sop for training program
1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for providing training to new and existing employees / workers of the organization.
2.0 SCOPE
2.1 This procedure is applicable for providing training to the new and existing employees / workers
3.0 RESPONSIBILITY
3.1 Asst. Officer or above–Quality assurance – Prepare the SOP and follow-up the SOP accordingly.
3.2 Asst. Manager – Quality Assurance-Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance / Chief Executive Officer
5.0 REFERENCE(S)
5.1 In-House
6.0 PROCEDURE
6.1 Methodology
The training program contains the following steps:
6.1.1 Medium / Mode of Training
Use media to be interesting and easy to understand. Cost and ease for program revision is also determining factors e.g. slide / lecture presentation, slide/type programs, work book program.
6.1.2 Training Syllabus
Outlines the contents of the program. The course content is determined by the needs of operation the underlying theme of each program under the basic concept of cGMP and safety, how it relates to the employee’s job. Employees understand their roles in overall operation, and jobs are performed. It is also mentioned the consequences of not following as per the SOP.
6.1.3 Techniques and Methods
1. Formal Class Room Training
2. On-job Training
3. Audiovisual Program
4. Seminars (External Training)
6.2 Induction Training (New Employee)
6.2.1 Induction training of all the employees shall be organized by HR department at the time of joining so that new employee is introduced with the interacting departments, staff member and gets familiarized with the overview of organization, unit and department.
6.2.2 All the new employees shall be given induction training for maximum seven working days.
6.2.3 HRA along with concerned department head shall prepare the induction program as per Format and provide details as mention in format.
6.2.4 The inductee shall acquaint knowledge of the systems and procedures and shall induct with all concerned as per Format
6.2.5 He/she shall be inducted with each department to understand the activities of the department through the SOPs of the department.
6.2.6 After the induction training program is complete, induction training report to be submitted to HR department and final meet with Chief Executive Officer.
6.3 On Job (SOP) Training
6.3.1 On job training shall be imparted to all in their concerned areas.
6.3.2 The employee shall be trained in all the SOP’s of the department, which are job specific to the concerned person. On job training record shall be maintained as per performa given under in Format
6.3.3 Annual SOP training calendar shall be prepared as per Format
6.4 GMP Training Programme
6.4.1 All the employees in the system shall be trained periodically with adequate frequency on Good Manufacturing Practices. Annual GMP training calendar shall be prepared as per Format
6.4.2 Training shall be provided by external members, or any other technical person relating to the department function.
6.4.3 All other areas such as process validation, cleaning validation, equipment qualification, regulatory guidelines, safety, first aid and personality development shall be covered under this head.
6.5 Training Matrix
6.6 Identification of Training Needs
6.6.1 Department head shall evaluate and identify the training needs for his subordinate in his area of work.
6.6.2 If required the concerned shall be send to outside agency for training purpose.
6.7 Evaluation of Training
6.7.1 Pre and post training evaluation (as applicable) shall be done by oral or written.
6.7.2 Written feed back shall be taken through questionnaire.
6.7.3 Minimum passing marks obtained by a trainee (in post training evaluation) shall be not less than 80 %.
6.7.4 In case a trainee scores less than 80 % marks retraining shall be imparted to him.
6.8 Records
6.8.1 “Training Attendance Record” shall be filled during any type of the training given as class room training or on-job training on the working area by all the trainees as per Format
6.8.2 All Training records shall be maintained for individual employee by individual department.
7.0 ABBREVIATIONS
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
IT : Information Technology