Helping Quality and Engineering Teams Stay in Sync: EQMS Integrated with Design Controls and Requirements Traceability & Product Risk Solution

Today, it is critical that engineering and quality teams work together from day zero – right from the early stages of the design phase. This is important for several reasons:

• To bring high-quality products into the market with full compliance
• Robust documentation of all quality and product design activities
• Complete visibility into all design inputs, outputs, validations, and verifications
• Integrated management of product risks – across the lifecycle of the product

Needless to add, the success of any product revolves around two key aspects – whether it conforms to specifications and whether it meets customer requirements.

Integrating the EQMS with a Design Controls Solution and Requirements Traceability and Product Risk Solution will certainly ensure greater collaboration between engineering, quality, and risk management teams.

The EQMS ensures end-to-end quality and compliance requirements are met across supplier, manufacturing & production, and customer processes. By having design controls, requirements traceability, and product risk processes integrated we’re able to close the loop of capturing feedback from the customers, pushing it back into the design and manufacturing process, and making changes as needed.

The Food and Drug Administration defines design controls as an interrelated set of practices and procedures that must be integrated with the product design and development process to help with:

• Identifying deficiencies in design input requirements
• Discrepancies between the proposed designs and requirements
• Ensuring necessary integration between final specifications and design data points
• Robust documentation spanning quality, compliance, product risk management, and design compliance requirements

If detected at the design stage, flaws can be corrected at an early stage of product development, reducing wastage and scrap. This will also bring down the cost of manufacturing, improve product quality, and increase customer delight. Implementing quality at the product design stage improves the chances of the final product performing as per its intended use. Designers and managers have visibility into the design process when the design control approach is taken.

Design review meetings are crucial in ensuring design process deliverables are being sufficiently performed, design plans are updated, and all steps are being taken to deliver a high-quality product. CQ’s design controls solution allows you to schedule and manage design review meetings in one place. You can assess project progress, assign, and easily track assigned actions during the meeting and meeting minutes are automatically documented for full traceability.

Integrating Quality Management with Product Design

While product design does have an element of quality integrated into it, an EQMS like ComplianceQuest can help make it more pervasive and standardize capabilities. It can help with measuring and tracking quality right from the word go – when inputs are gathered for the design process and integrate reviews at every stage thereafter to ensure there is a seamless flow from inputs to output. Any changes on the way should be incorporated and reviewed to make sure the specifications are met and that the product will perform as expected.

Some of the key areas of integrating quality and design include incorporating the following:

• Failure Mode and Effects Analysis (FMEA): A closed-loop quality management system can be effective with FMEA, which encompasses engineering, manufacturing, and the field, by providing a single definition of failure modes.
• Standardized Bill of Process: This can enable greater collaboration between different plants and improve quality significantly.
• Work Instructions and Plans for Quality Inspection: Visual instructions should be shared by engineers with shop floor systems and the feedback gathered in return to incorporate necessary changes.
• Supplier Collaboration: The requirements should be clearly shared with suppliers, the quality of their inputs checked, and feedback shared for rectification, as needed.
• Ensuring Compliance: The design should incorporate data and workflows related to regulated and hazardous substances to ensure quality and compliance.
• Risk Management: Risk is as integral to design as quality and risk profiling, apart from being mandated by FDA for medical devices, can also impact the processes.

By integrating risk management and quality with design, product lifecycle management becomes more holistic and facilitates continuous improvement by enabling a closed-loop approach to quality management.

Factors Impacting Quality and Design

According to Gartner, a transformation of organizational behavior is essential to effectively integrate quality and product design. Empowering and rewarding teams, sharing information, collaboration, and communication between various stakeholders are essential to implement best practices and effect continuous improvement.

CQ Product Design Management Solution helps companies implement a comprehensive design and development process that mitigates product risks and leads to higher quality products all the while ensuring compliance with quality and regulatory standards.

It offers engineering teams complete visibility over the design process and 100% traceability over design controls to make sure nothing falls through the cracks. With a unified repository for all design documentation and advanced collaboration tools, engineering and quality teams can easily work together and bring quality products to market faster and with confidence.

ComplianceQuest for Improving Product Design Capabilities

The Product Design Management Solution from ComplianceQuest is a solution that caters to product designing needs. Its features include:

• Design Control: Product designers and quality leaders can ensure higher quality products with shorter time-to-market with full compliance and comprehensive documentation. Quality and engineering teams can access a single source of truth for all product design activities.
• Requirements Traceability and Product Risk Management: This provides visibility into the design process and helps to track and manage all design inputs, outputs, validations, and verifications, along with integrated management of product risks.

It also integrates with ComplianceQuest’s cloud-based EQMS and empowers design teams with features for:

• Document Management: The entire document lifecycle from the time of creation to reviews, approvals, version control, and retrieval is enabled
• Management Review: The management team and quality leaders can access a tower of design-related data to ensure the product is designed as intended
• Audit and Inspections: At every stage of the design process, reviews can be performed by internal and external experts to ensure that the design process is seamless
• Change Management: A design undergoes constant revisions and corrections, making it necessary to understand the impact on all aspects of the product
• Supplier Management: The design needs to be shared with partners and the quality of inputs ensured for the correct output
• Risk Management: The EQMS facilitates a thorough understanding of the risks and controls needed to mitigate it

To find out how ComplianceQuest can improve product design capabilities in your organization, request a demo: https://www.compliancequest.com/online-demo/