SC QUALITY GUILDDesign review and DFX checklist
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Run a stage-gate design review with the right functions in the room and an independent reviewer. Answer the design for X questions area by area, raise a finding for each gap, and record the decision. The tool scores readiness by area and flags missing functions, unraised gaps and open must-close findings.
ON THE EXAM · CQE III.B.2, CQE III.B.3, CSSBB IX.B, CSQP III.A.1, CMDA III.D.2 · FREE · NOTHING YOU TYPE LEAVES YOUR BROWSER
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What a design review is
A design review is a planned, documented examination of a design at a set stage, to judge whether it meets its requirements and is ready to move on. It is not a presentation. The people who will have to make, test, buy, service and support the product ask the questions only they will think of, while changes are still cheap.
Stages
- Concept review: does the concept answer the customer need and the requirements?
- Preliminary design review (PDR): is the chosen approach sound, with risks known and a plan to verify it?
- Critical design review (CDR): is the detailed design complete and ready to build prototypes or pilot units?
- Final or pre-production review and design transfer: are verification and validation complete, and can production make it consistently?
Roles
The chair keeps the review to its purpose and records the decision. The presenter, usually the design owner, shows the evidence. Reviewers come from each function the stage affects. At least one reviewer should be independent: no direct responsibility for the stage under review. Medical device design control has long required this, and it is good practice everywhere; designers cannot see their own blind spots. A scribe keeps the record, which becomes part of the design history.
Design for X
Design for X (DFX) is a family of guidelines, each named for the property it protects:
- Manufacturability (DFM): tolerances the process can hold, familiar materials, features that suit the process.
- Assembly (DFA): fewer parts, parts that cannot go in wrong, top-down assembly, few fastener types.
- Test (DFT): access to test points, tests that catch the high-risk failure modes, capable gauges.
- Service and maintainability: wear parts that can be reached, diagnosable faults.
- Reliability: targets allocated, derating, life testing.
- Cost: a target cost, standard parts, value engineering.
- Environment: restricted substances, recyclability, end of life.
Every "No" answer should become a finding with an action, or an explanation of why the gap is acceptable. The readiness bar for each area shows where the design is weakest.
The decision
A review ends with a decision: proceed, proceed with conditions, or repeat the review. Proceeding with open must-close findings is a decision to accept risk, and should be written as one.
On the exam
CQE III.B.3 asks you to identify and apply the elements of the design review process, including the roles and responsibilities of participants, and III.B.2 to apply DFX and DFSS. CSSBB IX.B covers design for X: cost, manufacturability, test and maintainability. CSQP III.A.1 covers internal design reviews, and CMDA III.D.2 design and development controls, including design review, under ISO 13485 and the QMSR. Expect questions on who should attend, what independence means, and which DFX area a given guideline belongs to.