PROTOCOLREFERENCE OUTLINE

Design Qualification (DQ) Protocol

DQ protocol template verifying that the detailed design meets the URS and the identified critical aspects — URS-to-design traceability matrix, critical-aspect verification, design-review record, acceptance criteria, and the documented DQ conclusion Annex 15 expects.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

Checking your Professional access…

REGULATIONS MAPPED
EU GMP Annex 15ASTM E2500-25ISPE Baseline Guide Vol. 5 (2nd ed.)
DOCUMENT TYPE
Protocol
LAST UPDATED
August 2026
PURPOSE

The documented check that the design about to be built actually satisfies the requirements and the critical aspects — performed while changing the design still costs a drawing revision rather than a shutdown. It fails when it becomes a signature page on a design nobody re-read, or when the design revision under review was never frozen. Which aspects are critical is your determination, made before this protocol is written.

What's Inside

✓System boundary and scope, so the protocol reviews one defined system rather than an ambiguous package
✓The frozen design-document revision set under review, listed by document number and revision
✓Requirements-to-design traceability matrix showing which design element satisfies each user requirement, and which have none
✓Critical-aspect to design-element verification table, with the objective evidence cited for each line
✓Design-review record naming attendees, their disciplines, and the findings each of them raised
✓Findings register with dispositions, so an accepted finding stays visible rather than being absorbed
✓Acceptance criteria, the DQ conclusion recorded against them, and the engineering, subject-matter-expert and quality approvals

How to Use It

1Define the system boundary and freeze the design-document revisions under review; a moving design set makes the conclusion unverifiable
2Trace every requirement to the design element that satisfies it, and challenge any requirement with no element behind it
3Verify each critical aspect against objective evidence in the design documents, not against the designer’s explanation in the room
4Hold the design review with the disciplines that will operate and maintain the system, and minute every finding raised
5Disposition each finding explicitly; a finding accepted without a recorded rationale reappears as a deviation during qualification
6Record the conclusion against the acceptance criteria and route for approval before procurement or construction commits the design
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose and System Boundary
2Reference Documents
3URS-to-Design Traceability
4Critical-Aspects-to-Design-Element Verification
5Design-Review Record
6Acceptance Criteria and DQ Conclusion
7Approvals
REGULATORY CONTEXT

EU GMP Annex 15 defines design qualification as the documented verification that the proposed design is suitable for the intended purpose. ASTM E2500-25 and the ISPE Baseline Guide Vol. 5 (2nd ed.) concentrate that verification on the critical aspects — the design elements controlling product quality — rather than on every attribute of the system. What none of them supplies is your list of critical aspects. Identifying them is a subject-matter-expert and quality determination made upstream; this protocol verifies against that list and records who approved it.

MAPPED STANDARDS
EU GMP Annex 15ASTM E2500-25ISPE Baseline Guide Vol. 5 (2nd ed.)
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