As a result of the initial success, today more than a dozen departments in the company use AssurX, with more than 60 active action request forms to automate processes such as:
• Complaint management
• Deviations and noncompliance investigations
• Change management
• Audit management
7. Medical device manufacturer eliminates 2,400 labor hours annually with automated nonconformance management
VELCO implemented AssurX for its versatility and industry-specific capabilities, allowing the company to store evidence, track tasks, and provide visibility across the organization.
Before implementing the software, a single employee was responsible for managing all documents, such as forms and SOPs. This required spending a disproportionate amount of time sending emails and chasing down reviews and approvals. In addition, the company’s corrective and preventive action (CAPA) system was paper-based, with hand-written responses on printed forms needing manual entry into an access database.
These manual processes reduced visibility and accountability over the process. By using AssurX to automate these two processes alone, the company was able to free up 20 hours weekly in administrative work.
As a result, the utility was able to reduce labor preparation hours from 24.5 hours to fewer than 11 hours per requirement. The organization was also able to automate the generation of reliability standards audit worksheets (RSAWs). After a demonstration of the utility’s initial controls to the Northwest Power Coordinating Council (NPCC), regulators reduced the organization’s next audit scope by nearly 50%.
Conclusion
A leading national manufacturer of automotive maintenance products with more than $1 billion in annual revenue turned to AssurX to address challenges around time-consuming corrective action and document management processes.
Toray CMA chose AssurX due to its configurability, using the platform to create workflows for tracking issues from intake to root cause analysis to resolution. The organization has increased accountability over issues while reducing labor hours on manual processes, and is able to configure workflows without changes to source code.
Published March 14, 2024, by AssurX.
منبع: https://www.qualitydigest.com/inside/lean-article/real-life-results-implementing-compliance-management-systems-040424.html
Today, tasks and reminders are automated to keep processes on track, while the company also performs extensive analytics on quality data to identify trends and accelerate problem-solving.
5. Semiconductor manufacturer reduces wafer production time from months to days
Companies today implementing automated compliance management systems are motivated by a wide variety of factors.
As a result of implementing an integrated compliance management system, the company was able to:
• Eliminate 800 personnel hours per audit
• Save 1,400 personnel hours by eliminating manual information gathering
• Eliminate 2,100 personnel hours on manually logging defects
• Save 3,000 personnel hours by eliminating in-person meetings
• Reallocate 1.5 full-time employees to more value-added work
4. Highline Warren saves 20 hours per week with automated document management and corrective actions
Rather than being a cost sink, however, an automated compliance management system can deliver staggering results, in some cases saving hundreds of thousands of dollars annually.
A global manufacturer of diagnostic imaging agents was struggling with the complexity of using multiple quality management applications. Legacy applications with minimal integration and compatibility issues lived on 18 servers, increasing costs and compliance risks.
Within two weeks of deployment, more than 400 users were using the new compliance management system without administrator support. Within three months, daily meetings were no longer required, with real-time status of defects and events immediately visible in the system.
Implementing an automated compliance management system is a significant effort requiring input and buy-in from a number of stakeholders. Engaging your team in the process is key. Those who put in the effort upfront are more likely to reap bigger rewards in the long run.
A semiconductor manufacturer using siloed systems to manage field service incidents needed to deploy an automated system for early data collection, failure reporting, analysis, and corrective actions (FRACAS). Maintenance, downtime, and privacy concerns were all top challenges the new system would need to address.
After tripling in size, a cardiovascular device manufacturer needed a better system to manage electronic and paper-based records of compliance data at U.S. and EU facilities. Analyzing reported problems was time-consuming, which resulted in delays throughout the quality chain.
As a result of this early success, the company has since deployed a number of additional quality processes in AssurX, including:
• Deviation tracking
• EHS incident management
• Complaint management
The manufacturer chose AssurX for its expertise in regulated industries, providing a system that supported HIPAA and SEMI E10 compliance along with easy workflow configurability.
The manufacturer initially deployed an automated compliance management system to manage CAPAs and external corrective action reports. Since then, the company has also deployed automated process workflows for:
• Nonconformance management
• Receiving and inspection
• Complaint management
• Electronic medical device reporting (eMDR)
Toray Composite Materials America (CMA), a manufacturer of advanced materials used in a variety of industries, was struggling with inefficiency related to paper-based nonconformance tracking. Challenges included time-consuming meetings, approvals, and data retrieval, plus an inability to effectively track issues.
To see how, we explore eight real-life stories of what organizations across a range of industries have achieved by automating compliance.
1. Contract manufacturer achieves zero findings on ISO 13485 audit
As a result of deploying a compliance management system, the contract manufacturer achieved:
• Zero findings on ISO 13485 audits
• Significantly reduced labor hours for document creation, approval, and routing
• Complete visibility into employee training completion, on-time training, and overdue tasks
2. Diagnostic imaging manufacturer achieves $266,000 in savings
By replacing manual processes with automated workflows, the company eliminated more than 2,400 labor hours in nonconformance management alone, and can now generate and submit eMDR/MedWatch reports with just two clicks.
8. Vermont Electric Power Co. cuts audit preparation time by more than half
A contract manufacturer in custom blending and extrusion of biomedical polymers and additives faced significant challenges around a shared corporate QMS that wasn’t built for FDA compliance. The company led its QMS implementation with AssurX Document Management and Training Management solutions to support its goals around data integrity and secure document access.
For those who do—and those who are truly committed to using the system to drive continuous improvement—the results can more than pay for the initial investment. From reduced labor hours to greater efficiency, compliance, and accelerated issue management, the sky truly is the limit.
For many, it’s about reducing manual labor hours required to execute quality processes—and achieving greater efficiency and effectiveness in their operations. For others, the priority is building a rock-solid compliance program that protects customers and the business from risk.
Facing new electric utility regulations, Vermont Electric Power Co. (VELCO) sought an automated solution to ensure compliance with 83 standards covering roughly 800 requirements. The utility needed a way to verify that required actions were completed to operate and maintain systems, and to provide evidence of this work on a continuous basis.
The manufacturer deployed 16 processes as part of its compliance management system, creating simplified workflows and engaging AssurX in data migration and training to streamline implementation. Results included:
• Nearly 20,000 lifecycle documents and 100,000 training records migrated
• Server maintenance costs reduced by 65%, with licensing costs reduced by 90%
• More than 3,000 personnel hours saved
• Total savings of $266,000 in first year
Within the first two months of deploying the FRACAS system, the manufacturer fabricated more wafers in a single day than it had previously in an entire month. The system also allowed it to:
• Automate root cause analysis and CAPA for more effective issue management
• Collect accurate reliability, availability, and maintainability (RAM) metrics to ensure SEMI E10 compliance and customer confidence
• Capture detailed data around failures for deeper analysis and risk mitigation
• Maintain all data in a secure environment that protects against unauthorized access
6. Toray Composite Materials America digitizes 60-plus action request forms to automate workflows
All in all, the manufacturer more than doubled its number of quality processes while simultaneously achieving significant savings and increasing user efficiency.
3. Pharmaceutical and chemical manufacturer saves more than 10,000 personnel hours per year
A global pharmaceutical and chemical company using paper and spreadsheets implemented multiple QMS solutions to integrate its processes, including CAPA management, complaint handling, supplier quality management, and audit management.
View all these case studies to learn how AssurX has helped companies like yours revolutionize compliance management.