A standard operating procedure or SOP, is an instructional document. Instructional documents teach a reader to understand a rule or principle, envision a process or workflow, perform a task and or use a tool to do a task. They are telling someone how to do something. Therefore, instructional documents are reader-centered, rather than rule-centered. It is important that when SOPs are written they are written with the reader in mind to ensure the reader understands the instructions. You are not just giving them a rule and telling them to interpret it, but you are telling them how to do something. Because the goal of an SOP is standardization. This is important for quality assurance and quality control work.

 Let us look now at writing SOPs. Here I want to give you some generic guidelines about how to write them and highlight important parts. Most SOPs have four major sections. You can always add more to these, but I think these four must be addressed. What are the conditions? The context that the SOP is working under. The actions that need to be taken and the documentation required. I’ll explain each one of these now, one by one.
The conditions describe who should use the SOP. When it should it be used. Why the SOP should be used and where it should be used. Therefore, it’s establishing the framework for this SOP. It addresses, who, when, why and where for this SOP.

 The context of an SOP basically describes the process. The input, plus the actions, equal some output. The input describes what reagents, equipment, or tools that you might need. The output describes what are you expecting to have happen and what you going to end up with. In addition, the context will also describe the preparation that is required in order to be ready to conduct the SOP. The context therefore is a just a general description of how this SOP is being done.
The actions are the specific steps of how you are going to move from the input to output. For example, if you are doing some work in a biosafety cabinet. You take out the vials – you put them in the biosafety cabinet – you remove one milliliter of fluid – you close the vial tightly and so on. Very detailed, step by step-by-step instructions.
Finally, an SOP often ends with documentation. There may be references to other SOPs that are important because they are related to this SOP. Cross references are very important, because they provide details on crucial related parts of the process. In addition, there may also be information on regulatory requirements for the process. Why you are doing things the way you are doing them. For example, if the SOP is about treating biomedical waste, it should reference waste management laws and regulations in your country or State. The SOP should cite the regulatory sources for why the SOP is being done.

There is a lot more to know about writing SOPs, therefore I encourage those that are responsible for writing them to take further training on quality management and how to go about putting these together.
Now I would like you to stop for a minute and find a SOP for each of the activities below from your workplace. If you cannot find one, maybe you should start thinking about writing one of your own. Do you have a standard operating procedure for waste disposal at your facility? Do you have a SOP for entry and exit to the building and laboratory? Do you have one for donning and doffing personal protective equipment? Do you have one for spill cleanup on the floor? These are all common activities that can occur and do occur at your facility. Hopefully you have some documentation somewhere that describes how these activities are being done. They may not necessarily be SOPs, but may be written somewhere else in one of your other manuals. If you find the activities described, please read and ensure the elements we discussed about SOPs are covered. If you cannot find them, maybe you should start thinking about writing your own SOPs and see how far you get. You may want to share this with your supervisor after you have gone through this course to see if you can start to build these at your facility.

 Testing an SOP. Let us see if we can actually test the SOPs (if you found them). Do you understand the SOP that you found? Could you physically do what the SOP asked you to do? Was the outcome the intended outcome? Can different individuals achieve the same outcome? Whether you wrote the SOP or found some work instructions, the questions are the same. So remember, when you write an SOP be sure to test them based on these questions,
Finally, in summary, I want to remind you of some of the highlights. Biorisk management involves a lot of administrative controls at various levels. Examples of administrative controls include guidance documents, program management, defining roles and responsibilities, risk assessment, written safety manuals, selection of staff, practices and techniques, education and training, use of committees, registration and inventory control, signs and labelling, inspections and audits, medical surveillance, and of course documentation. Every facility should have a biosafety manual, a biosecurity manual, an incident and emergency response manual, and a facilities operation and maintenance manual and an animal biosafety manual, if you work with animals. All the manuals need to be supported by standard operating procedures (SOPs). An SOP is an instructional document. Instructional documents teach a reader to understand a rule or principle, envision a process or workflow, perform a task and or use a tool to do a task. They are telling someone how to do something. Having solid documentation gives everyone a sense of confidence that work is controlled and managed which supports quality control and quality assurance.

Thank you again for taking this module on administrative controls. I hope it was helpful in getting you to think about what kind of written documents you have that might assist you in managing the biorisk at your facility. Now please take the quiz questions that will help remind you of some of the important topics that we talked about in this module. Thank you again, we’ll see you in the next module.