Employee Training

Employee Training

1.0       OBJECTIVE 

To ensure that all the employees have the knowledge and skills necessary to perform there assigned duties and responsibilities consistent with the current Good Manufacturing Practices (cGMP). 

2.0       SCOPE          

This SOP is applicable to all the employees of Company,

3.0       RESPONSIBILITY

All the department heads and Training Coordinator, QA Head shall be responsible for training programme in the factory.

4.0       PROCEDURE                       

 4.1      REQUIREMENT OF TRAINING:

It is necessary that all the employees at the plant have an appropriate combination of education, training and experience to enable them to perform their assigned functions. Therefore a training program covering the following aspects shall be designed for all the employees.  

4.1.1        cGMP training shall be given as per the nature of job to all employees, twice a year criterion.

4.1.2        In house qualified individuals and external faculty shall conduct training. The trainer will make the training material (such as power point presentation).

4.1.3        The HOD shall prepare ‘Identified Training needs and Schedule’ for individual employee refer as per Annexure-VI, X.

4.1.4         Training coordinator shall maintain employee training record and the training given in the course of employment as per Annexure-IX

4.1.5        For every training coordinator shall maintain attendance record duly signed by trainees.

4.1.6        Each training shall be concluded by written or verbal evaluation.

4.2       QUALIFICATION FOR TRAINERS:

4.2.1        The basic qualification for the trainer is compliance to one or more of the following    criterion.

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

4.2.3        Good communication skills in both writing and oratory sound knowledge in the relevant field.

4.2.4        Certified or qualified to impart training in the specific subject

4.2.5         As per Annexure-VII shall be used for documentation of Trainer qualification

4.3              TRAINING OF NEW RECRUITS:

4.3.1        INDUCTION PROGRAM:

4.3.1.1 Every new employee shall be given induction training with a view to facilitate entry into the organization and to explain with the systems and procedures applicable.

4.3.1.2 During the induction training all new employees shall be formally inducted to the company. The Training Coordinator & HR and the QA Heads shall be responsible for training the employees at this stage.

4.3.1.3 During induction training, the employees shall receive instructions in the   following areas as appropriate

a)      General GMP

b)      Good Documentation Practices

c)      Entry / Exit Procedure and controls

d)     Cross contamination & mix up

e)      Tablet and Capsule

f)       Ware housing

g)      Utilities & Planned Preventive Maintenance

h)      Quality Control 

i)        General Health and Industrial Safety

4.3.1.4 The induction training shall be carried out in accordance with the schedule specified and the details of training imparted shall be recorded by the training coordinator in ‘Induction Training’ record. Refer the Annexure-I, II.

4.3.1.5 At the end of the induction training, the evaluation shall be done as per ‘Induction Questionnaire’. Refer the Annexure-III.

4.3.1.6 After completion of the induction training, department head shall prepare “Identified Training needs and Schedule” for the new employee and copy of the same is with department head.

4.3.1.7 The questionnaire related to topics mentioned in “Identified Training needs and    Schedule”.

                                             -  Induction training refer Annexure-III

         -  General GMP: Printed copy available with QA along with questionnaire.

                                             -  QA SOP (Critical) questionnaire if require with QA department

                                             -  Departmental SOP questionnaire if require with respected department.

4.3.2    EVALUATION

4.3.2.1 The effectiveness of training shall be evaluated by written test or by verbal evaluation. Trainee shall write the answers in the stipulated time period or can answer verbally.

4.3.2.2 Trainer shall evaluate the trainee based on the marks scored by him/her. The details of evaluation shall be recorded in ‘Training Evaluation Sheet’. Refer Annexure-V.

      Criteria for evaluation                     Grades

100%                                       Excellent

 > 90%                                    Very good

80-90%                                   Satisfactory

< 80%                                     Poor and Retraining required

4.3.2.3  All the training evaluation sheets should be reviewed and signed by QA    personnel.

4.3.2.4  Unsuccessful employees (< 80%) shall be retrained immediately as per Annexure-VIII. 

            4.3.3    ON THE JOB TRAINING

4.3.3.1 After completion of induction and orientation programme new employee shall be sent to respective departments for under going on job training.

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

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

4.3.3.4 Only successful employee shall be allowed to perform his assigned duties and responsibilities as per annexure-XI.

4.3.3.5 On job training shall be documented in Annexure-IV

                        4.3.4    EVALUATION

                                    4.3.4.1 Refer point no. 4.3.2 for Evaluation Criteria.

Note: For on the job training (Standard Operating Procedure) Evaluation criteria shall be not less than 100 %

4.3              TRAINING IN THE COURSE OF EMPLOYMENT

4.4.1    In-house training or training from outside faculties including seminars shall be organized as per the training plan / card. For any training outside the scope of training card shall be given by external faculty or consultancy by training institution and shall be recorded in as per Annexure-IX.

4.4.1.1 In addition to the training imparted based on the “Identified Training needs and Schedule” shall be given in the event of following:

a)      Introduction of new Quality Assurance SOP

b)      Revision of SOP

c)      Observations of Audits

d)     Explanation of incidence

e)      Sharing investigation finding

4.4.3    The details of training programme conducted shall be recorded in ‘Training Record’. Refer the as per Annexure-IX.

4.4.4    The details of training given as recorded in the Training Record Annexure-X and the training Evaluation result record shall be posted in the format as per Annexure-IX.

4.4.5    Training Record as per Annexure-IX shall be filed in a separate file for training imparted in the course of employment.

4.4.6    As and when required the personnel shall be sent for attending training programme conducted by external training institutions, manufacturers of machineries, equipment, etc.

4.4.7    The individual after attending the external training shall submit the training report along with hand out & documents received during training to QA for record.

                        4.4.2    EVALUATION:

                                    4.4.2.1 Refer point no. 4.3.2 for Evaluation Criteria.

4.5       SELF TRAINING RECORD

4.5.1    Details of all the training Programmes attended by trainees shall be entered in training record (Annexure-IX) and photocopy of the same to be filed in Individual Training Record.

4.5.2    Individual training schedule for complete year to be prepared and enter in Individual training schedule record. (Annexure-X)

                        4.5.3    The following details shall be entered in the training record, 

1.            Topic

2.            Trainer

3.            Date, Time, From, To, Duration

4.            Venue

5.            Mode of training

6.            Details of participants

7.            Trainer, Name, Sign, Date

8.            Reviewed by (Training co-ordinator) Name, Sign, Date

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

5.0       ANNEXURES

            Annexure-I: Personal information

            Annexure-II: Induction training and orientation programme.

            Annexure-III: Induction training questionnaire. 

Annexure-IV: On job training record.

Annexure- V: Training questionnaire Format and evaluation format.

Annexure-VI: Identification of training needs.

Annexure-VII: Trainers Qualification.

Annexure-VIII: Retraining.

Annexure-IX: Training attendance sheet.

Annexure- X: Training Calendar.

6.0       REFERENCES:

            SOP-QAD-001-02

7.0       ABBREVIATIONS:                         

Abbreviation used           Full form of abbreviation used

SOP                                 Standard Operating Procedure

QA                                  Quality Assurance

QAD                               Quality Assurance Department

HR&A                            Human Resource and Administration

QCD                               Quality Control Department

No.                                  Number

c-GMP                            Current Good Manufacturing Practice

HOD                               Head of Department

Sign                                 Signature

8.0       DISTRIBUTED TO:

Quality Assurance Department

Quality Control Department  

Warehouse Department

Manufacturing and Capsule Department

Human resource & Administration Department

Engineering Department

9.0       REVISION HISTORY

Revision Number	Change control No.	Reason for the Modifications