What is Risk Management Review (during Product Planning)

[janah214]

I have a new (potential) customer audit coming up. They are asking that I do a self assessment audit. One of their questions is do we perform risk management reviews (under product planning). We are ISO 9001:2000 compliant which does not include this requirement. Can anyone help explain to me what this is and maybe send me an example of one?

[Stijloor]

Originally Posted by janah214

I have a new (potential) customer audit coming up. They are asking that I do a self assessment audit. One of their questions is do we perform risk management reviews (under product planning). We are ISO 9001:2000 compliant which does not include this requirement. Can anyone help explain to me what this is and maybe send me an example of one?

I believe that your Customer is asking if you perform Design Failure Mode Effects Analysis (DFMEA) during the design and development of product.
If you search the Cove on FMEA you will find lots of good information and examples. Good luck with your Customer audit.

[janah214]

They are ISO 13485 and FDA21CFR820 compliant. Do these type of companies typically expect to see FMEA's for risk management reviews?

[Stijloor]

Originally Posted by janah214

They are ISO 13485 and FDA21CFR820 compliant. Do these type of companies typically expect to see FMEA's for risk management reviews?

I am not a medical devices "expert." Do you have access to these documents? You may want to study those and find out what the risk analysis requirements are for suppliers.

Any ideas "medical devices" Covers?

[avedeka]

Please search for ISO 14791 here.
This is the guidance document for risk management in the medical equipment environment.

Lots of success,

Avedeka

[mmantunes]

Both ISO 13485 and FDA21CFR820, being quality systems requirements for medical devices, have a risk management component (and it isn´t related just to the design phase but to the whole product life cycle. As avedeka said, ISO 14791 is the standard normally used in the application of risk management to medical devices, as ISO 13485 references it and the FDA recognizes it as a means of conformance. The risk management "review" would be an iteration of the risk management during the produt life cycle.

[Al Rosen]

Risk management includes more than FMEA. It includes the risk involved in the normal use of the device. Risk should be assessed periodically based on experience with the device. Every device has a risk associated with its use. See ISO14971 for more detail.

[km214]

Hello Forum Folks,
I just started a contract role where my first project is to review and perform a GAP of their risk management docs against the new ISO 14791:2007. In my search for info here in the cove I found a gap on the old 14791:2000 version. So far the only things I have noted is more specificity in the new edition and it seems to me that they have made this standard more in line with ISO 13485 and the medical device CFR's. I am looking to receive some input into this from other Quality professionals...
I appreciate any and all input...
THANK YOU
Katherine McKay