1. Purpose:
· To ensure that the personnel performing work affecting quality is competent on the basis of education, training, skills and experience.
· To identify personnel training needs, provides required training, and evaluates the effectiveness of the training provided.
· To make employees aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives.
· To maintain records of personnel qualifications and training are maintained.
2. Scope:
This SOP is applicable for all the employees’ working in xxxx (Company Name).
3. Responsibility:
Department Responsibility
Departmental Head: Responsible for identifying training needs and awareness programs for company-wide participation, such as: general orientation, rules and regulations, quality system, safety, and other company-wide systems and issues.
Process Leads: Responsible for identifying competency requirements and training needs in their departments, and for requesting departmental training sessions. Departmental training is primarily focused on increasing the level of skills in operating equipment and processes. Operational Managers and Supervisors are responsible for coordinating with the Administration Department in relation to any training activities.
Training Department: Responsible for maintaining centralized training records for each employee and for supplying this information to Department Managers and Supervisors as required.
4. Abbreviations:
RF: Record Form
5. Definitions
NA
6. Procedure:
6.1 In xxxx (Company Name) job responsibility have been identified and prepared to ensure the competency of personnel whose work affects the conformity to product/services requirements. Competency Matrix identifying the qualifications required for each position, including education, skills and experience requirements, along with the training required to provide the competence required for each position.
(1: Job Responsibility).
6.2 Competence:
6.2.1 Employee qualifications are reviewed upon hire, when changing positions or when the requirements for a position change.
6.2.2 Each process lead shall identify the competency needs for personnel within their department performing activities affecting conformity to product requirements.
6.2.3 Managers shall evaluate employees under their direction to determine competency gaps.
6.2.4 If differences between the employee’s qualifications and the job requirements are found, training or other action is taken, where applicable, to provide the employee with the necessary competence for the job.
(2: Competency Matrix)
6.3 Types of Training: Following are the training performed by xxxx (Company Name).
6.3.1 Induction/General orientation and quality system awareness training: Explains how xxxx(company name) services are used in the different industries and how the quality system works to ensure process quality. Introduces employee to organization's internal structure. Provided to all employees.
6.3.2 Document Training: The newly joined employee shall be given the job function training as per the job description before he takes on the change of his post. Generally the training includes introduction to the Quality Management System (QMS), job responsibilities, reporting pattern, and procedural training.
6.3.3 cGMP Training: Current trends in Good Manufacturing Practices as per Schedule M of Drug and Cosmetic Act (1940, 1945) of India, WHO cGMP guidelines and other statutory and regulatory requirements and international guidelines relevant to the scope of work.
6.3.4 External training: External seminars, conferences, and courses. Provided to individual employees on as-need basis.
6.3.5 Skill training: Training in specific skills as per the requirement of the Project or function assigned to the employee. Often provided as special training, hands on and skill level training.
6.3.6 Self-study: Reading training manuals, magazines, books, and reports. While all employees are encouraged to broaden their knowledge through reading, in some cases self-studying may be required as formal training.
6.3.7 Remedial training/ Retraining: in case of evidence that the original training was not adequate to a person who could not perform efficiently; a deviation; out of specification result; accident or as a result of regulatory audit observations.
6.3.8 Temporary employee and contractor training include training on fundamental cGMPs and specific training on duties assigned.
6.4 Induction Procedure:
6.4.1 HR shall extend a warm welcome to the newly appointed staff and give a brief description of the company.
6.4.2 HR shall get completed all the requirements as per the company’s policy in respect of newly appointed staff.
6.4.3 Shall provide the new joinee with the induction program which after completion of the induction shall be submitted to the HR.
6.4.4 Introduce the newly appointed staff with relevant key members of the company with whom the staff shall directly or indirectly interact during their normal course of work.
6.4.5 Inform staff of the concerned department about arrival of the newly appointed staff in advance.
6.4.6 Brief the newly appointed staff about the company, its policies and practices.
6.4.7 Accompany the newly appointed staff to his / her department of placement.
6.4.8 The Head of the concerned department shall welcome the newly appointed staff and explain:
· About the functions / roles of the department.
· Job descriptions of the newly appointed staff.
· Shall explain the type and nature of the work that have to be performed.
· Gives introduction to GMP and related functions
· Provide them with sitting place and day to day use stationery items.
· Shall introduce the newly appointed staff to other colleagues in the department.
· Shall appoint a mentor to guide the new employee during his first few weeks in office.
6.4.9 After induction period is over the employee is placed in training period and shall be trained in all the job functions he or she will perform. The employee is requested to fill induction feedback form.
(3: Induction record)
(4: Induction Feed Back)
6.5 Job function training:
6.5.1 It is the responsibility of the departmental head to provide the job function training of the newly joined staff. No employee shall be given charge of his functions unless his job function training is complete.
6.5.2 The training includes introduction to Quality Management System (QMS), job responsibilities, reporting pattern, and procedural training.
6.5.3 After the Job function training is over the training record form shall be filled and submitted to HR department to be attached to the employee training file.
6.5.4 Whenever the Job responsibility of the employee is changed, revised due to transfer, new job assignment etc the employee shall be trained as per the new job requirement and the updated training record shall be submitted to the HR department to be attached in the employee training file and one copy is also with the employee.
6.6 cGMP Training
6.6.1 All the employees who have the technical responsibility shall be trained for Current trends in Good Manufacturing Practices as per Schedule M of Drug and Cosmetic Act (1940, 1945) of India, WHO cGMP guidelines and other statutory and regulatory requirements and international guidelines relevant to the scope of work.
6.6.2 These trainings shall be provided at regular interval to keep them updated in the field. The record of these trainings shall be kept and submitted to the HR department to be attached in the employee training file.
6.7 External training: External seminars, conferences, and courses. Provided to individual employees on as-need basis. The records of these trainings shall be maintained in HR department in the employee training file.
6.8 Skill training: Training in specific skills as per the requirement of the Project or function assigned to the employee. Often provided as special training, hands on and skill level training. If available the records of these trainings shall also be maintained.
6.9 Self-study: Reading training manuals, magazines, books, and reports. While all employees are encouraged to broaden their knowledge through reading, in some cases self-studying may be required as formal training.
6.10 Remedial training/ Retraining: in case of evidence that the original training was not adequate to a person who could not perform efficiently; a deviation; out of specification result; accident or as a result of regulatory audit observations.
6.11 Temporary employee and contractor training include training on fundamental cGMPs and specific training on duties assigned.
6.12 Training Need Assessment:
6.12.1 Organizational training needs: The focus shall be on organizational goals, departmental performance issues and future development needs.
6.12.2 Job related training needs: Job/Task related training needs shall be identified to analyze the role that employees have to play in the organization. Assigned job training needs assessment shall focus on the job characteristics and improvement of current skill levels required by the employees to perform their present job according to identified performance parameters.
6.12.3 Personnel Training Needs: Training needs assessment at personnel level shall focus on the current knowledge levels or performance parameters and expected future responsibility.
(5: Training Calendar)
6.13 Conducting Training:
6.13.1 For Conducting an effective training session the following logistical arrangements shall be considered before training is imparted:
· Suitable training venues (well-lit and well-ventilated with adequate space away from source(s) of noise.
· Preparation of training agenda and circular to notify the trainees and HODs of the dates, time and location of training.
· Preparation of instructional materials including the Student materials like texts, handouts, assignments, computer-based materials and instructional 3aide like audiovisual materials, models, demonstration equipment.
· Arrangement for appropriate training equipment (may include microphone, whiteboard and marker, flipchart paper, writing materials, slide and/or overhead projector, LCD projector and computer, video equipment, screen etc.).
· Arrangement of training room, seating arrangements, name cards (if required), position of whiteboard, screen, etc.
· Arrangement of tea/coffee and meal breaks during course.
· Arrangement of transportation/accommodation as needed for outside speakers/trainers.
(6: Training Agenda)
6.14 Evaluation of Training
6.14.1 Trainee Evaluation:
· Trainees shall be evaluated to assess the transfer of knowledge by various evaluation methods like -written tests (multiple choice, true/false, descriptive etc.) demonstrations and performance checklist, problem solving, or interviews, (verbal evaluation).
· These training methods may be used for pre-training, on-going, post-training or follow up evaluation as deemed fit by the trainer.
· The trainer shall select appropriate evaluation method to evaluate trainee performance.
· The criteria for evaluation or assessment and pass percentage shall also be decided by the trainer and shall be documented in Training Program Overview.
6.14.2 Evaluation of trainer and the training program:
· The trainees shall be provided with Course Evaluation Form to evaluate the effectiveness of training and the performance of the trainer.
· The feedback forms shall be reviewed by training section, QA Department to find out whether the course objectives were achieved and also in improving the efficiency of training.
(7: Training Attendance Sheet)
(8: Training Evaluation Sheet)
(9: Training Questionnaire)
(10: Training Feedback)
7. ReportingAnnexure 1 to 10
8. Annexure:
Annexure No: Title
· To ensure that the personnel performing work affecting quality is competent on the basis of education, training, skills and experience.
· To identify personnel training needs, provides required training, and evaluates the effectiveness of the training provided.
· To make employees aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives.
· To maintain records of personnel qualifications and training are maintained.
2. Scope:
This SOP is applicable for all the employees’ working in xxxx (Company Name).
3. Responsibility:
Department Responsibility
Departmental Head: Responsible for identifying training needs and awareness programs for company-wide participation, such as: general orientation, rules and regulations, quality system, safety, and other company-wide systems and issues.
Process Leads: Responsible for identifying competency requirements and training needs in their departments, and for requesting departmental training sessions. Departmental training is primarily focused on increasing the level of skills in operating equipment and processes. Operational Managers and Supervisors are responsible for coordinating with the Administration Department in relation to any training activities.
Training Department: Responsible for maintaining centralized training records for each employee and for supplying this information to Department Managers and Supervisors as required.
4. Abbreviations:
RF: Record Form
5. Definitions
NA
6. Procedure:
6.1 In xxxx (Company Name) job responsibility have been identified and prepared to ensure the competency of personnel whose work affects the conformity to product/services requirements. Competency Matrix identifying the qualifications required for each position, including education, skills and experience requirements, along with the training required to provide the competence required for each position.
(1: Job Responsibility).
6.2 Competence:
6.2.1 Employee qualifications are reviewed upon hire, when changing positions or when the requirements for a position change.
6.2.2 Each process lead shall identify the competency needs for personnel within their department performing activities affecting conformity to product requirements.
6.2.3 Managers shall evaluate employees under their direction to determine competency gaps.
6.2.4 If differences between the employee’s qualifications and the job requirements are found, training or other action is taken, where applicable, to provide the employee with the necessary competence for the job.
(2: Competency Matrix)
6.3 Types of Training: Following are the training performed by xxxx (Company Name).
6.3.1 Induction/General orientation and quality system awareness training: Explains how xxxx(company name) services are used in the different industries and how the quality system works to ensure process quality. Introduces employee to organization's internal structure. Provided to all employees.
6.3.2 Document Training: The newly joined employee shall be given the job function training as per the job description before he takes on the change of his post. Generally the training includes introduction to the Quality Management System (QMS), job responsibilities, reporting pattern, and procedural training.
6.3.3 cGMP Training: Current trends in Good Manufacturing Practices as per Schedule M of Drug and Cosmetic Act (1940, 1945) of India, WHO cGMP guidelines and other statutory and regulatory requirements and international guidelines relevant to the scope of work.
6.3.4 External training: External seminars, conferences, and courses. Provided to individual employees on as-need basis.
6.3.5 Skill training: Training in specific skills as per the requirement of the Project or function assigned to the employee. Often provided as special training, hands on and skill level training.
6.3.6 Self-study: Reading training manuals, magazines, books, and reports. While all employees are encouraged to broaden their knowledge through reading, in some cases self-studying may be required as formal training.
6.3.7 Remedial training/ Retraining: in case of evidence that the original training was not adequate to a person who could not perform efficiently; a deviation; out of specification result; accident or as a result of regulatory audit observations.
6.3.8 Temporary employee and contractor training include training on fundamental cGMPs and specific training on duties assigned.
6.4 Induction Procedure:
6.4.1 HR shall extend a warm welcome to the newly appointed staff and give a brief description of the company.
6.4.2 HR shall get completed all the requirements as per the company’s policy in respect of newly appointed staff.
6.4.3 Shall provide the new joinee with the induction program which after completion of the induction shall be submitted to the HR.
6.4.4 Introduce the newly appointed staff with relevant key members of the company with whom the staff shall directly or indirectly interact during their normal course of work.
6.4.5 Inform staff of the concerned department about arrival of the newly appointed staff in advance.
6.4.6 Brief the newly appointed staff about the company, its policies and practices.
6.4.7 Accompany the newly appointed staff to his / her department of placement.
6.4.8 The Head of the concerned department shall welcome the newly appointed staff and explain:
· About the functions / roles of the department.
· Job descriptions of the newly appointed staff.
· Shall explain the type and nature of the work that have to be performed.
· Gives introduction to GMP and related functions
· Provide them with sitting place and day to day use stationery items.
· Shall introduce the newly appointed staff to other colleagues in the department.
· Shall appoint a mentor to guide the new employee during his first few weeks in office.
6.4.9 After induction period is over the employee is placed in training period and shall be trained in all the job functions he or she will perform. The employee is requested to fill induction feedback form.
(3: Induction record)
(4: Induction Feed Back)
6.5 Job function training:
6.5.1 It is the responsibility of the departmental head to provide the job function training of the newly joined staff. No employee shall be given charge of his functions unless his job function training is complete.
6.5.2 The training includes introduction to Quality Management System (QMS), job responsibilities, reporting pattern, and procedural training.
6.5.3 After the Job function training is over the training record form shall be filled and submitted to HR department to be attached to the employee training file.
6.5.4 Whenever the Job responsibility of the employee is changed, revised due to transfer, new job assignment etc the employee shall be trained as per the new job requirement and the updated training record shall be submitted to the HR department to be attached in the employee training file and one copy is also with the employee.
6.6 cGMP Training
6.6.1 All the employees who have the technical responsibility shall be trained for Current trends in Good Manufacturing Practices as per Schedule M of Drug and Cosmetic Act (1940, 1945) of India, WHO cGMP guidelines and other statutory and regulatory requirements and international guidelines relevant to the scope of work.
6.6.2 These trainings shall be provided at regular interval to keep them updated in the field. The record of these trainings shall be kept and submitted to the HR department to be attached in the employee training file.
6.7 External training: External seminars, conferences, and courses. Provided to individual employees on as-need basis. The records of these trainings shall be maintained in HR department in the employee training file.
6.8 Skill training: Training in specific skills as per the requirement of the Project or function assigned to the employee. Often provided as special training, hands on and skill level training. If available the records of these trainings shall also be maintained.
6.9 Self-study: Reading training manuals, magazines, books, and reports. While all employees are encouraged to broaden their knowledge through reading, in some cases self-studying may be required as formal training.
6.10 Remedial training/ Retraining: in case of evidence that the original training was not adequate to a person who could not perform efficiently; a deviation; out of specification result; accident or as a result of regulatory audit observations.
6.11 Temporary employee and contractor training include training on fundamental cGMPs and specific training on duties assigned.
6.12 Training Need Assessment:
6.12.1 Organizational training needs: The focus shall be on organizational goals, departmental performance issues and future development needs.
6.12.2 Job related training needs: Job/Task related training needs shall be identified to analyze the role that employees have to play in the organization. Assigned job training needs assessment shall focus on the job characteristics and improvement of current skill levels required by the employees to perform their present job according to identified performance parameters.
6.12.3 Personnel Training Needs: Training needs assessment at personnel level shall focus on the current knowledge levels or performance parameters and expected future responsibility.
(5: Training Calendar)
6.13 Conducting Training:
6.13.1 For Conducting an effective training session the following logistical arrangements shall be considered before training is imparted:
· Suitable training venues (well-lit and well-ventilated with adequate space away from source(s) of noise.
· Preparation of training agenda and circular to notify the trainees and HODs of the dates, time and location of training.
· Preparation of instructional materials including the Student materials like texts, handouts, assignments, computer-based materials and instructional 3aide like audiovisual materials, models, demonstration equipment.
· Arrangement for appropriate training equipment (may include microphone, whiteboard and marker, flipchart paper, writing materials, slide and/or overhead projector, LCD projector and computer, video equipment, screen etc.).
· Arrangement of training room, seating arrangements, name cards (if required), position of whiteboard, screen, etc.
· Arrangement of tea/coffee and meal breaks during course.
· Arrangement of transportation/accommodation as needed for outside speakers/trainers.
(6: Training Agenda)
6.14 Evaluation of Training
6.14.1 Trainee Evaluation:
· Trainees shall be evaluated to assess the transfer of knowledge by various evaluation methods like -written tests (multiple choice, true/false, descriptive etc.) demonstrations and performance checklist, problem solving, or interviews, (verbal evaluation).
· These training methods may be used for pre-training, on-going, post-training or follow up evaluation as deemed fit by the trainer.
· The trainer shall select appropriate evaluation method to evaluate trainee performance.
· The criteria for evaluation or assessment and pass percentage shall also be decided by the trainer and shall be documented in Training Program Overview.
6.14.2 Evaluation of trainer and the training program:
· The trainees shall be provided with Course Evaluation Form to evaluate the effectiveness of training and the performance of the trainer.
· The feedback forms shall be reviewed by training section, QA Department to find out whether the course objectives were achieved and also in improving the efficiency of training.
(7: Training Attendance Sheet)
(8: Training Evaluation Sheet)
(9: Training Questionnaire)
(10: Training Feedback)
7. ReportingAnnexure 1 to 10
8. Annexure:
Annexure No: Title
- Job Responsibility (Template)
- Competency Matrix (Template)
- Induction record
- Induction Feed Back
- Training Calendar (Template)
- Training Agenda (Template)
- Training Attendance Sheet
- Training Evaluation Sheet
- Training Questionnaire (Template)
- Training Feedback
9. References:
9.1 ISO 9001:2008- Quality Management System-Requirements.
9.2 ISO/TR 10013: Guidelines for quality management system documentation.
10. Distribution:
Master Copy: Archived at Quality Department
Controlled Copy 1: Administration Department
Subsequent Controlled Copy: Department making request
11. History:
Revision Number: Change Summary
00: None
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