capable people blog

Posts Tagged ‘Clause 8.5.2’

Corrective & Preventive Actions – Truths and Myths

The key to understanding the spirit of Corrective and Preventive Action probably revolves as much around applying the terms in accordance with the ISO 9000 definition than anything else

Corrective Action:
Action to eliminate the cause of a detected nonconformity or other undesirable situation

Preventive Action:
Action to eliminate the cause of a potential nonconformity or other undesirable potential situation

ISO 9000 does not embolden the key terms as I have done, but frankly those little words are at the crux of the matter

There is so much continuing confusion about the whole “CAPA” subject, I’ve tried to summarise some key points in a few common “TRUE OR FALSE” scenarios. These questions really strike at the heart of the majority of the inappropriate and clumsy procedures and controls I see. Check out the table below and let me know if anything here strikes a cord with you

Corrective Action is action to correct a problem, whilst Preventive Action is taking additional measures to prevent it happening again

FALSE

This is a very common misconception. Whilst part of the corrective action process will involve an aspect of putting things right, the ISO 9001 requirement for corrective action requires an additional assessment or investigation of feasible action to prevent recurrence – therefore there are generally two parts to the corrective action process, that is, immediate actions and longer term actions

Preventive Action is the implementation of proactive controls to stop something EVER happening (refer to the ISO 9000 definitions above for clarification)
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