05 Sop For Competence, Awareness & Training

REVITAL HEALTHCARE (EPZ) LIMITED
STANDARD OPERATING PROCEDURE

T I T L E :SOP FOR COMPETENCE, AWARENESS AND TRAINING
PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

RHEL/HR/SOP/140 03/01/2022 03/01/2022 03/01/2024
REVISION NO.:01
COMPETENCE, AWARENESS AND TRAINING

PROCEDURE
APPROVED BY: SIGN & DATE

Lorraine Kai
(Human Resource Manager)
(Prepared By)
Nancy Mwangi
(Ass. Quality Assurance Manager)
(Reviewed By)
Caroline Njambi
(Ass. Quality Assurance Manager)
(Reviewed By)
Vikrant Chowgule
(Head Quality)
(Approved By)
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RHEL/HR/SOP/140 03/01/2022 03/01/2022 03/01/2024
REVISION NO.:01
REVISION HISTORY
Revision No. Revised Page(s) Description Date
00 00 Original Issue 01/01/2020
01 All Header, footer, Revision 03/01/2022
table, Approvals
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RHEL/HR/SOP/140 03/01/2022 03/01/2022 03/01/2024
REVISION NO.:01
PURPOSE:
To establish a method for the providing competence to perform tasks that may impact Environment in
the workplace. The procedure provides a method for identification of the training needs and providing
appropriate training.
SCOPE:
The procedure is applicable to all the employees and contractors performing operations pertaining to
significant aspects at RHEL.
RESPONSIBILITY:
HR executive or Designee - Implementing this procedure.
ACCOUNTABILITY:
EMR or Designee and Managing Director or Designee shall be accountable for Implementation and
compliance of the total system.
PROCEDURE
 Identify the training needs pertaining to the Environment Management System during the
following stages:
 At the start of implementation of Environment Management System
 At the time of employees performance appraisal and at the time of joining (for new
employees).
 Introduction of New Product / Process / Activity, which has Significant Environmental
Aspects.
 HR Executive in consultation with the respective department in-charge, identifies the areas
for training and personnel to be trained as per the following table:
Area/ Topic Personnel to be Trained

a) Awareness of Environment All employees
Management system
b) Awareness of Environment Policy All employees
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RHEL/HR/SOP/140 03/01/2022 03/01/2022 03/01/2024
REVISION NO.:01
Employees from respective areas of

c) Significant Environmental Impacts of
operation identified in Environment
respective area of operation.
Management system
d) Roles & Responsibilities in achieving Employees from respective areas of
conformance with Environment operation identified in Environment
Policy Management system
e) Potential Consequences of departures operation identified in Environment
from specified Operating Procedures Management system
f) Competence Training operation identified in Environment
Management system
g) Emergency Preparedness & Response
All Employees
like Mock Drill.
 The period wise training need is updated in “Training Calendar”, it updated as & when new
training needs are identified and information given to the employees through concerned
department in-charge on training schedule.
 Also, Department In-charges identify the training needs as and when required and inform the
same to HR Executive to include in the training schedule.
 HR Executive reviews and monitors transfer of employees and update the training needs if
necessary.
 Personnel performing specific tasks / working in specific areas like, Maintenance of
machinery/utility, forklift operation, Internal Auditing etc. are qualified on the basis of their
relevant qualification / experience / training. Wherever required necessary required trainings are
provided.
 The employee-wise training record is maintained Employee Training Record
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RHEL/HR/SOP/140 03/01/2022 03/01/2022 03/01/2024
REVISION NO.:01
 HR Executive Updates training schedule on regular basis and ensures that the appropriate
training is completed. Trainings planned, its status and effectiveness are discussed in MRM.
RELATED DOCUMENTS:
 Employee Personal File
 Training Schedule
 Training records.
REFERENCE:
 ISO 13485:2016: Medical Devices-QMS-Requirements’ for regulatory purposes, “Clause 4.2.3

Control of Documents and Clause 4.2.4 Control of records”.
 ISO 15378:2015: Primary Packaging material for medical products particular requirements for
the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP),
“Clause 4.2.3 Control of Documents” and “Clause 4.2.4 Control of Records”.
 ISO 14001:2015: Environmental Management System: Clause 4.4.5 control of documents and
4.5.4 Control of records.
 EMS manual; Revital Healthcare (EPZ) Ltd. EMS-Z/F/04/30
ABBREVIATIONS:
EMR: Environment Management System Management Representative

MRM: Management Review Meeting
MOM: Minutes of the Meeting.
HRD: Human Resources Development
EMS: Environmental Management System
GMP: Good Manufacturing Practice
Dept.: Department
RHEL: Revital Healthcare (EPZ) Ltd.
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RHEL/HR/SOP/140 03/01/2022 03/01/2022 03/01/2024
REVISION NO.:01
SOP: Standard Operating Procedure

N/A: Not Applicable
Page 6 of 6

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REVITAL HEALTHCARE (EPZ) LIMITED

STANDARD OPERATING PROCEDURE

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

COMPETENCE, AWARENESS AND TRAINING

APPROVED BY: SIGN & DATE

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

Area/ Topic Personnel to be Trained

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

Employees from respective areas of

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

 ISO 13485:2016: Medical Devices-QMS-Requirements’ for regulatory purposes, “Clause 4.2.3

EMR: Environment Management System Management Representative

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

SOP: Standard Operating Procedure

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