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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.
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.
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.”
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:
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.
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.
Some of the features of the solution include:
Some of the key benefits of ComplianceQuest’s Product Design Management Solution and, especially, its RTM capability include:
To know more about ComplianceQuest’s Requirements Traceability Matrix management, visit: https://www.compliancequest.com/requirements-traceability/
You can also book a demo with us: https://www.compliancequest.com/lp/design-management/
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