Process validation demonstrates that parts can be assembled and the intended manufacturing process can produce a conforming product. The focus is on repeatability, process controls and evidence from representative builds.
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Process validation demonstrates that parts can be assembled and the intended manufacturing process can produce a conforming product. The focus is on repeatability, process controls and evidence from representative builds.
Use the applicable project plan, approved engineering requirements and quality procedures as the authority for exact criteria. This guide provides a transferable structure; it does not replace customer-specific or company-approved requirements.
The APQP framework links product-process verification to the PPAP approval decision. Design Validation checks that the component meets product requirements; Process Validation demonstrates that the intended manufacturing process can repeatedly produce conforming parts. The evidence must be consistent with the final product definition and the process intended for series production.
Design Validation: checks component conformity to design requirements using parts produced from the tool before the manufacturing process is fully validated.
Process Validation: checks whether the intended manufacturing process, controls and operating conditions consistently produce conforming parts; it is not a repeat of Design Validation.
Use the approved APQP grid and applicable customer procedure for exact acceptance criteria; this public guide is a practical summary, not a substitute for controlled requirements.
See the APQP phase-to-gate map →PRATIXUS guidance: adapt this checklist to the product, manufacturing process, supplier setup and applicable customer requirements. Avoid sharing confidential project records in public resources.
