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articles:preventive_action_not_equal_to_risks_and_opportunities [2020/01/11 14:21]
rrandall [Is the use of "Preventive Action" still valid?]
articles:preventive_action_not_equal_to_risks_and_opportunities [2020/01/11 14:23] (current)
rrandall [Is the use of "Preventive Action" still valid?]
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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>​ 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-specific 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)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 ===== ===== 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 QMS for addressing “negative risks"/​threats PROVIDED that the organization also has a separate methodology of addressing “positive risks" and opportunities.