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Hello everyone, advance apologies for an incoming wall of text.
I'm currently trying to plan and execute risk management for a new device according to ISO 14971 and I'm running up against a wall.
My first problem seems to be in documenting the sequences of events resulting in a hazardous situation. No matter how I seem to approach this, I find the posssible sequences multiplying and branching out uncontrollably.
For example;
At this point I'm already confused, but this is further exacerbated by the fact that each control I consider seems to beg additional controls, for example; if I introduce a control "Device packaging will include an opaque outer layer to prevent degradation due to UV exposure" or "Device materials will be selected for compatibility with expected X-ray exposure over in-situ life", I find myself compelled to consider the possibility of production deviations resulting in omission of these controls, introducing new events ad infinitum (ad nauseam?).
I think there must be some principle for organising risk analyses (particularly sequences of events), or dividing it into manageable chunks that I must be missing. Otherwise, something about my approach is deeply, fundamentally flawed.
Does anyone have any insights into this particular madness that might steer me in the right direction?
Thanks,
I'm currently trying to plan and execute risk management for a new device according to ISO 14971 and I'm running up against a wall.
My first problem seems to be in documenting the sequences of events resulting in a hazardous situation. No matter how I seem to approach this, I find the posssible sequences multiplying and branching out uncontrollably.
For example;
For my device (a novel vascular access system) a hazard is 'Loss of functionality (gas/fluid sealing)' with an associated hazardous situation of 'Leakage of device connections'.
In considering the foreseeable sequence of events leading to the hazardous situation the basic iniating events come easily enough (eg, "Connector design/materials are inappropriate for expected loadings" or "User applies pressure loadings outside the safe range"), but once I start to consider more detailed initiators (eg, "production deviations result in degraded connection sealing" or "Degradation due to environmental exposures during transport/storage or use") the possible event sequences multiply uncontrollably due to consideration of issues such as multiple degradation sources (temperature, humidity, x-ray, UV, procedural materials etc) in multiple environments (transport/storage, cath lab, hospital environment, outpatient environment etc).
This becomes further compounded by consideration of deviations in the production and how these interact with the identified events and I end up with multiple additional events to consider "Production deviations result in compromised performance of connections" and "Production deviations result in substitution of materials incompatible with expected environmental. exposures"
In considering the foreseeable sequence of events leading to the hazardous situation the basic iniating events come easily enough (eg, "Connector design/materials are inappropriate for expected loadings" or "User applies pressure loadings outside the safe range"), but once I start to consider more detailed initiators (eg, "production deviations result in degraded connection sealing" or "Degradation due to environmental exposures during transport/storage or use") the possible event sequences multiply uncontrollably due to consideration of issues such as multiple degradation sources (temperature, humidity, x-ray, UV, procedural materials etc) in multiple environments (transport/storage, cath lab, hospital environment, outpatient environment etc).
This becomes further compounded by consideration of deviations in the production and how these interact with the identified events and I end up with multiple additional events to consider "Production deviations result in compromised performance of connections" and "Production deviations result in substitution of materials incompatible with expected environmental. exposures"
At this point I'm already confused, but this is further exacerbated by the fact that each control I consider seems to beg additional controls, for example; if I introduce a control "Device packaging will include an opaque outer layer to prevent degradation due to UV exposure" or "Device materials will be selected for compatibility with expected X-ray exposure over in-situ life", I find myself compelled to consider the possibility of production deviations resulting in omission of these controls, introducing new events ad infinitum (ad nauseam?).
I think there must be some principle for organising risk analyses (particularly sequences of events), or dividing it into manageable chunks that I must be missing. Otherwise, something about my approach is deeply, fundamentally flawed.
Does anyone have any insights into this particular madness that might steer me in the right direction?
Thanks,
