Traceability Matrix Best Practice

Traceability is the heart of the product development process and mandated by the medical device standards and guidelines. As traceability is central to the development of safe medical devices and essential for regulatory compliance, it must be implemented in the most effective way.

What is an effective traceability method?

  • Effective traceability helps you document the life of the product development process so that every input/ output can be easily traced all the way back to the source of the initial requirement.
  • Effective traceability should be synchronized with your QMS system
  • Effective traceability should be flexible enough to respond to changes
  • Effective traceability should show clear linkages back through to the original requirements – including risks – through the different stages of the product development and lifecycle.
  • Effective traceability should demonstrate that the design was developed in accordance with an approved design plan and the requirements of 21CFR 820
  • Effective traceability should be integrated with Risk controls and Risk assessment. Hazards have to be traceable back to the risk analysis, risk evaluation and the implementation and verification of the risk control measures.
  • Audit trail

But the implementation of effective traceability can be time consuming and complex, especially if documenting and managing requirements and changes are dealt with using a traditional, a.k.a. manual, system.

Why is an effective traceability method important?

A traceability matrix is required by both FDA and CE mark. It’s important because it has been proven to increasing safety and reducing defects in medical device development and keeping the development process on the right track. An effective traceability helps companies reduce the risk of missed requirements, ensures 100% test coverage, and that it is documented.

Why is so hard to implement an effective traceability method?

While the standards and guidelines mandate traceability, there is diversity in the level of traceability that is required and a lack of detailed guidance on how to best implement an effective and compliant traceability matrix.  

How to achieve and implement effective traceability method?

Implementing an effective traceability process can be difficult, time consuming and messy. 

An ideal solution is to implement a Traceability Matrix that is designed specifically to meet the FDA’s and CE Mark regulatory and compliance requirements for Traceability.

It should be also be flexible, adaptable and customizable to meet individual medical device projects. 

It should also be integrated into your companies QMS, so every input can be organized cross-reference to Project Tasks, Design Input changes and revisions, Approvals, testing, verification and validation testing, and this right from the very beginning of the product development stage. 

A strong traceability matrix solution must be able to capture information that needs to be traced at different points in the process, share the information with the right people at the right time, and generate useful reports.

Although Excel can be useful, there is one such ideal solution that you should consider. It will help with product development, save time, foster innovation, improve quality and reduce development process costs.

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7 replies to “Traceability Matrix Best Practice”

  1. Good work , very interesting post, have a wonderful day.

  2. Very good post, keep up the good work. Thanks!

    1. Alexander says:

      Thank you, dear, Maryellen 🙂

  3. Pietro Ricci says:

    Have somebody tried this solution:

    1. Ahmed Hossein says:

      I haven’t heard for these guys, but my company uses Matrix Requirements. You can create requirements and specifications and documents from these requirements and specifications. A relation between identified risks and design outputs can be set as well.

    2. Neil Pathak says:

      We use qmsWraspper’s TM in our work. It’s a great tool for mapping out a project in one place!

  4. Sophia Nicholls says:

    When we were preparing our first submission it was a nightmare to prepare traceability matrix – it took us about two months to prepare it. Til we checked all the requirements, do we have all validation and verification with proper testing and risks… Arghhhh! The Excel was a great tool to reference all of that. But we needed a more interactive tool, which could be connected with our project management. We found an interesting solution at Green Light. We are not totally satisfied, because it is a little bit rigid (it’s aimed to create DHF). We need a more flexible solution.

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