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April 2006
The FDA Food Code only requires a comprehensive HACCP plan when conducting certain specialized processes that present a significant health risk if not conducted under strict operational procedures. Examples include Reduced Oxygen Packaging (ROP) and formulating a food to render it non potentially hazardous by adding acids or preservatives. In most cases, however, the implementation of food safety management systems based on HACCP principles is a completely voluntary effort by retail and food service operators. As discussed in Chapter 3, a retail or food service establishment may wish to develop and implement a food safety management system based on HACCP principles as a way to control the occurrence of identified foodborne illness risk factors. This manual does not apply to mandatory HACCP as required by the FDA Food Code.
In order to provide feedback to an operator about their food safety management system and its implementation, an operator may invite you to review their system. In this capacity, you will act as an advisor or consultant to the operator by observing the establishment's actual practices and procedures. You may wish to make recommendations to the operator based on your observations of how they are implementing their system in comparison to what is written in their plan. This chapter provides you with information that may assist you in conducting a review of a voluntary food safety management system based on HACCP principles.
In Chapter 3, several intervention strategies that can be implemented by an operator to achieve long-term compliance of risk factors were introduced. For example, an operator may develop a risk control plan as an intervention strategy for controlling a specific out-of-control process identified during an inspection.
The implementation of a comprehensive food safety management system to cover all processes conducted in a facility offers possible advantages to an operator by providing a mechanism for achieving active managerial control of multiple foodborne illness risk factors associated with an entire operation. In other words, rather than the operator "fixing" only the specific items that you identify as lacking active managerial control during the inspection, the operator might choose to implement a comprehensive food safety management system to ensure continuous control over all foodborne illness risk factors of concern.
Other advantages of using HACCP principles may include the following:
It is recommended that prior to reviewing a voluntary food safety management system based on HACCP principles you read the FDA document entitled, Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishment. Information on obtaining a copy is found in Annex 1.
A voluntarily implemented food safety management system using HACCP principles needs to be "validated." Validation, for the purposes of this discussion, means to focus on scientific and technical information to determine if the system in place will effectively control the food safety hazards once implemented. You may use observations, measurements, and evaluations taken in the establishment, as well as scientific studies and other reference materials such as the Food Code or other applicable regulations when validating food safety management systems.
Since voluntarily implemented food safety management systems involve normal processes and not high-risk specialized processes that might otherwise require a HACCP plan, regulators or other food safety professionals should be able to validate a voluntary plan without assistance. This is especially true since the critical limits listed in the plan should either be the same or more stringent than those established by the Food Code or other applicable regulations.
Reviewing a voluntary food safety management system to determine whether the corrective actions and the monitoring, verification, and record keeping procedures are sufficient to support the system may be time consuming. Because of this, it may be helpful to seek expert advise from outside sources. Outside sources include, but are not limited to, members of academia, private food safety consultants, and other federal and state governmental officials.
The written plan for a voluntary food safety management system based on HACCP principles may be relatively simple and therefore probably will not include complex information that you might otherwise expect to see in a mandatory HACCP plan. You should be very flexible in the application of HACCP principles during your review. Generally, a written, voluntary food safety management system developed using the FDA document entitled, Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishment, will include:
The proposed food safety management system should also detail:
As you review the identified hazards in the plan, it is recommended that you check to see that all control measures vital to food safety are somehow implemented in the operation. You may use Annex 3 of this Manual to assist you. Due to the flexible nature of voluntary food safety management systems, control measures, such as proper refrigeration or cooling, may be implemented as part of the establishment's Standard Operating Procedures and not as critical control points. Remember that the goal of voluntary food safety management systems is active managerial control of foodborne illness risk factors. How the establishment achieves this goal is clearly their choice.
As you review the critical limits associated with each CCP, be sure to verify that the critical limits are in compliance with the Food Code or other applicable regulation. If the critical limits are not the same or more stringent than those in the Food Code or other applicable regulation, it may be an oversight on the part of the operator or they could be conducting a specialized process without even knowing it. If the former is true, you may merely need to inform the operator of the applicable regulations for that food or process. If the latter is true, this Manual does not apply.
Your regulations will dictate how specialized processes and deviations from your code requirements are to be handled. In some jurisdictions, deviations from the requirements stated in the regulations are not allowed. In other jurisdictions, including those that have adopted the FDA Food Code, a variance and HACCP plan would be required.
In reviewing monitoring procedures at each CCP, it is recommended that the monitoring procedures include answers to the following questions:
You should also look to see that the monitoring intervals are adequate enough to ensure hazards are being controlled. For instance, if hot holding is designated as a CCP and the plan states that the manager will check the product temperature only once per day, the lack of frequent temperature checks may allow time for spore-forming or toxin-forming bacteria to grow to dangerous levels without any ability to take corrective action. It is clear to see how important adequate monitoring is to achieving active managerial control.
In reviewing the corrective actions for each CCP, it is recommended that you use Chapter 3 and Annex 6 of this Manual. As you look at the corrective actions the establishment has listed for each CCP, ask yourself if the procedure listed will result in safe food. If it will, then ask yourself if the procedure listed includes a mechanism for making sure that the problem does not happen again. If the answer is no to either of these questions, changes probably need to be made to the plan. The plan should also list who is responsible for taking corrective actions.
In reviewing verification procedures, look to see that the plan contains who is responsible for the verification and at what frequency. It is also suggested that voluntarily implemented food safety management systems be reviewed periodically to make sure all food safety hazards are still adequately controlled. Changes in menu items, equipment, or buyer specifications often require a change in the system. In this Manual, this review and subsequent change in the system is referred to as "revalidation."
Lastly, when record keeping procedures are reviewed, look to see that the procedures are clearly outlined including what is to be recorded and who is responsible for documenting the activities. It is recommended that you focus your review on helping the establishment determine whether or not they are using the easiest record keeping system for them, not on whether or not records should be kept for certain activities. If you can think of a more efficient record keeping system than what is being implemented, you may want to make a suggestion to the manager for his or her consideration. You may propose something that the establishment did not consider when it was developing the plan. The idea is that simple records, especially those that are already part of the establishment's normal operation, will most likely be maintained. However, the facility may be completely comfortable with the record keeping that is already specified in their plan.
If you see that records are not specified for certain CCPs but are for others, you may want to bring it to the manager's attention since records may be helpful in verifying that monitoring and corrective actions are conducted properly. Keep in mind that the facility has developed a voluntary food safety management system tailored to their needs and available resources. If the facility does not want to keep records, your opinion of what should be documented is irrelevant as long as active managerial control is achieved. Clearly your role as a consultant becomes particularly important with regard to your review of record keeping procedures.
The primary purpose of field verification is to determine whether the activities carried out in support of a validated food safety management system are conducted according to the written plan. In other words, "Is the firm accurately doing what it said it does and are they operating according to the food safety management system they have in place?" By conducting a verification inspection, you can help an operator identify strengths and weaknesses in the system and offer suggestions for improvement.
Keep in mind that that there are many different types of food safety management systems. Some may control foodborne illness risk factors using only some of the principles of HACCP. Therefore, flexibility is an important component when providing guidance for voluntarily implemented food safety management systems using HACCP principles.
The verification of food safety management systems involves three major activities:
The review of the documents related to the food safety management system should be completed before you make on-site observations and can either be done at the office or at the establishment prior to the inspection. In order for you to gain a better understanding of the food safety management practices and procedures in place, several documents may be reviewed, including the following:
A preliminary review of the food safety management system and associated documents may provide you with the following information:
It is also recommended that before conducting the on-site verification you become familiar with the following:
The record review is a "spot check" to ensure that routine monitoring and in-house verification by management is occurring as specified in the plan. As you conduct the record review, ask yourself, "Do the records show that activities are being performed as specified in the plan?"
The record review should take place after the document review because it will provide -
There are at least 5 types of records or information generated to support the food safety management system that may be spot-checked:
To review the records, two approaches are suggested:
Randomly select a variety of records, spot checking different time periods. Then review each record to verify that all the CCPs, associated critical limits, monitoring procedures and frequencies, corrective actions, verification and calibration activities have taken place on those days.
For example: Pick one week from the previous month and identify the CCPs and critical limits for the processes used. Check to see if the monitoring was done properly and at the required frequency stated in the plan. If you note deviations from the critical limits, check to see that the appropriate corrective actions were documented. Additionally, check to make sure that the activities were verified and that the equipment used was properly calibrated.
Randomly select a few days of records, but focus only on the CCPs that appear difficult to monitor or that have shown record-keeping or compliance problems in the past. Use these records to review the associated critical limits, monitoring procedures and frequencies, corrective actions, verification and calibration activities for those days.
For example: Looking over past inspection reports, you see that hot holding has historically been a problem in this establishment. You may select one week at random from the past month and check to see if hot holding was monitored properly and at the required frequency, as stated in the plan. If deviations from the hot holding critical limit were noted, check to see that the appropriate corrective actions were documented. Additionally, check to make sure that the activities were verified and that the equipment used was properly calibrated.
It is also a good idea to include the current day's records in your review. Seeing the real-time activities of the plan will give you insight into the accuracy and consistency of the monitoring prescribed in the plan.
Some questions to ask yourself as you review the records include:
At the conclusion of the record review, determine if there are any patterns to the deviations. Multiple deviations at the same CCP can indicate that difficulties exist in controlling or monitoring that CCP. Such observations may trigger a revalidation of the system. Also, be sure to keep the group of records that you have reviewed with you so that you can continue to evaluate the critical limits, monitoring, corrective actions, etc. during the on-site verification portion of your inspection.
Remember that the maintenance of records is required in the Food Code only in a limited number of cases. Records generated in support of a voluntary food safety management systems are not to be used to verify compliance with your regulations unless the records are specifically required by your regulations.
An example of when records may be used to verify compliance with your regulations would be the maintenance of shellstock tags. If there is a requirement in your regulations for the operator to maintain shellstock tags in chronological order for at least 90 days, you could verify this requirement just as you would during a normal routine inspection.
In contrast, if for instance you find documented cases of inadequately cooked or hot held foods being sold to consumers, you cannot take regulatory action based on the documentation. Documentation of hot holding and cooking, like most processes in your regulations, is not required. The fact that the establishment is keeping records of these processes means they are going above and beyond what is required by your regulations to establish a system that will ensure food safety. You do not want to discourage this effort by attempting to take regulatory action on voluntarily kept records. Of course, you should point these discrepancies out to management and offer recommendations to the establishment to prevent the problems from happening again. Revalidation of the system may result from your recommendations.
To avoid any confusion, it is not recommended that you conduct an on-site verification of a voluntary food safety management system at the same time as your regulatory inspection. If, due to time and resource constraints, you must conduct an on-site verification at the same time as your regulatory inspection, remember that items on your inspection form can only be marked for violations of procedures or practices that you observe during your inspection. Records may not be used to support a violation of the code unless their maintenance is specifically required in your regulations.
Another important consideration is that a food safety management system may have critical limits that exceed those of your regulations. For example, many operators choose to set their critical limits for cooking all foods at 180 °F for 15 seconds. If you discover during your record review or on-site verification that foods are only cooked to 165 °F, then they are adhering to your regulations but not their written plan. This should be pointed out to management so they can take whatever action they deem necessary.
Of course, if during your record review you find evidence that a product still in circulation poses a serious health threat to the public, you should not only alert the operator but you should also initiate an appropriate regulatory investigation as dictated by your regulatory agency. If it is known by either party that a product still on the market poses a health threat to consumers, both parties must play their respective roles to remove the product immediately. This may involve voluntary recall of the suspected products.
On-site verification is used in conjunction with the document review and record review to determine whether the activities carried out in support of the food safety management system are conducted according to the written plan. During the on-site verification, remember to look at whether activities you observe are consistent with what is noted in the records and supporting documents.
On-site verification involves observing activities of all the elements involved in the plan, i.e. the employees, the person in charge, the equipment, etc. It is important to spend sufficient time during the inspection to get a feeling for whether the activities in the plan are really part of the operation's daily routine. Be sure to ask the person in charge and the food employees many open-ended questions to obtain information that you need about the operation. For example, ask, "How often do you check the temperature?" rather than, "Do you check the temperature every 2 hours?" The information you gather from the person in charge and the food employees, along with your own observations, should provide answers to the following questions:
One key objective of on-site verification should be to confirm that the flow diagrams and the equipment layout are still accurate. This can be done by selecting a sample of menu items, with diverse preparation requirements, and "walking" through the food preparation process from receipt to service.
During the on-site observation, place special emphasis on determining whether corrective actions are taken when critical limits are not met. You should assume that corrective actions were anticipated in the operation of the system.
For example, if you note that critical limits are not being met at a CCP, observe and record the food worker's response based on the following:
At the conclusion of the on-site verification, a report similar to the one in Annex 7 of the Manual may be completed. The report in Annex 7 contains a suggested checklist to use when evaluating a food safety management system. It can be modified to the particular needs of your jurisdiction or a particular establishment.
FDA has provided guidance to operators of retail and food service establishments who wish to implement voluntary food safety management systems based on HACCP principles. Periodic review of these systems provides the operator with valuable information that can be used to make improvements. As a food safety professional, your knowledge and expertise make you qualified to conduct such reviews, but only at the request of the operator. It should be noted, however, that you can sufficiently determine if an operator has active managerial control of foodborne illness risk factors by simply conducting a risk-based inspection. Validation and verification of voluntarily implemented food safety management systems are services you can offer your industry partners to provide them with feedback on how well their system is working.
