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articles:preventive_action_not_equal_to_risks_and_opportunities [2020/01/11 14:23]
rrandall [Is the use of "Preventive Action" still valid?]
articles:preventive_action_not_equal_to_risks_and_opportunities [2020/07/10 09:39] (current)
rrandall [Conclusion]
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   * [[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)]]   * [[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 ===== ===== 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). ​ 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"​).