Author Topic: visual inspection  (Read 1961 times)

sofiane

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visual inspection
« on: August 09, 2012, 09:22:11 AM »
dear forum member
while reading a not so recent 483
I came across this sentence
- The visual inspection acceptance and rejection of lyophilized finished product vials is performed by the production department and not by the Quality Unit.

what can be the meaning,
visual inspection operators depend of the QCU and not the production?
visual inspection operators depend of the production, but QCU operators accept or reject the vials (by visual inspection again or just approve the record?)

can we have the following option: visual inspection operators are operators from production unit but they can have a delegation from QCU to perform both task

have a nice day

crysogenum

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  • Organisation: Claris Lifesciences Limited
Re: visual inspection
« Reply #1 on: October 21, 2012, 12:39:16 PM »
As per general practice, visual inspectors are part of Production Department. Each visual inspectors are qualified by challanging with 'visual inspection kit' by QCU (with regular frequency of re-testing and authorization).

100% visual inspection shall be done by visual inspector. QCU shall check inspected samples randomly or as per AQL sampling method to assure that visual inspection activity is being performed satisfactory. 

QCU can not re-inspect each rejected unit identified by visual inspector, but it shall be checked on random sample basis and approve record. Ultimate goal of organization is business with compliance, hance both shall be balanced.

Apar

sofiane

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Re: visual inspection
« Reply #2 on: November 03, 2012, 09:50:55 PM »
thank you very much
this sound clear

bharatbuk

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Re: visual inspection
« Reply #3 on: November 10, 2012, 12:27:52 PM »
Interesting post shared here.visual inspection is done with the fiberscope,mirrors,magnifying glasses. Inspections requiring Ultrasonic, X-Ray equipment, Infra-red, etc. are not typically regarded as Visual Inspection as these Inspection methodologies require specialized equipment, training and certification..

 


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