Juice HACCP Regulator TrainingSeptember 2002 Return to Juice HACCP1

Table of Contents1. Introduction 2. Review of HACCP Principles 3. Components of a HACCP Inspection 4. Conducting the Initial Interview 5. Performing Your Own Hazard Analysis 6. Evaluating the Processor's Hazard Analysis 7. Evaluating the Processor's HACCP Plan 8. Determining If the HACCP Plan is Properly Implemented 9. 5-Log Reduction Performance Standard 10.Reviewing Records: HACCP Records 11.Determining if Sanitation Monitoring is Properly Implemented 12.Reporting HACCP Violations 13.Importer Inspections and Imports 14.Special Considerations

Chapter 1

IntroductionThis guidance document for regulator training represents FDA's current thinking on the individual components of a juice HACCP inspection and attempts to provide the tools necessary to conduct inspections of juice processing firms operating under HACCP and to effectively assess their compliance with the Juice HACCP regulation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of applicable statutes and regulations. In addition, this regulator training manual references the Juice HACCP Hazards and Controls Guide which is a draft guidance document that is subject to change, therefore this manual is also subject to change.

BackgroundIn January 2001, the Food and Drug Administration (FDA) issued juice regulations based on the principles of Hazard Analysis and Critical Control Point (HACCP) 21 CFR Part 120. The FDA issued these regulations to ensure the safe processing and importing of juice. All juice sold as juice, or for use as an ingredient in other beverages except juice produced at retail establishments, is subject to the juice HACCP regulations. This includes juice sold in both intrastate and interstate commerce (21 CFR Part 120.1). Juice processors must implement a HACCP based system to be in compliance with the new regulations. Certain critical jobs must be performed by individuals trained in HACCP. These persons are responsible for developing and modifying the HACCP plan and reviewing records. This course, the Juice HACCP Regulator Training Course, is a continuation of the training provided by the Juice HACCP Alliance Training or equivalent. This course will provide you with tools to conduct inspections of juice processing firms operating under HACCP and to effectively assess their compliance with the regulation.

Components and Presentation of TrainingThe training program begins with a quick review of the seven principles of HACCP in the context of the juice HACCP regulation (21 CFR Part 120). It is not our intent to re-teach the HACCP concept. We expect that you already know this from your prior training. We will then cover the individual components of a HACCP inspection, including special considerations for imported juice products. We will discuss performing the initial interview, performing your own hazard analysis, reviewing a processor's hazard analysis, evaluating the processor's HACCP plan, determining whether the plan is being properly implemented, the 5-log reduction performance standard, reviewing records, and documenting objectionable conditions. At the conclusion of this course you will complete a course evaluation.

Chapter 2

Review of HACCP PrinciplesPurposeThe intent of this review is to refresh your memory on how a HACCP plan is developed. Knowing all the stages that a processor goes through in developing a HACCP plan is essential if you are going to audit the processor's HACCP program.

Prerequisite ProgramsBefore a HACCP plan can be developed, a firm must have their prerequisite programs in place. Of

particular importance is a sound sanitation control program. Each processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing (21 CFR Part 120.6). SSOPs outline the firm's controls for ensuring: 1. The safety of the water that contacts the food or food contact surfaces or that is used in the manufacture of ice; 2. The condition and cleanliness of food contact surfaces; including utensils, gloves, and outer garments; 3. The prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product; 4. The maintenance of hand washing, hand sanitizing, and toilet facilities; 5. The protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; 6. The proper labeling, storage, and use of toxic compounds; 7. The control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and 8. The exclusion of pests from the food plant. Processors must keep records that document their compliance with the requirements of Good Manufacturing Practice regulations (21 CFR Part 110). Records (21 CFR Part 120.12) are required that document monitoring and any corrections that are made as a result of the monitoring.

Preliminary StepsOnce a firm's prerequisite programs are in place, the firm should then address the five preliminary steps of HACCP, although these are not mandated by the regulation. They are: 1. 2. 3. 4. Obtain Top Management Support Obtain HACCP Training Assemble HACCP Team Identify Product product description method of distribution and storage intended customer intended use of the product 5. Develop Flow Diagram The processor or individual(s) who will develop the HACCP plan must receive HACCP training (21 CFR Part 120.13), such as training provided by the Juice HACCP Alliance Course. The firm should assemble a HACCP team to conduct the hazard analysis, and to develop and oversee the HACCP plan. The team may consist of management, maintenance personnel, quality control personnel, line workers, and others, including experts, as necessary, from outside the company. The processor's first duty should be to describe the product to be covered under the HACCP plan. The description should include the characteristics of the product, the method of distribution and storage, the intended customer, and the intended use of the product. This information is useful in performing a

hazard analysis. The processor's second duty should be to develop a flow diagram for the product, listing each step in the process, although once again, this is not required by the regulation. Once the flow diagram is complete, the team should verify the accuracy of the flow diagram by walking through the process on the processing floor.

HACCP PrinciplesPrinciple 1. Conduct Hazard Analysis Once the processor completes the five preliminary steps, if they chose to do so, remember these five preliminary steps are not mandated by the regulation, and determines that the prerequisite programs are adequate, the processor must then conduct a hazard analysis (21 CFR Part 120.7). The hazard analysis begins with the HACCP team brainstorming the potential ingredient-related and process-related food safety hazards that could affect the product. They then determine the significance of each potential hazard - whether it is reasonably likely to occur. For each reasonably likely to occur hazard the team needs to identify control measures. The Juice HACCP Hazards and Controls Guide and the Juice HACCP Questions and Answers document are two references that may be used to assist the team in their hazard analysis. The results of the hazard analysis can then be recorded on the Hazard Analysis Worksheet. Remember that the regulation requires that every processor perform a written hazard analysis to be included in their HACCP plan (21 CFR Part 120.7). Principle 2. Determine Critical Control Points (CCPs) After completing the hazard analysis, the processor determines the appropriate critical control points for each of the significant hazards (21 CFR Part 120.8). Remember that a critical control point is a point, step or procedure in a food process at which control can be applied, and a food-safety hazard can be prevented, eliminated, or reduced to an acceptable level. The processor may use the CCP decision tree as a tool in identifying critical control points. Principle 3. Establish Critical Limits Once the critical control points are determined for each of the significant hazards, the processor establishes critical limits for each control measure (21 CFR Part 120.8). The definition of a critical limit is the minimum or maximum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard (21 CFR Part 120.3). Principle 4. Establish Monitoring Procedures The processor then establishes monitoring procedures (21 CFR Part 120.8), to ensure that the critical limits were consistently met. Each procedure should specify: what has to be monitored; how it is to be monitored; the frequency of monitoring; and who is to perform the monitoring.

Monitoring is usually performed using physical or chemical measurements or by observation. It must provide real-time data, but may be continuous or intermittent. Principle 5. Establish Corrective Action Procedures After monitoring, the processor may establish corrective action procedures to be followed when critical limits are not met (21 CFR Part 120.10). If corrective actions are predetermined, they must be included in the HACCP plan (21 CFR Part 120.10). Corrective action procedures must be sufficient to restore control to the process and to ensure that no unsafe product is distributed (21 CFR Part 120.10). The regulations do not require that processors predetermine their corrective actions; but if they do not, they must follow the standard procedure prescribed by the regulation (21 CFR Part 120.10). Principle 6. Establish Verification Procedures The processor then establishes verification procedures (21 CFR Part 120.11). Verification is the use of methods, procedures or tests, in addition to those used in monitoring, to determine if the HACCP system is in compliance with the HACCP plan and whether the plan is adequate to address the significant hazards. Verification may include calibration, product testing at the option of the processor, record review, and plan reassessment. As with the monitoring principle, verification procedures should state both the method and frequency of the procedure. Principle 7. Establish Recordkeeping System Finally, the processor develops a system of recordkeeping to document the accomplishment of the monitoring procedures, corrective action procedures, and verification procedures (21 CFR Part 120.12). The regulations require that monitoring records be listed in the HACCP plan (21 CFR Part 120.12). With that, the processor has developed a HACCP plan. The information may be recorded on the HACCP Plan form, an example of which is provided in the Juice HACCP Hazards and Controls Guide.

Chapter 3

Components of a HACCP InspectionGeneralIt is important to remember that HACCP is only one element of a juice inspection, not the entire agenda. You will need to continue to apply your existing skills to look for violations of other regulations and statutes, such as those relating to economic fraud, filth, sanitation, and good manufacturing practice. HACCP is another tool in addition to those which you are already using, one which is designed to address the safety of the product.

Keep in mind that every inspection is unique. Conditions during an inspection may require you to adjust the inspectional approach provided in this course. You will need to use your judgment at these times. As the course progresses, you will see that your existing inspectional skill of interviewing will be called upon even more than before. Communication between you, plant management, and line employees is important for you to fully understand how the firm's HACCP program works, and to resolve disagreements over whether it is adequate. To begin, the steps of the HACCP portion of the inspection are: 1. 2. 3. 4. 5. 6. 7. 8. Conduct the Initial Interview Perform Your Own Hazard Analysis Evaluate the Processor's Hazard Analysis Evaluate the Processor's HACCP Plan and Determine Whether the HACCP Plan is Properly Implemented Understanding and Evaluating the Processor's 5-Log Reduction Performance Standard Review Records Document Objectionable Conditions

Conducting the Initial InterviewIn addition to identifying yourself, displaying your credentials, and issuing a Notice of Inspection, the primary purpose of the initial interview is to determine which product or products you will be covering during the inspection. This portion of the inspection should be as brief as possible, so that you can take full advantage of the nature of the unannounced inspection.

Performing Your Own Hazard AnalysisThe second component of the inspection, developing your own hazard analysis, is conducted primarily during your initial "walk-through" of the firm. In this phase of the inspection, you will be gathering as much information about the process flow and the firm's controls as you can, both by observation and by interview. This will help you to deduce the significant hazards. This is also an important phase of the inspection for documenting other types of violations.

Evaluating the Processor's Hazard AnalysisYou will then compare your hazard analysis to the firm's written hazard analysis. The firm's opinion of the significant hazards may differ from yours so you will need to be prepared to discuss your judgments and to review the basis of their decisions. Communication is critical at this stage of the inspection.

Evaluating the Processor's HACCP PlanAfter you and the processor have reached agreement on the significant hazards of the processor's juice process, you will evaluate the firm's written HACCP plan. During the evaluation, you will make decisions about the adequacy of the critical limits and the monitoring procedures, among other things.

Determining Whether the HACCP Plan is Properly ImplementedNext, you will evaluate the firm's implementation of the HACCP plan. This evaluation is best

accomplished by observing what occurs on the production floor. It is a continuation of the initial "walkthrough." The goal is to see whether the monitoring procedures contained in the HACCP plan are being accomplished, and that the plan is otherwise being followed.

Understanding and Evaluating the Processor's 5-Log Reduction Performance StandardYou will then evaluate what the processor is using to accomplish the required 5-log reduction performance standard. During this evaluation, you will make decisions about the adequacy of the 5-log reduction and how it is being implemented. Communication and date gathering is critical at this stage of the inspection.

Reviewing RecordsAn integral part of your evaluation of a firm's HACCP plan implementation is an evaluation of the firm's HACCP records. The records you will be reviewing include implementation of SSOPs, the written hazard analysis, written HACCP plan, monitoring records, corrective action records, verification, and validation documents.

Documenting Objectionable ConditionsYou should document any violations of the requirements of the juice HACCP regulations that you encounter during your inspection. FDA inspectors will continue to use the form FDA-483.

Chapter 4

Conducting the Initial InterviewInformation You Will Need to Perform a HACCP InspectionThe first part of the inspection is the initial interview. The initial interview is important because it sets the stage for the rest of the inspection. After you present your credentials and the proper paper work to management, take a brief period of time to collect the information that will help you properly focus your inspection. You will be able to perform the interview more efficiently if you have taken the time before hand to learn what types of juice products the firm processes and how the processing is performed and controlled. This kind of information can generally be acquired from previous inspection reports. Some relevant questions to ask at the start of the inspection include: What juice products do you process?

What are you processing today? How many employees work at the firm? What production lines will you be producing them on? What time does processing begin and when will it end today? How are the products that are being produced today shipped and stored? What is the intended use of the products that are being produced today? Do you have HACCP plans for these products? Do you have sanitation SOPs?

You may notice that some of these questions are asked during the preliminary steps in establishing a HACCP plan. You will need this information in order to develop your own hazard analysis, which will be discussed in the next section.

Choose a Product to Develop Your HACCP PlanUnless your inspection is specifically directed towards a particular product, you should cover one of the products being produced on the day of the inspection. This is important because the adequacy of the HACCP plan and its implementation cannot be fully judged by an in-office review of the plan and the records. If a firm is producing more than one product on the day of the inspection, you will need to determine which product(s) to evaluate. Several factors should be considered in making this decision: The product's potential for a safety hazard The products covered during the previous inspections The firm's compliance history The Juice HACCP Hazards and Controls Guide provides information about the kinds of hazards to expect in the various types of juice. Where past inspections of a firm detected significant problems with HACCP programs for a particular product, your follow-up inspections should concentrate on those, or similar products before moving on to other products.

Chapter 5

Performing Your Own Hazard AnalysisReasons for Conducting an Independent Hazard AnalysisPerforming a complete hazard analysis is crucial to the successful implementation of a HACCP system. It is usually best to avoid looking at the firm's Hazard Analysis, HACCP plan, or Sanitation Standard Operating Procedures until after you have performed your initial "walk-through" and have completed

your own hazard analysis. To establish a plan that effectively prevents food-safety hazards it is important to identify all significant food safety hazards and control measures. Although the processor is required to perform a hazard analysis (21 CFR Part 120.7), it is equally important that you develop your own hazard analysis independent of the processors. The purpose of this independent assessment is to determine whether or not the processor has addressed all of the relevant hazards. This is done by: considering the intended use of the product; determining the method of distribution and storage; watching the processing operation. By doing this before you review the firm's hazard analysis, you independently reach tentative conclusions about the food safety hazards that are reasonably likely to occur, without being swayed by the firm's hazard analysis. It's also necessary to develop your own hazard analysis if the firm did not perform a hazard analysis or performed it improperly.

Performing the Hazard AnalysisYou will conduct your hazard analysis in much the same way as the processor conducts their hazard analysis. However, where the processor may use a HACCP team, you must make decisions on your own. For this reason, your hazard analysis will involve asking a lot of questions of plant management and line employees to learn about the process and where in the process a loss of control could lead to a food safety hazard. Conducting the hazard analysis also involves using your own experience with the industry and applying the information contained in the Juice HACCP Hazards and Controls Guide. The hazard analysis process usually starts with a "walk-through" of the processing facility, from receipt of raw materials to finished product shipping including any alternative product paths for byproducts resulting from fruit extraction that may be added back to the juice later. Depending on the firm, you may or may not be accompanied during this walk-through. During this process, you should: Develop a flow diagram Write a brief process description at each step in the flow diagram Observe the processing operation and ask yourself questions such as: How long does product remain at a processing step? At what temperature is the product held? What is the potential for delay beyond the conditions that you noted? Is there equipment that could cause metal fragments to become incorporated into the product? Are any food additives used? How are raw materials delivered and stored? What instruments are in place for measuring or controlling the process? Ask questions of plant management and line employees, e.g.,: Where do your raw materials come from? What checks do you make on your raw materials? What, if any, information does your supplier provide to you about your raw materials? What time/temperature combination is used to pasteurize the product? (if applicable) How long do you usually hold this product under refrigeration? At what temperature do you hold the product? What is the maximum amount of time that you will hold the product?

Brainstorm biological, chemical, and physical hazards at each processing step in the flow diagram and judge whether the hazard is "reasonably likely to occur" and needs to be controlled. You may want to use a tool such as a CCP decision tree to help you during this process. Determine if the processor is applying any control measures at some point in the process to control the significant hazards, such as: time/temperature controls metal detection raw material screening Document non-HACCP violations as you encounter them, such as insanitation, economic fraud, and filth, etc. Your initial "walk-through" is very often the most likely time to encounter these kinds of violations, so you should pace your HACCP inspection accordingly.

Independent EvaluationAfter you perform the "walk-through" portion of the inspection it is important that you independently evaluate the information that you have gathered. You may wish to transfer the information collected onto a Hazard Analysis Worksheet. If you have any questions concerning the hazards or controls that you identified during the walkthrough this is the time to consult other sources of information that are available, including: Juice HACCP Hazards and Controls Guide; Juice HACCP Questions and Answers; National, district, and state experts; Center for Food Safety and Applied Nutrition experts.

The Juice HACCP Hazards and Controls Guide will ordinarily be the first reference. This is a valuable reference for juice processors. You may also contact national, district and state Experts, including those at the Center for Food Safety and Applied Nutrition. At this time, you should make your best judgment about the significant hazards, control measures, and critical control points that the processor is utilizing to provide a safe juice product.

Chapter 6

Evaluating the Processor's Hazard AnalysisComparing Flow DiagramsAfter you have performed your own hazard analysis you will review the processor's hazard analysis. The first step in this process is to make sure the firm has included all of the process steps in their

hazard analysis; you can do this by comparing your flow diagram to the steps outlined in the processor's hazard analysis. Some firms may not have prepared a flow diagram or may not choose to share it with you. There is no regulatory requirement for either. If the process steps do not match, you should revalidate your own flow diagram and discuss the differences with the firm's management. It is possible that either you or the firm missed something during the development of the flow diagram. It is important that no process step is missed, including process steps that involve diverted product because it could affect the validity of the hazard analysis and could add or eliminate a hazard or critical control point.

Comparing Hazard AnalysesUnder the regulations, juice processors are required to have a written hazard analysis (21 CFR Part 120.7) in addition to or as part of their HACCP plan. You're now ready to look at the firm's hazard analysis. The goal of this step is to compare the processor's list of potential hazards, their decisions about the significance of the potential hazards, their list of control measures, and their CCP determinations, with the information contained in your own notes. The firm should identify the specific hazards that are present, not just the type. For example, the term "microbiological hazards" may not be descriptive enough. Controlling Salmonella and Escherichia coli, may require distinct control strategies and therefore should be identified. In your hazards analysis, determine if the same significant hazards that you identified are named as significant in the firm's written hazard analysis. When they are not, interview the processor to determine the reason(s) for the difference(s). Does the firm's reasoning concur or conflict with: Information contained in the Juice HACCP Hazards and Controls Guide? Your own experience? The experience(s) of national, regional, or district experts? Do your best to resolve differences between your hazard analysis and the processor's. There may be a good reason a processor controlled a hazard in a way that is different than that outlined in the Juice HACCP Hazards and Controls Guide. However, understand that if there is a control measure utilized that is different from that listed in the Guide, it is the burden of the processor to provide an equivalent level of control. Remember the Guide is a guideline and not a regulation. It is possible, and appropriate, that a processor judged some hazards as insignificant because of the existence of prerequisite programs, such as sanitation. For example a pasteurized juice processor may determine that pathogen recontamination is a significant hazard after the heat process, but because their existing sanitation program controls the hazard, a CCP was not mandated. In this case, the firm's sanitation monitoring program should include checks on their recontamination controls. Also, hazards should not be ruled as not reasonably likely to occur because of the existence of control measures. For example, it would be inappropriate for an apple juice processor to conclude that the hazard of patulin is not significant because the firm is controlling the hazard by buying apples from reputable growers. In this case, the control measure(s) is purchasing apples from known growers and that should be monitored as part of their HACCP plan. As was previously referenced, some hazards may be controlled by controlling sanitation, in a program separate from HACCP. You should consider sanitation controls at the very beginning of your inspection. By determining which hazards are controlled by a processor's sanitation monitoring program - "ruling them out," so to speak - you will be left with fewer significant hazards that need to be controlled in the HACCP plan. If the firm's hazard analysis relies upon sanitation controls to control

certain hazards, the firm's sanitation records should indicate that the hazard is being controlled. If after reviewing the sanitation records you determine that the controls are ineffective, you should consider whether the hazard analysis was based on inappropriate assumptions. This could result in an inadequate HACCP plan. After reviewing the firm's Hazard Analysis, compare the firm's number and placement of CCPs and control measures with your own determinations.

Hazard Analyses that Do Not MatchYou may find that the firm has additional hazards or CCPs, fewer hazards or CCPs, or CCPs in different locations. What if the processor does not have a written hazard analysis? The firm is in violation of 21 CFR Part 120. This condition should be documented as such. Collect as much information as available and submit it with your establishment inspection report. This will help agency experts review the case. What if the processor identified MORE CCPs than I did in my Hazard Analysis? If the firm has additional hazards, you will first need to determine if they are all food safety related. You may find that some relate to quality or economic fraud. For these non-food safety hazards, tell the firm that the hazard is not referenced as a food safety hazard in the Juice HACCP Hazards and Controls Guide; and you will concentrate your efforts on food safety related hazards and CCPs. The firm is free, however, to include such hazards in their plan. You may find the firm has identified some significant food safety hazards that you did not consider, or which you determined to be insignificant. Or, you may agree on the hazards, but the firm may have identified CCPs that you did not identify. In either case, engage the firm's management in a discussion about why they selected the hazards or the CCPs. There may be something about the food or the process you did not know that caused the firm to make the determination they did. The goal is to understand the firm's rationale for the extra controls. You will have to use judgment about whether to change your initial determination, using any available references. If you remain unconvinced about the significance of the hazard, do not expend any effort to review controls for the hazard or the CCP. If appropriate, you can point out that a HACCP plan may lose focus if points are unnecessarily identified as CCPs, and that too many CCPs may reduce the effectiveness of the HACCP plan. If you see some validity in the firm's contention that the hazard is significant, and that the CCP is appropriate, you should proceed as if it were a significant hazard or a CCP. Be sure to collect any documentation that supports the firm's contentions. A final agency position on the significance of the hazard or the CCP can be made, if necessary, during the agency's review process. What if the processor has identified FEWER CCPs than I did in my Hazard Analysis? If the processor has identified fewer hazards or CCPs then you determined were present, you should ask the processor to justify the difference. If the processor does not convince you that the additional hazard(s) you identified are insignificant, or that the hazard is being properly controlled through other CCPs, you should document the condition. Again, remember to use any available references. It is important to collect documentation supporting the firm's point of view, and submit it with your establishment inspection report. That will help agency experts review the case. What if the firm has identified CCPs in different locations?

A critical control point can be established at any process step where you can effectively apply control. If the firm has different locations for CCPs than those you determined, again find out why. When you use the Juice HACCP Hazards and Controls Guide as a reference, remember that control strategies other than those specified in the document may also be effective. When a processor is using another control strategy, compare the level of safety assurance that you believe it provides to the level of assurance that the strategies contained in the Hazards and Controls Guide provide. Document the condition if you remain unconvinced that the firm's strategy provides at least the same level of assurance.

Chapter 7

Evaluating the Processor's HACCP PlanHACCP Plan OverviewAfter you have settled on the appropriate hazards reasonably likely to occur and critical control points, the next step is to take a look at the firm's HACCP plan to see whether these hazards are properly controlled at the CCPs. You should look at the in-plant operations for a product even if the firm does not have a HACCP plan. In this case, you must determine whether the necessary controls may be in place, despite the absence of a written plan. Therefore, existence or absence of a HACCP plan should not ordinarily affect your selection of a product for coverage during an inspection. The HACCP plan itself may consist of a one-page document or a group of related documents. For example, a process authority may have provided a process establishment letter that sets the critical limits for a pasteurization process. This should be listed as part of the firm's verification procedures in the HACCP plan, and may be attached to the plan as a supporting document. Additionally, not every processor will use the standardized HACCP Plan Form that is provided in the Juice HACCP Hazards and Controls Guide.

Reviewing the Firm's HACCP Plan DevelopmentNext, determine who developed the plan. The juice HACCP regulation requires that the person or persons developing, verifying and modifying the plan be trained in the application of HACCP principles to juice processing (21 CFR Part 120.13). This can be accomplished either by completing a standardized course, or through experience. The trained individual does not have to be an employee of the processing firm (21 CFR Part 120.13). The most straight-forward way for a processor to meet this requirement is to have the person who is going to develop and modify the plan and perform record review attend a training course based on a standardized curriculum recognized as adequate by the FDA or an equivalent (21 CFR Part 120.13). HACCP training is also available from a variety of other sources. None of these have been specifically recognized as meeting the requirements of the regulation, although many probably do. You should collect relevant information about the course(s) the individual(s) attended - the course date, and

provider in order to confirm appropriate HACCP training. If the individual's training requirement is met by on-the-job experience, you should collect relevant information about that position, responsibilities of the individual, and years of experience. Unless the firm has clearly not met the training requirement, you should not ordinarily challenge the HACCP-trained person's qualifications. The real test is whether the firm can properly develop and implement a HACCP plan. If your inspection discloses serious violations of the regulation that cast doubt on the processor's understanding of HACCP concepts, you should document those findings, with the information that you collected about training, in your inspection report for review by the agency.

Signature of the HACCP PlanThe signature or initials on the HACCP plan identifies the creator of the record. If the plan is developed by an outside contractor, the signature or initials identify the processors official who accepted the plan (21 CFR Part 120.12). The person signing the plan must be the most responsible individual on site at the processing facility or a higher company official (21 CFR Part 120.12). The plan must be signed initially, whenever it is modified, and at least annually (21 CFR Part 120.11 and 120.12). Determine if it has been signed within one year of your inspection. Also, if during the inspection you learn about a modification in plant operations within the last year that caused the plan to be modified, look to see that the plan was re-signed at that time, or shortly thereafter.

Firms Without HACCP PlansThe regulation requires juice processors to have and implement a HACCP plan whenever the hazard analysis reveals one or more food safety hazards that are reasonably likely to occur during processing (21 CFR Part 120.8). We don't expect a large percentage of the industry will be able to support a claim that there are no significant hazards in their products, but some probably will. Therefore, some firms may not have a HACCP plan because they do not need one. Others may not have a plan because they did not know that they needed one or because they chose to ignore the requirement. Not having a HACCP plan when one is required is a serious violation of the regulation (21 CFR Part 120.9).

Technical Requirements of a HACCP PlanYou need to evaluate the technical aspects of the plan. It is here where you will really begin to apply your understanding of HACCP. You may begin by asking yourself the following questions: Is the HACCP plan specific to this processing location and this type of juice? Does the plan include a written hazard analysis that identifies all food safety hazards that are reasonably likely to occur for that product? (Principle 1) Does the plan list the critical control points for each of the identified food safety hazards that are reasonably likely to occur? (Principle 2) Does the plan identify critical limits for each CCP? (Principle 3) Are the critical limits appropriate? (Principle 3) Does the plan list the procedures that will be used to monitor each of the CCPs to ensure compliance with the critical limits? (Principle 4) Does the plan list the frequency of the monitoring procedures? (Principle 4)

Is the monitoring and the frequency of that monitoring appropriate for the product? (Principle 4) Does the plan describe corrective action procedures that are both process and product specific for each critical limit? Keep in mind that processors are not required to predetermine corrective actions. If not, does the processor understand the regulation mandated corrective actions? (Principle 5) Are any corrective action procedures that are listed appropriate for the product? (Principle 5) Does the plan provide for a record-keeping system that documents the monitoring of the CCPs, corrective actions, and verification procedures? (Principle 6) Do these monitoring records contain actual values and observations? (Principle 6) Are verification and validation procedures, such as product testing and HACCP plan review, included in the plan? (Principle 7) Is the frequency of verification and validation procedures included in the plan? (Principle 7) As will be discussed later in this course, the juice HACCP regulation specifies that processors of juice products must include in their HACCP plans control measures that will consistently produce, at a minimum, a 5-log (or 100,000 fold) reduction in the pertinent microorganism for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions (21 CFR Part 120.24). If the firm's hazard analysis indicates microbiological hazards, you should see in the firm's HACCP plan, validated treatments intended to achieve a 5-log pathogen reduction.

Review of the HACCP Plan Hazards, CCPs and Critical LimitsThe plan may or may not list all of the reasonably likely to occur hazards, critical control points or critical limits that you have identified. Those which are not included but which you have identified as necessary should be cited as objectionable conditions, as we discussed in the previous session. The initial step in reviewing the firm's control strategy is to compare it to those strategies that are described in the Hazards and Controls Guide. Remember to use the Hazards and Controls Guide as a guideline and compare controls included in the processor's plan to those in the Hazards and Controls Guide to determine whether they provide an equivalent level of control. For example, a firm may base its critical limits on information other than the Hazards and Controls Guide. In this instance you'll need to review the information and determine if the critical limit is sufficient to control the identified hazard. You should rely on experience and any available references. You may not be able to make that determination during the inspection if the firm's scientific data needs to be evaluated by other FDA personnel. In this case, you should gather all pertinent information and submit it with your inspection report. Examples of HACCP control measures used in the processing of juice that you may encounter include: the thermal processing of juice for the elimination of microbial pathogens, culling (or trimming) of apples after storage to eliminate moldy, damaged, or rotten apples to ensure that patulin will not be present at levels of concern in the finished apple juice, or observing processing lines for evidence of glass breakage. Remember that some actions undertaken in processing juice are not HACCP control measures, such as Good Agriculture Practices (GAPs), Current Good Manufacturing Practices (CGMPs), and Sanitation Standard Operating Procedures (SSOPs).

Reviewing Monitoring ProceduresWhen reviewing the firm's monitoring procedures, check to see that the monitoring frequency is

sufficient to detect any deviations from the critical limits. Continuous monitoring is not always required, but, in many cases, it is the only way to assure that the limit is consistently met. If discontinuous monitoring is used, look carefully to see whether the critical limit could be violated between monitoring events, without being detected. Do not be bound by traditional means of monitoring. Industry implementation of HACCP will undoubtedly require some changes, and one likely area of change is monitoring equipment. Ask the firm for an example of each monitoring record that is listed in the plan, so that you can determine whether the documentation is sufficient to cover the monitoring being performed at the prescribed frequency, and that the critical limits were met. When you review the firm's completed monitoring records later, you will be able to take a closer look at the firm's ability to monitor the critical limits.

Reviewing Corrective ActionsIf the firm includes predetermined corrective actions in its HACCP plan, you should assess the adequacy of those actions. The corrective action must return control to the process by fixing the cause of the deviation, and it must ensure the safety of the product produced under the deviation (21 CFR Part 120.10). Keep any predetermined corrective actions in mind, so that when you review the firm's records you can verify that the prescribed corrective action was taken when needed.

Reviewing Verification ProceduresThere are three basic verification procedures. These include records review, calibration of process monitoring instruments (or other instruments), and product testing. Virtually all process-monitoring instruments need to be calibrated. Look for calibration procedures and frequencies in the plan. When monitoring procedures are weak, verification procedures should be strong to compensate. For example, if a processor uses a supplier's guarantee as his monitoring procedure, he may need to couple it with periodic product testing as a verification tool, in order to ensure control. The entire control strategy for a particular food safety hazard is interrelated. You should not look at one component, for example, the monitoring procedure, individually. You should look at the entire strategy and determine whether it is likely to control the hazard. One example is the coupling of monitoring and verification procedures. Another example is the inter-relationship between the critical limit and the corrective action. The point at which a processor sets his critical limit will, in part, determine what options are available to him when the limit is not met. Remember, in essence, verification is ensuring that the processor is following what they say they will follow. A mandatory verification procedure for citrus juice processors that use exterior cumulative surface treatments to achieve the 5-log reduction performance standard is conducting finished product analysis. The regulation is very specific regarding the analysis; you must ensure that the firm is following the steps as outlined in the regulation. The regulation is also very specific in regards to corrective actions that must be taken in response to positive identification of E. coli. You need to ensure that the firm is following these corrective action procedures, when necessary, as outlined in the regulation. Obviously, ensuring that the juice processor is following their HACCP plan and sanitation monitoring through a comprehensive records review is one of the primary functions of verification.

Reviewing Validation ProceduresValidation is a subset of the overall verification system. In validation, the processor is checking to ensure that the system, as set up, will actually control those hazards identified in the HACCP plan. For example, is the process time and temperature (and other related critical factors) in a flash-pasteurizer adequate to ensure a 5-log reduction of the most pertinent microorganism of concern? A prudent processor would have support documentation available to "back-up" their decisions at critical control points. For example, a study to show a certain time/temperature set-up is effective to ensure microbiological inactivation at the 5-log level. Validations of the HACCP plan must occur at least once within 12 months after implementation of the HACCP plan and at least annually after that or whenever any changes in the process could affect the hazard analysis or the HACCP plan. If a processor does not have a HACCP plan because they have determined that no reasonably likely food hazards are likely to occur, the processor must still validate the adequacy of the hazard analysis whenever there are changes in the process (21 CFR Part 120.11).

Chapter 8

Determining if the HACCP Plan is Properly ImplementedBasis for Determining HACCP Plan ImplementationAfter you conduct your own hazard analysis, compare that analysis to the firm's hazard analysis, and evaluate the firm's HACCP plan, the next step is to determine whether or not the firm has properly implemented their HACCP plan. In other words, is the firm doing what they say they are doing in their HACCP plan? This element of the HACCP inspection may be one of the most important aspects of your inspection. You start this process by asking, "Does this plan reflect what is happening in the plant?" This is accomplished in two ways: observation and interview. Observation A large part of your job is observation. For example, you determine whether or not a plant is clean by observing the clean up operations at the facility first and then observing any evidence of insanitation after the cleanup. In the same way, if a firm's HACCP plan says that they are monitoring product temperatures every four (4) hours, you should observe the firm's employees to see if they in fact take the temperatures at the proper frequency and in an appropriate manner. Time in the plant also helps to verify the integrity of the records. Are they really prepared in the manner that they appear to be? Remember, during the in-plant portions of your inspections, you should always continue to look for other kinds of violations, such as insanitation, filth, economic fraud, decomposition, etc.

Interview Interviewing managers and line employees can serve the same purpose. Properly conducted, they are an important tool for sorting through the large number of issues that must be addressed in assessing whether the processor is properly implementing their HACCP plan. These interviews will, in many cases, enable you to identify those areas where you are satisfied that things are under control and those areas where you believe that further investigation is warranted. Wherever possible, negative findings from an interview, especially an interview of a line employee, should be verified by observation, or checked with other evidence. Interviewing line employees may be necessary to further an investigation. However, it is not appropriate to interview an employee when it is clear that they are busy. Distracting an employee not only disrupts the firm's production but may also create safety hazards.

Purpose of Observation and Interview InformationThe purpose of interviews and observations is not only to determine whether or not the firm is following their HACCP plan but also give you valuable information to use during record review. You will do a much better job of reviewing records if you have a good understanding of how the firm and its employees implement the plan. Through observation and interviewing, you can determine how, at what time, and under what conditions the monitoring is being performed. You can determine who performs the monitoring and judge their competency. You can learn about the equipment and instrumentation and its limitations. The answers to these questions and other questions will help make sense of what otherwise might appear to be a stack of sterile paper. The bottom line is you will know what the employee is filling out on the records and why.

Verification of HACCP Plan ComponentsIn order to determine if the firm's HACCP plan is being properly implemented, there are several components of the plan that should be verified in-plant. Some of the more important issues are: Is monitoring performed as prescribed by the plan? Is monitoring performed at the prescribed frequency? e.g., If the plan calls for hourly monitoring, are they actually checking every hour, or is the employee too busy or disinterested to monitor that often? Is the appropriate monitoring equipment available? Sometimes the plan will prescribe specific equipment. In other cases, you will have to use your judgement to determine whether a particular piece of equipment is right for the job. Is the monitoring equipment operated properly, and in good working order? e.g., If the equipment is provided with a mercury-in-glass thermometer does it have a divided column? Is the recording thermometer accurately keeping time? Is the monitoring equipment calibrated as prescribed by the plan? e.g., Is the mercury-in-glass thermometer calibrated yearly as outlined in the plan? Are the monitoring results accurately and promptly recorded? Monitoring results must be recorded at the time of the observation, not beforehand, and not significantly after-the-fact. The actual values must be recorded, not judgements, such as

"meets," or "exceeds." You should check the readings on monitoring equipment to see if the values correspond with what the firm has recorded. For example, check the temperature of the cooler with your own calibrated thermometer, and check the concentration of a sanitizer solution with your own test strips. Are corrective actions taken after critical limit deviations? Corrective actions should correct the cause of the deviation and ensure that no unsafe product is distributed. Remember that the firm does not have to predetermine their corrective action (s). If corrective actions are predetermined, processors must follow their own HACCP plan or the standard procedures outlined in the regulations. If corrective actions are not predetermined, processors must follow the standard procedures (21 CFR Part 120.10). Are corrective actions properly documented? Are other verification procedures, such as product testing, performed as prescribed? Where required, are verification procedures properly documented?

Chapter 9

5-Log Reduction Performance StandardBackgroundProcessors of juice products must include in their HACCP plans control measures that will consistently produce, at a minimum, a 5 log (or 100,000 fold) reduction in the pertinent microorganism for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions (21 CFR Part 120.20). The 5-log pathogen reduction standard is intended to assure that juice is safe regardless of the method used to process it. The standard is based on the expert advice of a panel of recognized food safety experts, the National Advisory Committee on Microbiological Criteria for Food (NACMCF).

"Pertinent Microorganism"The likelihood that a pathogen present on fruit will survive in the juice depends on the type of pathogen and its ability to survive in the conditions of the juice. There are many factors that may affect the survival of any microorganism in a juice product such as the pH of the juice or pH of the treatment process, brix, viscosity, total solids, the presence of particulate material, temperatures of treatment(s), and even color. The pertinent microorganism is defined as the most resistant microorganism of public health significance that is likely to occur in the juice (21 CFR Part 120.24). The 5-log reduction performance standard is applied to the population of the most pertinent microorganism. The pertinent pathogen may not be the same for all juice products or all processes. For example, E. coli O157:H7 and Cryptosporidium parvum are both pathogens likely to occur in apple cider. However, Cryptosporidium parvum is more heat resistant than E. coli O157:H7 is, therefore, if you were pasteurizing apple cider, Cryptosporidium parvum would be the pertinent organism of concern. On the

other hand, if the firm is using UV light to treat the juice, the pertinent pathogen may or may not be Cryptosporidium parvum as the relative resistance of a pathogen is not necessarily the same as its resistance to heat treatment.

ExemptionsThere are exemptions from the mandatory 5-log reduction that are to be included in a processor's HACCP plan. Firms that may claim exemptions include (21 CFR Part 120.24): 1. a juice processor that is subject to the requirements of 21 CFR part 113 or part 114 and 2. a juice processor who uses a single thermal processing step sufficient to achieve shelf-stability of the juice or a thermal concentration process that includes thermal treatment of all ingredients. However, these processors must include a copy of their thermal process used to achieve shelf-stability or concentration in their written hazard analysis (21 CFR Part 120.24). During the inspection you will have access to the firm's hazard analysis and you should confirm that their process does result in a shelf-stable product, therefore exempting their juice from the 5-log pathogen reduction requirement.

Parameters of the 5-Log TreatmentThe 5-log reduction must be applied to the population of the pertinent microorganism that may be in a juice product (21 CFR Part 120.24). For our purposes, each log represents a 10-fold difference in the number of bacterial cells in a juice, for example, 1-log is equal to 10, 2-log is equal to 100, 3-log is equal to 1000, 4-log is equal to 10,000, and 5-log is equal to 100,000 cells. Therefore, if you were going to reduce 100,000 bacterial cells by 5-log, you would need to reduce the population to 1 cell. Alternatively, if you started with 100 bacterial cells, you would need to go down to 0.001, less than one cell. Of course, the 5-log reduction standard doesn't apply to a hypothetical number. So, while you cannot reduce 100 cells to less than 1 cell, you can go from finding 100 bacterial cells in one cup of juice to finding 1 cell in 100 cups of juice. All juice processors subject to the 5-log pathogen reduction performance standard must achieve the 5log reduction by treatment of the extracted juice with the exception of citrus juice processors (21 CFR Part 120.24). The 5-log reduction, whether applied as a single treatment or as cumulative treatments, must be accomplished within a single production facility where the juice will be packaged into its final form (21 CFR Part 120.24). The facility must be operating under current GMPs. Note that processors who claim the exemption must also process and perform final product packaging of all juice subject to the exemption within a single production facility that is operating under current GMPs (21 CFR Part 120.24). [NOTE: A new guidance document from CFSAN regarding bulk concentrate transport and the 5-log reduction is currently under review by the Center and General Counsel]. During your "walk-through," make a note of the 5-log treatment that the firm is employing. You should ask yourself: Is the facility operating under cGMPs? Is the 5-log treatment applied in a single production facility where the final product will be packaged? Is the 5-log treatment applied to the extracted juice for non-citrus juices?

Citrus Although many citrus juice processors may elect to apply 5-log reduction treatments to the extracted juice, they also have the option to utilize treatments applied to the fruit surfaces provided that the treatment process begins after culling and cleaning of the fruit. Cleaning is defined as washing with water of adequate sanitary quality and culling means the separation of damaged fruit from tree-picked, undamaged fruit. No dropped fruit, damaged fruit or ground harvested may be used for this type of juice product. Surface treatment processes to accomplish the 5-log standard for citrus juices may involve a series of cleaning, brush washing, and sanitizing steps. The 5-log pathogen reduction standard, whether it is applied as a single surface treatment or as cumulative surface treatments on citrus must be validated (21 CFR Part 120.24). Furthermore, all such cumulative treatments for the 5-log reduction must occur in one facility prior to final consumer product packaging (21 CFR Part 120.24). For some citrus products, the extraction method may also be part of the cumulative 5-log reduction. Validated extraction methods that may be included consist of a single pinpoint extraction method. For this method, only a single puncture is made and care is taken that the peel of the fruit is not brought into contact with the extracted juice. Remember that the use of cumulative surface treatments will require a number of validation and monitoring steps that must be detailed in the firm's HACCP plan (21 CFR Part 120.24). You should expect the firm to validate and monitor such things as: the concentration of the chemical used; the pH of the treatment; the duration of exposure to the treatment; and the temperature of treatment.

Validation of the 5-Log TreatmentOnce the pertinent pathogen for the product has been determined, the firm must validate the process they use for the 5-log reduction (21 CFR Part 120.11 and 120.24). Validation needs to be performed with clearly defined physical and chemical parameters. In addition, if the firm is using a model pilot system, whole citrus fruit or other juices that have been artificially inoculated or inoculated at higher then normal pathogen levels, confirm that additional studies have been conducted to ensure that the pilot production method accurately mimics real plant production conditions. Under the juice HACCP regulation, use of surface treatments on citrus for achieving the 5-log pathogen reduction standard requires that end product microbial testing be implemented as part of the verification process. End product testing for citrus juice is detailed in 21 CFR 120.25. Testing consists of examining a specific amount of juice for the presence of non-pathogenic E. coli. One 20 mL sample consisting of two 10 mL subsamples for each 1,000 gallons of juice produced must be sampled each production day (21 CFR Part 120.25). If less than 1,000 gallons of juice is produced per day, the sample must be taken for each 1,000 gallons produced but not less than once every 5 working days (21 CFR Part 120.25). Each subsample shall be a randomly selected package of juice ready for consumption by the consumer. If either 10 mL subsample is positive for E. coli, the 20 mL sample is recorded as positive and the processor must take and document appropriate corrective actions to ensure that the process achieves a 5-log reduction in the pertinent microorganism (21 CFR Part 120.25). If, in a series of 7 tests, 2 samples are found to be positive for E. coli, then the process to

achieve the 5-log reduction standard will be assumed to be inadequate and corrective steps must be taken (21 CFR Part 120.25). A review of the firm's HACCP plan and records should verify the procedures for end-product testing, implementation and monitoring of the testing, and any deviations and subsequent corrective actions taken in response to positive identification of E. coli. Corrective actions may include the use of an alternate process to achieve the 5-log reduction on the extracted juice, an extensive review of monitoring records to determine if control measures were properly applied. The corrective action taken must ensure that no product enters commerce that is dangerous to the health of consumers. Validation of the HACCP system will need to be documented within 12 months of implementation and at least once annually. If, at any time, the firm's process or product changes significantly from the original HACCP plan, the entire process may need to be re-validated (21 CFR Part 120.11). In addition, once a system is in place, the processor must maintain records to verify that the firm is following the procedure and monitoring as required by the HACCP plan (21 CFR Part 120.12).

5-Log Treatment Methods for Extracted Juices PasteurizationPasteurization is a heating method commonly used to reduce the number of pathogens in fluid products. The purpose of pasteurization is to provide only enough heat to destroy pathogenic microorganisms and possibly to inactivate food enzymes in the juice. Pasteurization will not kill all microorganisms present and will not provide a shelf-stable product. Some processors will use a heat treatment that goes far beyond pasteurization that will result in a shelf-stable product. As discussed previously, shelf-stable products are exempt from the 5-log pathogen reduction requirement provided that the processor includes a copy of their heat treatment with the written hazard analysis (21 CFR Part 120.24). Pasteurization has historically been used for fluid milk and appropriate heating requirements for dairy products are well established. Unfortunately, appropriate parameters for juice products are not as well established. However, factors that will influence the efficacy of such a heat treatment are well known and characterized, for example, higher solids content in the product will require a more extensive heat treatment. Given the many factors that may influence the efficacy of thermal treatment, it is important that any pasteurization process be validated for each specific product. The actual validation process requires a high level of expertise in the field of food processing. Processors will most likely consult with process authorities for assistance with validation procedures. The Juice Guide will also provide assistance in this area. You should be aware of the two types of thermal pasteurization methods used in juice processing. Batch Method The first type of thermal pasteurization is known as the batch method. In the batch method, heat is applied to one large lot, or batch, of juice. The temperature is brought up to the point where it will result in the inactivation of pathogenic organisms. The entire batch of juice is held long enough to ensure the pathogens are reduced in population by at least 5-log. Following the holding period, the juice is cooled.

During your walk-though and when you review the firm's records, you should observe that the temperature is monitored to ensure adequate heat treatment. Also, it is important the firm monitors the length of holding time, and the cooling step as detailed in their HACCP plan. If the critical temperatures and times deviate from those specified in the HACCP plan the firm must make and document corrective actions. Continuous Method The second type of thermal pasteurization is known as the continuous method. In this process, juice is pumped at a specific rate from a storage vessel to heat exchanger plates and brought to the temperature required for pathogen destruction. From the heat exchanger the juice continues through holding tubes. The holding tubes are insulated pipes that will maintain the juice at the temperature required for pathogen destruction. These holding tubes need to be designed long enough and large enough, with proper slope to ensure the juice maintains the appropriate temperature for an appropriate length of time to achieve the 5-log standard. How long the juice remains in the holding tubes will be determined by the pump rate. Therefore calibration and proper operation of the pump will be important to the success of such a process. Following the holding period, the juice will once again pass through heat exchangers to bring the temperature back to what is required for hot or cold filling and packaging. Continuous systems have an advantage over batch systems in the speed at which they can heat and cool the product. Consequently, the amount of heat applied can be better controlled. Temperatures used in the continuous method are usually higher than those used in a batch system. This results in faster destruction of the pathogen and a much shorter holding time is required. For this reason, such systems are called "high temperature short time" or HTST pasteurization. Some processors will use very high temperatures in order to further reduce holding times to seconds instead of minutes. Such systems are referred to as "flash pasteurization" or ultra-high temperature, UHT systems. In addition to heat exchangers and holding tubes, HTST systems frequently contain "flow diversion valves." The purpose of such values is to redirect any juice that does not meet the minimum temperature requirement back to the storage tank for reprocessing. Such flow diversion valves are a very important safety feature of this type of equipment. If the firm's equipment does not have such a feature, and the juice fails to meet minimum temperature requirements specified in the HACCP plan as critical limits, the firm must document that the juice was separated to be reprocessed at a later time (corrective actions as specified in 21 CFR Part 120.10). For all such systems, the firm is required to monitor temperatures throughout the processing and ensure that appropriate holding times and temperatures for the process are maintained as outlined as critical limits in their HACCP plan (21 CFR Part 120.8), unless the firm qualifies for the shelf stable/concentrate exemption as outlined in the regulation in 21 CFR Part 120.24.

Alternative TreatmentsAlthough pasteurization is currently the most common and well-studied process for achieving the 5-log standard, other methods do exist and are becoming more popular. However, as with pasteurization, the use of any new technology will require proper validation and documentation of the 5-log reduction process. After validation, proper controls and records must be maintained to assure the process is properly implemented (21 CFR Part 120.12). One of these alternative treatments is the use of UV irradiation, which was approved in 2000 for use on juices. UV radiation works primarily by breaking apart the DNA of organisms. The amount of radiation required to kill microorganisms may vary dramatically since UV radiation is absorbed by many of the

components in juice. In general, the more colored a juice is and the more particles there are in a juice, the more difficult it will be to kill any microorganisms present. Consequently, each type of juice will likely require its own processing parameters and UV irradiation may not be applicable to all types of juices. Current requirements for the use of UV radiation on juice specify the use of low-pressure mercury lamps emitting 90% of the emission at a wavelength of 253.7 nanometers or 2,537 Angstroms. In addition, any juice treated with UV irradiation must undergo turbulent flow through tubes with a minimum Reynolds number of 2,200. Ozone was also approved for food use in June 2001. Ozone is a strong oxidizing agent that has historically been used to clean and disinfect water. Its mode of action is similar to chlorine. Ozone is a highly unstable chemical and is also toxic to people at very low concentrations. Although it is approved for food use, the firm should take care to prevent excessive exposure of workers. As with UV irradiation, parameters for usage are not well characterized and the use of a process authority is highly recommended. A number of other processes are used to a more limited extent. Most of these processes, such as pulsedlight, use of high hydrostatic pressure, or the use of CO2 in combination with high pressure are still in the developmental stages and may become more generally available in the future.

Chapter 10

Reviewing Records: HACCP RecordsRecord Review - GeneralRecords play a vital role in the HACCP inspection process. Records enable you to determine whether the HACCP plan is being properly and consistently implemented. It is usually best to save your intensive record review until near the end of the inspection, because records are more meaningful when you understand their relationship to the operation of the plant and after you have seen how they are prepared. It is also often advisable to take advantage of the unannounced feature of the inspection by first performing certain in-plant activities, such as a review of the plant's sanitary conditions. By the time you review the records you will have already reviewed the firm's HACCP plan. As part of that review, you will have determined whether the monitoring procedures specified in the plan are adequate to ensure critical limits are consistently being met. You will also have made a determination about whether the specified monitoring records are adequate to document that the monitoring procedures have been accomplished. These records must be listed in the HACCP plan.

Types of Mandatory RecordsEach processor is required to maintain certain records documenting their HACCP system (21 CFR Part 120.12). These include:

1. 2. 3. 4.

Records documenting the implementation (monitoring and corrective actions) of the SSOPs; The written hazard analysis; The written HACCP plan; Records documenting the ongoing application of the HACCP plan that includes CCP monitoring and corrective actions; and 5. Records documenting verification of the HACCP system and validation of the HACCP plan or hazard analysis, as appropriate. Importer verification records are required elsewhere in the regulation. These will be covered in Chapter 13. However, the principles included in this chapter should be applied to those records as well. As a regulator, you have access to all of these records. This includes the right to copy the records.

Record SelectionYou should initially select sufficient numbers of each of the monitoring, verification, and corrective action records to evaluate whether: The records are complete and accurate; The appropriate critical limits are consistently met; Appropriate corrective actions are taken when the critical limits were not met; Calibration and product testing are performed in accordance with the HACCP plan; and Record review is performed in a timely manner.

Initially, select complete record sets for given production days. This should include the relevant sanitation monitoring records. Looking at all of the records for a particular production day gives you a complete picture of the plant operations on that day, and also provides you with some tools for judging the integrity of the records. Unless you are directed to cover a particular product during the inspection, select records that relate to the product or products that are being produced on the day of the inspection. This enables you to understand how the records relate to the operation and how they are prepared. If you uncover a problem, during the in-plant portion of the inspection or during record review that you believe may affect other products as well, you should also review records for those products. Your goal should be to determine the extent of the problem over time, and across product lines. There are a number of ways to select the records that you will review. Many inspectors develop their own system, and some of these methods are quite good. Here is one approach: First, determine the number of production days, and their dates, since the last inspection or since a HACCP plan was first implemented for the product. Remember that monitoring records must be retained for one year for refrigerated products and two years for frozen, preserved, and shelf-stable products (21 CFR Part 120.12). Second, take the square root of the number of production days. This is the number of dates that you should select, except that you should always select at least twelve dates. Third, the dates selected should be distributed over the months of production. Attempt to select dates from a month proportionate to the number of production days in that month - more from months with high production and fewer from low production months. Finally, within the month, selectively chose the dates, targeting potentially worst-case dates, such as: After seasonal shut-downs or changes;

After HACCP plan revisions; After equipment changes; After personnel changes; During peak production, especially where production volume exceeds design capacity; During long shifts or overtime situations; During holidays or weekends.

If the firm operates properly under these conditions, they are likely to operate well under more ideal conditions. If you encounter significant problems during the review of this initial selection of records, you should select more records from the time period from which you detected the problem, expanding outward until you have determined the scope of the problem. It is important to know whether the problem is an isolated event, or if it represents a pattern of noncompliance.

Review of Monitoring RecordsOf primary importance in the review of monitoring records is to determine: Has monitoring been performed as specified? Have the critical limits been met? Has corrective action been taken when necessary and is it adequate to address the product and the process? Are actual values and observations recorded, rather than conclusions, such as "OK," "Met," or "Exceeded?" The records should be designed so that these kinds of determinations can be made. Of secondary importance is to determine: Is the date and time of the monitoring activity recorded? Is the signature or initials of the person performing the monitoring activity recorded? Is the identity of the product and the production code, if any, recorded? Is the name and location of the processor recorded? Is the signature and date of review recorded? Is the date of review within one week of the date of the record?

During record review, you should pay particular attention to those areas in which problems or indications of problems were detected during the in-plant portion of the inspection.

Review of Corrective Action RecordsCorrective action records should be reviewed to ensure that any critical limit deviations that you noted during your monitoring record review or in-plant inspection have been properly addressed, and that the corrective action was documented. If a processor maintains a separate file of critical limit deviations you should review the entire contents of the file for products produced since the last inspection of the firm, or since a HACCP plan was first implemented for the product. Corrective actions must either conform to the standard procedures described in the regulations, or must be detailed in the processor's HACCP plan (21 CFR Part 120.10). The regulations do not give you access to consumer complaints - only to the records of corrective actions that are taken in response to consumer complaints.

Of primary importance when reviewing corrective action records is to determine: Is the nature of the corrective action described? Is the date of the corrective action recorded? Is the signature or initials of the person taking the corrective action recorded? Is the identity of the product and the production code, if any, recorded? Is the name and location of the processor recorded? Is the signature of the person performing the record review and the date of the review recorded? Is the date of the review within one week of the date of the record.

Review of Verification RecordsYour selection of verification records for review will depend primarily upon the frequency of the verification activity. If, for example, a thermometer used at a critical control point is calibrated semiannually it would be reasonable for you to request all of the calibration records since the date of the last inspection. If, however, a pH meter used at a critical control point is calibrated daily, it may only be necessary for you to request calibration records for the same dates as the monitoring records that you requested for review. Of primary importance when reviewing verification records is to determine: Is instrument calibration and product testing conducted in the manner and at the frequency specified in the HACCP plan? Is appropriate corrective action taken when the verification procedures reveal a need? For example, if, during calibration the processor determined that a pasteurizer thermometer was registering too high the following corrective actions might have been taken: the thermometer should be adjusted, if possible; and the pastuerizer temperature monitoring records generated since the last calibration should have been reviewed again by the firm and adjusted for the instrument error. You should also review the same records, looking for any deviations from the critical limits after adjustment for the instrument error. Are the actual values and observations recorded? Of secondary importance when reviewing verification records is to determine: Is the date of the calibration or testing recorded? Is the signature or initials of the person performing the calibration or testing recorded? Is the identity of the product and the production code, if any, recorded? Is the name and location of the processor recorded? Is the signature of the person performing the record review and the date of the review recorded?

Records FalsificationA lot hinges on the legitimacy of HACCP records. For this reason, looking for signs of records falsification is an important part of the HACCP inspection. There are some "tricks-of-the-trade," but most inspectors find that they develop their own as they get used to the kinds of records that processors use and how they look under ordinary circumstances. Records falsification can sometimes be detected during the in-plant portion of the inspection. In fact, that is the best time to detect one type of falsification - the pre-recording of data. For example, you may discover when you arrive at the start of a day's operations, that the results of the

visual check of the pasteurizer temperature for a pasteurized product, which were to have been performed every 1/2 hour over the course of the day, are already recorded for the entire day. This information should be documented as evidence of falsification. The documentation should include information about: whether the visual checks were ever really performed; if they were, whether the results differed from the pre-recorded data; and, if they did, whether the data was corrected. This kind of information helps establish the employee's motive for falsification. The motive might be a scheme to disguise a problem, such as expected poor results or a lack of intent to perform the check, or it might be that the employee simply found it easier to pre-record the data, which might have historically been very consistent. Interviewing employees who are responsible for performing monitoring functions is another good way to expose records falsification. If you suspect falsification, discretely watch the monitoring operation. At some point later in the inspection ask the employee responsible for monitoring to describe how and at what frequency he performs the monitoring function. Look for inconsistencies. Sometimes employees falsify monitoring records because they do not know how to perform the operation, because they are too busy to accomplish it at the required frequency, or because they are afraid of management's reaction to adverse monitoring results. Other evidence of falsification can be detected during record review. Some of the most obvious signs are: Monitoring frequencies that are uncharacteristically regular. It is not often possible for processing employees to perform monitoring functions at precise intervals - for example, 7:00, 7:30, 8:00, etc. - because they must also accomplish their production function. When you see this kind of record-keeping you should become suspicious about the possibility of data pre-recording. Monitoring data that is unusually constant. For example, it is unusual for the temperature of a cooler to hold consistently at 40F for extended periods of time. Likewise, it is unusual for product weights or counts to remain constant for extended periods of time. There is a natural variation in most attributes that are measured in a HACCP program. Become suspicious when you don't see it in records, especially if your in-plant experience tells you that it should be there. Unusually neat monitoring records. Some monitoring records and many corrective action and verification records are generated in an office or laboratory setting. In these cases, they are often very neat in appearance. Of course, some production employees will also maintain their records in an orderly manner. However, if, based on your in-plant experience, you know that a record is generated in a processing area where it is exposed to wet conditions, lubricants, or food, become suspicious if some records are immaculate. The absence of handwriting or ink changes when a record covers more than one personnel shift. If you suspect falsification, you should also compare handwriting styles on dissimilar records that were reportedly prepared by the same or different employees. The absence of characteristic instrument markings on mechanically generated records. For example, most temperature recorders leave four pinholes in the chart, the result of contact with the drive mechanism. Other instruments may leave different types of impressions or markings on the record, the absence of which is an indication of possible falsification.

Improbable events. Again, your in-plant experience will help you identify improbable events that may be chronicled in records. For example, if you see that it takes about one hour for a processor to refill a pasteurizing vat under ordinary circumstances, you should become suspicious when a record shows a series of turn-around times of only twenty minutes. You should also become suspicious when the heating curves on a temperature-recording chart are different for a single record or group of records than for other records for the same product and pasteurizer. To recognize these improbable events, you will have to become familiar with the plant's normal operations. Perhaps one of the best ways to uncover falsification during your record review is to look at the "overlap" between records. Processors will often use separate records to document the monitoring of separate critical control points. However, you can often link the records by considering the relationship of the product covered by one record with product covered by another record. Is it the same product? If so, do the records cover the same processing step or sequential steps? By comparing the times that monitoring operations are recorded and keeping in mind the answers to the previous questions and your in-plant experience, you may be able to detect irregularities. When you discover records that you suspect have been falsified, it is usually important to investigate the magnitude of such falsification before discussing the situation with management of the firm. You should copy the records as soon as possible. This may be your only opportunity to obtain them. They may subsequently be removed or altered by the firm. It is usually best to discuss your findings with management and provide them with an opportunity to explain the events represented by the records. However, in some circumstances, especially where you suspect that there was intent to conceal a problem, it may be necessary to discuss the situation with your supervisor before you disclose the information to the firm's management. Remember that falsification with the intent to defraud may be a felony violation of Title 18 of the Code of Federal Regulations.

Copying RecordsThere are four reasons to copy records: 1. 2. 3. 4. To document records falsification; To document deficiencies; To provide information for agency review; To facilitate the next inspection

Records are often needed to document deviations from the regulations, such as: inadequate corrective actions; inadequate monitoring or inadequate monitoring frequency; inadequate verification activities as specified in the HACCP plan; and, incomplete records. In some cases, it may be necessary for you to collect the complete set of records for that day's production, to facilitate a full review of the significance of the deficiency. Records may be needed to enable an agency review of the adequacy of a processor's HACCP plan, critical control parameters, certain control measures, or corrective actions. For example, if you are not sure about the suitability of a critical limit that a processor has selected, you should collect any data that the processor has to support his selection. If you are not sure of the appropriateness of a corrective action that a processor has taken, you should collect records that document the monitoring activities and the corrective action, as well as any data that the processor may have to support the adequacy of the corrective action that was taken. These records should be submitted by the district office to the Center for Food Safety and Applied Nutrition for review.

Finally, records may be collected to facilitate the performance of the next inspection. If you believe that having a copy of the HACCP plan, blank copies of records, or other documents to which the regulations grant access, will assist in the efficient enforcement of the regulations by helping prepare the next inspector, you may copy the documents and include them in the district's files.

Chapter 11

Determining if Sanitation Monitoring is Properly ImplementedYou should view compliance with the sanitation monitoring requirements of the Juice HACCP regulation in the larger context of the existing requirements of the Part 110 GMP's. Although sanitation-monitoring requirements are new, sanitation standards for all foods have been in place for many years as part of FDA's Good Manufacturing Practice Regulation - 21 CFR Part 110 or GMP's which still apply to juice processors. With the advent of HACCP, many have recognized that sanitation is a prerequisite to HACCP and provides a foundation for safe food production. In writing the Juice HACCP regulation, FDA recognized that monitoring sanitation conditions would be necessary to achieve and maintain improvements in sanitation in juice processing operations (21 CFR Part 120.6). When looking for compliance with the regulation the investigator will need to: Determine what key areas of sanitation need to be monitored Determine if the processor has implemented sanitation monitoring in those areas Determine if monitoring is at a sufficient frequency to ensure conformance with the GMP's Determine if the processor makes corrections to sanitation deficiencies detected during monitoring Determine if the processor maintains sanitation monitoring records and sanitation correction records. Determining what key areas of sanitation need to be monitored. The regulation requires monitoring in eight key areas of sanitation (21 CFR Part 120.6). Not all of these areas are relevant to all processing facilities. For example, many are not relevant to warehouses that store finished packaged juice. The key areas are somewhat arbitrary and overlapping, but were designed to include those aspects of GMP's that are most likely to have an impact on the safety of the product. The eight key areas cited in the regulation are:

1. Safety of WaterThis area relates to the sourcesave treatment of water that comes in contact with food or food contact surfaces, or is used in the manufacture of ice. It also relates to cross connections between potable and

non-potable water systems. In juice processing plants cross connections can be found in: hard plumbing between potable and non-potable water lines; unprotected hose bibs (i.e. those with no backflow prevention devices) lying in pooled water or submerged in a wash tanks; or metering pumps used for cleaning chemicals without a backflow prevention device.

2. Conditions and Cleanliness of Food Contact SurfacesThis area relates to the design, workmanship, materials, and maintenance of food contact surfaces and the cleaning and sanitizing of those surfaces. It includes gloves and outer garments that may contact the food. Processing equipment must be designed to be easily clea