Kalal Jagadeesh Kumar

1.0 OBJECTIVE: To lay down the procedure for training of employees. 2.0 SCOPE: This procedure is applicable for all employees & contract employees working in all the departments. 3.0 RESPONSIBILITY: Employee : Complete the assigned trainings as per annual training calendar. Complete the required training before engaging the assigned activity. Report the external training if attended. HR : To organize and ensure effectiveness of induction training in coordination with various departments for new employees/ Transferred employee from other location To organize all the trainings in coordination with training coordinators from each department. To prepare annual cGMP training plan and conduct training as per the schedule. Responsible for all the training attendance records of trainings which are organized as a part of Annual Training plan Develop training modules with help of subject matter expert (SMEs) Identification of training needs in consultation with respective department heads. Department Head/Designee : To identify the job specific training needs for new joiners, transferred employees from other location and whenever there is change in role. Department Training coordinator : To coordinate for all training programs in the respective department. To ensure all the employees (Staff & Contract) undergo the required trainings. To ensure all the training cards are updated by all the employees in their respective department. To maintain the training attendance records and training cards of employees in their respective department. To ensure the training to the visitors/service providers before entering to the work area. Quality Assurance : To finalize GMP training needs and ensure effective implementation of procedure defined in this SOP. 4.0 ACCOUNTABILITY: For training calendar v/s execution of mandatory trainings: For GMP trainings : All Department HODs For Other than GMP Environment, Health & Safety (EHS) : HOD - EHS Other Trainings : HOD - HR & Administration 5.0 PROCEDURE: 5.1 General requirement: 5.1.1 Personnel imparting training shall be trained personnel on the topic or subject matter expert and/or experience in the specific area. 5.1.2 Before performing an activity by the employee shall be trained on the respective/applicable procedure. 5.1.3 Employees who are absent for more than 6 Months due to maternity, health issues and other reasons or employee who return to the base location after completion of deputation for the period exceeding 1 year shall require to complete training through self-training / CRT all the SOPs which are identified by his/her department HOD / Designee to perform his/her job. 5.1.4 Trainings attended through online mode shall be recorded in Training attendance record i.e Annexure-4 (HR-F-004) and facilitator shall mention the name of the trainer and sign the training record and complete the evaluation process if applicable 5.1.5 Class Room Training: Training given by trainer in a class room set up or through face to face interaction in a dedicated environment. 5.1.6 Online training: Training given through online mode like webex , Conference call and through other online modes. 1.1.1 Training is not mandatory for the following instances: People who are involved as signatories of the document like preparation/review/approver of the respective document/SOP/module. If no changes in the existing procedure during periodic review 5.1.7 The evaluation Acceptance criteria: 80% and above-Qualified Less than 80%-Needs retraining If a personnel secure less than 80%, require re-training, preferably within a week time. Respective personnel will be called to HR-Department to undergo re-training by reading the available material followed with assessment. HR / QA personnel will correct the assessment using ‘KEY’ available in the department and if a personnel secure 80% but not 100%, trainer shall explain all the correct answers to ensure the effectiveness of the training 5.1.9 Training module number shall be defined as follows for the modules which we use for new joinees GMP training TM/GMP/XX TM – Training Module GMP – Good Manufacturing Practice XX – Serial number for the module 5.2 Categorization of trainings: Training programs are categorized as below Induction Training: Training given to a new recruit / Transferred employee from other location, which is carried out at the time of starting of the employment to understand the organization systems and policies is called as Induction training. On the job training: Training given to an employee on the procedure or task in the actual work environment/shop floor is called as on the job training. Ongoing job training: Training given to employees on new SOP or revised SOP before making it effective, Up gradation of systems (automation, new software) & New Equipment operating procedures cGMP Training: Training given to employees on requirements of cGMP as per the ICH Q7,schedule M, EU guidelines and 21 CFR part 210/211 guideline External training: All Trainings workshops/seminars conducted by external agencies within or outside organization. 5.3 Induction Training: 5.3.1 Newly joined/ employee Transferred from other location shall undergo common induction training on overview of the organization, company polices, Code of conduct, cGMP, Data Integrity etc. 5.3.2 Before starting the induction program HR shall obtain specimen signatures from the employee as per Specimen Signature SOP PHL-DG-HR-SOP- HR department shall organize the Induction training to all employees who are newly joined/ Transferred from other location in the organization. Induction training schedule shall be completed in such a way to cover all the applicable departments 5.3.4 Respective department HOD / designee shall brief on departmental activities. If respective department HOD / designee is not available, he/she can give induction through online mode and training coordinator / facilitator shall mention the details of trainer and sign the induction record 5.3.5 Induction training details shall be documented in Induction Training Record i.e Annexure-2(HR-F-011). 5.3.6 Induction training module on cGMP and Data integrity (Ref. No. TM/GMP/01) shall read and understand by the newly joined/ transferred employee from other location, followed by assessment. 5.3.7 After completion of the induction training from assigned departments and successful evaluation of the cGMP and Data Integrity training module, HR shall certify for completion on induction training and send the employee to his/her assigned department for On The Job Training. 5.3.8 Induction training is not required in case of any employee changed to permanent role from contract roles. 5.4 Contract Staff Training 5.4.1 All the contract staff who are working in GMP area shall be trained on basic safety & GMP aspects before going to the work place. 5.4.2 Training needs shall be identified by respective HOD/Designee which contains the following as applicable. cGMP (Current Good Manufacturing Practices) training. Work related safety Trainings. Relevant SOPs 5.4.3 Contract employee shall complete identified trainings through classroom training only 5.4.4Training shall be given in local language (Preferably), on the “Basic GMP Awareness” module (TM/GMP/02) 5.4.5After the completion of training, by taking oral feedback based on case to case basis and document the evaluation appropriately in the Training Attendance record i.e Annexure-4(HR-F-004). 5.5 On The Job Training (Job Specific Training): 5.5.1 New employee / employee transferred from other location shall be trained on all applicable Standard Operating procedures and instructions before assigning him/her with job responsibilities by HOD. 5.5.2 On the job training requirement shall be identified by the respective department HOD/designee as per the Annexure-9 (HR-F-034). 5.5.3 The training needs shall be identified and which contains the following as applicable. cGMP (Current Good Manufacturing Practices) training. Data integrity Relevant SOPs 5.5.4 Employee shall complete his required trainings through class room training / Self-Training / on the job training or a combination. Trainings undergone through self-training / read & understood shall be recorded as per Annexure-3 (HR-F-030) and class room trainings shall be recorded as per Annexure-4 (HR-F-004). 5.5.5 Employee, who are having less than one year relevant experience shall undergo on the job training of SOPs through class room training mode and job related equipment operations training on shop floor by shift incharge / block manager and same shall be recorded as per Annexure-4(HR-F-004) 5.5.6 Individual Employee Training Cards shall be maintained in the respective departments by Department Training Coordinators. 5.5.7 Training details shall be entered in the training card of the employee as per annexure-6(HR-F-006) by individual employee and this card shall be maintained for all the employees in the department by the respective Department Training Coordinator. 5.5.8 HOD/Designee shall review the trainings undergone by employee and sign on each training card / page once completion of each training card / page in training card booklet 5.5.9 Job description shall be prepared by HR department personnel in coordinate with respective department HOD/Designee and approved by the respective department HOD/ designee. Job description shall be prepared as per SOP Job responsibilities and Site Organogram (PHL-DG-HR-SOP-100008). 5.6 Ongoing Job Training: 5.6.1 Ongoing training shall be conducted before effective of a new SOP or revised SOP. 5.6.2 Ongoing program shall include the following: SOP Training Program (new / revised) BMR/Manufacturing process trainings (New/revised) Specification & STP trainings (New/revised) Safety Training Qualification protocol and validation protocols All QMS related activities/ Training on the protocol based activities Up gradation of systems (automation, new software) New Equipment operating procedures General trainings External trainings 5.6.3 It is the responsibility of immediate supervisor to conduct the ongoing training as and when required. 5.6.4 For ongoing trainings, assessment is oral interaction between trainer & trainee, the trainer shall take the feedback and trainee has to comment whether it is satisfactory or not. The trainer shall enter this as evaluation at the bottom of the Training attendance record i.e Annexure-4(HR-F-004) after asking relevant questions. 5.6.5 After completion of ongoing training program the training cards shall be filled in by Individual employee and same shall be maintained by respective department training coordinator 5.7 cGMP Training 5.7.1 cGMP training modules shall be prepared by covering the requirements of cGMP requirements as per the ICH Q7,schedule M, EU guidelines and 21 CFR part 210/211 guideline. 5.7.2 Every year by the end of the month of March, HOD-HR & Admin shall finalize the training needs for the next year, after individual discussion with HOD-QA and other HODs. 5.7.3 The training calendar is rolled 31st March every year. 5.7.4 Head of concerned department should ensure completion of all the trainings required by the personnel in his department. For those who have not attended the training, the same shall be rescheduled in the next schedule or trained separately as required. 5.7.5 Employees who are joined on or before 31st December in the financial year are to be mandatorily covered in the same financial year annual GMP training calendar and rest who are joined from 1st January shall be covered in next financial year annual GMP training calendar preferably by end of June month 5.8 EHS Trainings 5.8.1 Trainings related to EHS shall be identified every financial year by HOD-EHS in coordination with HOD-HR as per EHS Training SOP No. EHS/SOP/008. These trainings shall be termed as ‘Other than GMP trainings’ and shall be monitored by HOD-EHS for delivery. 5.8.2 After the completion of training, personnel are evaluated through the questionnaire on the topic trained, to know the extent of training understood. 5.8.3 All the filled questionnaires are evaluated by Trainer / Training coordinator / Facilitator 5.9 External Training 5.9.1 External training shall be availed through the vendors/other technical agencies in the company premises or outside the premises like seminars and conferences sponsored byprofessional societies, commercial training groups, regulatory agencies etc. 5.9.2 Concerned responsible staff of each department will be attending such seminars/training. 5.9.3 External training programs conducted in the company premises / external location shall be recorded as per Annexure-4(HR-F-004). For trainings conducted in company premises, feedback shall be taken as per annexure-10 (HR-F-007). 5.9.4 Staff attending training sessions through external trainers shall give training to the other concerned personnel. 5.10 Procedure For Training Needs Identification (TNI): 5.10.1 HOD-QA along with HOD-HR & Admin shall identify the mandatory training needs for GMP for employees across bands for the ensuing year. This assessment shall be done based on performance of employees in GMP evaluated during audits, regulatory requirements, changes/ weaknesses found out during internal audits, justified remarks from customers, etc. 5.10.2 HOD-EHS shall identify the training needs for EHS for employees across Bands for the ensuing year. 5.10.3 TNI shall be Band and Topic specific. These trainings are mandatory. Training In-charge shall review to see that it is executed as planned. 5.10.4 Additional training not included in the original training plan, if required, shall be provided and documented. 5.11 Selection Of Trainer: 5.11.1 Training shall be conducted by appropriately qualified, experienced personnel with their respective subjects. 5.11.2 Trainer shall be selected based on the their experience, knowledge on the subject and other related aspects 5.11.3 Identification of trainers for individual departments shall be done by the respective department Head/section in charge based on their experience and technical expertise in specific activity. 5.11.4 After identification of trainer, trainers shall be certified by department/selection head as per Annexure-7(HR-F-032) based on the following (as applicable) but not limited to Presentation skills Communication skills Listening skills Technical knowledge Functional experience External training undergone. 5.11.5 Trainers who are responsible for mandatory GMP trainings shall be qualified through imparting of “Train the Trainer curriculum” or certified by HOD-QA as eligible trainer based on qualifications and years of experience in the domain of training. 5.11.6 “List of training faculty” shall be revised for every six months or as and when required 5.12 Review of mandatory trainings completion status: 5.12.1 Review of mandatory GMP trainings is done quarterly by HR department to evaluate whether the mandatory GMP trainings are covered. 5.12.2 Review shall be done quarterly on or before 15th first month of succeeding quarter every year. Quarterly review gives an idea of actual covered employees versus planned for the GMP trainings as per Annexure-1 (HR-F-002). 6.0 RECORDS Identification of Training Needs Training Cards Feed Back Questionnaire Attendance Sheet Examination Papers Induction record 7.0 ANNEXURES: Annexure-1 : Annual Training Plan (HR-F-002-07) Annexure-2 : Induction Training Record (HR-F-011-06) Annexure-3 : Training Attendance Record for Read & Understood / Self-training (HR-F-030-01) Annexure-4 : Training Attendance Record (HR-F-004-07) Annexure-5 : Training Questionnaire (HR-F-031-01) Annexure-6 : Employee Training Card (HR-F-006-07) Annexure-7 : List of Training Faculty (HR-F-032-01) Annexure-8 : List of Department Training Coordinators (HR-F-033-00) Annexure-9 : Training Need Identification for On The Job Training (HR-F-034-00) Annexure-10 : Training feedback Form (HR-F-007-05) 8.0 ABBREVIATIONS & DEFINITIONS: HR & Admin : Human Resources & Administration TNI : Training Needs Identification EHS : Environment Health Safety QA : Quality Assurance cGMP : Current Good Manufacturing Practices HOD : Head of Department TM : Training Manual SOP : Standard Operating Procedure CRT : Class Room Training ICH : International council for Harmonization CFR : Code of Federal Regulations BMR : Batch Manufacturing Record STP : Standard Testing Procedure QMS : Quality Management System ANNUAL TRAINING PLAN FOR __________ S. No. Training Topic/Course title Applicable department/Role Total audience* Training Schedule April to June July to September October to December January to March Plan Actual** Plan Actual** Plan Actual** Plan Actual** Signatory Prepared By (HR Manager) Reviewed by (HR&Admin-HOD / Designee) Approved By (QA HOD/Designee) Name Sign & Date *Total number of audience may vary based on resignation / new joiners **Actual may be higher or lower than planned, based on attendance INDUCTION TRAINING RECORD A. EMPLOYEE DETAILS: Name : Employee Code : Date of Joining : Date of transfer (If applicable) : Highest Qualification : Total years of experience : Designation : Department : B. INDUCTION PROGRAMME: Department Induction training Date & Time Trainers Name & signature EHS Safety awareness & Initiatives, PPE Occupational safety Time office Biometric system & Attendance & Leave management Production Unit-I Manufacturing flow Production Unit-II Manufacturing flow Production Unit-III Manufacturing flow Supply Chain Management & Stores Warehouse management system I.T. IT activities and initiatives E&M Department activities Regulatory Affairs Program Management Quality Control Department activities QA Department activities, Quality initiatives HR Introduction, Short summary of PPL history Personnel Hygiene & Medical examination req Operational Excellence Accounts Administration & Security Department Induction training Date & Time Trainers Name & signature TSD Projects R&D Any other departments_________ Note: If an employee joined for Production Unit-III induction training of Production Unit-I & Production Unit- II can be skipped and vice versa Reviewed by the HR HOD/ Designee: Name: ______________________ (Signature & Date) Training Attendance Record for Read & Understood / Self Training Name : Employee Code : Designation : Department : SOP / Document Title SOP / Document No. SOP / Document Version / Issue No. Sign & Date *Evaluation (Mention Satisfactory or Unsatisfactory): ___________________ *Evaluated by (HOD / Designee): Name : _________________ Signature & Date:_____________________ *HR HOD / Designee Signature: Name : _________________ Signature & Date:_____________________ Note: * Evaluator signature applies to OJT only and additional sheets can be used if required. TRAINING ATTENDANCE RECORD TRAINING MODULE/ DOCUMENT/SOP TITLE : DOCUMENT No. (if any) : Version / Issue. No. : Trainer Name : TYPE OF TRAINING : Class Room Training / On-the-job Training / ongoing job training / Online Training TRAINING CLASSIFICATION : GMP / Other than GMP DATE : DURATION : From (HH:MM):____________To (HH:MM)________ Duration (HH:MM)______ VENUE/Location : THE FOLLOWING EMPLOYEES ATTENDED TRAINING PROGRAM Sl. No. Employee Code No. Name of the Employee Department Signature Remarks Evaluation: Trainer / Training coordinator / Facilitator Sign & Date: TRAINING QUESTIONNAIRE Topic with reference document number, if any Department Training Date Name of the Trainee Employee Code Sign & date Name of the trainer or faculty: Q1: Ans: Q2: Ans: Q3: Ans: Q4 Ans: Q5: Ans: Assessment: Total marks allotted Total Marks obtained % of Marks Qualified / Disqualified (Tick on correct option) Retraining required Yes/No Trainer / Training coordinator / Facilitator Sign & Date EMPLOYEE TRAINING CARD Name   Designation Department   Employee Code   Date of Joining Year Sl. No. Date of Training SOP Number or Document Number or Training Module Training topic Name of Trainer / Faculty Training Classification Training Hrs. Evaluation after the training Training attendance sheet s.no. Recorded By sign & Date GMP * Other than GMP * Qualified * Needs retraining *           Reviewed by HOD / Designee (Signature & Date): _____________________________ *Note: Use tick mark “√“ or “_” or “NA” in relevant fields wherever applicable in this format List of Training Faculty S.No Emp ID Employee Name Designation Department Qualification Total Exp. Qualified for the topic/s Remarks                                                                                                                               Prepared By Reviewed by Approved by HR Manager / Designee Dept HOD / Designee HOD QA / Designee Name: Name: Name: Sign & Date: Sign & Date: Sign & Date: List of Department Training Coordinators S. No. Name of the Training coordinator Employee Code Department/Section/Block Remarks Prepared By:Approved By: HR Manager / DesigneeHOD QA/Designee Name:Name: Signature & DateSignature & Date Training Need Identification for On the Job Training* Name : Employee Code : Designation : Department : S. No SOP No. SOP Name Department Applicable (Yes / No) *This format is used only for new joiners for OJT Approved By HOD / Designee Name: Signature & Date: Note: Additional sheets can be used if required TRAINING FEEDBACK FORM* Program Name: Your Name: (Optional): Date: Learning Facilitator: Learning Effectiveness 1 Strongly Disagree 2 Disagree 3 Agree 4 Strongly Agree The learning objectives of this program were clear and fully met The design and content of the program was effective The delivery style of the facilitator was clear and interactive Comments: (Please provide us with specific observations) 1) 2) 3) Learning Impact 1 Strongly Disagree 2 Disagree 3 Agree 4 Strongly Agree My knowledge of the subject has improved I found the learning from the program relevant and practical This program will help improve my performance at work. Comments: (Please provide us with specific observations) 1) 2) 3) How likely are you to recommend this program to your colleagues? Not At All Likely Extremely Likely - Overall Program Feedback: (Please provide us with specific observations) Aspects of the program I found most effective: 1) 2) 3) Suggestions to improve the program: 1) 2) 3) 9.0 Revision history: Version No. Brief Description of The Changes Made Effective Date Change Control No. 10.0 Incorporated revision history version 10.0 along with last revision summary as given below. To elaborate Training of Employee SOP for better clarity. 01/11/19 CC/HR/- Included virtual induction process and technical training for new joinees who joins in production with less than 1 Year relevant experience 23/11/20 CC/HR/- Organization name changed from “Piramal Enterprises Limited” to “Piramal Pharma Limited” Annexure-4 format number changed to HR-F-004-7 Annexure-6 format number changed to HR-F-006-7 23/11/20 CC/QA/- Introduced version number for training module which we use for contract employees for basic GMP training Refer header CC/HR/0159