This article is written to meet the following sections of the Standards:

BRCGS Food Safety Issue 83.7 Corrective and preventive actions
BRCGS Packaging Issue 63.6 Corrective and preventive action
BRCGS Agents & Brokers Issue 33.9 Corrective and preventive actions
BRCGS Storage & Distribution Issue 43.3 Corrective and preventive action
FSSC22000 Version 5.1ISO 22000: 10.1 Nonconformity and corrective action
IFS Food Version 75.11 Corrective actions
SQF Edition 92.5.3 Corrective and preventative action

Managing the non-conformance action system

In order for the non-conformance system and the associated actions to be effective, a person should be appointed accountability for it and also responsibility for managing it.

Non-conformance action procedure

A procedure is required for handling non-conformance actions, that details how:

  • The non-conformance is:
    • Clearly documented.
    • Assessed for consequence.
  • Corrective action is:
    • Identified with responsibilities and due dates.
    • Verified.
  • Assessment of root cause (for major and critical non-conformances).
  • Preventive action:
    • Identified with responsibilities and due dates.
    • Verified.
  • The final close-out of the non-conformance is completed.

Documentation to manage the non-conformance action system

To ensure that the system is managed effectively, the procedure must be incorporated into the management system along with the associated record forms.

The records need to ensure that the required information is documented for the non-conformance, the corrective action, preventive action, verification and finally close of the non-conformance.

The procedure for corrective and preventive action, including root cause analysis is included within Pack 3: Continuous improvement eDocs, along with the required record forms for recording and managing non-conformances. If you need to improve the management of your non-conformance action system, this pack is the perfect solution.

Non-conformance

The system must ensure that non-conformances must be applied where there’s a failure to meet the requirements.

The system must include non-conformances from:

  • External audits.
  • Non-conforming product.
  • Complaints from non-conforming product.
  • Incidents, including withdrawal and recall.
  • Internal audits and GMP inspections.
  • In-line, at-line or off-line monitoring.

Consequence assessment

Each non-conformance must be assessed for consequence, so that the appropriate action can be taken.

The consequence assessment typically determines non-conformances to be:

  • Minor.
  • Major.
  • Critical.

The procedure must detail how the consequence assessment must be carried out and how this will determine what action must be taken.

All non-conformances must have corrective action applied. Corrective action corrects the immediate problem.

Where the non-conformance is determined to be a risk to the safety, legality, authenticity or quality of the product, preventive action must be applied through root cause analysis. Preventive action ensures that the problem will not happen again in the future.

Determining minor, major and critical

Our mini training ‘Managing the non-conformance action system’ teaches you how to manage the system in compliance with the standards. It includes the consequence assessment that we use in audIT.app to determine if non-conformances are minor, major or critical.

It also provides you with a specific process for when root cause analysis must be applied, in order to determine preventive actions.

Managing the non-conformance action system

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