Traceability matrix

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A Traceability Matrix (or traceability analysis/documentation) is a structured mechanism, typically a key element of the Risk Management File, that links inputs, outputs, and corresponding activities throughout a controlled process, ensuring that every element of a product's design or identified hazard is accounted for and managed.

A Traceability Matrix is a management tool used to document explicit links, usually in a table format, showing how a specific requirement, hazard, or item is connected to corresponding documentation of its development, testing, implementation, and final status. For medical device manufacturers, it is essential to demonstrate that every potential safety risk or design input has been accounted for and mitigated.

The Traceability Matrix is fundamental in demonstrating the systematic control required by Quality Management Systems (QMS), particularly within design controls and risk management processes.

Central Role in Risk Management Documentation

The ultimate record for all risk-related documentation is the Risk Management File (RMF). Within the RMF, the concept of traceability, often fulfilled by a matrix or similar documentation, is critical:

• Mandatory Linkage: The RMF must contain traceability that specifically links every identified hazard to the associated risk analysis, risk evaluation, risk controls, and the ultimate evaluation of residual risks.
• Comprehensive Assessment: This process ensures that hazards identified early in the design phase—including those stemming from intended use or foreseeable misuse—are tracked through to the final determination of their acceptability.
• Documentation Output: When documentation is reviewed and assessed, if labeling is employed as a risk control measure (a mitigation), the RMF must contain a reference to the specific label, typically by document number, to prove the control measure was properly implemented.

Application in Technical and Software Design

The utilization of traceability documentation, such as a matrix or analysis, is explicitly mandated for ensuring the safety and effectiveness of products containing software components:

Device Software: For complex products, such as an interoperable automated glycemic controller, validation documentation must include a detailed traceability analysis demonstrating that all hazards are adequately controlled and that all necessary controls have been verified and validated in the final device design.

Specific Regulatory Requirement: For highly regulated software systems like Blood Establishment Computer Software (BECS), a Traceability matrix must be performed.

Risk Mitigation: Traceability documentation is vital in performing risk analysis and in identifying risk control measures implemented to address device system hazards.

Verification of Controls

The matrix links the initial risk estimation to the efforts taken to reduce that risk (risk controls). Post-mitigation, the control measures must be reviewed to determine if they were effective in reducing the probability of harm occurring.

Verification Evidence: The evidence of implementation and verification activities related to risk control measures must be part of the Risk Management File and must be traceable to each hazardous situation identified during the risk analysis.

Analogy for Understanding the Traceability Matrix

If manufacturing a complex medical device were like building a skyscraper, general Traceability would be the system of tracking every individual girder and bolt from the mill to the finished building. The Traceability Matrix (or Risk Management File traceability) is the dedicated engineering logbook that maps every known structural weakness, corrosion risk, or seismic hazard that the architects identified. For every single one of those hazards, the matrix meticulously lists which specific beam material, weld inspection, or foundation reinforcement step was implemented to mitigate it, ensuring that every potential weakness has a documented, verified countermeasure.

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