Final report of an audit conducted in the United States of America to evaluate the food safety systems governing the production of meat and poultry products intended for export to Canada – January 23rd to February 10th, 2017
5 HACCP plan and pre-requisite programs
HACCP, pre-requisite programs and/or SOP were audited in the M, P and V establishments. In the M and P establishments, the operator must have and implement a HACCP plan and FSIS verify the implementation via HACCP verification task. V establishments may choose to have a sanitation SOP or HACCP, but are not required to do so. Similarly, the inspection program personnel are not required to perform SSOP or HACCP verification activities listed in Directive 5000.1 revision 2 in these establishments. However, IPP verifies compliance with the requirements of 9 CFR 416.1 - 416.6 or Part 592 (for egg products) at all facilities requesting reimbursable services. The V establishments may conduct more than one type of activities under voluntary inspection services and may be situated at the same location as the official I, M and P establishments. As per the Canadian requirements (MIR 30.1 (1)), the operator of an establishment shall develop, implement and maintain the required prerequisite programs, HACCP plans and other control programs as set out in the food safety enhancement manual (FSEP) and the meat hygiene manual of procedures.
The FSIS oversight of the establishment's HACCP risk evaluation was audited on site. The flow diagrams (a systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item) were audited and it was observed that the food safety hazard (any biological, chemical, or physical property that may cause a food to be unsafe for human consumption) were not identified on the flow diagrams but were identified on the CCP descriptive form. Furthermore, it was observed that establishments were not required to develop plant schematic as per 9 CFR 417. A plant schematic include the flows of raw products, ingredients and finished products, the flows of packaging materials, the employee traffic pattern throughout the establishment including change rooms, washrooms and lunchrooms and the flows of the waste, inedible products, chemicals, and other non-food products. In Canada, plant schematic is part of HACCP plan as required by CFIA's FSEP Manual. It provides a basis for evaluating potential areas of cross-contamination by pathogens, foreign materials, chemicals or allergens. Overall, it was concluded that differences in implementation of HACCP exist between Canada and the USA, however, both systems results in similar outcome to ensure that food is safe for human consumption.
In the current environment where food safety systems and their controls provide flexibility for establishment to implement their own procedures and critical limits, the validation process for these measures a significant importance. The auditors were informed the operators are responsible for the validation of these control measures. The Codex Alimentarius definition of validation is obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome. As well, in the Canadian FSEP manual, every establishment shall demonstrate that the critical control points are capable, on a consistent basis, of achieving the intended level of hazard control. Validation is performed at the time the CCP is designed, or when changes indicate the need for re-validation. Validation of a CCP is, whenever possible, performed before it is fully implemented. This validation has to be supported by scientific, technical or regulatory support, commissioned testing data and supporting data.
As per CFR 417.4, every establishment shall validate the HACCP plan's adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented. Furthermore, IPP verifies the validation by conducting hazard analysis verification (HAV) task. As per HAV verification task, validation is composed of two parts or elements: (1) scientific and technical support and (2) initial in-plant demonstration proving the HACCP system can perform as expected.
5.1 EV program
FSIS and the agricultural marketing service (AMS) have designed an export verification (EV) program for RTE closed face sandwiches that are produced under the voluntary inspection reimbursable services and intended for export to Canada. The program and a list of eligible establishments are available on the AMS website. The auditors were informed the EV program will be implemented on February 13, 2017, as outlined in FSIS notice 98-16. The program includes the following:
- registration of all establishments under the voluntary inspection reimbursable services producing closed-face sandwiches intended for export to Canada
- all establishments under the EV program must implement a HACCP plan;
- FSIS will be conducting daily inspections, which will include inspection oversight of HACCP and SOP controls
- AMS will conduct a microbiological testing program, for Listeria and Salmonella, on behalf of FSIS, to verify the adequacy of establishment's food safety system in producing these products
9 establishments producing and exporting closed face sandwiches are currently listed. FSIS will perform AMS – fully cooked-not shelf stable HACCP task twice per week. AMS will conduct a microbiological testing program on behalf of FSIS; the program will include 2 types of testing (routine and intensified) to ensure that participating establishments are controlling Listeria monocytogenes and Salmonella. The EV program was in the process of being implemented at the time of the audit. Therefore, auditors were unable to complete the evaluation of the implementation of the AMS program.
The development and implementation of HACCP is not required for establishments operating under voluntary reimbursable inspection service model (V Establishments). The EV program was in process of being implemented at the time of audit and therefore was not auditable.
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