Design Review

A design review is a documented examination of a design against its requirements, held by people competent to challenge it, while changing the design is still cheap. It is the single highest-leverage quality activity in a capital project: a requirement caught in design is a specification, the same requirement caught at qualification is a change order, and caught after handover it is a deviation with product implications.

Under a risk- and science-based approach, design review carries verification weight rather than merely preceding it. When the review is performed by subject-matter experts, documented, and its findings resolved and closed, it can serve as evidence that the design meets its critical aspects — which is what allows qualification to verify rather than to rediscover. That only holds if the review challenged something; a review whose record shows no findings has documented attendance.

The quality function’s presence is what makes the review a quality activity. Engineering can confirm the design works; the question of whether it protects product quality, permits cleaning and inspection, and can be maintained in its qualified state is not answered by the same expertise.

• —Held while the design can still change — the whole economics of the activity.
• —Findings, resolutions and closures are the record; an empty findings list records attendance.
• —Can carry verification weight under a risk-based approach if performed and documented by SMEs.
• —Quality participation is what distinguishes it from an engineering review.
• —A requirement found here is a specification; found later it is a change order or a deviation.

ISPE Baseline Guide Vol. 5, Commissioning and Qualification (2nd ed., 2019); ASTM E2500-25; EU GMP Annex 15 (2015) §3 for design qualification.