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Introduction
In essence, the ISO 14001: 2004 is based upon the methodology known as Plan-Do-Check-Act or PDCA. It can be further described in the following manner:
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Step one: Plan – establish the objective and processes necessary to deliver the desired results
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Step Two Do- Implement the process described in the Planning Phase
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Step Three Check – Monitor and measure the process against environmental laws, policies, objectives or legal targets.
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Step Four Act – Continually improve the performance of the environmental management system by following the three steps above as new information and insight are provided.
It should be noted that this process-centered approach is cyclic in nature, and each step is interdependent on the success of each other step. The guidance presented in the ISO 14001:2004 documentation, and other supplementary information is designed to help the individual company establish a viable environmental management system that would act in compliance with the guidelines set forth in the standard. (Acorn, 2004)
It is important to note that the ISO does not maintain absolute requirements for environmental performance beyond the commitments outlined in applicable environmental policies or laws. It is up to the company to determine which laws are applicable and make the necessary adjustments to the overall EMS. (International Standards Organization, 2009)
Procedure
There are six basic steps to implementing, maintaining, and improving a companies environmental management system.
If no current environmental management system is in place, the first step in the process is to systematically review and potentially establish its current position regarding the environment. All environmental aspects of the organization should come under scrutiny, and be used to establish a quality environmental management system. In general, this initial review should cover four areas:
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Identification of environmental aspects, such as those associated with normal operating conditions, emergency procedures, and start-up or shut down procedures, and accidents.
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Identification of legal or industry-standard requirements for the company.
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Examination of the existing environmental management practices, both in written and practical.
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The evaluation of historical emergency situations and any accidents.
Tools and methods for this review include checklists, interviews, direct inspection of records and facilities. (Sullivan and Wyndham, 2001)
Once a systematic review has been conducted, the next step in the process is to establish the scope of the baseline assessment. A baseline assessment includes the physical boundaries, as well as a description of the activities that would fall under the environmental management system. There are several methods used to determine the baseline scope, and these can include the following. (U.S. Department of Health and Human Services, 2006)
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Mapping of the physical boundaries of the proposed EMS. Areas of concern could include the building’s drainage plan, location of waste skips, chemical storage points, and car parks, areas of frequent spills, and local and regional neighbors, as well as the wind direction.
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In most cases, the baseline assessment for a pharmaceutical company does not lend itself to scope determination through physical mapping alone. Another method for the establishment of a baseline includes the use of process flow diagrams. These can be used to identify how the business activities interrelate to each other, and how those interactions affect, and are affected by the various environmental inputs and outputs previously identified in the overall review. (Barrow, 1999)
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One of the unique aspects of ISO 14001 and BS 8555 is the requirement to not only identify business processes that can be controlled by the company, but also those that are influenced or could potentially be influenced by the company. Methods of identification can include such things as brainstorming, process mapping, interviews, and input/output charts.
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Once the results from the above exercises have been completed, the next step in establishing the baseline assessment is to identify the environmental impacts of the company, as well as the activities conducted by the company that can affect these impacts. (Dakin, 2003)
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Finally, conduct a systematic review of the companies legal and industry-standard requirements, as well as a review of the current environmental practices.
By completing a simple baseline assessment, a company can easily see the present environmental situation, as well as areas that need improving. This viewpoint is an essential part of the remaining steps for certification, and should not be overlooked. (European Committee for Standardization, 2003)
The next step in the process is to develop a working model of an environmental management system for use in the company. It should be noted that even in its final form, the plan is a living document that can be altered as the situation warrants. At this stage it is important to consider the relevant legal, and industry requirements, opportunities for ongoing improvement, and the prevention of pollution. This is also an opportune time to focus on the potential commitments that will be made by your organization. It is important to make sure that any obligations that the company ascribes to will be met. (The Acorn Trust, 2003)
The fourth step in the process is to identify environmental costs and benefits to the organization or company. These can include such things as waste handling, energy usage, and raw materials. Identification of the concerns for the company and other interested parties is also an important step in this portion of the process. Finally, it is important to establish achievable measures of performance, and that accurately reflect the area of concern, such as water usage, waste hauling, or amount of electricity used. In addition, it is important to determine the type of training and monitoring equipment that will be used to collect the data need to monitor the success rate for the program. (International Standards Organization, 2009)
Once you know the scope of the environmental management plan, the next step in the process is to establish what actions are needed for implementation. The first step in this phase of the process is establishing a timetable or set of milestones for implementation. These milestones can include events based on compliance levels, or arbitrary dates. (Hospitals for a Healthy Environment, 2006)
Once the milestones have been established, the next step is to draw up a preliminary plan, including the identification of key personnel and necessary tasks. Again, it is more beneficial to keep everything as general as possible, to allow for any potential alterations that may become apparent after the plan is implemented. In addition to identifying the tasks and key personnel, it is also important to establish resource and time needs, as well as the cost estimates for implementation and maintenance.
Finally, it is important to establish a plan to present and communicate the overall environmental management system. Methods of communication can include posters, regular training seminars, distributed literature, and regular press releases and public notices
Once the basic plan, and how it is to be communicated with the employees and people of interest has been established, the next step is to assess how well it has been integrated into the company as a whole. This phase of the process should be ongoing. It is important to determine the levels of compliance in the following areas:
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Company awareness of environmental issues and pressures, especially those facing the company specifically
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Awareness of the company’s commitment to environmental management, and what this means on a practical level
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The ability to present new ideas from all levels of the company. Beneficial practices and ideas can come from many different levels and people.
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Ongoing training based on the individuals or departments’ needs and expertise.
It is important to remember that communication, especially in a business setting needs to be a two-way street. Many times, the employees can identify innovations or necessary changes that the upper or top management simply does not see.
Works Cited
Acorn, Institute for Environmental Management and Assessment. The BS 855 SME Workbook Phase 1. Commitment and Establishing the Baseline. 2004
Barrow, C. J. Environmental Management: Principles and Practice. London: Routledge, 1999.
Bronson, Jackie, and Bram Noble. “Measuring the Effectiveness of Parks Canada’s Environmental Management System: A Case Study of Riding Mountain National Park.” The Canadian Geographer 50.1 (2006): 101
Dakin, Susan. “There’s More to Landscape Than Meets the Eye: Towards Inclusive Landscape Assessment in Resource and Environmental Management.” The Canadian Geographer 47.2 (2003): 185
European Committee for Standardization. ISO 14001:2004 International Standard Environmental Management Systems. Requirements with Guidance for Use 2004
Hospitals for a Healthy Environment. Managing Pharmaceutical Waste. A Ten Step Blueprint for Health Care Facilities in the United States. 2006
International Standards Organization. International Standards Organization. Management System Standards. 2009
Sullivan, Rory, and Hugh Wyndham. Effective Environmental Management: Principles and Case Studies. St. Leonards, N.S.W.: Allen & Unwin, 2001.
The Acorn Trust. “The Acorn Trust and B8555: A Presentation for Management” Environmental Management System 2003
U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research Center for Veterinary Medicine, Office of Regulatory Affairs. 2006
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