sop for Qualification of Visual Inspector
1.1 To lay down a procedure for Qualification of Visual Inspector.
2.1 This Standard Operating Procedure is applicable for Qualification of Visual Inspector
3.1 Officer / Executive QA and Production
4.1 Head – QA
Note: Each newly joined visual inspector shall undergo a training program before going through qualification procedure.
Training shall be imparted by QA on visual inspection booth which is used for routine activity.
5.1 Qualification of Trained Visual Inspectors:
5.1.1 Officer / Executive – QA shall issue Qualification Protocol & Report to IPQA personnel for execution of qualification activity.
5.1.2 Visual inspector shall be qualified on the basis of methodology of approved protocol in the presence
of IPQA personnel by providing a kit of Filled & Sealed Glass Ampoules having known defects.
5.1.3 Personnel under qualification shall put a tick mark ‘√’ in the box of respective defects column of
qualification report. Identification of correct defects, which is ‘√’ mark by concern visual inspectors
in respective qualification report column shall be checked by production, verified by QA and reviewed
by QA from the respective visual inspector qualification Protocol.
5.1.4 All new visual inspectors shall be qualified as per respective challenge test kit and after successful
qualification, name of visual inspector shall be incorporated in visual inspector qualification
list & allowed for routine visual inspection activity.
5.1.5 Personnel shall be qualified if he / she able to detect the defect as per acceptance criteria mentioned in
protocol i.e. 100 % defect shall be identified by the visual inspectors.
5.1.6 After completion of visual inspector qualification, IPQA personnel shall hand over the qualification
report with all training records to documentation cell.
5.1.7 After successful evaluation of qualification report, QA- Documentation cell shall prepare list
of Qualified Visual Inspector and displayed in respective packing area
as per Annexure-I, Titled “List of Qualified Visual Inspector”.
5.1.8 Visual Inspector List shall be updated every six month or whenever required.
5.2 Frequency of Qualification: Visual Inspector shall be qualified in following cases
5.2.1 If a new person to be deputed as visual inspector.
5.2.2 Re-qualification of all individuals shall take place once in a year ± 30 days and eye checkup of visual
inspector should be done twice in a year.
5.2.3 Re-qualification reports shall be prepared annually on the basis of medical fitness and visual
inspection challenge test of all individual.
5.2.4 After major eye treatment i.e. eye operation.
Precaution: No personnel shall be allowed for routine visual inspection activity of Filled and Sealed Glass
Ampoules Injection in production area without training & visual inspector qualification.
|S. No.||Abbreviations used||Full form of Abbreviation used|
|2.||SOP||Standard Operating Procedure|
7.0 ATTACHMENTS (ANNEXES) :
7.1 Annexure-I: List of Qualified Visual Inspector
8.0 REFERENCE :
|S. No.||Reference Title|
|1.0||As per GMP Guideline|
Annexure-I: List of Qualified Visual Inspector