Record of Decision - FSEP Requirements versus DEIM – Prerequisite Programs

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Question or Description of Problem

  1. When the Food Safety Enhancement Program (FSEP) recognized establishment is amending their HACCP (Hazard Analysis Critical Control Points) system to reflect the updates to the FSEP manual (by April, 2011) do they amend to the FSEP requirements or to meet the current DEIM requirements?
  2. Should the current Dairy Establishment Inspection Manual (DEIM) requirements or the new FSEP requirements be used to rate the prerequisite programs in the non-FSEP recognized establishments?

Background

The Food Safety Enhancement Program (FSEP) manual was updated in July 2010. The update included changes to:

  • clarify plant management responsibilities,
  • streamline the prerequisite programs,
  • improve allergen hazard control,
  • introduce the concept of process controls,
  • clarify the requirements for maintenance and reassessment of a HACCP system and,
  • improve consistency and efficiency of CFIA oversight.

The Dairy Establishment Inspection Manual, dated January 2010 and implemented April 1, 2010, reflected the requirements of the FSEP manual being applied at the time. The recent update to the FSEP manual resulted in discrepancies between both documents with respect to the prerequisite programs.

Requirements

DEIM (January 2010) Inspection Criteria for Written Prerequisite Programs:

The written programs required by DEIM must specify monitoring procedures (what is done, how it is done, person responsible, inspection frequencies, records to be kept, parameters of acceptability/unacceptability, results of monitoring), verification procedures (both on-site and record review) and actions taken for deviant situations. In addition, the monitoring and verification procedures must clearly define the preventative measures taken to prevent re-occurrence of deviations. The person responsible for verifying the program must be different from the person performing the task and the program must be updated as required when changes occur. These requirements were the same as those in the previous FSEP manual.

FSEP (July 2010) Documented Prerequisite Program Requirements:

The prerequisite program documentation required by the FSEP manual (July 2010) must include specific program procedures when required (e.g. Sanitation program, Pest Control program), monitoring procedures, deviation procedures and record keeping.

The monitoring procedures shall be established for each prerequisite program and specify any tests, measurements or observations to assess that the programs, policies, standard operating procedures and tasks defined or referenced in the prerequisite programs are effectively implemented and that the standards are met. The monitoring procedures must include the name or title of personnel responsible for the monitoring and evaluation of the monitoring results, monitoring frequency, the standard(s) to be met, methods or instructions for testing, measurements or observations to be performed, exact title of the record(s) used to document the monitoring results and record keeping instructions.

The deviation procedures must include name or title of personnel that have the responsibility and authority to take actions, instructions on corrective actions to be taken, exact title of the record(s) used to describe the deviation and to document all actions taken in response to a deviation, and record keeping instructions. The deviation procedure shall at least instruct the responsible employee to perform and document the following activities:

  • describe the deviation and its cause,
  • take immediate action to control affected product or potentially affected product,
  • implement corrective actions to restore control of the prerequisite program requirements,
  • verify the effectiveness of the corrective actions taken,
  • evaluate the need to implement additional measures to prevent reoccurrence of preventative measures taken.

Preventative measures shall be applied when product is affected or potentially affected and repeated deviations are noted during monitoring activities which may indicate a trend towards a loss of control.

Records must be up-to-date, legible, accurate and properly filed.

The concept of verification has been integrated into the reassessment activities. The objective of reassessment and verification is similar, to ensure that the program in place is effective and results in the desired outcome. The reassessment activities include a written review, an on-site assessment and a record review of all prerequisite programs and must be completed at least annually to ensure that the programs are:

  • up to date
  • conform to regulatory requirements
  • conform to the requirements defined in the FSEP manual
  • are conducted according to the written programs
  • result in the desired outcomes.

Decision

Equivalent assessments for both FSEP and DEIM establishments with respect to the prerequisite programs:

  1. Until the DEIM is updated to reflect the FSEP requirements for both the removal of verification and addition of the annual reassessment, as well as any content changes to the programs (e.g. allergen hazard control), FSEP recognized establishments are to follow the prerequisite program requirements as outlined in the FSEP manual (July 2010) both for content and format. When conducting in-depth inspections in FSEP recognized establishments the prerequisite programs are to be assessed against the FSEP requirements and rated as satisfactory if they meet those requirements. As has always been the case, any enhanced program requirements in the DEIM must be reflected in the programs of the FSEP recognized establishments.
  2. When conducting indepth inspections in non-FSEP recognized establishments, either the current DEIM requirements should be used to assess the prerequisite programs, or if the non-FSEP recognized establishment has amended their programs to reflect the FSEP requirements, then the FSEP criteria should be used during an in-depth inspection.
Jennifer Miner
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Recommended by: Program Chief
29/03/2011
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Date
Wassim El-Khoury
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Approved by: National Manager
31/03/2011
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Date
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