Beruflich Dokumente
Kultur Dokumente
Table of Contents
1. 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
Introduction
This 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 In addition, this regulator training manual references the Juice HACCP Hazards and Controls Guide which is a draft guidance document that is subject to change, therefore this manual is also subject to change.
Background
In 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.
Chapter 2
Prerequisite Programs
Before 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 Steps
Once 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 Principles
Principle 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
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
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.
Reviewing Records
An 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.
Chapter 4
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.
Chapter 5
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.
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 Evaluation
After 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
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.
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.
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
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.
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.
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.
Chapter 8
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.
"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
"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.
Exemptions
There 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.
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.
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).
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 Treatments
Although 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
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 Selection
You 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.
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.
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.
Records Falsification
A 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 Records
There 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
1. Safety of Water
This 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.
8. Exclusion of Pests
This area relates to the presence of pests, such as rodents, birds, and insects. These pests carry a variety of human disease agents, which can be introduced into the processing environment. The presence of rodents, insects, birds or other pests in the processing plant is unacceptable. Even if pest control is contracted to an outside company, it is still the responsibility of the plant owner to make sure that there are no pests in the facility. The table that follows takes each of the eight key areas of sanitation and relates them to specific parts of the GMP. You can use the table to help evaluate the adequacy of the processor's sanitation selfmonitoring efforts. SANITATION PROVISIONS OF THE JUICE HACCP REGULATION AND RELEVANT REQUIREMENTS OF THE FOOD GMPs PART CORRESPONDING PART 110 REQUIREMENT(S) 120.6(a)REQUIREMENT (1): Safety of water that comes into contact with food or foodcontact surfaces or that is used in the manufacture of ice 110.37(a): The water supply shall be sufficient for the operations intended and shall be derived from an adequate source. Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. 110.80(b)(16): When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary quality, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in part 110. (2): Condition and cleanliness 110.10(b)(5): Maintaining gloves, if they are used in food handling, in of food contact surfaces, an intact, clean, and sanitary condition. The gloves should be of an including utensils, gloves, and impermeable material. outer garments 110.35(d): All food-contact surfaces, including utensils and foodcontact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food. 110.40(a): All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of
equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives. (3): 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 110.10(b)(5): Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material. 110.35(d): All food-contact surfaces, including utensils and foodcontact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food. 110.40(a): All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives. (4): Maintenance of hand washing, hand sanitizing, and toilet facilities 110.37(d): Each plant shall provide its employees with adequate, readily accessible toilet facilities. 110.37(e): Hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing: (1) Hand washing and, where appropriate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands.
(2) Effective hand-cleaning and sanitizing preparations. (3) Sanitary towel service or suitable drying devices. (4) Devices or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands. (5): 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 110.20(b)(4): Plant construction and design-constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact. 110.40(a): All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives. 110.80(b)(12)(iv): Providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them. (6): Proper labeling, storage, and use of toxic compounds 110.35(b)(2): Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. All relevant regulations promulgated by other Federal, State, and local government agencies for the application, use, or holding of these products should be followed. 110.35(c): Pest control - The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-
packaging materials. (7): Control of employee health 110.10(a): Any person who, by medical examination or supervisory conditions observation, is shown to have, or appears to have, and illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is reasonable possibility of food, food-contact surfaces, or foodpackaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors. (8): Exclusion of pests 110.35(c): No pests shall be allowed in any area of a food plant. During an inspection, consider whether each standard in the table is relevant to the firm's operations. If it is, the processor should be monitoring its own operations to ensure compliance with the standard. Remember, the insanitary condition need not have a direct impact on product safety in order to judge it relevant. The insanitary condition need only have an impact on product adulteration. Poor employee hygienic practices or vermin activity in a juice processing plant are not reasonably likely to affect the safety of the product, but either of these insanitary conditions certainly could cause the product to be deemed adulterated, and are, therefore, relevant. Because of this, most of the standards listed in the table are relevant to most processors, but there are some exceptions. For example, it would not be relevant to monitor employee hand washing in a facility such as a warehouse where there is no employee contact with exposed product. During your "walk-through," in addition to looking at the process flow and controls, you should be making judgments about the relevance of the listed sanitation standards. You will also need to determine where in the plant the relevant standards should be monitored. For example, hand washing may need to be monitored in certain processing areas, but not in the packaged finished product storage areas, or on the loading docks. Basis for Determining Sanitation Monitoring Implementation Once you have determined the relevant areas of sanitation that the plant must monitor, you should evaluate the firm's monitoring efforts to determine whether they are adequate. Remember that sanitation monitoring can be performed either as part of the HACCP program or as part of a separate sanitation program. If a processor elects to perform some or all of the sanitation monitoring as part of their HACCP program, you should evaluate those sanitation components as you would any other part of the HACCP program. This discussion covers how to evaluate the adequacy of sanitation monitoring that is part of a separate sanitation program, the option that most processors will likely select. The scope and effectiveness of a processor's sanitation monitoring program is determined in the same way the HACCP Plan is: Reviewing the firm's sanitation monitoring records; Observing sanitation monitoring operations; and Interviewing the person responsible for sanitation monitoring. After reviewing the firm's records and while you accompany the person performing the monitoring you should determine: The key areas of sanitation their monitoring covers
What areas of the plant are monitored; and How often the monitoring is performed. Sanitation Standard Operating Procedures (SSOP's) Processors are required to have SSOPs, but the regulation does not specify that they must be written (21 CFR Part 120.6). The standard that you are bound to apply toward sanitation is the standard that is contained in 21 CFR Part 110. If you judge that the standard the firm has set is inadequate because it does not meet the standard contained in 21 CFR Part 110, you will need to document the firm is not meeting the proper standard. If through observation you determine that the equipment is unclean or a cleaning procedure is inadequate, you should link the deficient item to the corresponding weakness in the SSOP in order to strengthen the observation. Determining if Monitoring Is At A Sufficient Frequency and Corrections to Deficiencies Are Adequate Compliance with the sanitation monitoring requirements require: observing and recording on the conditions in the plant; and making and recording corrections for any deficiencies noted. There are also two factors to consider in sanitation monitoring. First is the frequency sufficient to meet the requirements in 21 CFR Part 110, and is that frequency reasonable. For example, if the equipment were cleaned daily, it would meet the standards set forth in 21 CFR Part 110 if the processor checks the condition of the equipment each time the equipment is cleaned (e.g. daily). On the other hand, to meet the requirements of 21 CFR Part 110 employees wash their hands every time they use the restroom, or handle unsanitary objects either at or away from their workstation, it isn't reasonable that the processor would have to check hand washing each time. It is reasonable to check periodically over the course of the day, particularly at times when large numbers of employees would be required to wash their hands such as after breaks or returning from lunch. Secondly, you need to consider if there are any special circumstances that might affect your judgment about a reasonable frequency. For example, did you note any sanitation deficiencies during your walk through, or did the firm's monitoring records note problems in a particular area; or is there something about the operation that would affect the firm's ability to meet the sanitation standard such as equipment that is difficult to clean. There are many ways the processor can set up a sanitation-monitoring program to comply with the regulation. One way is to place the sanitation elements into groups based on the frequency of monitoring. For example, monthly or daily, etc. with monitoring records prepared accordingly. This can be done as follows (Note: recommended frequencies in these examples below are based on 21 CFR Part 110 and used for illustrative purposes; other frequencies may be adequate to comply with the regulation):
Monthly monitoring
Areas that can be covered in a monthly monitoring report are: Safety of water; and Condition and cleanliness of food contact surfaces; and Prevention of cross contamination. Common terms for reporting conditions are "satisfactory" or "unsatisfactory, or "pass"/"fail".
1. Safety of water
How a firm monitors their water supply is dependent on the source of their water. Municipal source: Frequency: For a municipal source it is usually sufficient that a firm attaches a copy of the water bill to their monthly SSOP monitoring report or they can also request verification of the water quality from the city and maintain that record on file. Private source: Frequency: The firm could have the water tested for total coliform on a semi-annual basis. The results of analysis could be maintained with the monthly report. Cross Connections: Monitoring of hard plumbing between potable and non-potable water: Frequency: Once a month and more often if there are any changes to the plumbing.
Daily monitoring
Areas that could be covered in a daily monitoring report are: Safety of water; and Condition and cleanliness of food contact surfaces; and Prevention of cross contamination. And all of: Maintenance of hand-washing, hand-sanitizing, and toilet facilities; and Protection from adulterants; Proper labeling, storage and use of toxic compounds; Employee health conditions; Exclusion of pests
Note: just like the monthly monitoring records, daily monitoring records need to reflect the actual observations made in the plant, as well as any corrections taken as a result of an observed deficiency.
1. Safety of water:
In addition to concerns about cross connections between hard plumbed water and sewage lines covered in monthly monitoring, there could be daily monitoring of cross connections in the plant environment such as unprotected hose bibs with the hose submerged in the wash tank, or metering of cleaning chemicals. Frequency: Before operations begin (pre-op) and every 4 hours of operation.
Protection from adulterants Frequency: Monitoring must be done to ensure that the food is protected from all contaminants including such things as condensate, floor splash, glass breakage, use of toxic chemical and other sources of contamination. Frequency of monitoring these conditions could be at start-up and every four hours after. Labeling, storage and use of toxic compounds Frequency: Once per day during the pre-op inspection could be an established frequency.
8. Pest control:
Frequency: Monitoring for pest could be done daily, during the pre-op inspection. Sanitation Corrections It is important to remember that the sanitation correction requirements of the regulations are different than the corrective action requirements for critical limit deviations in the HACCP plan. In many cases corrections will not involve corrective action to the product itself, but more often will involve such actions as repairing or re-cleaning the equipment, providing training to employees, improving ventilation, or moving cleaning supplies out of the processing area. These corrections must be timely, but don't always need to be immediate. For example, if an employee returns from the restroom without washing their hands and then handles the product, it would not be reasonable to expect the processor to hold and evaluate the product or destroy the product. A more reasonable correction would be to re-train the employee. Under other circumstances, action against the product might be warranted, for example, an overhead sewage pipe found leaking on exposed product. Critical to the success of both the monthly and daily monitoring record is the correction column where corrections that have been taken as a result of an observed deficiency are recorded. Examples could include: If the monthly monitoring of a well water supply showed high total coliform counts, correction may be for the firm to stop processing and to resample immediately. If the resample is satisfactory, processing can begin. Another acceptable corrective action would be to find an alternative water source until the problem is corrected. All of this information is to be recorded in the correction column. If the daily check of the storage warehouse found rodent excreta pellets, correction made might be to remove the pellets, assure no raw material has been contaminated, and clean the area before start-up, and call the pest control company. This correction would be recorded in the correction column of the daily report.
Sanitation Records
The regulations require that sanitation monitoring and corrections be documented in records. All sanitation records must have (21 CFR Part 120.12): Firm name;
Firm location; Date of record; Signature or initials of the person performing the monitoring; and The actual time the observation was made.
All of the principles discussed in the HACCP records chapter of this course apply to sanitation records. You should select sanitation records for the same product days for which you select HACCP records. This ensures a complete package of records for those days and affords a greater opportunity to look at the overlap between records.
Report Date:________________ Firm Name:________________________________ ____ Firm Address:______________________________ _________________________________________ Sanitation Area and Goal Pre-Op Time: Start Time: 4 Hour Time: 8 Hour Time: Post-Op Time: Comments / Corrections
S/U
2) Condition and cleanliness of food contact surfaces (See Monthly Sanitation Report) Equipment cleaned and sanitized Sanitizer Strength Sanitizer Type:___________ ____
Line 1: (circle one)
S/U
(circle one)
S/U
___ ppm ___ ppm
Minimum Strength: ___ ppm Gloves and aprons clean and in good repair
Line 1:
(circle one)
S/U
(circle one)
Line 2:
S/U
3) Prevention of cross-contamination (See Monthly Sanitation Report) Hands, gloves, equipment, and utensils washed / sanitized after contact with unsanitary objects Employees working on raw products, wash and sanitize hands / gloves / outerwear before working with cooked products Unpackaged cooked products separated from raw products
(circle one)
(circle one)
(circle one)
S/U
S/U
S/U
(circle one)
(circle one)
S/U
(circle one)
S/U
(circle one) (circle one)
S/U
S/U
S/U
4) Maintenance of hand-washing, hand-sanitizing, and toilet facilities Hand-wash and hand-sanitizing stations adequate
Line 1: (circle one)
Hand-wash station
Line 2:
S/U
(circle one)
S/U
___ ppm ___ ppm ___ ppm
Hand-sanitizing station
Line 1:
Sanitizer Type:___________ ____ Line 2: Minimum Strength: ___ ppm Toilets clean, properly functioning, and adequately supplied
___ ppm
___ ppm
___ ppm
(circle one)
S/U
5) Protection from adulterants and 6) Labeling, storage, and use of toxic compounds Product protected from contamination Cleaning compounds, (circle one) lubricants, and pesticides S/U labeled and stored properly 7) Employee health conditions Employees do not show signs of medical problems 8) Exclusion of Pests Pests excluded from processing area Other area(s)
(circle one) (circle one) (circle one) (circle one) (circle one)
S/U
S/U
S/U
S/U
S/U
"FOR EXAMPLE ONLY" MONTHLY SANITATION REPORT Report Firm Name:________________________________ Date:____________________ Line 1: Apple juice Firm Address:______________________________
_________________________________________ Sanitation Area and Goal 1) Safety of Water Safe and sanitary source (semiannual) No cross-contamination - Hard Plumbing
(circle one)
Decision
Comments / Corrections
S/U
(circle one)
S/U
2) Condition and cleanliness of food contact surfaces Processing equipment and utensils in suitable condition
(circle one)
S/U
S/U
Chapter 12
Background
It is important to recognize that approaches for reporting objectionable conditions may vary from district to district. It is not the intention here to change or debate the various philosophies for reporting inspectional findings. Rather, it is to provide the basics so that you can apply them in a manner consistent with the agency's policies. The Federal Food, Drug and Cosmetic Act (FD&C Act) requires that FDA Investigators leave processors with a written list of any conditions or practices they observe during the inspection. These written observations typically indicate that the food processed in the establishment may consist in whole or in part of any filthy, putrid, or decomposed substance, or may have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The HACCP deficiencies that you will report will most likely fall under the portion of the FD&C Act that talks about foods that are prepared, packed, or held under insanitary conditions. Preparing a list of the objectionable conditions and practices observed during an inspection and presenting that list to management can be done in many different ways. Some state agencies present their findings verbally unless they are issuing some type of warning or order. FDA investigators also handle some of their objections verbally, when there are only a few minor problems. Written lists of objectionable conditions may take the form of a checklist, an abbreviated outline, or a detailed narrative. FDA Investigators report their findings in writing to management on a FDA-483 form. Some state agencies use similar forms. This chapter will address the FDA-483 format.
IOM. One of the easiest traps to fall into is the need or desire to be original. This almost always gets you into trouble. If a particular word, phrase, or format describes an objectionable condition directly and succinctly, then use it when appropriate. If you see the same or similar problem in different areas, the same wording can be used to emphasize the similarity of the problem. Eliminating redundancy does not mean that you need to vary how you describe the objectionable conditions or how you refer to a particular observation. Redundancy in the context of FDA-483s refers to repeated items that are similar and should be grouped together. The phrase, "During an inspection of your firm (I) (We) Observed:" precedes the block on the FDA483 where individual items are to be written. This lets you write items as incomplete sentences without a verb. For example, you might write: 1. No HACCP plan for the processing of apple juice outlining the controls measures for the hazard of Cryptosporidium parvum. In this case "we observed" is understood to be the verb for each item. This can be confusing to the reader. Consider, instead using full sentences. This allows the verb to be varied and better fit the situation. The previous examples could be written in full sentences as follows: 1. There is no written HACCP plan for the processing of apple juice outlining the controls measures for the hazard of Cryptosporidium parvum. You should lead with the deficiency or problem in the first part of the written observation. This identifies the problem right up front instead of burying the problem in a lot of verbiage. This is particularly important when the written observations get quite lengthy. You should use words that indicate frequency, like repeatedly or routinely, carefully and very deliberately. When an item can be counted, such as the number of deficient documents or the number of times an objectionable practice occurred, you should include that number in the written observation. For example: "On three occasions corrective actions were not taken for....;" or, "On five occasions employees did not...." You should fully describe the magnitude of the problem. For example, if your HACCP record review revealed eight pasteurization records that did not have the required temperature entries, you might simply write: "Record review revealed eight pasteurization records that did not have the required recording chart temperature entries." But this does not make it clear whether the observation was the result of reviewing an entire year's worth of monitoring records or just a limited number of monitoring records during a period when the employee monitoring the cook step was out sick. A more appropriate way to write this item would be: "Eight out of the 20 pasteurization records reviewed for the week of 6/12/02 did not list the required recording chart temperatures." When the deficiency recurs on an irregular basis but the number of documented occurrences is limited only by the number of documents you choose to review or the length of time you choose to watch the operations, then you should cite this as a repeated occurrence. For example, "The employee operating and monitoring the pasteurizer repeatedly failed to list the recording chart temperatures on the Pasteurization Log, as observed during the inspection and after review of 25 production records." In other words the more records you would have looked at or the longer you would have watched the operations, the more instances of this intermittent deficiency you would likely have found. When the deficiency occurs all the time, or almost all the time and it is a regular practice of the firm, then this would be reported as a routine occurrence. For example, "The temperature recording charts
for the pasteurizer are routinely not signed or dated by the operator or reviewed by a reviewing official."
HACCP Records
1. Problem: When the investigator arrived at the firm he checked the locations where data was being entered on HACCP records. When he checked the Pasteurization Temperature Record at 8:20 AM, the blanks for the rest of the day were prematurely filled in with false numbers. This is a falsified document and a very serious violation, because the validity of all Pasteurization Temperature Records from this firm was immediately questionable. FDA-483 Item: At 8:20 AM on 6/12/02 the times and temperatures on the Pasteurization Temperature Record were filled out in advance for the entire day in half hour intervals from 8:30 AM through 1:30 PM.
HACCP Plan
2. Problem: This firm processes apple juice and orange juice. The firm has made no attempt to prepare a HACCP plan for either of the products FDA-483 Item: There are no written HACCP plans outlining controls for Cryptosporidium parvum or Salmonella during processing of apple juice and orange juice processed at your facility.
Hazards
3. Problem: This firm also processes fresh apple juice, but did not identify patulin formation as one of the hazards in their HACCP plan. However, the firm does control the condition of the incoming apple, as part of their operating procedures. FDA-483 Item: The written HACCP plan for fresh apple juice does not address the hazard of patulin formation.
Verification
6. Problem: The juice firm changed the way they monitor for glass fragments. Previously, the firm used visual monitoring to prevent the incorporation of glass fragments into the finished apple juice. Now the firm is using x-ray equipment to continuously monitor for glass. The HACCP plan states that a quality assurance technician will challenge the x-ray equipment at the start of the day's production and at four-hour intervals after that. The investigator observed that
a quality assurance technician did not challenge the x-ray equipment either after start-up or any other time during the processing day. FDA-483 Item: The verification procedures at the x-ray machine are not being implemented as outlined in the HACCP plan in that the x-ray equipment was not challenged at the start of processing or at 4 hour intervals after that.
Verification
7. Problem: The plant manager, who is the reviewing official has not signed and dated any monitoring records showing they were reviewed. Observation revealed that the monitoring records are placed on his desk but are routinely filed without being reviewed. FDA-483 Item: Review of the Pasteurization Temperature Log and the Metal Detection Log monitoring records for all dates reviewed found they are not signed and dated as being reviewed as outlined in the HACCP Plan.
Chapter 13
relative to that importation. A juice HACCP MOU acknowledges that a foreign country's juice inspection system is equivalent to the U.S. FDA inspection system. With an MOU in place, it becomes the responsibility of the participating country government, not the importer, to verify compliance with the HACCP regulations. An MOU may deal with all juice products that a particular country exports to the United States or may just deal with a particular juice product. In addition, an MOU may cover all juice processors in the country, or only selected processors.
Product Specifications
The importer must develop product specifications that are designed to ensure that each imported product is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act. These product specifications must list limits for relevant safety issues (21 CFR Part 120.14). For example, a specification for Salmonella could be listed as "no Salmonella present."
Affirmative Steps
In addition to the written specifications, the importer must have and follow written procedures that describe the affirmative steps that the importer will take to ensure that the juice product is being produced in accordance with the regulations (21 CFR Part 120.14). The juice HACCP regulation lists five affirmative steps. The importer may use one or more of these steps. The importer may: 1. Obtain from the foreign processor the HACCP and sanitation monitoring records that relate to the specific lot offered for import; 2. Obtain a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported juice was processed in accordance with the HACCP regulation; 3. Inspect the foreign processor's facilities to ensure that the product is produced in accordance with the HACCP regulation; 4. Maintain a copy, in English, of the foreign processor's hazard analysis and HACCP plan along with along with a written guarantee from the processor that the juice was processed according to the HACCP regulation; or 5. Periodically test the imported juice and maintain a written guarantee from the processor that the juice was processed according to the juice HACCP regulation. The regulation also allows importers to develop their own affirmation procedures as long as they provide an equivalent level of assurance of compliance with the HACCP regulation. The importer must also maintain records that document the performance and results of their affirmative steps. These records are subject to the record retention, access, and other record provisions of the regulation.
Select Product
Importers may only deal with one or two products but, most likely, they will handle numerous juice products and you will need to determine which product or products to evaluate. You should consider the same factors that you use in inspecting domestic processors when you make this determination. Examples are: the product's potential to contain a safety hazard, products covered during previous inspections, and the product's compliance history. Where past inspections of an importer detected significant problems with a particular product, your follow-up inspections should, as usual, concentrate on those or similar products. However, in the absence of past compliance problems, you should ordinarily review products which have not yet been inspected.
Inspection Frequency
Inspections of importers will be conducted at a frequency and under conditions specified by the agency, independent of the entry process. Districts will be assigned a number of such inspections to be performed. The compliance program will also provide a prioritization system to assist the districts in selecting importers for inspection.
Chapter 14
Special Considerations
Overview
There are three special considerations relating to HACCP inspections, which will be discussed in this chapter. They are: Collecting physical samples Federal - state contracts Preliminary HACCP inspections
juice HACCP regulation. The main objective of a contract is to harmonize and eliminate duplication in juice processing inspections. Doing so should more effectively utilize the expenditure of resources by the agencies. Another benefit will be information sharing including current, pertinent enforcement data.
Preliminary Inspections
FDA recommends that all firms implement HACCP as quickly as possible in the interest of public health safety. However, under the regulation, the effective dates vary depending on the size of the business. The effective dates for compliance with the juice HACCP regulation are January 22, 2002 for all businesses not defined as "small businesses" or "very small businesses," January 21, 2003 for small businesses, and January 20, 2004 for very small businesses. Initial inspections are planned as educational, i.e., to assist the processor in determining deficiencies in their plan. It will also provide you, the inspectors, with hands-on experience in HACCP-based juice inspections. These evaluations should serve to aid the development of both the industry's HACCP programs and the inspector's HACCP inspection skills. However, violations unrelated to the implementation of the HACCP system, or, if no attempt has been made to implement HACCP, FDA will take regulatory action. var maincontentcss = document.getElementById("middle_js"); if(maincontentcss) { maincontentcss.style.width = "68%"; }-