Managing SOPs With the QMS

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, and documents run the risk of getting buried in emails.

First published on the Assurx blog.

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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.

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.

Management

Managing SOPs With the QMS

Common mistakes and best practices for your quality management system

This scenario highlights the risks of ineffective SOP management, and why manufacturers must regularly review and update SOPs to protect quality.

SOPs must say what you’re going to do, using internal audits to verify that you do what the SOPs say. Even minor changes must be documented to ensure you audit to the right procedure, including changes resulting from a corrective action.

SOPs are a foundational element of quality and must be updated continuously to account for process changes and emerging risks. Employee training is a vital link in the chain, including a post-training assessment to verify that people actually know how to perform the SOP.

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.

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 affects existing SOPs.

For instance, suppose your SOP says you use a particular process on a production line in a specific order. If you decide to use a different production line at some point, that must be documented. You can be certain it will come up during an ISO certification audit and create a problem if you haven’t looked at your SOP in five years.

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Mistakes around standard operating procedure (SOP) management are widespread and costly, especially given the pace of change in manufacturing today.

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.

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