Event Informarion

  • 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):

  • The data generated is accurate (i.g. System Suitability was within specifications, elements of the analysis were found correct)

  • Type of Result

  • Inmediate Correction:

  • Initial Impact Assesment (What is the extention of the event)

Laboratory Investigation:

Analyst Evaluation

  • The analyst that perform the analysis was qualified to perform the analysis?

  • The analyst has experience in the analysis (He/She performed the test on the past)?

Standard Preparation Evaluation

  • The Standard Weight are correct?

  • The Glassware used was correct

  • Standard preparation reference:

  • The standard preparation was performed as per method instructions?

Sample integrity

  • Did sample was received in the correct container

  • Did the sample came in a bag with desicant?

  • 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 sample was received in the appropriate container

  • The glassware used in the analysis is correct (i.g. volumetric flask, pippets, etc)?

  • The sample weight performed was correct?

  • The solution used for the sample preparation is correct (Reference)

  • Evaluate the sample preparation against the method instruction with the analyst. That any deviation or error was found?

  • Re-measutements was performed?

  • Results of re-measurements

  • The original result was confirmed??

  • 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 Evaluation

  • Instrument used

  • Calibration Due Date:

  • The instrument was verified and it was detected an error (i.g leak, error message, etc)

  • All the instrument parameters were correct (No error message or equipment malfuntion was detected)

Re-Test

  • Re-Test Performed?

  • Re-Test Results (Document)

  • Did re-test results confirmed the original results

Trending Evaluation

  • Evaluate the history the previous year and document the findings

Root Cause

  • Laboratory Root Cause

  • Trackwise Root Cause

Correction or Corrective Action

  • Type:

  • Action Taken

Preventive Action (This prevent the recurrence of the root cause identified)

  • Action Taken

Final Conclusion

  • Describe the results that will be used as official to report the test.

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