DEPTT/

SECTION
COMPANY
WIDE

TITLE
ENVIRONMENTAL ASPECT IDENTIFICATION AND
ANALYSIS
RELATED CLAUSE:
REVIEWED BY

DOCUMENT #
RP-SP/F-08

ISSUE #.
01

ISSUE DATE
11-10-2012

PAGE #.
1 OF 3

APPROVED BY

1.0 Purpose
The purpose of this procedure is to provide a system and instructions to identify
environmental aspects of Ray Pharma manufacturing activities and products
including waste
in order to determine those, which may have a significant impact on the
environment.
2.0 Scope
This procedure covers all activities and products including wastages associated with Ray
Pharma manufacturing processes.
3.0 Responsibility
3.1 QCM is responsible to perform the aspect identification, impact analysis and develop
the
operational controls plan for environmental impacts for all the existing and new
processes.
3.2 QCM is also responsible to re-perform the aspect identification, impact analysis
and update the operational controls plan for environmental impacts in case of
any change in the process , change in control limits, available information
regarding environmental hazards etc
4.0 Procedure
4.1 The procedure consists of following activities which will be executed in the logical
sequence.
a. Make list of all activities / processes
b. Inspect each process and activity and conduct material balance on
Environmental Aspect Identification Form
c. Identification of Environmental Aspect
d. Make List of all aspects.
e. Determine the impact associated with each aspect
f. Perform Environmental Aspect /Impact Analysis based on current status
and applicable regulations and determine the aspect significance.
g. Develop the Operational Control Plan as Environmental Testing/Monitoring
Plan
h. Develop the system procedures, work instructions and guidelines as a part
of operational controls.
5.0 Related Documents
5.1 Environmental Aspect Identification Form (RP-ENV-01)
5.2 List of Environmental Aspect (
5.3 Environmental Impact Matrix

5.4
5.5

Environmental Aspect Control and Monitoring

Environmental Testing-Monitoring Plan

6.0 Procedure

PROCESS

ACTIVITY

Identification of process

Identification of
Environmental Aspect

Make list of all

Environmental Aspects

Determine Impact associated with

each aspect

Perform Impact & Aspect Analysis

QCM Manager will identify all the activities and

process carried out under the factory of Ray
Pharma
Using the material balance equation, the inputs
and outputs for all the processes will be identified.
Inputs into the process may include supplies, raw
materials, chemicals, packaging, and energy
consumption, water consumption, oil consumption
etc. Outputs from the process may include
products, solid wastes, liquid wastes, emissions,
noise, and odor.
QCM record the results of Environmental Aspect
on EAI form

After the Environmental Aspect Identification study,

QCM will make the list of all the identified aspects.

QCM will determine the impact associated with

each aspect.

QCM will perform the Aspect & Impact Analysis.

QCM will identify the positive and negative impact
associated with each aspect
For each impact associated with aspect, QCM will
identify whether the aspect falls within any EPA,
local regulatory or Areva requirement.
During the analysis, QCM will also consider the
existing controls and mitigation measures in place
to reduce or eliminate the significance of aspect
Using the rating matrix, significance level of each
aspect is determined