Building an Effective Supplier Control Program
Building an Effective Supplier Control Program :A review of key Program elements & their LeeVP RQCSMedtronic Surgical Technologies2 | AFDO 210 Annual ConferenceBuilding an Effective Supplier Control Program A review of key Program elements & their of risk; & classification of suppliers; performance & monitoring; responsive action; of who is responsible for what; and development 3 | AFDO 210 Annual ConferenceBut 1st: What s the business motivation? Good business Drives quality back to the source Reduces variation & uncertainty Reduces waste hence costAnd Regulatory agencies like it ...4 | AFDO 210 Annual ConferenceGuidance - Devices CFR 820 Quality System Regulation Subpart E--Purchasing Controls ISO 13485 Quality System Standard: Purchasing GHTF SG3 (WD) N17R7 Bonn (2/8/08) Guidance on the Control of products and services obtained from suppliersFor completeness -Drugs Testing and approval or rejection of components, drug product containers, and closures ICHQ7A: GMP for API USP<1078>: GMP for Bulk Pharmaceutical Excipients5 | AFDO 210 Annual Conf
5 | AFDO 210 Annual Conference. 1. Determination of risk. Proportional & Balanced: • Supplier Controls proportionate to the severity and risk identified in the risk management program.
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