Hardware Podcasts

088 - Production Part Approval Process(PPAP) with Subhi Saadeh

Let's Combinate · 7 Jun 2023 · 21m

What this episode covers

Subhi Saadeh, host of the Combinate Podcast and Quality Professional, explains the Production Part Approval Process (PPAP), an automotive quality tool adapted for medical device and pharma industries. He details key PPAP elements including specifications, PFMEA, control plans, and the critical distinction between First Article Inspection (FAI) and capability studies. Saadeh highlights how this framework ensures consistent communication between sponsors and manufacturers, reducing risk during design transfer and supplier qualification.

Most relevant to

early-stage companies

Topics

Mentioned

Tools
PFMEA, Control Plan, Gauge R&R, CMM
Also
AIAG, ISO TS 16949, ISO 13485, ICH Q10

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