3. Continuous improvement
Managing the non-conformance action system
The corrective and preventive action procedure for non-conformances
This article is written to meet the following sections of the Standards:
| BRCGS Food Safety Issue 9 | 3.7 Corrective and preventive action 3.4.3 Internal audit non-conformances 3.4.4 GMP inspection non-conformances |
| 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 |
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.
Requirements
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.
BRCGS Food Safety Issue 9
The main points that impact the management of non-conformances are that:
- GMP inspection non-conformances must follow the same process as those raised through internal audits.
- Results of non-conformances must be monitored at performance review meetings, to ensure that the appropriate action is being taken.
Review
Management of non-conformances is a key aspect of performance management. This means that non-conformance related KPIs must be monitored and the results reported to senior management.
Summary and close out non-conformances must be regularly reviewed as part of performance review meetings. These meetings should take place monthly, however non-conformances must be reviewed at all relevant performance review meetings, which would include:
- Monthly management meetings.
- Weekly team meetings.
- Daily shift huddles.
Make your non-conformance system – super slick and simple!
No longer do non-coformances need to be managed using loads of bits of paper- audIT.app automates the whole process for you.
It’s been designed by Techni-K so you can be sure that it’s fully compliant to GFSI and retailer standards.
Which means that you can focus on the really important bit – gettting the actions done.
With due respect, I am not agreeing with your following information.
“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.”
ISO 9000 and ISO 9001, have defined three actions in case of identified or potential non-conformity. (Identified one would be that has be detected and/or recorded. Potential one would be expected after data analysis or trend analysis).
1- Correction: Action to remove or reduce identified non-conformity.
2-Corrective action: Action to remove or reduce CAUSE of identified non-conformity.
3-Preventive action: Action to remove or reduce CAUSE of potential non-conformity.
Hope these concepts would be CORRECTED:)
Hi Muhammad
I agree with those definitions for ISO standards. However, we work to GFSI standards, so the definitions are different – if you look at the references table at the top, you’ll see we don’t reference ISO9000 or ISO9001.
This means, that the definitons that we’ve provided for the standards that we’ve specified, are correct.
It’s very confusing I know…
Kassy