Environmental Control

8/3/2019 Environmental Control

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ENVIRONMENTALCONTROL

Presented By: Guided By:K. Anupama Mr. Anil SharmaM.Pharm [Q.A] H.O.D [ Q.A Dept ]1st Semester


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Environment

An "environment" is the whole ofsurrounding things.

In ecology, environment refers tothe surroundings of humankind.

Generally, environment refers tothe biological, physical and socialthings on the earth or ininhabitable space outside theearth's atmosphere.

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Need of environmental control

Concern for the environment is growing dayby day.

Damage to the environment is caused by ourever increasing demands which consume theworlds natural resources, and by thepollution of land, water and air caused by ouractivities and the wastes we create.

More and more companies are seeking tounderstand how their operations impact onthe environment, and these companies thenput management systems in place to keepcontrol of the impacts.



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Climate change The worlds environment is continually

changing. Originally this was caused by physical

factors, for example erosion by rivers leading

to mountains and valleys. Cycles of long-term climate change led to

glacial erosion followed by a return to warmerconditions; deserts were created by sun and

wind. Man has caused his own changes and in thelast centuries, since the Industrial Revolution,the rate of change has become faster andfaster.



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We need to use the worlds resources to liveand create all the things that we regard as

necessary to live a good life. In the process we create pollutants and

wastes that cause more and more damageand put the remaining resources at risk.

For the sake of future generations somecontrol has to be exercised.A comprehensive overview The key indicators of environmental impact

that need to be at the front of every persons mind when planning any change, and thetypes of actions that cause that impact, areshown in the following tables:

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Climate Change


EFFECTS EXAMPLES OF CAUSES

Global warming

Ozone depletionDeforestationAcid rainDesertification

Vehicle exhaust emissions, power station and furnaceemissions.Use of CFCs (now banned).Logging; burning forest for short-term agricultural gain.Power station emissions e.g. SO 2 and NO 2.Over extraction of natural water supplies; removingvegetation, trees , hedges.

POLLUTION

Air pollutionWater pollutionLand contamination

Gaseous emissions from factories, vehicles.Chemical discharges to drains and watercourses.Toxic substances disposed off incorrectly; spillages.


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Natural ResourcesResource Examples of how the resource is depleted

Fuel Burning of fossil fuels e.g. coal, oil, gas; wasting energy

Land Landfill; erosion; building

Water Over-extraction; pollution of natural water sources

Minerals Over-extraction

Clean air Emissions; vehicle exhausts

Biodiversity Poor farming practices e.g. monoculture, use of pesticidesand herbicides; destruction of habitats and sites of specialscientific interest (SSSIs).

Waste hierarchy Little attempt to move up the waste hierarchy from landfill(least desirable); incinerate for energy; re-use; recycle;reduce (best option).



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Beneficial ActionsResource Example of action

Energy Insulate buildings; switch off lights and computers; buyenergy efficient equipment.

Resources Economical use of resources reduce costs

Waste Producing less waste saves resources and reducesdisposal costs.

Marketing Reductions in costs lead to more competitively pricedproducts; consumers and customers are becomingmore environmentally aware.



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Environmental impacts by PharmaceuticalIndustries:

VOC emissions from reactors separation and purification processes

Particulate emissions from grinding and polishing

operations. Solvent residues in wastewater from

Two phase separations Wet scrubbers

Solid wastes (often containing solvent residues) fromextractive operations Difficulty of instituting process changes due to

FDA approval requirements

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ENVIRONMENT MANAGEMENT SYSTEM Environmental management system (EMS) refers to

the management of an organization's environmentalprograms in a comprehensive, systematic, planned anddocumented manner. It includes the organizationalstructure, planning and resources for developing,implementing and maintaining policy for environmentalprotection.

By environmental management we mean keeping controlof our activities so that we do what we can to conservethese physical resources and to avoid polluting them.

Our concern must be for the world as a whole, its air, water, land, natural resources, flora, fauna, humans, andtheir inter- relations, to quote from ISO 14001.



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Benefits of EMS:

There are four reasons why everyorganization should take environmentalfactors into account in its managementprocesses:

1. Ethical As human beings we have a duty to look afterthe world in which we live and to hand it on toour children in good shape.

2. Economic Conserving resources and not generatingwaste products or wasting energy means wesave on cost.



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There is also increasing evidence thatinsurance companies will consider areduction in premiums if by having proper

managerial control over environmental risksthe likelihood of there being a disaster shouldbe reduced.

3. Legal

More and more governments including ourown are passing laws to control how weinteract with the environment. Therefore weneed systems to make sure we stay within

the law, otherwise we can be fined anddamage our reputation.

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4. Commercial

More and more large organizations are takingcontrol of their environmental responsibilitiesand they expect their suppliers andsubcontractors to do the same.

By being able to demonstrate goodenvironmental practice, new marketopportunities may open up to you.



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International and national governmental actionfor environment protection

The serious threats to our environment have beenincreasingly recognized by governments since the 1960s,gathering momentum all the time. Some of the landmarkmilestones at the international level are described in thefollowing paragraphs.

The Brundtland Report 1987 The World Commission on Environment and Development

chaired by Norways Prime Minister Gro Harlem Brundtlandproduced a report Our Common Future . In it, the phrasesustainable development was defined as forms ofprogress which meet the needs of the present withoutcompromising the ability of future generations to meet their

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The UN Framework Convention on Climate Change 1997 The UNs concern for climate change took a further significant step

with the Kyoto Protocol, which set the target of reducing the emissionof greenhouse gases to 5.2 per cent below 1990 levels by 2008 2012.World Summit on Sustainable Development 2002 (Second Earth Summit)

The Johannesburg conference was billed as Rio + 10. Reactions tothe outcome of the conference were mixed, with some people feelingthat hard progress was obscured by politics.

o Nevertheless, firm commitments were agreed, including: harmonizing the classification of chemicals by 2008 and producing

and using chemicals that will not harm human health by 2020; increasing the efficient use of energy and the proportion of energy

from renewable sources; reversing the trend of losses in biodiversity by 2010; ending destructive fishing and establishing protected areas by 2012.



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ISO 14001evolution

ISO 14001 has been developed as a formalized structurefor an environmental management system which can beindependently assessed for compliance.

The British Standards Institute (BSI), a world-respectedstandards body, in conjunction with many othercommittees and interested parties, developed andproduced BS 7750:1992, the worlds first environmentalstandard.

ISO (the International Standards Organization)established a new technical committee to developinternational standards in environmental management.



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Thus ISO 14001 was first published in 1996 with a swiftuptake by organizations world-wide.

All ISO standards are periodically reviewed, typicallybetween 3 and 5 years.

The revised ISO 14001 has no major changes. However,the brief of the committee responsible was to:

1. Ensure compatibility with ISO 9001:2000 which was amajor review of ISO 9000:1994.

2. Improve the clarity of the text i.e. clarity of intent especiallyfor translation purposes.



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Reasons for seeking ISO 14001certification

The reasons why organizations implement ISO 14001 aregenerally given as:

To gain or retain market share via a green corporateimage

To attract more ethical investment To reduce insurance risks To reduce prosecution risks

To reduce costs



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ISO 14001 ISO 14001 requires organizations to identify theenvironmental aspects of their activities, products or

services and to evaluate the resulting impacts on theenvironment, so that objectives and targets can be set forcontrolling significant impacts and for improvingenvironmental performance.

ISO 14001 specifies the EMS requirements that anorganization must meet in order to achieve certification bya third party the certification body.(The Standard wasspecifically designed to be an auditable standard leadingto independent certification.)



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The requirement of ISO 14001 include:

Development of an environmental policy.

Identification of environmental aspects and evaluation ofassociated environmental impact. Establishment of relevant legal and regulatory

requirements.

Development and maintenance of environmentalobjectives and targets. Implementation of a documented system, including

elements of training, operational controls and dealing withemergencies.

Monitoring and measurement of operational activities. Environmental internal auditing Management reviews of

the system to ensure its continuing effectiveness andsuitability.



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Clauses of ISO 14001

The six main clauses of ISO 14001 are titledas follows:

4.1 General Requirements

4.2 Environmental Policy 4.3 Planning 4.4 Implementation and Operation 4.5 Checking and Corrective Actions

4.6 Management Review



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4.1 General considerations This clause of the Standard describes, at length, the intended

purpose of the EMS (that is, an improvement in theenvironmental management system is intended to show animprovement in environmental performance).

There must be some objective evidence of the system being inplace and reviewed and revised.

Such review processes can take the form of monthly progressmeetings, corrective actions from audits and of course auditsthemselves.

Keeping documentary evidence of management reviews (even

if not the fully formalized Management Review that clause 4.6of the Standard refers to) and having some evidence ofawareness training for those staff who control thoseenvironmental aspects that have a highly significantenvironmental impact, would also be wise steps to take.

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4.2 Environmental policy There must be an environmental policy that is consistent with

any group or sector policy, is relevant to the organization'sactivities, commits to prevent pollution and observe relevantlegislation, has a commitment to continual improvement andsetting environmental objectives and targets, and states how it ismade available to all employees and public.

Thus, the policy was intended to be the main driver of theenvironmental management system and all other elements ofthe system would follow on naturally from it.

The clause includes the statement be available to the public . Infact, the concept of public availability is open to manyinterpretations and in reality it is only the stakeholders who areinterested in the content of the environmental policy (rather than

the general public).Free template from www.brainybetty.com 24


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4.3 Planning Through its sub-clauses, clause 4.3 directs the

implementing organization towards key areas in theplanning process.4.3.1 Environmental aspects

Environmental aspects shall be identified both for normaloperating conditions, for reasonably foreseeable deviationsand for emergencies. This is usually documented in aRegister of Environmental Aspects.4.3.2 Legal and other requirements

Relevant legislative, regulatory and other environmentalrequirements must be identified .This is usuallydocumented in a Register of Environmental Legislationwhich must be kept up to date.



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4.3.3 Objectives and targets Environmental improvement objectives and targets must

be set, consistent with the policy.4.3.4 Environmental management programme

Programmes must be set for the achievement of theobjectives and targets, and responsibilities must bedesignated.



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4.4 Implementation and operation4.4.1 Structure and responsibility

Responsibilities must be defined. Adequate human resourceswith appropriate skills must be provided. There must be amanagement representative with the authority to ensure theEMS is implemented and to make sure that performance is

reported upon to management.4.4.2 Training, awareness and competence All employees must be aware of the environmental objectives,

have appropriate job training in relevant environmentalprocedures and know the consequences of departing from theprocedures.4.4.3 Communication

There must be a system for receiving and responding tocommunications regarding environmental aspects, from both

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For example, when contractors are working on site,

whether in a long-term or short-term capacity, they need to

be aware of, and observe, the local environmental rulesand procedures. Assessors are paying particular attentionto the control of contractors, simply because experiencehas shown that they can be the cause of a significantnumber of environmental incidents.

4.4.7 Emergency preparedness and response Reasonably foreseeable and emergency situations must

be identified and appropriate procedures implemented.They must be reviewed, especially if they have ever beencalled into action, and tested periodically.


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4.5 Checking and corrective action4.5.1 Monitoring and measurement

There must be procedures for monitoring activities which impacton the environment. Any monitoring equipment must becalibrated.4.5.2 Nonconformance and corrective and preventive action

There must be a system for handling non compliances, with

investigation and corrective actions.

4.5.3 Environmental management records Records must be kept and archiving requirements specified.

4.5.4 Environmental management system audit The EMS must be audited regularly to ensure the system is

operating effectively. There must be an audit programme and a

reporting and follow-up system.Free template from www.brainybetty.com 30


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4.6 Management Review

Management must periodically review the environmentalpolicy, objectives and the EMS to ensure they are stilleffective and relevant to the organization's needs in thelight of changing circumstances.

A guideline for the time interval between reviews is 3 to 6months in the early stages of implementation followed byannual reviews once the system becomes more mature. Inreality, the time intervals should be determined by events.



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ISO 14001 implementation cycle for continuousimprovement


Clause 4.6ManagementReviewClause 4.4

Clause 4.5Checking andCorrectiveAction

Clause 4.3Planning

Clause 4.2EnvironmentalPolicy

Clause 4.1GeneralRequirements

Clause 4.4Implementationand Operation


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The structure of documented EMS


EnvironmentalManagementManual

Register ofEnvironmentalLegislation

Register ofEnvironmental

Aspects

OperatingProcedures

Work Instructions(if needed)


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By examining the review, the auditor will get a measure ofthe environmental competence of the organization and anindication of the level of understanding of environmentalissues by the organization.

If an organization decides to undertake this preparatoryreview, there are two options open:

1. Perform the preparatory environmental review usinginternally available resources.

2. Perform the preparatory environmental review usingexternal consultants.

These options are considered below:



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1. Internally available resources: Several options exist for this approach. One option is to send out

questionnaires to each department head, requiring thoseindividuals in charge to complete a series of questions, including,for example:

What materials are used What quantities of materials are used How much energy is used

The amount and type of waste streams Possible emergency situations Abnormal situations (frequency of start-ups and shut-downs,

maintenance, breakdowns and incidents) Any history of out of the ordinary incidents

Any areas of training required This will form a meaningful exercise by establishing the baseline to

work from after analysis by management.



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2. External environmental consultants: The individual chosen to lead the environmental

management team and implement ISO 14001 is the

quality assurance manager. To commence from a standing start into the complex

world of environmental issues and perform a meaningfulpreparatory review is something not to be undertaken

lightly. The organization is well advised to use the services of

an environmental consultancy and ask them to perform apreparatory review prior to ISO 14001 implementation.



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Importance of EMS :An Environmental Management System (EMS):

Serves as a tool to improve environmental performance. Provides a systematic way of managing an organizations

environmental affairs.

Is the aspect of the organizations overall managementstructure that addresses immediate and long-term impactsof its products, services and processes on theenvironment.

Gives order and consistency for organizations to address

environmental concerns through the allocation ofresources, assignment of responsibility and ongoingevaluation of practices, procedures and processes.

Focuses on continual improvement of the system.



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References:

Ken Whitelaw; ISO 14001 Environmental SystemsHandbook; Page no. 1-122

A. J. Edwards; ISO 14001 EnvironmentalCertification Step by Step

http://ecm.ncms.org/ERI/new/IRRpharm.htm#impacts

http://en.wikipedia.org/wiki/Pharmaceutical_drug


Go Green
http://ecm.ncms.org/ERI/new/IRRpharm.htmhttp://ecm.ncms.org/ERI/new/IRRpharm.htmhttp://en.wikipedia.org/wiki/Pharmaceutical_drughttp://en.wikipedia.org/wiki/Pharmaceutical_drughttp://ecm.ncms.org/ERI/new/IRRpharm.htmhttp://ecm.ncms.org/ERI/new/IRRpharm.htm


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Earth allows you to stand. Let it stand the way it is.!

Go Green

Nurture Nature For Our Future!

Pollution, pollution green is the solution.

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Environmental Control

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