Hazard Traceability Matrix 3 Examples (ISO 14971, Medical Device)

2. Maintain records of participation in the various risk management activities in the participation records sheet, remember that this preferably should match what you said in the risk management plan.

3. Fill in your hazards and so on in the risk analysis columns of the hazard traceability matrix.

4. Evaluate the risks.

5. Fill in risk controls and estimate the residual risk.

6. Check that you have implemented all the risk controls.

Please note that only the Hazard trace matrix contains a header which would satisfy requirements on document control. You may consider implementing similar headers or your own on other pages that you will print and make part of your risk management file.

In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before review of the document. All texts that are not blue are example texts that can and should be edited by you. Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text customized to work with the current project.