AAR M-1003 - No design exclusions permitted

[Jaybee]

Hi,
This is my first post here. New to the forums and have read some great stuff.

I'm a quality manager for an ISO 9001 certified company, and because we make railroad products, we must also be M-1003 certified, which is the American Association of Railroads QMS spec that is basically structured like the 1994 version of the ISO standard, with several unique requirements as well.

We have asked an overseas supplier to produce a particular product that will require them to become M-1003 certified, too. They are already 9001 certified, and because they do not do design work, they have take a section 7.3 exclusion in their ISO registration. I will be working in the US as their representative to the AAR, so am tasked with recommending the changes they make to their QMS to make it M-1003 certifiable.

For companies that are already ISO certified, the AAR will issue "reciprocity" certifications, meaning that as long as the ISO registration is in good standing, the AAR auditor will just perform a certification audit on the AAR-specific requirements. However, I have learned that the AAR has a problem with D&D exclusions. To wit, here is an excerpt from the AAR audit checklist that will be used during the certification audit:

"If it is determined that design control is not applicable to the ISO registration, the supplier must adequately address this element in their QA Manual to satisfy M-1003. Statements such as "Not Applicable" are not acceptable and a detailed description of exactly what is being done in lieu of design control is required. The supplier could treat this requirement by describing how they would do Design Control if they actually did make design changes."

Sooo... I'm not sure how to get around this obstacle. I have to write something for the manual or procedures, but am not sure how to go about it.

Does anyone here have any AAR experience, or any ideas on how to proceed in getting through this requirement?

Thanks to all for reading., and looking forward to some feedback.
John Barnicoat

 

[Helmut Jilling]

..."If it is determined that design control is not applicable to the ISO registration, the supplier must adequately address this element in their QA Manual to satisfy M-1003. Statements such as "Not Applicable" are not acceptable and a detailed description of exactly what is being done in lieu of design control is required. The supplier could treat this requirement by describing how they would do Design Control if they actually did make design changes."

Sooo... I'm not sure how to get around this obstacle. I have to write something for the manual or procedures, but am not sure how to go about it.

John, Welcome to the Cove. However, it would appear the answer is in your own post (see bolded area above). What remaining obstacle do you see?

 

[Marc]

Statements such as "Not Applicable" are not acceptable and a detailed description of exactly what is being done in lieu of design control is required. The supplier could treat this requirement by describing how they would do Design Control if they actually did make design changes."

I'd like to hear other opinions on this. That sounds weird. If there is no design system or function in a company, how could anyone ask for a company to think one up?

 

[Al Rosen]

I'd like to hear other opinions on this. That sounds weird. If there is no design system or function in a company, how could anyone ask for a company to think one up?

I think that it just has to be addressed in the manual some how. You could state:

7.3 Design and development
Currently we manufacture to customer specifications and are not responsible for any design and development. If this were to change in the future, procedures will be developed in accordance with the standard including:
Design and development planning
(verbage based on the standard's requirements)
Design and development inputs
(verbage based on the standard's requirements)
Design and development outputs
(verbage based on the standard's requirements)
Design and development review
(verbage based on the standard's requirements)
etc

 

[Jim Wynne]

The supplier could treat this requirement by describing how they would do Design Control if they actually did make design changes."

Unbelievable. It sounds like they painted themselves into a corner by foolishly not accounting for companies that have no design responsibilities, and now want those companies to construct fantasies to fill the hole. I think Al's answer is good, but it's a shame that companies have to jump through these flaming hoops just because the owners of the standard are ignorant dolts.