What's New in Windchill Quality Solutions 10.2
Enhanced functionality for quality, reliability, risk, and compliance
PTC Windchill Quality Solutions 10.2, released in August, 2013, offers a host of new updates to support product quality, reliability, risk management, and compliance across a wide range of industries. The latest PTC Windchill Quality Solutions suite offers expanded connectivity to PTC Windchill PLM through Quality-Driven Change, enhanced enterprise-wide Global Risk Management through Web-based Fault Tree Analysis, a new solution to support the FDA’s UDI regulation, updated FMEA and MSG-3 capabilities, and new support for Medical Device compliance with eMDR submissions.
Quality-Driven Change in PTC Windchill Quality Solutions 10.2 offers new capabilities to drive engineering change in the PLM system from any software module in the suite. This functionality leverages optional connectivity to a PTC Windchill PDMLink Bill of Materials and a new, centralized Problems Table in PTC Windchill Quality Solutions that can be accessed from any module to report a quality issue. As incidents are reported from across the product lifecycle, they may be associated with problems that will then be addressed through change objects introduced into the PLM system. From the common Problems Table, users can generate an ECR (Engineering Change Request), CAPA (Corrective / Preventive Action) or Problem Report in PTC Windchill that follows established workflows and processes for traceable change management.
New, Web-based fault tree analysis in PTC Windchill Quality Solutions 10.2 enables global, enterprise-wide collaboration around risk management processes – a feature mandated by industry-wide requirements like Medical Device Risk Analysis (ISO 14971), Automotive Functional Safety Analysis (ISO 26262), and Civil Aircraft Safety Analysis (ARP4761).
The new, Web-based PTC Windchill FTA offers the complete functionality of the PTC Windchill FTA (Fault Tree Analysis) module, including a full range of analytics, CAFTA converter, dashboards, graphing and reporting, data linking, build from FMEA, library support, built-in toolbar, and more – all in a lightweight, distributable web environment with a robust, intuitive interface. It enables enterprise-wide access to critical Fault Tree analysis, reporting, root cause analysis, and quality improvement functionality.
The PTC UDI Solution utilizes new PTC Windchill technology to support the FDA’s UDI regulation for Unique Device Identification. This new regulation was introduced by the FDA to eliminate the misidentification of medical devices in the field as a result of hospital and supplier renumbering. In order for companies to continue selling devices across state lines, this regulation requires that every product, product version, and product variant be labeled with a unique fourteen-digit identification number. In addition, critical information about the device associated with this number must be electronically submitted to the FDA’s new GUDID (Global Unique Device Identifier Database). Collecting this internal data from the myriad sources in which it resides, electronically submitting it to the FDA, and tracking responses to ensure compliance and avoid penalties will present a huge internal burden to medical device firms’ personnel, resources, and technology.
The PTC UDI Solution addresses that challenge. Developed in partnership with the FDA and major medical device manufacturers, PTC UDI offers a purpose-built UDI data model to help companies manage and control critical UDI data from multiple sources throughout the organization. PTC UDI automates the collection, formatting, review, approval, and electronic communication of UDI submissions to the FDA’s GUDID. It also streamlines future UDI-related activities to help companies maintain compliance following product changes, including new versions or variants; handle changes to the FDA’s UDI regulation; and accommodate additional global UDI regulations from other worldwide governing bodies. Robust functionality including pre-submission data checks that use the same algorithms used by the FDA, response monitoring and flagging of rejections or exceptions, and product templates to automate electronic submission of many similar products all help companies achieve compliance as quickly and efficiently as possible, while helping them maintain compliance in the future as products – and global regulations – continue to change.
- Medical Devices: eMDR in PTC Windchill CEM
PTC Windchill CEM (Customer Experience Management) newly supports eMDR (electronic Medical Device Record) submissions to more efficiently comply with 2009 FDA requirements for electronic adverse event reporting.
- Civil Aviation: MSG-3 (Maintenance Steering Group V.3)
New PTC Windchill MSG-3 functionality expands support for the Civil Aviation standard MSG-3 (Maintenance Steering Group Version 3). In addition to the MSI (Maintenance Significant Item) analysis available in previous versions of the tool, PTC Windchill 10.2 adds functionality for the SSI (Structurally Significant Item), Zonal, and L/HIRF (Lightning / High Intensity Radiation Field) analyses also required by the standard.
Structured decision trees for each of these analysis types guide users through the selection of maintenance plans and risk mitigation activities in an easy-to-use, intuitive interface. These robust, logic-guided decision trees are dynamically connected to the tool’s FMEA back-end to identify any items whose failure may result in safety, operation, economic, or structural impacts.
- PTC Windchill FTA
Updates to large fault tree display and navigation, long-running task calculation over the Web, and Enhanced calculations including support for Multiple Distributions, Monte Carlo Simulations, specialized gate and event logic in support of ISO 26262 in the Automotive industry, and enhancements to common monitors to detect latent failures across events in support of ARP 4761 in the Commercial Aerospace vertical.
- PTC Windchill FMEA
FMEA enhancements in support of risk management include a customizable risk matrix with an easy, intuitive, and flexible interface; updated user calculations; and failure modes library updates in support of ISO 26262 requirements in the automotive industry. What’s more, a brand-new FMEA Actions table helps users track actions taken to address failure modes and their effects, record the results of these actions, connect them to a common problems table, and – through that connection – launch engineering change requests against system tree parts shared by both PTC Windchill FMEA and a synchronized PDMLink or MPMLink Bill of Materials.
- Across the suite
Other new features across the PTC Windchill Quality Solutions suite include updates to graphs and reports, Web enhancements, FRACAS team subtables, API enhancements, and updates to LSAR functionality.
Additional capabilities in PTC Windchill Quality Solutions 10.2 extend quality, reliability, and risk management for products across a wide range of industries. For more information about what's new, please review the Enhancement Details and updated data sheets on the PTC Windchill Quality Solutions product pages.
The latest update to PTC Windchill Quality Solutions is expected to be available in August, 2013.* Maintenance customers can download the software from the PTC Technical Support software download web page. Other users can download the tryout version for a free, 30-day trial.
If you have technical questions or feedback on the latest PTC Windchill Quality Solutions release, please contact PTC Technical Support.
*The timing of any product release, including any features or functionality, is subject to change at PTC's discretion.