Danielle Tan
Managing Consultant
Corrective action for nonconformity needs to be imposed wherever there is a failure to fulfill the requirements, and the Food Safety Management System needs to make sure that this happens.
“There is no failure. Only feedback.”
Robert Allen
In any management system, sometimes we see the nonconformities as failures because things didn’t turn out as they were supposed to. You did what you knew and how to do at that time.
The truth is, when you knew better, you did better. Think of every nonconformity that happened in the Food Safety Management System as a chance to learn and grow. Even if it didn’t go exactly as planned, that is not failure. There’s a chance there. With that chance, we get feedback. With the feedback, we can take the scenario and make it better. Each experience of nonconformity gives us the information (feedback) for the following steps to take. From the experience learned, we strive to grow stronger from the experience.
Managing Corrective Action for Nonconformity
ISO 22000:2018 specifies requirements for Nonconformity and Corrective Action in clause 10.1. Accountability and responsibility for managing the nonconformance system and associated actions are required for its successful implementation.
Corrective action for nonconformity needs to be imposed wherever there is a failure to fulfill the requirements, and the Food Safety Management System needs to make sure that this happens. Types of nonconformities from the following sources shall be included in the control:
- External audits.
- Product that does not conform to specifications (internal, customers, legal).
- Complaints regarding products that do not conform to requirements.
- Incidents, such as the withdrawal and recall of products.
- Internal audits as well as GMP inspections.
- Monitoring that is performed either in-line, at-line, or off-line.
What ISO 22000:2018 clause 10.1 says about nonconformity and corrective action:
For the proper management of nonconformity activities, a procedure for dealing with nonconformity that outlines the following requirements shall be established:
#1. Document and Record the Nonconformity
Nonconformity shall be clearly documented. Along with the corresponding record forms, the method that trigger the recording needs to be implemented into the management system so that it can be handled effectively. This is necessary in order to ensure that the system is efficiently managed.
When it comes to the nonconformity, the corrective action, the verification, and finally the closing of the nonconformity, the records need to guarantee that all of the necessary information is properly documented.
#2. Assess for Consequence
Each nonconformity needs to have its potential impact evaluated before suitable corrective measures may be adopted to determine their severity levels:
- Minor
- Major
- Critical
The procedure needs to include specific instructions for conducting the consequence assessment and explaining how the results will be used to choose the appropriate course of action.
#3. Correction
Every single nonconformity calls for some kind of correction to be taken to react to the nonconformity, take action to control and correct it, and deal with the consequences. Examples of correction include reject the affected batch of the nonconforming product, dispose them or rework.
#4. Root Cause Analysis
When it is found that the nonconformity poses a threat to the safety, legality, or quality of the product, corrective action must be taken by conducting a root cause analysis. This is to ensure action is taken based on the root cause to prevent the issue from occurring in the future or will not happen again.
#5. Corrective Action
Implement any action needed to eliminate the root causes identified. Corrective action shall be identified with their respective deadlines and responsibilities.
Once corrective action has been taken, review and verify the effectiveness of the actions taken and make changes to the Food Safety Management System, if necessary. Corrective actions shall be appropriate to the effects of the nonconformities encountered.
#6. Review
In performance management, one of the most important aspects is the management of nonconformities. This indicates that key performance indicators (KPIs) relating to nonconformity shall be monitored, and the findings need to be reported to top management.
As part of the performance review sessions, the summary and close out nonconformities shall be examined on a regular basis. These sessions can take place at planned intervals, for example during:
- Meetings of managers held once a month.
- Weekly team meetings.
- Daily morning huddle/ briefing.
Conclusion
If nonconformity ever happen again, implement these 6 steps to examine your current strategies and controls. When it is required, make any necessary changes. If the organization learn to take responsibility for its actions and view nonconformity (or some call it “failure”) as information, you’ll be more motivated and strengthen your problem-solving skills after encountering each nonconformity.
Reference/Source:
- ISO 22000:2018 Food Safety Management Systems- Requirements for Any Organization in the Food Chain.
- https://techni-k.co.uk/continuous-improvement/managing-the-non-conformance-action-system/?mc_cid=4205dd80d7&mc_eid=db6bb31c3d
- https://drcherrycoaching.com/wp-content/uploads/2021/02/There-Is-No-Failure-Only-Feedback-.pdf
