Clause 10.2.1 (e) requires to review risk and opp when there is any non-conformity. This leads to very micro level of risk review, which is more on FMEA method. What is your opinion.
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I have a different opinion. The standard is recommending us to, after reviewing of corrective actions, consider whether there are risks or opportunities that have not been determined previously, or if their evaluation should be updated. Please check that “if necessary” at the end of clause 10.2.1 e).
I find it very useful. Don’t consider this clause as applicable to every and each non-conformity. For each non-conformity we are not obliged to develop a corrective action. We develop them when non-conformities are very serious or are trending. In this free webinar on demand - How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar/ I say something like “Consider the non-conformities, complaints, devolutions, lost customers as signs, as warnings about the need to update the risk register or the risk evaluation. Are they signaling that changes must be made?”
You can find more information below.
- 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/
- Does ISO 9001 require a procedure for addressing risks and opportunities?: https://advisera.com/9001academy/blog/2017/10/10/does-iso-9001-require-a-procedure-for-addressing-risks-and-opportunities/
- For a free preview of an example of the Registry of Key Risks and Opportunities - https://advisera.com/9001academy/documentation/registry-of-key-risks-and-opportunities/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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Sep 01, 2020