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OOS Tree

The document outlines the process flow for investigating samples that fail an initial out-of-specification (OOS) test. It involves repeating tests with additional analysts until the reason for the original failed test is determined or the sample is confirmed to fail specifications. If the sample fails specifications, documentation is forwarded to quality assurance.

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Anton Mymrikov
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2K views1 page

OOS Tree

The document outlines the process flow for investigating samples that fail an initial out-of-specification (OOS) test. It involves repeating tests with additional analysts until the reason for the original failed test is determined or the sample is confirmed to fail specifications. If the sample fails specifications, documentation is forwarded to quality assurance.

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

Attachment: I

Decision OOS Investigation Flow Chart

ANALYST "A"
PERFORMS THE
TEST

ANALYST "A" FAIL ANALYST "A" PASS

PERFORM ANALYST EVALUATION

INDETERMINATE ERROR
DETERMINATE ERROR- PERFORM CLERICAL ERROR- PERFORM
CORRECTIVE ACTION CORRECTIVE ACTION

INITIATE OOS CORRECTIVE


INVESTIGATION ACTION FAILS

CORRECTIVE
ANALYST "A" & "B"
ACTION PASSES
REPEAT

ANALYST "A" FAIL ANALYST "A" PASS ANALYST "A" FAIL ANALYST "A" PASS
ANALYST "B" FAIL ANALYST "B" FAIL ANALYST "B" PASS ANALYST "B" PASS

ANALYST "C"
REPEAT

ANALYST "C" FAIL ANALYST "C" PASS

INDICATE MATERIAL
FAILS SPECIFICATIONS

FORWARD
SEND E-NOTIFICATION DOCUMENTATION ACCEPT MATERIAL
(IF APPLICABLE) TO QA

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