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--- articles:preventive_action_not_equal_to_risks_and_opportunities [2020/01/11 14:23] – [Is the use of "Preventive Action" still valid?] rrandall
+++ articles:preventive_action_not_equal_to_risks_and_opportunities [2020/07/10 09:39] – [Conclusion] rrandall
@@ Line 51: / Line 51: @@
   * [[https://www.monogramwebstore.org/publications/item.cgi?7a832d46-1fb0-4650-a57e-963108b9f71d|API Spec Q1, "Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry" (Ninth Edition, June 2013)]]
 ===== Conclusion =====
-An organization can certainly continue to use “preventive actions” as a methodology within its QMS for addressing “negative risks"/threats PROVIDED that the organization also has a separate methodology of addressing “positive risks" and opportunities.
+An organization can certainly continue to use “preventive actions” as a methodology within its ISO 9001:2015 or AS9100:2016 QMS for addressing “negative risks"/threats PROVIDED that the organization also has a separate methodology of addressing “positive risks" and opportunities.
 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").