Nonconformance software that catches the defect at the step — not at the end of the batch.
V5 Ultimate opens a nonconformance record the moment a step fails, routes the Material Review Board, signs the disposition (use-as-is, rework, scrap, return-to-supplier) under Part 11, and links the CAPA when the same failure recurs. ISO 9001, ISO 13485, AS9100 and cGMP evidence delivered from one live system.
You're shopping for NCR software because your defects are being disposed of in email.
NCRs are opened days after the failure — the operator has already moved on
MRB is a weekly meeting with a spreadsheet, not a signed workflow
Dispositions ('use-as-is', 'rework') get emailed and nothing enforces them
The same failure recurs three times before anyone opens a CAPA
Supplier NCRs never make it back to purchasing or supplier scorecards
Audit asks for NCR-to-CAPA traceability and you rebuild it from scratch
The NCR / MRB workflow ISO auditors and quality managers actually want.
NCR auto-open at the step
Out-of-tolerance reading, failed in-process check, or expired material triggers an NCR at the moment of failure — with the operator, step, quantity, and evidence attached automatically.
MRB workflow
Material Review Board convenes on the record, not by email. Quality, engineering, production sign the disposition under Part 11 with rationale and any conditions.
Enforced disposition
'Use-as-is' requires signed rationale and links to the deviation and any customer notification. 'Rework' generates the routing. 'Scrap' updates inventory and cost. Nothing moves without a signed disposition.
CAPA trigger rules
Configurable rules — three of the same NCR in 90 days, severity above threshold, customer complaint linkage — automatically raise a CAPA. No more silent recurrence.
Supplier NCR loop
Supplier NCRs route to purchasing, update the supplier scorecard, and trigger supplier CAPA where required. Return-to-supplier paperwork generated from the same record.
Trending & Pareto
Live Pareto by defect code, product, line, shift, supplier. Trending is a signal, not a quarterly PowerPoint.
What NCR / MRB looks like when the system runs it.
- NCR opened at the failing step — with operator, quantity and evidence auto-attached
- MRB dispositions signed under Part 11 with enforced downstream actions
- Recurring defects trigger CAPA automatically — no silent repeat failures
- Supplier scorecards update from real NCR data, not manual entry
- NCR-to-CAPA-to-effectiveness traceability answered in one query at audit
The standards NCR / MRB evidence maps to.
ISO 9001:2015 (10.2)
Nonconformity and corrective action — controlled, contained, evaluated, corrected, verified. Linked to management review and internal audit.
ISO 13485:2016 (8.3, 8.5.2)
Control of nonconforming product and corrective action for device manufacturers. Feeds risk management (14971) where residual risk shifts.
AS9100D (8.7, 10.2)
Control of nonconforming outputs and corrective action for aerospace and defence — including counterfeit-parts and FAI hooks.
21 CFR 211.192 / Part 820.90
Investigation of any unexplained discrepancy or failure; control of nonconforming product for drug and device cGMP.
21 CFR Part 11
Bound e-signatures on MRB dispositions, hash-chained audit trail, RBAC with author-cannot-self-approve.
Nonconformance management software, answered.
What's the difference between an NCR and a CAPA?
A Nonconformance Record (NCR) documents a specific defect or failure — this batch, this lot, this shipment. A Corrective and Preventive Action (CAPA) addresses the systemic cause when the failure is significant or recurring. V5 links them: NCRs trigger CAPAs by rule, and CAPA effectiveness is measured against the NCR recurrence rate.
What is an MRB and why does it need software?
The Material Review Board is the cross-functional group (quality, engineering, production) that decides what to do with nonconforming material. Software enforces the workflow — the right people sign, dispositions are captured with rationale, and downstream actions (rework, scrap, customer notification) are executed, not forgotten.
Does V5 handle supplier NCRs?
Yes. Supplier NCRs route to purchasing, update the supplier scorecard, and where required, raise a supplier CAPA with response tracking. Return-to-supplier paperwork is generated from the same record.
How does 'use-as-is' work in V5?
'Use-as-is' requires a signed rationale, and where the deviation affects a validated attribute, links to the change-control or customer-notification workflow that authorizes it. The disposition is not a checkbox — it is an evidenced decision.
Which standards does this cover?
ISO 9001 (10.2), ISO 13485 (8.3, 8.5.2), AS9100D (8.7, 10.2), IATF 16949 nonconforming product controls, and 21 CFR 211.192 / Part 820.90 for pharma and device cGMP. Part 11 e-signatures apply where records are electronic.
How long does implementation take?
Most sites run NCR-at-the-step, MRB workflow and CAPA linkage live within 30 days. Full supplier NCR loop and multi-site Pareto trending typically takes 6–10 weeks.
Stop finding defects at the end of the batch — catch them at the step.
Free trial. NCR + MRB + CAPA on one validated platform.