FOOD SAFETY
COMBINED ACTIVITY:
62. He should cooperate with experts on different fields in order to evaluate a specific deviation (e.g. with a microbiologist to examine and evaluate a deviation from microbiological
62. He should cooperate with experts on different fields in order to evaluate a specific deviation (e.g. with a microbiologist to examine and evaluate a deviation from microbiological standards in order to detect if this deviation is a possible source of a hazard).
After the evaluation of a deviation a corrective action should be taken in order to prevent the production of unsafe products. Corrective action procedures are necessary to determine the cause of the problem, to prevent recurrence and to follow up with monitoring and reassessment to ensure that the action taken is effective. The producer’s corrective action programme should include:
(1) investigation to determine the cause of the deviation,
(2) effective measures to prevent recurrence of the deviation and (3) verification of the effectiveness of the corrective action taken.
Examples of deviation procedures for different products45.
Canned Vegetables: “The scheduled thermal process is not met because of a loss in steam pressure”!
The operator notices the deviation before the product is released and refers immediately to the written deviation procedures.
According to the deviation procedures the operator adds an additional processing time.
However the problem is not completely over! The operator following the instructions, reports the incident to his superior and they mark the suspected lot for further inspection by the experts, leading to its authorisation or final condemnation.
In case that the same problem persists, beyond the above-mentioned detention of the product for inspection, the processor should examine the underline cause of the deviation, i.e. he should determine the reason for the loss in steam pressure and the actions that should be taken to prevent recurrence of the problem.
Milk: “Antibiotics are detected by a rapid screening test”
The operator notices the deviation before the product is unloaded from the truck and refers immediately to the written deviation procedures.
According to the deviation procedure the operator/manager should follow up with the milk supplier involved. All corrective actions are recorded.
Cooked sausages: “Sausages are sliced with equipment that has not been cleaned at specific frequency.”
45 PAHO/INPAZ 2001/HACCP Essential Tool for Food Safety.
The operator notices the deviation and believes that the product has an excessive bacterial contamination. He informs the supervisor according to the deviation procedure and the suspected product is withheld and subjected to microbial testing.
The employee responsible for equipment cleaning is questioned according to the written procedures and is retrained if necessary.
20.6. PRINCIPLE 6.VERIFICATION/ESTABLISH VERIFICATION PROCEDURES.
The Codex Alimentarius guidelines define “Verification” as the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine compliance with the HACCP plan.
In other words “Verification” refers to all these activities undertaken to check compliance with the plan and its implementation. These activities should be planned ahead, because they should be approved by the responsible person in the establishment, at the same time as all other activities of the HACCP study.
Originally, the producer did verification in order to check out the effectiveness of the HACCP system. For this reason he was using a qualified individual or individuals who were capable of detecting deficiencies in the plan or its implementation. However, since HACCP has been incorporated into legislation and recommended by Codex Alimentarius, State regulators have seen also verification as their task. However, there are no “written” internationally accepted definitions of the tasks of regulators or law enforcement officers.
In this chapter we will use the word verification to include any activity performed by the food handler, which is in accordance with the HACCP plan, because we should agree that the food handler is the first person in line that has the opportunity and the possibility to perform the everyday verification in order to determine conformity46 with the HACCP plan.
Of course we should define as verification any inspection from the side of the Authorities, but only when the results of these tests are used for the benefit of the industry.
When during a regulatory assessment books and records are reviewed, this again can be seen as verification, as long as the results are used by the industry.
If results of assessment activities by regulatory authorities are not communicated to the industry and used by the industry these activities should not be called verification.
The word “Conformity”47 is used in reference to proper industrial activities whether
“Confirmation” means compliance with State regulations (conformity of a food industry with GMP, / confirmation of the industry with local Food Legislation).
In definitions both of conformity and confirmation, it is mentioned that they refer not only to HACCP, but also to its prerequisites48. Foods in international trade have to be produced according to General Principles of Hygiene and HACCP. Even for foods,
46 PAHO/INPAZ 2001/HACCP Essential Tool for Food Safety.
47 System conformity means that the seven principles have been correctly applied and that the HACCP plan is correctly and consistently implemented. It is not an approval of the system, i.e. that all the hazards have been correctly identified, that critical limits have been correctly chosen etc. It only means that the system was understood and the resulting activities put into action.(for distinction between conformity and confirmation see par. 20.7)
48 Prerequisites of HACCP are practices and conditions needed prior to and during the implementation of HACCP and which are essential for food safety, as described in the Codex General Principles of Food Hygiene and other Codes of Practice.
which are intended for domestic use, GHP should be the basis whereas HACCP is complementary to the system, but cannot stand-alone. For this reason the word
“prerequisites” has been introduced.
Although there is not yet international agreement on what verification should encompass, it is universally accepted as “checking for the implementation and effectiveness of the HACCP system”. Therefore it is carried out to determine if the HACCP system is working correctly and eventually to highlight deficiencies that should be rectified. Verification may also be initiated for other reasons, e.g. changes in the process with potential safety consequences.
Verification may –and– should also be performed by someone other than the person who is responsible for performing the activities specified in the plan. According to the abovementioned definitions for Verification, we can say that it may be conducted by:
Business personnel,
External personnel,
Governmental organizations,
Inspection services,
Private organizations,
Quality control laboratories,
Trade associations,
Consumer associations,
Buyers,
Importing country authority
HACCP team.
The verification may be done:
(a) After each HACCP plan elaboration,
(b) As part of a continuous revision, established by the program in order to demonstrate that the HACCP plan is efficient,
(c) When there is any change that affects hazard analysis or changes HACCP in any way.
Accordingly it can be applied in each step of the HACCP plan, in the HACCP plan of each product (including each step) and when there is any change in the process or materials used, affecting hazard analysis.
Verification comprises of “checking system conformity” and “confirmation of effectiveness”49 of the system.
20.6.1. Verification activities
Verification is an ongoing activity. A new hazard analysis is necessary after changes in raw materials, processing conditions, line layout, distribution conditions, preparation and use etc. The outcome of such an analysis may need to be validated and verified. As a consequence of trends detected in monitoring results, or results of raw material and end product testing, changes may be made which need to be verified. External auditors or government inspectors should keep records of all these verification activities for examination.
The verification activities are mentioned more detailed below:
Analyse the HACCP plan documents and its registers,
49 Confirmation of Effectiveness means that evidence is sought to confirm that the system delivers what is expected.
Scientifically evaluate all hazards,
Analyse deviations of critical limits,
Analyse corrective actions taken for each deviation in the past,
Guarantee that all CCP are under control,
Guarantee -through calibration- that all measuring equipment are working properly
Perform laboratory analysis to guarantee that the critical limits are well established, and
Evaluate suppliers for quality assurance.
20.6.2. Review
Review means a retrospective view or survey of past events, experiences etc. A review should show whether unacceptable deviations were followed up and/or whether CCPs were kept under control. The review of consumer complaints can demonstrate that deviations were not detected, and thus that things have to be changed: the system did not deliver what was expected. If the review shows that CCPs were not always monitored as foreseen, or that instruments used for monitoring were not accurate, the system or its implementation has to be improved.
End product testing may provide some evidence that the plan was effective, and that objectives were achieved, but especially as regards to the control of pathogens it is a poor verification tool.
20.7. PRINCIPLE 7. ESTABLISH DOCUMENTATION CONCERNING ALL PROCEDURES AND RECORDS RELEVANT TO THE HACCP
PRINCIPLES AND THEIR APPLICATION.
Records are written evidence through which an action is documented. A record shows the process history, the monitoring, the deviations and the corrective actions that occurred in the past. Accurate documentation and record keeping is essential to the application of a HACCP system. They should be appropriate to the nature and size of the operation. They should also be sufficient to enable the business to be confident that controls are in place and being maintained. Records document that the critical limits at each CCP were met or that appropriate corrective actions were taken when the limits were not met. They can also record that the actions performed were verified. Therefore it is imperative that the producer maintains complete, current, properly filed and accurate records.
Four types of records should be used in the HACCP plan:
63. Basic Support Documentation (bibliographical or other data used for the