qms-nonconformance

Nonconformance Management

Identify. Disposition. Control.

1.2% moisture instead of 1.0%. Use as is. Six similar decisions in eighteen months—nobody connected the dots. NCMR workflows that surface patterns across dispositions.

Nonconformance Management

The use-as-is decision that cost $12 million.

Excipient arrived at 1.2% moisture. Specification said NMT 1.0%. Friday afternoon, production waiting, next supplier shipment two weeks away.

Engineering said 1.2% wouldn't affect the formulation. Quality noted this supplier had been marginal before. Manufacturing wanted to run. Decision: use as is.

Three months later, stability data showed accelerated degradation. Root cause: moisture in the excipient batch. Eighteen months of commercial product recalled. FDA asked: "Why did you accept out-of-specification material?"

Nonconformance MRB flow

This was the sixth moisture exceedance from this supplier in eighteen months. Nobody had connected the dots. Each decision looked reasonable in isolation. Together, they revealed a supplier who couldn't meet the specification.

The gray area is where quality culture lives

One use-as-is decision might be reasonable. Twenty use-as-is decisions for the same specification should trigger a different question: is the specification realistic, or are we slowly normalizing deviation?

Material Review Board

MRB Workflow

Use-as-is decisions require cross-functional review. QA: does acceptance comply with our quality system? Engineering: will this material perform acceptably? Manufacturing: any handling considerations? Regulatory: any notification required?

Concession tracking

Concession Patterns

Which suppliers generate the most nonconformances? Which materials require the most use-as-is decisions? Are concession rates increasing?

Trend analysis surfaces patterns that should trigger process improvements or specification reviews.

Batch traceability

Which NCMR approved the use? Which batches incorporated the nonconforming material? Which products shipped to which customers?

If a problem emerges later, trace forward from the nonconformance to all affected products.

Capabilities

01Segregation Control
Automatic inventory holds for nonconforming material. Physical and system controls ensure no inadvertent use.
02Material Review Board
Configurable MRB workflows with required participation, voting, and documented rationale for use-as-is decisions.
03Disposition Tracking
Track scrap, return, rework, and use-as-is decisions. Execute disposition with documented evidence of completion.
04Concession Justification
Structured documentation of why nonconforming material is acceptable. Technical assessment, risk evaluation, regulatory impact.
05Batch Traceability
Link nonconforming material to all batches that used it. Trace forward to products and customers if needed.
06Trend Analysis
Track concession rates by supplier, material, and time. Identify patterns that indicate systemic issues.
01 / 06
Segregation Control
Segregation Control

Entities

Entity
Description
Kind
NCMR
Out-of-spec material. The gray area is where quality culture lives. Clear cases are easy—the hard ones define you.
type
Incoming NC
Supplier shipped out-of-spec material. Friday afternoon, production waiting, next shipment two weeks away.
template
NCMR-2024-001
Excipient at 1.2% moisture. Spec NMT 1.0%. Friday afternoon. MRB says use-as-is. $12 million recall.
instance
In-Process NC
Material was acceptable at receipt. Something went wrong during manufacturing.
template
Finished Product NC
Failed final inspection. Too late to fix easily. Scrap or rework.
template
Concession Pattern
Sixth moisture exceedance in 18 months. Each decision looked reasonable. Together, they revealed a supplier who can't meet spec.
type
Concession Trend 2024
Same spec, same supplier, sixth time. Pattern invisible until someone looked. Now it's obvious.
instance
Material Review Board
QA, Engineering, Manufacturing, Regulatory. Use-as-is requires cross-functional judgment, not one person's convenience.
type
Disposition
Scrap, return, rework, use-as-is. The decision—and especially the pattern of decisions—reveals your culture.
type
Use As-Is
Engineering says 1.2% won't affect formulation. Quality notes supplier has been marginal. Decision: use. Three months later: recall.
template
Scrap
Clear failure. Destroy and dispose. No ambiguity, no justification needed.
template
Use-As-Is Justification
Why is 1.2% moisture acceptable when spec says 1.0%? Technical assessment, risk evaluation. Auditors will ask.
type
Segregation
Quarantine until disposition. System holds prevent inadvertent use. Material can't sneak into production.
type
Batch Traceability
Which batches used the 1.2% moisture excipient? If stability fails in 3 months, you need to trace forward.
type

FAQ

The system places automatic inventory holds on nonconforming material. It cannot be issued to manufacturing or shipped until the NCMR is dispositioned and the hold is released. Physical segregation procedures complement the system controls.