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--- articles:preventive_action_not_equal_to_risks_and_opportunities [2019/11/24 13:15] – [Preventive Action ≠ Risks and Opportunities?] rrandall
+++ articles:preventive_action_not_equal_to_risks_and_opportunities [2020/01/11 14:12] – [Preventive Action ≠ Risks and Opportunities?] rrandall
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 ====== Preventive Action ≠ Risks and Opportunities? ======
-While not mentioned in the original ISO 9001:1987, the term “preventive action” was introduced into ISO 9001:1994. Intended to be a simplistic, yet formalized proactive approach toward addressing “risks”, the new term created a great deal of confusion. This was primarily because the term wasn’t defined in the standard and users rarely purchased ISO 8402:1994, “//Quality management and quality assurance–Vocabulary//”.
+While not mentioned in the original ISO 9001:1987, the term “preventive action” was introduced into ISO 9001:1994. Intended to be a simplistic, yet formalized proactive approach toward addressing “risks”, the new term created a great deal of confusion. This was primarily because the term wasn’t defined in the standard - and users rarely purchased ISO 8402:1994, “//Quality management and quality assurance–Vocabulary//”.
 With the release of ISO 9001:2000, ISO 8402 was renumbered and renamed to ISO 9000:2000, “//Quality management systems–Fundamentals and Vocabulary//”. The definition of “preventive action” is still present in ISO 9000:2015, and has remained unchanged since 1994 as:
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-Compounding the confusion, someone decided to use the same form for both corrective and preventive action (CAPA).
+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__ throughout the standard (in sections 4.4f, 5.1.2b, 6.1, 9.1.3e, 9.3.2e & 10.2.1e).
+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).
 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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 </blockquote>
-Interestingly, while a definition for “risk” was added to the ISO 9000:2015, “//Quality management systems–Fundamentals and Vocabulary//”. Unfortunately, ISO struggles with properly defining the word "risk" (Ref.: [[articles:a_matter_of_risk|A Matter of "Risk"]]). Regardless of how ISO 9000:2015 defines "risk", ISO 14001:2015 makes it clear that "risks" are "threats". Therefore,  So, for the sake of simplicity, let's use the definition contained in [[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)]], published by the [[https://www.api.org|American Petroleum Institute (API)]].
+Interestingly, while a definition for “risk” was added to the ISO 9000:2015, “//Quality management systems–Fundamentals and Vocabulary//”, there is no definition for "opportunities". Unfortunately, ISO struggles with properly defining the word "risk" (Ref.: [[articles:a_matter_of_risk|A Matter of "Risk"]]). Regardless of how ISO 9000:2015 defines "risk", ISO 14001:2015 makes it clear that "risks" are "threats". So, for the sake of simplicity, let's use the definition contained in [[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)]], published by the [[https://www.api.org|American Petroleum Institute (API)]].
 <blockquote>**API Spec Q1** \\