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articles:as9100-under_revision [2024/01/06 14:57] – created rrandall | articles:as9100-under_revision [2024/01/07 13:07] (current) – [Sub-tier Control] rrandall | ||
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- | **__Culture__** \\ | + | {{: |
+ | ====== First Thoughts ====== | ||
+ | |||
+ | ===== Culture ===== | ||
The proposed IA9100 includes the following language regarding " | The proposed IA9100 includes the following language regarding " | ||
//§ Leadership – Clause 5.1.1.k – (NEW) ensuring goals and objectives intended to build a quality culture are consistent with policies, vision, mission, values, and the context of the organization (See clause 4.).//” \\ | //§ Leadership – Clause 5.1.1.k – (NEW) ensuring goals and objectives intended to build a quality culture are consistent with policies, vision, mission, values, and the context of the organization (See clause 4.).//” \\ | ||
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//§ Environment for the Operation of Processes – Clause 7.1.4 NOTE: d. – (NEW) culture (e.g., quality, ethical behavior, product and personnel safety, quality of work life).// | //§ Environment for the Operation of Processes – Clause 7.1.4 NOTE: d. – (NEW) culture (e.g., quality, ethical behavior, product and personnel safety, quality of work life).// | ||
- | My thoughts... \\ | + | __My thoughts...__ \\ |
While sec. 5.1.1k is a requirement, | While sec. 5.1.1k is a requirement, | ||
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- | **__Ethics__** \\ | + | ===== Ethics ===== |
//§ Leadership – Clause 5.1.1.l. – (New) promoting an ethical work environment – NOTE: For example, policy, expectations of conduct, periodic training and awareness, reporting channels, investigation, | //§ Leadership – Clause 5.1.1.l. – (New) promoting an ethical work environment – NOTE: For example, policy, expectations of conduct, periodic training and awareness, reporting channels, investigation, | ||
§ Environment for the Operation of Processes – Clause 7.1.4 NOTE: d. – (NEW) culture (e.g., quality, ethical behavior, product and personnel safety, quality of work life).// | § Environment for the Operation of Processes – Clause 7.1.4 NOTE: d. – (NEW) culture (e.g., quality, ethical behavior, product and personnel safety, quality of work life).// | ||
\\ | \\ | ||
- | My thoughts... \\ | + | __My thoughts...__ \\ |
I see "// | I see "// | ||
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- | **__Information | + | ===== Information |
§ 7.5.3.1 - Control of documented information (Enhanced) \\ | § 7.5.3.1 - Control of documented information (Enhanced) \\ | ||
When documented information is managed electronically, | When documented information is managed electronically, | ||
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The organization shall plan, implement, and control information security to safeguard the QMS to achieve its intended results. \\ | The organization shall plan, implement, and control information security to safeguard the QMS to achieve its intended results. \\ | ||
- | My thoughts... \\ | + | __My thoughts...__ \\ |
While some people in the Aerospace community are " | While some people in the Aerospace community are " | ||
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Minimal impact. | Minimal impact. | ||
- | **__8.1.3 Product | + | ===== 8.1.3 Product |
- | The organization shall plan, implement, and control the processes needed to assure product safety. These processes include, as appropriate: | + | |
+ | //The organization shall plan, implement, and control the processes needed to assure product safety. These processes include, as appropriate: | ||
a. identification of hazards, including reactive and proactive methods; \\ | a. identification of hazards, including reactive and proactive methods; \\ | ||
b. analysis, assessment, and control of safety risks associated with identified hazards(see 8.1.1); \\ | b. analysis, assessment, and control of safety risks associated with identified hazards(see 8.1.1); \\ | ||
- | c. identification and management of changes that may impact product safety; d. assessment of the effectiveness of safety processes (see 9.1.3 and 10.1); \\ | + | c. identification and management of changes that may impact product safety; |
+ | d. assessment of the effectiveness of safety processes (see 9.1.3 and 10.1); \\ | ||
e. provision of training on product safety responsibilities to relevant personnel (see 7.2 and 7.3); \\ | e. provision of training on product safety responsibilities to relevant personnel (see 7.2 and 7.3); \\ | ||
f. communication and awareness of product safety information, | f. communication and awareness of product safety information, | ||
- | g. reporting of safety events to the customer, authorities, | + | g. reporting of safety events to the customer, authorities, |
- | My thoughts... \\ | + | __My thoughts...__ \\ |
I find this addition very interesting considering that I've __not__ gotten a consistent interpretation of what " | I find this addition very interesting considering that I've __not__ gotten a consistent interpretation of what " | ||
For " | For " | ||
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Moderate impact. | Moderate impact. | ||
+ | ===== 8.1.4 Prevention of Counterfeit Parts (Enhanced) ===== | ||
+ | |||
+ | //The organization shall plan, implement, and control processes, appropriate to the organization and the product, for the prevention of counterfeit or suspect counterfeit part use and their inclusion in product(s) delivered to the customer. These processes shall include, as applicable: \\ | ||
+ | a. training of appropriate persons in the awareness and prevention of counterfeit parts (e.g., personnel involved in procurement, | ||
+ | b. application of a parts obsolescence monitoring program; \\ | ||
+ | c. controls for acquiring externally provided product from original or authorized manufacturers, | ||
+ | d. requirements for assuring traceability of parts and components to their original or authorized manufacturers; | ||
+ | e. verification and test methodologies to detect counterfeit parts; \\ | ||
+ | f. monitoring of counterfeit parts reporting from external sources; \\ | ||
+ | g. segregation, | ||
+ | |||
+ | __My thoughts...__ \\ | ||
+ | Provided that a company is effectively complying with " | ||
+ | |||
+ | __Conclusion: | ||
+ | Minimal impact. | ||
+ | |||
+ | ===== Sub-tier Control ===== | ||
+ | |||
+ | //Clause 8.4.3.k.d. – (New) Determining the level of control of their direct and sub-tier external providers;// | ||
+ | |||
+ | __My thoughts...__ \\ | ||
+ | This is simply an expansion of the current requirement in Clause 8.4.1: \\ | ||
+ | //"The organization shall require that external providers apply appropriate controls to their direct and sub-tier external providers, to ensure that requirements are met."// | ||
+ | Since the AS9100 " | ||
+ | |||
+ | __Conclusion: | ||
+ | Minimal impact. | ||
+ | |||
+ | ===== Operational Planning and Control (Enhanced) ===== | ||
+ | |||
+ | //8.1.k. – planning and implementing operations to prevent, detect and mitigate the risk of foreign objects and debris.// \\ | ||
+ | |||
+ | __My thoughts...__ \\ | ||
+ | All I can say about this " | ||
+ | |||
+ | __Conclusion: | ||
+ | Minimal impact. | ||
+ | |||
+ | ===== Design and Development of Products and Services – Clause 8.3.2.1 – (Enhanced) ===== | ||
+ | |||
+ | //"< | ||
+ | |||
+ | __My thoughts...__ \\ | ||
+ | The biggest change here is the removal of "When Appropriate" | ||
+ | |||
+ | __Conclusion: | ||
+ | Minimal impact. | ||