18.7.5 Step 5 - Assessment of Operator's Action Plan

An acceptable action plan is to be submitted by the operator to the CFIA on the date specified when the CAR was issued.

The inspector who issued the CAR is responsible to review all written action plans submitted by the operator in response to the CAR within seven calendar days from the date the action plan was submitted by the operator. The date on which the inspector completes the review of the action plan must be entered in the follow up section of the CAR.

If the inspector is unable to review these action plans within the seven days, the inspector makes arrangements with the supervisor to assign this work to another inspector. The inspectors seek support from Supervisors, FSEP or Program Specialists if needed.

18.7.5.1 Acceptable Action Plan

During the course of reviewing an action plan, the responsible inspector must ensure that the criteria described below are met.

It is important to ensure that all immediate and short term actions taken in relation to affected or potentially affected product are described to the inspector's satisfaction.

It is normal for inspectors to question the root cause of a deviation or perhaps the validity of corrective and preventative measures. These concerns should be discussed with the establishment representative in a professional manner. Please note that "concerns" are not concrete facts and are not sufficient reason to consider the action plan as unacceptable.

Any concerns or doubt as to the action plan effectiveness will be confirmed by observable or measurable facts during the follow-up inspection. At this time, the inspector will have concrete information to support additional enforcement actions, if necessary.

An acceptable action plan must include:

Component 1 - Description of the problem

The objective is to accurately describe the problem, which will assist to identify the:

• action to be taken on affected or potentially affected product, other things or animals;
• immediate measures necessary to restore control of the deviation; and
• root cause(s).

Establishments must collect information to find out the exact problem. One situation of non-compliance is typically the result of multiple problems or causes.

• What is the non-compliance?
• Did the problem affect product?
• Where is the problem located?
• How widespread is this problem?
• Does the deficiency affect other areas of the facility or HACCP system?
• When did the problem occur?
• Who is involved in this problem?
• Is this the first time the problem occurred?

Written Action Plan:

• Describe the problem as it relates to the non-compliance noted on the CAR.

Component 2 - Person(s) responsible for measures

The objective is to determine the people who have the knowledge, time, authority and competence to correct the non-compliance.

Written Action Plan:

• Identify the name or title of person(s) responsible for the immediate/short term and preventative measures.

Component 3 - Description of Immediate /short term measures

The objectives are to:

• control affected product or other thing(s); and
• take immediate measures to restore control over the deviation so that food products are produced and/or animals are handled according to legislative requirements.

Written Action Plan:

• Describe the measures taken on affected or potentially affected product, animals or other thing(s).
• Describe the results of the assessment completed to determine if other products, animals or other things were implicated.
• Describe the food safety assessment performed or to be performed on the affected or potentially affected product including any disposition of product.
• Describe the immediate / short term measures taken to restore control over the deviation until permanent/preventative measures are planned and implemented.
• Describe the procedure to verify the effectiveness of immediate/short term measures taken.
• List records used to document the actions taken.

Note: Depending on the non-compliance, immediate measures may not be required.

Component 4 - Identification of root cause(s)

The objective is to identify the root cause(s) so establishments can form appropriate and comprehensive corrective measures that will prevent the recurrence of the deviation.

Start with the problem description.

• Why has the CFIA found the deviation and not the establishment?
• Identify all potential causes (Environment, Equipment, Personnel, Training, Written Programs, etc.).
• Some causes have already been corrected by immediate measures.
• Identify the root cause(s).

Written Action Plan:

• Describe root cause(s).

Component 5 - Description of Preventative Measures

The objective is to identify and implement corrective measures to eliminate the root cause(s) and prevent recurrence of the deviation.

Written Action Plan:

• Describe the preventative measures.
• Establish a date for completion of each planned preventative measures.
• List records used to document the preventative measures taken.

Component 6 - Description of Activities Planned to Verify the Effectiveness of Preventative Measures

The objective is to provide feedback as to whether or not further adjustment is necessary.

The assessment is the application of temporary procedures, tests or other evaluations to determine the effectiveness of the measures taken to correct the problem.

Examples:

• On-site assessment of corrective measures taken.
• Ensuring that staff is adhering to new procedures/instructions by observing and interviewing them.
• Temporarily increasing sampling.
• Temporarily increasing monitoring procedures.

If the problem is not resolved:

• Additional corrective measures are required.

Written Action Plan:

• Describe the activities planned to verify the effectiveness of preventative measures.
• Establish a date for completion.
• List the records used to document the activity.

18.7.5.2 Notice of an Unacceptable Action Plan

When the action plan is first submitted, the inspector must discern if critical components of the plan are missing or if there are only minor details missing that need clarification. The inspector should work with the operator to clarify any minor details that are missing.

If this approach fails, or if critical components are missing, the inspector will issue the Notice of Unacceptable Action Plan to specify which part of the action plan is incomplete or unacceptable. The inspector must specify a date for submission of the amended action plan on the Notice. This date specified on the Notice of an Unacceptable Action Plan must respect the initial date for submission of an acceptable action plan specified on the CAR. In other words, the turn-around time for amending and re-submitting an action plan must be quick but reasonable and is at the discretion of the inspector.

If the amended action plan still does not contain all the components, or if the operator is unwilling to submit an acceptable action plan by the specified date, the inspector records the following information in the "follow-up inspection" part of the CAR:

• A Notice of an Unacceptable Action Plan was issued on (date) and not all reasons identified on the notice have been addressed by the operator;

The inspector will then follow up on the specified date for completion of corrective measures. The information gathered during the follow up will determine whether the CAR can be closed or not.

The Notice of an unacceptable action plan is available through Desktop eForms (See section 18.8 - List of forms). Detailed instructions are included with each form and are available in two formats: as pop-up help (where help appears when you place the cursor over a field) and as a printable instruction page.

18.7.5.3 Action Plan Extensions

The CFIA may grant an extension to the date for completion of corrective measures (the corrective actions and preventive measures outlined in the operator's action plan) under the following circumstances:

• Food safety is not compromised.
• The operator will not meet the specified date for completion of corrective actions due to reasons beyond its control.
• The operator submits a written request for an extension before the specified date for completion of the action plan.
• The written request includes the reason for the extension request and the proposed new completion date.

Note: All criteria must be met in order to qualify for an extension to the completion date.

If an action plan extension is requested by the operator, the inspector must attach the written request to the CAR and record the following information in the Follow-up page of the CAR:

• If the extension was accepted or not by the CFIA.
• The reasons for the refusal.
• The new specified date the operator has committed to completion of the action plan.

The inspector must provide the operator's representative with a copy of the Follow-up page of the CAR.

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