TRAINING PROGRAMME AND MANAGEMENT
PURPOSE : To lay down a procedure to conduct training of working personnel at all levels and its evaluation.
SCOPE : This SOP shall be applicable for all employees working in this company.
REFERENCE (S) :
A WHO guide to good manufacturing practice (GMP) requirements.
ASEAN-TMHS-GMP-Training-Chapter-5-Documentation.
PIC/S PE 009-14
CROSS REFERENCE DOCUMENTS
Job Responsibility
Attachment/Format/Annexure Title
- Annual Training Calendar
- Trainer Evaluation Record and Certificate
- List of Internal Trainer or Departmental Training Coordinator
- Training Circular
- Training Attendance Sheet
- Induction Training Form
- On The Job Training (OJT)
- Training Feed Back
- Training Need identification
- Individual Training card
- Training Questionnaire and evaluation sheet / Questionnaire Answer sheet
- Destruction Record of Training
DEFINITION
Employee Training record: It is a record of training activities that employees has undergone.
Transferred Employee: A person transferred from Unit-I to Unit-II such employees shall be treated as a new employee.
Trainee: The person who is being trained on specific subject or activity.
Training: A process that involves the acquisition of knowledge, skills, concepts, rules, procedures, processes etc. Thus, personnel remain competent to perform the task(s) assigned.
Induction training: Training of an employee to introduce/understand the organization systems and policies is termed as Induction Training. A training which includes familiarization of general concepts like organizational structure, rules & regulations, basic concept of cGMP, EHS, facilities, introduction with personnel in various departments Does and Don’t etc.
GMP Training: Training which is given to employee after completion of induction training at the time of joining the organization or during the Job rotation or assigning new task. This training shall include SOP training and Technical skills training.
Awareness Training: Training given to employee on particular topic for awareness purpose only.
On the Job training (OJT): Training conducted at Department where that particular activity is being done shall be termed as OJT.
External Training: Any training / seminar / conference, which is conducted outside the location or by an external faculty is termed as external training.
Training Coordinator: An individual who manages the training program. Departmental TC executing the training program in their respective department.
Training Need Identification (TNI): Training need identification is a list of SOPs that will be identified for employees based on work allocation and job description before plan training. Training shall be conduct of all new employees of all identified SOPs before work allocation.
Refresher Training: The Refresher Training is a training programmed designed for the old or existing employees of an organization, with a purpose to acquaint and update with his/her JD related work to improve their performance or consistency on the jobs.
RESPONSIBILITY
Departmental Training Coordinator(DTC) shall be responsible for:
All departmental training coordinator shall be responsible to maintain their individual training Card.
All DTC shall responsible to submit training calendar and trainer list to QA department.
All DTC or Trainer shall be responsible for evaluation of questionnaire, completeness of employee training, individual cards and feedback form.
Trainer shall be responsible for preparation and Updation of list of certified trainer/ DTC.
QA shall be involved in the certification procedure of trainer.
All employee shall be responsible to follow the procedure in the SOP.
Departmental Head/ training coordinator shall be responsible for compliance of training as per mentioned procedure in the SOP.
Plant Head & QA Head shall be accountable for overall compliance of the SOP.
PROCEDURE
Every employee of the organization shall be trained on his area of operation prior to start the work. The training shall be imparted depending on the nature of job and responsibilities and the cGMP, Health & hygiene, GDP and data integrity and data reliability training is mandatory to all employee / staff in each department.
Training Procedure
The training needs shall be based on the criticality of the operation performed by the employees working in different areas.
Training coordinator of concerned department shall prepare training need identification of individual employee of his/her department with the help of his department head and forward to QA Department. The training need identification shall be primarily based on the scope of cGMP and technical aspect related to the operational area.
At the start of year concerned department Head/Designee/ DTC/ Trainer shall prepare TNI for existing employees on the basis of employee status assessment. The same shall be informed to training coordinator QA. The training coordinator informed to QA Head for identification of general training needs as per Document the training needs.
DTC Prepare an Annual Training Calendar on the basis of current TNI which shall include the aspect of cGMP and Technical training related to work area.
The Annual Training Calendar shall be reviewed by Head of concerned department after review forward to QA for approval.
One week prior to execution of training, the concerned HOD/designee shall circulate the circular either via mail to all interlinked department about the topic of training, date and time of Training session, so that concern department can plan accordingly the activities of their employees.
Trainer shall prepare the power point presentation or hard copy of training material for the training session.
On the identified training topic, trainer shall prepare the training materials.
All training records with training materials shall be submitted by DTC personnel to QA documentation.
All employees who participate in training shall bring their individual training card at the time of training and update the same after training imparted.
Individual training cards are only for payroll employees / staff it shall not applicable for contract workers.
All the coordinator (TC) shall be responsible to maintained and update individual training card after each training programme and review at the end of each month in his/ her department for completeness.
The training planned date is pre-printed in training calendar and the training execution will be ± 7 Days of training planned date as per the approved training calendar.
Selection of Trainer
Internal trainer from different departments shall be identified based on his / her qualification, communication / presentation skills, experience, knowledge and expertise or combination thereof in the different areas of operation.
For class room training, identified trainer shall conduct pre-certification training on the identified topic based on his / her area of expertise, on the basis of training the trainer shall be evaluated and certified on parameters as detailed in detailed.
QA personnel shall prepare list of internal trainers, which shall be approved by Head – Quality Assurance. The list shall be updated as and when required.
If trainer is absence for training programmed then his/her designee shall be responsible for conduct training as per the approved training schedule.
Prior to start of the training the participants shall fill their attendance sheet as per Attachment-V.
Types of Training : The types of training are divided into two major categories as mentioned below.
- Internal Training
- External Training
Planning and Execution of Internal Training
Internal training is the training which shall be conducted within the organization by internally certified trainers only. Internal training is of four main categories as mentioned below:
- Induction Training
- cGMP/QMS/GLP
- On the Job Training (OJT)
- Refresher / Re-training
Induction Training
Training which shall cover the overview of organization, units, company policies and departments called induction training.
The induction training shall be imparted to every new employee, who joins the organization.
Induction training shall be coordinated by HR department.
Initial induction training is carried out by HR department, which cover topics like
Organizational Structure
Key personnel and organization structure of various departments
Product range
HR policies e.g. shift timing, leave policy and other employee benefit policies.
As per the induction training schedule, the new joinees shall go to applicable departments for the interaction with concerned HOD and staff members.
HOD of various departments or his / her designee shall brief to the new joinee about their departmental structure, departmental functions.
Induction training shall be conducted for 1st day from the date of joining of the new joinee by HRD.
cGMP : cGMP training covers minimum following Sops (Sop On Induction & Behavioral, Sop On Personal Hygiene, Entry And Exit Procedure For Production Area, Documents And Data Control Procedure, Good Documentation Practices, Change Control Procedure, Handing Management And Investigation Of Deviation, Data Integrity And Data Reliability and CAPA )
NOTE: – Employee Joined In Q.C GLP Training Is Mandatory.
Technical training is the training which is designed to develop specific and cross functional skill and to update the technical knowledge.
cGMP/ QMS/ GLP training shall be conducted every new joined employee after induction training and cGMP/QMS/GLP training existing employee per Calendar or whenever needs identified.
cGMP training shall be mandatory for all new joinees within a month of joining.
The cGMP at induction training shall be conducted by trainer as class room training.
Different training sessions shall be conducted for Level – 1, Level – 2 and Level – 3 employees. The levels details are as follows:
- Level – 1: Includes from Asst. staff and above.
- Level – 2: Supervisor and Machine Operators.
- Level – 3: Workmen and Housekeeping staff.
The scope of cGMP / Technical training includes but not limited to the following topics:
Basic cGMP aspects requirement.
Other as identified during the routine operation.
Based upon the topic of training program if required, evaluation shall be done through questionnaire.
After completion of the GMP/QMS/GLP training, specimen of full signature and initial shall be recorded in the specimen signature log available in QAD and job responsibility shall be finalized at the end of the day of Induction training by concern department head/designee.
Photocopy of job responsibility shall be attached to the training file of each employee/staff.
On the Job Training (OJT)
On the job training shall include the in-depth training in the concerned and cross functional departments of the new employees / existing Employee / Staff and other as identified.
On the job training shall be imparted to all the new Joinee / existing employees / staff by the concerned HOD or his/ her designee related to the area of operation. This training program shall include the training related to the specific aspects of an individual’s role including use of equipment, unit operations, safety norms to be followed and adherence to cGMP as per Attachment-IX.
OJT shall be given to concern employees at work place by HOD/ designee / DTC / TCQA.
The mode of imparting training shall be through Standard Operating Procedures, Cleaning Procedures, Operating Instructions, Preventive Maintenance Procedures and Practical Assessment wherever possible.
Concerned HOD / designee shall prepare the detailed schedule for On Job Training (OJT) based on the assigned job responsibilities and record as per Attachment-IX.
Training on the required SOP to the operator / worker shall be imparted by the concerned area HOD/ designee / DTC/Trainer.
After approval of any new / revised SOP the training shall be imparted by the concerned user department to concerned persons before implementation of new / revised SOP.
If any employee is transferred from one area of operation to other area of operation within the department, training on related SOPs shall be imparted to the employee.
Routine training of SOP shall be imparted to the employees as on job training.
HRD shall conduct expert trainings on firefighting, first aid and handling of emergency situations as and when required and attendance shall be maintained in Attachment No.-V
Refresher Training
Refresher training shall be carried out as per ongoing training calendar, and whenever there is a procedural change or revision in the SOP.
Training provision for those person who resume office after more than 30 days leave or after long medical leave shall be carried out as per the ongoing training calendar, and on the basis of evaluation their status assessment.
All employees shall undergo Refresher training on the procedures of their respective functions and related or cross functional department processes, wherever needs identified.
Awareness training
Awareness training given to employee on particular topic for awareness purpose only and there is no need of evaluation of participated employee.
External Training
Any training / seminar / conference, which is conducted outside the location or by an external faculty is termed as external training.
After attending the training program at outside, employee/ staff / trainer shall give same training to all concern person and attendance shall be recorded.
Evaluation
The evaluation shall be conducted for each type of training except the external training by the means of questionnaire.
The questionnaire shall include questions related to training topic and the questions shall be of objective types as well.
If the scored marked is less than 80% or fail, then the employee shall be retrained & re-evaluated.
Evaluation of re-training shall be done and same shall be recorded in training record.
A person shall be allowed to work in the respective area after successful re-evaluation.
Documentation
All DTC will confirm the completion of training of all employees and related documents.
If any employee leaves the organization, then his training records shall be maintained for a minimum period of five years from the date of relieving of the employee. Subsequently the records shall be destroyed and recorded.