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: