YS Class in DFMEA & Process Control Measures

N

Nick-C

Hi All

I am a little stumped!

In my DFMEA I have a Sev 8, Occ 3, Det 3 that relates to leakage of an air valve. This does not call for a YS / YC.

The reason for occurrence 3 is that we have robustly captured the specification for leakage.
We are not design responsible for the valve. We specify our requirements as leak rate targets.
The suppliers focus would be bore size, bore depth, surface finish etc for the seal.

My concern is that I can imagine the suppliers machining process used to make the part, and if not performed with the correct controls I can see leakage occurring.


So my DFMEA has no YS for leakage - My design spec is good.
But the process could get it wrong, and the DFMEA doesn't drive the suppliers PFMEA / Control plan without the YS.

I feel that leakage should be cascaded to the supplier as a YS, but I only say this because I have knowledge of the process risks which will not always be the case across a team of engineers.

Any help for clarity here would be appreciated.


Thanks!
 

Marc

Fully vaccinated are you?
Leader
A quick "Bump". My Thanks in advance to anyone who can help with this unanswered question. And, should you be browsing threads and it still has no reply, if you can help we will all appreciate it.
 
Thread starter Similar threads Forum Replies Date
S Clean Room Class ISO 8 EU Medical Device Regulations 3
adztesla Design change and Process change Class 3 medical device Medical Device and FDA Regulations and Standards News 2
C CMO for class 2, 510k exempt device Manufacturing and Related Processes 4
E Class II symbol - where to apply it? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Class Ir device have to be certified under MDR ? EU Medical Device Regulations 2
B Under MDR, are VATS and MICS still considered just class Ir? ISO 13485:2016 - Medical Device Quality Management Systems 1
Leigh76 CE Marking of Class II Bulk NonSterile Products for Kit Packers EU Medical Device Regulations 1
E Class II ME EQUIPMENT and subclause 8.9.1.12 IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
M MDEL Holder Class 1 Device Canada Medical Device Regulations 2
T Class B IEC 62304 - 5.4 Software Detailed Design IEC 62304 - Medical Device Software Life Cycle Processes 4
J Determination of software safety class (62304) prior to software risk analysis ISO 14971 - Medical Device Risk Management 3
M Class III IVD PMA Amendment to FDA Medical Device and FDA Regulations and Standards News 1
J Is ISO 13485 certification necessary for Class I (non-sterile) medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 7
R Class I devices in the extended MDR transition period EU Medical Device Regulations 17
J Class II device with lithium ion batteries IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Fluorescent Video System risk class EU Medical Device Regulations 6
K Question on registration of class 1 medical device in Turkey Other Medical Device Regulations World-Wide 0
A Clinical Evaluation Report Between Class I and Class IIa CE Marking (Conformité Européene) / CB Scheme 2
E Insulation from MAINS of the PE of a CLASS I PS used as FE IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M How to 'delist' a Class II device that was incorrectly registered as such? Medical Device and FDA Regulations and Standards News 2
N Class II Medical Device with Metallic Enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
D Swiss Documentation Requirements for Class 1 Medical Device Other Medical Device Related Standards 0
D Correct form to amend medical devices class III (IMDRF vs Form 2016) Canada Medical Device Regulations 0
O Is a Certified 13485 for class I devices needed ISO 13485:2016 - Medical Device Quality Management Systems 3
E Insulation class II device with metal enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
V Tendon Harvestor (Class Im or Class I) EU Medical Device Regulations 1
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
V SaMD/MDSW - Class I - CE Mark CE Marking (Conformité Européene) / CB Scheme 1
MaHoDie Is it possible to assign medical software to security class A (according to IEC 62304)? EU Medical Device Regulations 8
F Class A - sterile vs non sterile EU Medical Device Regulations 5
B Painted surface of a protective Class I equipment. CE Marking (Conformité Européene) / CB Scheme 1
B Post-Market Surveillance Requirements for Canada - class IIa/IIb device Canada Medical Device Regulations 1
N Direct Part Marking of the "CE" symbol- Class I Device EU Medical Device Regulations 1
A PMSR or PSUR for legacy MDD-class I becoming MDR class-IIa EU Medical Device Regulations 8
T PMCF Surveys for Class II a devices: basic requisites EU Medical Device Regulations 0
T PMCF Surveys for Class II a devices : basic requisites CE Marking (Conformité Européene) / CB Scheme 0
D Conformity Assessment for a System Class IIb EU Medical Device Regulations 0
F Philippines: Old Certificate of exemption for Class B device and new LTO. How to proceed? Other Medical Device Regulations World-Wide 0
R Class I MDSW CE Mark CE Marking (Conformité Européene) / CB Scheme 6
N Class III PMA shelf life extension US Medical Device Regulations 2
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
A Class 2a CE Mark Regulatory Pathway CE Marking (Conformité Européene) / CB Scheme 1
normhowe Surprising shoe policies for Class 7 Cleanrooms US Medical Device Regulations 5
L Class I under MDD EU Medical Device Regulations 1
C Legacy device under Class A sterile devices EU Medical Device Regulations 0
N FDA class 1 US Food and Drug Administration (FDA) 6
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
J Clinical Evaluation For Instruments - Class I, Class Ir, Class Im, and Class IIa - EU MDR EU Medical Device Regulations 4

Similar threads

Top Bottom