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| articles:preventive_action_not_equal_to_risks_and_opportunities [2019/11/15 17:24] – [Conclusion] rrandall | articles:preventive_action_not_equal_to_risks_and_opportunities [2019/11/24 13:15] – [Preventive Action ≠ Risks and Opportunities?] rrandall |
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| Compounding the confusion, someone decided to use the same form for both corrective and preventive action (CAPA). | Compounding the confusion, someone 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). And 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"]]). 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)]]. | 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). |
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| <blockquote>**API Spec Q1** \\ | |
| 3.1.19 risk \\ | |
| Situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.</blockquote> | |
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| 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). | |
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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//". |
| potential adverse effects (threats) and potential beneficial effects (opportunities) | potential adverse effects (threats) and potential beneficial effects (opportunities) |
| </blockquote> | </blockquote> |
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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". 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)]]. |
| | |
| | <blockquote>**API Spec Q1** \\ |
| | 3.1.19 risk \\ |
| | Situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.</blockquote> |
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| ===== Is the use of "Preventive Action" still valid? ===== | ===== Is the use of "Preventive Action" still valid? ===== |
