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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-06-07
- Length: 21m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-07-088-production-part-approval-process-ppap-with-subhi-saadeh
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/088---Production-Part-Approval-ProcessPPAP-with-Subhi-Saadeh-e24f2np

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-07-088-production-part-approval-process-ppap-with-subhi-saadeh#t=0) Introduction to PPAP and Subhi's Background

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Test & measurement](https://hardwarepodcasts.com/topic/test-and-measurement)

## Most relevant to

early-stage companies

## Mentioned

- AIAG (other)
- ISO TS 16949 (other)
- ISO 13485 (other)
- ICH Q10 (other)
- PFMEA (tool)
- Control Plan (tool)
- Gauge R&R (tool)
- CMM (tool)

## Related episodes from other shows

- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [S2E34 How Process Engineering Will Make You An Invaluable Engineer | Zach O’Ferrell](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-08-06-s2e34-how-process-engineering-will-make-you-an-invaluable-engineer-zach-oferrell) (Being an Engineer)
- [Ajay Panwar | Statistical Control Processes, Regression Analysis, and Philanthropy](https://hardwarepodcasts.com/podcast/being-an-engineer/2022-03-18-ajay-panwar-statistical-control-processes-regression-analysis-and-philanthropy) (Being an Engineer)
- [S2 E8: Quality Engineering and Strategy for Hardware with Matt Lipsitz](https://hardwarepodcasts.com/podcast/the-builder-circle/2024-03-05-s2-e8-quality-engineering-and-strategy-for-hardware-with-matt-lipsitz) (The Builder Circle)
- [What are the Opportunities for Improvement (OFI) for Quality?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality) (Global Medical Device Podcast)

## Citing this page

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