← Template Library
REPORTREFERENCE OUTLINE
Out-of-Specification (OOS) Investigation Report
Two-phase OOS investigation — Phase I laboratory assessment then Phase II manufacturing investigation — driving a scientifically sound result-validity and disposition decision.
REGULATIONS MAPPED
FDA OOS Guidance (2022)21 CFR Part 211
DOCUMENT TYPE
ReportLAST UPDATED
January 2025PURPOSE
A two-phase out-of-specification investigation record — laboratory assessment first, then full manufacturing investigation — that reaches a scientifically sound conclusion on result validity.
What's Inside
✓Phase I laboratory investigation
✓Hypothesis testing and retest justification
✓Phase II full-scale manufacturing investigation
✓Batch disposition decision
✓CAPA and trend linkage
How to Use It
1Open the record immediately on the OOS result
2Complete the Phase I lab assessment before any retest
3Justify and control any retesting or resampling
4Escalate to Phase II when no lab cause is confirmed
5Document the disposition decision and its scientific basis
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
1OOS Result Identification
2Phase I — Laboratory Investigation
3Hypothesis Testing and Retest / Resample Plan
4Phase I Conclusion
5Phase II — Full-Scale Manufacturing Investigation
6Batch Impact and Disposition
7CAPA and Trending
8Approvals
REGULATORY CONTEXT
The FDA OOS guidance (2022) and 21 CFR 211.192 define the expected two-phase investigation. This template enforces the Phase I / Phase II separation that inspectors look for.