《Guidebook for HACCP》HACCP-1 Guidebook for the Preparation of HACCP Plans

Guidebook PRINCIPLE IV: ESTABLISH MONITORING PROCEDURES To carry out HACCP principle four, your team needs to establish monitoring procedures Monitoring procedures are those things, which are done routinely, either by employee or by mechanical means, which, measure the process at a given CCP, and create a record for future use. Some monitoring procedures are employee observations or checks, such as checking the documentation accompanying incoming materials. Some monitoring procedures are records from instruments such as recording thermometers Continuous monitoring is al ways preferred when it is feasible. When it is not possible, then your HACCP team will need to decide what will be their non-continuous monitoring procedures and how frequently they will be performed. There are several issues to consider when deciding the frequency of non-continuous monitoring checks; the most important is that the procedures mus be performed sufficiently often to accurately reflect that the process is under control. Expert advice from people with knowledge of practical statistics and statistical process control will be important in making your decisions about frequency Another factor that HACCP teams must consider is the capacity of the plant to take corrective actions when monitoring procedures reveal that there have been deviations from critical limits When monitoring procedures show that there has been a deviation from a critical limit, corrective actions need to be applied to all the potentially noncomplying product. This usually includes all the product produced since the time of the last successful monitoring procedure result. So, if your monitoring procedure was to perform a physical check on arriving product, and your team decided to do this only once per shift, a deviation from the critical limit would mean that you needed to apply corrective actions to all the product which had arrived during the shift monitoring procedures and how frequently they should be performed is the need for rapid rea o Another matter for your HACCP team to consider when they are deciding on what should be th time feedback. Generally, physical and chemical procedures are preferred over microbial approaches for monitoring because they provide more rapid feedback. Monitoring procedures need to be well planned and effective because of the potentially serious consequences of loss of control. Employees monitoring CCPs should be trained in the technique to be used to monitor each preventive measure or control. They should fully understand the purpose and importance of monitoring and accurately report monitoring activities and results They must have complete access to the CCp being monitored and to the process-monitoring instruments being used The performing monitoring must record exact values where exact values are indicated not"yes/no"or"OK "observations. This means that if the critical limit is a minimum internal temperature of 160 F, the observations on the monitoring record would be recorded as"162F, 163°F” rather than"yes”or“OK.” Attachment 7 is a simple form, which your team might use to help them decide on monitoring procedures and their frequency

Guidebook PRINCIPLE IV: ESTABLISH MONITORING PROCEDURES To carry out HACCP principle four, your team needs to establish monitoring procedures. Monitoring procedures are those things, which are done routinely, either by employee or by mechanical means, which, measure the process at a given CCP, and create a record for future use. Some monitoring procedures are employee observations or checks, such as checking the documentation accompanying incoming materials. Some monitoring procedures are records from instruments, such as recording thermometers. Continuous monitoring is always preferred when it is feasible. When it is not possible, then your HACCP team will need to decide what will be their non-continuous monitoring procedures and how frequently they will be performed. There are several issues to consider when deciding the frequency of non-continuous monitoring checks; the most important is that the procedures must be performed sufficiently often to accurately reflect that the process is under control. Expert advice from people with knowledge of practical statistics and statistical process control will be important in making your decisions about frequency. Another factor that HACCP teams must consider is the capacity of the plant to take corrective actions when monitoring procedures reveal that there have been deviations from critical limits. When monitoring procedures show that there has been a deviation from a critical limit, corrective actions need to be applied to all the potentially noncomplying product. This usually includes all the product produced since the time of the last successful monitoring procedure result. So, if your monitoring procedure was to perform a physical check on arriving product, and your team decided to do this only once per shift, a deviation from the critical limit would mean that you needed to apply corrective actions to all the product which had arrived during the shift. Another matter for your HACCP team to consider when they are deciding on what should be the monitoring procedures and how frequently they should be performed is the need for rapid, real time feedback. Generally, physical and chemical procedures are preferred over microbial approaches for monitoring because they provide more rapid feedback. Monitoring procedures need to be well planned and effective because of the potentially serious consequences of loss of control. Employees monitoring CCPs should be trained in the technique to be used to monitor each preventive measure or control. They should fully understand the purpose and importance of monitoring and accurately report monitoring activities and results. They must have complete access to the CCP being monitored and to the process-monitoring instruments being used. The persons performing monitoring must record exact values where exact values are indicated, not “yes/no” or “OK” observations. This means that if the critical limit is a minimum internal temperature of 160° F, the observations on the monitoring record would be recorded as “162 °F,” “163°F” rather than “yes” or “OK.” Attachment 7 is a simple form, which your team might use to help them decide on monitoring procedures and their frequency. 12

Guidebook PRINCIPLE V: ESTABLISH CORRECTIVE ACTIONS HACCP principle five says: Establish corrective actions to be taken when monitoring shows that there is a deviation from a critical limit. In addition,$417.3 identifies the four features of corrective actions that FSiS regulators will be checking; they are 1. Has the cause of the deviation been identified and eliminated? 2. will the ccp be under control after the corrective action has been taken? 3. Have measures to prevent recurrence of the deviation been established? and, 4. Do the corrective action procedures make sure that no product, which is injurious to health or otherwise adulterated because of the deviation enters commerce? HACCP is a preventive system to correct problems before they affect the safety of the food products people actually consume. Deviations from critical limits will occur; therefore, you need to have a plan to make sure those deviations do not lead to unsafe products. Planned corrective actions are the way you do this. Your HACCP team needs to understand how important it is to carefully carry out this principle For each CCP, your team needs to devise a standardized set of actions that company employees will follow when there is a deviation from a critical limit. These are some questions they might ask in developing corrective actions How will people be informed when the deviation occurs? If a person is performing the monitoring procedure, who will that person contact? Who will be responsible for controlling the product that may have been affected by the deviation? How should that person decide how much product needs to be controlled? affected by the deviation ing Who will be involved in deciding what to do about the product which might have been How will we decide what was the cause of the deviation? If we need technical experts outside the company, how do we get them? Once we have figured out what was the cause of the deviation, who will be involved in deciding how to get the process back in control and prevent recurrence of the deviation? If our HACCP trained individual is not available in the plant immediately, how can w get HACCP expertise to help decide if our plan needs to be modified? Who in the company needs to sign off on any modifications to our plan? Who will be responsible for keeping the records of everything we do in response to a eviation from a critical limit at this ccp?

Guidebook PRINCIPLE V: ESTABLISH CORRECTIVE ACTIONS HACCP principle five says: Establish corrective actions to be taken when monitoring shows that there is a deviation from a critical limit. In addition, § 417.3 identifies the four features of corrective actions that FSIS regulators will be checking; they are: 1. Has the cause of the deviation been identified and eliminated?; 2. Will the CCP be under control after the corrective action has been taken?; 3. Have measures to prevent recurrence of the deviation been established?; and, 4. Do the corrective action procedures make sure that no product, which is injurious to health or otherwise adulterated because of the deviation enters commerce? HACCP is a preventive system to correct problems before they affect the safety of the food products people actually consume. Deviations from critical limits will occur; therefore, you need to have a plan to make sure those deviations do not lead to unsafe products. Planned corrective actions are the way you do this. Your HACCP team needs to understand how important it is to carefully carry out this principle. For each CCP, your team needs to devise a standardized set of actions that company employees will follow when there is a deviation from a critical limit. These are some questions they might ask in developing corrective actions: How will people be informed when the deviation occurs? If a person is performing the monitoring procedure, who will that person contact? Who will be responsible for controlling the product that may have been affected by the deviation? How should that person decide how much product needs to be controlled? Who will be involved in deciding what to do about the product which might have been affected by the deviation? How will we decide what was the cause of the deviation? If we need technical experts outside the company, how do we get them? Once we have figured out what was the cause of the deviation, who will be involved in deciding how to get the process back in control and prevent recurrence of the deviation? If our HACCP trained individual is not available in the plant immediately, how can we get HACCP expertise to help decide if our plan needs to be modified? Who in the company needs to sign off on any modifications to our plan? Who will be responsible for keeping the records of everything we do in response to a deviation from a critical limit at this CCP? 13

Guidebook If any person who has a responsibility in our corrective action plan is not available, who will be the back-up? Is this set of corrective actions feasible at all times? Attachment 8 is a simple form to help your HACCP team make sure they have developed appropriate corrective actions for each CCP. Part 4 17 includes regulatory requirements, which must be followed when a deviation not covered by a specific corrective action occurs or if an unforeseen hazard occurs. Your team should study $417.3(b)so that you know what to do when this happens. In many ways, the actions to be taken will be generally similar to what you plan to do at any specific CCP-get control of the product, figure out what was the cause and how to keep it from happening again, decide whether to modify your HACCP plan, etc. Your team should at least think about how you want to handle these situations PRINCIPLE VI: ESTABLISH RECORDKEEPING PROCEDURES HACCP principle number 6 is to establish effective recordkeeping procedures that document the HACCP system. The regulatory recordkeeping requirements for meat and poult establishments are found in $417.5 and are quite comprehensive. Your team should review them carefully Even though people often complain about it, recordkeeping is an essential feature of a HACCP system and must be planned and carried out as carefully as any other element. This principle requires the development and maintenance of records about both plan development and the operation of the system. In a study on HACCP prepared by the Department of Commerce it was clear that, without recordkeeping, problems were more likely to recur Even though people may grumble about keeping records, the practice can be made sensible and suitable for the operation in question. Clearly more sophisticated records will be required for more complex operations. One way to approach development of the recordkeeping requirements of your HACCP system is to review the records you already keep and see if they are suitable, in their present form or with minor modifications, to serve the purposes of your HACCP system The best recordkeeping system is usually the simplest one that can be easily integrated into the existing operation to make the record entry, who will need to review the record prior to shipping, plus, whenang'o? When you are setting up your recordkeeping system, think about who will be in the best positio where will be the best place to keep the records. Think about making simple understandable forms that will work well situation. Make sure your employees know exactly what is expected if they are responsible for making a record entry. It is extremely important that they sign and date the records at the time the specific event occurs Records do not need to be in any particular format. Often HACCP plans are presented in a tabular form. Attachment 9 is an example of a blank HACCP Plan form in a typical format Attachment 10 is a list of some typical records of a HACCP system in operation. The

Guidebook If any person who has a responsibility in our corrective action plan is not available, who will be the back-up? Is this set of corrective actions feasible at all times? Attachment 8 is a simple form to help your HACCP team make sure they have developed appropriate corrective actions for each CCP. Part 417 includes regulatory requirements, which must be followed when a deviation not covered by a specific corrective action occurs or if an unforeseen hazard occurs. Your team should study § 417.3(b) so that you know what to do when this happens. In many ways, the actions to be taken will be generally similar to what you plan to do at any specific CCP—get control of the product, figure out what was the cause and how to keep it from happening again, decide whether to modify your HACCP plan, etc. Your team should at least think about how you want to handle these situations. PRINCIPLE VI: ESTABLISH RECORDKEEPING PROCEDURES HACCP principle number 6 is to establish effective recordkeeping procedures that document the HACCP system. The regulatory recordkeeping requirements for meat and poultry establishments are found in § 417.5 and are quite comprehensive. Your team should review them carefully. Even though people often complain about it, recordkeeping is an essential feature of a HACCP system and must be planned and carried out as carefully as any other element. This principle requires the development and maintenance of records about both plan development and the operation of the system. In a study on HACCP prepared by the Department of Commerce it was clear that, without recordkeeping, problems were more likely to recur. Even though people may grumble about keeping records, the practice can be made sensible and suitable for the operation in question. Clearly more sophisticated records will be required for more complex operations. One way to approach development of the recordkeeping requirements of your HACCP system is to review the records you already keep and see if they are suitable, in their present form or with minor modifications, to serve the purposes of your HACCP system. The best recordkeeping system is usually the simplest one that can be easily integrated into the existing operation. When you are setting up your recordkeeping system, think about who will be in the best position to make the record entry, who will need to review the record prior to shipping, plus, when and where will be the best place to keep the records. Think about making simple understandable forms that will work well in your situation. Make sure your employees know exactly what is expected if they are responsible for making a record entry. It is extremely important that they sign and date the records at the time the specific event occurs. Records do not need to be in any particular format. Often HACCP plans are presented in a tabular form. Attachment 9 is an example of a blank HACCP Plan form in a typical format. Attachment 10 is a list of some typical records of a HACCP system in operation. The 14

Guidebook PR/HACCP regulation also includes a requirement for preshipment review in$417.5(c). This step can provide you added assurance that you have done everything in your HACCP plan before you ship the product. There are examples in each of the generic models on how this can be accomplished PRINCIPLE VII: ESTABLISH VERIFICATION PROCEDURES HACCP principle seven is to establish verification procedures to make sure the plan is working correctly Your team needs to decide on what procedures the plant will perform to verify that the HACCP system is working effectively and how often these actions will be performed. Verification uses methods, procedures, or tests in addition to those used in monitoring to see whether the HaCCP system is in compliance with the haCCP plan or whether the HACCP plan needs modification There are three types of verification Validation is the initial phase in which the plan is tested and reviewed. The choices made while working through the preliminary steps and HACCP principles must be repeatedly tested and shown to prevent or control identified hazards in the "real world". In this phase, microbial or residue testing can be used effectively to verify that the process is in control and is producing acceptable product. Such testing provides clear evidence that the techniques and methods adopted by the plant to control hazards are not just effective in theory but will work in this pla Ongoing verification ensures that the HACCP plan is working effectively on a day-to-day basis This type of verification includes such tasks as calibrating monitoring instruments, observing monitoring activities and corrective actions, and reviewing HACCP records to see that they are being made and kept according to the plan Reassessment is an overall review of the plan that must be performed at least annually, or whenever any changes occur that could affect the hazard analysis or alter the HACCP plan Reassessment is similar to validation in that it considers whether the plan is adequate in general rather than focusing on the plans daily operations. It is also similar to validation in that it must be done by a HACCP-trained person

Guidebook PR/HACCP regulation also includes a requirement for preshipment review in § 417.5(c). This step can provide you added assurance that you have done everything in your HACCP plan before you ship the product. There are examples in each of the generic models on how this can be accomplished. PRINCIPLE VII: ESTABLISH VERIFICATION PROCEDURES HACCP principle seven is to establish verification procedures to make sure the plan is working correctly. Your team needs to decide on what procedures the plant will perform to verify that the HACCP system is working effectively and how often these actions will be performed. Verification uses methods, procedures, or tests in addition to those used in monitoring to see whether the HACCP system is in compliance with the HACCP plan or whether the HACCP plan needs modification. There are three types of verification. Validation is the initial phase in which the plan is tested and reviewed. The choices made while working through the preliminary steps and HACCP principles must be repeatedly tested and shown to prevent or control identified hazards in the “real world”. In this phase, microbial or residue testing can be used effectively to verify that the process is in control and is producing acceptable product. Such testing provides clear evidence that the techniques and methods adopted by the plant to control hazards are not just effective in theory but will work in this specific plant. Ongoing verification ensures that the HACCP plan is working effectively on a day-to-day basis. This type of verification includes such tasks as calibrating monitoring instruments, observing monitoring activities and corrective actions, and reviewing HACCP records to see that they are being made and kept according to the plan. Reassessment is an overall review of the plan that must be performed at least annually, or whenever any changes occur that could affect the hazard analysis or alter the HACCP plan. Reassessment is similar to validation in that it considers whether the plan is adequate in general rather than focusing on the plan's daily operations. It is also similar to validation in that it must be done by a HACCP-trained person. 15

Guidebook ATTACHMENtS

Guidebook ATTACHMENTS 16