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
FSSC 22000 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

Identifying non-conformance

Non-conformances must be identified where there’s a failure to meet the standard, for example during:

  • 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.

Impartiality

Staff raising non-conformances must be impartial to the subject. This means that internal auditors and GMP inspectors must not assess their own work.

Consequence assessment

Each non-conformance must be assessed to determine the possible consequence, which must define the type of non-conformance action that must be taken.

As a minimum, corrective action must be applied to all non-conformances.

Where defined by the consequence assessment, root cause analysis and preventive action must also be applied.

Identifying conformance and non-conformance

Detail

When documenting a non-conformance, it must include sufficient detail so that anyone who wasn’t involved, can read it and understand the problem.

The documented explanation and the provided evidence must also allow an impartial person, to carry out their own assessment and reach the same conclusion.

Documenting internal audits

Internal audit reports must clearly document:

  • The topic and the details of any physical areas being audited.
  • The requirements being audited.
  • A detailed response with evidence to support conformance and non-conformance.

Documenting GMP inspections and monitoring activities

Documentation must clearly state:

  • The details of what’s being assessed, such as location, equipment, product.
  • The requirements being assessed.
  • Confirmation of conformance or non-conformance.
  • Details of the monitoring result.
  • A detailed response and evidence where the result is non-conforming.

Communication

Non-conformance, including the consequence assessment must be communicated to staff who are accountable, so that action can be taken. This includes the internal audit reports and GMP inspections.

Identifying conformance and non-conformance

Our mini training ‘Identifying conformance and non-conformance’ teaches internal auditors, GMP inspectors, staff carrying out monitoring activities and those responsible for handling non-conforming product – how to detail non-conformance and where needed, conformance.

Identifying conformance and non-conformance

Have your say…

Share your thoughts…

Your email address will not be published.