1.0 PURPOSE
1.1 To lay down the procedure for Training and evaluating employees.
2.0 SCOPE
2.1 This procedure is applicable for employees working in all departments
3.0 RESPONSIBILITY
3.1 Head - Concerned Department (s) / Block (s).
3.1.1 To ensure all employees of their department (s) / block (s) under go training.
3.1.2 Identification of on training topics.
3.1.3 To ensure all employees of the department (s) / block (s) attend training programs as per cheduled.
3.2 Training Co-Ordinator
3.2.1 Implement training programs as scheduled.
3.2.2 Report on the training activities.
3.2.3 Maintaining all training records.
4.0 ACCOUNTABILITY
4.1 Head- Quality Assurance
5.0 PROCEDURE
5.1 Training shall be given to employees in all the departments.
5.2 Training is sub divided in to the following categories:
5.2.1 Induction training
5.2.2 Job Oriented training
5.2.3 cGMP Training
5.2.4 On going training
5.3 Induction training
5.3.1 This is the an introduction of new employee to the following, But not limited to:
5.3.1.1 Introduction on the Organization
5.3.1.2 Heads of department and other key employees
5.3.1.3 The regulations or requirements of Organization
5.3.1.4 Organization rules
5.3.1.5 Personnel hygiene policies
5.3.1.6 Personnel policies
5.3.1.7 Do (s) & don’t(s)
5.3.1.8 Basic GMP requirements.
5.3.2 Human Resources department is responsible to impart Induction training.
5.3.3 At end of Induction training, employee shall fill the Induction report as per format xxxxx. Human Resource department shall forward the filled report to Quality Assurance.
5.4 Job oriented Training
5.4.1 Below Executives
5.4.1.1 Job oriented training involves the new recruit working in their assigned area along with an experienced person for a designated period deemed fit by head of the department (s) / block (s).
5.4.1.2 At the end of the training period assessment on the training will be conducted by head of the department (s) / block (s) or designee by reviewing the employees work performance during training period by physically observing the work carried out against standard operating procedures.
5.4.1.3 At the end of the training evaluation is made by conducting written test as per format Personnel Training
5.4.1.4 Job oriented training report shall be prepared as per format Personnel Trainingand evaluation form (s) is attached to it.
5.4.2 Executives
5.4.2.1 This is an introduction to actual requirements of the job.
5.4.2.2 Head or his designated person (s) of the respective / department (s) / block (s) is responsible for conducting this training.
5.4.2.3 New employees are required to read standard operating procedures and documents relevant to his department (s) / block (s), witness relevant operations and to self certify that he has understood the contents, operations and requirements as per the format Personnel Training
5.4.2.4 At the end of training evaluation is made by conducting written test as per format Personnel Training.
5.4.3 Manager and above
5.4.3.1 New employees are required to read all standard operating procedures and documents relevant to their department (s) / block (s), witness relevant operations and to self certify that they have understood the contents, operations and requirements as per the format Personnel Training
5.4.4 At the end of training period the head of the department (s) / block (s) or designee will review ability to manage the particular department.
5.4.5 Quality Assurance department shall maintain the Job oriented training records of all the departments.
5.5 Contract Employees
5.5.1 The training procedure shall be carried out same as 5.2.
5.5.2 Quality Assurance department shall maintain training records.
5.6 Duration of training
5.6.1 Induction training - 1 – 2 Days
5.6.2 cGMP Training - 10 to 180 Days
5.6.3 Job oriented training - 5 – 30 Days
5.6.4 On going training - No time limit
5.7 Failure in training (In case of new employee)
5.7.1 If a new employee is not found to have sufficient knowledge following an assessment of training, retraining is given at the end of Job oriented training. If this training is still unsuccessful the employee may be assigned task requiring lesser skills.
5.8 cGMP Training
5.8.1 Basic GMP training shall be imparted during Induction training.
5.8.2 Operation / system standard operating procedures shall be imparted during Job oriented training.
5.8.3 Training Co-Ordinator shall schedule the cGMP training for all employees module wise. At the end of each module employee shall be evaluated.
5.8.4 Training Certificate shall be issued as per format Personnel Training for the employee after successful completion of GMP training programs.
5.8.5 Refresher GMP training shall be conducted as and when required for all the employees. It is ensured that each employee receives refresher GMP training at least once in Year.
5.9 On Going SOP / Safety / Any other Training
5.9.1 This is a provision for additional training for employees due the following reasons, but not limited to:
5.9.1.1 Updated regulations
5.9.1.2 cGMP
5.9.1.3 Introduction of new documentation
5.9.1.4 New process controls
5.9.1.5 New SOPs or systems.
5.9.2 Training on block / departmental SOPs and systems is carried out by departmental head / block (s) or designates.
5.9.3 Skills up-dation training requirements are reviewed by head of department (s) / block (s) as a result of job change or promotion required for new job. This training may include internal or external courses to keep up to date with current technology or professional knowledge.
5.9.4 At the end of the training, assessment is made to check employee understanding of the subject and current requirements by conducting written test as per format Personnel Training
5.9.5 On going training needs shall be identified for each employee based on their responsibility by the departmental or block (s) heads.
5.9.6 Head- of the department (s) / block (s) ensure that employee is trained.
5.9.7 Safety training is carried out on need basis as and when required by the safety and Environment department. Services of external consultants may be utilized as and when required.
5.9.8 Any other training need arises due to the following reasons, but not limited to, shall be trained.
5.9.8.1 Out of product complaints
5.9.8.2 Non-conformances observed during external and internal audits
5.9.8.3 Deviations and other investigations
5.9.8.4 Trends of errors noticed by Quality Assurance during document reviews.
5.9.9 This training is carried out as and when required by the department / block-heads or designated Quality Assurance person or QA- Manager.
5.9.10 Training responsibilities are as follows.
5.9.10.1 Induction - Human Resource department
5.9.10.2 GMP - Quality Assurance department
5.9.10.3 Job Oriented Training - Concerned department (s) / block (s)
head (s)
5.9.10.4 Safety & Environment- Safety & Environment department
5.9.10.5 On going / Any other - Concerned department (s) / block (s)
5.9.11 External Training.
5.9.11.1 A copy of certificate issued for externally attended courses and / or any other relevant document shall be kept in the training file of the employee at the Quality Assurance department.
5.10 Method of training
5.10.1 Training shall be given by providing course material / Interactive sessions / Class room sessions / Practical sessions etc.,
5.10.2 An yearly GMP Training planner shall be prepared by the Quality Assurance Department in conjunction with all department / block (s).
5.10.3 For all training sessions an attendance record “Training Attendance form” as per format Personnel Training. shall be signed by all attendees.
5.11 Training Records
5.11.1 Quality Assurance department shall maintain all training records.
5.12 Selection of trainers
5.12.1 Trainers shall be selected based on the following, but not limited to:
5.12.1.1 Qualification
5.12.1.2 Training and experience on respective functions
5.12.1.3 Knowledge in the topic
5.12.1.4 Delivering the course content
5.12.1.5 Verbal skills
5.12.1.6 Ability to handle questions and comments in proper manner
5.12.2 Trainers list shall be attached to yearly GMP training planner.
5.12.3 Persons who prepared, checked and approved the documents/ procedures/ systems etc., will be the initial trainers.
5.13 Training Evaluation process
5.13.1 Qualifying marks shall be more than 75 %, based on the written test.
5.13.2 Failing to obtain 75 % marks calls for re-training and re-training shall be given in the next schedule.
END OF DOCUMENT
Quality assurance, personnel training,training, evaluating employees
