Design Project Management

Design Project Management

design project management
design project management
design project management video

Product development takes effort and time. Compliant design development requires extensive documentation that can affect productivity, leading to delivery delays or non-compliance. Every minor change must be tracked as it can lead to a series of changes, tests, reviews, validations, and verifications. Teams using spreadsheets or disparate systems find it difficult to document these changes. Having a design project management helps improve visibility and traceability and supports high-quality design products that meet regulatory and quality standards.


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What is Design Project Management?

Design Project Management is a comprehensive development process that accounts for every part, design requirement, design input, user need, and product risk during the design lifecycle. With design project management, manufacturers can have end-to-end control over the design aspects of any project. With design project management, the project manager can define the project’s goals, assign and track tasks across teams, maintain focus, and organize everyday tasks to achieve the goals. Design project management helps:

  • Ensure consistency among team members working together. As there is a process in place, the team can collaborate effectively, ensure design consistency, and improve the overall cohesiveness of the finished product.
  • Align the final product with design expectations set at the beginning of the process. With design project management, the team can ensure the expectations and opinions match the results.
  • Establish effective communication channels among various teams working together on the project
  • Clearly define every contributor’s role to reduce confusion and overlap of work.
  • Mitigate risk and delays by evaluating potential roadblocks. With these anticipated hurdles, teams can plan their work accordingly.
  • Improve the overall quality of the product

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How can Product Design Management Solution help a business?

Product design in manufacturing companies involves various stakeholders that need to work together to create an end product. This includes understanding customer requirements, evaluating raw materials, product designing, product testing, and compliance check. The end-to-end process of product design can be long and tedious. Having a manual system can be laborious and time-consuming as all parties involved cannot work together at the same time. A robust, cloud-based Product Design Management Solution, on the other hand, can help manufacturers across industries to:

Create efficient design processes that reduce development time, minimize scrap, and rework

Implement changes and updates faster without missing delivery timelines

Reduce human errors in the documentation that can directly impact approvals and entry into market

Improve the quality of products by addressing all expectations, requirements, and risks

Host all product and design-related data in one centralized location for everyone to access, thus creating visibility and coordination

Minimize development costs while reducing the development cycle, thus increasing profits

  • Create efficient design processes that reduce development time, minimize scrap, and rework

  • Implement changes and updates faster without missing delivery timelines

  • Reduce human errors in the documentation that can directly impact approvals and entry into market

  • Improve the quality of products by addressing all expectations, requirements, and risks

  • Host all product and design-related data in one centralized location for everyone to access, thus creating visibility and coordination

  • Minimize development costs while reducing the development cycle, thus increasing profits

What are the features of Design Project Management Software?

A robust Product Design Management software makes collaboration easier, offering design teams better control over design inputs, requirements, and risks to improve product quality while ensuring compliant documentation. CQ’s Product Design Management Solution includes various components such as:

  • Project Management
  • Design History File
  • Product Change Management
  • Design Review Meetings
  • Requirements Traceability Matrix
  • Design Controls
  • Product Risk Management
design project management software features

Some of the features of of CQ’s Product Design Management Solution include:

  • Embedded Project Management helps quality and engineering teams assess, identify, mitigate, and document all product related risks.
  • Automatic product documentation in compliance with regulatory and quality standards such as 21 CFR 820.30 and ISO 13485 allows teams to collaborate for approvals, signatures, revisions and meeting notes. With built-in revision control, these are automatically documented for teams to review and share.
  • Unified repository for all design documentation that can import data from other sources, including ERP, Jira.
  • Living Requirements Traceability Matrix (RTM) file offers 100% visibility over links between different design controls and flags changes for version control.


design quality

Design Quality: Connecting Design to Documentation

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How to select a Product Design Management Solution for your business?

Businesses are moving towards cloud-based product design management solutions as paper-based systems became tedious to maintain and affected compliance. Manufacturers in the medical device industry are constantly looking for solutions that can interact with other systems in the organization and minimize the efforts of collaboration. While selecting a product design management solution for the business, it is important to look at the various features the solution offers, including its ability to

  • Assign roles
  • Track progress
  • Foster collaboration among team members
  • Import data from other sources
  • Assess potential risks and roadblocks

ComplianceQuest Product Design Management is one of the leading solutions in the market for its ability to show results. The solution can

  • Improve time to market by 20%
  • Increase competitive advantage by 77%
  • Reduce business challenges by 23%
  • Improve supplier visibility by 20%
  • Decrease product recalls by 20%

What are the advantages of CQ’s Product Design Management Solution?

CQ Product Design Management Solution helps manufacturers implement a comprehensive design development process that mitigates product risks to create higher quality products while ensuring compliance with quality and other regulatory standards. The solution offers engineering teams complete visibility over the design process and 100% traceability over design controls. The solution offers a unified repository for all design documentation and advanced collaboration tools. Built on Salesforce.com, ComplianceQuest Product Design Management works with various stakeholders, including engineering, quality, suppliers, regulatory, and manufacturing. With the solution, users can:

  • Improve product quality as teams have better control of product risk and traceability with real-time input tracking

  • Teams can collaborate better with a single source of truth for all design files and documents

  • Increased compliance with quality and regulatory standards

  • Reduce risk by implementing necessary risk control measures and tracking residual risks

  • Smooth transition to manufacturing and create a better product development cycle that allows businesses to speed up time to markets.

  • Leverage modern project management tools to plan, schedule, and track design review meetings

  • Better control over product risks

  • Complete traceability of all design controls

  • Better collaboration and efficiency among teams

  • Easily share design files

  • Assign specific actions to each team member based on their roles

  • Real-time tracking of inputs increases verification testing efficiency

Moving Beyond ASL

Moving Beyond ASL with Design Controls and Supplier Management

How can engineering and quality teams use various design project management tools available in CQ’s Product Design Development solution?

design project management tools
design project management tools

  • 100% traceability: The design teams can have better control over design inputs, requirements and risks to improve product quality while remaining compliant.
  • Unified repository for all design documentation : Built-in unified repository for all design documentation allows the team to keep track of all design inputs and requirements. The solution can store design requirements, deliverables, and changes and can import product data from other sources (ERP, Jira, etc.).
  • Access to Requirements Traceability Matrix (RTM) file for complete visibility: CQ’s RTM is always up to date and can create links between different design controls and flags changes to ensure all controls are current and accounted for.
  • Effortless Documentation and Compliance: All steps, requirements, outputs, reviews, and changes are well documented for compliance with regulatory and quality standards such as 21 CFR 820.30 and ISO 13485. These documents can be easily shared with others from the team at the click of a button. The solution can be used for approvals, signatures, revisions and meeting notes, with built-in revision control for design files.
  • Embedded product risk management: Teams can assess, identify and mitigate all risks that surround the product design process with embedded product risk management. Quality and engineering teams can document, implement, keep track of the appropriate risk controls along and conduct risk assessments for full compliance.
  • Multi-team collaboration and tracking: Modern collaboration tools built specifically for design management allow design leaders to invite their teams to work on easily accessible design files, assign, assess project progress, assign, and easily track actions for each team member based on deliverables. Review Meeting Management capabilities allow leaders to schedule and manage design review meetings in one place.

ComplianceQuest Setting High Standards!

Our organization approached ComplianceQuest to help implement Aphira Inc.’s first ever Electronic Quality Management System. With a very tight project timeline, ComplianceQuest was able to execute and hit all milestones on schedule that has increased our company’s Quality procedures two fold. What impressed me the most was the unparalleled customer service! The employees go above and beyond to ensure your projects success is their top priority, while also learning your company’s internal processes to provide potential solutions/enhancements. ComplianceQuest (CQ) has set the bar high and I would strongly recommend them to any organization looking for a state of the art QMS.

Jake Nickels
Aphria Inc (now Tilray)

tilray testimonial
tilray testimonial

What are the steps involved in implementing Design Project Management?

Performing design and development activities manually is labour intensive, error-prone, and has a high chance of rework. It can increase the cost, cause wastage of limited resources, delay the commercialization process, and contribute to loss of business. Globally, the primary objective of all manufacturers (irrespective of the risk class of medical devices) is to ensure the product is safe and effective. The foundation for this is rooted at the “design stage” of product development, so safety and efficacy have to be built in. When implementing design project management, it is important to:

  • Understand the user’s needs as it is the foundational step to success. Gather every piece of information to understand what customers want to improve chances of approval.

  • Determine the specific requirement of the product by classifying the collected information into different categories.

  • Create goals and budgets for team members based on expectations. Document these in the Requirement Traceability Matrix for checking.

  • Define the design process to ensure there is consistency. This includes specifying tools and various communication channels that will be used to update the design process.

  • Assign tasks to every team based on their expertise to avoid confusion and waste of time.

  • Test, review and validate product design to avoid reworks.

  • Design feedback and approval are critical to understand if the product meets the requirements and expectations of the client it set out to fulfil.

  • Medical device manufacturers must get compliance approval before pushing the product to the market.

  • Understand the user’s needs as it is the foundational step to success. Gather every piece of information to understand what customers want to improve chances of approval.

  • Determine the specific requirement of the product by classifying the collected information into different categories.

  • Create goals and budgets for team members based on expectations. Document these in the Requirement Traceability Matrix for checking.

  • Define the design process to ensure there is consistency. This includes specifying tools and various communication channels that will be used to update the design process.

  • Assign tasks to every team based on their expertise to avoid confusion and waste of time.

  • Test, review and validate product design to avoid reworks.

  • Design feedback and approval are critical to understand if the product meets the requirements and expectations of the client it set out to fulfil.

  • Medical device manufacturers must get compliance approval before pushing the product to the market.

Improve traceability and visibility and track every minor change with CQ’s Design Project Management solutions

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Frequently Asked Questions

  • From a regulatory perspective, ‘design control’ or ‘design and development’ is a mandatory requirement for any regulatory authority while reviewing for market approval/authorization. To ensure the product is developed safely considering all the necessary stages, there should be adequate and relevant evidence so as to assure the same was reviewed, approved, verified and validated before moving into commercial production and distribution.

  • CQ Product Design Development allowing all departments involved in the design process to collaborate effectively and remain in-sync. With the solution, engineering, quality, regulatory, suppliers, regulatory, and manufacturing teams can work together without siloes.

    • Inefficient processes leads to longer development time, slows the ability to implement changes, affects delivery timeline, and increase cost due to scrap, waste, and rework.

    • Increased risk of non-compliance due to improper change management, human error due to manual processes, missed approvals in documentation process, and delays in entry to market.

    • Lower quality products due to inability to identify, track, and manage product related risks.

    • Less product innovation as there is scattered product data.

    • Increased development costs due to low design quality and missed profits.

  • A good product design will have:

    • Utility value that meets customer expectations and delivers steady performance throughout the product lifecycle

    • Economic value that adds to the sales and profit of the organization

    • Different from its competitors in terms of features and marketing

    • Producible using available production methods

    • Aesthetically appealing to the end customer and larger market

  • Having a clear vision for the product design at the beginning of the project helps all the stakeholders by creating a course of action that can be followed end-to-end. From a quality performance perspective, design project management helps in three different ways. They are:

    • Quality issues are easier to fix at the design stage rather than rework after manufacturing. This saves on production cost and redesign time.

    • Having a quality policy document in place right from design phase will give all key stakeholders clarity on what is expected in terms of quality performance.

    • Overall cost of quality(CoQ) reduces when the right design control process is adopted and reduces the chance of product failure.

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