To describe the procedure for Training procedure for QC persons. This SOP applies to the training procedure for QC persons.
3.0 RESPONSIBILITY
    Officer/ Executive  -
Quality Control
4.0 ACCOUNTABILITY
    Manager – Quality Control
5.1 QC Training Procedure
5.1.1 Qualified individuals, knowledgeable in the subject/topic and who can effectively communicate the information should conduct training. A person of supervisory or managerial cadre 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 procedures in addition to a regular job.
5.2.0 The program should include the following kinds of training:
5.2.1 Orientation / general information for new and temporary
employees.
5.2.2  GMP and GLP concepts and procedures.
5.2.3 Theoretical knowledge for job-related training.
5.2.4 On-the-job training.
5.2.5 Safety.
5.2.6 General Operations / Procedures.
5.2.7 Outside seminars, conferences,s, etc.
5.2.8 Training required to be imparted to the person should be
decided in December every year.
5.2.9Â A program is to be
established for the entire subsequent year by the HOD and recorded as per the format for the training schedule.
5.2.10Â Â Depending upon
the individual job requirement the areas of training to be imparted and goals of the training are to be decided by
the HOD and QA/QC Â Manager.
5.2.11 Training should be continuous 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.
5.3.0 Program
5.3.1 Conduct the training session by any of the following
methods.
5.3.2 Â Lecture or
presentation.
5.3.3 On-the-job training.
5.3.4Â Educational
material/handouts.
5.3.5Â Slide/tape/video
presentation.
5.3.6 Â Computer program.
5.3.7 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.
5.3.7 Prepare a report containing the name of the trainer, his
designation, names of trainees, subjects covered, evaluation sheets, any raw
data that may have been generated during training, marks obtained
by the trainee, and comments of the trainer, etc. as per Annexure.
5.4.0 Evaluation Criteria
5.4.1 In the case of questionnaires / individual discussions candidates should score between (90 to 100%) marks. Evaluation counted as Excellent performance.
5.4.2 In the case of questionnaires/ individual discussions candidates should score between (80 to 90%)Â marks. Evaluation counted Very good performance.
5.4.3 In the case of questionnaires/ individual discussions candidates should score between (70 to 80%) marks. Evaluation counted as Better performance.
5.4.4 In the case of questionnaires/ individual discussions candidates should score between (60 to 70%)Â marks. Evaluation counted as Good performance.
5.4.5 Â In the case of
questionnaires/individual discussions candidates should score between (50 to 60%) marks. Evaluation
counted Average performance.
5.4.6 Â In the case of
questionnaires candidates do score below 50% marks. Evaluation counted, provide
retraining for candidates.
5.4.7 Â In the case of parallel
testing compare the results of the trainer and trainee and if the results of the trainee are found satisfactory then the trainee may be allowed to undertake the
particular testing.
5.4.8  Retraining is necessary if the trainee scores less than 50% marks or does not qualify for testing.
5.4.9 Â Frequency: Â As per schedule and whenever required.
6.0 ABBREVIATIONS:
6.1 Â SOP - Standard Operating Procedure
6.2 Â No. - Number
6.3 Â QA - Quality Assurance
6.4 Â NA - Not Applicable
6.5 Â CCF - Change control format
6.6  QC - Quality Control                           Â
7.0 REFERENCE:
 7.1 NILL