Is Risk Management Process compliant to ISO 14971 in absence of Hazardous Situations?

[alimary15]

Good afternoon,

I would like to know your opinion of the following topic:

Within an organization, would you say the Risk Management Process is complaint to ISO 14971 when there is no definition or documentation of hazardous situations?

Would a Risk Analysis that indicates Hazard, Cause ( intended as "events that lead to the Hazard") still be compliant to the ISO standard even though no Hazardous Situations ( Patient is exposed to Hazard) and sometimes no Harm were properly identified and documented?

To my understanding it is a requirement of the standard ( section 4.4) to have hazardous situations identified and documented.

Thank you very much

 

[Marcelo]

Re: Hazardous situation- Compliance with ISO 14971

Cause ( intended as "events that lead to the Hazard")

This is wrong, please note that cause, in the context of ISO 14971, are initiating causes that leads to harm, not hazards.

Hazardous Situations ( Patient is exposed to Hazard) and sometimes no Harm were properly identified and documented?

If there?s no exposure to hazard, there?s no harm, and there?s no risk involved. So no, if no hazardous situation is defined, it?s obviously not in accordance with ISO 14971 (although you do not need to defined ALL hazardous situation.

This is very clear in the title and requirement of 4.4:

4.4 Estimation of the risk(s) for each hazardous situation
Reasonably foreseeable sequences or combinations of events that can result in a hazardous situation shall be considered and the resulting hazardous situation(s) shall be recorded.

 

[Marcelo]

Re: Hazardous situation- Compliance with ISO 14971

You can also take a look at this thread : http://elsmar.com/Forums/showthread.php?t=52848

 

[alimary15]

Re: Hazardous situation- Compliance with ISO 14971

Thanks Marcelo... It is as I supposed but being pretty unexperienced I wanted to have a confirmation. This will make a nice finding for my internal audit

 

[alimary15]

Re: Hazardous situation- Compliance with ISO 14971

I might have another question. Is it a requirement of ISO 14971 to identify and document the HARM related to each hazardous situation?

 

[Marcelo]

Re: Is Risk Management Process compliant to ISO 14971 in absence of Hazardous Situati

Is it a requirement of ISO 14971 to identify and document the HARM related to each hazardous situation?

4.3 requires that you estimate the risk of hazardous situation, which means estimating probability of occurrence of harm and severity of the harm. You cannot estimate them if you don?t know the harm.

Please take a look at Figure E.1 for pictorial representation of the different definitions.