Performance requalification report of visual inspectors

REPORT CONTENTS

SERIAL NO.
SECTION TITLE
1.0 Report Approval

2.0 Summary Plan of Study

3.0 Description of Operating conditions

4.0 Results, Discussion and Conclusion

5.0 Deficiencies Observed and Corrective Action Taken

6.0 Annexure reports

1.0 PROTOCOL APPROVAL

Designation	Signature	Date
Prepared By
( Executive –QA)
Checked By
( Sr. Executive-QA )
Approved By
(Manager- Quality Assurance)

REMARKS

Contents of this report are specific to the Qualification study of visual Inspection Personnel. This report stands valid till one year from the effective date.

2.0 SUMMARY PLAN OF STUDY

The tests performed for the qualification of the Visual Inspectors are as detailed below.
For shorting

Used the 200 tab. which 190 optically good tablets and 10 tablets optically reject
Make the 10selected reject tablets having coating problem ,capping, half tab, sticking, break ,black spot ,picking ,creaking, colour variation and other particle
For on line packing and pack stock
Used the 200Blister. which 190 optically good blister and 10 blister optically reject
Make the 10select reject blister having powder, pin hole, other particle, cutting problem. empty pocket, puncher, printing problem, black spot, break & text matter
Procedure

All the defected mixed with goods tablets or blister during the visual inspection.
During the blister inspection put the 200bister manually one by one on the conveyer at slow, medium& fast speed.
Inspectors to be qualified inspect the blister and find out the good and defected blister.
After Check the total 200 blister QA person check and verified if the rejected blister if the QA person found the 10 rejected blister which found by checker the checker is qualified if found the less than 10 blister reject the checker is not qualified
In case of shorting inspection mixed the 10 selected defected tablets with 190 good tablets.
Run the inspection belt slow, medium & fast speed
After completed shorting the tablets QA person check and verified rejected tablets by checker if the QA person found the 10 rejected tablets which found by checker the checker is qualified if found the less than 10 tablets reject the checker is not qualified
Completed the checker validation procedure all good and defected tablets/ blister destroy .
The results of visual inspection for each inspector are recorded
Data collected is analyzed for required parameters as per acceptance criteria.

3.0 DESCRIPTION OF OPERATING CONDITIONS:

The Optical Inspection is carried out at the following parameters:

Area Temperature: 22 ± 2 ºC

Room: With optical inspection tables and conveyers belt having appropriate light.

4.0 RESULTS AND DISCUSSIONS AND CONCLUSION:

The eyesight and color vision of all the optical inspectors is found as per the acceptance criteria.

The ability to detect different type of rejections by the entire inspector is good.

The compiled result for all the visual inspectors, for all products

Name of inspector	VISION		COLOR VISION	OBSERVATION
Name of inspector	LEFT EYE	RIGHT EYE	COLOR VISION	Slow	Medium	Fast	Inspector for
Salelta	6/6	6/6	WNL	Pass	Pass	Pass	On line packing
Mamta	6/6	6/6	WNL	Pass	Pass	Pass	On line packing, shorting
Babli	6/6	6/6	WNL	Pass	Pass	Pass	On line packing
Pinky	6/6	6/6	WNL	Pass	Pass	Pass	On line packing
Lokesh	6/6	6/6	WNL	Pass	Pass	Pass	On line packing
Kushum	6/6	6/6	WNL	Pass	Pass	Pass	On line packing
Kanta	6/6	6/6	WNL	Pass	Pass	Pass	On line packing
Mushkan	6/6	6/6	WNL	Pass	Pass	Pass	Pack stock, on line packing

CONCLUSION

All visual inspectors are found to have good vision, without ophthalmic disorder and are able to perform the visual inspection with the results in acceptance limit.

5.0 DEFICIENCIES OBSERVED AND CORRECTIVE ACTIONS TAKEN

No deficiency has been observed.

Online Rejection in parenteral

Receipt of Batch from Production to Packing Department

sop for for Spillage Handling in parenteral area

sop for calibration of vessels with dipstick

sop for Cleaning of Bins and Containers

cip of mixing vessel and holding vessel

SOP FOR BATCH MANUFACTURING

sop for placebo batch

sop for Cleaning of Ampoule Filling and Sealing Machine

sop for Fogging in Sterile and Non Sterile Area