1.0 OBJECTIVE
This SOP lays down a procedure for validation of visual checking inspectors2.0 SCOPE
This is applicable to the personnel assigned the job for visual checking during the filling/ packaging process3.0 RESPONSIBILITY
Packing Chemist / Asst. Production Manager4.0 ACCOUNTABILITY
Asst. Production manager / Q.A. Manager5.0 PROCEDURE
5.1 Select 100 no. of filled bottles which contain 5 bottles with poor sealing; 5 bottle with particulate matter, 2 bottles with molding defect, 5 bottles with less or more volume; 2 bottles with glass particles and 81 clear & good bottles.5.2 Paste 1 to 100 no. sticker or mark the cap with a suitable marker on all the bottles & make a list of all no. bottles and write the remark like a good, sealing defect particle, module, volume to identify the bottles on the sheet. This remark should be against the bottle no. and fill the form.
5.3 Ask each inspector to check the bottle against black & white background & remove the rejected bottle.
5.4 If the inspector rejects all the marked bottles he/ she passes the validation test.
5.5 If the inspector fails to identify minor rejection like small mold defect or minor sealing defect he/she shall be considered to pass the test.
5.6 If the inspector fails to identify even one major defect like the suspended particle, glass particle, volume variation he/ she fails in the validation test.
5.7 A new inspector has to pass the validation test in two consecutive test then only he/ shall be allowed to check the bottles.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 QA: Quality Assurance
6.3 No.: Number
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