Google Analystics

Monday, 6 July 2015

ISO 9001:2008 - Corrective Actions and Preventive Actions

Somebody asked for clarification in implementing Clauses 8.5.2 (Corrective Actions) & 8.5.3 (Preventive Actions).

I don't claim to know all the thinking behind the elimination of the term 'preventive action' in the soon to be released 2015 revision of the Standard, but I do know that many people of my acquaintance are not clear as to the distinction IN PRACTICAL TERMS between corrective and preventive action even though they can rattle off the definitions from ISO 9000 which I still find relevant and helpful: corrective action PREVENTS RECURRENCE of a nonconformity, preventive action prevents first time occurrence of potential nonconformities. The word 'prevent' is possibly the source of confusion. Indeed, if the action taken for a corrective action is to revise a process, that will likely prevent other, potential nonconformities as well as prevent the recurrence of the nonconformity or defect under consideration; that is, a preventive action comes as a by-product of the corrective action even if the potential nonconformities have not been explicitly identified, and quality will improve.

In my last position (medical devices) it was part of the process to consider the desirability of performing a preventive action after every corrective action. If the root cause analysis suggested a process change then this was usually done as a preventive action as that invariably went wider than just the nonconformity under consideration.

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The practice of considering corrective actions when doing corrections is quite common in my experience and seems like common sense. Do not skimp the very important step of investigation to fully identify and describe the problem. What, where, when, who, how often, what is the impact? This is a prerequisite to root cause analysis and risk analysis.

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