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8.3.5.1/8.3.5.2IATF 16949:2016

Product & process design outputs (IATF only)

Plain-language summary

IATF specifies what design must hand over: for product — DFMEA, results, special characteristics, error-proofing, drawings/GD&T, service/repair information; for process — PFMEA, control plan, layout, work instructions, capacity analysis, process approval acceptance criteria and more.

What the clause is really asking

Two explicit output lists forming the launch package. Process design outputs include the complete manufacturing system definition: specifications and drawings, floor plan, characteristics matrix, PFMEA, control plan, instructions, approval criteria, data for quality/reliability, error-proofing results, rapid detection/feedback methods.

What auditors look for

Auditors use the lists as checklists against your launch file. Missing capacity analysis or characteristics matrix? The list says it should exist. They also check coherence: PFMEA-control plan-instruction alignment.

Typical evidence

Launch/PPAP file containing the listed outputs; characteristics matrices; capacity analyses; error-proofing verification records.

How to comply — recommendations

Make the two IATF output lists your launch-file index pages — completeness becomes a tick exercise, and audits become file walks instead of hunts.

Common nonconformities

Launch files missing capacity analysis or characteristics matrix; PFMEA and control plan diverging; service information never produced.

Related clauses

Builds on ISO 9001 8.3.5

In the book

Chapter 8 — Operation — Where the Product Is Won or Lost treats this clause family in full: what it is really asking, what auditors look for, the evidence that satisfies, how to make it work on a real floor, and where companies stumble. This IATF requirement is covered in the Automotive Edition, in the same six blocks as the ISO clause around it.

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