The Quality and Compliance Challenge

Quality

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.

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Key Features

  • 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>/li>
  • 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
Freudenberg-NOK: Secrets to Eliminating Disparate APQP Systems with Aras

Freudenberg-NOK: Secrets to Eliminating Disparate APQP Systems with Aras

Read how Freudenberg-NOK achieves Advanced Product Quality Planning (APQP) compliance success and develops higher quality products faster with Aras Innovator.

Read the Case Study

Benefits

  • 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

Availability

The Aras® Quality Management System is an Aras Innovator application. It is available on an open-access basis or through an annual subscription, which comes with additional features, full support, training, and upgrades.

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Key Characteristics of an Ideal Quality Management System

A guide to building a Quality Management System (QMS) for Medical Device Companies.

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Ogihara Achieves Quality & Compliance Success with Aras

Learn how Ogihara has improved quality management & compliance with Aras to achieve better responsiveness to customers.

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Funktionalität

ALM Integration

Ermöglicht komletten Systemüberblick über multi-disziplinäre Produkte durch das Einbinden von Embedded Software Komponenten in die übergeordneten unternehmensweiten Prozesse, während der Quellcode mit ALM-Systemen verwaltet wird.

Stücklisten

Ermöglicht konsistente BOM-Strukturen durch automatisierte Updates basierend auf den entsprechenden CAD-Modell-Strukturen.

Änderungsmanagement

Stellt sicher dass alle Teammitglieder, Zulieferer und Partner den aktuellen Status von Änderungen sehen und vorgegebene Änderungsprozesse eingehalten werden. Reduziert dadurch Fehler, Kosten und Verzögerungen.

Component Engineering

Erleichtert die Suche, Auswahl und Genehmigung von extern beschafften elektronischen Komponenten unter Einhaltung von Compliance- und Einkaufsrichtlinien.

Konfigurationsmanagement

Bietet ein umfassendes "Closed-Loop" System durch CMII- und CMPIC- zertifizierte Methoden für das Verwalten von Konfigurationen eines Produkts oder Systems über den gesamten Lebenszyklus.

Dokumente

Bietet das umfassende Verwalten von Dokumenten in unterschiedlichen Formaten inkl. Versionierung und Änderungskontrolle in einem sicheren, durchsuchbaren Repository.

Manufacturing Process Planning

Provides an integrated approach to managing manufacturing data and processes in PLM, bridging the gap between engineering and manufacturing with a digital thread.

Teile

Bietet konsistentes Management der Informationen bei automatischer Verwaltung der Beziehungen zu relevanten CAD-Modellen, Zeichnungen und anderen Dokumenten.

PDM Integration

Aras bietet umfassende PDM Funktionen. Integration von bestehenden PDM Umgebungen die bereits CAD-Daten, Teile, BOMs und Dokumente verwalten ist ebenso möglich.

Projekte

Ermöglicht Sichbarkeit und Kontrolle über Projekte und Programme. Schafft die Vorraussetzungen für Unternehmen Resourcen zu planen und zu verwalten, Risiko zu minimieren und Verzögerungen zu vermeiden.

Anforderungen

Ermöglicht das Erstellen einer einzigen, disziplin-übergreifenden Anforderungshierarchie. Wichtig für das Design von komplexen Produkten die Hardware, E/E und Software kombinieren.

Systems Engineering

Management des Lebenszyklus von komplexen, mullti-disziplinären Produkten von den Anforderungen über Konstruktion und Entwicklung bis zur Fertigung und Support.

Technische Dokumentationen

Ermöglicht disziplin-übergreifendes Erzeugen, Anzeigen, Teilen und Veröffentlichen von themen-basierter, modularer Dokumentation innerhalb einer sicheren Umgebung.