Department | Environmental, Health and Safety | Document no | EHS-050 | ||
Title | Environmental Management System Plan | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: |
1. AFFECTED PARTIES
All Environment, Health and Safety personnel
2. PURPOSE
This SOP details the Environmental Management System (EMS) that ensures the GMP plant complies with the in-house Environmental Guidelines and local, state and national government regulatory requirements and has an ongoing improvement plan for environmental performance.
3. SCOPE
This procedure applies to all activities, products or services provided by the GMP facility. It defines the policies and regulations which apply to the site and the Environmental Management System in place to ensure compliance.
4. RESPONSIBILITY \ BUSINESS RULES
The EHS Manager is responsible for developing and maintaining the environmental management system.
All operational colleagues are responsible for the implementation of environmental procedures and commitment to continual improvement.
The EMS Plan shall be reviewed at least on a two yearly basis. If deemed appropriate it can be reviewed more frequently as necessary to reflect any significant changes.
5. PROCEDURE
The site will implement and maintain programs to assure that it:
– Designs, constructs, operates, maintains and manages its operations with ‘due diligence’ to prevent environmental incidents and unacceptable risk to human health;
– Complies with all applicable governmental and internal EHS requirements;
– Makes a continuous improvement in the areas of waste minimisation, incident and pollution prevention, hazard control, conservation, and environmental preservation and promotion;
– Monitors, evaluates and reports to senior management on a periodic basis the status of EHS programs;
– Develops an EHS Management System to meet regulatory and policy requirements;
– Documents the EHS Management System in standard procedures as required;
– Evaluates the effectiveness of the EHS Management System annually;
– Encourages the participation of all colleagues in EHS programs and activities. A training matrix will be developed and maintained to identify training needs;
– Provides necessary training and controls to ensure EHS compliance (including induction training for all new colleagues and periodic refresher training); and
– Evaluates the performance of managers and others involved in EHS programs.
Failure to comply with the requirements of this and all other EHS procedures and programs will be dealt with in accordance with the normal counselling and disciplinary procedures.
The plan for the Environmental Management System is outlined herein.
5.1 Policy
Site will conduct its operations in a manner designed to comply with all relevant environmental policies and regulatory requirements. An EHS policy will state the intentions of the environmental programs on site. The copy of this policy is found at the main foyer of the reception building.
5.2 Planning
5.2.1 Environmental Aspects
Documented procedures are maintained to identify the environmental aspects of the activities of the organization and products that it can control and over which it can be expected to have an influence. These aspects are identified in order to determine those, which have, or can have, significant impacts on the environment. Those aspects related to significant impacts are considered in setting the environmental objectives of organization. The procedure is the responsibility of the EHS Manager and includes update provisions to ensure that the information concerning environmental aspects is up to date.
5.2.2 Legal and Other Requirements
Procedures are maintained to identify and provide access to legal and other requirements to which the organisation subscribes that are directly applicable to the environmental aspects of its activities and products.
5.2.3 Objectives and Targets
Procedures are maintained for establishing and maintaining documented environmental objectives and targets at each relevant function and level within the company.
The procedures include provisions for consideration of legal and other requirements, significant environmental aspects, technological options, financial, operational and business requirements and the views of interested parties when establishing and reviewing EMS objectives.
The objectives and targets are reviewed to ensure that they are consistent with the environmental policy including the commitment to prevention of pollution.
5.2.4 Environmental Management Programs
Management programs are established and maintained for achieving environmental objectives and targets. At a minimum, the programs include:
– Designation of the responsibility for achieving objectives and targets at each relevant function and level of the organization; and
– The means and timeframe by which they are to be achieved.
The procedure includes provisions for the review of new and/or modified activities and products to ensure they are taken into consideration in establishing and/or modifying management programs.
Environmental management programs are developed from the objectives and targets and are outlined in the Strategic Plan.
5.3 Implementation and Operation
5.3.1 Structure and Responsibility
The roles, responsibilities and authorities of colleagues are defined in the procedures, job instructions, and position job descriptions. Management colleagues are responsible for providing resources within their functional areas essential to the implementation and control of the EMS. These resources include human resources, specialised skills, technology and financial resources.
The EHS Manager as the EMS management representative has responsibility and authority for:
– Ensuring that the EMS requirements are established, implemented, and maintained in accordance with this policy document.
– Reporting on the performance of the environmental management system to top management for review and as a basis for improvement of the EMS.
The relationship between environmental responsibility and individual performance shall be reviewed periodically through the reward and recognition program and performance review process.
On review of the aspects register, the colleagues who manage, perform or verify work affecting the environment will be identified. The responsibilities and accountabilities for those colleagues shall be defined and documented in standard procedure such as “EHS Roles and Responsibilities”.
5.3.2 Training, Awareness and Competence
Procedures are maintained for identifying training needs. All colleagues whose work may create a significant impact upon the environment shall be identified through the aspects review. Colleagues will receive appropriate training and periodic training will be scheduled through the approved training system.
New colleagues in the production building will receive environmental induction training. Training sessions are designed to make colleagues at each relevant function and level aware of:
– The importance of conformance with the environmental policy, procedures and the requirements of the EMS;
– The significant environmental impacts, actual or potential of their work activities, and the environmental benefits of improved personal performance;
– Their roles and responsibilities in achieving conformance with the environmental policy, procedures and requirements of the EMS including emergency preparedness and response requirements; and
– The potential consequences of departure from specified operating procedures.
Competency of colleagues performing tasks, which can cause significant environmental impacts, is based on appropriate education, training and/or experience.
5.3.3 Communication
5.3.3.1 Internal Communication
The EHS Manager shall ensure internal communications between various levels and functions of the organisation are maintained. This communication will include the Environmental Aspects and the EMS. This communication will be accomplished through the inclusion of environmental instructions in production operator instructions, training sessions and review sessions, environmental induction training, and team meetings.
The Environmental Policy shall be posted on noticeboards. Environmental performance will be posted on the environmental noticeboards. Audit results will be communicated to all relevant departments via information sessions or results copied to colleagues involved as hard copies or via electronic mail.
Environmental updates will be posted on the environmental noticeboards and periodic electronic mails will be sent out to reflect any change or update to environmental requirements.
5.3.3.2 External Communication
The EHS Manager shall receive communication from external parties. The EHS Manager shall confer with the Manufacturing Director prior to responding to relevant communications from external interested parties regarding the organisation’s environmental aspects and EMS.
External communications, which do not fall within the scope of the EHS Manager, shall be forwarded to the responsible department, including but not limited to, i.e. Corporate EHS. All communications from external interested parties are retained and relevant communication is considered at the time of reviewing the aspects register and setting objectives and targets as the leadership team considers public perception during the significance rating of the aspects. Replies / acknowledgment of external correspondence will be completed within 4 weeks of receiving the correspondence.
The public may view the site EHS Policy in the main reception foyer of the site.
5.3.4 Environmental Management System Documentation
The core elements of the EMS are defined in this procedure document. The interaction and directions to related documentation of the elements are defined in this policy document and the referenced procedures.
5.3.5 Document Control
Procedures are maintained for controlling all documents required by this policy to ensure that:
– They can be located to a secure access control program.
– They are periodically reviewed and revised as necessary and approved for adequacy by authorized colleagues.
– The current versions of relevant documents are available at all locations where operations essential to the effective functioning of the system are performed.
– Obsolete documents are promptly removed from all points of issue and points of use.
– Obsolete documents retained for legal and/or knowledge preservation purposes are identified.
Documentation is maintained such that it is legible, dated (with dates of revision) and readily identifiable. It is maintained in an orderly manner with retention period specified.
Procedures are maintained defining responsibilities for and methods of, creation and modification of all documents within the system.
5.3.6 Operational Control
It is the responsibility of the EHS Manager to maintain procedures to identify operations and activities associated with the identified significant environmental aspects. These activities, including maintenance, shall be planned to ensure they are carried out under specified conditions. Documented procedures shall be maintained to cover applicable activities as listed below. Documented procedures exist for communicating relevant procedures and requirements to suppliers and contractors.
5.3.6.1 Control Procedure
On completion of the annual aspects register review any significant environmental aspects with identified control needs shall be documented. The EHS Manager is responsible for preparing lists of critical functions and processes associated with the significant environmental aspects and reviewing the effectiveness of the controls and procedures.
The existence of procedures shall be verified and any void that is identified will result in initiating development of the appropriate procedure. These procedures include operating criteria as appropriate. An EHS colleague will review this list. Changes shall be communicated to colleagues, contractors and suppliers who are involved. This communication shall be documented.
5.3.7 Emergency Preparedness and Response
Procedures are maintained for identifying the potential for and responding to accidents and emergency situations and for preventing and mitigating the associated environmental impacts. The EHS Manager and Engineering Manager are responsible for identifying the need for response plans associated with environmental aspects or impacts.
Emergency preparedness and response procedures shall be reviewed and revised after the occurrence of accidents or emergency situations and as deemed necessary by the EHS Manager.
5.4 Checking and Corrective Action
5.4.1 Monitoring and Measurement
Documented procedures are maintained to regularly monitor and measure the key characteristics of operations and activities that can have a significant impact on the environment. These procedures include provisions for recording information to track performance, relevant operational controls and conformance with established objectives and targets.
Documented procedures exist for the maintenance and calibration of monitoring equipment. Records of these procedures are retained according to records control procedures.
Documented procedures are maintained for the periodic evaluation of compliance legislation and regulations.
5.4.2 Non-Conformance and Corrective and Preventative Action
Documented procedures are maintained for defining responsibility and authority for handling and investigating non-conformances, taking action to mitigate any impacts caused, and for initiating and completing corrections and preventive actions. On review of the monitoring and measuring results, a hazard / near miss form may be raised.
All colleagues are responsible for identifying and reporting a non-conformance or suspected non-conformance to the EHS Group.
Immediate action will be coordinated by the EHS Manager to reduce environmental impact.
If the non-conformance is a one-off accident or incident and requires an investigation, it shall be investigated by completing an EHS Incident / Accident Investigation Report. The cause of the incident will be identified. If the non-conformance is an observation for improvement a hazard / near miss assessment and control card can be submitted.
– The EHS Manager will issue the required form to the responsible manager in the area in which the non-conformance was identified.
– The investigation to determine the root cause is the responsibility of the Manager / Team Leader in the area.
– The development of the corrective and preventative action, is the responsibility of the Area Manager / Team Leader.
– The EHS Manager has the responsibility to approve or work with the manager to develop an acceptable corrective and preventative action.
– The Area Manager / Team Leader is responsible for implementing the corrective and preventative action.
– The EHS Manager is responsible for following up the corrective and preventative actions by maintaining a log and reviewing the effectiveness prior to signing off on the card.
– The EHS Manager and the Area Manager / Team Leader are responsible for ensuring the corrective and preventative actions are completed with a suitable time period.
– The EHS Manager is responsible for maintaining records of the corrective and preventative actions and record cards.
A review of the corrective actions, hazard / near miss logs, monitoring and measurement records and EMS audit reports will be conducted periodically to identify any trends or deficiencies in similar areas. During this review the time taken for correction will be reviewed. This review is the responsibility of the EHS Manager.
5.4.3 Records
Documented procedures are maintained for the identification, maintenance and disposition of environmental records. These records include training records and the results of audits and reviews.
The records are maintained such that they are legible, identifiable and traceable to the relevant activity, product or service. They are stored and maintained in such a way that they are readily retrievable and protected against damage, deterioration or loss. Retention times are established and recorded.
Records are maintained to demonstrate conformance to the requirements of this standard.
5.4.4 Environmental Management System Audit
Documented procedures are maintained to define the environmental management system audit program. The program requires periodic audits be carried out in order to determine whether or not the EMS:
– Conforms to the requirement of ISO 14001 and this Environmental Management System Policy Manual.
– Is implemented and maintained in accordance with this policy manual.
– Information on the results of audits is one of the inputs to the formal management review.
The audit program is based on the environmental importance of activities and the results of previous audits. The audit procedures include audit scope, frequency, methodologies, responsibilities and requirements for conducting and reporting results.
5.5 Management Review
Documented procedures shall be maintained for the review of the EMS by top management to ensure its continuing suitability, adequacy and effectiveness. Minutes of the review meeting are recorded.
The EMS is reviewed for the possible need for changes to policy, objectives, and other elements of the EMS in light of EMS audit results, changing circumstances and the commitment to continual improvement.
5.6 Annual EMS Review
The Leadership Team shall regularly review environmental performance in the form of the Aspects Register. Minutes of meetings shall be retained and copied to colleagues involved. The Leadership Team shall complete a review of the EMS annually; this review includes but is not limited to:
5.6.1 A review of environmental objectives, targets and performance. Representatives from all departments will provide feedback for the review. This feedback will detail:
5.6.1.1 Progress on objectives and targets.
5.6.1.2 Suitability of objectives and targets.
5.6.1.3 Improvement progress.
5.6.2 Findings of the EMS audits. This feedback will detail:
5.6.2.1 Similar issues that have been addressed in areas other than where the finding was identified
5.6.2.2 Trend of findings?
5.6.2.3 Corrective and preventative action to be implemented
5.6.2.4 Effectiveness of corrective and preventative action
5.6.3 An evaluation of the effectiveness of the EMS. This feedback will detail
5.6.3.1 Verify some procedures and look for evidence of the procedures being followed.
5.6.4 An evaluation of the suitability of the EMS in relation to:
5.6.4.1 Changing legislation.
5.6.4.2 Changing expectations and requirements of interested parties.
5.6.4.3 Changes in products or activities of the organization.
5.6.4.4 Advances in science and technology.
5.6.4.5 Lessons learned from environmental incidents.
5.6.4.6 Market preferences.
5.6.4.7 Reporting and communication.
5.6.5 External Considerations; This feedback will detail
5.6.5.1 A request for suggestions and feedback to be sent out to all colleagues for review.
5.6.5.2 External communications with governing bodies such as EPA, Council Water and Corporate assessments should be reviewed.
The review shall be documented and filed in the EHS files. Improvements will be managed through the corrective action process as per Section 5.4.2.
The review results will be communicated to all colleagues via an information session, team brief or article.
6. DEFINITIONS / ACRONYMS
EHS1: Environmental Health and Safety EMS (Environmental Management System)
7. SUMMARY OF CHANGES
Version # | Revision History |
EHS-050 | New |