Edited by Jeremy Russell
July 17, 2000
GUIDELINES TO PREPARE FOR A FSIS IN-DEPTH VERIFICATION (IDV) REVIEW
By Robert Savage
President, HACCP Consulting Group
FSIS has begun to conduct In-Depth Verification (IDV) reviews of plants’ HACCP plans and systems as well as its SSOP program and procedures. Unlike the role of the local FSIS Inspector, who is responsible to determine that plants "say what they do and do what they say," the IDV reviews determine the adequacy of the HACCP plans and system as well as the SSOP program in meeting regulatory requirements as well as technical/scientific expectations. IDVs may be conducted by multidisciplinary teams and involve experts from various parts of the agency like the Technical Service Center, headquarters, field laboratories and district offices. Plants should receive advance notice so that they can gather together the material for the review team.
There will be two types of reviews: random and "for cause." "For cause" reviews will be conducted when the district manager believes there are recurring problems at a particular establishment and may be used as the basis for enforcement actions. The IDV reviews focus on, among other areas, the adequacy of the HACCP hazard analysis and the supporting information and justifications made during the hazard analysis; the validation of the HACCP plans and system; and, when, how and who conducts reassessments of the HACCP plans.
It is extremely important that each establishment be prepared for the possibility of a Food Safety and Inspection Service (FSIS), In-Depth Verification (IDV) Review. The following guidelines were prepared for NMA by HACCP Consulting Group L.L.C. President Robert Savage. He has assisted several companies in preparing for the IDV team.
- Be Organized
- Be Cooperative
- Avoid Confrontation
- Reserve a conference room or other large work area for the IDV team AND ensure that the conference room’s calendar is cleared.
- Be available for both an entrance and an exit conference with the team and keep good notes of what is discussed.
- Assemble ALL HACCP/SSOP related materials, including, but not limited to:
HACCP plans and all supporting documentation (e.g., scientific literature, summary reports of in-house programs, etc.).
HACCP monitoring, corrective action and verification records.
Sanitation Standard Operating Procedures (SSOP) program.
SSOP Pre-operational and operational records.
E.coli test results and written program (if applicable).
GMP/Prerequisite Programs and records.
Non-compliance (NR) reports.
A glossary of plant terms used in the programs that may be uncommon in the industry (e.g., the plant’s definition of rework, etc.)
- Have key plant personnel available to answer questions.
- Have back-ups to key personnel knowledgeable in the programs.
- Assign someone (e.g., technical staff) to log questions and response
- Make a duplicate copy of everything given to the IDV team.
- Do not allow original documents to leave the facility.
- Ensure that all copies of documents given to the IDV team are stamped with the phrase, "Trade Secret—Confidential Commercial Information"
- Decide in advance what other records to share with the IDV team - seek legal counsel.
- Make sure that everyone involved with the HACCP plan and system and the SSOP program is aware of the team’s visit.
- Make phones, FAX and copying machine available to the team
- Follow any company "visitors policy" when the team tours the plant.
- Be prepared to provide the team with head cover, beard nets, boots and coats for the plant tour and other work in the plant.
- Be prepared in the event the team takes samples of products, etc.
- Ensure that all team members follow the same personnel hygiene requirements as plant personnel (eg. RTE areas).
- Assign key personnel to answer questions while team members are in the plant.
- Ensure personnel responsible for conducting monitoring, taking corrective actions and verification activities are well versed in their duties and responsibilities.
- Be prepared to work long hours and on the weekend.