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Responsibility for Outsourced Process, ALL in-house Mfg/QC done (prior FG PN)

#1
We are having difficulty ensuring Customer acceptance due to complications involving "recently re-assigned" outsourcing responsibility on parts longtime considered finished. This follows a round of similar NCs and CARs a year ago for the same issues, which were only closed after a Customer acceptance to resume purchasing the uncoated version p/n (both on same master print) as the final part. When the modified p/n prefixes indicating the final coating per Customer spec./ASL reappeared on the shop floor en masse, I was sure to review my CAR records to be prepared for recurrences.

Essentially, SS parts built for our largest medical OEM (30+ percent) were, since '05, bought as finished p/n prior to an outside coating. What was our Final QC became an In-process QC with all of the previous checks, then the Outside process, and our QC Final for the coating. We were responsible for about a year, then the Customer for maybe 9 months; it's just become ours again after New Years'.

We are under a renewed barrage of issues similar to the prior cycle. :argue:

As a QE, I accept my role to operate effectively within the requirements agreed to by those responsible for the contract decisions, without (my) knowing all the (projected/ actual) $$$ implications.

Really wish though, I could find an overarching Quality principle which would advise against our ownership of a process over which our firm has limited expertise, acceptance discretion, or vendor influence and is performed after a full QC acceptance for all print specs. controlled by our Operations, which ARE fully documented in our WI and such.
:frust:

Submitted for your esteemed thoughts, experiences and/or opinions...
 
Last edited:
Elsmar Forum Sponsor
#2
Don't get me wrong; feal free to give me a reality check or a swift kick if you think I'm out of line or way off the reservation here.

Can I break down a question? Is it appropriate to refer to the prior agreement for the Customer to resume control over this process as part of my CAR investigation?

We are locked in to using 1 of 2 Customer ASL vendors named on the spec. print. With our lack of final say over the coating process, is there any way to make an influential argument for return of responsibility to the Customer who owns the specs. and ASL, and cosmetic, and visual criteria?
 

Golfman25

Trusted Information Resource
#3
Seems to me you have a couple of approaches.

One, you can get with the coating provider and try to fix the issues they are having. Or if necessary, find a new provider.

or Two, you can get sales and estimating in and make a decision to either push back to the cutomer to buy the uncoated version (and subesequently let the customer have all the problems) or add some money to cover the issues.

From my perspective, we view these outside processes as service items. We'll do it as a service to our customer. We'll work to resolve any issues which arise. However, if there is a cronic issue which can't be solved -- we reserve the right not to provide the service. Good luck.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
is there any way to make an influential argument for return of responsibility to the Customer who owns the specs. and ASL, and cosmetic, and visual criteria?
It is my impression that your customer HAS DELIBERATELY turned the responsibility for the coating process BACK to you, because there are problems with this (customer designated) coating supplier. Per your own admission, your organization does NOT have the expertise to assess the special process (coating) vendor. Since the supplier is mandated by your customer, a sensible approach would be to try a COLLABORATIVE dialogue with the supplier so they improve their performance and products don't get rejected anymore. You would probably have to engage with an outside consultant who is knowledgeable in coating processes to assist you.

Other avenues to explore:

1. convince your customer that the coating supplier needs nadcap approval.
2. convince your customer to qualify another coating supplier.
3. if the coating supplier has some form of QMS certification, such as ISO 9001, AS9100, etc., complain to their certification body about their performance and lack of effective corrective actions.

Good luck.
 
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M

MIREGMGR

#5
Is this part a medical device, so that the specification conformance and shifting responsibility each have a device regulatory aspect? What are the part's risk situation, or other criticality concerns?
 

somashekar

Staff member
Super Moderator
#6
Don't get me wrong; feal free to give me a reality check or a swift kick if you think I'm out of line or way off the reservation here.

Can I break down a question? Is it appropriate to refer to the prior agreement for the Customer to resume control over this process as part of my CAR investigation?

We are locked in to using 1 of 2 Customer ASL vendors named on the spec. print. With our lack of final say over the coating process, is there any way to make an influential argument for return of responsibility to the Customer who owns the specs. and ASL, and cosmetic, and visual criteria?
To keep things simple, as an ISO13485 manufacturer of medical device to a customer, if you are getting a coated part received coated and ready for next assembly OR you receive uncoated part, inspect it and then send out for coating to get back the coated part., You as a manufacturer is outsourcing this coating process.
If your customer has approved this source for coating, please get from your customer all the records of evaluation performed by them to approve and use the same to exercise your controls with the knowledge of the coating source who are anyway the experts in the field.
The ownership of the entire product is with your customer, and this does not absolve you from the responsibility of your controls over the coating process, as you are manufacturing the product.
It is technical solution that you have to seek directly from the coating source and again it is not a puzzle. Degreasing, cleaning, solution concentration, current density, time etc are the parameters that needs to be tweaked to get the desired coating (considering plating) and get the source to stick to determined parameters and conduct suitable tests for every batch / period either inhouse or at a third party lab for ongoing controls.

In other words your coating source must validate his process to get your desired result and demonstrate it to your understanding.
 
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