Laboratory Investigation

• Audit Title

• Document No.

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

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)

  Yes

  No

  N/A

• Type of Result

  Out of Specification (OOS)

  Out of Trend (OOT)

  Atypical Result

  Not Applicable (N/A)

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Standard Preparation Evaluation

• The Standard Weight are correct?

  Yes

  No

  N/A

• The Glassware used was correct

  Yes

  No

  N/A

• Standard preparation reference:

• The standard preparation was performed as per method instructions?

  Yes

  No

  N/A

Sample integrity

• Did sample was received in the correct container

  Yes

  No

  N/A

• Did the sample came in a bag with desicant?

  Yes

  No

  N/A

• 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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• The sample weight performed was correct?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• Re-measutements was performed?

  Yes

  No

  N/A

• Results of re-measurements

• The original result was confirmed??

  Yes

  No

  N/A

• 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)

  Yes

  No

  N/A

Re-Test

• Re-Test Performed?

  Yes

  No

  N/A

• Re-Test Results (Document)

• Did re-test results confirmed the original results

  Yes

  No

  N/A

Trending Evaluation

• Evaluate the history the previous year and document the findings

Root Cause

• Laboratory Root Cause

  Incorrect Glassware

  Analyst Error

  Equipment Error

  Enviroment

  Sample (No Lab Error)

• Trackwise Root Cause

  Select Enviroment Machine Manpower Material Multiple Quality Systems Undetermined

  • Enviroment
  • Machine
  • Manpower
  • Material
  • Multiple
  • Quality Systems
  • Undetermined

Correction or Corrective Action

• Type:

  Correction

  Corrective Action

• 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.