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--- articles:preventive_action_not_equal_to_risks_and_opportunities [2020/07/10 09:38] – [Conclusion] rrandall
+++ articles:preventive_action_not_equal_to_risks_and_opportunities [2021/12/17 17:49] – [Preventive Action ≠ Risks and Opportunities?] rrandall
@@ Line 18: / Line 18: @@
 Compounding the confusion, some organizations decided to use the same form for both corrective and preventive action (CAPA).
-ISO 9001:2015 replaced the concept of “preventive action” with the more expanded “risks and opportunities” (in section 6.1). Upon reading ISO 9001:2015, take note that it repeatedly uses the term “//risks and opportunities//” as __two separate concepts__ (in sections 4.4f, 5.1.2b, 6.1, 9.1.3e, 9.3.2e & 10.2.1e).
+In ISO 9001:2015 the requirement for “preventive action” had been removed. And many viewed the concept as having been replaced with the more expanded of “risks and opportunities” (in section 6.1). Auditor training emphasized that this was not the case. Instead, “//risks and opportunities//” were not to be considered during the planning. This becomes obvious when reading the requirement:
+Upon reading ISO 9001:2015, take note that it repeatedly uses the term “//risks and opportunities//” as __two separate concepts__ (in sections 4.4f, 5.1.2b, 6.1, 9.1.3e, 9.3.2e & 10.2.1e).
 While not defined in ISO 9000:2015 or ISO 9001:2015, the term "//risks and opportunities//" is defined in ISO 14001:2015, "//Environmental management systems — Requirements with guidance for use//".
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 Supporting this, there is nothing stated in either the "[[https://committee.iso.org/files/live/sites/tc176sc2/files/documents/Interpretations/ISO9001_2015_Approved_Interpretations.doc|ISO/TC 176/SC 2 Listing of Approved Interpretations against ISO 9001:2015]]" or "[[https://asq.org/quality-resources/iso-9001/us-tc176|US TC 176 - TG22 - Interpretations]]" forbidding or restricting use of the "preventive action" methodology. And ISO 9000:2015 continues to recognize "preventive action" as a legitimate methodology (Ref. ISO 9000:2015, sec. 3.12.1).
-HOWEVER, I recommend eliminating the use of this confusing term because it is so widely misunderstood. A MUCH better way to approach this topic is through the implementation of actual //risk management tools// (which is what ISO 9001:1994 //should// have required) incorporating the use of [[https://asq.org/quality-resources/fmea|FMEAs (Failure Modes and Effects Analysis]]. A FMEA should be completed for each process (aka **PFMEA** - "Process Failure Modes and Effects Analysis") and design (aka **DFMEA** - "Design Failure Modes and Effects Analysis").
+HOWEVER, I recommend eliminating the use of this confusing term because it is so widely misunderstood. A MUCH better way to approach this topic is through the implementation of actual //risk management tools// (which is what ISO 9001:1994 //should// have required) incorporating the use of [[https://asq.org/quality-resources/fmea|FMEAs (Failure Modes and Effects Analysis)]]. A FMEA should be completed for each process (aka **PFMEA** - "Process Failure Modes and Effects Analysis") and design (aka **DFMEA** - "Design Failure Modes and Effects Analysis").