Managing SOPs With the QMS

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 quick access
• 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• Add a watermark that says “superseded” on all previous document versions so people don’t use outdated SOPs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

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.

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, which leaves room for preventable mistakes.

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• Compare version number against document age to identify outdated SOPs and unstable processes needing review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

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

Management

Managing SOPs With the QMS

Common mistakes and best practices for your quality management system

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

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.

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.

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.

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.

First published on the Assurx blog.