Sub-Part I - Laboratory Controls

8.4 - Laboratory Controls - Out of Specification Investigation

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An out of specification investigation must be completed each time a laboratory test, examination or the result of any monitoring fails to meet an established specification; one investigation per OOS test parameter. This applies to physical, chemical, & microbiological tests or examinations, stability testing, monitoring, and validation.

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An arrow missing its white and red ring target and sitting out of specification in the yellow background