The Quality and Compliance Challenge
With increasing product complexity and shortening development cycles, ensuring product quality and regulatory compliance can be challenging for companies focused on fast innovation.
However, many business use stand-alone systems and spreadsheets for managing quality, creating information silos and process gaps.
The result of this disconnected approach is reflected in the growing number of product recalls, leading to costly fines and damage to brands.
Integrated Quality and Compliance Management
The Aras® Quality Management System application addresses this gap in quality management processes by integrating the proactive and reactive aspects of quality into PLM. By bringing quality into the Aras® PLM Platform it can be linked to product designs, manufacturing plans, and business-critical processes such as change management.
The result is a comprehensive solution that provides cross-disciplinary teams and the extended supply chain with powerful closed-loop capabilities to identify and manage risk, improve quality, meet customer requirements, and attain environmental, safety, medical, and other forms of compliance.
- Implement Advanced Product Quality Planning (APQP) processes to achieve compliance with regulatory requirements and quality standards including TS/16949, AS9100, FDA QSR
- Closed-loop corrective action/preventive action (CAPA) and Root Cause Analysis (RCA) to accelerate identification, containment & analysis of issues, and tracking of affected items
- Create and maintain critical quality documents, including:
- Design/Process Failure Modes Effects Analyses (DFMEA/PFMEA)
- Process Control Plans (PCP) & Process Flow Diagrams (PFD)
- Fault Tree Analysis, Fishbone, and Five whys
- Manage libraries of critical characteristics, failure modes, effects, and control mechanisms
- Integrate quality throughout the concept, design, and manufacturing lifecycles and related change processes
- Coordinate quality reviews through Visual Collaboration, business rules & workflow, and aggregation & packaging of CAP items
- Reduce risk by exposing potential quality issues and defects before product release
- Increase efficiency when reacting to quality issues when they occur and drive product changes to remove future quality escapes.
- Manage compliance from product design through to product delivery
- Save money, improve product quality, and meet customer requirements by integrating quality management with product development and process planning
- Streamline quality management and improve the productivity of quality management personnel by maintaining consistent quality processes across products and in the supply chain
Find Out More
Learn about Configuration Management with ISO 9001 and ISO 10007 Quality standards.
A guide to building a Quality Management System (QMS) for Medical Device Companies.
Learn how Ogihara has improved quality management & compliance with Aras to achieve better responsiveness to customers.