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Blogging

Deviation vs Nonconformance (NCR): Pick the Right Path

Byadmin September 18, 2025September 19, 2025

Introduction

Calling everything a “deviation” or everything an “NCR” leads to noise, rework, and audit risk. Here’s how to choose the right path quickly and defensibly.

Definitions

Deviation: A departure from an approved process or instruction (the method wasn’t followed).
Nonconformance (NCR): A product/result that fails to meet a specified requirement.

Decision tree

Process not followed? → Deviation
Result out of spec? → Nonconformance (link to deviation/CAPA if process failure caused it)

Examples

Skipped in‑process check → Deviation; investigate why the step was missed.
Batch fails assay spec → NCR; investigate cause; consider CAPA if systemic.

Documentation essentials

Clear description and scope
Impact and immediate containment
Investigation summary
Disposition/next steps
Links to related CAPA/change/training

Typical pitfalls

Treating NCRs as deviations to avoid disposition
Raising CAPA for every deviation

Metrics

Rate of deviations by process/equipment
NCR rate by product/lot
% linked to CAPA or change control

How an eQMS helps

Distinct templates and required fields by record type
Routing and approvals by role
AI Assist: condenses narrative into a reviewer‑friendly summary and suggests checklists based on context

Conclusion

Use deviation for process departures, NCR for out‑of‑spec results, and connect them via CAPA/change when systemic. The clarity keeps audits calm and throughput high.

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