AS9100D excluding Design and Development - Small Job Shop

[MichelleQA]

We had our certification audit and were written up for a finding regarding 8.3. Previously we had excluded this from our scope, yet this auditor stated it could no longer be done. (FYI- We are a build to print job shop)

NC From Audit:
8.3 Design and Development ➢ Company does not design or develop any of its products. Design and development is the sole responsibility of the customer. Company clearly advertises and communicates they are a “build to print” shop with no change or design authority. Our customers have the sole design authority of any and all parts.

NC 1 generated since RM Machine does perform development, they develop CNC programs for all machined items IAW customer drawings / Specs. Additionally, RM Machining provides value added external services in their scope in the quality manual which requires them to develop those processes as well.

I see in the IAQG 9100:2016 clarifications it notes that "9100 requirements is for design and development of products and services, no of processes. An organization can use clause 8.3 for process development but it is not a requirement."

If I am understanding this correctly - based on the write up and the clarification this is NOT an NC, since the intention is for the design and development of product not for a process, correct? Should I challenge the NC?

 

[howste]

If you really are just a build-to-print shop then this shouldn't be a nonconformity. If you could "exclude" it before it should be "not applicable" now. CNC program development would not fall under 8.3 unless you provide the program to the customer for them to use.

I'm interested to know what value added external services the auditor is referencing though. Design of services could fall under 8.3. If you are doing generic services such as deburring to customer print or bead blasting per their specifications, then I would say it's not applicable. If it's a heat treat process where they give you an application and you develop a solution to treat the product to meet their needs then it would fall under 8.3.

 

[BoardGuy]

We were given a heads up by our auditor that their training suggests that an organization could not fully exclude D & D because an organization might need to take a customer design and perform additional development for manufacturability. In our quality manual we say Clause 8.3 is not applicable because products produced are manufactured to customer’s specifications using standard industrial processes.

[FONT=&quot]Would I appeal this NC, yes but plan a 3 to 4 month period of back and forth with your registrar. I am 2 and O with our registrar on similar non justified findings. Request their documented appeal procedure and plan at some point to involve the IAQG. Remember that AS9100D is based on a poorly developed ISO 9001 Standard.[/FONT]

 

[MichelleQA]

Thanks for the insight. The value added external services are such things as painting, plating, silk screen, deburring, bead blasting per the customer drawing, etc. We have absolutely no design authority. We went round and round about this during the audit.

 

[MichelleQA]

The auditor had also noted we develop CNC Programs for all machined items IAW customer drawings, in hind sight I should have pushed back on this as well, for this falls under configuration management. Either way, under the clarification this is not a product or service we sell to a customer, programs are owned by us.

 

[Kronos147]

NC 1 generated since RM Machine does perform development, they develop CNC programs for all machined items IAW customer drawings / Specs. Additionally, RM Machining provides value added external services in their scope in the quality manual which requires them to develop those processes as well.

Since you are design not applicable, in your operational planning and control you could say in your procedure you can help the customer with design verification and validation activities when required.


"8.1 Operational Planning and Control

The organization shall plan, implement, and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in clause 6, by:
a. determining the requirements for the products and services;
b. establishing criteria for:
1. the processes;
2. the acceptance of products and services;

NOTE: According to the nature of the product and depending on the specified requirements, statistical techniques can be used to support:
− design verification (e.g., reliability, maintainability, product safety);"

 

[howste]

When I was taking the IAQG AS9100 Auditor Transition Training there was a statement I remember that hinted it would be pretty hard to justify any requirements as not applicable. It seemed likely to me that some auditors would take the statement to mean that they should no longer allow things that were previously allowed.

Later when I was going through an activity in the IAQG materials relative to justifying non-applicable requirements I came across this statement in an IAQG subject matter expert's answer to a scenario, so I wrote it down: "The justification for non-applicability of clause 8.3 is acceptable. XXXX Machining is a strictly a build-to-print organization. Manufacturing process development activities are addressed in 9100:2016 clause 8.1."

Your case sounds almost exactly like the scenario in the auditor training. Definitely appeal.

 

[Sidney Vianna]

The value added external services are such things as painting, plating, silk screen, deburring, bead blasting per the customer drawing, etc. We have absolutely no design authority. We went round and round about this during the audit.

The issue about value added work is of concern when an aerospace distributor that performs such type of services applies for AS9120 certification, rather than AS9100/9110. This auditor is really confused.

The auditor had also noted we develop CNC Programs for all machined items IAW customer drawings, in hind sight I should have pushed back on this as well, for this falls under configuration management.

While revision control of the NC programs definitely impacts configuration management, such category of software is covered under AS9100:2016 8.5.1.1.

As Howste and you said, the CB auditor is confused and as a build-to-print machine shop, you can most certainly identify Product D&D as non applicable to your QMS.

 

[MichelleQA]

Thank you for all the information. I submitted an appeal to the auditor and received this response:
"We have recently reviewed these requirements at a RMC meeting, auditor work shop and it is now of the opinion that this requirement would only apply when product design is being accomplished. Based on this direction I have modified the NC to address on post delivery support."

Thank you all for the very quick replies and information. It was very helpful and valuable when crafting my response to the NC.

 

[Big Jim]

Thank you for all the information. I submitted an appeal to the auditor and received this response:
"We have recently reviewed these requirements at a RMC meeting, auditor work shop and it is now of the opinion that this requirement would only apply when product design is being accomplished. Based on this direction I have modified the NC to address on post delivery support."

Thank you all for the very quick replies and information. It was very helpful and valuable when crafting my response to the NC.

Thanks for the feedback. There are many here that encourage pushing back when an auditor overextends. What you accomplished with your push back helps many.