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| articles:as9100d_product_safety [2020/08/03 13:52] – [AS9100 - Product Safety] rrandall | articles:as9100d_product_safety [2020/08/03 21:19] – [What "Specifically" should AS9100 Companies 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. |
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| | 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> |
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| | So let's look at the definition provided in AS9100 to see if that provides any greater clarity: |
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| | <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> |
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| | 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> |
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| | The above definitions provide much more clarity. But if we read "Product Safety" as "Product Integrity", that makes it's meaning more easily understood. |
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| 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. |
| Glossary]] | Glossary]] |
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| 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. |
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| 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> | |
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| So let's look at the definition provided in AS9100 to see if that provides any greater clarity: | |
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| <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> | |
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| The above definition provides much more clarity. But if we read "Product Safety" as "Product Integrity", that makes it's meaning more easily understood. | |
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| 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. |
| <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> |
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| ===== What "Specifically" should AS9100 Companies address "Product Safety"? ===== | ===== What "Specifically" does AS9100 require regarding "Product Safety"? ===== |
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| 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? |
