PHA (Preliminary Hazard Analysis) and Safety Case per UK MOD requirements

W

w_grunfeld

#1
Hello,
Did anyone perform a PHA (Preliminary Hazard Analysis) and/or Safety Case Analysis, in particular per UK MOD requirements?
Any samples/ advice will be wellcomed
My main problem is that the equipment in question is a very simple piece of equipment, unpowered, no software, no moving parts (just sliding/folding manually)
It is inherently safe having to retort to streching my imagination to come up with a list of possible hazards , even remote ones.
Yet the customer expects full fledged multi page analyses and report same as if it were a sophisticated guided missile....any sugestions?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
V Risk Assessment Precedence - FMEA > Risk Matrix (Modified PHA) > Ishikawa? FMEA and Control Plans 11
V FMEA vs. Process Hazard Analysis (PHA) FMEA and Control Plans 2
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
A GMDN Registration Basic preliminary Information EU Medical Device Regulations 0
R Preliminary MSA and Sockets' correlation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
M Informational EU – Hearing on the SCHEER preliminary Guidelines on the presence of Phthalates in certain medical devices (Brussels, 04 April 2019) – Summary records Medical Device and FDA Regulations and Standards News 0
M FDA News US FDA – Statement about rates of duodenoscope contamination from preliminary postmarket data Medical Device and FDA Regulations and Standards News 0
K Seeking guidance on Preliminary Steps to enable Hazard Analysis Food Safety - ISO 22000, HACCP (21 CFR 120) 1
J Assistance on ISO14001 - Preliminary assessment of my Environmental Legal Register ISO 14001:2015 Specific Discussions 1
S Cost of an AS9100 Preliminary Assessment Audit General Auditing Discussions 6
B Submitting a "Preliminary PFD Definition" Process Maps, Process Mapping and Turtle Diagrams 4
B Difference between Ppk (Preliminary), Cpk, Performance Capability Statistical Analysis Tools, Techniques and SPC 2
Y Reserve APQP documents such as Preliminary Bill of Material? APQP and PPAP 3
Manix Preliminary/Prototype/Production - Transition of Documentation stage to stage FMEA and Control Plans 6
B Ppk or Cpk - Preliminary Process Capability vs. Process Performance Capability, Accuracy and Stability - Processes, Machines, etc. 16
Marc PPAP Preliminary Capability Studies - Batches - Paint Company APQP and PPAP 3
I Hazard Identification and Naming ISO 14971 - Medical Device Risk Management 10
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
D Failure rate vs hazard rate vs rate of failure Reliability Analysis - Predictions, Testing and Standards 2
D Hazard symbols and labeling ISO 13485:2016 - Medical Device Quality Management Systems 1
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
M Informational Work in progress at the FDA for biological evaluation – Color Hazard and RISk calculator (CHRIS) Medical Device and FDA Regulations and Standards News 0
A Fire hazard classification - Clause in IEC 60601 about gauze and electricity ISO 14971 - Medical Device Risk Management 0
N Should it even be on the hazard analysis (software)? FMEA and Control Plans 2
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
A Moving and positioning of patient - Mechanical hazard IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
A Risk-benefit Analysis - Hazard Analysis (HA) and FMEAs ISO 14971 - Medical Device Risk Management 18
S The Severity of a Medical Device Hazard - Risk Analysis Clarification ISO 14971 - Medical Device Risk Management 6
D Hazard analysis for our medical device - Hazards seem to overlap 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
F Medical Device HACCP (Hazard Analysis and Critical Control Point) Risk Management ISO 14971 - Medical Device Risk Management 2
L No entanglement hazard of applied parts cables? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Biological and Chemical Risks to the user in the Hazard Analysis ISO 14971 - Medical Device Risk Management 1
E EN/UL/CSA 61010 -1 (ed3) Safety and use of Software to Prevent Electrical Hazard CE Marking (Conformité Européene) / CB Scheme 3
M Hazard Identification for Pest Control Activities Other ISO and International Standards and European Regulations 9
N Hazard Probability of Occurrence Definition ISO 14971 - Medical Device Risk Management 11
A ISO 14971 Figure E.1 that starts with Hazard and ends with Risk ISO 14971 - Medical Device Risk Management 3
R Risk Analysis and Hazard Identification concerning Clinical Decision Support Systems ISO 14971 - Medical Device Risk Management 1
M IVDD ER 8.3 Vs. Hazard Labelling Regulations - Which outranks? EU Medical Device Regulations 2
G Combining Aspect Impact and Hazard Risk Register Miscellaneous Environmental Standards and EMS Related Discussions 8
R Risks which must be Distinctly Identified - Harm, Hazard, Severity ISO 14971 - Medical Device Risk Management 7
S Hazard Identification and Risk Assessment - Can Risk Assessment be "Grandfathered"? Occupational Health & Safety Management Standards 4
2 Medical Device Hazard Risks - Normal Use Risks vs. Faulty Use Risks ISO 14971 - Medical Device Risk Management 4
K Regarding ISO 62304 Clause 7.3.3 - Hazard and Risk Controls IEC 62304 - Medical Device Software Life Cycle Processes 9
S PMA Submission Software Hazard Analysis Document vs. Product Hazard Analysis doc ISO 14971 - Medical Device Risk Management 5
S Aspect vs. Impact and Hazard vs. Risk - Short/clear explanation & example Miscellaneous Environmental Standards and EMS Related Discussions 11
K When, whom, how to conduct hazard analysis of PRP?s, OPRP?s and CCP?s? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
K Differences between "Hazard" and "Risk" in ISO 22000 Food Safety - ISO 22000, HACCP (21 CFR 120) 4
K General HACCP (Hazard Analysis Critical Control Point) Questions Food Safety - ISO 22000, HACCP (21 CFR 120) 8
D Occupational Hazard....is it worth ? Imported Legacy Blogs 3
somashekar Lead acid Batteries inside DG set acoustic enclosure - What Hazard and Risk and how ? Occupational Health & Safety Management Standards 5

Similar threads

Top Bottom