Risk Acceptability Criteria - Probability and Acceptability Level

alimary15

Involved In Discussions
#1
Good afternoon,

My problem/doubt is the following:

We have a medical device ( I will call it System) which is composed by different sub-systems, which are also medical devices.
Each sub-system can be seen as an indipendent product (Software in most cases) which comes with its own risk management plan and risk acceptability matrix and criteria.

The System is looking at the integration of these sub-systems and also for the System a risk matrix, with related risk acceptability criteria, is defined.

My doubt is the following: how to handle at system level different acceptability criteria that might come from different sub-units? :frust:

My guts tell me that we always have to consider the most critical acceptability level but I am not sure if this is right.:confused:

I believe that the scale of probability and severity should not change , because the probability is always a number from zero to one and should have the same meaning for all the products. However, I wonder how different level of acceptability criteria for two risks that are rated with same P and S can be assessed.


Do you have any experience or suggestion in how such cases could be handled?

Thanks so much for your help!
 
Elsmar Forum Sponsor

Bev D

Heretical Statistician
Leader
Super Moderator
#2
Good afternoon,

My problem/doubt is the following:

We have a medical device ( I will call it System) which is composed by different sub-systems, which are also medical devices.
Each sub-system can be seen as an indipendent product (Software in most cases) which comes with its own risk management plan and risk acceptability matrix and criteria.

The System is looking at the integration of these sub-systems and also for the System a risk matrix, with related risk acceptability criteria, is defined.

My doubt is the following: how to handle at system level different acceptability criteria that might come from different sub-units? :frust:
hmmm. I always provide an assessment of any failure mode/risk for components at both the component AND system level. could you give us an example of what you are concerned with?

My guts tell me that we always have to consider the most critical acceptability level but I am not sure if this is right.:confused:
well yes you need to address the most critical somehow. but I think is in the context that you cannot simply address the lower risks while ignoring the higher risks...some failure modes will have several effects and if we only address the worst effect we are not assured that the slightly less (yet still serious) risks will be addressed. does that make sense?

I believe that the scale of probability and severity should not change , because the probability is always a number from zero to one and should have the same meaning for all the products. However, I wonder how different level of acceptability criteria for two risks that are rated with same P and S can be assessed.
hmm, in general items with the same probability and severity should have the same acceptability criteria. Perhaps if you give us an example of this dilemma it will help. I can see where two items having the same Probability and Severity would land on different sides of the acceptability criteria based on cost to mitigate vs cost of the total number of occurrences...(usually this happens when the probability is low and/or the severity is low...
 
Thread starter Similar threads Forum Replies Date
M How to create the Policy for determining criteria for Risk Acceptability ISO 14971 - Medical Device Risk Management 11
A Correlating Hazard Analysis and DFMEA Risk Acceptability Criteria FMEA and Control Plans 8
T Defining Criteria for Risk Acceptability - ISO 14971 Clause 3.2 ISO 14971 - Medical Device Risk Management 4
P Risk acceptability alignment between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 6
D Rationale for Risk Acceptability Matrix - ISO 14971 ISO 14971 - Medical Device Risk Management 9
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
K What is the policy for Risk Acceptability per ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 2
Sam Lazzara ISO 14971 Clause 7 - Evaluation of Overall Residual Risk Acceptability ISO 14971 - Medical Device Risk Management 3
B Residual Risk Acceptability - Where do I get this Data/Figures from? CE Marking (Conformité Européene) / CB Scheme 9
A How to Rate a Risk Acceptability and on What Basis is it Measured? ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
T Risk based CA AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T IVD Risk - destruction of patient samples - Harm to property? ISO 14971 - Medical Device Risk Management 5
E Do anyone have document of automotive production risk and control of risk? Lean in Manufacturing and Service Industries 1
R Using RPN to Confirm Risk Reduced to an Acceptable Level Risk Management Principles and Generic Guidelines 12
T IVD Device Software - Risk Classification IEC 62304 - Medical Device Software Life Cycle Processes 3
G Help:Risk Management - Accessories US Food and Drug Administration (FDA) 1
N Writing Risk Management procedure for small manufacturing and we don't know where to start. Manufacturing and Related Processes 9
E How to risk assess tooling? For a medical device and is it needed??? Manufacturing and Related Processes 2
M Clinical evaluation interface with the risk management process EU Medical Device Regulations 9
L Risk analysis Manufacturing and Related Processes 4
J Risk Analysis for Proficiency Testing Reliability Analysis - Predictions, Testing and Standards 1
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
B Risk Management Procedure updates needed for 14971:2019 ISO 14971 - Medical Device Risk Management 11
M What is the Risk of Using Obsolete Versions of C=0 & ANSI/ ASQ Z1.4 Sampling Plans? ISO 13485:2016 - Medical Device Quality Management Systems 8
D AS9100D 8.4.2 Note 2 Significant Operational Risk AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A Calculating Risk Estimation ISO 14971 - Medical Device Risk Management 28
M Intended Use vs Actual Use and Scope of Risk Management EU Medical Device Regulations 8
S IDCB 0129/0160 Clinical Risk Management ISO 14971 - Medical Device Risk Management 2
H At what level (harm, hazardous situation, seq. of events, etc) is "risk" estimated? ISO 14971 - Medical Device Risk Management 12
A Risk Management Team IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
S Risk Management File - Procedure Packs ISO 14971 - Medical Device Risk Management 3
B ISO 14001 Risk assesment ISO 14001:2015 Specific Discussions 4
J What risk to cover when NOT using ISO 17025 accredited/certified labs for calibration ISO 17025 related Discussions 3
G Risk Management for IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
S What is your favorite Usability Risk Analysis tool? IEC 62366 - Medical Device Usability Engineering 5
T Assessing risk where harm is indirect - Generic devices / accessories / intermediates ISO 14971 - Medical Device Risk Management 8
K Do you have separate clinical risk management group or experts in your manufactures? EU Medical Device Regulations 4
W IATF 9.2.2.1 Internal Audit how to determine risk IATF 16949 - Automotive Quality Systems Standard 12
S Risk control through Information for safety ISO 14971 - Medical Device Risk Management 8
A Derive Risk Acceptance Matrix from Risk Policy ISO 14971 - Medical Device Risk Management 8
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
I Estimation of overall residual risk. How to? EU Medical Device Regulations 11
Sidney Vianna ISO Practical Guide on ISO 31000:2018 - Risk Management Other ISO and International Standards and European Regulations 0
T IEC 62304 : Risk control for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 8
T Risk Assessment and Management Misc. Quality Assurance and Business Systems Related Topics 0
P Scenario based risk assessment IEC 27001 - Information Security Management Systems (ISMS) 1
Q KPI risk assessment - Criteria for the given score IATF 16949 - Automotive Quality Systems Standard 3
S Foreign Risk Notification Canada Medical Device Regulations 2
J HELP NEEDED ! Risk Management Exercise ISO 14971 - Medical Device Risk Management 12
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom