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8.3.1.1/8.3.2.1IATF 16949:2016

D&D of products AND processes — supplemental (IATF only)

Plain-language summary

IATF widens design to include manufacturing process design and demands a documented D&D procedure; planning must include all affected stakeholders — APQP in all but name.

What the clause is really asking

Even a build-to-print supplier designs its manufacturing process: that design work needs the same discipline — documented process, multidisciplinary planning including (not limited to) project management, design/quality/manufacturing input, and supply chain involvement where relevant.

What auditors look for

Auditors ask the build-to-print plant: show me your manufacturing process design for this part — PFMEA, floor layout for the line, control plan development trail, who participated. 'We excluded design' does not answer; product design exclusion never covers process design.

Typical evidence

Documented APQP-style procedure; process design files (PFMEA, flow diagrams, control plans with development history); multidisciplinary team records.

How to comply — recommendations

Adopt the APQP five phases as your documented process even in simplified form. Keep attendance visible on PFMEA and control plan development — multidisciplinary is evidenced by names.

Common nonconformities

No documented process design procedure; PFMEAs written by one engineer alone; process design treated as excluded because product design is.

Related clauses

Builds on ISO 9001 8.3.1/8.3.2

In the book

Chapter 8Operation — 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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