Best practices for an effective and robust traceability matrix

The product life cycle consists of several steps from the time of its conceptualization to the time it is made obsolete. In development and manufacturing stages, it undergoes several changes. The design and development process is highly iterative as inputs are gathered from various teams to create a product that will solve a customer pain point. During the manufacturing and testing stages too, changes may be introduced due to raw material unavailability or nonconformance that needs rework.

These changes and the back and forth between the various stakeholders can make it difficult to keep track of all the features that were finalized and the specifications that were decided on at subsequent stages. This can make tracking the project to ensure it is progressing along the planned lines difficult. Therefore, a documentation of all the was finalized needs to be consolidated in a centralized location accessible for all stakeholders to be able to see the progress from beginning to end.

A Requirements Traceability Matrix (RTM) is the document that creates the thread that lets project managers track project progress and monitor deliveries across industries such as aerospace, automobiles, life sciences, and so on, as part of their Quality Management System. ISO 13485:2016 provides a guideline to the best practices for Design Control traceability.

It enables ensuring that the project meets the original purpose and that the final products are error-free.

Best Practices to create and maintain RTM

Since RTM plays a key role in conformance and compliance, it is crucial that the companies adopt industry best practices to get their product lifecycle right.

Some of the best practices include:

• Step 1: Create standard operating procedures for creating and maintaining the RTM and share it with all employees to make sure there is clarity and consistency.
• Step 2: Ensure that the document has all the required components such as the requirement ID, requirement type, description, test requirements, etc.
• Step 3: The document must delineate the user requirement that the product or project aims to fulfill. This should include the reasoning for all features and must be derived from customer inputs and feedback.
• Step 4: The user requirements must next be converted into Design Inputs with specifics. For instance, dimensions, colors, weight are some of the quantifiable elements that must be specified appropriately for each feature.
• Step 5: Next step is to explain what the result or output of the Design Inputs will be. This can be in the form of drawings and diagrams and includes information on packaging, labeling, and so on.
• Step 6: Establish the link between the various elements to enable traceability for demonstrating conformance to the specifications.
• Step 7: Establish metrics for validating the design’s relevance to user requirements. This completes the circle from user need to final product and explains how the validation can be performed - simulation, testing, etc.

Maintaining the traceability

As mentioned above, product development is an iterative process. Therefore, the RTM may undergo changes from time to time based on any new requirements or modifications to the existing ones coming up. Every time a change is made, it must be reflected in the document as well.

Every change must be reviewed and approved by the authorized personnel and all stakeholders made aware of so that they can make appropriate changes to their processes based on the new need.

In a manual process, this can be very challenging. Alerting all parties of the changes and ensuring everybody sees it within a specific time is the first hurdle. If people are traveling or busy, they may miss the alerts, which may get buried in the inbox and missed. This can cause delays.

Audit trail also can become difficult as a result of multiple documents being managed on the system, and version control can become a nightmare.

A cloud-based Requirement Traceability Matrix solution such as the one from ComplianceQuest can help automate the process as well as ensure all stakeholders access the same document at any given time. They can also access it from anywhere, anytime, ensuring timely reviews and approvals. As it is stored in a centralized location, all changes can be tracked and version control becomes easier. Communication and collaboration happens from within one platform, providing visibility and transparency.

This minimizes errors and nonconformance and allows for early detection and correction in case of any deviations.

ComplianceQuest Requirements Traceability Matrix helps to automate the process and improve the effectiveness of RTM. It improves compliance and provides other benefits such as enhanced decision-making by providing an overview of the various interlinked elements of the product development process. Change management is more effective with lower risk of errors due to greater visibility into all interrelated processes. This helps assess the impact of any change on the processes upstream and downstream, thereby revealing risks. It also provides an audit trail to demonstrate compliance. Traceability improves risk identification and implementing controls to mitigate the impact.

To know more about ComplianceQuest Requirements Traceability Matrix solution, visit www.compliancequest.com