The FDA’s latest new guidance has made requirement traceability a part of premarket submission content. A requirement traceability matrix (RTM) traces each requirement back to its origin, implementation, and testing. This helps all the relevant teams ensure the conformance of their processes by monitoring progress, validating its completeness, and identifying any deviations from the specifications.
For companies operating in highly regulated industries such as life sciences, creating and managing RTM is essential for compliance. Some of the key best practices for creating and maintaining RTM include:
- Compiling RTM Goals from All Stakeholders: The first step to creating an RTM is to gather requirements from stakeholders such as potential customers, internal teams, suppliers, outsourced partners etc. These inputs could be about the features to be added to the product, how to price it, what raw materials to use, how to manage risks, and so on, covering all aspects of the product lifecycle - from design to obsolescence. At this stage, the specifications are being formulated and finalized.
- Gather Documentation to Create Traceability: Once the specifications have been finalized, the next step is to gather all the project-related artifacts to create smooth workflows and traceable relationships between them. This forms the foundation for the requirements traceability matrix, enabling testing teams to ensure conformance once the product is ready.
- Establish Metrics to Measure Success: As processes become more complex, having clear measurable metrics becomes crucial at every stage of the manufacturing process. This minimizes rework at a later stage and enables taking corrective action promptly. The RTM must include measurable metrics to track progress and links upstream and downstream for traceability.
- Review and Update: The requirements traceability matrix document is a live document that is constantly changing as there are changes made to the products or processes based on feedback and practical considerations such as availability of raw materials or introduction of new technology, and so on. Therefore, the RTM must be periodically reviewed and updated to reflect these changes and keep it relevant.
- Automate RTM Creation and Maintenance: The RTM is a complex document as it interlinks several functions, components, and processes. Manual creation and maintenance can be a challenge, time-consuming, and prone to errors. Automating the process enables a faster and more efficient way of creating and maintaining documents. Centralizing its storage and providing permission-based access, also minimizes version mismatch and confusion, allowing all stakeholders to be updated with the latest changes.
- Change Management: The product development lifecycle is an iterative process with constant changes that must be reviewed and approved. The changes will impact processes upstream and downstream. Therefore, it is crucial to share information, and have the changes reviewed and approved, and shared with all stakeholders. Having a process for change management is essential to make it efficient.
- Compliance Audits: The RTM is also a crucial element for auditing to ensure conformance and compliance. At the time of audits, the RTM must be referred to ensure that the processes are compliant and minimize errors being found later.
Benefits of Requirements Traceability Matrix
While compliance is a compelling reason to create RTM, businesses also can experience other benefits such as:
- Improved Decision-Making: By providing an overview of the various interlinked elements of the product development process, the RTM improves data-driven decision-making related to product and project management.
- Improved Change Management: It minimizes errors due to changes in requirements mid-way by providing 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.
- Risk Management: Traceability improves risk identification and implementing controls to mitigate the impact.
Using a cloud-based requirement traceability solution helps automate the processes and improve the RTM’s quality. It also enables accessing product data from other enterprise solutions such as ERP Jira, synchronizing the quality and engineering teams.
Some essential parameters to incorporate into the Requirements Traceability Matrix (RTM) are as follows:
- Requirement Identifier: A distinctive code assigned to each requirement for identification purposes.
- Requirement Explanation: A succinct and lucid description outlining the intent and purpose of the requirement.
- Origin: The source of the requirement emanates, be it user stories, business documents, or client specifications.
- Current Status: An indication of the present state of the requirement, whether it is under review, approved, or subject to changes.
- Traceability Links: Connections to associated test cases, design documents, and other pertinent artifacts.
- Revision History: A log detailing any modifications made to the requirement over time.
- Comments/Annotations: Additional information or elucidations about the requirement.
The Requirements Traceability Matrix (RTM) encompasses various types: Forward Traceability, Backward Traceability, and Bidirectional Traceability.
Forward Traceability involves linking each requirement to a corresponding test case, ensuring comprehensive testing from the top to the bottom, and validating the project's consistent and well-directed progress.
The Backward Traceability Matrix facilitates mapping test cases to design requirements, preventing the project from surpassing the initially defined requirements.
Bidirectional Traceability integrates both Forward and Backward Traceability into a unified document, establishing connections between each requirement and its associated test case.
