Material Review Board (MRB) – Structured Disposition of Nonconforming Materials Without Compromising Safety, Quality, or Traceability

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

Updated October 2025 • Quality Governance & Release • Deviations/NC, CAPA, 21 CFR 211, Annex 11

Material Review Board (MRB) is the cross-functional governance mechanism that evaluates nonconforming or at-risk materials, components, intermediates, labeling, and finished goods to determine their fate—use as is, rework, regrade, or scrap—with full consideration of patient safety, product quality, regulatory commitments, and business continuity. In a disciplined operation, MRB is neither a rubber stamp nor a theatrical meeting after the fact; it is a hard gate embedded in the digital thread so that MES, LIMS, and WMS will not allow movement, consumption, or release when status is uncertain. True MRB practice couples governance with Lot Traceability and data integrity so that every decision is defensible: the who, what, when, why, and risk rationale are contemporaneously recorded, linked to objective evidence, and propagated to the eBMR/eDHR and downstream labels and certificates.

“MRB is where facts outrank opinions: genealogy, test data, and validated risk tools decide whether a material moves—or it doesn’t.”

1) What MRB Is and Where It Applies

MRB operates wherever the product path intersects uncertainty. That includes incoming inspection for raw materials and components, in-process stages where in-process controls (IPC) detect excursions, packaging lines where label verification flags mismatches, laboratories where LIMS results trend toward failure, and warehouses where storage conditions or FEFO rules are violated. The triggers are not limited to hard fails; they also include suspect conditions such as equipment out-of-status at time of use, line-clearance anomalies, tamper evidence concerns, or supplier notifications. The MRB scope spans raw lots, work-in-process, finished goods, labels, printed instructions, and even ancillary items like containers or closures whose failure could impair identity, potency, purity, or safety. In practice, MRB decisions are only as strong as the data that feeds them; that is why modern MRB is inseparable from Batch Genealogy, audit trails, and validated master data controlled by Document Control.

2) Regulatory Anchors and the Role of Data Integrity

Regulations expect that nonconformances are investigated, decisions are justified, and records are complete. For pharmaceuticals, 21 CFR 210/211 require control of components, in-process materials, and finished products with documented review and disposition; for medical devices, 21 CFR 820 requires control of nonconforming product and records that connect to the DHR; for food and nutraceuticals, HACCP and FSMA emphasize hazard-based controls with traceable corrective actions. Where records are electronic, Part 11 and Annex 11 demand unique users, e-signature meaning, secure audit trails, time synchronization, and validated backup/restore. MRB is where Data Integrity is either proven or compromised: if acquisition, transfer, or interpretation of evidence is loose, the decision is indefensible no matter how experienced the panel. Hence, MRB evidence must remain attributable to people, instruments, lots, and times; any manual data transfer or spreadsheet “massage” is a red flag and should be replaced with system-to-system exchange under CSV controls.

3) How MRB Connects to Deviation, CAPA, and Change

MRB is not a substitute for Deviation/NC or CAPA—it is a consumer and producer of both. A deviation often triggers MRB when material status is uncertain; an MRB outcome often triggers CAPA to prevent recurrence. When the chosen disposition requires changes to process, equipment, or specifications, the fix must flow through Management of Change (MOC) so that new limits, labels, or routes are deployed to the point of use. Without MOC, an MRB decision is at best advice; with MOC, it becomes the new validated reality. Mature organizations codify this handshake: MRB closes only when linked CAPA and MOC items are approved, deployed, trained, and verified effective in production data (CPV and SPC trending confirm outcomes).

4) The MRB Workflow—From Detection to Disposition

The disciplined MRB path begins with Detection (test fail, barcode mismatch, environmental excursion, supplier alert). The system sets Hold at the lot, container, or serial level; WMS blocks moves; MES prevents consumption; LIMS blocks result certification; labels cannot be printed without an MRB override. Next comes Containment: physical segregation, status labeling, and where needed, line-clearance to eliminate co-mingling. Investigation pulls genealogy: which MMR/MBR revision was in force, what instruments were used and their calibration status, which operators participated (dual verification where required), which labels were printed and verified, and what environmental conditions prevailed (EM). Risk Assessment applies FMEA/HAZOP logic: potential failure effects, detectability, severity, and occurrence. Options Analysis examines rework feasibility (validated method exists?), regrade impact on claims and labeling, or scrap costs including destruction and reconciliation. Decision is recorded with e-signatures and meaning under Part 11. Execution is automated: routes update, tests publish, labels change, and holds lift only when pre-conditions are proven by system checks and training completion. Finally, Effectiveness Check reviews CPV/SPC metrics and post-disposition complaints or trends to verify the decision was sound.

5) Evidence Requirements—What “Good” Looks Like

“Good” MRB evidence reads like an investigator’s file, not a summary. It contains raw LIMS results with instrument IDs and timestamps; gravimetric readings and tolerance checks from the eBMR step; barcode scans proving identity at pick and dispense; photographs or attachments for line-clearance and packaging anomalies; supplier CoA and incoming inspection records; audit trail extracts demonstrating that post-factum edits did not occur; and training records that show competence at the time. If the disposition is rework, evidence includes the validated method reference, document-controlled instructions, and confirmation of released intermediates. When regrade is chosen, the file must show labeling and regulatory impact analysis (claims, GTIN changes, EPCIS events) and that label verification succeeded. For scrap, there must be destruction evidence, quantity reconciliation to prevent shrink or diversion, and updates to inventory accuracy metrics. Thin evidence is a process smell; audits will find it, and patients deserve better.

6) Risk Tools Applied to MRB

Risk tools are not décor—they guide the disposition. FMEA converts scattered concerns into ranked failure modes with prevention and detection controls mapped to actual system gates (e.g., MES interlocks, LIMS specification bands). HAZOP is powerful for continuous operations (mixers, reactors, utilities), revealing consequences of deviations like “more/less” residence time or “no” agitation. JHA/JSA closes the gap on operator-level tasks—what steps are error-prone, what poka-yoke exists, and what verification is required. The MRB record should show the specific risk outcome and the engineered stop that will prevent recurrence, often implemented through MOC as a new standard.

7) Hard Gates—Making MRB Unskippable

To be credible, MRB must be unskippable in systems of record. That means WMS only picks lots with Released or MRB-authorized status tied to the specific disposition; labels can only be printed from controlled templates at the MRB-approved grade; MES steps check material status at scan and block adds if status ≠ acceptable; and LIMS will not post a pass result against a held lot. These gates tie back to master definitions in the MMR/MBR and to approval workflow in QMS. If the gate can be bypassed with a spreadsheet, shared drive, or local printer, you don’t have MRB—you have theater. Hard gates also apply to reversal: once regraded or reworked, legacy labels and lot attributes cannot be resurrected accidentally; the system should block reverse transitions without a new MRB case and fresh evidence.

8) Common Failure Modes and How to Avoid Them

Disposition by opinion. Senior voices override data. Fix: require objective evidence and risk tools in the record; gate decisions behind e-signatures with meaning. Shadow movement. Materials move while under Hold. Fix: enforce WMS status checks at pick/putaway and handheld scanning with barcode validation. Identity drift. Right test, wrong lot. Fix: bind tests and labels to container IDs and GTIN/UDI; reject mismatches. Paper fixes. Rework instructions emailed. Fix: deploy via Document Control into MES with enforced step logic. Weak destruction controls. Scrap leaves no trail. Fix: require witness, photo, and weight reconciliation; update inventory immediately. CSV blind spots. LIMS interface changed, no re-validation. Fix: route through CSV and GAMP 5.

9) Metrics That Prove Control

Track MRB cycle time (detection to disposition), Hold inventory value, first-pass MRB closure rate, rework success rate without subsequent deviations, repeat MRB on same cause (signals weak CAPA), scrap reconciliation accuracy, blocks at point-of-use that prevented misuse, label verification pass rate after regrade, and customer complaint rate for lots with MRB history. Trend by supplier, component, line, and equipment to prioritize improvement and to validate supplier scorecards. Feed results into APR/PQR so leadership sees the cost and risk footprint of nonconformance and the ROI of prevention.

10) How This Fits with V5

V5 by SG Systems Global makes MRB executable, not rhetorical. Nonconformance detection in V5 MES and LIMS automatically places lots/containers on Hold and blocks consumption, movement, printing, and release. The MRB case aggregates genealogy from Batch Genealogy, raw instrument signals (weighing, torque, leak test), label scans, and EM data; users add photos and supplier docs. Risk tools are integrated; outcomes route through Approval Workflow with e-signature meaning under Part 11/Annex 11. If rework is chosen, instructions are deployed via MMR/MBR changes through MOC; MES makes the new route the only executable path upon effectivity and training completion. For regrade, V5 updates item/grade, GTIN, and label templates, and enforces print-and-verify with scan-back. For scrap, V5 orchestrates destruction tasks with witness, photo capture, and real-time inventory reconciliation. Once the MRB criteria succeed, the system lifts Hold automatically; until then, every station enforces the block. Dashboards show cycle time, prevented misuse events, and recurrence rates; outcomes flow into CAPA and MOC without retyping, preserving data integrity and speed.

FAQ

Q1. Can we release “use as is” if the batch passes final tests?
Only if risk analysis shows no impact to identity, potency, purity, or labeling claims and genealogy confirms no affected sublots remain at risk. “Passed tests” alone is insufficient; MRB must document the rationale and ensure gates prevent reuse of conditions that caused the event.

Q2. When is rework acceptable?
When a validated rework method exists under Document Control, deployed through MOC into the MMR/MBR, with documented acceptance criteria and training completed. Ad hoc fixes are not rework; they are risk.

Q3. How do we prevent held lots from slipping through?
Enforce status checks and barcode scans in WMS/MES at every movement and consumption point; block label printing; require e-signature overrides with reason codes and approvals; and monitor “block events” as a metric to ensure the gates actually fire.

Q4. How does MRB interact with suppliers?
Supplier-caused events should create partner-facing corrective actions; trend MRB by supplier and material and feed into incoming sampling plans and component release logic. For critical alternates, implement via MOC with specification updates and label impacts analyzed.

Q5. What belongs in the MRB record to satisfy inspectors?
Complete genealogy; raw test data with instrument IDs; environmental and equipment status; photos/attachments; risk assessment outputs; disposition with e-signature meaning; deployment evidence (route/spec/label updates); training completion; and effectiveness results in CPV/SPC. If any of those are missing, expect questions.

Related Reading
• Governance & Risk: Deviations/NC | CAPA | MOC | GAMP 5 | 21 CFR Part 11 | Annex 11
• Execution & Records: MES | LIMS | ELN | eBMR/eDHR | MMR | MBR
• Traceability & Release: Lot Traceability | Finished Goods Release | Hold/Release | Label Verification | EPCIS