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.

Note: The process is identical for all the ISO Management System Standards, ISO 14001, ISO 45001, ISO 13485, etc.

ISO 9001:2015 Clause 10.2, Nonconformity and Corrective Action, requires that when a nonconformity occurs, including those arising from complaints, the organization shall "review the effectiveness of any corrective action taken."  

That being the case, four things usually happen:

1. the requirement is ignored;
2. the signature to complete  a Corrective Action Report has no significance stated in a procedure;
3. the persons responsible don't know of any significance to their signature being added to the report; 
4. 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.

1. Check if operating personnel were made aware of the change and the purpose of the change.
   
2. Check if the organization 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.
   
3. Check if all relevant documents, system requirements, and recordkeeping requirements were modified to reflect the change to the process or systems, such as...
   
   • Instructions
   • Bills of materials
   • Formulations
   • Testing and Inspection
   • Specification and design
   • Packaging and markings
   • New purchased materials
   • Product storage
   • Service procedures
     
4. Check if the person or function responsible for the authorization of process changes was clearly designated.
   
5. Check if the product or service provided to the customer was affected and if the customer was notified of the change.
   
6. Check if the change has been followed consistently
   
7. Check if output measures to monitor and verify that the process is achieving the desired result were identified.
8. Ensure that the evidence of effectiveness and the identity of the person responsible for confirming that effectiveness are recorded in the Nonconformance Report or similar.

Would you like a free copy of our Effectiveness of Corrective Action Checklist?

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