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.
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.
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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 using 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
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• Add a watermark that says “superseded” on all previous document versions so people don’t use outdated SOPs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
Version errors can be particularly expensive. Consider, for example, the implications of using an SOP that doesn’t reflect new controls added after corrective action.
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
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.
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.
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Published: Wednesday, August 2, 2023 – 12:03
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