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 | ||||
| LEFT EYE | RIGHT EYE | 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 Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area
