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INTRODUCTION
A daily commitment from all individuals in an institution is required for an effective safety and security program. It is important for individuals at all levels to work together to eliminate the risk of exposure to hazardous materials and conditions in the laboratory. In 2008, the U.S. Department of State contracted with the National Academies of Sciences, Engineering, and Medicine1 to produce informational materials including a baseline of practices for handling, storage, and use of chemicals on the laboratory scale that are required to promote safety and security in the developing world. To accomplish this task, an expert committee created and published in 2010 the reference guide, Chemical Laboratory Safety and Security: A Guide to Prudent Chemical Management, and its accompanying toolkit. The toolkit includes a quick guide for laboratory managers, an executive summary to share with institutional leaders, an instructor’s guide, forms and signs to photocopy and distribute, preplanning reference cards to distribute to laboratory personnel, and helpful reminder signs for posting in the laboratory. All of these products, including the 2010 reference guide, have been translated into Arabic, Bahasa Indonesia, and French and distributed broadly. Together, the 2010 reference guide and its accompanying toolkit provide researchers with best laboratory practices to improve chemical management and increase the level of safety and security in the laboratory. Within the 2010 toolkit, however, a detailed guide on how to develop a standard operating procedure (SOP) is not covered; this Guide to Developing Standard Operating Procedures2 fills this gap and serves as an additional product in the toolkit.
WHAT IS A STANDARD OPERATING PROCEDURE?
For the purposes of chemical safety and management, an SOP is a detailed, written set of procedures that explains how to utilize and manage hazardous chemicals, processes, and procedures to prevent or minimize health and safety concerns. The development and use of SOPs are integral parts of a successful safety program. Poorly written SOPs are of limited value. Therefore, SOPs should be clear, concise, and detailed but not overly complicated. SOPs should provide sufficient detail and be specific to the institution or facility so that someone with limited experience or knowledge of the procedure can successfully and safely follow the procedure. Typically, SOPs focus on
- processes,
- operational ranges and conditions,
- individual hazardous chemicals,
- classes of hazardous chemicals,
- management and use of chemical equipment,
- emergency shutdown,
- authorized users, and
- lab-specific safety and security risks, based on surroundings and environmental factors.
Workers in industry, private research institutions, and academic laboratories use SOPs when their laboratory standards do not sufficiently address the use of hazardous chemicals or conditions. The primary
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1 As of July 2015, the National Research Council is no longer used, and all references are now given as the National Academies of Sciences, Engineering, and Medicine.
2 Details regarding the statement of task for the Guide to Developing Standard Operating Procedures can be found in Appendix A.
objective of a laboratory standard is to communicate basic safety principles governing laboratory activities. Laboratory standards are developed in conjunction with and approved by the institution and conform to best practices as exemplified in Chemical Laboratory Safety and Security: A Guide to Prudent Chemical Management, Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards, Updated Version, and, if applicable, the U.S. Occupational Safety and Health Administration’s (OSHA) Laboratory Standard (or equivalent), among other resources. Additional details on laboratory standards are provided in Section 2B, pages 14-15 in Prudent Practices in the Laboratory (Appendix B).
WHO IS RESPONSIBLE FOR DEVELOPING STANDARD OPERATING PROCEDURES?
Laboratory personnel who supervise or direct hazardous operations are responsible for developing an SOP, in addition to those conducting the hazardous operations. New students and employees are responsible for learning and familiarizing themselves with SOPs. Tailoring the SOP to the specific chemical(s) or process and laboratory setting is required. Existing SOPs from reliable resources can provide background knowledge but should not be directly adopted because of the possible differences in laboratory environment and location, user experience, and equipment. SOPs are needed even when published methods are being followed.
After an SOP has been developed, the principal investigator (PI) or equivalent, who will be responsible for enforcing the SOP, should review the document for accuracy and completeness. If available, then the safety manager should also review the completed SOP.
GUIDE TO DEVELOPING STANDARD OPERATING PROCEDURES
The objective of this Guide to Developing Standard Operating Procedures is to provide a framework for laboratory personnel tasked with developing SOPs. The guide builds on the 2010 report Chemical Laboratory Safety and Security: A Guide to Prudent Chemical Management and can be added to the related toolkit. The guide consists of
- Risk Assessment Flowchart
- Chemical Storage Matrix
- Moderate Risk Standard Operating Procedure Form
- High Risk Standard Operating Procedure Form
- Scenarios
- Neutralization of Carbonate by Acid
- Use and Filtration of a Pyrophoric Catalyst
- Toxic and Explosive Gases: Handling Diazomethane and Alternatives
- Reagent Storage
The Risk Assessment Flowchart (Chapter 2) can be used to determine whether an SOP is required for the proposed work, and, if so, then which type of SOP. The Chemical Storage Matrix (Chapter 3) identifies the safest methods to store and manage hazardous chemicals. If the chemical is (1) used in a specific process that involves some level of risk, (2) a chemical of concern (COC)3 or a dual-use chemical, or (3) a
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3 See Appendix A in Chemical Laboratory Safety and Security: A Guide to Prudent Chemical Management for a list of COCs.
newly synthesized compound, whose properties may not be fully known, then laboratory personnel should develop an SOP. When the laboratory standards are not sufficient for the scope of work, laboratory personnel will use either a Moderate Risk Standard Operating Procedure Form (Chapter 4) or a High Risk Standard Operating Procedure Form (Chapter 4). Four hypothetical examples (Chapter 5) are presented to demonstrate the application of the Guide to Developing Standard Operating Procedures. It is suggested that each institution consider its specific economics, culture, regulations, experience, and scale of operations when applying the best practices presented in this guide. For example, chemical laboratories in areas that are densely populated or have high rates of crime or theft, or where there is conflict or insurgency, could consider adopting a high security level for their facility (see A Guide to Prudent Chemical Management, pp. 59–70). Forms for use in training sessions or for development of SOPs are provided in Chapter 6.
Users of these materials are expected to have at least a B.S. degree in chemistry, chemical engineering, or an allied field such as biochemistry or materials science or at least 5 years experience as a chemical technician/technologist. Laboratory technicians and undergraduate students, who may not possess a B.S. degree in one of these fields, can contribute to SOP development with guidance from trained staff with a B.S. degree in chemistry, chemical engineering, or an allied field.
The following chapters provide instructions that are pertinent to each product in the guide, and Appendix B provides additional resources.
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