Drop the PA from CAPA


The new revision of ISO 9001 is going to be released later this year. One of the changes proposed, that piqued my interest, was removal of the Preventive Action section. Preventive Action is “replaced” with Risk Based Thinking.

Preventive Action is proactive in nature. So is risk based thinking. Since my field is medical devices, risk based thinking is deeply engrained in me. It is my understanding that this revision is proposed to create a management system that is risk based.

One of the ways that I have used the PA of CAPA is to identify potential opportunities to implement what we learned from the CAPA. This could be similar products, processes or designs. This is similar to Yokoten in Lean Manufacturing. Jon Miller at Gemba Panterai calls this as “Horizontal Deployment”.

Yokoten means “horizontal deployment” and refers to the practice of copying good results of kaizen in one area to other areas.

The new revision does not take away this meaning. The new revision has in fact moved the thought of risk based thinking to Planning section. Thus, the intent is to spread the idea of risk based management throughout the organization.

As mentioned earlier, risk based thinking is proactive by definition. When properly done, risk based thinking can reduce the nonconformity occurrences, thus reducing the need for corrective actions. Corrective actions are reactive in nature. Risk based thinking leads to more preventive actions throughout the organization.

Paraphrasing heavily from the proposed changes;

When planning for QMS, the organization shall determine the risks and opportunities that need to be addressed to (among other things) prevent or reduce undesired effects.

It will be interesting to see how this will be handled with ISO 13485 standard.

Keep on learning…

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