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articles:as9100d_product_safety [2020/08/03 13:52] – [AS9100 - Product Safety] rrandallarticles:as9100d_product_safety [2020/08/05 08:31] – [What should you "really" do to address "Product Safety"?] rrandall
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 If you're like most AS9100 companies, this requirement appears ambiguous/vague. That's because it is. And the "Note" is so nebulous that it is almost worthless. Sadly, there are a few articles, posts, and videos on the Internet from uninformed or poorly informed consultants confidently stating what they //think// "product safety" means. A couple of them are laughable. If you're like most AS9100 companies, this requirement appears ambiguous/vague. That's because it is. And the "Note" is so nebulous that it is almost worthless. Sadly, there are a few articles, posts, and videos on the Internet from uninformed or poorly informed consultants confidently stating what they //think// "product safety" means. A couple of them are laughable.
 +
 +The term "product safety" is confusing to many... because "safety" is often associated with "//the state of being safe; freedom from the occurrence or risk of injury, danger, or loss.//" While that is the most common definition, [[https://www.merriam-webster.com|merriam-webster.com]] defines "[[https://www.merriam-webster.com/dictionary/safety|safety]]" as:
 +<blockquote>safety \\
 +the condition of being safe from undergoing or __causing__ hurt, injury, or loss.</blockquote>
 +
 +So let's look at the definition provided in AS9100 to see if that provides any greater clarity:
 +
 +<blockquote>**3.4 Product Safety** \\
 +The state in which a product is able to perform to its designed or intended purpose without causing unacceptable risk of harm to persons or damage to property.</blockquote>
 +
 +AS9120:2016 (for distributors) contains a similar definition:
 +<blockquote>**3.6 Product Safety** \\
 +Maintaining the state of product so that it is able to perform to its designed or intended purpose without causing unacceptable risk of harm to persons or damage to property.</blockquote> 
 +
 +The above definitions provide much more clarity. But if we read "Product Safety" as "Product Integrity", that makes it's meaning more easily understood.
  
 I searched the definitions of 14 CFR and glossaries of the below organizations attempting to find any other use of the term. I found none. I searched the definitions of 14 CFR and glossaries of the below organizations attempting to find any other use of the term. I found none.
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 Glossary]] Glossary]]
  
-Consequently, it appears that IAQG simply invented the term "Product Safety". +Consequently, it appears that "Product Safety" is a non-standard term created (invented) by IAQG.
- +
-The phrase "product safety" is confusing to many... because "safety" is often associated with "//the state of being safe; freedom from the occurrence or risk of injury, danger, or loss.//" While that is the most common definition, [[https://www.merriam-webster.com|merriam-webster.com]] defines "[[https://www.merriam-webster.com/dictionary/safety|safety]]" as: +
-<blockquote>safety \\ +
-the condition of being safe from undergoing or __causing__ hurt, injury, or loss.</blockquote> +
- +
-So let's look at the definition provided in AS9100 to see if that provides any greater clarity: +
- +
-<blockquote>**3.4 Product Safety** \\ +
-The state in which a product is able to perform to its designed or intended purpose without causing unacceptable risk of harm to persons or damage to property.</blockquote> +
- +
-The above definition provides much more clarity. But if we read "Product Safety" as "Product Integrity", that makes it's meaning more easily understood. +
  
 While I ordinarily don't like to reference regulatory requirements, this is one of those instances where the regulatory requirements are more clear... and make sense.  While I ordinarily don't like to reference regulatory requirements, this is one of those instances where the regulatory requirements are more clear... and make sense. 
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 <note>Due to civil liability issues, the vast majority of AS9100 auditors (and CBs) would not reference one of these regulatory requirements in a nonconformity, but instead, would cite a nonconformance with AS9100, sec. 8.1.3.</note> <note>Due to civil liability issues, the vast majority of AS9100 auditors (and CBs) would not reference one of these regulatory requirements in a nonconformity, but instead, would cite a nonconformance with AS9100, sec. 8.1.3.</note>
  
-===== What "Specifically" should AS9100 Companies address "Product Safety"? =====+===== What "Specifically" does AS9100 require regarding "Product Safety"? =====
  
 Let's assume that some design-responsible company has identified one or more "critical items". What must be done? Let's assume that some design-responsible company has identified one or more "critical items". What must be done?
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 AS9100 is so poorly written that IAQG should be embarrassed. So let's forget about AS9100 and just focus on doing "the right thing".  AS9100 is so poorly written that IAQG should be embarrassed. So let's forget about AS9100 and just focus on doing "the right thing". 
  
-1 - Walter Sam O’Connor, Vice President - Technical Services for the [[https://www.aviationsuppliers.org|Aviation Suppliers Association (ASA)]], provides a far superior explanation of how to ensure "product safety" (than AS9100) in his presentation: +1 - Walter Sam O’Connor, Vice President - Technical Services for the [[https://www.aviationsuppliers.org|Aviation Suppliers Association (ASA)]], provides a presentation on how to ensure "product safety" (focusing on AS9100/AS9110/AS9120): 
 [[https://www.aviationsuppliers.org/ASA/files/ccLibraryFiles/Filename/000000001848/SamO'Connor-WorkshopF.pdf | Product Safety as it applies to AS9100D/AS9110C/AS9120B]] [[https://www.aviationsuppliers.org/ASA/files/ccLibraryFiles/Filename/000000001848/SamO'Connor-WorkshopF.pdf | Product Safety as it applies to AS9100D/AS9110C/AS9120B]]
 +
 +In his presentation, Mr. O’Connor identifies several good ideas... applicable to ANY "good" quality management system (regardless of "product safety"). In effect, Mr. O’Connor is politely "pointing out" some of the many inherent flaws in AS 9100 as a QMS standard. He builds his examples around the 6 Ms (which was a GREAT idea) and promotes Lean Six Sigma (also a GREAT idea).
 +
 +It is a bit more challenging to identify specific actions that go above and beyond normal activities necessary to addres the special considerations for "product safety" 
 +
 +
  
 2 - If you have an Engineering function, download and adopt the applicable requirements of [[http://everyspec.com/MIL-STD/MIL-STD-0800-0899/MIL-STD-882E_41682/|MIL-STD 882, "System Safety"]]. 2 - If you have an Engineering function, download and adopt the applicable requirements of [[http://everyspec.com/MIL-STD/MIL-STD-0800-0899/MIL-STD-882E_41682/|MIL-STD 882, "System Safety"]].
  
 MIL-STD 882 requires a more detailed risk assessment for "product safety"; one that AS9100 should have required. MIL-STD 882 requires a more detailed risk assessment for "product safety"; one that AS9100 should have required.
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