Layered Process Audits - FCA 9.2.2 - Exemption Clause?

Dan M

Involved In Discussions
#1
Hi,

This is a very specific situation; I hope there is someone reading this message with a similar experience.

We received a minor nonconformance in our recent surveillance audit because we were not doing the layered process audits. We have a very small automotive customer who flows down the FCA US LLC CSRs for IATF 16949. We manufacture this product specifically for our customer (who is the Tier I to FCA) very infrequently (every 2-3 months). We wanted to take the exemption clause in the FCA CSR (8/2020 revision) stated in section 9.2.2 Layered Process Audits. On page 41 it states,

"Layered process audits are not required for specific materials, parts or assemblies produced on such an infrequent or irregular basis that it would prohibit establishing a regular, weekly audit schedule....

  • Such infrequently or irregularly produced materials, parts or assemblies shall be subject, at a minimum, to a process audit at start-up and shutdown of each production run.
  • Organizations shall evaluate and document the applicability of this exception for each material, part or assembly under consideration based upon the production schedule for all customers.
  • The evaluation document shall be maintained as an organization-controlled record (7.5.3.2.1); reviewed annually and updated as required."
We would, of course, have someone in production leadership do a process audit at start-up and shut-down and have an appropriate evaluation documenting the applicability of this exception. We'd provide the order and production history as objective evidence.

My question is, Since this seems to be an acceptable alternative allowed within the FCA CSR, do we need to get a written approval from our direct customer (the tier I to FCA) to do start-up / shut-down process audits in lieu of a CQI-8 LPA program? Background: our customer representative believes we'd have a very difficult time getting a response from the customer about this.

Also --- is there any specific criteria for the process audit we'd need to complete at start-up and shut-down? I notice a "control plan process audit checklist" referenced in the FCA CSRs. Does anyone know what this is?

Many thanks!
 
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Johnny Quality

Involved In Discussions
#2
Dan,

In regards to your LPA minor conformance I'd ask how long is a typical production batch for this infrequent part? If you can't make a "regular, weekly audit schedule" from your production batch then I would say this exempts you. Mind you, I do worry who writes the OEM CSR's as some of them are very vague, such as this one.

In reference to the "control plan process audit checklist", I would say that is describing a tick box exercise with a list of everything on the control plan and making sure all is to the control plan.
 

Dan M

Involved In Discussions
#3
Dan,

In regards to your LPA minor conformance I'd ask how long is a typical production batch for this infrequent part? If you can't make a "regular, weekly audit schedule" from your production batch then I would say this exempts you. Mind you, I do worry who writes the OEM CSR's as some of them are very vague, such as this one.

In reference to the "control plan process audit checklist", I would say that is describing a tick box exercise with a list of everything on the control plan and making sure all is to the control plan.
Hi Johnny. A production batch can be completed during a single shift. Thanks for the reply!
 

joekirk

Involved In Discussions
#4
Why do you not just go to your customer and/or FCA and request a deviation / exemption from this requirement?
I have had several clients that have an exemption letter on file related to FCA's requirements for LPA's.
 

Dan M

Involved In Discussions
#5
Why do you not just go to your customer and/or FCA and request a deviation / exemption from this requirement?
I have had several clients that have an exemption letter on file related to FCA's requirements for LPA's.
Your suggestion seems like the logical solution. We considered asking the customer for a waiver. Based on our knowledge of this customer, we predict it's unlikely they would respond to our request within the 60-day window we have to respond to the corrective action.
 

normzone

Trusted Information Resource
#6
Oh, one of THOSE customers ... I love those, you must reply promptly to them but they do not have to reply to you when they're not in the mood ...
 
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