OBJECTIVE:
To lay down the procedure for Sample distributing and Reporting system in QC Department.
SCOPE:
This procedure is applicable for the all samples received for testing in Quality Control Department.
RESPONSIBILITY:
Quality Control Officer / Executive is responsible to follow procedure as per the procedure mentioned in this SOP.
QC Head is responsible for implementation and compliance of the procedure as per this SOP.
ABBREVIATIONS
SOP : Standard Operating Procedure
QC : Quality Control
QA : Quality Assurance
ATDS : Analytical Test Data Sheet
COA : Certificate of Analysis
IPQA : In Process Quality Assurance
PROCEDURE:
Distribution of Samples
Executive – Quality control receives the samples as per SOP titled “(Receipt, Testing and release of In-process Samples; Receipt, Testing and release of Raw Materials; Receipt, Testing and release of packing materials and Receipt, Testing and release of Finished Products”.
Executive – Quality Control shall distribute the samples to the analyst for the analysis.
The samples are distributed along with the Analytical Test Data Sheet. Before issuing the analytical test data sheet check the issued no., issued stamp, issued signature and date on each page.
Maintain the ATDS accountability register while issuing as per SOP titled ‘Preparation and control of analytical test data sheet’.
The analyst shall be follow the current version of respective test procedure.
After completing the analysis is the analyst has to check the ATDS and hand over to executive – QC. He shall check all the entries, calculation, attachments and sign “checked by” wherever applicable.
After checking the ATDS, COA will be prepared by officer and checked by the executive quality control and approved by quality control manager or his deputy.
Send the finished product analysis request cum report sheet duly sign to IPQA.
After approval, the ATDS and COA shall be hand over to QA – Deptt.
Tags
QC SOP