Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design


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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.  That’s very 20th century thinking! We live in a time when new and aggressively logical processes are being promoted by quality compliance professionals. The medical device community has a guideline produced by the International Medical Device Regulatory Forum (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 ensure risks in considering material cost and availability included in the design plan! When the design team is sourcing suppliers, a criteria-based plan must be used to evaluate the complexion of suppliers. Yes, I’m talking PROCESS (again)!

Quality by design (QbD) is an approach that demands that 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. In this case, the objective of sourcing a commodity, equipment, test or any of the 6-M factors (e.g., cause and effect diagram) of a product SIPOC (supplier, inputs, process, outputs and customer) is the responsibility of the design team. This design team 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 design team developing a product include ALL key contributors in the development of that plan. This also means that critical thinking is being used to develop product and process design while keeping sourcing issues at the forefront of the objectives criteria in the sourcing condition of the design plan. Supplier quality will never be a fallacy as long as you include a thorough process for evaluating sources during the design phase.


 

2018-bl-author-walt-murrayWalt Murray is a quality management and regulatory affairs professional with more than 32 years working with internationally recognized and highly-regulated companies, including J&J, Merck, Pfizer, Stryker, USANA and Del Monte Foods. A Six Sigma Black Belt, Murray is certified (CSSMB) in quality and environmental systems auditing (RAB/QSA/IATCA/IRCA), critical-thinking skills (CTS Facilitator) and process control (SPC/SQC). Having personally performed more than 350 1st/2nd/3rd-party audits for a variety of Fortune 500 life sciences companies, Murray has hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada (CMDR). Walt is based in Salt Lake City, Utah, and works as an independent expert as he supports regulated clientele for GMP, GLP, IVD, GCP and the cross-disciplinary development of MDSAP companies.