Do the "Potential Failure Mode" and "Potential Effects of Failure" columns of an FMEA address what is required in ISO 14971 - 4 Risk Analysis?
What about "Potential Causes / Mechanisms of Failure" and "Current Design/Process Controls" for ISO 14971 - 5 Risk Evaluation?
Any Recommended Actions should address ISO 14971 - 6 Risk Control, correct?
Note: The headings I used above were off my FMEA form which was derived from other forms found on the web. Specific names for these might vary from form to form.
Overall, I am trying to figure out how the use of the FMEA process and FMEA form fits into ISO 14971. (and yes, I already looked at Annex G in the spec)
What about "Potential Causes / Mechanisms of Failure" and "Current Design/Process Controls" for ISO 14971 - 5 Risk Evaluation?
Any Recommended Actions should address ISO 14971 - 6 Risk Control, correct?
Note: The headings I used above were off my FMEA form which was derived from other forms found on the web. Specific names for these might vary from form to form.
Overall, I am trying to figure out how the use of the FMEA process and FMEA form fits into ISO 14971. (and yes, I already looked at Annex G in the spec)