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.
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.
A two-phase record that establishes whether an out-of-specification result is attributable to the laboratory or reflects the batch — laboratory assessment first, full manufacturing investigation second, with retesting controlled in between. The phase separation is the whole discipline: invalidating a result on a hypothesis that was never tested, or retesting until a passing value appears, is the failure mode this record is built to prevent.
What's Inside
How to Use It
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.
FDA's guidance on investigating out-of-specification test results for pharmaceutical production sets out the two-phase structure, the limits on retesting and resampling, and the expectation that an original result is not invalidated without a confirmed assignable laboratory cause. 21 CFR 211.192 requires any unexplained discrepancy or failure to meet specifications to be thoroughly investigated, with the investigation extending to other batches and the conclusion recorded. The disposition decision remains the quality unit's, on the evidence this record assembles.