To describe a standard operating procedure (SOP) for sampling of in-process checks
1.0 PURPOSE:
To describe a standard operating procedure (SOP) for sampling of in-process checks.
2.0 SCOPE:
The SOP describes in detail the method of carrying out sampling of in-process checks.
3.0 RESPONSIBILITY:
The responsibility of collecting samples at appropriate step of operation and taking to QCD along with request cum test report as per the standard operating procedure lies with the staff of rank not lower than Operator of Production Department.
The responsibility of preparing, reviewing and approving the SOP lies with the Officer / Executive (Production), Head of Production and Head of QAD respectively.
4.0 METHOD:
4.1 FOR SOLID SAMPLES:
4.1.1 Collect 5 g for LOD and 10 g for moisture content sample in self sealing poly bag with stainless steel spoon at appropriate step.
4.1.2 Label the bag with product batch No. date and operator/supervisor initial.
4.1.3 Enter the details in request cum test report in duplicate and carry the sample along with report to QCD.
4.1.4 The QC person will analyse the sample and get the result checked by his QC colleague.
4.1.5 The QC person will enter the details in request cum test report and hand over the duplicate copy of request cum test report to the production operator/supervisor. The QC person will file the other copy.
4.2 FOR SLURRY/LIQUID SAMPLES:
4.2.1 Collect 50 ml sample with the help of plastic long handle sampler in a clean plastic container of 100 ml with screw cap lid.
4.2.2 Label the bottle with product batch No. date and operator/supervisor initial.
4.2.3 Enter the details in request cum test report in duplicate and carry the sample along with report to QCD.
4.2.4 The QC person will analyse the sample and get the result checked by his QC colleague.
4.2.5 The QC person will enter the details in request cum test report and hand over the duplicate copy of request cum test report to the production operator/supervisor. The QC person will file the other copy.
4.3 All formats with 'REQUEST CUM TEST REPORT' will be revised to include 'checked by' column.
5.0 RECORDING:
The responsibility of recording the details in relevant documents and results in the batch records lies with staff of rank not lower than technical assistant of quality control department and with operator / supervisor of production department respectively.
Production, process checks, sampling
