Training SOP

1.0 OBJECTIVE

To lay down a procedure for training of new employee and periodic retraining of technical staff.

2.0 SCOPE

This procedure is applicable to all employees present in the departments of XXX, Place

3.0 RESPONSIBILITY

3.1 Head-Department - Identification of Training needs

3.2 Head-QA - Plan and ensure training schedules.

4.0 PROCEDURE

4.1 Qualification For Trainers

4.1.1 Necessary education with minimum 5 years of total experience in the relevant field in which training is being imparted.

4.1.2 Good communication skills and sound knowledge in the relevant field.

4.1.3 Certified or qualified to impart training in the specific subject.

Annexure-1 shall be used for documentation of Trainer qualification.

4.2 Induction Training

4.2.1 Head-Administration shall fulfill the general requirements of new recruits as per Annexure-2 and then introduce them to all the department heads in the factory and fill the form (Annexure-2) and send them to Quality Assurance department.

4.2.2 New recruits after introduction shall go to Quality Assurance department for technical training, this programme shall be documented in Annexure-2.

4.2.3 After completion of induction and orientation programme, new employees shall be sent to respective departments for undergoing onjob training.

4.2.4 Initially the senior technical personnel would explain the procedure, steps involved, precautions to be taken and would perform the activity with the new recruit observing.

4.2.5 After a minimum of three such sessions or as and when the trainer is confident of new recruit’s performance, the new recruit would perform the activity under the observation of a senior technical personnel.

4.2.6 After successful completion of onjob training new recruit is eligible to perform the job individually. Onjob training shall be documented in Annexure-3.

4.3 Requirement of Training, & Retraining

4.3.1 Training is required in any one or more of the following conditions

4.3.1.1 All new recruits.

4.3.1.2 New job responsibility(s)

4.3.1.3 Any change in policy matter & regulatory matters.

4.3.1.4 Any new procedure or a change in existing standard operating procedure.

4.3.2 Training to be conducted for all the new procedures before it is implemented. Original copy of the training record shall be attached with the master SOP.

4.3.3 Training shall also be given for any changes made in the SOPs before making the affected SOP is effective. If the SOPs are reviewed on periodic basis without any change, in such cases training need not be essential. Original copy of training record shall be attached to master SOPs.

4.3.3.1 All identified training needs as per job responsibilities, included as curriculum of the individual to be trained once in a year

4.3.3.2 Training shall be given to all the employees who are involved directly on the job and persons who are supervising the activities.

4.3.3.3 SOP training shall not be specific wherever the type of operations carried out are similar, in such case one relevant SOP shall be sufficient to cover all such SOPs.

4.3.3.4 Additionally the managers shall also be given training on the SOPs in the relevant areas and GMP every one year.

Document the training activity of each individual in Annexure-4.

4.4 Requirement of Retraining

4.4.1 Retraining is required in case of failure to secure qualifying Marks(85%) in the evaluation. A minimum of 85% marks is required for the person to be considered as qualified. In some instances 85% marks will not be considered as qualified if the personnel fail in some critical questions.

4.4.2 Once in six months retraining shall be conducted for all operators of

Aseptic processing area, Optical inspection, staff of Production, QA, QC, maintenance and Warehouse on cGMP. Frequency of cGMP & SOPs training shall be once in a year.

4.4.3 If the trainee remains absent or is not able to attend beyond the 30 days period, then Department Head in coordination with Head-QA shall ensure that the individual is given retraining within a week after rejoining duties before attending to the job.

4.4.4 Retraining for Failure on the job

4.4.4.1 Proven inconsistent performance of an employee.

4.4.4.2 Proven low or no understanding of the job assigned or performed as discussed in his/her job description.

4.4.4.3 Failure to execute the functional responsibility with in the specified.

4.4.4.4 For all above reasons the individual shall be taken out of operation, retrained, and qualified, shall only be allowed toperform his/her function.

4.4.4.5 In case of repeated failure (Failure within three month of retraining) department Head shall review with the individual and allow for retraining after counseling, and if qualified is allowed to perform his function.

4.4.4.6 Document the retraining activities in Annexure-6.

4.5 Method of Training

4.5.1 A training programme shall be established for each employee covering all process tasks and activities carried by the employees.

4.5.2 Depending upon the nature of work the personnel involved are divided into different groups and accordingly the training programme is designed.

4.5.3 Training schedule shall be drawn to all employees independently.

4.5.4 If any employee is unable to attend the training on planned date, alternate date shall be chosen for providing training to such employees before the next months schedule.

4.5.5 Training method includes: Class room – lecture, power point presentation, on job training, video presentation, Educational materials / Handouts, or any combination thereof.

4.5.6 Evaluation of trainees shall be done, if required, through questionnaire or viva and details of evaluation shall be entered in training evaluation record-Annexure-5 or annexure-11. Each new recruit shall undergo training before he/she puts on the job.

4.5.7 Minimum percentage of marks to be scored for qualifying the evaluation is 85%

4.5.8 Use Annexure-5 for preparation of questionnaire or use annexure-11 for oral explanation by practical approach method of evaluation.

4.5.9 For staff training and evaluation shall be English, and for workers either Telugu (local language) or English

4.6 Identification of training needs and preparation of yearly training schedule

4.6.1 Department Head shall identify the training needs of individuals once in a year and shall inform to Head-QA.

4.6.2 Head-QA shall prepare yearly training schedule as per the training needs of all the individuals.

4.6.3 Document the training needs in Annexure-7 and yearly training schedule in Annexure-8

4.6.4 Based on the training needs identified and finalized by department head the Individual training need shall be prepared for each employee for cGMP and SOPs.

4.7 Selection and nomination of External Training programmes

4.7.1 Selection

4.7.1.1 Department head shall evaluate the relevance and proficiency of the external training programme on following basis.

4.7.1.2 Educational Qualification, experience and expertise of the trainer in the field under consideration.

4.7.1.3 Review of course content through brochure, pamphlet or interaction and decide its relevance to our type of operation.

4.7.1.4 Training profile of the institute and or the trainer.

4.7.1.5 Opinions of common resource either internal or external about effectiveness of the programme offered.

4.7.2 Nomination

4.7.2.1 Department Head shall nominate eligible personnel based on the need and relevance of the course.

4.7.2.2 Head-QA shall seek necessary approvals for participation from Managing Director or Director (technical) or his or her designee.

4.7.3 Review

4.7.3.1 Participant on return shall hand over a copy of the training material to the Training department.

4.7.3.2 Participant would give a presentation to the relevant group about the learning from the training session.

4.7.3.3The outcome and review of external training shall be documented by the participant in Outside / Inside training feedback-cum-evaluation report-Annexure-9. Department Head shall review with the individual and sign the report with his comment if any.

4.8 Individual Training Record

4.8.1 Details of all the training Programmes attended by trainees shall be entered in Individual training record. (Annexure-3).

4.8.2 Individual training schedule for complete year to be prepared and entered in Individual training need identification (Annexure-10).

4.8.3 A file for each employee shall be maintained with all the details of schedules, training records and evaluation sheets.

4.9 Yearly Training Manual

4.9.1 Yearly training manual to be prepared by training department covering the following.

4.9.1.1 Number of employees in the plant requiring cGMP training.

4.9.1.2 Contents of cGMP training.

4.9.1.3 Time required covering the training programme.

4.9.1.4 Qualification & experience of the trainer.

4.9.1.5 Frequency of training & retraining of employee.

4.9.1.6 Recording methods of training.