ISO 13485 Contract Manufacturer Controls and Quality System Requirements

Q

QTP492

Registered
I’m looking for advice/perspective on a situation.
I’m overseeing quality for a company (The Company) with design and commercialization responsibility for a class II medical device. Manufacturing is outsourced. The CM has a 13485 certificate and passed several notified body audits. There is a production manager with The Company overseeing the CM and expectations are fairly high. CM is to provide detailed component certs, process diagrams, pFMEA, DHR, in-process and final inspection records, validation, CoC and others. Records are maintained in the CM QMS and also copied/signed off in The Company QMS.

Recently, The Company production manager has been claiming that CM records are insufficient and mandating use of forms, WI’s, and SOP’s that are part of The Company QMS. The Company QMS is more complicated in details of record keeping but there is no evidence that this results in better end quality or compliance.
The CM allows this, although there is some push back, under the “customer is always right” mantra. From my POV, I’d like to get back to more traditional supplier control -- specify needs in quality agreement, audit both QMS and production outcome, agree on development plans, etc.

Please share any similar experiences and/or your thoughts on the situation.
 
Y

yodon

Leader
Super Moderator
QTP492 said:
CM records are insufficient
Click to expand...

If this is accurate, then maybe the production manager is correct. If not, maybe the production manager is just having a bit of a Napoleon Complex.

The CM could always push back with increased rates to accommodate imposed inefficiencies.
 
Q

QTP492

Registered
I think it is more on the Napolean side -- the production manager does have a strong need to micro-manage. I had the CM send me the NB audit report. The audit was conducted by a top tier NB and comprehensive. I believe my next move is to have a 3rd party audit (one more data point) and pending outcome, start looking into this as a behavior issue rather than a QMS issue.
 
Y

yodon

Leader
Super Moderator
May be a case of "pick your battles." Are the changes causing a significant negative impact? Maybe the changes make your Production Manager's life better? Would winning this cause a (bigger) rift between you and your Production Manager?
 
William55401

William55401

Quite Involved in Discussions
My two cents. Creating / controlling manufacturing documents by a Design Center defeats the entire purpose of selecting and having a great contract manufacturer. You outsourced for a reason. You want to be a design site and not have to deal with the grind of component supply chain and day to manufacturing. If you, as the design site, do not like what the CM is doing, ask for a change(s) within their QMS. You would have review and approval oversight via your quality agreement. If your CM is so poor you need to do this level of handholding (issue them documents), improve the CM or leave them. Thanks for listening.
 
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