Hi,
the requirements regarding the traceability of risks or hazards in risk analysis are not entirely clear to me and hopefully your comments can help me to better understand it.
DIN EN ISO 14971 states that traceability is intended to ensure that all hazards have been considered and I would then number the hazards, whereby I could already use the characteristic (e.g. unsuitable raw material) to avoid discussions in small parts (as the hazard is e.g. toxic raw material, material-incompatible raw material etc.) and rather dealt with them under a general term (in this case the characteristic). For tracing purposes, I thus number the characteristics and then assign a sub-item for the hazard that fall under them, which could be also a combination of a letter abbreviation with a number.
But somewhere (unfortunately I can't remember where) its said, that the risks should be traceable, which means the potential damage. This is where things get complicated for me in terms of numbering and tracking, as each hazard is broken down into different harms for users, third parties, environment, medical device, etc and also leads to different risk minimization measures (RMM). I also had codes for each harm and RMM in the past, but didn't see an advantage of having them and thus stopped to use them.
How do you implement the traceability requirement and which aspects do you include in your traceability code?
What I would also be interested in is, at what point does this code actually benefit me? In the clinical evaluation I copy the data 1:1 from the risk analysis (feature, danger, damage, risk minimization measure) and taking over an additional column with a traceability code only needs unnecessary space. At least I don't see any advantage here. For reasons of readability, I would always speak specifically about the danger instead of just stating the code. Am I missing any advantage here or where can the traceability codes be used practically?
I am curious about your enlighting thoughts
the requirements regarding the traceability of risks or hazards in risk analysis are not entirely clear to me and hopefully your comments can help me to better understand it.
DIN EN ISO 14971 states that traceability is intended to ensure that all hazards have been considered and I would then number the hazards, whereby I could already use the characteristic (e.g. unsuitable raw material) to avoid discussions in small parts (as the hazard is e.g. toxic raw material, material-incompatible raw material etc.) and rather dealt with them under a general term (in this case the characteristic). For tracing purposes, I thus number the characteristics and then assign a sub-item for the hazard that fall under them, which could be also a combination of a letter abbreviation with a number.
But somewhere (unfortunately I can't remember where) its said, that the risks should be traceable, which means the potential damage. This is where things get complicated for me in terms of numbering and tracking, as each hazard is broken down into different harms for users, third parties, environment, medical device, etc and also leads to different risk minimization measures (RMM). I also had codes for each harm and RMM in the past, but didn't see an advantage of having them and thus stopped to use them.
How do you implement the traceability requirement and which aspects do you include in your traceability code?
What I would also be interested in is, at what point does this code actually benefit me? In the clinical evaluation I copy the data 1:1 from the risk analysis (feature, danger, damage, risk minimization measure) and taking over an additional column with a traceability code only needs unnecessary space. At least I don't see any advantage here. For reasons of readability, I would always speak specifically about the danger instead of just stating the code. Am I missing any advantage here or where can the traceability codes be used practically?
I am curious about your enlighting thoughts
