ISSUES RELATED TO ENVIRONMENT MANAGEMENT SYSTEM

Document Name Risk Analysis related to Environment Management System

Reference Number SCPL/EMS-EIR
Dated Updated: 07-07-24
Risk
Description of Risk Risk Risk
S. No. Risk involved Existing controls accepted Opportunities
issue severity likelihood level
(Y/N)
Customer
Customer dissatisfaction with Implemented and
satisfaction with
1 respect to EMS leads to certified for ISO 4 1 4 Y
respect to
business loss 14001.
environment
Internal audits
conducted once in
Not meeting GMP six months to
2 Regulatory Issues requirements will lead to check the 5 1 5
No additional
Cancel the GMP certification implementation of Y control Required
GMP
requirements.
As unit is located
Government
3 Approved Phama 5 1 5 Y
policy on pharma
Re-location of unit Zone, ( No additional
industries
) control Required

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 ISSUES RELATED TO ENVIRONMENT MANAGEMENT SYSTEM

Document Name Risk Analysis related to Environment Management System

Reference Number SCPL/EMS-EIR
Dated Updated: 07-07-24
Risk
Description of Risk Risk Risk
S.No. Risk involved Existing controls accepte Opportunities
issue severity likelihood level
d (Y/N)
Situated in Air Quality to be
Issues with
Odour-Smell to neighbour Approved 3 2 6 Y monitored.
neighbour
industries Pharmacy city Greenery to be
industries
developed
No effluent is
being directly
5 Issues with near Odour-Smell to neighbour 3 1 3 Y Not required
released. No such
locality/villagers/ villagers
incidents occurred
so far.
Situated in
Approved
Pollution from Poor Air Quality levels, pharmacy city, no Air Quality to be
6 other neighbour Effects on performance of Risk of from 3 2 5 Y
monitored
industries employees other industries as
PCB monitors
regularly

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 ISSUES RELATED TO ENVIRONMENT MANAGEMENT SYSTEM
Document Name
Reference Number
Dated Updated: 07-07-24
SNO DESCRIPTOR
1 Rare
2 Unlikely
3 Possible
4 Likely
5 Very likely
SNO DESCRIPTOR
1 Minimal
2 Minor
3 Moderate
4 Major
5 Severe
Risk Ranking:
Below 9 – Low risk; between 9-16 – Medium risk; above 16 – High Risk
Risk Analysis related to Environment Management System
SCPL/EMS-EIR
QUALITATIVE MEASURE OF LIKELIHOOD
DESCRIPTION
Extremely unlikely, may only occur in exceptional circumstances. Has never occurred before.
Unlikely to occur, but possible.occured less than once in 6 months.
May occur/reoccur, but not definite. Has previously occurred once or twice in 3 months
Will probably occur/reoccur. Has happened several times per month before
Continuous exposure to risk. Has happened before regularly and frequently
QUALITATIVE MEASURE OF CONSEQUENCE
Little impact on Environment and Business, interested parties not affected
Slight impact on Environment, Process Environment may impact
May affects achievement Environment performance of the organisation. Minor affect on legal compliance as
well as interested parties
Likely to affect Environment performance of the organisation, Effect on interested parties, Affect on legal
compliance
Likely to affect Environment performance, global environment, Dissatisfaction of interested parties. Not
meeting Compliance obligation
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