Planning the product and process development
Plain-language summary
The up-front planning that turns customer requirements into a defined product and a defined manufacturing process — the 'what we will make and how' stage.
What the clause is really asking
This element controls the risk of going into development without fully understanding the requirements or without a plan for how the product and the process will be created and validated. Weak planning here surfaces later as design changes, capacity shortfalls, missing equipment, or unbuildable tolerances. The aim is that everything needed — requirements, feasibility, resources, timing — is identified before serious money is spent.
What auditors look for
The auditor examines how customer and statutory requirements were captured and turned into product and process targets, and whether feasibility was genuinely assessed. They look at the planning for design FMEA, prototypes, tooling, equipment, gauges, and capacity, and check that procurement of long-lead items is scheduled. The question is whether the development is planned as a coherent whole or assembled piecemeal.
Typical evidence
Requirements/specification capture records; feasibility assessment; planning for design and process FMEAs; tooling/equipment/gauge plans; capacity planning; long-lead procurement schedule; planned validation and prototype activities.
How to comply — recommendations
Capture all requirements — customer, legal, internal — early and confirm feasibility before committing. Plan the technical building blocks (FMEAs, tooling, gauging, capacity, validation) with owners and dates, and identify long-lead items so they are ordered in time. Make the plan cross-functional so engineering, quality, purchasing, and production share one view. Solid planning here is what prevents firefighting during realization.
Common nonconformities
Requirements incompletely captured or not traceable; feasibility assumed rather than assessed; FMEA and validation activities not planned in; long-lead tooling/equipment ordered late; capacity planned optimistically without a basis.
Related clauses
IATF 16949 8.3.2 / 8.3.3 (design inputs, planning); ISO 9001 8.3.2–8.3.3 (planning, inputs)
Qlause provides interpretive guidance only and is not a substitute for the standard. Refer to your licensed copy of the relevant standard for the authoritative text.