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--- articles:preventive_action_not_equal_to_risks_and_opportunities [2020/01/11 14:16] – [Preventive Action ≠ Risks and Opportunities?] rrandall
+++ articles:preventive_action_not_equal_to_risks_and_opportunities [2020/07/10 09:38] – [Conclusion] rrandall
@@ Line 37: / Line 37: @@
 While many organizations continue to use the term “preventive action” to address “negative risks"/threats (e.g., because it was embedded into their corrective action forms, databases, etc.), it fails to address "positive risks" and "opportunities".
-Even though use of “preventive action” is still permitted to address “negative risks"/threats, many ISO 9001 and AS9100:2016 registrars are //encouraging// their clients to eliminate use of the term “preventive action” and adopt the term “risks and opportunities” to ensure that "positive risks" and “opportunities” are also addressed within their QMS.
+Even though use of “preventive action” is still permitted to address “negative risks"/threats, many ISO 9001 and AS9100:2016 registrars are //encouraging// their clients to eliminate use of the term “preventive action” and adopt the term “risks and opportunities” to ensure (or at least give the appearance) that "positive risks" and “opportunities” are also addressed within their QMS.
 A reason for this preference can be found in ISO JTCG N359, "JTCG Frequently Asked Questions in support of Annex SL" (dated 2013-12-03), explaining why the concept of “Preventive Action” was replaced with "risks and opportunities".
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 The high level structure and identical text does not include a clause giving specific requirements for “preventive action”. This is because one of the key purposes of a formal management system is to act as a preventive tool. Consequently, a MSS requires an assessment of the organization’s “external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome(s)” in clause 4.1, and to “determine the risks and opportunities that need to be addressed to: assure the XXX management system can achieve its intended outcome(s); prevent, or reduce, undesired effects; achieve continual improvement.” in clause 6.1. These two sets of requirements are considered to cover the concept of “preventive action”, and also to take a wider view that looks at risks and opportunities.</blockquote>
-However, this presents challenges because other industry standards, such as ISO 13485:2016, “//Medical Devices — Quality management systems — Requirements for regulatory purposes//”, ISO 17020:2012, “//Conformity Assessment — Requirements for the operation of various types of bodies performing inspection//” (Option A) and AAR M-1003:2019, Section J, "//Specification for Quality Assurance//”, and [[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)]], all specifically require “preventive action” to be included in the QMS.
+However, this presents challenges because several other industry-specific standards specifically require “preventive action” to be included in the QMS. For example:
+  * ISO 13485:2016, “//Medical Devices — Quality management systems — Requirements for regulatory purposes//”
+  * ISO 17020:2012, “//Conformity Assessment — Requirements for the operation of various types of bodies performing inspection//” (Option A)
+  * AAR M-1003:2019, Section J, "//Specification for Quality Assurance//”
+  * [[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").