"User feedback is one of the most important resources for improving an organization's
quality control. If you're serious about quality control, you can't assume that
you know what the user wants." - Anonymous
Quality control (QC) is a procedure or set of procedures intended to make sure that a manufactured product or performed service adheres to a defined set of quality criteria. The US Food and Drug Administration (FDA), which is the regulatory agency for the pharmaceutical and medical devices industries, requires written Standard Operating Procedures (SOPs) for all systems and operations that impact the quality and safety of drugs and medical devices in the United States.
FDA inspectors look for good documentation practices in SOPs. Following such practices helps companies create SOPs that actually get used by their target audience.
The Purpose of SOPs
Most people think of SOPs as pieces of paper that contain step-by-step directions about how employees must complete their individual jobs. That image is partially true. But, SOPs are more than that. They are a means to remove variation in work performance caused by employees completing the same work processes in different ways.
A process is a set of actions that an individual or group of people must perform to complete a job or task. The SOP describes the specific steps that everyone should use to complete the process so that, regardless of who performs the process, it is done in the same way.
Effective SOPs contribute to the overall compliance of your company by documenting your processes and then making sure everyone understands them and knows who to contact when there is a problem or a change is needed. Without effective documentation, a process can quickly lead to confusion and potential error.
Characteristics of an SOP That Gets Used
Creating documentation with the above characteristics provides employees with a reference to common business practices. New employees are able to use the SOPs to learn how to perform certain jobs or tasks; experienced employees can use them as a refresher when quality or performance slips.
Attribute: Photo above courtesy of David Castillo Dominici / freedigitalphotos.net
6 Tips for Creating SOPs that Get Used
- Involve stakeholders in the preparation. This ensures that the documented process is an actual process.
- Make sure the meaning of the process is clear and is not open to misinterpretation. Use simple English to explain the steps.
- Use flowcharts and graphics to support the text. Visuals make it easier for the reader to better understand the process.
- Have peers review your document before submitting it for approvals. Test the document on someone who is unfamiliar with the process and have them tell you what they think it means. Then, incorporate user feedback.
- Make sure your document’s history is recorded for every version change. You need to be able to show auditors that you have a monitoring process in place that allows you to evaluate your documentation for relevancy on a scheduled basis and track changes.
- Update your SOPs immediately. Never be afraid to revise an SOP if new information or resources become available that enables a process to be completed more efficiently. The same goes if previously unknown factors are discovered that renders one or more steps in a process as irrelevant.
To be prepared for an FDA audit or inspection, you will need to show the FDA inspectors that you have a system in place for developing, monitoring, and controlling your SOPs.