Out of Specification Results

1.0. PURPOSE: To provide a procedure to deal with the out of specification results obtained by an analyst in Q.C.L Test.
2.0. SCOPE: This procedure covers the individual chemist’s analytical performance, reagents and solutions, calibration and validation.
3.0. RESPONSIBILITY: Q.C. Chemist, Q.C. Manager and Q.A. Manager
4.0. ACCOUNTABILITY:
5.0. DEFINITION:
6.0. PROCEDURE:
This exercise is based on the assumption that the process followed is validated and the product is of standard quality. If the results are not within acceptable limits of Product Release specification, then follow as per the steps mentioned here below.
6.1. OOS results submitted to Quality Control Manager by a chemist.
6.2. Discuss the method of analysis and check calculation to prove that what is done is right.
6.3. If the analysis is okay ask for repetition with standard and earlier released batch
6.4. In case all the samples fail, change the set of reagents and solutions and check calibration of the instrument used
6.5. If only OOS sample fails, then resample and analyse.
6.6. If the result of analysis of resample is found okay and comparable in all respects with standards and earlier released batch then it can be concluded that the earlier sample was defective.
6.7. Counter check the results of analysis of first analyst by analysing with another chemist using same set of chemicals, reagents and solutions
6.8. Q.C Manager should collect all the above data of OOS results of a particular laboratory test and refer the matter to Q.A Manger with his conclusion.
6.9. Q.A Manager after review of all the Q.C operations in regards to OOS results should authorise the conclusion made by Q.C Manager and close the non-conformance report.