AS9100C Audit must include FAA Part 145 (FAA Repair Station)?

[Colley82]

I am currently in the process of getting my company AS9100 Rev. C certified. I have been through the stage 1 audit already and am awaiting the stage 2 audit. During the auditors stage 1 visit, one of his concerns was that we have an FAA Repair Station (FAA 145) which the company was audited on approx 6-8 months prior by the FAA. While getting all the companies ISO processes and procedures in order and up-to-date, I only concentrated on the processes that are applicable to the ISO AS9100 Rev. C standard and not FAA RS only processes.

The question I have is, how can my ISO AS9100C certification audit take the FAA 145 ONLY procedures into consideration while performing the audit?? In other words, how can an ISO audit force you incorporate other certification requirements into your ISO processes??

And...

If it's true that you must incorporate any and all company processes and procedures, this would include any HR documentation for example, where in the ISO AS9100C standard does it give direction on what is required of HR documents or any other departments??

I understand that ISO has it's own "Repair and Overhaul" standard, but my company is not interested in getting this certification, because of the FAA 145 that we currently have.

 

[Sidney Vianna]

Re: ISO AS9100C Audit must include FAA 145..??

If you leave repair and overhaul out of the scope of your AS9100C certification, the CB auditors should not touch that part of your operation. In other words, the repair station would be out of bounds during the course of the stage 2 audit.

That should have been discussed and agreed upon during the stage 1 audit.

If you need additional help, please let us know the proposed scope of certification you currently have with your CB.

 

[Colley82]

Re: ISO AS9100C Audit must include FAA 145..??

Thanks for the response! The companies scope is as follows;

The design and development, manufacturing, and repair of motion controls and
actuators for space vehicles, commercial and private aircraft, military equipment,
industrial machinery and off road equipment.

However, the scope itself wasn't a high priority for the auditor. During our initial plant walk-through I mentioned that we had an FAA 145 repair station, only then did the auditor make a note of the certification, and on the Stage 1 Audit Report it was marked down as a "Regulatory Requirement" and the auditor is going to follow up to see if there is any additional documentation needed.

So, if we have the word "repair" in our scope, that automatically makes our FAA RS grounds for auditing under ISO??

Also, if that is true, then using the word "repair" in a company's scope would automatically impose AS9110 standard requirements?? Is that correct??

 

[Sidney Vianna]

Re: ISO AS9100C Audit must include FAA 145..??

So, if we have the word "repair" in our scope, that automatically makes our FAA RS grounds for auditing under ISO??

Do you repair (previously delivered) products outside of the Repair Station? It seems to me that repair is inherent to your Repair Station.

Also, if that is true, then using the word "repair" in a company's scope would automatically impose AS9110 standard requirements?? Is that correct??

Not necessarily. If you repair only the product that you were the original manufacturer, you can have that covered under the AS9100 scope. If you repair products manufactured by other organizations, then you should be looking into 9110. That position was taken by the largest Aerospace OEM in the world and communicated to their suppliers.

 

[Colley82]

Re: ISO AS9100C Audit must include FAA 145..??

This is the big disconnect for my company in particular. The company is small, and we mostly deal with prototype projects and/or part orders. The company has yet to land an actual production job. With that being said, the idea is that someday the company will actually have products in the market that will need to be "repaired".

The FAA RS, in my opinion, was a marketing tool to drum up any and all business that the company could get their hands on. This was one of the first things they decided to invest in almost 6 years ago now. To this day, the company has had 0 (zero!!) orders that have actually required the FAA RS. Which is why I was confused about including any Repair Station procedures, in an ISO audit.

So this now brings up more questions...How can a company be audited on processes that are not being used due to the current state of the company?? (e.g. Future repairs, or production processes and metrics, when you have no production?)

 

[Sidney Vianna]

Re: ISO AS9100C Audit must include FAA 145..??

How can a company be audited on processes that are not being used due to the current state of the company??

In principle, they can't. That is why AS9101D requires a stage 1 audit to ensure the organization to be "ready" for a stage 2 audit.

The following are requirements from AS9101D for the stage 1 audit:

The audit team leader shall require the organization to provide the necessary information and documentation for review, including the following:
• quality manual;
• description of processes showing their sequence and interactions, including the identification of any outsourced processes;
NOTE 1: The processes can be depicted in various ways [e.g., process maps, turtle diagrams, SIPOC method (breakdown of supplier, inputs, process steps/tasks, outputs, customer), octopus].
• performance measures and trends for the previous 12 months;
• evidence that the requirements of the applicable 9100-series standards are addressed by the organization’s documented procedures established for the quality management system (e.g., by referencing them in the quality manual or by using a cross reference);
• interactions with support functions on-site or at remote locations/sites;
• evidence of internal audits of processes/procedures, including internal and external quality management system requirements;
• the latest management review results;
• list of all major (e.g., top five) aviation, space, and/or defense and any other customers requiring 9100-series standard compliance, including an indication of how much business each customer represents and their customer specific quality management system requirements, if applicable; and
• evidence of customer satisfaction and complaint summaries, including verification of customer reports, scorecards, and special status or equivalent.