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OOS Report

This document reports on an out of specification test result. It identifies the material and sample tested, lists the test results and specifications. An investigation was conducted to determine if the error was determinate, indeterminate or clerical. Corrective actions were detailed. Repeated tests by three analysts produced results within specification, confirming the original failure was not replicated. An impact analysis found no issues with related batches. Quality assurance approved the report and corrective actions as complete and adequate.

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Anton Mymrikov
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2K views2 pages

OOS Report

This document reports on an out of specification test result. It identifies the material and sample tested, lists the test results and specifications. An investigation was conducted to determine if the error was determinate, indeterminate or clerical. Corrective actions were detailed. Repeated tests by three analysts produced results within specification, confirming the original failure was not replicated. An impact analysis found no issues with related batches. Quality assurance approved the report and corrective actions as complete and adequate.

Uploaded by

Anton Mymrikov
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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OUT OF SPECIFICATION INVESTIGATION REPORT Page 1 of 2

OOS Report No.:


(i) Material Name :

(ii) Sample Code :

(iii) Test result(s) :

(iv) Specification limit :


(v) Specification reference :
(vi) STP reference :
Analyst Name Signature Date

Review of analysis: (Use OOS review checklist)

□ Determinate Error □ Indeterminate Error □ Clerical Error

Details of corrective / Preventive action:

Investigation done by Name Signature Date

Analyst

Lab -In charge


xxxxxxxxxx
OUT OF SPECIFICATION INVESTIGATION REPORT Page 2 of 2

Results of Investigation (attach copies of repeat results if applicable)


Repeat analysis Result(s) Analyst / reference Date

Analyst “A”

Analyst “B”

Analyst “C”

Reported results:_______________________________________
Sample status: □ Meets specification □ Failure confirmed
Impact analysis (Related batches):

Lab In-charge Name Signature Date

QA Assessment
(i) Lab investigation has been reviewed and is
□ Complete □ Incomplete □ Further investigation required:
(ii) Corrective action adequate
□ Yes □ No □ Further corrective action required
(iii) Is this a recurring problem for this product
□ Yes □ No □ Further corrective action to eliminate the problem
(iv) Comments, if any:

OOS Report Name Signature Date


Approved by (QA)
Authorised by (Director)
IQAD/038-02/01

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