In my role as a quality manager, I see ongoing challenges in managing quality records and related documents within our PLM system. Ensuring that all quality documents are properly controlled, linked to product changes, and approved on time is critical for compliance and audit readiness. We want to discuss best practices for document control processes that support quality records management, including automated workflows for approvals and maintaining comprehensive audit trails. The role of document control in managing quality records and approvals is significant, as are best practices for linking quality records to product data and change orders. Workflow automation for quality document review and sign-off, maintaining audit trails and compliance documentation within PLM, and challenges in keeping quality records current and accessible are all important topics. How do others ensure quality records remain accurate and accessible throughout the product lifecycle?
Expectations for document control and audit trails during audits are high. Auditors want to see that quality records are controlled, traceable, and complete. Our PLM system provides comprehensive audit trails showing document creation, revisions, approvals, and access. We can quickly produce reports demonstrating compliance with quality standards like ISO 9001 and ISO 13485. This capability has been critical in passing audits and maintaining certifications.
Configuring workflows for document approvals involves defining approval paths based on document type and criticality. Quality records like validation protocols and test reports require multi-level approvals from quality, engineering, and regulatory teams. Our PLM system routes documents automatically and tracks approval status. Reminders and escalations ensure approvals don’t stall. This automation has reduced approval cycle times and improved compliance with quality procedures.
Best practices for version management of quality records include maintaining clear revision histories, enforcing check-in/check-out procedures, and using lifecycle states to control document usage. Our PLM system ensures only approved quality records are accessible for production and customer submissions. Obsolete records are archived but remain accessible for historical reference. This discipline has improved quality record accuracy and reduced errors.
Document control challenges in quality management include ensuring all quality records are properly versioned, approved, and linked to products. We’ve implemented a PLM-based document control system that enforces strict versioning and approval workflows. Quality records like inspection reports, test results, and certifications are linked directly to product lots and serial numbers. This linkage ensures traceability and supports root cause analysis when quality issues arise. Our audit readiness has improved significantly.