3. Continuous improvement
Identifying conformance and non-conformance
Non-conformances are identified where there’s a failure to meet a set standard.
This article is written to meet the following sections of the Standards:
| BRCGS Food Safety Issue 9 | 3.7 Corrective and preventive actions |
| BRCGS Packaging Issue 6 | 3.6 Corrective and preventive action |
| BRCGS Agents & Brokers Issue 3 | 3.9 Corrective and preventive actions |
| BRCGS Storage & Distribution Issue 4 | 3.3 Corrective and preventive action |
| FSSC 22000 Version 5.1 | ISO 22000: 10.1 Nonconformity and corrective action |
| IFS Food Version 7 | 5.11 Corrective actions |
| SQF Edition 9 | 2.5.3 Corrective and preventative action |
Contents
Requirements
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.
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.
BRCGS Food Safety Issue 9
The key change for Issue 9 is that all non-conformances must follow the same process, including those identified through GMP inspections. This includes reporting them to those who must take action, ensuring that timescales for completion are agreed and verifying them before closure.
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.
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