SBS - The Best Value in QMS software

Safety and/or Government Regulation question on a PSW (Part Submission Warrant)

V

vardar3

#1
How would i know if a part requires a yew or no check for " Safety and/or goverment regulation" on the PSW?

I would gues it would be on the print but how would that appear on the print. Would it say FMVSS or or safety requirement?
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Re: Safety and/or Goverment Regulation question on a PSW (Part Submission Warrant)

How would i know if a part requires a yew or no check for " Safety and/or goverment regulation" on the PSW?

I would gues it would be on the print but how would that appear on the print. Would it say FMVSS or or safety requirement?
There would normally have to be something in the specifications that requires you to meet specific safety and/or regulatory requirements. In U.S. automotive work, reference to FMVSS (Federal Motor Vehicle Safety Standards) is usually the key for safety requirements.
 
D

dmc95

#3
Re: Safety and/or Goverment Regulation question on a PSW (Part Submission Warrant)

Hello,
Would a Special Safety Characteristic (diameter, or material chemical composition for example) shown on the part print lead the PSW to become Safety/Regulation ?
Regards
 

Jim Wynne

Staff member
Admin
#4
Re: Safety and/or Goverment Regulation question on a PSW (Part Submission Warrant)

Hello,
Would a Special Safety Characteristic (diameter, or material chemical composition for example) shown on the part print lead the PSW to become Safety/Regulation ?
Regards
Welcome to the Cove. :bigwave:

If a thing is identified as a Special Safety Characteristic, then yes.
 
D

dmc95

#5
Thank you Jim for your reply.
It is somehow difficult to admit that one feature declared safety on a part makes the whole part becoming "Safety".
Do you know for any (AIAG or other) documentation I could refer to for communication purpose and to study this topic deeper ?
Regards
 

Jim Wynne

Staff member
Admin
#6
Thank you Jim for your reply.
It is somehow difficult to admit that one feature declared safety on a part makes the whole part becoming "Safety".
Do you know for any (AIAG or other) documentation I could refer to for communication purpose and to study this topic deeper ?
Regards
Strictly speaking, the field on the PSW pertains to regulations, and not necessarily self-declared safety concerns. The best guidance on this would come from your customer, or whomever it was that put that on the drawing.
 
Thread starter Similar threads Forum Replies Date
H Government Safety & Environmental Regulations process audit example IATF 16949 - Automotive Quality Systems Standard 5
Z Choice of PTC heater voltage to maximize user safety and ease of CE compliance to LVD CE Marking (Conformité Européene) / CB Scheme 0
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 3
D Northern Ireland Field Safety Corrective Actions (FSCA) UK Medical Device Regulations 3
chris1price Notified Body responsible for product safety under MDD? EU Medical Device Regulations 4
H Class II a vs "software safety class A" IEC 62304 - Medical Device Software Life Cycle Processes 3
S Cyber Security and Safety Risks Medical Information Technology, Medical Software and Health Informatics 5
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 2
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 2
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
E 60601-1 - Tilt testing - Tensile safety factor IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
D Safety data sheets software REACH and RoHS Conversations 2
M ECG lead leakage currents - How to specify ECG leads during electrical safety testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
N German National Requirements - Safety Officer/Authorised Rep Other Medical Device Regulations World-Wide 0
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
A Baby food manufacture - food safety requirements Food Safety - ISO 22000, HACCP (21 CFR 120) 0
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
D Safety Assurance Case Report Format ISO 14971 - Medical Device Risk Management 5
B Product Safety Responsibility - Job shop such as a machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
K Things to learn during lockdown.... Safety-related books/articles/threads Book, Video, Blog and Web Site Reviews and Recommendations 1
JAMESH Job Safety - Lockout/Tagout and Respiratory Protocols Manufacturing and Related Processes 3
J Raw material certificates - CC - Safety products - Sheet metal stamping IATF 16949 - Automotive Quality Systems Standard 1
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
adir88 Information of safety can reduce risk now? ISO 14971 - Medical Device Risk Management 12
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
S VW Supplier Product Safety Representative (PSB) upgrade to PSCR VDA Standards - Germany's Automotive Standards 8
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11
T Confirming The Local Safety Regulations for Equipment - I'm in Malaysia General Measurement Device and Calibration Topics 1
MrTetris Unacceptable risk and information for safety ISO 14971 - Medical Device Risk Management 16
A Contraindication Safety Statement in website - Radiotherapy equipment Other Medical Device and Orthopedic Related Topics 1
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
C Safety lettering on a product CE Marking (Conformité Européene) / CB Scheme 5
M EU – Chemical Safety Report – CSR – REACH Authorisation decisions – Triton X-100 – Ortho-clinical-Use1 REACH and RoHS Conversations 0
M Informational EU – Minutes of the 24 July 2019 SCHEER Working Group on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) meeting Medical Device and FDA Regulations and Standards News 0
M EMC Directive and product safety standards CE Marking (Conformité Européene) / CB Scheme 1
S Safety Class A with no test? IEC 62304 - Medical Device Software Life Cycle Processes 1
M Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 Medical Device and FDA Regulations and Standards News 0
D Requirement of Pharmacovigilance (Drug Safety) Risk Based Strategic and Tactical Audit Plan General Auditing Discussions 0
M Informational Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health Medical Device and FDA Regulations and Standards News 0
S System safety assesment Federal Aviation Administration (FAA) Standards and Requirements 0
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2

Similar threads

Top Bottom