25. Management review, quality objectives and accountable outputs
Govern management review from immutable QMS inputs and metric snapshots through independent completeness, top-management objectives/outputs, assigned completion evidence, effectiveness verification and executive closure.
Purpose
Govern management review from immutable QMS inputs and metric snapshots through independent completeness, top-management objectives/outputs, assigned completion evidence, effectiveness verification and executive closure.
Quality Management Representative, different QA Head, separate Accountable Executive, separately assigned Management Review Action Owner, Auditor read-only
MR-E2E-001 input v1 rejected → refreshed immutable v2 approved → objective QO-E2E-001 plus two outputs → action response v1 rejected → v2 effective → executive closure.
Before you begin
- One site and same-site ACTIVE, CLEAN evidence version exist
- Quality Management Representative, QA Head, Accountable Executive and Management Review Action Owner are four distinct active, site-scoped and cleared users
- The reporting period has ended and meeting date is not earlier than period end
- Any customer/external manual metric has a controlled source reference
Management-review metrics, objectives and authority boundaries
Scope, context changes, customer feedback, process/product performance, resource adequacy, risks/opportunities, prior actions, improvements and evidence freeze with the version. QA rejection retains v1 and v2 receives a new snapshot.
Each input snapshots site-/classification-scoped open NCR, overdue NCR, open CAPA, SCAR, audits, accepted-report findings, FAI acceptance rate, product escapes and escape obligations. Later source-record changes never rewrite the snapshot.
Customer satisfaction or another external indicator must name its code, value, unit, trend and controlled source reference. A manual code cannot impersonate a governed system metric.
Every prior site objective visible at the review classification is copied into the immutable input version so top management can review achievement and missed follow-up without rewriting history.
A separate QA Head approves whether inputs are complete and sourced; QA does not chair the top-management output decision.
The Accountable Executive sets a unique key, metric, baseline, target direction/value, unit, measurement method, due date and named owner. Exactly one attributable action must link each objective.
Objectives, QMS changes, resources, risks, customer focus, supplier or other improvements have named owners, success criteria and optional authoritative route/reference. The route is a pointer, never execution authority.
Before verifying a system-metric objective, Moduvio recalculates the governed metric and rejects a supplied value that does not match. The Representative still verifies evidence and effectiveness independently.
A missed objective may become final only with an independent ACCEPTED_MISSED decision and controlled follow-up reference. A met objective cannot be marked missed, and a missed target cannot be marked effective.
Flow 19 never changes current_stock, stock_ledger, an NCR/CAPA, SCAR, audit, escape, supplier approval, product baseline, controlled document or notification delivery. Owners must perform work in the authoritative module and cite it.
The Accountable Executive closes only after all actions are VERIFIED and every objective is ACHIEVED or MISSED with follow-up. Closure retains CLEAN evidence and acceptable or monitored residual risk.
Procedure
- 1
Create input v1 as Quality Management Representative and confirm nine governed system metrics plus any sourced manual metric are frozen.
- 2
Reject v1 as QA, create/submit refreshed immutable v2, then approve it as the separate completeness authority.
- 3
Record executive QMS/resource/improvement/risk/customer decisions, at least one measurable objective and named actions as Accountable Executive.
- 4
Submit action response v1 as the assigned owner, reject it as Representative, then submit immutable v2 and verify it effective; cite authoritative records for routed work.
- 5
Confirm the system rejects a mismatched governed objective value and requires follow-up for ACCEPTED_MISSED.
- 6
Close as Accountable Executive only after all outputs are final, then reconcile the read-only chain as Auditor with zero source-domain effects.
Expected result
- Lifecycle follows DRAFT → INPUT_REVIEW → MEETING_PENDING → ACTION_TRACKING → CLOSURE_REVIEW → CLOSED
- Representative, QA, Accountable Executive and Action Owner are four different user IDs
- Rejected input and action-response versions remain immutable
- Each input version retains governed metrics, manual sources and prior-objective snapshots
- Each objective has exactly one linked attributable action with the same named owner
- System-backed actual values must match a fresh governed calculation
- A routed response requires its authoritative record reference but never changes that record
- ACCEPTED_MISSED requires a controlled follow-up reference
- Closure is blocked until every action and objective is final
- Flow 19 creates zero notification deliveries and never changes inventory, NCR, audit, escape, supplier, document or configuration records
- Auditor mutation attempts are rejected