Requirements for Standard Operating Procedures (SOPs)

Your vision is that when you make a process change, employees would just get it and start moving along with the new way to do things.

You are working to get employees to change their process and you have read about how to get them engaged to achieve successful adoption, but when it comes down to the day-to-day, you are unsure of how to get everyone on the same page. It may not even be about change, but simply you need to get your team or teams on the same page with process and procedures.

The case is changing a shipping and receiving process aka standard operating procedure or SOP.

Let's say you're managing a warehouse team at a laboratory that runs prenatal tests. The team handles various reagents or ingredients for running tests. As you might imagine the items that are delivered have to be handled properly including consideration of storage location for proper foot traffic and workflow patterns, temperature, and tracking lot numbers. If you have employees on various shifts handling these items in the way they best see fit, you are unlikely to pass CAP and CLIA laboratory inspections, you are likely to have poor testing accuracy and poor efficiency in workflow.

The solution is to begin implementing standard operating procedures or SOPs

SOPs are instructions that your team(s) assemble, distribute, sign off on, and have readily available at all times for reference so that everyone is operating under the same set of guidelines. Prior to beginning the writing process, think about the types of SOPs you will have so that you can come up with a logical numbering system. For example, warehousing at a lab is likely to be a smaller subset of SOPs so maybe the lab falls under the 1000 numbers and warehousing in the 2000 range and then drill down from there similar to setting up a table of contents.

Why Are SOPs Important?

• Consistency: Ensure tasks are performed the same way every time, minimizing errors.
• Training: Serve as a resource for onboarding new employees and training staff.
• Compliance: Help meet regulatory requirements and avoid penalties.
• Efficiency: Streamline processes and reduce time wasted on misunderstandings or rework.

Top items to include in an SOP

1. Revision table: This should include the SOP number, publish date, and by whom and the relevant department. You must keep track of the date, who, and what was changed after it's published so that anyone can go back and see what has changed.

2. Notification process: When a change occurs, the team must be notified so that they are following the proper procedure. You may use software like iMeet or Asana, that has that built-in, or you may notify in meetings or email. Whichever way you choose, make sure it is consistent and communicated with the team(s) for expectations.

3. The purpose: Briefly detail the reason the SOP is being written so it is clear why and when it is to be used.

4. The audience: Note the scope or who should be following the procedure.

5. Definitions: List the terms and what they mean that may be specific to the SOP or department for clarity. If you are wanting lot numbers tracked for example, make sure it is clear where those are to be found on the packages and what the number represents.

6. The procedure: This is the section to list out in clear steps what is to be done. Check to make sure after writing that you can follow it, the flow makes sense, measurements are there, temperatures, every detail required.

7. References: If further documents are required, make sure to note or link to those as well. Contact information may be required as well if there are people who need to act in order for a task to be completed.

8. Signature line: Your procedures may be on a drive or in a binder, but each procedure needs its own signature area for each team member to sign and date to acknowledge receipt. When a revision occurs, that signature page needs updating. Auditors will look for this.

9. Safety Precautions (if applicable) Highlight any hazards associated with the task and how to mitigate them.

10. Quality Standards Specify benchmarks or standards to ensure the process meets organizational or regulatory requirements.

11. References Include links to related documents, manuals, or policies for further information.

Best Practices for Writing SOPs

• Use simple and direct language. Avoid technical jargon unless necessary.
• Involve subject matter experts (SMEs) to ensure accuracy.
• Test the SOP by having someone unfamiliar with the process follow it to identify gaps.
• Regularly review and update SOPs to reflect changes in processes or regulations.

By including these elements, SOPs can become a reliable resource for maintaining consistency, ensuring compliance, and empowering your team to work efficiently.

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