All ISO Management System Standards require that the effectiveness of Corrective Action be checked. It's rarely done well.
Let's take ISO 9001:2015 as an example.
ISO 9001:2015 Clause 10.2, Nonconformity and Corrective Action, requires that when a nonconformity occurs, including those arising from complaints, the organisation shall "review the effectiveness of any corrective action taken".
That being the case, four things usually happen:
the requirement is ignored;
the signature to complete a Corrective Action Report has no significance stated in a procedure;
the persons responsible don't know of any significance to their signature being added to the report;
the signature confirms that action was taken, but whether it was sufficient to prevent recurrence was not considered.
And that's just the point - taking corrective actions to prevent the recurrence of costly and time-consuming issues. Unless you take time to monitor and note down changes following corrections in your management system, you don't know.
Verifying the Effectiveness of Corrective Action with a Checklist
The best way we know to monitor the effectiveness of action taken is to create a record using a form such as that shown here and for this to be a documented part of the Corrective Action Process.
- Check if operating personnel were made aware of the change and the purpose of the change
- Check if the organisation considered what would be required to implement the change, such as classroom training, on-the-job training, examples, new standards, directives issued, operator surveys, and so on
- Check if all relevant documents, system requirements, and recordkeeping requirements were modified to reflect the change to the process or systems, such as...
- Bills of materials
- Testing and Inspection
- Specification and design
- Packaging and markings
- New purchased materials
- Product storage
- Service procedures
- Check if the person or function responsible for the authorisation of process changes was clearly designated
- Check if the product or service provided to the customer was affected and if the customer was, were they notified of the change
- Check if the change has been followed consistently
- Check if output measures identified to monitor and verify that the process is achieving the desired result were identified
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deGRANDSON Global is an ISO Certified Educational Organization
In October 2021 we secured certification to three education-related ISO Standards. We now have a university-grade management system in place conforming to the requirements of …
We have chosen ISO 21001 certification because, unlike IRCA and Exemplar badges (which in our opinion are commercially compromised), it is based on independent third-party assessment. It is a ‘university grade’ standard in use globally by schools, colleges, and universities to demonstrate their competence.
Note: First published December 2017; updated February 2021.