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Laboratory Investigation Report

Use this template to investigate laboratory misconduct or accidents. Note who was responsible and the date and time of the incident on the report. Was the right lab equipment used? Did the attendant follow the correct protocol and procedure? Get to the root cause of the problem, and answer all these questions and more on the form below.
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Laboratory Investigation Report

Audit

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

Was the sample 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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