CFIA FSEP - Guideline for Written Program

8/17/2019 CFIA FSEP - Guideline for Written Program

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APPENDIX VI

Guidelines for a “Complete” Written ProgramFSEP Audit Scope Worksheet

FSEP Audit Worksheet

Corrective Action Request (CAR) GuidelinesFSEP Corrective Action Request Form FSEP CAR Tracking Table Form

FSEP Audit Report


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2006-10-27 SEP Manual - Appendix VI page 2

APPENDIX VI Guidelines for a “Complete” Written Program

WHO

Identifies those that are responsible for completing the monitoring, deviation and verification tasks

associated with each procedure.

Those responsible may be identified by the following:

1. A Position title (i.e. Leadhand) - the position title is linked to a persons' name listed

in a document of the written program. (i.e leadhands are John Smith and Suzie Smith)

2. An External Company (i.e PCO) - records are available for review and the personnel

available for interviewing.

3. A Name (i.e John Smith)

4. Delegate (i.e 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 simplesentence 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 (i.e. “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


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RECORDS

Must be listed for all monitoring, deviation and verification procedures. Monitoring, Deviation and

Verification procedures must indicate that records are signed/initialled 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 (i.e. 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/initialled 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 thedeviations.

“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


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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 meetingthe 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

Est name and # __________ Date:_____________

Selected Tasks Type of Task

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


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2006-07-06 FSEP Manual - Appendix VI

Appendix VI - FSEP Audit Worksheet

AUDIT TASKS(list in order of Audit

Scope)

• Outs. CARs

• Log Book• CCPs

• PP Sub-elements

• HACCP systemReview

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)

Date of Audit: ___________________ Lead Auditor ______________ Estab


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2006-07-06 FSEP Manual - Appendix VI page 7

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 proceduresYou 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 frameagreed 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/Reassessmentprocedures.

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 Subelement/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 2months)

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. Incompletes not corrected during the audit are notedon the audit report and selected at the next audit.

Part B: “Description of Action Plan”


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How to develop an

Acceptable Action Plan

Assess the situation to ensure that any affected product iscontrolled.

An Action Plan must ensure that:(1) a food safety assessment has been made

(2) all non conformities are corrected and

(3) prevented from reoccurring and(4) all corrective actions (CA) must be evaluated

for effectiveness.

All changes to the HACCP system must be recorded in thelog 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 evaluationprocedures 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 thefollowing 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); &- 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.


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Example: Corrective Action Request (CAR)

Establishment audited (Name, Address andReg.#):Hoof Packers Inc. Est # XXX456 Cowlane, Patchwork, Alberta MOO-1BO

Audit date: January 2-7, 2004CAR#: XXX-2004-01

N/C Major 9 Amended 9

Part A: Non-ConformityDescription of non-conformity:The company’s verification procedures for Sub element E2.1 Pest Control Programare not being implemented as per the company’s written plan as per the company’swritten plan and this is considered a non- conformity because it has an impact on theintegrity of this sub element.During the review of The Pest Summary Report for May-Nov 2003, the warehousesupervisor completed the verification once per month. The company’s written planstates 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, 2004Date for submission of corrective action (completed Part B) January 21, 2004Establishment 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-Nov 2003 by the warehouse supervisor to ensure they are completed as required bythe 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 holdproduct for disposition, as appropriate.Date for completion of corrective actions: Jan 12, 2004

B.2: Preventative Measures:By Jan 30, 2004, the warehouse supervisor will have been trained by QC to completethe record verification of the Pest Summary Report and the warehouse supervisor`straining file will be updated to include this training. On Jan 30, 2004, the written planwill be adjusted to change the Who for this task from the QC to the WarehouseSupervisor and this will be logged in the company logbook.From Jan 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, thecompany deviation procedures will be implemented.Date for completion of preventative measures: Feb 28, 2004Establishment representative*: Carl Control Date: Jan21, 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-conformityDescription 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 PlanB.1: Corrective actions:

Date for completion of corrective actions:

B.2: Preventative Measures:

Date for completion of preventative measures:

Establishment representative*: Date:

Part C: Follow-upC.1: Written action plan assessment (Part B): Acceptable ‘ Not acceptable ‘

Auditor*: Date:

C.2: Follow-up comments:

CAR closed: Yes ‘ No ‘

Auditor*: Date:

* Print name below signature


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2006-07-06 FSEP Manual - Appendix VI

Appendix VI - FSEP CAR Tracking Table

DATE

CAR

ISSUED

CAR # DESCRIPTION OF THE NON-CONFORMITY

N/C

OR

MAJ

DUE DATEDATE

CLOSEDINITIALS


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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 programsub-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 theaudit.

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’simplementation of the HACCP system.

Follow-up Audit Required

CFIA FSEP - Guideline for Written Program

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