Leading the Market in Quality Amidst Product Diversification
See how Bose is using PLM software for enterprise-wide quality governance.
Watch the webcastWhat is quality management
Quality management ensures quality is designed into every product and process across the enterprise, including external partners. Quality management provides automated failure mode and effects analysis (FMEA), enables closed-loop corrective and preventive actions (CAPAs) and accurate root cause analysis (RCA) to accelerate identification, containment, and analysis of issues and tracking of affected items. Quality Management is required to achieve compliance with regulatory requirements and quality standards in most industries. However, the complexities of dispersed teams, disconnected systems, and a changing regulatory environment create roadblocks to delivering high-quality products. PTC integrates quality management into the PLM process. This enables better management of quality early in the lifecycle which reduces late stage changes and reduces the costs of poor quality.
Closed-loop quality for the entire organization
PTC takes a holistic approach to quality across the organization from ideation to field service. Highly configurable, out-of-the-box workflows are associated with products and parts for a complete design master record (DMR) and design history file (DHF). Change and configuration management, requirements and test management, CAPAs, non-conformances, customer experience management (CEM), audit, document control, failure mode and effects analysis (FMEA), fault tree analysis (FTA), critical to quality (CTQ), and risk-based design (RBD), are centrally stored and aligned with engineering, manufacturing, and service bills of materials and process plans. By combining PLM and quality management into a single platform, PTC helps organizations of all sizes accelerate the delivery of high-quality products.
Key product features
Unify your engineering, quality, and regulatory teams by introducing best practice change, document, and design control processes.
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Change and configuration management: Communicate changes, requirements, test procedures, and manufacturing controls to downstream teams
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Document control: With integral training tracking
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Closed-loop feedback: Collect product failure and performance data from testing, manufacturing, field/IoT for root cause analysis and feedback to design
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Audit: Perform internal and supplier audits to ensure that key corporate processes, requirements, and directives are being followed
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MBD & MBE: Visibility into model based detailed design data to identify CTQ for development of validation and manufacturing control plans
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CAPAs, SCARS, and change requests: Initiate, evaluate, assign, monitor, review, and approve CAPAs arising from internal or external non-conformances
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Customer experience management: Capture all customer feedback, including customer complaints
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Digital product traceability: Standard OSLC, supports certification and qualification ISO26262, DO-178, etc.
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Non-conformances, deviations, waivers: Intake, evaluate, resolve, and track product and process nonconformance with integrated change management
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Risk and reliability: FMEA with direct connection of DFMEA to BOM, Weibull life data analysis, fault tree analysis, risk-based design, prediction, and critical to quality
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Standards and compliance: ISO9000, Six Sigma, APQP, CMMI, and medical device standards like FDA 21 CFR Part 820
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Medical device applicability: Pre-configured ISO 13485 processes
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Real-time connectivity: Remote monitoring of field products leveraging IoT
Customer stories
PTC customers have reaped the rewards that come with better quality management in industries ranging from life sciences to electronics and high tech. See for yourself.
Learn more about Windchill
PTC’s Windchill is a leading quality management solution. Windchill provides a single source of truth that can be shared across engineering, quality manufacturing, and supply chain and regulatory teams. It closes the loop on quality, making post-market intelligence available to all functions. It is a trusted and scalable product for collaboration and innovation.
