PPAPing an end of line Motor Tester

V

vardar3

#1
A supplier got a new tester for the motors that they supply us. The motors go into a seat mechanism. The PPAP they submitted says the tester checks for:
· Hi Potential test: to verify the isolation of the motor can protect against excessive electrical leakage.
· Test performance in both up and down direction
    • Speed
    • Current
  • Hall effect
  • Automatic label printer that links performance to the recorded serial ID,
I’m reading up on some of this motor testing because I have not been involved in it, but can any of you offer suggestion on what I should be asking for from our supplier, because all they supplied is Attributing gagging results.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
F Procedure for Device End of Life/Obsolescence Other Medical Device and Orthopedic Related Topics 3
B ISO 11607-1 for surgical instruments sterilized by end user Other Medical Device Related Standards 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
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M End of Life or Device transfer regulations for Legal Manufacturer Other Medical Device Regulations World-Wide 1
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
M FDA News USFDA Proposes to End Temporary Extension of GUDID’s Grace Period Medical Device and FDA Regulations and Standards News 3
supadrai My short yet eventful stint as a regulatory affairs lawyer dude is coming to an end! Career and Occupation Discussions 1
L Cytotoxicity at the end of life-time Other Medical Device Related Standards 3
M Where does our regulatory responsibility end? ISO 13485:2016 - Medical Device Quality Management Systems 11
J Medical Device End of Life and Complaints 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
T New to WEEE Directive - Selling a medical device directly to a professional end-user RoHS, REACH, ELV, IMDS and Restricted Substances 1
P Sample of an end-use-letter for drugs according to FDA requirements US Food and Drug Administration (FDA) 2
M Forced NOT to meet End Customer Expectations - Corrupt Third World Country ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Who is the Customer - Who is the End User Manufacturing and Related Processes 2
Colin I am retiring at the end of this month - March 2017 Coffee Break and Water Cooler Discussions 19
E Manufacturer's responsibility to notify the NB regarding Medical Device End-of-Life CE Marking (Conformité Européene) / CB Scheme 1
Marc Stem Cell stimulation to end tooth Root Canals World News 0
C Calibration Dates - Exact day or end of month? General Measurement Device and Calibration Topics 24
A End of Life for Medical Mobile App (Stand Alone Software) Medical Information Technology, Medical Software and Health Informatics 5
somashekar Info about a specific federal regulation - End use and end user information Misc. Quality Assurance and Business Systems Related Topics 2
A How to handle complaints after end of specified medical device life-time ISO 13485:2016 - Medical Device Quality Management Systems 5
J How to document discontinuation or end of life for a software version ? IEC 62304 - Medical Device Software Life Cycle Processes 3
A Medical Device Distribution in the EU to Patients (End-Users) EU Medical Device Regulations 3
E Callout of a length dimension and then P.I at the end - What does that mean? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K Biocompatability on End Component Other Medical Device and Orthopedic Related Topics 1
T Will the End of Windows XP Support affect anything in AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R End of Fake ISO 13485 Certificates? ISO 13485:2016 - Medical Device Quality Management Systems 0
A Device End Of Life Regulations and Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
hogheavenfarm Allowable End Gap of Split Lockwashers Manufacturing and Related Processes 2
M SOP for Egg Washing at the user end in the Catering Industry Food Safety - ISO 22000, HACCP (21 CFR 120) 4
J The end of the world is nigh!!! Coffee Break and Water Cooler Discussions 41
T End of Line Testers - When to use Red Rabbits? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M Justification for Month End Calibration Date Calibration Frequency (Interval) 24
B Need ideas for a friendly bet - Year-end food drive Coffee Break and Water Cooler Discussions 6
M Calibration of measurement equipment when product End Of Life is near General Measurement Device and Calibration Topics 2
B End of Contract Notice to Employer Career and Occupation Discussions 11
M 8.2.1.1 - Customer Satisfaction - How to satisfy the end requirement? IATF 16949 - Automotive Quality Systems Standard 1
optomist1 Feature Control Frame is applied to the end of a Cylinder - Datum Dilemma Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
T Outsourcing Shipping Product directly from our Warehouse to the End Customer ISO 13485:2016 - Medical Device Quality Management Systems 2
N 1st Shift vs. 2nd Shift Production Crews - How to end this war? Career and Occupation Discussions 15
N Doubt on Bias study for EOLT (End Of Line Tester) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
A When does a project end inside a software product? Life Cycle issue IEC 62304 - Medical Device Software Life Cycle Processes 5
T Reducing End of the Line Skipped Rabbit Testing Reliability Analysis - Predictions, Testing and Standards 3
N Gage R&R on an EOLT (End Of Line Tester) - Include Reference or not? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
B Performance Qualification Question - Downsizing the end of a tube Quality Tools, Improvement and Analysis 5
J Tracking the End Customer by Distributors 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
G How do OEM's manage Special Customer Requirements from its End Customers? Customer and Company Specific Requirements 1
F Replacing End of Life (EOL) Components - What triggers retesting to IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
S End of GHTF (Global Harmonisation Task Force) Other Medical Device and Orthopedic Related Topics 8

Similar threads

Top Bottom