sop for Training of Plant Personnel

REVISION SUMMARY

Version Number	Date Revised	Reason for Revision
00	Effective Date :	First Issue
01	Effective Date :	Incorporation of Qualification, Questionnaire and Evaluation Criteria of employee.

1.0 OBJECTIVE

1.1 To organize and conduct training program to all the plant employees at all levels.

2.0 SCOPE

2.1 This SOP is applicable for organizing and conducting the training to all personnel in Production, Quality Control, Quality Assurance , Warehouse, Personnel & housekeeping , Engineering & Utility, Projects, Process development laboratory, administration departments.

3.0 RESPONSIBILITY

3.1 Departmental Heads
3.2 QA-Training co-coordinator

4.0 ACCOUNTABILITY

4.1 Head-Quality Assurance.

5.0 PROCEDURE
5.1 Training programs on its nature are categorized as below:
5.1.1 Orientation and Induction Training program
5.1.2 cGMP Training
5.1.3 Safety Training
5.1.4 On the job Training
5.1.5 External training
5.2 Orientation and Induction Training program
5.2.1 This training is imparted to all employees who have newly joined in the organization.
5.2.1 This training is conducted immediately after the employee’s reporting to duty.
5.2.3 Personnel Department organizes the induction and Orientation programme to new recruits.
5.2.4 An orientation schedule is made for each new employee to familiarize the new recruit to the quality systems of the company, working nature of each department and to know the who’s who of the different departments of the Organization (Annexure-I).
5.2.5 Orientation schedule is limited for one week to ten days.
5.2.6 During the induction training, the new employees are made aware of the company’s objectives, rules and regulations, safety policies, policy of personal hygiene and general maintenance of cleanliness in factory premises.
5.2.7 On the initial day of orientation, employee is given training on QA system. During this period, a brief introduction to companies QA system is explained to the employee by Head-QA or his deputy.
5.2.8 Employees of Production, Maintenance, Quality Control, Quality Assurance and stores who will be involved in handling of material, components, dispensing are trained technically before they are put in to work.
5.2.9 All new employees receive direct training in each task, they are expected to perform.
5.2.10 New employees are given training by the person who has knowledge and experience in that particular area.
5.2.11 The department head has the responsibility for selection of the trainer.
5.2.12 New employees are permitted to perform task only under direct supervision until the employee demonstrates his competence to perform the task unsupervised.
5.2.13 In general the orientation and induction training comprises of two phases.
5.2.13.1 Phase-I –To know who’s who of the company and other departments and QA systems in general. This part of training shall be completed within 7 days.
5.2.13.2 Phase-II-To understand the job profile, responsibilities and related technical tasks associated with the present job. This part of training will be initiated after Phase-I.
5.2.14 After completion of induction training an immediate evaluation (as per Annexure –II) shall be carried out by the department Head and the trainee shall be qualified to start his work in the respective area.
5.2.15 Department head shall forward the evaluation sheet ( Annexure-II) to personnel department for archival.
5.2.16 All the induction training records are archived in the personnel department.



5.3 GMP Training program
5.3.1 Quality Assurance department is responsible for organizing cGMP training.
5.3.2 An Annual training schedule (Annexure-III) shall be made by Quality Assurance department which covers the topics related to Good Manufacturing Practices (GMP) & current national and international regulatory guidelines.
5.3.3 Training shall be conducted as per the Annual training Schedule.
5.3.4 Training co-ordinator shall be responsible for organizing cGMP training.
5.3.5 Training co-ordinator shall inform to concerned department about the topic and venue of training in advance.
5.3.6 Training attendance shall be recorded in the format as per Annexure-IV.
5.3.7 Video aids like cassettes on cGMP , aseptic practices as applicable may be used for the effective understanding of the subject.
5.3.8 Immediately after the completion of training, personnel are evaluated to know the extent of training understood.
5.3.9 For evaluation, questionnaires on the topic trained is used. The questionnaires can be objective /descriptive type as applicable.
5.3.10 All the filled questionnaires are assessed by QA – Executive against standard answer sheet and marks as specified in the questionnaire are allotted.
5.3.11 Finally the filled questionnaires are evaluated by Head – QA based on the performance, suitable grade is given to the trainee and the requirement of retraining is decided.
5.3.12 Criteria for evaluation
5.3.12.1 Average – 40 – 50 %
5.3.12.2 Good – A 50 – 70 %
5.3.12.3 Excellent – Above 70%
5.3.13 In case of score below average , retraining shall be conducted and reevaluated as per 5.3.12.
5.3.14 All the training records of cGMP are archived in Quality Assurance Department.
5.3.15 QA shall enter the details of GMP training in GMP training matrix as per the format given at Annexure- V.
5.3.16 On successful completion of GMP training and assessment , a GMP certificate shall be issued which is authorized by Head-QA. ( Annexure-VI)
5.4 On the job training/Technical Training
5.4.1 The head of the department is responsible for organizing the on-the-job training/Technical Training to each individual.
5.4.2 On-job training shall be given by the concerned Department Heads or Designee who is capable of training people and having adequate Knowledge
5.4.3 The frequency of On-the-job training/technical training is decided by the head of department as per individual job requirement.
5.4.4 All personnel will be given training to upgrade the technical knowledge and to know the current job description and the changes in process/machinery.
5.4.5 An annual training need identification ( Annexure-VII) for each employee is made and approved by the department head and Training co-ordinator . In such case update the Annual training need accordingly ( Use additional sheets as applicable).
5.4.6 SOP’s training related to the job shall be given as per the Annual training need identification and training in case of revision in SOP’s shall be given as and when required.
5.4.7 On-the-job training/technical training is effectively carried out with the help of lectures based on literature/SOPs, presentations and by the practical demonstration of the real operation as applicable.
5.4.8 On-job training shall be recorded as per Annexure-VIII.
5.4.9 Immediately after the completion of training, personnel are evaluated to know the extent of training understood.
5.4.10 For evaluation, questionnaires on the topic trained is used .The questionnaires can be objective/descriptive type as applicable.
5.4.11 All the filled Questionnaires are assessed by Department heads against SOP or topic trained and marks as specified in the Questionnaire is allotted.
5.4.12 Training co-ordinator /QA shall evaluate the training assessment and suitable grading is given as specified under point no: 5.3.12.
5.4.13 In case of score below average , retraining shall be conducted and reevaluated as per 5.3.12.
5.4.14 On successful completion of on-job training and assessment , training certificate shall be issued as per Annexure-IX
5.4.15 On –job training records shall be archived in the respective departments.
5.5 After completion of each class the details of training shall be recorded and subsequently the Training matrix and Training formats shall be updated with date and signature of the trainee, trainer and the training coordinator as applicable.
5.6 In case of new SOP’s / Revision of SOP’s, training shall be recorded in the SOP training record as per the SOP.
5.7 In case of Un-Scheduled trainings, training shall be recorded in the on-job training record of the respective employee ( Annexure – X).
5.8 Safety Training
5.8.1 Safety officer in co-ordination with personnel and administration shall be responsible for organizing and conducting safety training.
5.8.2 Safety training shall be given by the Safety co-ordinator.
5.8.3 Safety training records shall be maintained and archived in Safety department.
5.9 External Training
5.9.1 Quality Assurance Department shall liase with technical services department/regulatory affairs department and shall organize the technical training by vendors/other technical agencies from time-to-time.
5.9.2 Concerned responsible staff of each department will be attending such seminars.
5.9.3 The above seminars will be focused mainly on the technology development, sophistication of instrumentation, other advanced process/validation aspects and other current GMP and regulatory topics.
5.9.4 All such external training programmes will be recorded as per Annexure-XI
5.9.5 External Training records shall be archived in Quality Assurance Department.
5.10 Trainer Evaluation
5.10.1 The trainer shall be evaluated based on his/her
5.10.1.1 Knowledge
5.10.1.2 Earlier training
5.10.1.3 Earlier experience
5.10.2 Trainer shall be the immediate supervisor, executives of concerned department or department head as applicable.
5.10.3 Apart from the subject knowledge a trainer shall also have good interpersonal communication skills.
5.10.4 Trainer evaluation shall be conducted by Department head and QA-training co-ordinator.
5.10.5 Trainer evaluation shall be documented with Resume of trainer (Annexure – XII) & Certificate of trainer (Annexure – XIII) authorized y Head-Quality Assurance.
Note: The training shall be conducted for newly joined employee for one year and for officer
and executive category six months and for manager category one months.
6.0 ABBREVIATIONS
6.1 CCR-Change Control Request
6.2 QA-Quality Assurance
7.0 ANNEXURE
7.1 Annexure-I-Orientation schedule
7.2 Annexure-II-evaluation of job specific training During Induction.
7.3 Annexure-III-Annual planner for GMP training
7.4 Annexure-IV-cGMP training record
7.5 Annexure-V-GMP training matrix
7.6 Annexure-VI-GMP Training Certificate
7.7 Annexure-VII-Training need identification
7.8 Annexure-VIII-On-job training record
7.9 Annexure-IX-On the job training Certificate
7.10 Annexure-X-Unscheduled training record
7.11 Annexure-XI-External training record
7.12 Annexure-XII-Trainer resume
7.13 Annexure-XIII-Certification of Trainer.

ANNEXURE-I

 

Department: Personnel and Administration

 

ORIENTATION SCHEDULE

 

 



We introduce Mr/Mrs/Ms __________________________________ who has joined with us as _______________________ with effective from _____________.  All department heads are requested to co-operate and make him/her aware of the existing system and procedures during his/her orientation programme.

 

Department	Date	Time		Contact Person
		From	To

 

 

 

	Prepared by (Personnel & Administration)	Approved by (QA-Training Co-ordinator)
Name
Signature
Date

Annexure-II-evaluation of job specific training During Induction.

DATE
NAME		DESIGNATION
DEPARTMENT

Note                :           The Evaluation shall be conducted by the Head of  Department based on his/her performance during induction.

1.	Does the employee understand who’s who of the organization and departments.	Yes / No
2.	Does the employee understand the QA systems in general followed in the company	Yes / No
3.	Does the employee understand the related job	Yes / No
4.	Does the employee understand the standard operating procedure related to his / her job.	Yes / No
5.	Does the employee understand the safety process related to his/her job.	Yes / No
6.	Does the employee show interest towards the job assigned to him.	Yes / No

 

The overall performance of the employee is

Satisfactory / not Satisfactory

 

 

Comments

______________________________________________________________________

Annexure-III-Annual planner for GMP training

Topic Code	Topic	Faculty	Schedule	Related Dept

	Prepared by (QA-Training co-ordinator)	Approved by (Head-Quality Assurance)
Name
Signature
Date

Annexure-IV-cGMP training record

DATE
TOPIC
VENUE
FACULTY

 

 

TRAINING ATTENDED BY

 

S .No	Name	Employee Code	Department	Sign

 

	Trainer	QA-Training Co-ordinator
Signature
Date

 

Annexure-V-GMP training matrix

DEPARTMENT :

MANAGER CADRE

S.No

Employee Code

Employee Name

Date of Training attended

Remarks

Month

Topic Code

EXECUTIVE CADRE

STAFF CADRE

Annexure-VI-GMP Training Certificate

 

 

Annexure-VII-Training need identification

Annexure-VIII-On-job training record

Annexure-IX-On the job training Certificate

 

Annexure-X-Unscheduled training record

Annexure-XI-External training record

 

Annexure-XII-Trainer resume

 

Annexure-XIII-Certification of Trainer.