Realization of the product and process development

Plain-language summary

Carrying out the plan from P3 — actually building the product and the process, validating them, and confirming readiness for series production.

What the clause is really asking

The risk controlled here is that good plans are not actually executed: prototypes skipped, validations cut short, FMEA actions not closed, or production approval given before the process is truly capable. This element is about whether the development was delivered as planned and whether the evidence proves the process can make conforming parts repeatably at rate before launch.

What auditors look for

The auditor traces the plan into reality — were the FMEAs completed and their actions closed, were prototypes and validation runs done, were control plans and work instructions created, were gauges proven (MSA), and was process capability demonstrated? They look at run-at-rate / production-trial results and the part-approval (PPAP/PPF) status, and check that open points were resolved before sign-off rather than carried into series.

Typical evidence

Completed design/process FMEAs with closed actions; control plans and work instructions; MSA/gauge studies; process-capability studies; run-at-rate/production-trial records; part-approval (PPAP/PPF) submission and approval; safe-launch/early-containment plans.

How to comply — recommendations

Execute the development plan fully and keep the evidence: close FMEA actions, validate gauges, demonstrate capability on production tooling at production rate, and complete part approval before series. Resist the temptation to grant internal release with open points outstanding. Have a safe-launch plan so any residual risk is contained at the start of production. The best suppliers can show an unbroken chain from requirement to validated, approved part.

Common nonconformities

FMEA actions left open at launch; capability studies run on prototype tooling or off-rate conditions; MSA missing for key gauges; run-at-rate not done or not meeting target; part approval forced through with deviations; no safe-launch containment at start of production.

Resources for this clause

• ArticleProcess FMEA explained: the AIAG-VDA 7-step method, Action Priority vs RPN, and the process flow that feeds it
• Toolkit · $29PFMEA ToolkitProcess FMEA to the current method: type S, O and D and the Action Priority letter answers itself, colour-coded — with a linked process flow tab and the control plan handoff built in.
• Free downloadProcess Flow TemplateThe first document of the core-tools chain — every step the part actually takes, including the storage, transport and rework loops the control plan never shows.
• Free masterclass · ~21 minProcess Flow & PFMEA MasterclassThe AIAG-VDA 7 steps on one welded bracket — the process flow that feeds Structure Analysis, prevention vs detection, rating S/O/D, why RPN is gone and what the AP letters oblige you to do.