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articles:as9100d_product_safety [2020/08/01 17:20]
rrandall [What should you "really" do to address "Product Safety"?]
articles:as9100d_product_safety [2020/08/05 08:47] (current)
rrandall [What should you "really" do to address "Product Safety"?]
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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 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:+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 \\ <​blockquote>​safety \\
 the condition of being safe from undergoing or __causing__ hurt, injury, or loss.</​blockquote>​ the condition of being safe from undergoing or __causing__ hurt, injury, or loss.</​blockquote>​
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 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 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. ​+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. 
 + 
 +[[https://​www.law.cornell.edu/​cfr/​text/​14/​5.5|14 CFR (Chapter I - Federal Aviation Administration) § 5.5 - Definitions]] 
 + 
 +[[https://​www.law.cornell.edu/​cfr/​text/​14/​401.5|14 CFR (Chapter III - Commercial Space Transportation) § 401.5 - Definitions]] 
 + 
 +[[https://​asq.org/​quality-resources/​quality-glossary|ASQ "​Quality Glossary"​]] 
 + 
 +[[https://​www.dau.edu/​glossary/​Pages/​Glossary.aspx|Defense Acquisition University (DAU) "​Glossary of Defense Acquisition Acronyms and Terms"​]] 
 + 
 +[[http://​std.iec.ch/​terms/​terms.nsf/​welcome|International Electrotechnical Commission 
 +Glossary]] 
 + 
 +Consequently,​ it appears that "​Product Safety"​ is a non-standard term created (invented) by IAQG.
  
 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+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]]
  
-- 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"​]].+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 rather than differentiate "​product safety"​ from "​product quality"​. 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 address the special considerations for "​product safety"​. Which, if you haven'​t figured it out yet, "​really"​ apply to anything identified as a "​Critical Item". However, here are a few: 
 + 
 +  * Increase the measurement accuracy ratio between the measuring instrument used and the tolerance of the part. For example, if you normally maintain a Measurement Ratio nf 4:1, then increase that ratio to 10:1 in order to reduce the risk of that part being out of tolerance. 
 +  * Add inspection points (e.g., human or automated, using different techniques) to enhance verification that the product conforms to its requirements. 
 +  * Add "call-outs" in drawings, Work Instruction,​ procedures, etc. to emphasize any critical characteristics. 
 +  * Require greater control over any material or process supplier (beyond normal requirements). For example, require the supplier to create and maintain a PFMEA for that process. 
 +  * Obtaining and monitoring the process capability (i.e., Cp, Cpk) and/or process performance (i.e., Pp, Ppk) data related to each process producing each Critical Item. 
 +  * 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.