1.0 OBJECTIVE
1.1 To describe the procedure for training and development of all the employees.
2.0 SCOPE
2.1 This procedure is applicable to all the employees of the plant.
3.0 RESPONSIBILITY
3.1 Human Resources (HR) Department is responsible for:
3.1.1 Identifying and communicating with the faculties in consultation with head of the departments.
3.1.2 Providing necessary infrastructure for training programs.
3.2 Department Heads are responsible for:
3.2.1 Identifying the training needs of the personnel of their department.
3.2.2 Ensuring that the employees in their departments are adequately trained and evaluated.
3.2.3 Ensuring their personnel are completing training programs as per schedule.
3.2.4 The department head in concern with respective individual shall maintain the training records for individual employees.
4.0 ACCOUNTABILITY
4.1 Head –HR shall Accountable for compliance with this procedure.
5.0 PROCEDURE
5.1 Types of Training
5.1.1 There are various types of training that employee may require to undergo, which may include the following:
Induction Training
Job Related Training
Off Job Training
GMP Training
Annual Training
Unscheduled Training
5.2 Induction training
5.2.1 Human Resource Department shall organize Induction Training programs for new recruits.
5.2.2 This training shall be conducted immediately after the employee is reporting to duty.
5.2.3 During the induction training, the new employees shall be made aware of the company’s objectives, rules and regulations, safety policies, health and hygiene, general maintenance of cleanliness in factory premises, products and the company work systems relating to actual work, cGMP and cGLP statutory requirements.
5.2.4 During site round, conduct an introductory meeting with respective departmental head and departmental staff.
5.2.5 This training should be completed before the individual is allowed to enter, unsupervised or work independently.
5.2.6 The induction training report shall be prepared and maintained in HR department as per Format ‘Induction training record’ Format
5.3 Job Related Training
5.3.1 This training shall be given through written procedure viz.-SOP. This training should be related to specific aspects of an individual’s role. It is important that during workplace related training the relevant aspects of GMP are reinforced and explained.
5.3.2 The head of the department is responsible for organizing the On the Job training to each individual.
5.3.3 Department head shall decide an identification of the training required for each employee. The criteria shall be, need of person to be trained and job work to be allotted in future.
5.3.4 The concerned Department Heads or Designee shall give training which shall include operation/maintenance/calibration/cleaning equipments/instruments, handling various operations, recent developments, updates in functional area etc.
5.3.5 Respective department head shall maintain SOP training record as per Format ‘SOP Training Record’, Format
5.4 Off Job Training
5.4.1 This training shall be carried out in class room/conference room/training hall.
5.4.2 The Human resource head is responsible for organizing the off job training and Department head shall decide an identification of the training required for each employee.
5.4.3 Different aids like power point presentation and video may be used for the effective understanding of the subject.
5.4.4 Training attendance shall be recorded as per format for ‘Training Attendance Record’ Format No.
5.4.5 Immediately after the completion of training, personnel are evaluated to know the extent of training understood.
5.5 GMP Training
5.5.1 Quality Assurance Department is responsible for organizing GMP training.
5.5.2 This shall include training on Quality Assurance Procedures, Regulatory Guidelines, Good Laboratory Practices, Good Engineering Practices, Good Warehousing Practices, Personnel Hygiene etc.
5.5.3 GMP related training should be at least once in year
5.5.4 The training coordinator shall intimate the concerned departments for attending the training program
5.5.5 Training attendance shall be recorded in the format ‘Training Attendance Record’ Format
5.5.6 Different aids like power point presentation on cGMP may be used for the effective understanding of the subject.
5.5.7 Immediately after the completion of training, personnel are evaluated to know the extent of training understood.
5.5.8 GMP training records shall maintain in Quality Assurance Department.
5.6 Annual training
5.6.1 QA head shall prepare Annual Training Calendar in which all topics related to cGMP, GLP, Quality Management and Quality Functions, Safety, Regulatory Requirements.
5.6.2 Training calendar shall be maintained by QA Department as per Format ‘Annual Training Calendar’, Format
5.6.3 QA Head shall conduct the training in coordination with HR as per Annual Training Calendar. (Note- If there is any change in Training topic/ training date due to change in work environment, QA Head/Designee shall intimate to concern departments).
5.7 Unscheduled Training
5.7.1
In addition to the training imparted based on the Annual Plan training shall be given in the event of following:
Introduction of new Standard Operating Procedure (SOP)
Changes in SOP
Observations of Audit
Training on nonconformance
Training on any changes or modifications
5.8 Re-Training
5.8.1 If there is evidence that previous training has not been effective in providing the individual with the competence to perform their role to the required standards, then retraining is necessary. If despite repeated training, personal fails to meet the required standards he/she shall not be permitted to work in critical areas.
5.9 Internal Trainers
5.9.1 Internal Trainer Qualification:
5.9.1.1 The Internal Trainer shall be evaluated based on his/her
a) Knowledge
b) Earlier experience
c) Qualification
5.9.1.2 Internal Trainer evaluation shall be performed by quality assurance head as described in Format ‘Trainer Evaluation Form’ Format
5.9.1.3 After primary evaluation, if required training shall be imparted on areas for development. Records of training shall be maintained.
5.9.2 After qualification of trainer, QA Head shall prepare trainer qualification certificate as per Format for ‘Trainer Qualification Certificate’, Format
5.9.3 Trainers shall organize the training materials and methodology suited to the training objectives and trainer shall obtain feedback from course attendees in order to improve effectiveness of training skills and materials.
5.9.4 Quality Assurance shall prepare and maintain the List of Internal Trainers as per format ‘List of Internal trainers’ Format
5.10 Identification of Training Needs
5.10.1 Each Head of the Department identifies the training needs of all the employees.
5.10.2 The training categories are as follows.
Quality Aspects
On the job training / SOP’s
GMP/GLP Training
Trainings of QA Systems
Other than GMP subjects like communication skill development, Leadership, Motivation, Team building, Safety, First Aid.
5.11 Internal Training Program
5.11.1 The human resource head informs the concerned faculty for the dates on which they are supposed to give training.
5.11.2 The human resource head informs the concerned employees about their schedule of training program in advance.
5.11.3 Wherever required, the training faculty distributes subject material during training. This module shall be approved by the respective department heads, in case of technical training.
5.11.4 The list of employees and their signatures are recorded in ‘Training Attendance Record’ as per the Format which is kept with Quality Assurance Department.
5.11.5 The respective department head in concern with respective individual shall maintain the training records for individual employees as per Format ‘Employee Training Record’ Format
5.11.6 Departmental head shall prepare training matrix of SOP as per Format ‘Training Matrix’ Format along with Head Quality assurance.
5.11.7 Respective department head shall maintain the records of SOP Training as per Format ‘SOP Training Record’, Format
5.11.8 New Recruits: New recruits shall undergo induction program to familiarize with rules, regulations, policies and working culture of the different departments in the organization. The new recruits are kept under observation by the immediate supervisors. Similarly, promoted and transferred employees shall undergo required training that relate to the aspects of their job.
5.12 Effectiveness and Evaluation of Internal Training
5.12.1 The effectiveness of the Training program is done based on the written/verbal Questionnaire answered by the participants. The detail of the evaluation shall be recorded as per Format ‘Training Evaluation Record’, Format
5.12.2 The effectiveness of the training of employees shall be rated as follows
80% and above – Passes training
Less than 80% – Needs retraining
5.12.3 If an employee scores less than 80%, he or she shall be retrained within a week. Employee will be retrained for not more than three times at the time interval of 15 days and he or she shall allot the work only after passing in respective training topic. If the employee does not pass even after training three times, he or she shall be relocated to different location or necessary action shall be taken by the management.
5.12.4 The respective department head in concern with respective individual shall maintain the training records for individual employees as per Format ‘Employee training Record’ Format
5.13 External Training
5.13.1 Employees shall be sent for external training based on the recommendation made by the department heads during the tenure.
5.13.2 On attending an external training, he or she shall submit an External Training Feedback Form to QA department.
5.13.3 Quality Assurance shall maintain the all External Training Feedback Form as per Format ‘External training Feedback from’, Format
6.0 TRAINING
6.1 Trainer – Human Resource Department
6.2 Trainee – All concern department.
6.3 Period – One hour or as per required.
7.0 DISTRIBUTION
7.1 One set of master copy & controlled copy submitted the quality assurance department.
7.2 One set of Controlled copy submitted the Human resource department.
8.0 ABBREVIATIONS
8.1 SOP : Standard Operating Procedure
8.2 QA : Quality Assurance
8.3 HR : Human Resource
8.4 HOD : Head of Department
8.5 cGMP : Current Good manufacturing Practices
8.6 cGLP : Current Good Laboratory Practices
8.7 PRD Production department
INDUCTION TRAINING RECORD
| Employee Name | |
| Department | |
| Designation | |
| Employee Code | |
| Date of Joining |
| Human Resources : | |
| · Company profile (Induction PPT).
· Company HR policy. · Organization structure. · Main responsibilities & HR activities. · Hygiene instruction, clothing & conduct in Process areas, documentation practice. |
If others, specify below
Comments :
Department Head / Designate (Sign / Date): |
| Quality Assurance: | |
| · Functions of Quality Assurance Department.
· Brief about company quality system. · Good Manufacturing Practice. · Document management system. · IPQA activities. · Change control and deviation management. |
If others, specify below
Comments :
Department Head / Designate (Sign / Date): |
| Raw Material Store: | |
| · Functions of RM store.
· Material Receiving System. · Material Management System. · Dispensing System. · Labeling Procedure. |
If others, specify below
Comments :
Department Head / Designate (Sign / Date): |
| Packing Material Store: | |
| · Functions of PM store.
· Material Receiving System. · Material Management System. · Dispensing System. · Labeling Procedure. |
If others, specify below
Comments :
Department Head / Designate (Sign / Date): |
| Production: | |
| · Function of Production Department.
· Brief Description about Mfg Process of 1. Tablet. 2. Liquid |
If others, specify below
Comments :
Department Head / Designate (Sign / Date):
|
| Quality Control: | |
| · Functions of QC Department.
· Sampling , analysis and approval of Raw material, Packing material, intermediate , finished product · Operation and calibration of laboratory instruments. · Stability testing. |
If others, specify below
Comments :
Department Head / Designate (Sign / Date): |
| Maintenance: | |
| · Functions of Engineering.
· Preventive maintenance and calibration of Equipments. · Water system. · AHU system. · Utilities. |
If others, specify below
Comments :
Department Head / Designate (Sign / Date): |
Evaluation of Induction:
| Comments: ( This part should be filled by Inductee) |
|
Signature /Date: |
|
|
| Comments : (This part should be filled by Department Head)
Department Head / Designate (Sign / Date): |
|
|
| Comments : (This part should be filled by HR & GS Department)
Department Head / Designate (Sign / Date): |
TRAINING NEED IDENTIFICATION
Individual Training Needs (Discussed with the Department head and the employee).
* Mandatory training programs.
| Technical | |||
| Sr. No. | Modules | Tick Appropriate | Remarks |
| 1
|
Cost Reduction | ||
| 2 | Process Management | ||
| 3 | Vendor Management
|
||
| 4 | Statutory Requirements | ||
| 5 | Quality Consciousness | ||
| 6 | Computer Skills | ||
| 7 | cGMP * | ||
| 8 | Project Management | ||
| 9 | Preventive Maintenance | ||
| 10 | Finance/Accounts/ Cost Management Programme | ||
| Behavioral
|
|||
| 1 | Leadership | ||
| 2 | Communication Skills | ||
| 3 | Problem solving & Decision Making Ability | ||
| 4 | Team Building
|
||
| 5 | Time Management | ||
| 6 | Change Management | ||
| 7 | Motivation | ||
| 8 | |||
| Others (specify):
|
|||
| 1 | |||
| 2 | |||
| 3 | |||
| 4 | |||
EMPLOYEE TRAINING RECORD
| EMPLOYEE TRAINING RECORD | ||
| Employee Code | : | |
| Name | : | |
| Designation | : | |
| Department | : | |
| Date of Joining | : | |
| Effective From | : | |
TRAINING MATRIX
| Department Name and Year : | |||||||||||||||||||||||
| Employee ‘s Name | Employee Code | Month | Month | Month | Month | Month | |||||||||||||||||
| SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | SOP No | ||||
| Prepared by | : | Approved by (QA) | : | ||
| Sign/Date | : | Sign/Date | : |
TRAINING CALENDAR
| Sr.
No |
Month of Training | Training Topic | Department | Training to be Conducted On | Trainer Name and Department |