SBS - The Best Value in QMS software

Сorrespondence between hazards and risks

Igor Guba

Starting to get Involved
#1
Hello everyone,
I'm relatively new to the area of risk management knowledge, so I'm going to ask a lot of questions here.

Say we have a device equipped with a potentially dangerous laser. The laser radiation power is controlled on the safe level by the device control system.
Let's consider two scenarios:
1. The failure of the control system due to the software error. Dangerous situation: unsafe level of the laser radiation and injury - skin burn.
2. The failure of the control system due to the electromagnetic disturbance. Dangerous situation: unsafe level of the laser radiation and injury - skin burn.

So we have two possible ways to get into the same dangerous situation.

Now the question. Should I consider those two scenarios as two different risks (but associated the same hazard)?

Thank you!
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
So we have two possible ways to get into the same dangerous situation.

Now the question. Should I consider those two scenarios as two different risks (but associated the same hazard)?
That's quite common, and yes, different risks since they are likely to have different controls. In fact, as you drill down, there may be multiple ways, for example, that a software error can occur which possibly have different controls.
 
Thread starter Similar threads Forum Replies Date
R Whats different between these position CE Marking (Conformité Européene) / CB Scheme 8
G What's the difference between 1.32 and 1.33 Cpk? Capability, Accuracy and Stability - Processes, Machines, etc. 18
U How to pick between ANSI Z1.4 vs. ISO2859-1 for AQL Inspection? What are the major differences? AQL - Acceptable Quality Level 4
H Independence between the development and testing IEC 62304 - Medical Device Software Life Cycle Processes 6
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
N R&R for Differences between 2 measurements Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
S Distinction between a critical supplier and a Virtual manufacturer EU Medical Device Regulations 2
W What is the difference between TYPE B and TYPE BF? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
Q Terminal Lugs sizes - Difference between 225/24 vs. 275/24 lugs Manufacturing and Related Processes 2
T Relationship between ISO 9001 and ISO – IEC BS EN 870079- 34 2020 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Difference between "Production Trial Run" and "Run at Rate" IATF 16949 - Automotive Quality Systems Standard 8
Ron Rompen Surface Finish Correlation between Ra, Rz and Tp (bearing surface ratio) General Measurement Device and Calibration Topics 3
L MRA between EU and Switzerland - 1/2021 EU Medical Device Regulations 2
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 18
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
C Is my software an accessory? Telecommunication between HCP and patients EU Medical Device Regulations 10
K Verify Software Architecture - supporting interfaces between items IEC 62304 - Medical Device Software Life Cycle Processes 2
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
K %GRR was between 10-30% so we have to have a "backup plan" per auditor IATF 16949 - Automotive Quality Systems Standard 15
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 3
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 42
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
gramps What is the difference between discrete and continuous variables? Problem Solving, Root Cause Fault and Failure Analysis 3
R Plea for advice on transitioning between Notified Bodies (label updates) Medical Device and FDA Regulations and Standards News 1
M Measuring FIM (TIR) - Two inside diameters - Conflicting readings between inspectors Manufacturing and Related Processes 1
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 4
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
DuncanGibbons Clear differences between ISO 13485 and AS 9100D requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
H What is different between PED certificate and CPR certificate? Manufacturing and Related Processes 2
B Angle between two surfaces Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
D Variation between Faro Arms Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
K Differences between Manufacturing Process Audit & Layered Process Audit Lean in Manufacturing and Service Industries 4
P Risk acceptability alignment between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 6
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Reorganizing responsibilities between management teams and Employees in them ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Compatibility between MDD and MDR devices EU Medical Device Regulations 7
Q How should I analyze measurement correlation between me and customer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
S Relationship between IEC 62304 problem resolution and ISO 13485 IEC 62304 - Medical Device Software Life Cycle Processes 8
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
T Something between a manual and a procedure? Document Control Systems, Procedures, Forms and Templates 9
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8

Similar threads

Top Bottom