Design & development controls
Plain-language summary
Control the design as it progresses: reviews to judge progress, verification that outputs meet inputs, validation that the product works in the real application — problems acted on, everything recorded.
What the clause is really asking
Controls ensure: results to be achieved are defined; reviews evaluate ability to meet requirements; verification confirms outputs meet inputs; validation confirms the product meets application requirements; necessary actions taken on problems; records kept.
What auditors look for
Auditors distinguish the three Vs in your records: review (project judgement), verification (calculation/test against spec), validation (does it work in use). A project with reviews but no validation, or validation after launch, draws findings.
Typical evidence
Review minutes; verification test reports/calculations; validation reports; action tracking from reviews.
How to comply — recommendations
Keep three distinct record types — review, verification, validation — even if meetings combine them. Validation must reflect real use conditions, and finish before customer shipments.
Common nonconformities
Validation done on prototypes only, never production-representative parts; review actions untracked; verification 'by experience' with no record.
Related clauses
IATF 16949: extended by 8.3.4.1-8.3.4.4
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.
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