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How to check the Effectiveness of Corrective Action

Little man - Auditing.jpg All ISO Management System Standards require that the effectiveness of Corrective Action be checked.  It's rarely done well.

 

How should it be done?

To take ISO 9001:2015 as an example, Clause 10.2, Nonconformity and Corrective Action, requires that when a nonconformity occurs, including those arising from complaints, the organization shall 'd) review the effectiveness of any corrective action taken'.  This requirement is frequently ignored.  Or the signature to complete  a Corrective Action Report has no significance stated in a procedure.  Or the persons responsible don't know of any significance to their signature being added to the Report.  Or, worst of all, the signature confirms that action was taken but whether it was sufficient to prevent recurrence was not considered .

And that's just the point - action to prevent recurrance. Unless you check, you don't know.

How then should the effectiveness be checked and recorded?  The best way we know is to create a record using a form such as that shown here (we didn't create this form but have lost the identity of the copyright owner - sorry).

Effectiveness Checklist for Corrective Action

Implementation

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1.       Were operating personnel made aware of the change and the purpose of the change?

 

2.       Did the organization consider 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.       Were all relevant documents, system requirements, and record-keeping requirements modified to reflect the change to the process/system?

  • Instructions?
  • Bills of materials?
  • Formulations?
  • Testing and inspection?
  • Specification, design?
  • Packaging and markings?
  • New purchased materials?
  • Product storage?
  • Service procedures?

 

4.       Is the person or function responsible for authorization of process changes clearly designated?

 

5.       If the product or service provided to the customer is affected, was the customer notified of the change?

 

6.       Is the change being followed consistently?

 

Outcome

 

7.       Were output measures identified to monitor and verify that the process is achieving the desired result?

 

8.       Have desired expectations (outputs) been defined? Are outputs consistent with expectations?

 

9.      Were process measures identified to monitor and verify that the process/system is capable?

 

10.    Have desired expectations (processes) been defined? Are process measures consistent with expectations?

 

11.    Are there records of the results?

 

12.    Is an emergency change procedure in place to prevent nonconforming product or service if the change is not working?

 

 

Be a Certified Internal Auditor

 

Written by Dr John FitzGerald

Director and founder of deGRANDSON Global. After 15 years in manufacturing industry John has spent the past 25 years training, consulting and auditing ISO 9001 and other management systems. 'Our objective is to be a world-class provider of e-training using the best proven technology so to satisfy and, hopefully, delight all of our Learners. Great commercial success and professional esteem will surely follow.' Full profile: https://degrandson.co.uk/team/john-fitzgerald/
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