment to clean. Most food plants have protein as a component of the soil in the facility and must use a cleaning chemical to remove it. 21 CFR part 110 states that sanitizing must follow wet cleaning activities. The auditor will assess any sanitation activities that occur during the audit, including rinsing, brushing, hosing, wiping, etc. Where equipment is not in use, auditor will assess if the equipment is thoroughly cleaned. This includes equipment that has been in storage and is being placed back into service. For plants that have extended runs and shut down weekly and then perform sanitation on Friday night or Saturday, then a re-sanitizing step should take place on Monday morning prior to production.


1. Water reused or recirculated for washing, rinsing, or conveying food must have documented procedures to insure the water is not increasing the level of contamination. These can include microbiological testing, ph and free chlorine levels or other validated processes. Monitoring should occur on a routine basis and records must be available for review. (5 pts)

• Water reused or recirculated for

washing, rinsing, or conveying food must be monitored through written procedures to insure that the water does not increase the level of contamination of the food

• Records of the monitoring results must be available and meet the testing frequencies of the written program

When water is specifically used as a processing aid, (i.e. produce flume), a rinse system, or by moving the product with water, procedures must be in place to insure this water does not increase the level of contamination of the food. Pre-washes in vegetables plants are not part of this requirement. If those specific circumstances do not exist the question should be marked N/A. The auditor will verify when water is used as an aid and review the procedures to insure that it is monitored to assess the potential increase in contamination. Analysis used could be microbiological, ph, free chlorine levels, or those listed in the facility’s procedures. Microbiological testing could include, APC, Coliform, and Heterotrophic plate count. Most often, fresh produce processors will monitor re-circulated water by testing free chlorine levels or ph. Auditor will list the monitoring procedures used in the comment section of the question.



472. Thawing or tempering of frozen materials is done under controlled conditions (e.g., under refrigeration) and is monitored to insure proper temperature controls are maintained. Thawing procedures have been developed that assure safety and quality is maintained, and verification checks of compliance must be documented. (5 pts)

• Thawing or tempering is done under controlled conditions

• Thawing procedures have been developed that assure safety and quality are maintained

• Verification checks of compliance with the procedures are completed and documented

Acceptable thawing or tempering procedures are under running cold water < 70f, under refrigeration, as part of the cooking process, or at ambient temperature as long as the process is monitored and takes less than 12 hours. Thawed products must be refrigerated less than 45f to maintain product integrity if not immediately used. The facility should have a very specific process for tempering, and auditor is to verify process and review records of process. The acceptable methods listed above are guidelines and should not be used, if they would cause a regulatory violation for example, meat and poultry have defined thawing methods. If no frozen products are used in the plant, the question should be scored as N/A.

(Observation and Review of Records)


1. Appropriate process control points and limits are observed being monitored on a regular basis. The monitoring results are being recorded. Employees questioned during the audit are aware of and understand how to monitor their control points. Auditor will comment on what was asked and the worker’s response. (5 pts)

• Process controls points and

limits are observed being monitored, and the results are being recorded per the procedures

• Employees questioned understood their monitoring points

This is a verification of the written program described in section 2 part F. The auditor will verify through review of records and physical observation the process quality points identified in section 2 f. Monitoring of process control points should be followed as written in the lab and on the production floor or as appropriate for the area involved in the production process. Process control points verified shall include but are not limited to weight control, salt %, Ph, brix, piece size, piece count, time temperature controls etc. These points are determined by the facility according to the product and the process. The auditor will question employees responsible for monitoring process control points to insure knowledge of the program and corrective actions to be taken when out of specification results are found. Auditor will document in the comments section the process control points reviewed with the monitoring employee and the results of the review. Whenever possible the same process control points will not be reviewed at each audit. Whenever possible the auditor will verify three process control points that correspond with the written program in section 2 F 1.

2. Corrective actions are being taken as required and documented, whenever a process control point is outside of the established criteria or limits. Auditor will review random online monitoring and corrective action records and comment on compliance. (5 pts)

• Corrective actions are being taken as required and documented

This question is evaluated through review of historical records and those on the production floor the day of the audit. There should be established corrective actions that will be taken when process control points are found to be outside the parameters of the process specification. The process control points evaluated here will be the same process control points reviewed in 2 F 1 and in question 1 B above. Auditor will review processing records for any out of standard results. Auditor will verify that non-conformities are handled per written procedure in 2 F 1 and that rejection controls are in place. Auditor will record what corrective actions were taken when monitoring of control point being reviewed is found to be out of control. If no out of compliance issues are found the auditor will state this in the comments and the question will be scored full points. Score deviation: if corrective actions are not being taken, rating for this question = 1. If the facility does not have a written corrective action program in place, this question will score a 1 and will also carry over to question 1 in section 2 F. If the facility does not have a documented corrective action program, but through interviews



48it is determined that appropriate actions are taken, score 2 points with an explanation.

3. No equipment or processing operations (such as washing, trimming, sorting and inspection, shredding, extruding forming etc.) used are observed to have the potential to contribute to the contamination and/or adulteration of product with physical, chemical or microbial contaminants that could be introduced into the product. (5 pts)

• No equipment or processing operation used has the potential to contribute to the contamination / adulteration of product with physical, chemical or microbial contaminants

Equipment where required should have proper safety shields, proper use of shrouds to protect product or packaging; minimize or eliminate potential contamination from excess grease on grease zirts in product contact zones, and leaks on pressured product hoses. Fraying conveyor belts and areas of temporary repair that could be a source for potential contamination will be documented in this question. The scoring in this question is based on risk upon observation. Points will be deducted when the issue found is within a product zone directly associated with exposed product. If the issue that is allowing the potential contamination is related to equipment design or maintenance then it will also be addressed in that particular question in section 3. The comments in this question will describe the potential contamination and the comments in section 3 C (or as appropriate) would describe the specific cause.

4. No sanitation practices are observed, which could potentially cause product contamination. All food, food-contact surfaces and packaging are adequately protected during clean-ups. The use of hoses, including high-pressure hoses, during production, mid-shift clean-ups, or where food or packaging materials are stored, is done without causing contamination from water droplets and aerosols. (5 pts)

• No sanitation practices are observed, which could potentially cause product contamination

• Hoses must be used in such a way that they are not a source of contamination due to water droplets or aerosols

The creation of aerosols is a source of contamination and points will be deducted based on risk with RTE areas being the most sensitive. Raw product only production areas should not be subject to over spray and aerosols. Hoses should be used or handled in a way that does not contribute to potential contamination. Any aerosols created with a hose or air during production or around exposed product will be addressed in this question, including the act of sanitizing a piece of equipment while food product is exposed. The scoring will be based on risk and observations.

5. Breakdowns or line shutdowns are monitored to insure that time delays, temperature fluctuations and other factors do not contribute to contamination, decomposition, or other safety and quality changes in either the ingredients or products being processed. There are procedures for actions to be taken, when product safety or quality is affected. (5 pts)

• Breakdowns or line shutdowns are monitored to insure time delays, temperature fluctuations and other factors do not affect product safety and/or quality

• Procedures have been established for actions to take, when product safety or quality is at risk

During shut downs there must be procedures or actions taken to protect product against exposure to the environment and temperature degradation that could put product quality or safety at risk. The facility should have a predetermined time that product can be exposed during a down time. The procedure should include what steps will be taken if that time limit is exceeded. Even product that is not temperature sensitive should have guidelines in place to minimize the exposure to the processing room environment. NOTE: The intent of this question is not to calculate or evaluate the efficiency of the process.



496. All perishable product-processing rooms are monitored with a calibrated thermometer. The temperatures of products being processed and/or ingredients being used in the process are observed being maintained in their appropriate temperature range. Auditor is to report the temperatures observed for temperature-sensitive products. (5 pts)

• The temperatures of perishable product processing rooms are monitored with a calibrated thermometer

• The temperatures of products being processed or ingredients being used in the process are maintained in their appropriate temperature range

Guidelines should be in place for processing room temperatures if they are refrigerated. Most (but no all) will use 50 F for processing room temperatures. The temperature of the room should be monitored by a calibrated thermometer (not plastic dial). The auditor will take the temperature of the room and of products processed in the room to verify compliance with the facility temperature policy and record the results in the comments. If processing rooms are not refrigerated, the question should be N/A with a comment.

7. Ingredient containers are properly labeled and/or color coded and covered as appropriate. If a color coding system is used for labeling ingredient containers, signage on use of the containers and equipment is posted in languages appropriate for employees to understand. (5 pts)

• Ingredient containers are properly labeled and/or color coded and covered as required

• Appropriate signage on use of containers and equipment is posted

Ingredients not stored in their original containers must be labeled. If a color-coding system is used for edible, inedible, trash, etc. then edible and non-edible tubs or containers should not be stored nested together even if they have been cleaned. The auditor will verify compliance of color system in the facility by questioning employees as to the color coded system and how it is used. The color-coding system should be posted in an easily seen area within the areas of use and in languages appropriate for employees to understand. Labeling can be used instead of color-coding. Edible product containers should be covered or protected when not in use. Ay work in progress or rework should be stored in appropriate edible containers and labeled as well. If rework is not labeled and cannot be traced then it would be addressed in section 2 question E 7 as well.

8. Glass and brittle plastic packaging must be controlled in processing areas. Controls are in place for glass or brittle plastic containers used for the storage of raw materials. (5 pts)

• Raw material packaging that is glass or brittle plastic is not used in the processing areas

• Controls are in place if glass or brittle plastic finished product packaging is used

If glass packaging is used, controls for breakage should be in glass control policy (1 C 3) and will be verified by the auditor in this question. This would include ingredients in glass packaging (e.g. wine bottles used as an ingredient) Ideally raw ingredients packaged in glass should not enter processing rooms in the glass container. If glass is used as packaging material for finished products, controls must be in place for breakage and inspection of glass packaging before use. If glass packaging is not used for raw materials or finished products this question will be marked N/A with a comment: “No glass packaging is used.”

9. Staged packaging materials and ingredients are kept clean, dry and free from contamination during processing. (5 pts)

• Staged packaging materials are kept clean, dry and free from contamination during processing

• Staged ingredients are kept clean, dry and free from contamination during processing

The placement of staged packaging materials just prior to use must insure the packaging is covered, off the floor and protected from possible contamination. The placement of staged ingredients just prior to use must insure the ingredients are covered, off the floor and protected from possible contamination.

10. When magnets, screens, sieves, etc. are used in the processing lines, they must be inspected on a scheduled basis to insure proper performance. Inspection records must be documented and maintained. (5 pts)

• Magnets, screens and sieves are inspected on a scheduled basis

• Inspection records are documented and maintained

All screening devices should on a regular schedule, be monitored, changed or cleaned as necessary. The auditor will verify the schedule exists and is being followed through observation and review of records. This can be done by facility maintenance through a PM schedule or by production employees. If no screening devices are used, the question should be scored as N/A with a comment: “Magnets, sieves or screens are not used.”



5011. Metal detectors or other automated foreign material control systems are used as necessary, if the plant is highly automated, the potential for metal contamination exists, or customers require their use. These systems are online as close to final packaging as possible and must have automatic rejection or line stoppage mechanisms when metal or other foreign matter is detected. The systems are observed being calibrated on a specified frequency with ferrous, non-ferrous and stainless steel standards or as specified by the customer to insure proper functioning. (5 pts)

• Metal detection or other automated foreign material control systems are used online as applicable by the facility

• Foreign material control systems are online as close to the final packaging as possible

• The systems have automatic rejection or line stoppage mechanisms that are in good condition and are operating properly

• The systems are observed being calibrated correctly at specified frequencies

Auditor will verify procedure from section 2 F 3. Auditor should observe metal detector/foreign material checks for all products being audited. The metal detectors/automated foreign material control systems should be after the final package. Sensitivity standards should be specified in procedure and verified by auditor during check. The auditor will reference customer requirements for specific standards, and testing frequencies if required and verify compliance. The metal detector/ automated foreign material control systems should have a rejection mechanism or line stoppage when metal is detected. The auditor must observe that it is operational and effectively islolates rejected product. Auditor will consult with specific customer requirements to determine if the present or other type of system is a customer requirement or is an auto failure if not in place. Note: Silliker does not require that a metal detector be in place, as long as methods are used to prevent metal contamination in the final product.

12. Any compressed air or other gases (e.g., carbon dioxide, nitrogen) used in processing, packaging or cleaning are treated in such a way to prevent contamination. (5 pts)

• Any compressed air or other gases used in processing, packaging or cleaning are treated in such a way to prevent contamination

If compressed air is used in packaging or used as a cleaning aid to remove gross soil, (direct contact air) it should be filtered. Filter size should be between 1-10 microns and at the point of use. Indirect or direct air filters should be on a pm schedule to be changed on a regular schedule. Indirect contact air would be air used to operate equipment that does not involve food contact surfaces and is on a closed system. The filters on the air compressors are usually particulate, water and oil trap like filters.

13. Floors are observed to be free of standing water. (5 pts) • Floors are free of standing water

All processing floors should be free of standing water. Standing water will be an issue in raw and non RTE products, even though it is less risk than in a RTE facility. If water is part of the process and cannot be avoided, the facility should have the procedures to remove the water on a continuous basis to avoid excess standing water. This could be via drains or a person with a squeegee to move the water to a drain. All floors should be in adequate repair and allow for proper drainage and minimize standing water. In RTE areas, standing water is a major issue and should be rated very strictly. Excessive standing water in RTE packaging rooms will be rated a 1 or 2 depending on severity and will be reflected in the auditor’s comment. If the floor water contains sanitizer the auditor must verify this through the use of test strips.

14. Maintenance tools, gloves, rags and other miscellaneous materials are not found on or near processing equipment. Tools used for equipment adjustment must be clean and in good repair (no rust, etc.). (5 pts)

• Maintenance tools and other miscellaneous materials are not found on or near processing equipment

• Tools used for equipment adjustment must be clean and in good repair

Maintenance personnel or processing personnel that are responsible for repairs must be aware of the placement of tools and parts during repairs. This question is further verification of question G 6 in section 2. The auditor will verify that the policy is being followed and maintenance items are properly stored. Tools used for equipment adjustments must be clean; with no old filth and old residue build up that could be a source of contamination. If the facility does not have a policy then 2 G 6 will be scored accordingly but this question would still be evaluated in observation as loose tools, parts or miscellaneous materials have the potential to be foreign material contaminates.



51


1. The facility must have a documented food defense plan that designates a multidisciplinary team, which meets at least annually. The team must initially assess all facility operations to determine potential deliberate contamination risks and appropriate strategies to reduce these identified risks. The team must reassess the risks and strategies on at least an annual basis. (5 pts)

• Facility has developed a

documented food defense plan covering all operations

• There is a multidisciplinary food defense team that meets at least annually

• Facility has developed a reduction strategy for identified risks

• The plan is reassessed at least one time per year

A multidisciplinary food defense team is to be established that meets at least annually to address food defense for the facility. The facility needs to have done at least one comprehensive assessment of the facility with action items identified. This assessment could have been completed by an outside agency or performed internally. No established reference for the assessment is required, although recommendation would be to use USDA or FDA guidelines for food defense. The facility should identify all areas within facility that are sensitive and are restricted to only certain personnel. These areas would include areas where food is open with easy access (such as tubs, mixers, vats, conveyor belts, etc) as well as chemical storage areas, laboratory, and maintenance areas. Facility management decides what to protect and at a minimum certain areas with chemicals should be included as well as an onsite laboratory. The food defense plan must be reassessed at least one time per year.

2. The facility provides evidence that it meets all regulatory requirements for food defense (FDA’s Bioterrorism Act of 2002). These elements include facility records that identify the previous source of ingredients and materials and the next customer (one up and one down the food chain). Records verifying compliance are maintained for the appropriate time based on product shelf life. (5 pts)

• Facility provides evidence that it has registered with the Federal Regulatory Agency (letter stating this is adequate…auditor does not need to see actual registration number)

• Facility records identify previous source and next customer (one up and one down the food chain)

• Facility keeps records for the appropriate time (depending upon product shelf life)

Note: this element would not apply to facilities that are regulated by the USDA, these facilities would be rated N/A for this question with an appropriate descriptive comment. The facility must comply with FDA requirements concerning food defense and bio-terrorism act of 2002. These rules are constantly changing, but there are three major components they must comply with: The 4th bio-terrorism act record keeping regulation was published on December 9, 2004, with phase in compliance dates of December 2005 for plants with >500 employees; June 2006, for 11-499 employees; and December 2006 for </= 10 employees. This law only applies to US plants that manufacture, process, pack, transport, distribute, receive, hold or import food intended for human or animal consumption in the US. It does not apply to foreign facilities. Sites must identify the immediate previous source of the ingredient/product and the immediate subsequent recipient with records kept from 6 months to 2 years depending on the shelf life of the product.



523. The plan documents how access is controlled to all receiving/shipping, processing and storage areas within and around the facility. There must be a system for easy identification of employees, who belong in and around open food and who have access to open food sources, including food packaging materials and equipment that touches food. The ID system has procedures for supervising all non-employees in the facility, including contractors, visitors, outside drivers, etc. The access plan must identify how all critical departments and areas of the facility will be physically secured. (5 pts)

• The plan documents how access is controlled to all areas of the facility

• The plan includes an identification system for employees having access to open food sources, including food packaging materials and equipment that touches food

• The plan includes procedures for supervising all non-employees in the facility

• The access plan must identify how critical departments and areas of the facility will be physically secured. (e.g., locks, cameras, alarms, etc)

Note: the plant can have these things as a part of another program vs. having all of these elements only in the food defense program. The facility must have a documented food defense program that includes the following elements: The facility must utilize some system to be able to determine who belongs within any particular area of the plant (could be an id badge system, color coded uniforms, etc, workers must understand this system and those who do not belong should be challenged by employees. All non-employees are carefully supervised and monitored to ensure they do not pose a risk to food contamination. The facility should have a system to identify visitors and non-employees and to track them throughout the visitation period. The facility must have a program to review and address issues associated with ensuring all areas where food is received, processed, stored or shipped are properly secured (using such items as locks, cameras, alarms, etc) and that there is a system of controlling the keys, badges or combinations used to gain entry into these areas. This includes issuing and retrieval of ids, keys, etc.

4. The plan identifies the systems and procedures for controlling the integrity of all incoming materials. There are procedures that describe how receiving of raw materials will take place including the matching of seal numbers, evaluation of product integrity and delivery driver identification verification. There must be procedures to address the securing of bulk ingredient ports and the securing of water handling facilities. There is a policy in place on how LTL loads and other shipments are handled, which at a minimum describes that all LTL loads must be locked and inspected for load integrity. (5 pts)

• The plan includes procedures for the receiving of raw materials including the matching of seal numbers, evaluation of product integrity and delivery driver identification

• There are procedures for securing bulk ingredient ports and water handling facilities (system to limit access to only authorized personnel)

• A Procedure for less than full loads and other shipments is established and must include locks and assurance of product integrity for the LTLs

Incoming raw material, (ingredients, film, packaging material, etc) must come in secured and sealed. Security seals should be broken by employees for optimum control. Raw material inspection records should be reviewed to insure that seal number is being recorded and verified. Raw material inspection records include a product integrity review on all incoming loads both sealed and non- sealed. The integrity check should include at least an assessment of packaging materials of the loads to ensure that there is no obvious potential for tampering and no evidence that tampering occurred. Any on-site water handling facilities must be secured. This could be a pump house, chemical injection, or incoming water monitoring area. No outbound waste WATER TREATMENT AREAS need to be secured. Less than full loads (LTLs) need to be addressed in food defense program. At a minimum, the program must state that LTLs will be secured and inspected for load integrity.

5. There are established procedures for how the manufacturing process and product are protected from deliberate contamination. They must include controlled authorized access for all formulas and all formulation software and tamper evident packaging on finished product. (5 pts)

• There are established procedures to protect the process and product from deliberate contamination

• There is restricted access to documents and software associated with ingredients or finished products (formula, cleaning, etc)

All inventory control software, formulation software, product specifications and shipping software, as well as any software that is critical to integrity of the product must use adequate security procedures (such as password protection, biometrics, etc). Facility should keep a list or somehow track usage of who has access to critical software components. If connected to internet, use of protection software (anti-virus, anti-spam, anti-hacker, etc) should be utilized and kept current. Finished products should have some level of tamper evident packaging, depending on the customer and intended use. Tamper evident would basically be defined as not having repeated access to product without evidence of use.



53cleaning, etc)

• Finished product has tamper evident packaging

6. There are established procedures on how the shipment of product is protected from deliberate contamination, including the sealing of outbound trailers, control of LTLs and documentation of drivers. (5 pts)

• There are established procedures on how the shipment of product is protected from deliberate contamination

• Outbound trailers and LTL controls are in place and documented

• There is a system for identifying drivers

All outbound full trailers require a seal. Less than Full Load (LTL) shipments require multiple seals or locks. If a trailer is used to transport product within a facility perimeter, it does not require a seal, but it does need to be secured. Any trailer in the parking lot that contains product should be at least locked, and best practices indicate a seal is the preferred method of securing loaded trailers stored in the parking lot. If a trailer is going to outside storage, it needs a seal or lock, even if it is going to a company owned storage center. All seals are documented on shipping documentation. Paperwork on all shipment to customers has drivers documented.

7. There are policies and procedure in the plan for screening employees. At a minimum, they include a system to screen all employees prior to hiring, including reference checks for all employees and basic felony background checks for supervisors and above. Procedures have been set-up to educate and supervise current employees on how to report suspicious activities. (5 pts)

• The food defense program includes documented procedures on employee management from a defense perspective

• Procedures have been established to screen employees prior to hiring, including reference checks for all employees and basic felony background checks for all supervisors and above

• There are procedures in place for educating employees on how to report suspicious activity (what to report and who to report to)

All employees should have at a minimum a reference check and some form of verification of previous employment. Temporary employees should have checks done. The facility may also perform employee drug screening. Silliker will not ask to review any records pertaining to background and reference checks. All supervisory employees and above should have a basic screening process that includes a background check at least on felony convictions. If desired, additional criteria for background checks can include credit checks and Department of Motor Vehicles. Silliker will verify that basic screening of all employees we are only looking to see if they are performing any basic screening of supervisory personnel. Silliker will not ask to see any of these screening records. The audit criteria are only applicable for current and future hires, including temporary employees. Silliker is not requiring that a facility goes back and performs checks or screening for employees in place before the program was implemented. The facility must have an education program to ensure employee awareness of (at least) what to do when they see something suspicious (such as product or ingredient contamination) within or around the premises.

(Observation and Review of Records)


1. The facility is complying with their program restricting areas of the plant to authorized personnel only. The facility has systems in place on how to alert personnel about the restricted areas. All access points are secured or monitored according to the program. (5 pts)

• Auditor confirms that the facility

is complying with their program on restricting areas of the plant to authorized personnel only

• Auditor confirms compliance with the procedures to alert personnel about restricted areas (signs, locked doors, etc)

The site can get credit for this question, even if their policy is not documented, as long as they are complying with good food defense practices. If the facility has no sensitive areas, it could maintain that the screening process authorizes employees and there is no internal restriction. However that determination must be made in 9 A 1in the food defense policy. The auditor must verify that no sensitive areas exist. The auditor should assess restricted areas during the audit and ensure there is appropriate signage and that doors are locked and access points are secured and monitored as food defense plan dictates. Auditors should assess roof access as well if stairways to roof are present and accessible. Verification may be required if doors to facility are on the roof. Monitoring or securing all



54• All access points are observed

as being secured and/or monitored appropriately

Verification may be required if doors to facility are on the roof. Monitoring or securing all access points means locked, monitored by an employee stationed in the area, code required for entry, key card required for entry or monitored with a video camera.

2. All visitors must be in compliance with the facility’s program. The visitor policy is posted or provided to all visitors and non-employees. (5 pts)

• All visitors are observed to be in compliance with the facility’s program

• The visitor policy is posted or provided to all visitors and non-employees

Visitation policies should be posted or provided to all visitors and non-employees. All non-employees should be escorted at all times as dictated by the food defense plan. There may be certain vendors (PCO, Contractors) who are given temporary access to the facility without escort.

3. All inbound and outbound trailers are properly sealed or secured. Receiving records and shipping records document the matching of seals to receiving documents or outbound bills of lading. Delivery driver identification is verified. Records document that less than full loads are managed according to the facility policy. Bulk receiving ports and on-site water handling facilities are secured. (5 pts)

• Inbound/outbound trailers are secured (seals match receiving documents and bills of lading)

• Records and observations confirm that receiving records and outbound bills of lading are matched against seals and driver identification is verified

• Less than full loads are verified that they are handled according to policy

• Bulk receiving ports are secured and on-site water handling facilities are secured

Auditor will assess during the audit the trailers, doors, and on-site water handling facilities. All should be secured. Receiving personnel are checking inbound trailers for security and seals matching documentation. All new drivers or unknown drivers within the receiving or shipping areas should be identified and verified with vendor. Bulk receiving ports for ingredients, chemicals, cleaning chemicals, and anything that is received that will come into contact with the product needs to be secured. This would mean capped and secured, or have the port in a cabinet that is secured. Outgoing product residue (spent oil, grease, etc) not for use in human food or animal food (in food chain) does not need to be locked. Less than full loads are checked to ensure they are secured and that all previous access to load has been logged and limited. On-site water handling facilities are properly secured. Auditors should check outbound trailers for use of seals. LTL shipments require multiple seals or locks. If a trailer is used to transport product within a facility perimeter, it does not require a seal, but it does need to be secured. Any trailer in the parking lot that contains product should be at least locked, and preferably sealed. If a trailer is going to outside storage, it needs a seal or lock, even if it is going to a company owned storage center. Auditor will verify that all seals are documented on shipping documentation.

4. Formulas and all formulation software are protected by limited access. Tamper evident packaging is utilized. (5 pts)

• Documents and Software associated with ingredients or finished products have limited access

• Finished product has tamper evident packaging

All software and formulas should be protected by limited access that can include passwords, controlled copies and secured areas. Auditors will check finished products for some level of tamper evident packaging. Tamper evident would basically be defined as not having access to product without evidence of use.



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a

This rating system describes a food plant’s level of compliance with recognized food safety and Good Manufacturing Practices. The point system and definitions are objective guidelines for evaluating the plant’s compliance with the assessed standards and are intended to assure consistency in rating. Comments are provided for any standard rated lower than 5. Questions are scored per the matrix, with 5 being the highest rating possible and 1 being the lowest. If isolated issues for any element are found, an additional one point deduction will be applied to the question’s rating OR if numerous issues for any element are found, an additional two point deduction will be applied to the question’s rating.

Number of elements in the question

>3 elements missed

3 elements missed

2 elements missed

1 element missed

All elements fulfilled

>3 1 1 3 4 5 Rating 3 N/A 1 2 4 5 given 2 N/A N/A 1 3 5 to 1 N/A N/A N/A 1 5 question

Definitions: • Single issue - One observation, occurrence or instance of a specific/same issue or element • Isolated issues - Two observations, occurrences or instances of a specific/same issue or element. • Numerous issues – Three or more observations, occurrences or instances of a specific/same issue or element.

This rating system is an objective guideline. Auditors may use their discretion regarding scoring, considering the severity of food safety issues and numbers of observations of an issue noted. Each plant will receive a total overall score based on the ratings of the individual standards in the audit form. The minimum acceptable numerical score may vary depending upon the company requiring the audit.

Rating Numerical Score Further Guidance Excellent 97% or higher Meets audit expectations

Good 93 – 96.9 % Generally meets audit expectations Fair 88 – 92.9 % Partially meets audit expectations Poor < 88% Fails to meet audit expectations



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