OOS Investigation Workflow Wizard — Priya Life Science Tools

Step 1: Document Details & Specification Breach

Product / Material Name

Batch / Lot Number

Specification Range

Observed OOS Result

Test Parameter Name

Step 2: Phase Ia Laboratory Investigation Checklists

The analyst should review immediately prior to throwing out the sample or standard solutions.

Calculation checked and confirmed correct? (No transcription or mathematical error)

Standard solution preparation checked and confirmed correct? (No dilution, weight or contamination error)

Glassware & Pipettes cleaned and verified? (No contamination or volumetric error)

Test method followed exactly? (No deviation from standard operating procedure)

Instrument suitability parameters confirmed? (HPLC columns, system suitability parameters met)

Analyst trained, qualified, and verified for this specific test?

Describe any identified Laboratory Error (Leave blank if unconfirmed):

Initial Laboratory Check Status: No laboratory error checked yet. If lab error is confirmed, the test result is invalid.

Step 3: Phase Ib Retesting Protocol & Outlier Test

⚠ FDA Warning (Barr Decision): You cannot average OOS results with passing re-test results to obtain a passing mean. Every individual OOS result must be logged and evaluated. Averaging masking OOS data is a serious GMP compliance breach.

Grubbs' Outlier Tester (for Replicates)

Enter your replicate results (comma-separated, e.g. 92.4, 98.5, 99.1, 98.9, 99.3) to test if the OOS value (92.4) is a statistical outlier at $\alpha = 0.05$.

Replicate Assay Data Points

SOP Retest Plan Description (e.g. n=5 or n=7 replicates by a second analyst):

Step 4: Phase II Full-Scale Process & Manufacturing Check

Conducted by Investigator/QA when no clear laboratory error is found in Phase Ia.

Batch processing records reviewed? (All critical steps, addition weights, and temperatures in range)

No manufacturing deviations occurred during production of this lot?

Environmental monitoring parameters in cleanroom/compression suites confirmed in range?

Raw materials (active ingredient and excipients) release status and certificate of analysis confirmed correct?

Manufacturing equipment clean, calibrated, and maintained status confirmed?

Describe manufacturing process findings, if any:

Step 5: Investigation Conclusion & Batch Disposition

Root Cause Classification

Recommended Batch Disposition

Corrective and Preventive Actions (CAPA) Plan:

Print & File: When you are ready, print this page to PDF or printer. The print stylesheet automatically hides inputs and formats this wizard into a formal GMP document format.