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
Staff member
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
R Risk assessment on IT containers and the information they contain IEC 27001 - Information Security Management Systems (ISMS) 4
B Threat/Vulnerability Catalogue for risk assessment IEC 27001 - Information Security Management Systems (ISMS) 4
R Opportunity For Improvement vs Opportunity (Positive Risk) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
R FOD Risk Assessment - What tools would you recommend for assessing FOD risk? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
Q Example of the Risk Template Document Control Systems, Procedures, Forms and Templates 1
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D Importing a general wellness low risk product Other US Medical Device Regulations 3
C Quantifying risk in choosing the number of parts, operators and replicates in a GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R AQL, Consumer Risk and MA Statistical Analysis Tools, Techniques and SPC 2
M Risk managment report of Surgical Mask Example ISO 14971 - Medical Device Risk Management 14
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
R ECG Risk Analysis Standards ISO 14971 - Medical Device Risk Management 2
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
A 5 x 5 Risk Matrix - Looking for a good example Manufacturing and Related Processes 2
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
T How do you define your Hazards? <a Risk Management discussion> ISO 14971 - Medical Device Risk Management 16
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
B Risk Assessment Checklist for Non product Software IEC 62304 - Medical Device Software Life Cycle Processes 1
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
K Identification of hazards and Risk file IEC 62366 - Medical Device Usability Engineering 7
S Risk based internal auditing Internal Auditing 6
Robert Stanley I'm @ RISK of not showing my RISKS! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
M Estimating the benefit-risk ration under MDR EU Medical Device Regulations 1
adir88 Information of safety can reduce risk now? ISO 14971 - Medical Device Risk Management 12
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 15
Tagin Is SARS-CoV-2/COVID-19 on your risk register? Misc. Quality Assurance and Business Systems Related Topics 11
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 3
DuncanGibbons Classification of aerospace parts depending on their risk and criticality etc. Federal Aviation Administration (FAA) Standards and Requirements 3
D Performance specification as a Risk Control Measure, EN 14971 ISO 14971 - Medical Device Risk Management 7
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
Sidney Vianna IAQG SCMH explains "positive risk"..........but does it? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
MrTetris Unacceptable risk and information for safety ISO 14971 - Medical Device Risk Management 16

Similar threads

Top Bottom