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 Risk Analysis related to Environment Management System

Reference Number SCPL/EMS-EIR
Dated Updated: 07-07-24
QUALITATIVE MEASURE OF LIKELIHOOD
SNO DESCRIPTOR DESCRIPTION
1 Rare Extremely unlikely, may only occur in exceptional circumstances. Has never occurred before.
2 Unlikely Unlikely to occur, but possible.occured less than once in 6 months.
3 Possible May occur/reoccur, but not definite. Has previously occurred once or twice in 3 months
4 Likely Will probably occur/reoccur. Has happened several times per month before
5 Very likely Continuous exposure to risk. Has happened before regularly and frequently
QUALITATIVE MEASURE OF CONSEQUENCE
SNO DESCRIPTOR
1 Minimal Little impact on Environment and Business, interested parties not affected

2 Minor Slight impact on Environment, Process Environment may impact

May affects achievement Environment performance of the organisation. Minor affect on legal compliance as
3 Moderate
well as interested parties
Likely to affect Environment performance of the organisation, Effect on interested parties, Affect on legal
4 Major
compliance
Likely to affect Environment performance, global environment, Dissatisfaction of interested parties. Not
5 Severe
meeting Compliance obligation
Risk Ranking:
Below 9 – Low risk; between 9-16 – Medium risk; above 16 – High Risk

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