Quality by Design

What is Quality by Design?

Quality by Design

With Quality by Design you can build a culture of quality, starting with the first step of the product and service design process. Analyze product and process plans, establish metrics and benchmarks, and track the most critical quality processes in an organization.

Advanced Product Quality Planning (APQP)

Quality by Design ensures that all tasks are completed on time and within budget. With this tool, users can automate tasks, deliverables and activities across all quality and compliance projects. Project Control presents 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 important initiatives

Create milestones with required results 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 % complete or GANTT

Use the mobile app to complete assigned tasks, even when disconnected from the network

Track the 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

Quality by Design improves product lifecycle management from start to finish by helping to track and control all data specific to – or related to – a product and its components and subsystems. Product specification management introduces the ability to generate a bill of materials (BOM) within a hierarchy of multiple documents and the ability to initiate and manage change requests.

Manage product design through a rigorous review control process

Create a hierarchical view of BOM-aligned components

Record the costs and operational steps of each component and scroll down to the part/product level

Product specifications report by status

Integrate with PLM and ERP to research BOM details

Integrates with the FMEA application to identify and mitigate project risk

Integrates with training management application to improve operational compliance

Integrates with the Change Management application to track changes related to SOP, equipment, and suppliers

Failure Modes and Effects Analysis (FMEA)

Quality by Design automates the analysis of product design and process, thereby reducing the time spent to study the effects of failures and mitigate the risk of potential failures – ultimately enabling organizations to make better decisions in their quality planning initiatives.

Manage design risk 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 Planes Using the Web-based Interface or MS Excel

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

Apply review and approval workflows, with on-time tracking

Maintain strict revision control by product or at the subsystem and component level

Report FMEA status by product

Integrate with PLM and ERP to research BOM details

Integrates with Corrective Action (CAPA) for investigation and resolution

Integrates with Product Specification Management for component details

Research FMEA details in complaint management applications and non-compliance reports

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 evaluate biological, chemical and physical risks in the manufacturing process

Measure the 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 goals

Apply review and approval workflows, with on-time tracking

Maintain strict review control by process

HACCP status report by process or product

Integrates with Corrective Action (CAPA) for investigation and resolution

Integrates with Assets, Calibration and Maintenance for equipment monitoring and control

Integrates with Training Management to improve operational compliance

Assets, calibration and maintenance

This product automates the calibration and scheduling of maintenance and reporting for any rigid asset in a company's inventory. Any piece of equipment can be programmed and configured with automatic notifications to indicate when the equipment should be calibrated.

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 the parts used

Use the mobile app to complete assigned tasks, even when disconnected from the network

Track the timeliness of each task using flexible workflow rules

Integrate with ERP to search for equipment details

Integrates with Corrective Action (CAPA) for investigation and resolution

See the calibration status of devices in other quality processes, such as non-compliance reports

System Requirements:

CPU: 1.8 GHz dual core processor

RAM: 2 GB

HDD/SSD: 50 GB of free space on main drive

Operating system: Microsoft Windows 8 32-bit, Microsoft Windows 7 32-bit, and Microsoft Windows Vista 32-bit

Resolution: 1024×768

Supported Operating Systems

Mac OS X 10.5x (Leopard), Mac OS X 10.6 (Snow Leopard), Mac OS X 10.7 (Lion), Mac OS X 10.7 (Mountain Lion), OS X 10.9 (Mavericks), and Mac OS X 10.10 (Yosemite)

Hardware requirements

Memory - 1 GB RAM and more

Free disk space - 50 MB

System type - 32-bit and 64-bit OS