Blog

Standard Operating Procedure (SOP) for Training of Contractual Workers in pharma, A contract worker does not become a regular addition to the staff, hired for a specific job, perform under the close monitoring/supervision company staff.

Training of Contractual Worker

1.0   PURPOSE:

• • The purpose of this SOP is to define the procedure of training for CW (Contractual Worker) of all departments.

2.0   SCOPE:

• • This procedure is applicable for the training of Contractual Worker of all departments at pharmaceuticals plant.

3.0   REFERENCES:

• • SOP for Document Control and Data Control (Document Management System)

• • SOP for Training Management

4.0   RESPONSIBILITY – WORKER TRAINING:

• • Personnel & Administration shall be responsible for-

• • Issue training record to new Contractual Worker and to ensure induction training for newly joining Contractual Worker.

• • Imparting training to newly join Contractual Worker as per their expected job role and

• • To identify the training need by co-ordination with the respective section heads.

• • Review induction training schedule of newly join Contractual Worker,

• • After completion of induction training and to ensure that training Instructions and feedback sheet of training are filled by respective department (Dept.).

• • Ensure the compliance of their training and keep all the training record and feedback sheet of Contractual Worker.

• • Contractual Worker shall undergo the induction training as well to perform the assigned work.

• • Department Head or Designee shall be responsible for imparting training to the Contractual Worker according to their expected job responsibility and

• • To ensure that the work is assigned to CW after delivering the required training.

• • Plant Head and Quality Head shall be responsible for approval of the SOP.

5.0   ABBREVIATIONS – WORKER TRAINING:

• • cGMP: Current Good Manufacturing Practice

• • CW: Contractual Worker

• • Dept. : Department

• • EHS: Environment Health and Safety

• • HR: Human Resource

• • P&A: Personnel & Administration

• • Contract worker:

• • A contract worker does not become a regular addition to the staff, hired for a specific job, perform under the close monitoring/supervision company staff.

• • Training:

• • A process that involves the acquisition of knowledge, skills, concepts, rules, procedures, processes etc. Thus, personnel remains competent to perform the task(s) assigned.

• • Trainee: The person who is being trained on a specific subject or activity.

 6.0   PROCEDURE FOR WORKER TRAINING:

• • Contractual Worker shall be recruited through an interview by Human Resource (HR) Dept.

• • Joining order to contractor shall be given only after health check-up, document verification and Police verification of Contractual Worker by HR.

• • After compliance of all verification of Contractual Worker, the contractor shall take the signature on declaration form by CW and other required documentation shall be ensured by HR (if any) in coordination with the Contractual Worker contractor.

• • Training Procedure for newly join contractual worker:

• • When a new CW joins in the plant, the P&A coordinator introduces the new CW with P&A Dept.

• • All new CW joinees shall be trained by P&A Dept. in coordination with the respective Dept. head.

• • After joining each Contractual Worker, the training coordinator shall maintain the training record.

• • Individual training records of CW shall contain an induction training schedule and the induction training shall be documented as per annexure-1.

• • Updation of annexure-1 concerning entries shall be done by the concerned Dept.

• • P&A training coordinator shall impart basic training on

• • • Entry & exit procedure in the plant,

• • • Dress code procedure,

• • • Personal hygiene,

• • • The behavior to newly join CW

• • Details shall be recorded in the individual training files as per annexure-6.

• • All newly join CW shall also be trained on cGMP by the P&A coordinator and detail shall be recorded as per annexure-6.

• • Required study materials/modules such as the Induction manual shall be given to the new CW by the training coordinator for awareness/references. (Soft Copy can be shown to the persons)

• • Environment health and safety (EHS) Dept. shall be imparted safety training to new CW and training shall be imparted by modules (if any).

• • Department Training:

• • After recruitment of new CW, each CW shall undergo the induction training in their respective Dept. after completion of HR, GMP, and safety-related training.

• • Induction training shall be of a minimum of 1 day.

• • The training shall be given by the concerned Dept. head or his/her designee by pictures, videos, demonstration, and training modules to CW.

• • head/ designee shall explain intended SOPs to CW and may give the explanation in vernacular language with the help of already trained CW.

• • The concerned Dept. head or his designee shall ask questions to the Contractual Worker whether he/she has understood the content of the training.

• • After Dept. training of Contractual Worker head shall decide and assign the job responsibility of new Contractual Worker. as per annexure-3.

• • On the understanding of job responsibility, the respective Dept. head/designee shall take signature on acknowledgment by CW as per annexure-4.

• • After signing of Acknowledgement by Contractual Worker, Dept.

• • The Head shall be allowed him/her for working in the respective area.

• • The new Contractual Worker shall be monitor/supervisor by area in-charge/HOD or line leader on the basis of the criticality of the assigned job.

• • The training file of all individual Contractual Worker shall be kept to the designated place of the P&A department.

• • Training needs identification shall be done while assigning new activity to any Contractual Worker.

• • In case of Contractual Worker repeatedly doing a mistake or poor performance then retraining shall be provided by the respective Dept. head/designee.

• • Individual Dept. has to keep a common training attendance record file of Contractual Worker.

• • Training number, Training Allocation Log, and Training Attendance Sheet

• • Individual Dept. allocates their training number and maintains a training number allocation log as per annexure-5.

• • The individual department shall maintain their individual training number.

• • Training Allocation Log and Training Attendance Sheet issue by QA.

• • Training number shall be assigned to each training as per the following system:

                 ZZ/TRN/DC/YY/XXX

                 Where,

                 ZZ  – First 2 Letters of Company Name (Company Sort Name)

                 TRN           – Training

                 DC  – Dept. Code

                 YY – Last two digits of the current year.

                 XXX – Sequential training number like 001, 002

• • Maintenance, Retention & Destruction of Training Records

• • P&A Dept. has to keep the records till 5 years from their date of discontinuing work.

• • After which the records are destroyed and details of destruction shall be documented as per Document control SOP (Document Management System).

7.0   DISTRIBUTION OF SOP FOR WORKER TRAINING :

• • Environment Health and Safety

• • Information Technology

• • Maintenance

• • Personnel & Administration

• • Production

• • Quality Assurance

• • Quality Control

• • Warehouse

8.0   ANNEXURES – WORKER TRAINING:

Annexure 1: Induction Training Schedule of the new contractual worker

• The Induction Schedule of the new contractual worker for the respective recommended dept. HOD as under:

• Certification: Mr./Ms._____________________ has completed induction training and he/she is certified for departmental training.

Annexure 2: Worker Training Module.

Annexure 3: Job Responsibility.

Annexure 4: Training Acknowledgement of Contractual Worker.

Annexure 5: Contractual Worker Training Number Issuance Log Book

Annexure 6: Contractual Worker Training attendance Sheet.  

**********************************************END***********************************************