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SOP for Induction Program and Training of Personnel


OBJECTIVE
To lay down a procedure for training of plant personnel.

SCOPE
This procedure is applicable for all operations of XYZ Limited.

RESPONSIBILITY
Trainer: Responsibilities of individual(s) / concerned departments are as follows:
  • Induction Training: HRD and Department In-charge.
  • On-the-Job Training and safety training: Department Incharge / HOD.
  • cGMP Training / refresher cGMP training: QA Manager / His designate.
  • Retraining: Training In charge / HOD.
  • External Training and specific training: HOD.
Trainee: Responsible for attending the training, report writing and fill up the Training Log Book and keep up-to-date the Employee Training Card for self

PROCEDURE
Induction Training
  • Induction training program shall be organized, so that new employee is introduced with the interacting departments, staff members and gets familiarized with the overview of organization, unit and department.
  • HRD along with the concerned department in-charge shall prepare the induction schedule in consultation with the concerned HOD and record the details in the Induction Training Schedule (Refer Attachment-I).
  • New recruit shall be introduced by HRD to his / her in-charge, who is responsible to help the new recruit through the induction period and beyond.
On – the - Job Training
  • On the job training shall include the in-depth training in the parent department and cross-functional department of the new employee.
  • On the job 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, adherence to cGMP, assigned responsibilities etc.
  • The mode of imparting training shall be through a combination of one or more of the following: reading procedures, presentation, practical training, discussion and questionnaire.
  • If a person is transferred from one department to another, the training in-charge/Department in-charge shall be informed and separate on-the–job training shall be initiated by the head of the new department.
cGMP Training
  • This program shall be mandatory for all employees (New and Existing).
  • cGMP Training for New Employees: This program covers all new employees for the manufacturing, processing, packing or distribution. This program shall cover basics of cGMP and conducted as classroom training.
  • cGMP Training for Existing Employees (Refresher program)
  1. This training shall be conducted once in 6 months covering cGMP requirements. cGMP Programme for a calendar year shall be prepared by Training in-charge/Quality Assurance (Refer Attachment-II).
  2. For refresher cGMP Training programs employees shall be divided into 2 groups.
       Group-I comprises of Workmen & other operating staff
       Group-II comprises of Supervisor, Chemists, Officers, Executives 
       and above.


External Training
  • External training program shall include the training conducted by external institution or training conducted by external faculty in the organization.
Evaluation and certification of training
  • Training shall be imparted through the QA approved training modules/materials.
  • Effectiveness of the training programme shall be evaluated to ensure that it fulfills the intended requirements.
  • On completion of Internal Training program, the Trainer shall evaluate through an oral test, written test or a discussion or using workout sessions. Where necessary like SOP training, objective type questionnaire shall be prepared to determine the understanding as detailed in the Assessment record (Refer Attachment-III).
  • Wherever, evaluation is done through questionnaires, the Trainee shall be certified, if he has scored minimum qualification mark, which shall be 70% of the total marks allotted to the questionnaires.
  • If trainee fails to obtain the minimum qualification marks or incorrectly answer the compulsory questions, retraining (remedial) shall be conducted and the same shall be recorded in the Assessment Record (Refer Attachment-III).
  • After every training session, participants will be required to fill the Trainer’s Evaluation Form (Refer Attachment VI) to evaluate the trainer.
Documentation
  • All records pertaining to training of employee shall be maintained by the concerned Training in charge.
  • Employee Training Card: The employee training card shall be issued to each employee at the time of joining, by the training in charge.
  • All the training as mentioned above, attended by the employee shall be entered in the Employee Training Card (Refer attachment-IV).
  • For all internal training programme (On Job Training, SOP Training, cGMP Training, Specific Training and Retraining), the trainees shall enter their attendance in the Training Log. (Refer Attachment-V).
  • The trainer shall enter the comments and summary on the training conducted.
PEOPLE ALSO READ: SOP for Job Responsibility

Personal Training File:
  • At the time of joining, a training file shall be opened for each employee by the HOD of the specific department.
  • Induction report, training cards, evaluated reports/questionnaires, post training report (for external training), certificates and any other training related document of an employee shall be filed in the Personal Training File.
  • All the training files shall be maintained by Quality Assurance department.
  • All the training documents shall be retained for a period of one year after the date of resignation or retirement. After one year the documents shall be destroyed.
ABBREVIATIONS
SOP - Standard Operating Procedure
Q.A - Quality Assurance
Q.C - Quality control
No. - Number
e.g. - Example
HOD - Head of the department
HRD - Human Resources and Development
cGMP - Current Good Manufacturing Practices
OOS - Out of Specification

ATTACHMENT
Attachment-I - Format of Induction Training Schedule
Attachment-II - Training schedule
Attachment-III - Format of Assessment Record
Attachment-IV - Format of Training Attendance Sheet
Attachment-V - Format of Employee Training Card
Attachment-VI - Trainer’s Evaluation Form

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REVISION HISTORY
Nil

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