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Across industries – including medical devices and manufacturing – it is highly recommended that design, product management, quality, and engineering teams adopt a Requirements Traceability Matrix (RTM) for easier collaboration.

Adopting an RTM is a best practice that helps with traceability across a product’s lifecycle, from the time of conceptualization to manufacturing and post-market. A traceability matrix helps to visualize the linkages between the different processes in the product design and development workflow – right from gathering design inputs to device output, verification, and validation activities through to manufacturing transfer.

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To improve compliance, quality, and safety, manufacturers are required to document all procedures for traceability. The documentation should be done during the design and development planning stage, and maintained throughout a product’s lifecycle.

A traceability matrix provides quick insights into the different relationships in the design while ensuring that everything is as expected and matches the specifications as part of your overall Design Controls.

The RTM and Product Risk document should function as living design files that allow your teams to work together so they can ensure user requirements are met and all product-related risks are accounted for.

The unified view of user requirements simplifies collaboration between your engineering and quality teams and must be easily shared at any time during your product’s lifecycle.

Key Benefits of Using a Requirements Traceability Matrix

An effective traceability matrix helps the manufacturer assess what the end product will be – based on the design history, whether it will meet the quality requirements, and the objectives established at the beginning.

The sustainability of the design controls process can be ensured by the creation of a simple visualization of the product design and development process as it provides a roadmap for subsequent teams to work on it. The roadmap is also a regulatory requirement that will have to be shown at the time of inspection.

A traceability matrix improves the project management process by helping with the tracing and definition of complex requirements and expected results. It provides a holistic view of the design process so that project management can become more effective.

In the medical device industry, for instance, the ability to demonstrate traceability is also vital in the submission of a medical device for market approval. By establishing a traceability matrix between the device and its components, recalls in case of failures can be better managed. With full traceability, recalls can be restricted to the affected series without having to recall the entire production lot.

It is important to note that the RTM is a file that is best kept up to date. Requirements are subject to change throughout the product design lifecycle. It is, therefore, critical for engineering, quality, regulatory compliance, and manufacturing teams to have access to the latest inputs, validations and verifications in a destination that serves as the “single source of truth.”

Establishing the Right RTM Management Process Keeping in Mind Common Challenges

The Requirements Traceability Matrix should be activated right from the start and involves the following steps:

Defining Goals by Identifying User Needs: The “why” of the product design should be established at the outset to understand what problem it is trying to solve. Clarity on what the user needs will influence the design of the device, its features, functions, and even the components.

It is also important to note here that without a digital platform that acts as a single source of truth, it is difficult to maintain this single, trusted document that captures these goals.

Creating Design Inputs Based on User Needs: Based on the objectives established to meet the user needs, the specifications should be elucidated. These should be measurable.

User needs often change based on complaints, inputs from stakeholders, etc. The key is to keep this as a dynamic document and maintaining a single RTM is the key to this.

Design Outputs as Per Design Inputs: Design Outputs demonstrate that the Design Inputs have been incorporated into the design and meet the specifications.

Design Verification: Evaluate the device based on the measures established during the design inputs stage through testing.

Design Validation: This is a critical element that ensures that the device indeed meets the original purpose and achieves its purpose as per the ‘User Need’ using simulated (or real) performance evaluations.

Often Excel or similar tools are used to create the traceability matrix. But this has several limitations, such as:

  • Possibility of human errors due to manual entry of data. It is also slow, inefficient and ties up resources. As the scope and features of the product increases, so will the complexity, and the process of maintaining the RTM will become a tedious and time-consuming task.
  • Updating the RTM may get deprioritized and lead to non-compliance. As documentation is critical for traceability and compliance, this can lead to errors in the device as well as trouble with the FDA. In fact, in the medical device industry, one of the top reasons for receiving warning letters from the FDA is that – requirements related to general traceability are not being met by device manufacturers. This could be the result of not establishing and maintaining a design history file or not proving that the design inputs have been verified.

By automating and streamlining the product design management process with the help of a modern solution like ComplianceQuest, requirements traceability matrix creation (and ongoing management) can also be automated. This improves compliance, reduces the risk of errors, and ensures that the product meets the needs of the users.

An effective RTM must be created at the beginning of the project. All relevant teams should collaborate during the process. Roles and responsibilities must be assigned clearly at every stage. Periodic reviews are also important to monitor the end-to-end design controls workflow.

Automating RTM Process using ComplianceQuest

A cloud-based Product Design Management solution like ComplianceQuest, with integrated quality, safety, and risk management can help automate the management of RTM, improve compliance, and enhance overall product quality and performance.

  • ComplianceQuest’s Requirements Traceability and Product Risk solution help manage a living design file that facilitates collaboration across departments and ensures that all user requirements are met.
  • The Product Risk document ensures that all product-related risks are accounted for. It provides a unified view of user requirements, thereby improving collaboration between the engineering and quality teams.

Some of the features of the solution include:

  • The living Requirements Traceability Matrix (RTM) file is always up to date and offers 100% visibility over links between user requirements, design inputs, outputs, validations, and verifications.
  • It allows for identifying and controlling all product-related risks by helping assess, identify and mitigate the risks involved.
  • Provide a single source of truth to all the departments involved.
  • Engineering and quality teams can have access to the latest inputs, validations, and verifications as it is always up-to-date.
  • Any changes in requirements are instantly flagged and any changes to regulatory requirements can also be tracked

Some of the key benefits of ComplianceQuest’s Product Design Management Solution and, especially, its RTM capability include:

  • Collaboration Simplified: for all members with meeting minutes, action items and more
  • Single View: unified view of all requirements, inputs, outputs validations and verifications
  • Compliant: ensure proper documentation in compliance to various regulations
  • Efficient: decrease the time and labor needed for design projects
  • 100% Traceability: Track and access records of changes, reviews, validations and verifications
  • Embedded Risk Management: for all product related risks along with proper risk control
  • Always Up-To-Date: design file with change alerts to ensure proper change implementation

To know more about ComplianceQuest’s Requirements Traceability Matrix management, visit: https://www.compliancequest.com/requirements-traceability-product-risk/

You can also book a demo with us: https://www.compliancequest.com/lp/design-management/

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