Quality by Design

Quality by Design

Build a culture of quality, starting with step one of the product and service design process. Analyze product and process plans, establish metrics and benchmarks, and track the most critical quality processes across an organization.

Advanced Quality Product Planning (APQP)

Project Control ensures all tasks are completed on time and within budget. With this tool, users can automate tasks, deliverables and activities within all quality and compliance projects. Project Control features the type, subject, description, roles, owner(s) and start/end dates, along with updates and workflow functionality. Using workflows ensures that the project is on track, within budget and fully documented.

  • Manage projects and tasks for your NPR/NPI process and other major initiatives
  • Create milestones with required deliverables and task dependency
  • Define project templates for common project types, such as APQP
  • Use MS Project as a template and to update project information
  • Display progress as % completion or GANTT
  • Use the Mobile App to complete assigned tasks, even disconnected from the network
  • Track timeliness of each task using flexible workflow rules
  • Record the current risk level for each task and manage risk for the entire project
  • Report projects by status and risk levels
  • Integrates with Change Management, Product Specification Management and FMEA

Product Specification Management

Product Specification Management improves the management of the product lifecycle from start to finish by helping to track and control all data specific -- or related -- to a product and its components and subsystems. Product specification management features the ability to generate a Bill of Materials (BOM) within a multi-document hierarchy and the ability to initiate and manage change requests.

  • Manage the product design through a strict revision control process
  • Create a hierarchical view of components aligned with the BOM
  • Record the costs and operational steps for each component and roll up to the part/product level
  • Report Product Specifications by status
  • Integrate with PLM and ERP to lookup BOM details
  • Integrates with FMEA module to identify and mitigate risk in design
  • Integrates with Employee Training module to improve operational compliance
  • Integrates with Change Management module to track related changes to SOP, equipment and suppliers

Failure Modes and Effects Analysis (FMEA)

The FMEA automates the analysis of product and process design, thereby reducing the time taken to study failure effects and mitigate the risk of potential failures — ultimately enabling organizations to make better decisions in their quality planning initiatives.

  • Manage risk in design with FMEA projects to prioritize potential failures by RPN score
  • Create a hierarchical view of FMEA and Control Plans aligned with the Bill of Materials (BOM)
  • Update FMEA and Control Plans using Web-based or MS Excel interface
  • Integrate with HBM Prenscia xFMEA for advanced editing options
  • Create a Hazard Analysis to assess product risks to end-user safety
  • Track corrective actions for each risk
  • Enforce review and approval workflows, with timeliness tracking
  • Maintain strict revision control by product or at the sub-system and component level
  • Report FMEA status by product
  • Integrate with PLM and ERP to lookup BOM details
  • Integrates with Corrective Action (CAPA) for investigation and resolution
  • Integrates with Product Specifications Management for component details
  • Lookup FMEA details in Complaints Management and Nonconformance Reporting modulest

Hazard Analysis and Critical Control Points (HACCP)

HACCP is designed to automate the safety process and is dynamically linked to preventive control processes such as Hazard Prevention, Sanitation and Hygiene Documentation and Training, Environmental Monitoring and Food Allergen Control.

  • Identify and risk assess biological, chemical and physical hazards in the manufacturing processe
  • Measure inherent and residual risk after applying control measures
  • Identify critical control points (CCP) to monitor as part of the risk mitigation plan
  • Use the Mobile App to complete assigned tasks while remote or disconnected from the corporate network
  • Compare monitoring results with established targets
  • Enforce review and approval workflows, with timeliness tracking
  • Maintain strict revision control by process
  • Report HACCP status by process or product
  • Integrates with Corrective Action (CAPA) for investigation and resolution
  • Integrates with Assets, Calibration and Maintenance for monitoring and control equipment
  • Integrates with Employee Training to improve operational compliance

Assets, Calibration and Maintenance

This product automates the calibration and maintenance scheduling and report for any hard asset in a company’s inventory. Any piece of equipment can be scheduled and set up with automatic notifications to indicate when equipment is due for calibration.

  • Manage the complete lifecycle of calibration devices and production equipment
  • Schedule calibrations and maintenance based on usage, time or other factors
  • Define calibration plans with pass/fail criteria and calculated results
  • Define maintenance plans that track required tasks and a record of parts used
  • Use the Mobile App to complete assigned tasks, even disconnected from the network
  • Track timeliness of each task using flexible workflow rules
  • Integrate with ERP to lookup equipment details
  • Integrates with Corrective Action (CAPA) for investigation and resolution
  • Reference the calibration status of devices in other quality processes, like Nonconformance Reporting