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FSMA SUPPLY CHAIN MANAGEMENT VERIFICATION ACTIVITIES The Onsite Audit

FSMA SUPPLY CHAIN MANAGEMENT VERIFICATION · PDF fileFSMA SUPPLY CHAIN MANAGEMENT The Food Safety Modernization Act (FSMA) established in 2011 by President Obama is the single largest

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FSMA SUPPLY CHAINMANAGEMENTVERIFICATION ACTIVITIESThe Onsite Audit

FSMA SUPPLY CHAIN MANAGEMENT

The Food Safety Modernization Act (FSMA) established in 2011 by President Obama is the single largest legislation reform the food industry has seen since the GMP regulations for food processing were finalized in April of 1969. Food regulation change patterns observed throughout the 20th and the 21st century have been slow to progress. The origination of the Food and Drug Act was passed by Congress on June 30, 1906 to prohibit interstate commerce in misbranded and adulterated products. The next evolution of the Food and Drug Act was passed by congress in 1938 adding new provisions to include cosmetics, drugs, and food. The FD&C Act of 1938 revolution was led by largely women’s groups and others resulting in three new food provisions: standards of identity, quality and fill-of container for food ensuring consumer product quality and safety. Given the FD&C Act's vagueness in establishing violations and thus, the difficulty of enforcing it, FDA began working on draft GMP regulations by the mid-1960's. It's important these GMP regulations described the general rules for maintaining sanitary conditions that must be followed by all food processing facilities to ensure that the statutory requirements were met.

Traditionally, the US and Global Food industry food safety practices under the Codex Alimentarius Hazard Analysis Critical Control Point (HACCP). HACCP was developed by the Pillsbury Company, the US Army and NASA for the production of food in the Space Program in the 1970’s. In 1974 the FDA used HACCP Principals in the development of the low-acid canned food regulations. Almost twenty years later, in 1993 The Codex Alimentarius Commission (Codex) and the US National Advisory Committee on Microbiology Criteria for Food (NACMCF) published the HACCP Principles. HACCP focused on 7 processing principals: the hazard analysis, identity of critical control points, critical limits for each critical point, critical control monitoring, corrective actions, recordkeeping and verification of the HACCP system intent. FDA has HACCP Regulations for Seafood and Juice Products and the USDA has HACCP Regulations for meat and poultry products. Other countries including Australia, Canada, New Zealand and the European Union has endorsed HACCP to mitigate food safety hazards.

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FSMA REGULATION The FDA Regulations development process creation for the final rule ensuring the entire food supply-chain is covered domestically and internationally was a rigorous task. The FDA, Stakeholders, Certification Bodies, Interest Groups, Regulatory Bodies and the Public help mold the existence of FSMA Regulations. It took a little over 3 years for the regulations to become law. The first two regulations to come to fruition were the Human Food (21 CFR 117) and Animal Food (known as Animal Feed, 21 CFR 507). Its implementation date was Sept. 19, 2015. Shortly thereafter, the Produce Safety Rule Regulation (21 CFR 112) became effective Nov. 13, 2015 alongside the Third-Party Certification Body Accreditation Rule (21 CFR 1 Subpart M). In 2016, Sanitary Transportation (21 CFR 1 Subpart O) and Food Defense (21 CFR 121) became law. The Rules (titles abbreviated) above comprise the new FSMA Regulations.

WHO AND WHAT IS COVERED BY FSMA?The most difficult part of the regulations is understanding all the Final Rules. Who is covered by the FSMA Regulation? What industries are effected?

FSMA effects the processing, manufacturing, packaging and holding of human and animal food, (e.g. beverage manufacturers, RTEs) covered produced, dietary supplements and dietary ingredients processed as foods, transportation, foreign suppliers, importers and retailers. The goal is to identify what products under your organization apply to each rule. Some firms will have to apply to multiple Code of Federal Regulations.

The biggest battle is to ensure your organization understands and implements to its applicable regulations.

UNLIKE GSFI SCHEMES OR OTHER FOOD SAFETY SCHEMES, COMPLIANCE TO THOSES STANDARDS ARE VOLUNTARY. FSMA COMPLIANCE IS MANDATORY BECAUSE IT IS FEDERAL LAW.

The Food Safety Modernization Act Regulations:

• Foreign Supplier Verification Program (21 CFR 1 Subpart –L)

• cGMP, Hazard Analysis Risk Base Preventative Controls for Human Food (21CFR 117)

• cGMP, Hazard Analysis Risk Based Preventative Controls for Animal Food (21 CFR 507)

• Standards for the Growing, Harvesting, Packaging and Holding of Produce for Human Consumption (21 CFR 112)

• Sanitary Transportation of Human and Animal Food Final Rule (21 CFR 1 Subpart O)

HACCP systems identify the process-related hazards that can pose a food safety risk if there is an absence of control. The point of control in the process to prevent the hazard from causing illness or injury is called Critical Control Points (CCPs). Critical limits are operational limits established to control the CCP/Hazard and the firm is to monitor tat CCP. This method is a reactive way of approaching food safety hazards and risk.

FSMA Regulations do not dismiss HACCP principles, but incorporate risk-based hazard analysis, preventive controls, setting parameters and values to assess compliance monitoring and corrective actions to make a robust food safety system by preventing food safety hazard. The FDA has set new parameters for the safety of produce, human food and animal food (feed). The 2011 FMSA regulations incorporated new FDA food safety standards to regulate imported foods in the same manner as domestic food. FSMA Regulations were developed to bring transparency to the entire food supply-chain globally from farm to fork.

• Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR 121)

In each of these Federal Rules the general provision articulates who and what is covered. Each Final Rule will have exemption criteria for products and regulations which does not apply to the rule which are process specific. For example: human rule exemptions are alcohol, product for evaluations/research, etc. For more information about exemption on each Final Rule: 117.5 Human Food; 507.5 Animal Food; 112.2 Produce Safety, 1.501 Foreign supplier verification program; 121.5 Food Defense; and 1.900 Storage Transportation.

Once the organization selects the applicable final rule(s), it must determine its compliance dates for themselves and assure suppliers are doing the same.

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DEFINITIONS AND COMPLIANCE DATESThe FDA has defined when organizations must comply with each Rule by categorizing them under the following definitions: other business, small business, very small business, pasteurized milk ordinance, farm mixed- type and qualified exemption facilities. Each rule has a unique definition to categorize businesses by product, process, size and/or revenue. Below each Rule there is a distinct definition for small business and very small business to guide organizations where it stands under the compliance date guide line. Other businesses which do not fall under the small business or very small business definition must comply sooner.

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Human Food Definitions (21 CFR 117.3)

• Small business means, for purposes of this part, a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees.

• Very small business means, for purposes of this part, a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held.

Animal Food Definition (21 CFR 507)

• Small business means, for purposes of this part, a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees.

• Very small business means, for purposes of this part, a business (including any subsidiaries and affiliates) averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (e.g., held for a fee or supplied to a farm without sale).

Produce Safety Rule Definition (21 CFR 112)

• Small business means a farm that is subject to any of the requirements of this part and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $500,000; and the farm is not a very small business as defined in this section.

• Very small business means a farm that is subject to any of the requirements of this part and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $250.00

Foreign Supplier Verification Program (21 CFR 1 Subpart L)

• Very small importer means: (1) With respect to the importation of human food, an importer (including any subsidiaries and affiliates) averaging less than $1 million per year, adjusted for inflation, during the 3-year period preceding the applicable calendar year, in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee); and (2) With respect to the importation of animal food, an importer (including any subsidiaries and affiliates) averaging less than $2.5 million per year, adjusted for inflation, during the 3-year period preceding the applicable calendar year, in sales of animal food combined with the U.S. market value of animal food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee).

Food Defense (21 CFR 121)

• Small business means, for purposes of this part, a business (including any subsidiaries and affiliates employing fewer than 500 full-time equivalent employees

• Very small business means, for purposes of this part, a business (including any subsidiaries and affiliates) averaging less than $10,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).

Sanitary Transportation (21 CFR 1 Subpart O)

• Small business means a business employing fewer than 500 full-time equivalent employees except that for carriers by motor vehicle that are not also shippers and/or receivers, this term would mean a business subject to §1.900(a) having less than $27,500,000 in annual receipts.

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The compliance dates below were set by the FDA. Most organizations have already determined which FSMA Regulations and compliance dates apply to their organization, but have not done so for their supply-chain domestically and internationally. More information on FSMA compliance dates and compliance date extensions latest information can be found on the FDA website. Below is a brief summary of the compliance dates:

Rule Final Rule Date Other Business Small Business Very Small

Business PMO or Modified

21 CFR 117 Human Food

9/17/151 yr. after final rule (9/19/16)

2 yrs. after final rule (9/18/17)

3 yrs. after final rule (9/17/18)

PMO 3 yrs. (9/17/18)

21 CFR 507 Animal Food

9/17/15

After Rule cGMP - 1 yr. (9/19/16)

PC – 2 yrs. (9/18/17)

After Rule cGMP – 2 yrs. (9/18/17)

PC – 3 yrs. (9/17/18)

After Rule cGMP – 3

yrs. (9/17/18) PC – 4 yrs. (9/17/19)

Compliance dates given by FDA

21 CFR 112 Produce Safety

11/27/15

After Rule Produce - 2

yr. (11/27/17) Sprout -1 yr. (11/28/16)

After Rule Produce 3 yrs.

(11/26/18) Sprout – 2 yrs.

(11/27/17)

After Rule Produce 4 yrs.

(11/25/19) Sprout - 3 Yrs.

(11/26/18)

Modified Requirements for Qualified exemption

(1/1/20)

21 CFR 1 Subpart- O

Sanitary Transportation

4/6/161 yr. after

compliance date (4/6/17)

2 years after compliance date

(4/6/18)

Compliance dates given by FDA

Compliance dates given by FDA

21 CFR 121 Food Defense

5/27/163 years after rule

date (7/26/19)4 years after rule

date (7/26/20)5 years after rule

date (7/26/21)5 years after rule

date (7/26/21)

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The Foreign Supplier Verification Program (FSVP) has its own compliance dates according to the Code of Federal Regulations for imported food. The FSVP applies to an importer who is the U.S. owner, U.S. agency, representative or consignee of the food offered for import into the United States. The purpose of 21 CFR 1 Subpart-L FSVP is to verify that foreign suppliers are producing food comply with preventive controls or produce safety regulations to provide a level of public health protection to consumers in the US. It safeguards that the foreign food supply is not adulterated and is not misbranded with respect to allergen labeling. More information and the latest compliance dates can be found on the FDA Website. Compliance date summary for Foreign Suppliers are listed below:

FSVP - RuleFinal Rule

DateOther Business Small Business

Very Small Business

Qualified Facilities

Suppliers Subject to PMO

21 CFR 1 Subpart L w/ no PC or

Produce11/16 May 30, 2017 N/A N/A N/A N/A

21 CFR 117 Human Food

11/16 May 30, 2017 March 19, 2018 March 18, 2019 March 18, 2019 March 18, 2019

21 CFR 507 Animal Food – Subpart B & PC

11/16 May 30, 2017 March 19, 2018 March 18, 2019 March 18, 2019 N/A

21 CFR 507 Animal Food – Subpart C not

Subpart B

11/16 March 19, 2018 March 18, 2019 March 17, 2020 March 17, 2020 N/A

21 CFR 112 Produce Safety

11/16 July 26, 2018 July 29, 2019 July 27, 2020 N/A N/A

21 CFR 112 Sprouts Subpart

M & Qualified Exemption

11/16 July 26, 2017 July 26, 2018 July 29, 2019 N/A N/A

21 CFR 112 Farmed Produce

Qualified Exemption

11/16 N/A July 29, 2019 July 27, 2020 N/A N/A

FSMA SUPPLY CHAIN MANAGEMENTNow that we have reviewed the basic requirements under FSMA Regulations, understanding the requirements can assist you in prioritizing supply-chain management both foreign and domestic suppliers. Supply-Chain Management can no longer be approached monetarily to shave off cents on the dollar when selecting foreign and domestic suppliers; picking and choosing equivalent raw materials, ingredients or finished food products. FSMA changed the way the food industry conducts business, bringing transparency to the entire food supply-chain. The Human Food, Animal Food and Foreign Supplier Verification Program Rule address supply-chain in accordance to the preventive controls identification and risk.

Supply-Chain Management for the cGMP Hazard Analysis Risk Based Preventative Controls for Human Food (21CFR 117), cGMP, Hazard Analysis Risk Based Preventative Controls for Animal Food (21 CFR 507) and Foreign Supplier Verification Program (21 CFR 1 Subpart –L), must comply with regulatory criteria which each organization must perform in order to be compliant with Federal Regulations. So how do you mitigate the risk of the supply-chain? How is the supply-chain controlled and where do you start?

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SUPPLY CHAIN PRIORITIZATION Prioritization is the key to successfully implementing Supply-Chain Controls with numerous suppliers. First, identify the current approved supplier list to identify each supplier’s level of conformance. Most organizations will categorize its supplier by the volume purchased, but is that necessarily the correct way to make a determination based on organization risk? Is that the only factor that comes into play?

Intricately review the current approved supply-chain list dividing suppliers between domestic and foreign. Domestic Supplier will fall under the following Code of Federal Regulations for Human Food, Animal Food, Produce Safety, as well as Sanitary Transportation and Food Defense. International Suppliers importing into the US will fall under the Foreign Supplier Verification Program, Sanitary Transportation and Food Defense.

Once the supplier’s location has been determined, review the type of product and the volume purchased from the supplier. Larger volume product purchases may be of high risk to an organization, but may not necessarily be priority to the supplier due to their compliance date. It is necessary to inform suppliers of the firm’s intentions to comply with FSMA Regulations, request information (via survey or questionnaires) from the supplier and collect data to execute a risk-based analysis of the supply-chain and create a solid Supply-Chain Program.

THE SUPPLY-CHAIN PROGRAMMost organizations already have an extensive supplier approval program based on performance, product specifications, testing analysis, etc. The cGMP Hazard Analysis Risk Based Preventative Controls for Human Food (21CFR 117) Subpart-G describes the requirements for the Supply-chain Program which focus on preventive controls and minimizing the potential hazards. The cGMP, Hazard Analysis Risk Based Preventative Controls for Animal Food (21 CFR 507) Subpart –E also focuses on supply-chain controls. The Foreign Supplier Verification Program (21 CFR 1 Subpart –L) focuses on supply-chain control for imported food from the Human Food, Animal Food, Produce Safety Rules, as well as, Dietary Supplements (21 CFR 111). Each organization must have a written supply-chain program and conduct verification activities for each supplier. Verification activities may vary for each Final Rule, but there are a lot of similarities across the Regulations.

Supply-Chain Control Team QualificationHaving an educated, knowledgeable staff on the Final Rules can better assist the organization transition in the implementation of Federal Regulation. Compliance dates for other businesses are required to be compliant as of September of 2016 for human food and animal food.

Most firms will require to have more than one Preventive Control Qualified Individual to perform approval and review tasks for supply-chain, monitoring, verification, validation, etc. The team collaboration is imperative to manage the Food Safety System in any organization. It will take management commitment to ensure the operation is implementing preventive controls and comply with all applicable legislation.

Periodically testing the implementation of the system and the knowledge of the staff is one of the ways to assess if gaps exist in the Food Safety Program.

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SUPPLY CHAIN PROGRAM ACTIVITIES1. THE HAZARD ANALYSIS A hazard analysis for Human Food, Animal Food and FSVP must be conducted for each supplier to identify if a hazard exists, it is being controlled by the supplier or is it being controlled further down in the supply-chain. Human and Animal Food Suppliers applying preventive controls for the hazard at its facility are required to be part of the firms Supply-Chain Program. Meaning the hazard is controlled before the ingredient is received then it applies to the Supply-Chain Program. If the manufacturer/ processor administers the preventive control of the hazard it does not need to be included under the Supply-Chain Pro-gram, but execute as a preventive control elsewhere in the Food Safety Plan.

The FSVP is required to provide adequate assurance that foreign suppliers for each food imported provides a level of public health protections under FSMA. The haz-ard analysis conducted for human food, animal food and raw agricultural com-modities must identify, evaluate, based on experience, illness data, scientific reports and other information to determine known or foreseeable hazards requiring control. This includes imported food that does not have preventive controls or hazards.

2. USE OF APPROVED SUPPLIERS Supply-Chain applied controls ensure the hazard approval is required before receiv-ing the materials, as well as, justification for temporary exemptions for non-approved suppliers. Firms are required to have written procedures for the receiv-ing of ingredients and its supporting documentation for supplier approval and receiving records.

3. SUPPLIER VERIFICATION ACTIVITES Approved supplier evaluations are called verification activities. Verification activities are those activities other than monitor-ing, that establish the validity of the Food Safety Plan and the supplier’s system is operating according to the plan. The firm

must identify appropriate verification activ-ities and have preventive controls qualified individuals (Human and Animal Food) or qualified individual (FSVP) perform these tasks. The verification activities procedures and implementation with its results need to be documented/archived.

All Verification Activities must be conduct-ed before using, or periodically thereafter, an ingredient or an imported food utilized or imported. Appropriate Supplier Verifica-tion Activities include, but not limited to: an annual onsite audit, sampling and testing, a review of supplier’s food safety records and other applicable verification activities.

Other supplier Activities may consist of supplier performance, FDA written warn-ing letters, historical data, testing of audit results conducted by third parties, supplier transportation practices, etc. Written as-surance from qualified facilities suppliers must be provided to firms assuring Supply-Chain applied controls suppliers will com-ply with food safety regulations. The goal of the Supply-Chain Program, domestic and foreign, is to have total transparency in the supply-chain.

It is important to note: verification activi-ties can be conducted by a third-party. Onsite audits can be conducted by a third-party certification body for the FSVP and an accredited Third-Party Certification Body Approved by the FDA under 21 CFR 1 Subpart-M for all domestic onsite audits. Below, there will be more focus on the onsite audit

4. SUPPLIER NON-CONFORMANCES What happens when verification activities results are non-conforming? What does a firm do? Non-conformities on verification activities can occur from time to time. A firms’ written corrective action procedures would have to address the root cause and the corrective action results comply with the firm’s criteria and FSMA Regulations. A risk analysis and the re-evaluation of the supplier assessment will need to be performed to ensure food safety and the level of public health is adequate to FDA requirements.

Non-conformities corrective actions can be address by confirming a supplier onsite audit, giving the firm peace of mind the corrective actions were completed and

implemented effectively. There are also other methods to confirm implementation of the corrective actions, but the firm must ensure sufficient evidence is collected to rectify the non-conformance and its ef-ficiency.

5. WRITTEN SUPPLY-CHAIN PRO-GRAM The hazard analysis, uses of approve sup-pliers, verification activities, non-conformi-ties/corrective actions, implementation of the Supply-Chain Applied Control Suppliers procedures and activities are documented. Whether it is conducted by the firm or a third-party, the organization must keep re-cords of each activity conducted and have a written Supply-Chain Program Procedure in place.

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THE ONSITE AUDITOne of the most important verification activities is the on-site audit. Organizations must determine if the on-site audit is a requirement under the risked-based hazard analysis. Once that determination is made how will the firm conduct the audit? Do they have a qualified auditor? Are there procedures in place to conduct the onsite audit? Does the firm have the resources to perform the onsite audit themselves or will a third-party be needed?

The FDA set up specific criteria for on-site audits (found in 117.435, 1.506, and 507.135) for Supply-Chain Applied Control Suppliers and Dietary Supplements for the FSVP. On-site Audits must be conducted by a qualified auditor before using raw materials or importing foreign supplier.

If the supplier falls under more than one FDA Food Safety Regulation the onsite audit must consider all applicable regulations and include it in the review of the suppliers written food safety plan. Within the review of this food safety plan the hazards are to be identified with its control. The onsite audit should also consider if the suppliers operates under a Food Safety System that is officially recognized by the FDA or equivalent of that in the US.

Annual Onsite audit may be substituted only when FDA food Safety Audit is performed by a representative of other Federal Agencies, by a state, local, tribal, or territorial agencies representative, a foreign supplier has written results from a FDA inspection or the food safety authority for that country is officially recognized by the FDA or equivalent food safety system. For human and animal food onsite audits conducted by an accredited certification body, audit agent must comply with 21 CFR 1 Subpart-M. This requirement for a certification audit agent is not required for the FSVP.

One of the most important requirements is the documentation of the firms audit procedures. The onsite audit report has to include the date the audit was performed, conclusion of the audits, corrective action, documented by a qualified auditor, document sampling and testing as a supplier verification activity, etc. Some firms may not have the capabilities or qualified personnel to conduct an onsite audit and create procedures to assess its domestic and foreign supplier in accordance to FDA Regulation.

"THE ONSITE AUDIT CAN BE CONDUCTED BY THE FIRM OR A THIRD PARTY (UL REGISTRAR LLC). ENSURE THE ORGANIZATION CONDUCTING THE ONSITE AUDIT FOR THE SUPPLY CHAIN PROGRAM IS A QUALIFIED AUDITOR, THAT AUDIT PROCEDURES ARE IN PLACE AND ARE ADHERED TO IN ACCORDANCE TO FDA REGULATION"

-BARBARA ROMAN RIVERA

If there are any non-conformities during the supplier onsite audit how will the firm conduct its follow up procedure? There is a lot of resource involvement required for an onsite audit to be in compliance with FDA Regulations. The good news is the rule states supplier verification activities can be conducted by a third-party and the firm must have a qualified individual to review the results in a timely manner assessing the documentation for

Qualified Auditor

A qualified auditor is a person who is a qualified individual as defined in this section and has technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function. Examples of potential qualified auditors include: A government employee, including a foreign government employee; and an audit agent of a certification body that is accredited in accordance with subpart M of this part of this chapter.

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UL REGISTRAR FSMA AUDIT SERVICESUL Registrar LLC (UL R) is an independent legal entity within UL’s Consumer Retail Services Division to meet ISO 17065 impartiality requirements. UL R has developed an auditing program in accordance to the FDA Third-Party Accreditation Requirements. It is our goal to impartially and ethically assess organization food safety systems against the FDA Rule(s) with Qualified Auditors. All UL R Food Safety Auditors under the FSMA program are required to have industry experience and PCQI education or be a PCQI Instructor. UL R has years of experience creating auditing procedures, audit tools, assessment reports

and calibrating auditors to audit against FSMA Regulation. We have taken the guess work out of the FSMA onsite audit.

THE UL R AUDIT ACTIVITYUL R utilizes the FDA Quality System Approach per the FDA Compliance Program Guidance Manual: Drug Manufacturing, Inspection Program and follow the guidelines for 21 CFR 1 Subpart-M Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and to Issue Certification. At the present moment UL R can only certify organizations under ANAB Accreditation under our Retail Certification Program and National Brand Certification Program. This certification does not include FDA Third-Party Certification.

THE AUDIT PROCESSUL R has a 5 stage audit process starting with a client agreement and the selection of scope. The initial audit or gap assessment can be conducted at the location agreed upon. During the audit the firm will be inspected by a qualified auditor and the Food Safety System/Quality System, Production, Materials, Facilities and Equipment, Laboratory and Packaging will be assessed. For the Foreign Supplier Verification Program, UL R will assess pertinent documentation for the program in accordance to 21 CFR 1 Subpart L, also by a qualified auditor. During the Assessment nonconformities arise and will have to be address during the post audit process. The corrective action plans with root cause analysis must be submitted and verification can be conducted onsite or offsite. Corrective Action Plans, after an investigation is conducted, may or may not be accepted, warranting a certification decision for accepted plans. The Firm will be audited annually for the compliance of the FSMA program.

Application/ Agreement Selection of Scope, signed agreement

Initial AuditReview of Food Safety System, Identify Nonconformance, Corrective Actions

Post Audit Corrective Action Plan Submitted, Off-site/onsite review of audit

Certification DecisionCorrective Actions Accepted and Verified. Certification under RCP and NBCP (not FDA Certification)

Annual Audit/Revisionof ScopeMaintain Certification or expansion

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SUMMARY + CONCLUSION

For further information on "FSMA", please contact: [email protected] or visit www.UL.COM/CRS/REGISTRAR

Managing the supply-chain for supply-chain applied controls and the foreign supplier verification program can be an overwhelming task. The good thing is that you don’t have to do it alone. You have a team of professionals, whom can assist you in the process of identifying your supplier’s strength and weakness. UL Registrar LLC can also provide the same level of knowledge and dedication to your organization by assessing it for gaps in your Food Safety System against FSMA Regulation. There are so many things to worry about in your organization, let us help you lift that burden of auditing your supply-chain and ensuring your compliance.

UL SERVICES

Contact your CRS Sales Representative or contact UL Registrar LLC directly at [email protected] or 1.800.903.5600 for more information about Third-Party Onsite Audit Verification Activities for your supply-chain management. UL Registrar can also provide FSPCA education for Preventive Controls for Human Food, Preventives Controls for Animal Food, and Foreign Supplier Verification Program Courses. UL CRS can also provide sampling and testing for food products.

+1 800-903-5660 • UL.com

©2017 UL LLC. All rights reserved. This white paper may not be copied or distributed without permission. It is provided for general information purposes only and is not intended to convey legal or other professional advice.