Doğrulama Tabanlı Üretim: Tıbbi Cihaz Tesislerinde Denetim Bağımlıdan Süreç Güvenceli Kalite Sistemlerine Geçiş İçin Bir Çerçeve

Özet (abstract)

Inspection has carried the weight of product quality in medical device manufacturing for as long as the industry has existed. It has a built-in limitation, though: inspection finds nonconformances after they happen rather than preventing them. This paper argues that manufacturing facilities of sufficient maturity can move away from inspection as their quality gate and toward a process-assured release model built on rigorous validation, statistical process control (SPC), and risk-stratified parameter governance. This paper introduces a four-level Process Validation Maturity Model (PVMM) that lets a facility locate its current state and chart a path forward. It then proposes a statistical release architecture that ties confidence-bounded process performance indices (Ppk) to release decisions, replacing attribute inspection sampling with real-time, SPC-triggered intervention. The Manufacturing Assurance Decision Matrix (MADM) is the operational decision tool at the center of the framework; it integrates process maturity, control chart status, and post-market quality signals into a single release disposition. Throughout, the framework is grounded in its regulatory foundations: the FDA Process Validation Guidance (2011), ISO 13485:2016, and the Quality Management System Regulation (QMSR) Final Rule (2024). The result is a structured, defensible pathway for reducing inspection dependency while holding product quality assurance steady, and in mature implementations improving it. The framework is presented as a proposed, conceptually grounded structure illustrated with a worked example; empirical validation across implementing facilities is identified as future work.

Yazarların özeti; kaynağından alınmıştır. Quality Engineering, 2026 · DOI ↗