QsutraIPQA — Tablet Manufacturing Quality

What was found during investigation? *

Describe specific evidence gathered (measurements, observations, test results)

Confirmed Root Cause *

Root Cause Category *

Root cause detail *

5-Why Analysis

Trace root cause to its source (optional but recommended)

Why 1:

Why 2:

Why 3:

Why 4:

Why 5:

How much of the batch was affected? *

Checks OOS *

out oftotal checks

Tablets affected (estimated) *

Within overall acceptance criteria? *

Yes — batch passes overall quality standards No — batch fails overall quality standards

Immediate corrective actions taken *

Actions already completed to fix this occurrence

Description *

Completed by *

Date completed *

Batch Disposition Decision *

💡 RECOMMENDATION: CONDITIONAL RELEASE

Based on: Risk score 80/100, 1 OOS (14% of checks), yield 97.6%, MAJOR classification. Root cause identified, corrective action taken. CAPA required to prevent recurrence.

✅ RELEASE

Batch meets all quality standards for distribution

✅ CONDITIONAL RELEASERecommended

Release with documented justification and CAPA

🟠 REWORK

Reprocess specific portion, retest before release

🟠 REPROCESS

Full reprocessing required, complete retesting

🔴 REJECT

Batch does not meet standards — quarantine and destroy

Next Steps — Preventive Actions & CAPACreate CAPA from this investigation(recommended for MAJOR/CRITICAL)

CAPA will be created with:

Linked Deviation:DEV-MET-0891-002

Root Cause:Equipment — calibration drift

Suggested Actions:

Reduce Compression Machine A calibration interval to 20 days (from 30 days)
Set Cpk alert if Fill Weight Cpk < 1.5
Update SOP with new interval

Owner

Target Date

Supporting Evidence (optional)

QA Manager Sign-off — Phase II Certification

Before closing Phase II, confirm:

Root cause has been confirmed by investigationBatch impact has been fully assessedCorrective actions have been taken or plannedBatch disposition is documented with justificationCAPA created or skip justified

DEV-MET-0891-002

Phase II — Root Cause Analysis & Disposition