Auditing

Is Supplier Quality a Fallacy?

A supplier by any other name is still just a supplier!?…I’m amazed when I’m working with a 21st century regulated business that simply wants its buyers or procurement group to do “whatever” it takes to keep the material pipeline coming…very 20th century thinking! We live in a time when new and aggressively logical processes are being promoted by quality compliance professionals.

The Med Device community has a guideline produced by the IMDRF for supplier control. It is risk-based and encourages a planning component for the sourcing phase of supplier development. Should this be an interface condition of a good design team, not an afterthought of a production group?? The answer is a no brainer! If for no other reason but to balance risks in considering cost and availability are all in the mix.  A planning point must occur that drives fact-based decisions for alternatives of criteria-based development to flesh out the “complexion” of a supplier.

Yes, I’m talking PROCESS (again)! Quality by design (QbD) is an approach that demands the most critical components of design be scrutinized by process(es) so that risks and opportunities are being generated to build actions that reduce or eliminate risk while promoting the facilitation of opportunities.  It this case the object of sourcing a commodity, equipment, test, or any of the 6-M factors (e.g. cause and effect diagram) of a product SIPOC* is the responsibility of the design team which must include a production representative!

This can be an industrial or manufacturing engineer or any contributing member of the production group.  So, what are we really suggesting here? That the interfacing of a design team in the development of a plan have ALL key contributors to the development of that plan.  This also means that that critical thinking is being used to develop product and process design with sourcing issues at the front of the objectives criteria in the sourcing condition of initiating the design plan.

(*Supplier-Inputs-Process-Outputs-Customer)

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