Training Procedure For Quality Control Personnel
1.0 OBJECTIVE:
To
describe the procedure for training procedure for Q.C person.
2.0 SCOPE:
This
SOP is applicable for training procedure for Q.C persons.
3.0 RESPONSIBILITY:
3.1
Officer/ Executive-Q.C.
4.0 ACCOUNTABILITY:
4.1
Manager- Q.C.
4.2
Head of the Department.
5.0 PROCEDURE:
5.1 Method:
5.1.1
Qualified individual, knowledgeable in the
subject/ topic, who is able to effectively communicate the information should
conduct training. A person of supervisory is most often required to give
training.
5.1.2
Permanent and temporary employees must be
trained and have basic knowledge and understanding of their job function.
Experienced employees must also be trained for new or changed procedure in
addition to regular job.
5.1.3
The program should include the following
kinds of training:
5.1.3.1
Orientation/ general information for new
and temporary employees.
5.1.3.2
GMP and GLP concepts and procedures.
5.1.3.3
Theoretical knowledge for job related
training.
5.1.3.4
On the job training.
5.1.3.5
Safety.
5.1.3.6
General operations/ procedures.
5.1.3.7
Outside seminars, conference etc.
5.1.4
Training require to be imparted to the
personnel should be decided in the month of December every year. A program is
to be established for the entire subsequent year by the HOD and record as per
format for training schedule. Depending upon the individual job requirement the
areas of training to be imparted and goals of the training are to be decided by
HOD and QA/ QC Manager.
5.1.5
Training
should be on continuing basis and with sufficient frequency. It should include
the topics to be covered, the people to attend and the approximate timing for
each session. In some instances, it may be necessary to schedule the same topic
more than once to ensure that all relevant employees attend.
5.2 Program:
5.2.1
Conduct the training session by any of the
following methods:
5.2.1.1
Lecture or presentation.
5.2.1.2
On job training.
5.2.1.3
Educational material/ handouts.
5.2.1.4
Slide/ tape/ video presentation.
5.2.1.5
Computer program.
5.2.2
Evaluate effectiveness and training
through questionnaires, performance indicators (e.g. parallel testing by
trainer and trainee) direct observation or discussion/ review with supervision
for job competence.
5.2.3
Prepare a report containing the name of
trainer, his designation, names of trainees, subjects covered, evaluation
sheets, any raw data that may have been generated during the course of
training, marks obtained by trainee and comments of the trainer etc. as per
Annexure-I.
5.3 Evaluation Criteria:
5.3.1
|
Score |
Performance |
|
Between 90 to 100%
marks |
Excellent |
|
Between 80 to 90% marks |
Very good |
|
Between 70 to 80% marks |
Better |
|
Between 60 to 70% marks |
Good |
|
Between 50 to 60% marks
|
Average |
|
Below 50% marks |
Provide retraining for
candidates |
5.3.2
In case of parallel testing compare the
results of trainer and trainee and if the results of trainee are found
satisfactory then the trainee may be allowed to undertake the particular
testing.
5.3.3
Retraining is necessary if the trainee
score less than 50% marks or does not qualify for testing.
5.3.4
Frequency:
As
per schedule and whenever required.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
01/07/2020 |
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
Annexure 1: Training
Record.
Annexure:
1
Training
Record
Title: ________________________________________________________________
Trainer Name:
___________________ Date:
_______________
Sign. Of Trainer:
_________________ From: ______
to ______
|
Sr. # |
Name of the trainee |
Department |
Employ sign. |
Evaluation on the basis of
Questionnaires/ Discussion |
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9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
S
|
Standard
operating procedure |
|
& |
And
|
|
% |
percentage |