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.
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.