SOP For Training Of Employees

 

1.0              OBJECTIVE:

To lay down the procedure for training of all employees in the organization, to ensure that the employees are aware of their responsibilities and working procedure.

2.0              SCOPE:

This sop is applicable to all Employees in -----------------------------------------------------------

3.0              RESPONSIBILITY:

3.1              The responsibility of training files updating all the Employees personnel.

3.2              Originating Department Head responsibility for complies of the SOP.

3.3              QA Head and HR Head responsibility for updating Yearly Training Needs Identification as per new joining or replacement

4.0              ACCOUNTABILITY:               

4.1              QA Head accountable for implementation and compliance of the SOP

4.2              Concerned Department Head Accountable for all employee personnel update our training file

4.3              HR Head accountable for ensuring all employees update our file time to time and complies the SOP.

5.0              PROCEDURE:

5.1              Training shall be given to all the employees of the company as per respective concern work.

5.2              Training is divided into two types.

5.2.1        INDUCTION TRAINING – This type of training shall be given to employees on the joining day. It shall be given by respective Department Head. In this the person shall be introduced as per Standard Operating Procedure to all the Departmental Heads and shall be given general idea regarding the systems and functions. Induction of the Employee is recorded in Format No. F/PA-002-01

5.2.2        TRAINING BASED ON NEED IDENTIFICATION – After joining, the person is given regular trainings. It is divided into four types – General Training/ cGMP Training, Technical Training, On Job Training, and Safety Training EHS. It shall be recorded in Format No. F/QA–002–05 for attendance of people and Format No. F/QA–002–07 for Individual Training Record.

5.2.2.1  GENERAL TRAINING – General Training shall be conducted and arranged by HR Department. It shall be given once in 3 months. It shall cover topics like Motivation, GMP Management, Personal Hygiene, Exit & Entry Procedure, Good Housekeeping, Current affairs and trends in Pharmaceutical Industries.

5.2.2.2  TECHNICAL TRAINING– It shall be given once in 2 months. Technical Training shall include detailed knowledge about machinery, cGMP, SOPs, Calibration Process, Validation, Instrumentation, Computer, FDA Rules and Regulations etc.

5.2.2.3  ON THE JOB TRAINING- On job Training needs will be identified as per format no. F/QA-005-01 and given to all the employees. It covers new employee or during any change in job description. It shall be conducted every month or as required by concerned Department heads/Trained person.

5.2.2.4  EHS TRAINING – Training to be arranged by EHS/HR Department as per Planner. It shall be given quarterly or as when required. This training shall include safety measure, environmental and health related etc.

5.2.2.5  PLANNER FOR TRAINING SCHEDULE:

Yearly training planner: Training planner for the year for General Training, Technical Training & EHS Training shall be prepared as per format number F/QA -002-08.

On job training planner: Training planner for on job training shall be prepared as per format number F/QA-002-01.

5.3              TRAINING TO OUTSIDE CONTRACTORS: Training shall also be provided to the Outside agencies (Contract employees) on safety and hygiene related topics as and when required.

5.4              TRAINING BY EXTERNAL TRAINERS: Any training given by the External Trainer is categorized under this. Topic, date, time and venue shall be decided as per the suitability. Training shall also be provided by the External trainers on technical topics like validation and qualification, safety and hygiene related topics as and when required.

5.5              CRITERIA FOR SELECTION OF TRAINER:

5.5.1        Persons having experience in their related working area.

5.5.2        Persons who have been imparted training should have knowledge about the Current Good Manufacturing practices and regulatory affairs.

5.5.3        Trainer should have training in the respective topic before imparting training to the other. Note: “List of approved trainer” shall be maintained in QA department as per format No. F/QA–002–04, approved trainer shall be selected by HOD & Plant Head & issue the “Certificate for Approved Trainer” as per format no. F/QA-002-06 which shall be maintained by QA department.

5.6              According to the list of topics and types of Training, a yearly planner shall be made by QA Department in Co-ordination with other Department Heads. After getting the yearly planner from each department the immediate supervisor shall identify the training needs for different levels as per format no. F/QA-002-02.The head of the department shall review it and forward to the HR Dept to conduct/arrange the training. Based on the training needs, team is identified for each type of training as per format no. F/QA-002-05 by the respective Head of the Department.

5.7              Training shall be performed as per the Yearly Planner except On Job Training. Intimation shall be made in advance to the concerned department through circular regarding the Topic, Date, Time or any change in schedule.

5.8              Training shall be given by methods like - giving lecture, holding a group discussion.

5.9              Training Attendance and evaluation Record is maintained in Format No. F/QA–002–05 and maintained with Quality Assurance Department. Induction Training Record shall be available with Personnel Department in the individual’s file.

5.10          Training Evaluation - After training is conducted the person shall be evaluated with respect to Training imparted.

5.10.1    The effectiveness of the training shall be evaluated by a written test in questionnaire as per Format No. F/QA-002-03 and the attendance and evaluation record of all trainees are maintained as per Format No. F/QA-002-05.

5.10.2    Assessment shall be done against the standard answer sheet by the Trainer.

5.10.3    The qualifying marks for any training shall be NLT 80%. If anyone secures less than 80%, a retraining shall be given to them. Concern dept will prepare the list of the trainee who had not qualified in the training as per the Format No. F/QA-002-05. Once more the training shall be conducted /arrange by HR Dept.

5.11          TRAINING OF SENIOR STAFF:

5.11.1    Training for senior staff (Assistant Manager & above) may be conducted through discussion with senior staff (current guidelines, Quality initiatives) / self reading (Standard Operating Procedure), in this case trainee shall be fill attendance sheet as per format number F/QA-002-05 .There is no need to fill Questionnaire for evaluation (if trainee wishes, trainee can fill the  Questionnaire for evaluation).

5.11.2    Before imparting training to any topic to other employee trainer shall assure for the completion of their training on the said topic, trainer can complete training through Self reading, any body shall evaluate their questionnaire with standard answer sheet.

5.12          Retraining shall be conducted and verified in following cases.

                        5.12.1  It shall be given when employee doing repeatedly mistake related to the assign job.

                        5.12.2  In case employees come back from long leave and join the company.

                        5.12.3  It shall be given to employee for enhance the knowledge about assign job.

                        5.12.4  If any one secures less than 80% for that Topic then retraining shall be given before he / she appears for further training records are maintained format no. F/QA -002-03.

5.13          All the records of Training are reviewed by the Quality Assurance Department & submitted to the HR Department.

5.14          Individual training records are prepared & maintained by HR dept for staff only as per format no. F/QA-002-07. At the end of the year the Individual training sheet reviewed by concerned dept. head and finally submitted in QA dept for record purpose.

5.15          ABSENTEEISM: In case of any employee is absent during a particular training as scheduled, then that particular training shall be provided to him/her along with the next training programmed.

5.16          Certificate of Training as per Annexure 1.

5.17          ACCEPTANCE CRITERIA: All the trainees should secure 80% marks for qualifying in the training programmed for respective topic.

5.18          FREQUENCY: The frequency will be as mentioned below:

·      During any change in job description

·      As per scheduled training plan

6.0              LIST OF FORMATS:                       

Sr. No.	Title of Format	Format No.
	Yearly Training Needs Identification List	F/QA-002-01
	Training needs identification	F/QA-002-02
	Questionnaire for Training Evaluation	F/QA-002-03
	List of Approved Trainer	F/QA-002-04
	Training Attendance  And Evaluation Record	F/QA-002-05
	Certificate of Approved Trainer	F/QA-002-06
	Individual Training Record	F/QA-002-07
	Training planner for the year	F/QA-002-08
	Induction Training Form	F/QA-002-09
	Certificate of Training	F/QA-002-10

 

7.0              REFERENCES:

7.1              SOP-QA-001

7.2              F/QA-001-01

7.3              SOP-QA-014

 

8.0              ABBREVIATIONS:

Sr. No	Abbreviations	Details
	SOP	Standard operating procedure
	HR	Human resources
	QA	Quality assurance
	EHS	Environment, health and safety
	DEPT.	Department

 

 

 

 

 

 

 

 

9.0              REVISION HISTORY:   

Sr. No.	Date	Reason for Revision	Revision No
1.	31/10/2018	New SOP	R0
2.	31/10/2020	Schedule Revision	R1

 

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