July 12, 2023
Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today.
Consider, for example, an electronics manufacturer that introduces a new product model with updated features and components. This new model requires a specific voltage tolerance test for one of the new components, but the quality control SOP only covers testing steps for the previous model.
During assembly, an operator unaware of the new requirements performs the voltage tolerance test incorrectly. As a result, faulty products are shipped to customers, leading to defects, complaints, and ultimately, a recall.
This scenario highlights the risks of ineffective SOP management, and why manufacturers must regularly review and update SOPs to protect quality.
With that in mind, this article discusses common SOP management mistakes, best practices and how an enterprise quality management system (QMS) can help you implement them.
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SOP Review
Infrequent review is perhaps the biggest mistake manufacturers make when it comes to SOP management. Information and requirements can change throughout the product development cycle, making it essential to review SOPs regularly.
For instance, let’s say your SOP says you use a particular process on a production line in a specific order. If at some point you decide to use a different production line, that needs to be documented. You can be certain it will come up during an ISO certification audit, creating a problem if you haven’t looked at your SOP in five years.
SOPs must say what you’re going to do, using internal audits to verify that you do what SOPs say. Even minor changes must be documented to ensure you audit to the right procedure, including changes resulting from corrective action.
As a best practice, organizations should review their SOPs at least annually. Even if nothing changes, you must examine SOPs closely to confirm they reflect current processes. An automated QMS simplifies this process by allowing you to:
- Set review frequency for individual documents, with automated notifications and routing to keep reviews on track
- Break out tasks and assign responsibilities for SOP review
- Compare version number against document age to identify outdated SOPs and unstable processes needing review
Organization and Revision Control
Poor organization and revision control are pervasive problems that can lead to inefficiency and mistakes. That’s because when you’re using paper-based SOPs, it’s often unclear whether you’re using the most up-to-date version. Finding SOPs in paper filing systems or even shared server drives is time-consuming, with documents often becoming buried in emails.
Versioning errors can be particularly expensive. Consider, for example, the implications of using an SOP that doesn’t reflect new controls added after corrective action.
A digital QMS lets you centralize SOPs in one system so the most recent version is always at hand. Advantages here include the ability to:
- Create templates and file naming conventions for different document types to ensure consistency and findability
- Prevent unauthorized changes by establishing permissions for which personnel can view, edit and approve documents
- Add a watermark that says ‘superseded’ on all previous document versions so people don’t use outdated SOPs
Employee Training
Whenever you create or update an SOP, it’s essential that those changes be incorporated into employee training materials. It’s a critical link often missed with manual SOP management processes, leaving room for preventable mistakes.
Using the QMS to connect your document management and employee training processes reduces this risk. In fact, it’s why many organizations often begin QMS implementation by rolling out document management and training management first.
Here companies can link SOPs with employee training by:
- Assigning SOP training by individual users or groups
- Automatically triggering new training requirements anytime an SOP is updated
- Creating exams within the QMS that individuals must pass to complete their training
- Including different types of questions such as true/false and multiple choice into exams
- Building exam templates that can be reused for different SOPs
Change Management
Anytime a process is updated, manufacturers must consider the implications from a change management perspective. Whether it’s adding a new piece of equipment, changing processes or updating policies, it’s crucial to ask how the change impacts existing SOPs.
Companies using a change control solution within their QMS can create that essential link with SOPs by:
- Triggering document change requests directly from the change management software, or utilizing change management processes built directly into document management software
- Adding due dates and responsibilities to the change request to keep the process moving forward
- Linking the change request to all affected documents
- Upon approval, routing the request to add a new document or make changes to the existing document
Conclusion
SOPs are a foundational element of quality, and must be continuously updated to account for process changes and emerging risks. Employee training is a vital link in the chain, with a post-training assessment to verify that people actually know how to perform the SOP.
Making these best practices a reality requires strong organization and revision control, as well as integration with other quality processes. A QMS provides a distinct advantage in these areas, laying the groundwork for robust SOPs and processes that support quality from design to shipping.
Read this case study to learn how one manufacturer used the AssurX EQMS to automate their document management and employee training processes.
About the Author
Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.
