Listing of Qualified Personnel SOP


1.0   PURPOSE:

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.

4.0    PROCEDURE:

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.

5.0     REVIEW FREQUENCY:

SOP will be reviewed at least annually.


EVIDENCES OF RECORDS & REFERENCES
List of skilled personnel.
Training Records
FORMAL KPIs (Key Performance Indicators)
Retrieval and access is easy and possible as and when required.
GENERAL RISKS
CONTROL MEASURES

CUSTODIAN
Risks
Impact
Task not defined to skilled person/ operators.
Negligence and overlook of work may occurs.
Any harm to Machinery or Batch may occurs.
Task should be defined to skilled Person or operators.
Proper training sessions should be arranged.
QC Manager
QA Manager
All department Heads




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