Who should prepare DVP for components? Our suppliers or our product engineering?

L

leon song

#1
Recently our company had a discussion and argue about the responsibility of Component DVP.
Certainly our product engineering will prepare the assembly DVP for our customers, but we can not reach the agreement about Who should prepare DVP for components, our suppliers or our product engineering?
 
Elsmar Forum Sponsor
D

Detbyron

#2
Re: Who should prepare DVP for components, our suppliers or our product engineering?

I think whoever is design responsible for the component should be responsible for the DVP. Even if your supplier is design responsible, you should still review and approve their DVP, and probably you should have some expectations/assumptions as to what would be included in the DVP.
(Ultimetly if there is a failure at YOUR customer, they are going to come to you, not your supplier, so it is ultimetly YOUR responsibility to ensure everything is designed proerly.)
 
D

Dean Frederickson

#3
Re: Who should prepare DVP for components, our suppliers or our product engineering?

For anybody out there like me, that does not know what DVP stands for I think it is Design Verification Program:bigwave:
 
D

Detbyron

#4
Re: Who should prepare DVP for components, our suppliers or our product engineering?

I assumed Leon meant Design Verification Plan.


(I have actually never heard of Design Verification Program)


I was surprised to find netiher DVP nor DVP&R included within the definitions and acronyms section of this forum.
The AIAG APQP Manual (Revision 1) has DVP&R in Appendix B:
"The Design Verification Plan and Report (DVP&R) is a method to plan and document testing activity through each phase of product/process development from inception to ongoing refinement. This method is used by Chrysler and Ford."
 
C

crentinger

#5
Re: Who should prepare DVP for components, our suppliers or our product engineering?

I think whoever is design responsible for the component should be responsible for the DVP. Even if your supplier is design responsible, you should still review and approve their DVP, and probably you should have some expectations/assumptions as to what would be included in the DVP.

Detbyron is absolutely right. You should be producing the DVP. The purpose of design verification is to ensure the design works in your application to the standards you establish. Notice the use of you and your. If you do not do the DVP, then the risk is very high that the supplier will miss something that is a critical known unknown for your application. Only the customer knows application.
 
L

leon song

#6
Re: Who should prepare DVP for components, our suppliers or our product engineering?

I think whoever is design responsible for the component should be responsible for the DVP. Even if your supplier is design responsible, you should still review and approve their DVP, and probably you should have some expectations/assumptions as to what would be included in the DVP.
(Ultimetly if there is a failure at YOUR customer, they are going to come to you, not your supplier, so it is ultimetly YOUR responsibility to ensure everything is designed proerly.)
I agree with you. We do have the design resposibility to prepare the drawings, specs for our suppliers. But the problem is, should we have to prepare the DVP, maybe it is better to be prepared by suppliers. Because the suppliers have to understand our drawings, specs..., and then they can prepare the DVP.
Certainly we will review and approve the DVP. But the topic we argued is WHO prepares the record(DVP).
 
D

Detbyron

#7
Re: Who should prepare DVP for components, our suppliers or our product engineering?

So it sounds like the question is not really who is responsible to decide the content, but actaully who is responsible for keeping and updating the documentation? Ok.

In that case I would say the supplier, especially if they will be the ones conducting/coordinating the tests; and then of course you would need to approve it before starting.

You can also try to refer to the RFQ / contract to see if DV level testing was included in their responsibility. (If it wasn't, they may come back asking for more money?!?)

If you require to include PV level testing in the DVP, then I think that there is no question that it would be their responsibility. If you don't, then I think you could require them to create a PVP to cover their PV testing as well.

This is all just opinion based on 7yrs experience as a Project Engineer. Good luck.
 
L

leon song

#8
Re: Who should prepare DVP for components, our suppliers or our product engineering?

So it sounds like the question is not really who is responsible to decide the content, but actaully who is responsible for keeping and updating the documentation? Ok.

In that case I would say the supplier, especially if they will be the ones conducting/coordinating the tests; and then of course you would need to approve it before starting.

You can also try to refer to the RFQ / contract to see if DV level testing was included in their responsibility. (If it wasn't, they may come back asking for more money?!?)

If you require to include PV level testing in the DVP, then I think that there is no question that it would be their responsibility. If you don't, then I think you could require them to create a PVP to cover their PV testing as well.

This is all just opinion based on 7yrs experience as a Project Engineer. Good luck.
Yes, thanks very much for your clarification!
What you are saying is same with me, totally agree with you!
Our Purchasing didn't add any requirements to prepare DVP&PVP in RFQ package to suppliers. Actually they are trying to protect the suppliers and ask our Product Engineering to prepare the DVP/PVP for our suppliers. That is the problem and the reason why Engineering argues with Purchasing....

Now the argue is continued....
 
J

Jaroslaw.Malkowski

#9
DVP - it depends.
Example: Our company order PPAP. Some requirements are listed on the drawing. To meet it DVP is provided by supplier.
The same part goes to the other one - is assembled in our Co - so it is our responsability to perform those tests.
I think it is a political question = money :)
 
Thread starter Similar threads Forum Replies Date
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
A ISO 9001 Recertification Process - How should I prepare for it? Document Control Systems, Procedures, Forms and Templates 6
C How much fees should I prepare for the TGA certificate Other Medical Device Regulations World-Wide 1
W What kind of materials should I prepare for passing ISO IEC 60601-1-4 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
R Travel to China - What should I know? How should I prepare? Travel - Hotels, Motels, Planes and Trains 39
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 4
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 3
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
M Which incubation condition should be selected to recover both bacteria and fungus effectively Miscellaneous Environmental Standards and EMS Related Discussions 3
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
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M Who should receive the bills from suppliers and vendors, account payable or procurement? Consultants and Consulting 4
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 26
D Class II medical device - When should a complaint be closed? Customer Complaints 6
Sidney Vianna IATF 16949 News Presentations from the latest IATF Stakeholder Event - Expectation that IATF 16949 certification should equate with product quality. Misguided? IATF 16949 - Automotive Quality Systems Standard 7
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
D How long should we keep the spare parts available for our medical device, after we have stopped the production? ISO 13485:2016 - Medical Device Quality Management Systems 0
H Statistical Techniques Procedure - What should be included Document Control Systems, Procedures, Forms and Templates 4

Similar threads

Top Bottom