Template Information
Category: manufacturing
Template Questions
- Material / Product:
- Lot No.
- Test:
- Method No: / Rev. / Method Tittle / Effective Date
- Initial Result
- Specification:
- Test Date:
- When the event was detected (Date of Occurence):
- Description of Event (What Happened):
- Event Informarion
- Inmediate Correction:
- Initial Impact Assesment (What is the extention of the event)
- Analyst Evaluation
- Standard Preparation Evaluation
- Standard preparation reference:
- Sample integrity
- The sample was stored in the correct area (Document the area of storage (If applicable document the humidity of the room)
- Sample Preparation Evaluation:
- The solution used for the sample preparation is correct (Reference)
- Results of re-measurements
- If the OOS was confirmed, open and investigation to other area (i.g. Mfg, MTDP etc) to expand the investigation process. Refer to:Root
- Instrument used
- Calibration Due Date:
- The instrument was verified and it was detected an error (i.g leak, error message, etc)
- Instrument Evaluation
- Re-Test
- Re-Test Results (Document)
- Evaluate the history the previous year and document the findings
- Root Cause
- Trackwise Root Cause
- Correction or Corrective Action
- Action Taken
- Describe the results that will be used as official to report the test.