Differences

This shows you the differences between two versions of the page.

Link to this comparison view

Both sides previous revisionPrevious revision
Next revisionBoth sides next revision
articles:preventive_action_not_equal_to_risks_and_opportunities [2019/11/24 13:16] – [Preventive Action ≠ Risks and Opportunities?] rrandallarticles:preventive_action_not_equal_to_risks_and_opportunities [2020/01/11 14:12] – [Preventive Action ≠ Risks and Opportunities?] rrandall
Line 1: Line 1:
 ====== Preventive Action ≠ Risks and Opportunities? ====== ====== 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: 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:
Line 16: Line 16:
  
  
-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//". 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//".
Line 27: Line 27:
 </blockquote> </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". 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** \\ <blockquote>**API Spec Q1** \\