Food Safety Enhancement Program Manual

Appendix VI - Guidelines for a "Complete" Written Program

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Who
Identifies those that are responsible for completing the monitoring, deviation and verification tasks with each procedure.

Those responsible may be identified by the following:

1. A Position title (e.g. Leadhand) - the position title is linked to a persons' name listed in a document of the written program (e.g. lead hands are John Smith and Suzie Smith);
2. An External Company (e.g. Pest Control Service) - records are available for review and the personnel available for interviewing;
3. A Name (e.g. John Smith);
4. Delegate (e.g. Leadhand or delegate) - names of delegated employees are listed in a document of the written program.

What/How
"What" defines the monitoring, verification and deviation tasks to be completed, Use a simple sentence to state the goal of the tasks and its expected outcome. "What" must address the requirements of the bullet as well as any additional program requirements.

"How" defines how the tasks are conducted to ensure the company standard, the program standard, or critical limit is being met. This should be a step-by-step procedure that guide the "who" and explains how the task is performed.

When or Frequency
Is the frequency that the monitoring/verification function is conducted.
Frequencies must:

• be auditable/measurable (e.g. "as required" is not auditable)
• provide effective control to ensure company standard or critical limit is consistently met
• be conducted, at a minimum of once per year

Frequency Examples:

• Daily, weekly, monthly, yearly etc.
• Every hour, every 2 hours etc.
• Once every six months
• January and June.
• Each load or shipment

Records
Must be listed for all monitoring, deviation and verification procedures. Monitoring, Deviation and Verification procedures must indicate that records are signed/initialed and dated. Records of exception (recording only deviations and not recording when conditions are acceptable) are not allowed.

If on going monitoring is identified, a record must still be generated or it is not considered to be auditable.

Example: Observing GMP's will be completed on a continuous basis and will be recorded once per day at the end of the day. Deviations will be recorded whenever one is observed.

Monitoring Procedures must include, as a minimum:

• "Who" is performing the function
• "What/How" they are performing the function
  • monitoring must describe what will be done to address the requirements of the bullet/CCP as well as any additional program requirements.
  • must include a criteria which is measurable (e.g. critical limits or standard). These may either be quantitative (e.g. degrees or ppm) or qualitative (e.g. no holes in the carrier, product is stored off the floor, free from bones, etc.). Qualitative factors must be clearly described to be easily understood and uniformly applied by those responsible for monitoring.
• When - "Frequency"
• "Record" must identify the exact title of the record(s) and indicate that they are signed/initialed and dated.

Deviation Procedures must include, as a minimum :

• "Who" is responsible for the corrective actions
• "What"  The goal of the Deviation procedure is to ensure that:
  1. the cause of the deviation is identified;
  2. a corrective action is applied to eliminate the cause;
  3. the corrective action has brought the CCP critical limits or Prerequisite programs standards under control;
  4. a food safety assessment is performed.  Any affected product is controlled and the appropriate disposition is determined;
  5. preventative measures are implemented to prevent recurrence of the deviations.
• "How" defines how the corrective action and the preventative measure are performed.

Certain CCPs or other control measures (prerequisite programs) may require predetermined corrective actions and preventative measures for a particular deviation.   These must be documented so that the responsible employee is able to fully understand and perform the corrective action(s) appropriately.

It is difficult to predict every deviation that may occur, let alone develop corrective actions and preventative measures for each.  Therefore, deviation procedure will often include the 5 generic steps above that requires the monitor or someone with appropriate authority to make an on-the-spot decision as to the method to best get the deviation corrected, thereby meeting the standard again.  All information or results related to the 5 generic steps must appear on the deviation records.

• "Record" must identify all records associated with all of the corrective actions taken.

Deviation records must identify for each corrective action and preventative measure:

• a target date for completion of corrective actions and preventative measures
• the actual completion date for these corrective actions and preventative measures

Verification Procedures must include as a minimum:

• "Who" is performing the task - the monitor cannot be the verifier.
• "What/How" they are performing the task.
  • Verification must assess whether the monitoring procedures are effective enough in providing the control necessary to maintain the standard or meet the critical limits.
  • Verification must include, as a minimum:
    • Review of records for completeness;
    • On-Site assessment of the monitoring procedures;
    • Review of deviation records to ensure that appropriate corrective actions are taken and recorded in the event of a deficiency;
    • Sampling programs, if applicable.
  • Procedures to be followed when a deviation is identified during verification is identical as the deviation procedure stated in the "Deviation procedure" section.
• When - "Frequency"
• "Record" must identify the exact title of the record(s) and indicate that they are signed/dated.

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Appendix VI - FSEP Audit Scope Worksheet

Establishment name and number __________ Date:_____________
Selected Tasks	Type of Task

Type of Task:

• LB = Log Book;
• HP= HACCP Plan;
• HSR = HACCP System Review
• OC = Outstanding CAR;
• PPS=Prerequisite Program Sub-element;

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Appendix VI - FSEP Audit Worksheet

Audit Tasks (list in order of Audit Scope) - Outs. CARs - Log Book - CCPs - PP Sub-elements - HACCP system Review	Incompletes Note incompletes identified in the written program( "nil" if none identified)	Monitoring/ Deviation/ Verification Note non conforming objective evidence (including regulatory compliance action) identified during: - Past record(s) review; - Interviews; - On site observations. ( "nil" if none identified)	Audit Findings - Conformity - Audit observation - N/C - Major N/C (note CAR # if applicable)	Follow up date/initial (if applicable) when: - amended written procedures were reviewed and found to be complete and/or - CAR is closed

 

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Appendix VI - Corrective Action Request (CAR) Guidelines

Part A: "Description of Non conformity" 1. State the issue as it links to implementation of the company's procedures You may fill in the blanks to write the first sentence of your CAR. ____(select one)____ (1)The company failed to correct a previously identified non conformity within the time frame agreed upon or it was found that the corrective action that was taken was not effective and this previous CAR has now been closed and is replaced with a major non-conformity. (2)The company did not take effective corrective action when food safety was at risk and the CFIA was required to initiate compliance action, this is considered a major non-conformity. (3)The company's (select one or more of the following 4 that applies) monitoring procedures for Sub element X and/or CCP X deviation procedures for Sub element X and/or CCP X verification procedures for Sub element X and/or CCP X reassessment procedures of the HACCP system are not being implemented as per the company's written plan and this is considered a non-conformity because it has an impact on the integrity of this Sub element/CCP/Reassessment procedures. are being implemented as per the company's written program but are ineffective and this is considered a non-conformity because it has an impact on the integrity of this Sub element/CCP/Reassessment procedures. 2. State objective evidence What you observed, measured or noted When the deficiency occurred (Records for March 3, 8 and 12th, 2002....) Quantify how wide-spread was the deficiency (1 of 5 weekly verifications not completed for 2 months) 3. Specify the requirements in the establishment's written plan, FSEP requirements and/or Program requirements in relation to the deficiency. Note: if an establishment's written program does not meet the regulatory or FSEP program requirements, the establishment's program is considered incomplete. Incomplete not corrected during the audit are noted on the audit report and selected at the next audit.
Part B: "Description of  action Plan"
How to develop an Acceptable Action Plan	Assess the situation to ensure that any affected product is controlled. An Action Plan must ensure that: a food safety assessment has been made all non conformities are corrected and prevented from reoccurring and all corrective actions (CA) must be evaluated for effectiveness. All changes to the HACCP system must be recorded in the log book. Analysis required to develop a CA Plan may include: Identification of the cause, source, or trigger of the issue If there was a failure of the system or process The date issue first appeared If other products or processes were affected Reassessment of the HACCP system/written program including records Identification of any training requirements
Acceptable Action Plan must include:	Corrective Actions (short term and/or long term), if applicable Date for completion of CA Name of person responsible to ensure completion of CA Description of CA including evaluation procedures to verify effectiveness of CA Preventative measures; Date for completion of preventative measures Name of person responsible to ensure completion of preventative measures Description of preventative measures including evaluation procedures to verify effectiveness of preventative measures.

An extension on the agreed upon "date for completion of corrective action" could be granted under the following circumstances:

• requested in writing no later than the committed to "date for completion of corrective action";
• food safety is not compromised;
• the "date for completion for corrective action" is not met for reasons out of the company's control and this can be backed up with records (e.g. letter from parts suppliers that a part is on back order); and
• the new "date for completion of corrective action" must be agreed to by the CFIA and this date is entered and initialed by the CFIA in Part B of the CAR form.

Example: Corrective Action Request (CAR)

Establishment audited (Name, Address and Reg #): Hoof Packers Inc. Est # XXX 456 Cowlane, Patchwork, Alberta MOO-1BO	Audit date: January 2-7, 2004 CAR#: XXX-2004-01 N/C _X_ Major __ Amended __
Part A: Non-Conformity Description of non-conformity: The company's verification procedures for Sub element E2.1 Pest Control Program are not being implemented as per the company's written plan as per the company's written plan and this is considered a non-conformity because it has an impact on the integrity of this sub element. During the review of The Pest Summary Report for May-November 2003, the warehouse supervisor completed the verification once per month. The company's written plan states QC will verify records weekly. Area of reference (Company' written program): E2.1 Pest Control Program Auditor*: Suzie Safety Date CAR is issued: January 7, 2004 Date for submission of corrective action (completed Part B) January 21, 2004 Establishment representative*: Carl Control Date: January 7, 2004
Part B: Action Plan B.1: Corrective actions: On January 8, 2004 The QC resumed weekly verification of the pest summary report. By Jan 12, 2004 QC reviewed all Pest Summary Report Records verified from May-November 2003 by the warehouse supervisor to ensure they are completed as required by the written plan, and QC will initial and date all records reviewed. If deviations are identified during this review, QC will evaluate possible food safety concerns and hold product for disposition, as appropriate. Date for completion of corrective actions: January 12, 2004 B.2: Preventative Measures: By January 30, 2004, the warehouse supervisor will have been trained by QC to complete the record verification of the Pest Summary Report and the warehouse supervisor's training file will be updated to include this training. On January 30, 2004, the written plan will be adjusted to change the Who for this task from the QC to the Warehouse Supervisor and this will be logged in the company logbook. From January 30, 2004 - Feb 28, 2004, QC will also verify all the Pest Summary Reports that the warehouse supervisor verified to ensure they are being verified as required, and he will sign and date all reports reviewed. If any deviations are identified, the company deviation procedures will be implemented. Date for completion of preventative measures: February 28, 2004 Establishment representative*: Carl Control Date: January 21, 2004

* Print name below signature

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Appendix VI - FSEP Corrective Action Request (CAR)

Establishment audited (Name, Address & Reg #): Audit date : CAR#: N/C __ Major __ Amended __

Part A - Non-conformity Description of non-conformity : Area of reference (Establishment's written program): Auditor*: Date CAR is issued : Date for submission of action plan (Part B): Establishment representative*: Date :

Part B - Action Plan B.1 - Corrective action : Date for completion of corrective actions: B.2 - Preventative Measures: Date for completion of preventative measures: Establishment representative*: Date :

Part C - Follow-up : C.1 - Written action plan assessment (Part B) : Acceptable __ Not acceptable __ Auditor*: Date : C.2 - Follow-up comments: CAR closed: Yes __ No __ Auditor*: Date :

 

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Appendix VI - FSEP CAR Tracking Table

Date CAR Issued	CAR #	Description of the Non-Conformity	N/C or Major	Due Date	Date Closed	Initials	Comments

 

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Appendix VI - FSEP Audit Report

Follow-up Audit __

Establishment: Identifies Name, address and registration number of establishment audited.

Date of audit: Identifies day(s)/month/year audit conducted .

Scope: Lists audit tasks including outstanding CARs, Log book, CCP(s), Prerequisite program sub-elements, HACCP System Review .

Auditor(s): Identifies Lead Auditor and members of the Audit Team, if applicable.

Establishment representative(s): Identifies HACCP Coordinator/designated liaison and any other company representatives.

Reference documents: Lists company prerequisite programs, HACCP plans, SOP's etc. reviewed during the audit.

Comments: summarization of results Prerequisite Program(s) written program incompletes: HACCP plan(s) written program incompletes: Audit Findings (Audit Observations (including objective evidence) and Part A of CARS):

CAR #'s Attached: CAR's issued during the audit

Conclusion: Overall comments on the results of the audit and the company's implementation of the HACCP system. Follow-up Audit Required __

Signature of Lead Auditor(s) : Date:

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