SBS - The best value in QMS software

Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation

silentmonkey

Involved In Discussions
#1
Hi All,

I am wondering how others have implemented the requirement for Benefit/Risk Analysis between the risk management process and the clinical evaluation process.

For risk management, I understand that an overall benefit/risk analysis is required and currently, my organisation documents this in the Risk Management Report.

As part of our clinical evaluation process, a benefit/risk analysis is also documented in the Clinical Evaluation Report.

Currently, we use the exact same wording for the benefit/risk analysis in both reports. This makes some things logistically inefficient like not being able to update one report without updating the other. Both reports require approval from a different group of cross-functional SMEs so the turnaround time for both reports is conflated.

It could be possible to remove the Benefit/Risk Analysis from one of these reports and replace it with a reference to the actual Benefit/Risk Analysis maintained in the other report but this invites other issues related to the review/approval of the BRA.

How are others currently managing this? Is it acceptable for the BRA in the Risk Management Report and the CER to be equivalent in its wording?
 
Elsmar Forum Sponsor

Raisin picker

Involved In Discussions
#3
Well, if you have a change in the risk analysis that affects the RBA, this also requires to address that change in the clinical evaluation, and vice versa. The two processes should be closely linked.
 

FoGia

Involved In Discussions
#4
I would say that the risk benefit analysis should logically within the CER as it is one of its primary purposes (per MDR). It's also the document that captures up to date data on state of the art/alternatives/clinical background and a bunch of other information that aren't typically described in the RMR.
You could have the analysis be a stand alone document but as mentioned above it would need to be updated together with the CER anyway.
 
Thread starter Similar threads Forum Replies Date
I Realization processes input into overall risk ISO 14971 - Medical Device Risk Management 2
M ISO 14971:2019: Criteria for overall residual risk ISO 14971 - Medical Device Risk Management 6
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
C What is the difference between "Overall Risk" and "Risk"? (ISO 14971) ISO 14971 - Medical Device Risk Management 10
P Total Variation in Data - Overall Importance of the Principal Components Reliability Analysis - Predictions, Testing and Standards 1
Marc US wind capacity surpasses hydro, overall generation to follow World News 0
M Can OEE (overall equipment effectiveness) exceed 100%? Manufacturing and Related Processes 2
M Where does OEE (Overall Equipment Effectiveness) belong? Quality Tools, Improvement and Analysis 11
L OEE (Overall Equipment Effectiveness) and Cost Savings Manufacturing and Related Processes 2
S Measuring OEE (Overall Equipment Effectiveness) for each Job, not for Machine Lean in Manufacturing and Service Industries 2
8 OEE (Overall Equipment Effectiveness/Efficiency) Help Lean in Manufacturing and Service Industries 14
K Is there an overall standard for calibration of items used in TS 16949 Certified Co. IATF 16949 - Automotive Quality Systems Standard 3
Sam Lazzara ISO 14971 Clause 7 - Evaluation of Overall Residual Risk Acceptability ISO 14971 - Medical Device Risk Management 3
D Overall Equipment Effectiveness (OEE) Calculations Manufacturing and Related Processes 4
P Overall Cpk for Different Parts to Same Customer Statistical Analysis Tools, Techniques and SPC 6
Q Availability Calculation for monitoring Overall Equipment Efficiency Manufacturing and Related Processes 2
AnaMariaVR2 OEE (Overall Equipment Efficiency) on Pharma Packaging Lines Lean in Manufacturing and Service Industries 8
S How to Calculate Overall FPY (First Pass Yield) Quality Tools, Improvement and Analysis 2
Y OEE (Overall Equipment Efficiency) help Lean in Manufacturing and Service Industries 6
D QA's Role in the Overall Picture of the Organization and in Day to Day Activities Misc. Quality Assurance and Business Systems Related Topics 10
O Using SPC to determine overall Thread Quality Manufacturing and Related Processes 16
B Overall Process Capability - Simple question if you know how to answer it! Statistical Analysis Tools, Techniques and SPC 3
S OEE (Overall Equipment Efficiency) - One question Manufacturing and Related Processes 17
B Overall Equipment Effectiveness of Efficiency Quality Tools, Improvement and Analysis 2
P Overall and Within/Between STDEV - Why not the same? Statistical Analysis Tools, Techniques and SPC 20
S OEE Software - Automating the collection of Overall Equipment Efficiency data Statistical Analysis Tools, Techniques and SPC 8
M Advice on how to introduce Overall Equipment Effectiveness - Machining Manufacturing and Related Processes 4
P OEE (Overall Equipment Efficiency) and Downtime Manufacturing and Related Processes 17
V Overall Equipment Efficiency (OEE) calculation of 2 different scenarios. Manufacturing and Related Processes 5
J Overall Residual Risk Procedure based on the 2007 version of ISO 14971 ISO 14971 - Medical Device Risk Management 4
M OEE (Overall Equipment Effectiveness) Downtimes Calculation Manufacturing and Related Processes 8
V Emphasizing Severity more than Occurrence and Detection vs. Overall RPN FMEA and Control Plans 20
Raffy Is my machine setup control plan part of the overall control plan FMEA and Control Plans 2
E Control Charts for OEE (Overall Equipment Efficiency) Statistical Analysis Tools, Techniques and SPC 19
J Calculating the overall MTTR for an MTBF of 476, given four subsystems Reliability Analysis - Predictions, Testing and Standards 1
M Capability level applicable to SPC process or overall process? Statistical Analysis Tools, Techniques and SPC 16
J Overall Equipment Effectiveness Course - Word document .doc Manufacturing and Related Processes 4
F Method for aggregating individual RPNs and determining an overall risk rating? FMEA and Control Plans 3
F How do you calculate Overall Residual Risk - Requirement of 14971 Risk Management ISO 14971 - Medical Device Risk Management 7
D Definition OEE definition - Overall Equipment Effectiveness - Definition of A (Availability) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
Marc Definition OEE (Overall Equipment Effectiveness) - Initials and Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc Definition Expected "overall" performance - Definition - Process Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc Performance - Expected "overall" performance - From Minitab Using Minitab Software 5
J Help with Mintab concepts: Expected "overall" performance vs. Observed performance Six Sigma 5
A Overall equipment effectiveness - Computing OEE taking all machines taken together Manufacturing and Related Processes 12
M How do you rate your company overall? Coffee Break and Water Cooler Discussions 11
H OEE (Overall Equipment Effectiveness) and Run at Rate IATF 16949 - Automotive Quality Systems Standard 5
A OEE - Overall Equipment Effectiveness QS-9000 - American Automotive Manufacturers Standard 1
A OEE - Overall Equipment Effectiveness - A Ford Requirement Customer and Company Specific Requirements 7
J Component Calibration - Overall TUR for a loop? ANSI/NCSL Z-540 Standard Section 10.2 General Measurement Device and Calibration Topics 6

Similar threads

Top Bottom