Misuse of a Corrective Action System

I was recently visiting a new consulting client where I noticed that many of the issues identified in the company’s Corrective Action system were NOT actually nonconformities. When asked about this, the Quality Manager explained that it was their practice to input all “Observations” and any “Opportunities For Improvement” identified from audits (whether internal or external) into their corrective action system.

I explained that the definition of a “corrective action” requires there to be a nonconformity:

ISO 9000:2015, “Quality management systems — Fundamentals and vocabulary”, sec. 3.12.2:
corrective action
action to eliminate the cause of a nonconformity and to prevent recurrence

Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action (3.12.1) is taken to prevent occurrence.

Choosing to ignore this definition, the Quality Manager explained how the company had decided to use their corrective action system as an all-encompassing “change management” and “continual improvement” system. Although I attempted to explain how this was incorrect and actually misuse of their corrective action system, to my surprise their Quality Manager informed me that this was how their CB (Certification Body - aka Registrar) wanted them to use their corrective action system!

I was certain that there must be some misunderstanding. The Quality Manager explained that, in his experience, every CB auditor that he had dealt with, who had issued “Observations” or “Opportunities For Improvement”, had specifically stated an expectation for the company to address those issues through their corrective action system. If the company didn’t fulfill that expectation, then during the following CB audit, the “Observations” or “Opportunities For Improvement” would be re-issued as “nonconformities”.

This indicated an obvious history of CB auditors “soft grading” (i.e., identifying nonconformities as “Observations” or “Opportunities For Improvement” either to avoid the administrative work of reviewing and approving corrective actions or to avoid being perceived as a “bad guy” for issuing nonconformities).

As a result of this “soft grading”, the CB auditors had not only encouraged, but forced the company to misuse their corrective action system. Consequently, the company had accumulated a database containing dozens of nonsensical “corrective actions”.

Upon locating and reviewing the few “actual” nonconformities within their cluttered corrective action system, most were poorly handled or completely ineffective in preventing recurrence because the Quality Team lacks a sufficient understanding of how to perform a proper root cause analysis.

I explained that, eventually, when a CB auditor observes that the company's corrective action system fails to prevent the recurrence of nonconformities identified by the CB, the company will receive a Major Nonconformance for having an ineffective corrective action system.

The Quality Manager ignored this warning… insisting that this was how their CB wanted to use their corrective action system.