GxP Lifeline
Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design
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?
Walt 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.
