MRB software from hold to documented disposition.

• Nonconforming Stock Sits in the Yellow-Tag Area

  Waiting for the next MRB meeting — which is Thursday, and it's Monday, and the customer is waiting.

• Disposition rationale is a paragraph in a spreadsheet

  No linkage to the deviation, the CAPA or the customer notification obligation — auditor pulls the string and it comes out short.

• Cost of poor quality is a guess

  Scrap value, rework hours, expedited freight — never rolled up per supplier, per product family, per root cause.

• Segregation at Detection

  Receiving or in-process nonconformity tags the specific lot/serial, freezes it in the warehouse system, and opens the MRB record — no paper travellers.

• Quorum Board with Role Gating

  QA, engineering, operations and (where required) regulatory sign the disposition; missing roles block closure. Async or scheduled sessions, both e-signed.

• Disposition Options, All Traceable

  Use-as-is (with deviation and customer-notification link), rework (with revised routing and re-inspection), regrade (with new spec), return-to-vendor (with SCAR), scrap (with write-off).

• CAPA and Supplier Link

  Recurring nonconformity auto-links to the parent CAPA and updates the supplier scorecard — the MRB record isn't a dead end.

• Cost of Poor Quality Roll-Up

  Scrap value + rework labour + expedited freight aggregated per supplier, product family and root cause — reported to management review without a spreadsheet.

MRB in V5.

1. NC Raised. Receiving, in-process or supplier NC opens record.
2. Warehouse Move Locked. Status change moves material to quarantine location.
3. MRB Decides. Named disposition with required evidence.
4. Action Performed. Rework/return/scrap executed with evidence.
5. Supplier / CAPA / CoPQ. Scorecard, CAPA linkage and CoPQ recorded.

MRB fails when nonconforming material sits in a queue and CoPQ isn't measured. Criteria below expose it.

• Physical Segregation Link

  Are quarantine locations tied to record status? Material status and warehouse location interlocked.

• Disposition Workflow

  Are Use-As-Is / Rework / Return / Scrap / UAI-with-concession dispositions distinct with evidence? Each disposition a distinct workflow with required evidence.

• CoPQ Measurement

  Is Cost of Poor Quality captured per event? CoPQ captured with financial linkage; trended per supplier / product / process.

• Supplier NC Linkage

  Do supplier NCs flow to supplier scorecards? Supplier NC hits scorecard automatically.

• Concession Control

  Are concessions time-limited, quantity-limited and re-evaluated? Concessions bounded and re-evaluated on expiry.

MRB approaches.

MRB clauses.

• 21 CFR 820.90

  Distinct procedures per disposition with evidence.

• ISO 13485 §8.3

  Same platform serves 13485 §8.3.

• ISO 9001 §8.7

  Identification and control interlocked with warehouse.

• 21 CFR 211.87 (retesting of approved components)
• 21 CFR 211.89 (rejected components, drug product containers and closures)
• 21 CFR 820.90 (nonconforming product)
• ISO 9001:2015 §8.7 (control of nonconforming outputs)
• AS9100D §8.7 (control of nonconforming outputs — aerospace)

• Medical Devices
• Pharmaceuticals
• Nonconformance Management Software
• Supplier Quality
• CAPA Software
• Material Review Board (MRB)
• Nonconforming product (820.90)
• Nonconforming Material Segregation

Can MRB run async or does it need a scheduled meeting?

Both. Routine dispositions run async with role-gated e-signature; complex or safety-relevant cases can require a scheduled session with attendee capture.

Does V5 stop the material physically or just electronically?

Electronically at the warehouse system level — pick lists, shipments and next-operation moves refuse the lot until the MRB closes. Physical yellow-tag is still a good practice, V5 just doesn't rely on it.

How does V5 prevent use-as-is dispositions from hiding a real problem?

Repeat use-as-is on the same failure mode auto-escalates to CAPA and blocks further use-as-is until a corrective action is open — the pattern surfaces, it doesn't hide.