RECORDREFERENCE OUTLINE

Stage-Gate Quality Review Record

A gate-review record that fuses the project stage gate with the quality gate — capturing the quality acceptance criteria, evidence reviewed, open risks and actions, and the quality unit’s go / conditional-go / no-go decision at each phase boundary. Maps to ASTM E2500 and ICH Q9(R1).

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.

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REGULATIONS MAPPED
ASTM E2500ICH Q9(R1)
DOCUMENT TYPE
Record
LAST UPDATED
July 2026
PURPOSE

A gate review record that fuses the project stage gate with the quality gate, so a project cannot cross a phase boundary while its quality acceptance criteria are unmet. It records what was reviewed, what remains open, and the quality decision taken. The failure mode is the conditional-go used as a soft yes: conditions unnamed, undated and unowned, and the gate effectively passed anyway.

What's Inside

✓Gate identification with phase, date and attendees, so the decision is attributable to named people
✓Entry and exit criteria for the gate, stated before the review rather than negotiated within it
✓Quality acceptance criteria and their status, each scored against the evidence actually presented at the gate
✓Evidence and deliverables reviewed, listed specifically enough that a later reader can retrieve each one
✓Open risks, deviations and actions with named owners and due dates rather than functions and quarters
✓The quality decision — go, conditional-go or no-go — with the rationale that supports it
✓Closure plan for a conditional-go, with time-bound conditions and the person who verifies each one

How to Use It

1Hold the review at each phase boundary defined in the project quality plan, before work on the next phase begins
2Score each quality acceptance criterion against evidence presented at the gate, not against evidence promised for later delivery
3Record every open item as an action with a named owner and a date, since a function cannot be chased
4Grant a conditional-go only with explicit, time-bound closure conditions; conditions left vague make it a yes in practice
5Name who verifies closure of each condition, or the conditional-go closes itself at the following gate by default
6Retain the signed record as evidence of controlled progression, including the gates that were not passed first time
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
1Gate Identification (Phase, Date, Attendees)
2Entry and Exit Criteria for the Gate
3Quality Acceptance Criteria and Status
4Evidence and Deliverables Reviewed
5Open Risks, Deviations, and Actions
6Quality Decision and Rationale
7Conditions and Closure Plan (If Conditional)
8Approvals and Signatures
REGULATORY CONTEXT

ASTM E2500 frames verification as acceptance against predefined criteria set by subject matter experts, and ICH Q9(R1) requires quality decisions to be risk-based and documented. Neither prescribes a stage-gate structure, which gates a capital project needs, or what evidence is sufficient at a given boundary — those determinations belong to your organisation. Making the quality gate an explicit, signed decision point inside the project stage gate is SPEQ synthesis, not a regulatory requirement.

MAPPED STANDARDS
ASTM E2500ICH Q9(R1)
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