SBS - The Best Value in QMS software

Missing 1m visual alarm signal in case of software/display failure, mitigation?

#1
In case of a software/display failure of a class 3 device the 1m visual alarm signals will no longer visible but there might be things the user needs to act on real quick. Are there best practices to mitigate this risk before the user is able to exchange the device (e.g. LEDs next to symbols describing certain critical alarm causes) or is this most likely a residual risk? IMO the LED's solution is really hard to justify from a HF point of view.

I'm sorry if this question is too specific, I'm happy for any feedback.
 
Elsmar Forum Sponsor

Tidge

Trusted Information Resource
#3
I suspect you may be venturing down the path of multiple-fault conditions.

Alarms signals typically have both an audible and visual component, presumably for circumstances such as this.
 
#4
Thanks for your answers, I think we have to evaluate this in a formative as mentioned. It's crazy which situations you sometimes find in the risk assessment.
 
Thread starter Similar threads Forum Replies Date
K Addressing Missing Documentation Document Control Systems, Procedures, Forms and Templates 7
M Missing measuring equipment General Measurement Device and Calibration Topics 6
I Reissuing documents due to missing version / issue numbers Document Control Systems, Procedures, Forms and Templates 3
F Missing value of Uncertainty B Measurement Uncertainty (MU) 10
C Missing routers/documented information Nonconformance and Corrective Action 5
qualprod To raise a NC beyond the audit scope? Two signatures were missing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M What to do about Non Conformance forms that are deleted or missing? Nonconformance and Corrective Action 4
M Nonconformity for missing form number on the job description document Nonconformance and Corrective Action 1
N Original signed IQ/OQ/PQ missing - but have data - Do we do it over? ISO 13485:2016 - Medical Device Quality Management Systems 2
MarilynJ6354 Missing Corrective Actions - Workforce does not trigger corrective action requests General Auditing Discussions 6
Q Practical guide to scan for Risks in all QMS systems without missing any ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
O CQE Handbook - Missing Section VII - Risk Management Misc. Quality Assurance and Business Systems Related Topics 1
W AS9100 (8.5.1 j) - Missing Parts when received back from External Provider AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Missing Hardware in Accessory Kits Manufacturing and Related Processes 5
C Recurring Nonconformance - Missing Deadline for Closing a Corrective Action Problem Solving, Root Cause Fault and Failure Analysis 14
N "Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 5
O New Job 1 Month from Recertification Audit - Missing Documents, no Internal Audits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
H Incomplete forms and records missing date or a name Records and Data - Quality, Legal and Other Evidence 6
Marc Searching Linkedin Posts - What am I missing? After Work and Weekend Discussion Topics 14
K Revision History of Quality Manual Missing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
E Research or other consents missing from the Donor Medical Chart Document Control Systems, Procedures, Forms and Templates 5
D Missing Document in a TS 16949 Audit - Nonconformance IATF 16949 - Automotive Quality Systems Standard 5
F Fully nested ANOVA: A missing p-values (Minitab) Using Minitab Software 11
W The 2nd printing of the AWS D17.1 2010 which was 2011 - Page missing? Various Other Specifications, Standards, and related Requirements 3
J Eliminating Missing Steps In Manual Operations Human Factors and Ergonomics in Engineering 8
R How to report missing Procedures and Documents Document Control Systems, Procedures, Forms and Templates 9
C Missing Dimensions on the 2D drawings - FAI and 3D Models Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
P ISO 9001:2008 - I'm missing page 3 in my copy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Fender1 Corrective Action and Root Cause Analysis for a Missing Assembly Part ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
G Signature Missing from Calibration Certificates General Measurement Device and Calibration Topics 6
E What is missing in the attached Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
S Load Label Missing from Ladders Occupational Health & Safety Management Standards 7
Q Non Conformity in Audit: Missing Deputy Rule ISO 13485:2016 - Medical Device Quality Management Systems 10
M For ISO 9001: Missing Measurement Gage Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Information found missing in a Medical Device Record Other US Medical Device Regulations 4
A Missing expiry date on Class II Medical Device - Recall/Not? What are EU Requirements EU Medical Device Regulations 2
B IEC 60601 Annex D Symbols needed - I am missing Annex D from my standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M What to do about missing Quality Records? Records and Data - Quality, Legal and Other Evidence 11
L Eliminating a Recurring Problem of Missing Weld Nuts/Fasteners Manufacturing and Related Processes 27
Q Focused CAPA on Missing Finished Nonconforming Product ISO 13485:2016 - Medical Device Quality Management Systems 4
L How do you handle missing information? People seem to "forget" to enter information Document Control Systems, Procedures, Forms and Templates 148
Marc Items Missing from the US National Archives World News 0
J U.S. National Archives offers reward for missing hard drive After Work and Weekend Discussion Topics 1
D 21 CFR 820 - Missing Numbers - I have a reference to 820.84 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R FDA Audit - Medical Device missing Repair Record General Auditing Discussions 21
Stijloor Jet engines found with damaged, missing parts World News 3
B Need for revision (minor inconsistencies, missing dates and revision numbers, etc)? Document Control Systems, Procedures, Forms and Templates 3
S Missing inserts in injection molding Manufacturing and Related Processes 3
R Requirement to Complete Missing Documentation - Changing Registrars Quality Manager and Management Related Issues 6
K Missing Information in Training Records - Is it a Major Nonconformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23

Similar threads

Top Bottom