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articles:as9100d_product_safety [2020/08/03 13:52] – [AS9100 - Product Safety] rrandall | articles:as9100d_product_safety [2020/08/05 08:47] – [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/ | If you're like most AS9100 companies, this requirement appears ambiguous/ | ||
+ | |||
+ | The term " | ||
+ | < | ||
+ | the condition of being safe from undergoing or __causing__ hurt, injury, or loss.</ | ||
+ | |||
+ | So let's look at the definition provided in AS9100 to see if that provides any greater clarity: | ||
+ | |||
+ | < | ||
+ | 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.</ | ||
+ | |||
+ | AS9120:2016 (for distributors) contains a similar definition: | ||
+ | < | ||
+ | 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.</ | ||
+ | |||
+ | The above definitions provide much more clarity. But if we read " | ||
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, | + | Consequently, |
- | + | ||
- | The phrase " | + | |
- | < | + | |
- | the condition of being safe from undergoing or __causing__ hurt, injury, or loss.</ | + | |
- | + | ||
- | So let's look at the definition provided in AS9100 to see if that provides any greater clarity: | + | |
- | + | ||
- | < | + | |
- | 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.</ | + | |
- | + | ||
- | The above definition provides much more clarity. But if we read " | + | |
While I ordinarily don't like to reference regulatory requirements, | While I ordinarily don't like to reference regulatory requirements, | ||
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< | < | ||
- | ===== What " | + | ===== What " |
Let's assume that some design-responsible company has identified one or more " | Let's assume that some design-responsible company has identified one or more " | ||
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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:// | + | Walter Sam O’Connor, Vice President - Technical Services for the [[https:// |
[[https:// | [[https:// | ||
- | 2 - If you have an Engineering function, download and adopt the applicable requirements of [[http:// | + | In his presentation, |
+ | |||
+ | It is a bit more challenging to identify specific actions that go above and beyond normal activities necessary to address the special considerations for " | ||
+ | |||
+ | * 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, | ||
+ | * 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:// | ||
+ | |||
- | MIL-STD 882 requires a more detailed risk assessment for " |