Food Safety and Inspection Service United States Department of Agriculture Washington, D.C.  20250-3700

Office of Policy, Program Development and Evaluation

Meat and Poultry Advisory Committee Staff

HACCP Systems In-depth Verification Review

The sub-committee members did not receive the documents or the charge to the committee until the afternoon of the sub-committee meeting. Therefore, we were unable to make an assessment of the appropriateness of the checklists, although at first look, they do appear to be on target. We believe this type of tool is good and necessary. As an example it will help in determining whether the plant’s Hazard Analysis is a good, accurate and complete analysis.

The charge to the committee was to identify additional sources of technical information. The committee had no specific recommendations, but does recommend an interactive agency/industry HACCP group and "neutral" HACCP experts such as the International HACCP Alliance, certified HACCP trainers, and other recognized HACCP experts. The committee recommends the agency considers further work on this document be scheduled, specifically obtaining input and critique from "neutral" HACCP experts, in conjunction with the technical meeting scheduled for later this winter. The committee is particularly interested knowing that the questions asked in these checklists are the appropriate questions. We want this to be the best possible tool for evaluating the effectiveness of HACCP plans and their implementation in the plants.

The committee did note that this present tool does not indicate whether a category is or is not acceptable; there is no space or area to indicate the acceptability of each question area or checklist. We recommend that be included, giving more feedback to the plant. The committee suggests that this tool be a "living" document, in that continuous revisions are made as necessary to improve the effectiveness of the tool, but that each revision be a final document, that has gone through a process similar to those used in developing directives, before its use is implemented. Future revisions should be made through the use of the tool and input from the reviewer(s) as well as results of using the tool. Each revision should be done with the input of HACCP experts, including those outside the agency to ensure that the tool and therefore the review is fair and the evaluation is valid. We want to keep in mind that the reviews are conducted to evaluate the HACCP system. The goal should be to ensure that the HACCP plans are effective and if not provide input to make them effective rather than a process to find fault with plants. However, if the review determines that there is failure of the HACCP system, immediate and appropriate regulatory action should be taken by FSIS to prevent distribution of unsafe products.

The committee believes that the process of in-depth reviews should be an effort of cooperation, timing, and coordination between the review team and plant management to reduce time of the review, therefore making the process as efficient as possible. We recommend that the agency look at models from other regulatory agencies, such as HCFA, Health Care Financing Agency.

Before implementing in-depth reviews, we believe it is essential that the reviewers be provided with formal training and education regarding this audit process. The training should include not only technique, but also a study of the supporting documents such as the 97 National Advisory Committee on Microbiological Criteria for Foods document, to ensure a consistent interpretation of the meaning of the document. Industry representatives should be given the opportunity to participate in side-by-side training with Agency reviewers. We believe this will afford an opportunity for plant officials to effectively use this in-depth review system to self evaluate and improve their HACCP plans before they are selected for review by the Agency.

The committee proposed the process for HACCP Systems In-depth Verification reviews as follows:

• The agency provide the plants to be reviewed a notice and a date of the proposed review in advance

• The plant collects the documents required for the review and has them ready for the reviewers

• On date of review, the reviewers review the documents without requiring the presence of plant management – plant management provide working space in the plant or permit reviewers to remove documents to an appropriate area to conducts the document review

• After document review, the reviewers interview plant officials to discuss and ask question regarding the findings of the document review

• Reviewers conduct the systems review portion in the plant

• An exit conference is held with plant officials after completion of the review providing preliminary report – if there are HACCP failures, immediate and appropriate regulatory actions according to sections 416 and 417 are taken

• The agency provides a formal written report within two weeks. The report should include note of positive findings demonstrating especially effective methods. These reports could be used to generate new education information to improve HACCP Implementation

• Plant is given 30 days to respond formally in writing to the findings including corrective actions taken – the report does not become available under FOIA until after this 30 day period has expired and the plant response becomes a part of the record

• District managers are responsible to ensure plant takes appropriate steps to correct deficiencies identified and reports to the review team or appropriate HQ office that the deficiencies have or have not been corrected within an appropriate time frame.

The deficiencies identified will determine the appropriate time for correction and agency regulatory action, but it is imperative that agency action is consistent.

We also suggest that the Agency establish a standardization unit to establish and maintain correlation of the review team members. This will help ensure that the review team continues to direct their review efforts in a consistent manner that is in harmony with Agency goals. Finally we suggest that the format of the review forms be developed that lend the report to collation and analysis of the data collected.

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Last modified:  November 25, 2002