Advice from our founder, Simon Hoffman, on how to maintain a traceability matrix, using 7 top tips. We can’t emphasise number 4 enough!
When it comes to your Design History Files/Technical Files you need to maintain a traceability matrix. This must document:
- User needs
- User needs converted into design inputs
- Design outputs that meet design inputs
- Verification that the design meets the specifications
- Validation that the design meets the user needs
What we have discovered:
Some clients find maintaining the traceability matrix overwhelming and avoid updating the document until the end of the project, resulting in gaps, and increasing the risk of devices which are unfit for purpose.
7 tips on how to maintain a traceability matrix
So, here are our tips for helping you maintain these living documents, stay on top of your project, and be audit ready.
- You should start your traceability matrix as soon as the project is given the green light.
- Integrate risk management as this inevitably has an impact on the inputs and outputs.
- Where possible, work as a cross-functional team.
- Communicate! Changes need to be communicated quickly, clearly and to the relevant individuals.
- Go digital – Easier and quicker to update, easier to share and communicate with team members, easier to identify gaps.
- Responsibilities should be clearly defined regarding design control activities such as developing product specifications and verification protocols.
- Review, review, review
As part of our commitment to supporting others in bringing great healthcare to all, we are building the Information Hub to aid you in keeping up to date with the ever developing standards and regulations, alongside our first-rate knowledge, expertise, and friendly guidance.
Discover more https://hoffmanhealthcareconsultancy.com/pharmaceutical-and-medical-device-information-help-and-guidance/
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