agement system. When performing these reviews, it is important that the organization have a plan for following up on the results of the audit to ensure that problems are addressed and that recognition is given where it is deserved.
The concept of change management in the laboratory environment varies markedly from methods typically prescribed, for example, in manufacturing operations. By its very nature, the business of conducting experiments is constantly changing. Therefore, it is a part of everyday activities to evaluate modifications and/or technological developments in experimental and scale-up processes. As such, a number of standard practices are used to identify appropriate handling practices, containment methods, and required procedures for conducting laboratory work in a safe manner. Several examples of these practices include
• identification of molecules as particularly hazardous substances (PHSs),2 which specifies certain handling and containment requirements and the use of personal protective equipment (PPE);
• approval and training for new radioisotope users;
• completion of biosafety risk assessments for the use of infectious agents; and
• Material Safety Data Sheet (MSDS) review of chemicals being used.
2.A.6 Management Review of EHS Management System
Top management should review the organization’s EHS management system at regular intervals to ensure its continuing suitability, adequacy, and effectiveness. This review includes assessing opportunities for improvement and the need for changes in the management system, including the EHS policy and objectives. The results of the management review should be documented.
Among other information, a management review should include the following:
• results of EHS management system audits,
• results from any external audits,
• communications from interested parties,
• extent to which objectives have been met,
• status of corrective and preventive actions,
• follow-up actions from previous management reviews, and
• recommendations for improvement based on changing circumstances.
The outputs from management review should include any decisions and actions related to possible change to EHS policy, objectives, and other elements of the management system, consistent with the commitment to continual improvement.
The management system review ensures a regular process that evaluates the EHS management system in order to identify deficiencies and modify them. Systemic gaps, evidence that targets are not being met, or compliance issues that are discovered during compliance or risk assessments indicate a possible need for revision to the management system or its implementation.
2.A.7 Example Management System: Department of Energy Integrated Safety Management System
One example of a common EHS management system is that used by the Department of Energy (DOE). The agency’s Integrated Safety Management (ISM) system, adopted in 1996, is used at all DOE facilities, and has been used as a model for other agencies and institutions. The system consists of six guiding principles and five core management safety functions. The principles and functions in DOE Policy DOE P 450.4 (DOE, 1994), outlined below, require planning, identification of hazards and controls before work begins, and for work to be performed within these defined and planned methods.
• Line management responsibility for safety. Line management is directly responsible for the protection of the public, the workers, and the environment. As a complement to line management, the Department’s Office of Environment, Safety, and Health provides safety policy, enforcement, and independent oversight functions.
• Clear roles and responsibilities. Clear and unambiguous lines of authority and responsibility for ensuring safety shall be established and maintained at all organizational levels within the Department and its contractors.
• Competence commensurate with responsibilities. Personnel shall possess the experience, knowledge, skills, and abilities that are necessary to discharge their responsibilities.
• Balanced priorities. Resources shall be effectively allocated to address safety, programmatic, and operational considerations. Protecting the public, the workers, and the environment shall be a priority whenever activities are planned and performed.
• Identification of safety standards and requirements. Before work is performed, the associated
2The term “particularly hazardous substances” is used by Occupational Safety and Health Administration (OSHA) and defined in the Laboratory Standard 29 CFR § 1910.1450. (For more information see Chapter 4, section 4.C.3.)