A standard operating procedure (SOP) is a set of written instructions that describes, in detail, how to perform a laboratory process safely and effectively. Supervisors or laboratory managers are responsible for ensuring that accurate SOPs are developed and implemented in their lab. Many recur to laboratory compliance consultants to develop SOP and benefits managers, workers, and technical advisers. SOP used in combination with planned training and regular performance feedback lead to an effective and motivated workforce. Here are eight steps to consider when writing an excellent SOP.
1. Plan for results
SOP works best when they are designed to achieve specific results. Decide what business goals will be achieved and how those goals will be measured. Many benchmarks exist in the industry to help measure efficiency and quality in specific areas.
2. Produce the first draft
If you choose to use simple steps, hierarchical steps, or the graphic format, first make a detailed list of the steps in the order that they are done. If the procedure needs to appear as a flowchart, start with the most reasonable beginning point. Draw the decisions that a worker will need to make and the actions that follow each decision. Remember, this is the first draft so don’t try to be perfect because it is very likely that you’ll need to make many revisions.
3. Conduct Internal Review
Provide each laboratory staff member with a copy of the draft created. Ask them to review and suggest changes that will make the procedure easier to understand and that will help improve performance. It’s important to consider staff as they are the ones who perform the actions daily. Another reason to involve staff members is that they are likely to have good ideas. Highly successful managers actively engage their team to become more efficient, increase cost-effectiveness, and improve quality.
4. Conduct External Review
Managers increasingly rely on laboratory compliance consultants and advisers outside their own organizations for the SOP writing process. As they are experts, they can suggest any changes that will make it your SOP clearer and more effective. At Click On Laboratory, we assist with written Standard Operation Procedures (SOPs), test validation, instrument validation, and staff training.
There is only one way to be absolutely certain that a procedure is well written and it is to test or perform it in the workplace. Have a staff member test the procedure by performing each step exactly as it is described. Have a person not familiar with the work follow the procedure and also someone watching. Any steps that cause confusion or hesitation for the test worker should be revised.
Once the SOP has been revised, tested, and checked by a laboratory compliance consultant make a final draft of the procedure and post it in the appropriate workplace locations. A master SOP file should be kept in a central location so workers can review land update the SOPs when necessary.
One of the last steps in the SOP writing process is often the least done. Train and retrain everyone as necessary to follow the procedure exactly. Otherwise, individuals will interpret the meaning of procedures in different ways, leading to inconsistency in work routines and performance.
Each SOP should be audited about three months after implementation and after that at least annually. An audit will show whether the procedure is being adhered to and whether the objectives are being met. It can also help identify areas of improvement.
Writing an SOP is a crucial process if you are setting up a laboratory. This also helps you and your staff offer the best and safest performance for your clients. At Click on lab, we work as your trusted laboratory compliance consultants. Contact us today.