The following categories of hazardous substances, equipment and processes presents extreme hazards to personnel and requires written SOPs even for a single event where they are used:
- OSHA select human carcinogens, reproductive toxins, mutagens, teratogens
- compressed gases especially those that are flammable, reactive, corrosive, and toxic
- organic mercury
- unstable compounds that may explode (i.e., expired peroxide formers, dry picric acid),
- pyrophoric materials, and
- highly toxic liquids and solids
- pressurized systems
- equipment that poses significant physical hazards (cut, pinch, crush, high voltage, high pressure, extreme temperature, others)
- GHS category 1or 2 rating for all hazard classes except skin, eye, and respiratory irritant, skin sensitizer, hazardous to ozone layer and other environmental hazard classes
- process that involves the use of any one or combination of the above
The new safety data sheet format identifies the hazard class(es) of a substance in section 2. The hazard classification is based on the Globally harmonized system of hazard classification and labeling (GHS). If the chemical manufacturer or distributor assigns a GHS category 1 or 2 rating for a hazard class (see exceptions above), it is highly likely that a substance with this rating will require a written SOP. Consult EH&S (803) 777-7650 or firstname.lastname@example.org if in doubt about the high hazard status of a specific substance.
(The following text in italics is an excerpt from the American Chemical Society’s Hazard Assessment in Research Laboratories).
What it is
The result of the SOP method is a comprehensive document that outlines processes in the lab and identifies hazards and controls to eliminate or mitigate the risks.
Principal Investigators and senior lab workers oversee the SOP process, but everyone working in the lab should contribute and participate.
When to use
Scenarios where hazardous materials, equipment, or processes have been identified but could be streamlined for simple experiments, well-tested experiments, or those that are unchanging.
Principal Investigators and senior lab workers should lead SOP development. All lab workers at all experience levels should participate in SOP development, review, and updates.
Standard Operating Procedures (SOP) work well for designing experimental protocols in general. It provides an opportunity to identify risks and hazards at each step of an experimental process. An effective SOP analyzes potential hazards associated with a number of factors ranging from the types of materials the experiment requires, to the people working in the lab. Based on the identification of these hazards and risks, SOPs help predict what could go wrong and assess the impact of a safety failure.
Learn more about hazard identification factors to assess.
SOPs are typically developed for repetitive procedures known to have associated hazards, such as injury, property loss, or loss of productivity. The SOP outlines written steps that can be followed to safely execute the procedure. Each step of the experiment can be analyzed separately to identify failure points. After each step is analyzed for potential dangers, the whole experiment process should be examined from beginning to end to determine if combinations of the factors could impact safety.
The lab worker uses the hazard matrix to review the risks associated with the use of hazardous materials, hazardous processes, and hazardous equipment. They also measure impact of conditions including: adequacy of facilities, worker knowledge and experience and proposed hazard mitigation measures.
SOP Messages to Remember
When writing an SOP, make sure the appropriate research was performed to understand the hazards and identify safety measures including a review of past incidents.
1. Consult with coworkers, vendors, or other experts.
They may point out hazards you hadn’t considered or known about. For example, compressed gas vendors can explain appropriate handling. Include warning or trouble signs and what to do to prevent a lab accident. Submit the SOP for review by a supervisor and other laboratory workers.
2. Review literature and other guidance materials.
- Consult the Safety Data Sheet for specific hazards of substances to be used.
- Consult National Fire Protection Association codes (the safety office can obtain these) for control requirements for gas in storage and use, including tubing and connectors, emergency response equipment and facilities requirements.
- Review the literature for lessons learned.
- Review the experiment for what could go wrong/likely failures?
– What failures, even if unlikely, could lead to a catastrophic event?
3. Decide on what approach to take:
- Process (i.e., distillation, peptide synthesis, hydrogenation, organic synthesis)
- A specific hazardous substance (i.e., cyanogen bromide, HF, nitric acid)
- Hazard class – (i.e., organic solvents, peroxide formers, carcinogens, corrosives)
- By any other reasonable approach that addresses the health and safety concerns of the experiment
4. Use this SOP template and address the following required elements:
- Identity of the substance and important characteristics
- Material hazards
- Other special considerations such as extreme reactivity
- Availability of alternative safer materials
- Engineering controls
- Personal protective equipment (PPE) required
- Proper use and storage
- Work practices
- Emergency procedures for spill, exposure to the hazardous substance and/or process or equipment failure
- Availability of safety equipment
- Safety information resources
- SOP-specific training documentation
5. Prepare for the experiment. Perform a dry run.
- Remove any combustible or unnecessary material from the area around the experiment.
- Make sure there is a clear emergency egress, and have appropriate attire and PPE.
- Have a plan to monitor the experiment.
- Review the hazards and make sure measures have been taken to reduce risk.
- Address other laboratory or facility operations that might affect this experiment or be affected by it.
- Practice using nonhazardous materials or using a scaled down process.
6. Identify unsafe conditions. Revise SOP, incorporate new information.
- Do not perform an experiment in low humidity, with inadequate space or lighting, or in a cluttered or cramped area.
- Do not perform while working alone or without emergency response personnel, if needed.
- Do not perform an experiment if rushed, fatigued, or ill.
- Do not proceed if there is evidence of a gas leak or a tubing or equipment failure.
- Report any incidents or concerns to a supervisor.
1. Review and update SOP at least annually or every time one of these events happen:
- There is a major change in the scientific methodology
- A new person joined the lab and will be using the SOP
- A new SOP template with new required information and updated Emergency information was published by EH&S
2. Add review date on page 1, top section.
The following signatures are required on Section 9 of the current SOP template:
1. Principal Investigator - the PI ultimately signs off, indicating the final approval of the SOP.
2. Author - the author's signature indicates that they have written the SOP and it has gone through the required review process with the PI, peers, and EH&S as applicable.
3. EH&S signature is required only for SOPs involving materials listed in 1.1 below. EH&S signature indicates that we have reviewed the SOP and have evaluated the completeness of all required controls to enable reasonably safe conduct of the procedure.
4. Authorized Users - all lab personnel authorized to conduct the procedure described in the SOP must sign the printed document to indicate that they have read and understood the SOP, have completed all required trainings and will follow all controls, precautions, methods, emergency procedures, and all other aspects of the written SOP.
1. Prioritize updating of a large number of SOPs according to the following list:
1.1. Active SOPs for
- solids and liquid chemicals that are acutely toxic, pyrophoric or cryogenic
- gases that are flammable, corrossive, toxic, reactive, or pyrophoric
- processes or chemical reactions that generate high pressure and extreme heat or has a potential for an explosion
- equipment that poses significant risk of injury to users (involves cutting and pinching hazard, unguarded moving parts, high voltage manipulations, high magnetic field, lasers, others)
1.2. Active SOPs for
- solids and liquids that are flammable, corrosive or have other health hazards besides acute toxicity
1.3. Inactive SOPS for hazard categories listed in 1.1.
1.4. Inactive SOPs for hazard categories listed in 1.2.