ENVIRONMENTAL CONTROL and EMS

ENVIRONMENTAL MANAGEMENT SYSTEM [ISO 14001] : 

Presented By: K. Anupama M.Pharm [Q.A], 1 st Sem Gyan Vihar School of Pharmacy Suresh Gyan Vihar University, Jaipur ENVIRONMENTAL MANAGEMENT SYSTEM [ISO 14001]

Environment: 

Environment An "environment" is the whole of surrounding things. In ecology, environment refers to the surroundings of humankind. Generally, environment refers to the biological, physical and social things on the earth or in inhabitable space outside the earth's atmosphere. 2

Need of environmental control: 

Need of environmental control Concern for the environment is growing day by day . Damage to the environment is caused by our ever increasing demands which consume the world’s natural resources, and by the pollution of land, water and air caused by our activities and the wastes we create. More and more companies are seeking to understand how their operations impact on the environment, and these companies then put management systems in place to keep control of the impacts. 3

Climate change: 

Climate change The world’s 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 warmer conditions; deserts were created by sun and wind. Man has caused his own changes and in the last centuries, since the Industrial Revolution, the rate of change has become faster and faster. 4

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We need to use the world’s resources to live and 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 damage and put the remaining resources at risk. For the sake of future generations some control has to be exercised. A comprehensive overview The key indicators of environmental impact that need to be at the front of every person’s mind when planning any change, and the types of actions that cause that impact, are shown in the following tables: 5

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Climate Change 6 EFFECTS EXAMPLES OF CAUSES Global warming Ozone depletion Deforestation Acid rain Desertification Vehicle exhaust emissions, power station and furnace emissions. 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; removing vegetation, trees , hedges. POLLUTION Air pollution Water pollution Land contamination Gaseous emissions from factories, vehicles. Chemical discharges to drains and watercourses. Toxic substances disposed off incorrectly; spillages.

Natural Resources: 

Natural Resources Resource 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 pesticides and herbicides; destruction of habitats and sites of special scientific 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). 7

Beneficial Actions: 

Beneficial Actions Resource Example of action Energy Insulate buildings; switch off lights and computers; buy energy efficient equipment. Resources Economical use of resources reduce costs Waste Producing less waste saves resources and reduces disposal costs. Marketing Reductions in costs lead to more competitively priced products; consumers and customers are becoming more environmentally aware. 8

Environmental impacts by Pharmaceutical Industries:: 

Environmental impacts by Pharmaceutical Industries: 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) from extractive operations Difficulty of instituting process changes due to FDA approval requirements Need for product purity 9

ENVIRONMENT MANAGEMENT SYSTEM: 

ENVIRONMENT MANAGEMENT SYSTEM Environmental management system (EMS) refers to the management of an organization's environmental programs in a comprehensive, systematic, planned and documented manner. It includes the organizational structure, planning and resources for developing, implementing and maintaining policy for environmental protection. By ‘environmental management’ we mean keeping control of our activities so that we do what we can to conserve these 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, and their inter-relations’, to quote from ISO 14001. 10

Benefits of EMS:: 

Benefits of EMS: There are four reasons why every organization should take environmental factors into account in its management processes: Ethical As human beings we have a duty to look after the world in which we live and to hand it on to our children in good shape. 2. Economic Conserving resources and not generating waste products or wasting energy means we save on cost. 11

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There is also increasing evidence that insurance companies will consider a reduction in premiums if by having proper managerial control over environmental risks the likelihood of there being a disaster should be reduced. 3. Legal More and more governments including our own are passing laws to control how we interact with the environment. Therefore we need systems to make sure we stay within the law, otherwise we can be fined and damage our reputation. 12

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4. Commercial More and more large organizations are taking control of their environmental responsibilities and they expect their suppliers and subcontractors to do the same. By being able to demonstrate good environmental practice, new market opportunities may open up to you. 13

International and national governmental action for environment protection: 

International and national governmental action for environment protection The serious threats to our environment have been increasingly recognized by governments since the 1960s, gathering momentum all the time. Some of the landmark milestones at the international level are described in the following paragraphs. The Brundtland Report 1987 The World Commission on Environment and Development chaired by Norway’s Prime Minister Gro Harlem Brundtland produced a report ‘Our Common Future’. In it, the phrase ‘sustainable development’ was defined as ‘forms of progress which meet the needs of the present without compromising the ability of future generations to meet their own needs’. 14

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Montreal Protocol on Substances that Deplete the Ozone Layer 1987 In particular, this protocol led to the phasing out of chlorofluorocarbons (CFCs) as propellants in aerosols, as foaming agents in fire extinguishers and as refrigerants. The protocol has been regularly strengthened in the succeeding ten years. United Nations Conference on Environment and Development 1992 (‘Earth Summit’) The Rio de Janeiro conference in 1992 issued a declaration which included calling on national governments to ‘enact legislation and to formulate plans at national and local level to promote improved air quality, protect the quality of the environment and land-based resources, and address the problems of waste, poverty and lifestyles, and disseminate environmentally sound technology’. 15

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The UN Framework Convention on Climate Change 1997 The UN’s concern for climate change took a further significant step with the Kyoto Protocol, which set the target of reducing the emission of 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 to the outcome of the conference were mixed, with some people feeling that hard progress was obscured by politics. 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. 16

ISO 14001 Evolution : 

ISO 14001 Evolution ISO 14001 has been developed as a formalized structure for an environmental management system which can be independently assessed for compliance. The British Standards Institute (BSI), a world-respected standards body, in conjunction with many other committees and interested parties, developed and produced BS 7750:1992, the world’s first environmental standard. ISO (the International Standards Organization) established a new technical committee to develop international standards in environmental management. 17

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Thus ISO 14001 was first published in 1996 with a swift uptake by organizations world-wide. All ISO standards are periodically reviewed, typically between 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 a major review of ISO 9000:1994. 2. Improve the clarity of the text i.e. clarity of intent especially for translation purposes. 18

Reasons for seeking ISO 14001 certification: 

Reasons for seeking ISO 14001 certification The reasons why organizations implement ISO 14001 are generally given as: To gain or retain market share via a green corporate image To attract more ethical investment To reduce insurance risks To reduce prosecution risks To reduce costs 19

ISO 14001: 

ISO 14001 ISO 14001 requires organizations to identify the environmental aspects of their activities, products or services and to evaluate the resulting impacts on the environment, so that objectives and targets can be set for controlling significant impacts and for improving environmental performance. ISO 14001 specifies the EMS requirements that an organization must meet in order to achieve certification by a third party – the certification body.(The Standard was specifically designed to be an auditable standard leading to independent certification.) 20

The Requirements of ISO 14001 include:: 

The Requirements of ISO 14001 include: Development of an environmental policy. Identification of environmental aspects and evaluation of associated environmental impact. Establishment of relevant legal and regulatory requirements. Development and maintenance of environmental objectives and targets. Implementation of a documented system, including elements of training, operational controls and dealing with emergencies. Monitoring and measurement of operational activities. Environmental internal auditing Management reviews of the system to ensure its continuing effectiveness and suitability. 21

Clauses of ISO 14001: 

Clauses of ISO 14001 The six main clauses of ISO 14001 are titled as 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 22

4.1 General considerations: 

4.1 General considerations This clause of the Standard describes, at length, the intended purpose of the EMS (that is, an improvement in the environmental management system is intended to show an improvement in environmental performance). There must be some objective evidence of the system being in place and reviewed and revised. Such review processes can take the form of monthly progress meetings, corrective actions from audits and of course audits themselves. Keeping documentary evidence of management reviews (even if not the fully formalized ‘Management Review’ that clause 4.6 of the Standard refers to) and having some evidence of awareness training for those staff who control those environmental aspects that have a highly significant environmental impact, would also be wise steps to take. 23

4.2 Environmental policy: 

4.2 Environmental policy There must be an environmental policy that is consistent with any group or sector policy, is relevant to the organization's activities, commits to prevent pollution and observe relevant legislation, has a commitment to continual improvement and setting environmental objectives and targets, and states how it is made available to all employees and public. Thus, the policy was intended to be the main ‘driver’ of the environmental management system and all other elements of the system would follow on naturally from it. The clause includes the statement ‘be available to the public’. In fact, the concept of public availability is open to many interpretations and in reality it is only the stakeholders who are interested in the content of the environmental policy (rather than the general public). 24

4.3 Planning: 

4.3 Planning Through its sub-clauses, clause 4.3 directs the implementing organization towards key areas in the planning process. 4.3.1 Environmental aspects Environmental aspects shall be identified both for normal operating conditions, for reasonably foreseeable deviations and for emergencies. This is usually documented in a Register of Environmental Aspects. 4.3.2 Legal and other requirements Relevant legislative, regulatory and other environmental requirements must be identified .This is usually documented in a Register of Environmental Legislation which must be kept up to date. 25

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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 the objectives and targets, and responsibilities must be designated. 26

4.4 Implementation and operation : 

4.4 Implementation and operation 4.4.1 Structure and responsibility Responsibilities must be defined. Adequate human resources with appropriate skills must be provided. There must be a management representative with the authority to ensure the EMS 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 environmental procedures and know the consequences of departing from the procedures. 4.4.3 Communication There must be a system for receiving and responding to communications regarding environmental aspects, from both external and internal sources. 27

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4.4.4 Environmental management system and documentation There must be a documented description of the environmental management system, which brings together the policy, objectives and targets, and responsibilities. It must point to all the associated documentation (e.g. the Registers, Operating Procedures, including emergency plans). 4.4.5 Document control There must be a system for document control. 4.4.6 Operational control Documented procedures and Work Instructions must be prepared where they are needed to ensure compliance with the requirements of the EMS. These should also relate to goods and services with significant environmental aspects, and be communicated to suppliers and contractors. 28

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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 rules and procedures. Assessors are paying particular attention to the control of contractors, simply because experience has shown that they can be the cause of a significant number 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 been called into action, and tested periodically. 29

4.5 Checking and corrective action: 

4.5 Checking and corrective action 4.5.1 Monitoring and measurement There must be procedures for monitoring activities which impact on the environment. Any monitoring equipment must be calibrated. 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. 30

4.6 Management Review: 

4.6 Management Review Management must periodically review the environmental policy, objectives and the EMS to ensure they are still effective and relevant to the organization's needs in the light of changing circumstances. A guideline for the time interval between reviews is 3 to 6 months in the early stages of implementation followed by annual reviews once the system becomes more mature. In reality, the time intervals should be determined by events. 31

ISO 14001 implementation cycle for continuous improvement: 

ISO 14001 implementation cycle for continuous improvement 32 Clause 4.6 Management Review Clause 4.4 Clause 4.5 Checking and Corrective Action Clause 4.3 Planning Clause 4.2 Environmental Policy Clause 4.1 General Requirements Clause 4.4 Implementation and Operation

The structure of documented EMS: 

The structure of documented EMS 33 Environmental Management Manual Register of Environmental Legislation Register of Environmental Aspects Operating Procedures Work Instructions (if needed)

The Preparatory Environmental Review [ PER ]: 

The Preparatory Environmental Review [ PER ] An organization considering the implementation of ISO 14001 should decide whether or not it needs to perform a Preparatory Environmental Review (PER). This review is not mandated by the Standard, but in the Annex to the Standard (section A.3, Planning) it is suggested that an organization with no pre-existing environmental management system should establish its current position, with regard to the environment, by a review. 34

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By examining the review, the auditor will get a measure of the environmental competence of the organization and an indication of the level of understanding of environmental issues by the organization. If an organization decides to undertake this preparatory review, there are two options open: Perform the preparatory environmental review using internally available resources. Perform the preparatory environmental review using external consultants. These options are considered below: 35

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Internally available resources: Several options exist for this approach. One option is to send out questionnaires to each department head, requiring those individuals 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. 36

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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 meaningful preparatory 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 a preparatory review prior to ISO 14001 implementation. 37

Importance of EMS :: 

Importance of EMS : An Environmental Management System (EMS): Serves as a tool to improve environmental performance. Provides a systematic way of managing an organization’s environmental affairs. Is the aspect of the organization’s overall management structure that addresses immediate and long-term impacts of its products, services and processes on the environment. Gives order and consistency for organizations to address environmental concerns through the allocation of resources, assignment of responsibility and ongoing evaluation of practices, procedures and processes. Focuses on continual improvement of the system. 38

References:: 

References: Ken Whitelaw; ISO 14001 Environmental Systems Handbook; Page no. 1-122 A. J. Edwards; ISO 14001 Environmental Certification Step by Step http://ecm.ncms.org/ERI/new/IRRpharm.htm#impacts http://en.wikipedia.org/wiki/Pharmaceutical_drug 40

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Earth allows you to stand. Let it stand the way it is.! Go Green Nurture Nature For Our Future! Thank You Pollution, pollution green is the solution.