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articles:preventive_action_not_equal_to_risks_and_opportunities [2019/11/24 13:16] – [Preventive Action ≠ Risks and Opportunities?] rrandall | articles:preventive_action_not_equal_to_risks_and_opportunities [2020/01/11 14:16] – [Preventive Action ≠ Risks and Opportunities?] rrandall |
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====== Preventive Action ≠ Risks and Opportunities? ====== | ====== Preventive Action ≠ Risks and Opportunities? ====== |
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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//”. |
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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: | 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). |
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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). |
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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//". | 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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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". 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//”, ISO chose not to include a definition for "opportunities". Perhaps this is because 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 much better (more clear) 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)]]. |
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<blockquote>**API Spec Q1** \\ | <blockquote>**API Spec Q1** \\ |