APPENDIX VI

! Guidelines for a Complete Written Program

! FSEP Audit Scope Worksheet
! FSEP Audit Worksheet
! Corrective Action Request (CAR) Guidelines
! FSEP Corrective Action Request Form
! FSEP CAR Tracking Table Form
! FSEP Audit Report

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.
2.
3.
4.

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)
An External Company (i.e PCO) - records are available for review and the personnel
available for interviewing.
A Name (i.e John Smith)
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 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 (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:

2006-10-27

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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page 2

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 GMPs 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 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

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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 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

Est name and # __________
Selected Tasks

Date:_____________
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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Appendix VI - FSEP Audit Worksheet

AUDIT TASKS
(list in order of Audit
Scope)

Outs. CARs
Log Book
CCPs
PP Subelements

HACCP system
Review

INCOMPLETES
Note incompletes identified in the
written program ( nil if none identified)

Date of Audit: ___________________

2006-07-06

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)

Lead Auditor ______________

FSEP Manual - Appendix VI

AUDIT
FINDINGS

FOLLOW UP
DATE/INITIAL

- Conformity
- Audit
observation
- N/C
- Major N/C
( note CAR # if
applicable)

when:
- amended written
procedures were
reviewed and found
to be complete
and/or
- CAR is closed

(if applicable)

Establishment #: _________
page 6

Appendix VI - Corrective Action Request (CAR) Guidelines

Part A: Description of Non conformity
1.

State the issue as it links to implementation of the companys 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 companys (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 companys written plan and this is considered a nonconformity because it has an impact on the integrity of this Sub element/CCP/Reassessment
procedures.
are being implemented as per the companys 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 establishments written plan, FSEP requirements and/or
Program requirements in relation to the deficiency.

Note if an establishments written program does not meet the regulatory or FSEP program requirements,
the establishments program is considered incomplete. Incompletes not corrected during the audit are noted
on 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 is

controlled.
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 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 companys 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 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 Major 9 Amended 9

Part A: Non-Conformity
Description of non-conformity:
The companys verification procedures for Sub element E2.1 Pest Control Program
are not being implemented as per the companys written plan as per the companys
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-Nov 2003, the warehouse
supervisor completed the verification once per month. The companys 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 MayNov 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: Jan 12, 2004
B.2: Preventative Measures:
By Jan 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 Jan 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 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, the
company deviation procedures will be implemented.
Date for completion of preventative measures: Feb 28, 2004
Establishment representative*: Carl Control
Date: Jan
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#:
Major
N/C

Amended

Part A: Non-conformity
Description of non-conformity:

Area of reference (Establishments 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 actions:

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
Auditor*:

Not acceptable
Date:

C.2: Follow-up comments:

CAR closed:

Yes No

Auditor*:
* Print name below signature

2006-07-06

Date:

FSEP Manual - Appendix VI

page 10

Appendix VI - FSEP CAR Tracking Table

DATE
CAR

N/C
CAR #

ISSUED

2006-07-06

DESCRIPTION OF THE NON-CONFORMITY

OR
MAJ

DUE DATE

FSEP Manual - Appendix VI

DATE
CLOSED

INITIALS

COMMENTS

page 11

Appendix VI - FSEP Audit Report

Follow-up Audit 9

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, SOPs 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: CARs issued during the audit

CONCLUSION: Overall comments on the results of the audit and the companys
implementation of the HACCP system.

Follow-up Audit Required 9

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