Listing of Qualified Personnel SOP
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1.0
PURPOSE:
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1.1.
The
purpose of this document is to define procedure to determine a person as
“Qualified Person” for performance of particular job / activity.
2.1. This procedure is applicable to all personals
who are performing a technical operation like dispensing, batch manufacturing,
compression , filling etc at ______Plant.
3.1. Quality Control Manager.
3.2. Quality Assurance Manager.
3.3. All Department Heads.
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4.0 PROCEDURE:
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4.1. All
HOD will maintain the list of Qualified Persons for particular operation.
4.2. All
such lists will be supported by particular training and evaluation by concerned
head.
4.3. All
such lists will be reviewed by QA on Quarter basis for compliance.
4.4. QA
will ensure that no operation / activity are being performed by Un-qualified
persons.
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5.0
REVIEW
FREQUENCY:
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SOP will be reviewed at least annually.
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EVIDENCES
OF RECORDS & REFERENCES
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List of
skilled personnel.
Training
Records
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FORMAL KPIs
(Key Performance Indicators)
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Retrieval
and access is easy and possible as and when required.
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GENERAL RISKS
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CONTROL MEASURES
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CUSTODIAN
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Risks
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Impact
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Task not
defined to skilled person/ operators.
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Negligence
and overlook of work may occurs.
Any harm
to Machinery or Batch may occurs.
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Task
should be defined to skilled Person or operators.
Proper
training sessions should be arranged.
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QC Manager
QA Manager
All
department Heads
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