REPORTREFERENCE OUTLINE

Deviation & Nonconformance Report

Structured deviation/nonconformance record with risk classification, product impact assessment, root-cause analysis, and CAPA linkage. Built for a defensible quality-event system.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
21 CFR Part 211ICH Q10EU GMP Chapter 1
DOCUMENT TYPE
Report
LAST UPDATED
January 2025
PURPOSE

A structured record of a quality event — what happened, what was done immediately, what it may have affected, and what caused it. The two sections that decide whether the record is defensible are classification and impact: an event classified low because it was inconvenient to escalate, or an impact assessment that stops at the batch in front of you, is how a single deviation becomes a recall.

What's Inside

✓Event identification and a description written from the record and the people present, contemporaneously
✓Immediate actions and containment, including quarantine and any product or area segregation
✓Risk classification against defined criteria, with the rationale stated rather than the category alone
✓Product and batch impact assessment extending to concurrent, prior, and subsequent batches where the cause could reach them
✓Investigation and root cause analysis, with the method used and the evidence that confirmed the cause
✓Corrective and preventive actions, or the reasoned decision that none is required
✓Effectiveness, closure, and the quality-unit review and approval

How to Use It

1Record the event and the immediate actions contemporaneously; a description written three days later is a reconstruction
2Classify against written criteria and state the rationale, so the classification can be reviewed rather than merely accepted
3Assess impact beyond the batch in front of you — ask where else this cause could have acted and record the answer
4Investigate to a cause the evidence supports, and resist stopping at the first plausible explanation
5Where no corrective action is required, say so and justify it; an empty CAPA section reads as an unfinished investigation
6Route for quality-unit review, and close only when the effectiveness evidence supports closure
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Event Identification and Description
› Event description
2Immediate Actions and Containment
3Risk Classification and Rationale
4Product / Batch Impact Assessment
5Investigation and Root Cause Analysis
› Investigation summary› Root-cause methodology
6Corrective and Preventive Actions
7Effectiveness and Closure
8QA Review and Approval
REGULATORY CONTEXT

21 CFR 211.192 requires any unexplained discrepancy or failure of a batch to meet specifications to be thoroughly investigated, whether or not the batch has been distributed, with the investigation extending to other batches that may have been associated. EU GMP Chapter 1 expects deviations to be recorded and investigated, and ICH Q10 places deviation management within the pharmaceutical quality system. The classification criteria and the investigation depth appropriate to your operation are your determination, applied consistently and recorded here.

MAPPED STANDARDS
21 CFR Part 211ICH Q10EU GMP Chapter 1
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