Review By Exception: How BRBE Speeds QA Release in Regulated Manufacturing

Review By Exception

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • review by exception, batch review by exception (BRBE), electronic batch review, exception governance, release cycle time reduction, audit-ready evidence • Regulated Manufacturing (USA)

Review by exception is how regulated manufacturers cut QA release time without lowering rigor. It’s a simple idea with strict prerequisites: routine steps should not consume most of QA’s time; exceptions should. In other words, QA should review what actually introduces risk—missing evidence, overrides, deviations, holds, out-of-tolerance results, rework, late entries—not re-read every line of a batch packet that was executed correctly.

Most plants fail at review by exception because they try to “turn it on” in a reporting screen without fixing the inputs. Review-by-exception is only possible when execution is controlled, evidence is complete, and exceptions are captured as first-class governed events—not informal notes and emails. When those foundations exist, BRBE transforms release: QA reviews are faster, more consistent, and easier to defend in audits because exceptions are visible and traceable.

“Review by exception is not about reviewing less. It’s about reviewing what matters, with stronger proof.”

TL;DR: Review by exception works when your system can (1) enforce critical steps (hard gating), (2) automatically verify completeness, (3) capture exceptions structurally (deviation/override/hold records), (4) link exceptions to lots/steps/equipment, and (5) export audit-ready evidence packets. Demand a scenario demo: run a batch with one exception (wrong-lot attempt or out-of-tolerance), show how the exception is flagged in the review queue, show disposition evidence, then release the batch and export the packet.

Table of Contents

What buyers mean by review by exception
KPIs review-by-exception should improve
Why traditional batch review is slow and inconsistent
Prerequisites: what must be true for RBE to work
What counts as an “exception” (define it tightly)
Designing an exception-first review queue
Governance: deviations, holds, CAPA triggers, and approvals
Audit defensibility: how RBE improves inspection outcomes
Copy/paste vendor demo script and scorecard
Selection pitfalls (how RBE fails)
How this maps to V5 by SG Systems Global
Extended FAQ

1) What buyers mean by review by exception

When manufacturers ask for review by exception, they’re usually chasing one of these outcomes:

Shorter release cycles because QA reviews aren’t dominated by routine steps.
More consistent decisions because exceptions are structured and reviewed the same way each time.
Less record rework because completeness checks and enforcement reduce missing evidence.
Lower audit risk because you can show a clear exception story with evidence.
Scalability because QA can handle more volume without proportional headcount growth.

Hard truth: If your execution system doesn’t reliably capture exceptions, “review by exception” becomes “review by guessing.”

2) KPIs review-by-exception should improve

QA Touch Time
Minutes QA spends reviewing a normal batch vs an exception batch.

Release Cycle Time
Time from batch completion → QA release decision (target: hours).

Packet Rework Rate
% of batches requiring record correction due to missing/unclear evidence.

Exception Density
# of deviations/overrides/holds per batch (trend is the signal).

Practical target: Normal batches should be fast to review because completeness is verified automatically. QA time should scale with exceptions, not with volume.

3) Why traditional batch review is slow and inconsistent

Traditional batch review is slow because it’s trying to compensate for weak controls upstream. QA ends up doing detective work:

Missing data: fields left blank or written inconsistently.
Missing signatures: approvals not captured at the right time.
Manual transcription: weights and results copied from devices into paper.
Unstructured exceptions: issues handled in email or “notes.”
Status uncertainty: unclear whether held lots were actually blocked.

Those weaknesses force QA to review everything line-by-line because the system can’t confidently say “this step is routine and complete.” Review-by-exception replaces detective work with a controlled evidence model.

4) Prerequisites: what must be true for RBE to work

Review by exception is only credible when the system can prove routine compliance. That requires:

Hard gating: critical steps cannot be silently skipped (hard gating).
Completeness rules: required data and evidence captured before step completion.
Device integration where it matters: scale capture, scanner verification, automated timestamps.
Structured exceptions: deviations/overrides/holds exist as governed records, not informal notes.
Attributable actions: role-based access and audit trails (RBAC, audit trail).
Exportable evidence: review outputs can be turned into audit packets without screenshots.

Rule: RBE is a downstream benefit. If upstream controls are weak, RBE becomes theater.

5) What counts as an “exception” (define it tightly)

RBE depends on a clear definition of exceptions. Common exception categories:

Missing evidence: required fields or attachments missing, late entries, incomplete checks.
Wrong-lot attempts: blocked scans or substitutions.
Out-of-tolerance results: weights, process parameters, QC limits.
Overrides: tolerance overrides or bypass events that required approvals.
Deviations: structured deviation records linked to batch steps (deviation management).
Holds/quarantine: lots or batches placed on hold and dispositioned (hold/release).
Rework/repack: controlled rework actions that affect genealogy (rework/repack traceability).
Access anomalies: privilege changes or unusual admin actions (often reviewed separately).

Defining exceptions too broadly will flood QA with noise. Defining them too narrowly will hide real risk. A strong approach is risk-based: “exceptions that affect product disposition, identity, potency, labeling, traceability, or evidence integrity” must be reviewed.

6) Designing an exception-first review queue

An effective RBE review queue should feel like triage, not reading. Practical design elements:

Batch completeness indicator: shows if routine evidence is complete.
Exception count and severity: number of exceptions, with severity weighting.
Clickable exception list: each exception opens evidence, approvals, and disposition.
Disposition status: shows whether each exception is resolved, pending, or escalated.
Release readiness: clear gating conditions for batch release.
Export packet button: generate a reviewable batch packet including exceptions.

Practical target: A “normal batch” should be reviewed in minutes because the system proves completeness automatically.

7) Governance: deviations, holds, CAPA triggers, and approvals

Review by exception is not just UI; it’s governance. The system should enforce:

Deviation linkage: exceptions that matter should create or link to deviation records.
Hold enforcement: impacted lots are held and blocked from use until disposition.
CAPA triggers: recurrence thresholds create CAPA with effectiveness checks (CAPA).
Approval authority: only authorized roles can disposition and release.
Audit trail depth: who did what, when, and why—exportable (audit trail).

Rule: If exceptions can be “closed” without evidence, RBE will speed up the wrong thing.

8) Audit defensibility: how RBE improves inspection outcomes

Auditors want to see that you control the process and that you know where your risks are. RBE helps because it produces a consistent review story:

Routine compliance is verified by completeness and enforcement rules.
Exceptions are visible, categorized, and linked to evidence.
Dispositions are governed and attributable.
Trends are measurable (exceptions, overrides, deviation recurrence).
Evidence packets can be exported quickly without “screen tours.”

That is fundamentally easier to defend than a paper packet with handwritten notes and ambiguous corrections.

9) Copy/paste vendor demo script and scorecard

Use this script to compare systems fairly. It forces proof that exceptions are captured and reviewable.

Demo Script A — Create One Exception

Execute a short batch with routine steps.
Trigger one exception (wrong-lot attempt or out-of-tolerance weight).
System creates an exception record automatically or forces structured capture.

Demo Script B — Disposition the Exception

Open the exception record and attach evidence.
Require approvals and rationale where needed.
Show the exception status moving to “resolved.”

Demo Script C — Review Queue + Release

Open the RBE/BRBE review screen.
Show that routine steps are completeness-verified.
Show the exception highlighted and linked to disposition evidence.
Release the batch with governed approval.

Demo Script D — Export Packet

Export the batch review packet including exceptions and audit trail excerpts.
Verify readability without screenshots or system access.

Category	What to score	What “excellent” looks like
Exception capture	Structured exceptions, not notes	Every meaningful exception becomes a governed record with evidence
Completeness verification	Routine steps auto-verified	QA doesn’t re-check routine steps because the system proves completeness
Disposition governance	Approvals, rationale, audit trails	Exceptions cannot close without evidence; approvals are attributable
Release speed	QA touch time reduction	Normal batches reviewed in minutes; exceptions drive focused review
Auditability	Export packets and audit trails	One-click packets stand alone in audits
Trend intelligence	Recurrence and thresholds	Exception patterns trigger CAPA and process improvement automatically

10) Selection pitfalls (how RBE fails)

Trying to “dashboard” your way into RBE. If execution isn’t controlled, the dashboard lies.
Exceptions outside the system. Email-based deviations destroy RBE.
Too many exceptions. If everything is flagged, nothing is actionable; tune severity and rules.
Closure without evidence. Speeding closure without proof increases risk.
Holds that don’t block. If status isn’t enforced, exceptions don’t contain risk.
Weak exports. If auditors need screen tours, your evidence model is incomplete.

11) How this maps to V5 by SG Systems Global

V5 supports review by exception by connecting controlled execution evidence to governed quality workflows and enforceable inventory status.

Execution evidence: V5 MES supports hard-gated steps, weigh/dispense tolerances, and exception capture at the source.
Governance: V5 QMS supports deviations/CAPA and approvals tied to exceptions.
Containment: V5 WMS supports enforceable holds/quarantine so exceptions actually block action.
Integration: V5 Connect API supports structured exchange to ERPs and external systems.
Platform view: V5 solution overview.

12) Extended FAQ

Q1. What is review by exception?
It is a review method where routine compliant steps are completeness-verified automatically and QA focuses review time on exceptions that introduce risk.

Q2. Is review by exception the same as BRBE?
In batch contexts, yes. Batch review by exception (BRBE) is review by exception applied to batch release and electronic batch review.

Q3. What are the prerequisites for review by exception?
Enforced execution (hard gating), completeness rules, structured exceptions, governed dispositions, and audit-ready exports.

Q4. Why does RBE fail in many plants?
Because exceptions are handled outside the system, evidence is incomplete, and holds aren’t enforced—forcing QA back into detective work.

Q5. What should we demand in demos?
Proof that the system captures exceptions structurally, highlights them in the review queue, requires evidence and approvals, and exports a readable packet.

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