Guest user Created: Nov 30, 2016 Last commented: Nov 30, 2016

FMEA and addressing opportunities in ISO 9001

Failure Mode Effect Analysis and Control Plan are used in automotive world, in order to control the risks, however the opportunities how can we addressed, is it enough to do with a continuous improvement? your comments will be appreciated, thanks.

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Strahinja Stojanovic Nov 30, 2016

Answer:

FMEA (Failure Mode Effect Analysis) has a limited applicability when it comes to addressing risks and opportunities within QMS. Although it is highly applicable for risk assessment within production and design and development process, it fails to cover entire scope of the risk related to the QMS, since it doesn't perform well with the risks emerging from external context of the organization.

As far as opportunities are concerned, FMEA doesn't cover them at all. The best way to identify opportunities is to arrange a brainstorming session with most relevant people in the company and discuss the opportunities in terms of improving processes, enhancing customer satisfaction and achieving QMS or the company's objectives. Another problem is how you will take actions to address the opportuni ties, it can be done through corrective actions or any other action or project, what is important is to plan the actions and evaluate its effectiveness later.

For more information, about risks and opportunities, see:
- How to address risks and opportunities in ISO 9001 https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/

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Nov 30, 2016

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