deviations/dev met 0891 002/investigate
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DEV-MET-0891-002

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Phase I Investigation · Investigator: Rajesh Kumar

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Phase I Investigation

Capture initial assessment and proceed to Phase II root cause analysis.

  1. 1Phase I
  2. 2Phase II
  3. 3CAPA
  4. 4Closure
  5. 5Complete

Check all that apply

Based on deviation pattern and batch history

1. Equipment Calibration Drift

Machine A calibrated 16 days ago (Golden Batch: 1 day prior). 2 of 3 similar historical deviations had this cause.

2. Raw Material Particle Size Variation

Same raw material lot as previous 4 batches. Check lot certificate for particle size compliance.

3. Machine Speed or Pressure Setting Change

Verify compression force settings match batch record. 1 of 3 similar historical deviations had this cause.

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