SBS - The best value in QMS software

Who has Design Responsibility in this Scenario - Rubber Parts Manufacturer

Miner

Forum Moderator
Staff member
Admin
#11
A rubber parts manufacturing organization is provided product characteristics such as rubber type, hardness, elongation, colour by the customer. The organization, in turn, finalizes the rubber composition formula through a series of hits and trials which can meet the customer provided product characteristics. Is the organization product design responsible?
What is the specific product?
 
Elsmar Forum Sponsor

Rameshwar25

Quite Involved in Discussions
#12
Rameshwar25:

Can you make a change to the product characteristics without the customer's approval?

You might be design responsible for the manufacturing process. I would question if you are design responsible for the product.
ofcourse, the supplier can not change the specification but can change raw material composition to meet the product characteristics.
What is the specific product?
Miner, the question is not related to one supplier. As an auditor, I have audited many rubber molded parts manufacturing organizations and everywhere I accepted their exclusion of clause 7.3 of ISO 9001:2008. Recently during one audit, my colleague, who is ISO/TS 16949:2009 auditor asked me to think whether such companies were design responsible or not? My opinion is that since they can not change product characteristics without customer approval, they all are non-design responsible companies. My colleague says that raw material composition is also one of the product characteristics which is directly in control of such suppliers, these suppliers are design responsible and clause 7.3 should be applicable.

Regards
Rameshwar
 

Jim Wynne

Staff member
Admin
#13
ofcourse, the supplier can not change the specification but can change raw material composition to meet the product characteristics.

Miner, the question is not related to one supplier. As an auditor, I have audited many rubber molded parts manufacturing organizations and everywhere I accepted their exclusion of clause 7.3 of ISO 9001:2008. Recently during one audit, my colleague, who is ISO/TS 16949:2009 auditor asked me to think whether such companies were design responsible or not? My opinion is that since they can not change product characteristics without customer approval, they all are non-design responsible companies. My colleague says that raw material composition is also one of the product characteristics which is directly in control of such suppliers, these suppliers are design responsible and clause 7.3 should be applicable.

Regards
Rameshwar
How can raw material composition be in the direct control of a supplier if the supplier has no authority to change it? The compounding is a manufacturing process that's not substantively different from any other manufacture of a product in accordance with customer requirements.
 

Rameshwar25

Quite Involved in Discussions
#14
How can raw material composition be in the direct control of a supplier if the supplier has no authority to change it? The compounding is a manufacturing process that's not substantively different from any other manufacture of a product in accordance with customer requirements.
Jim, the compounding is done on part of suppliers. Rubber compounding typically is mixing of rubber and other chemicals. Although, the suppliers use formula to finalize percentage of different chemicals to get the customer-provided characteristics, usually you will find a lot of difference in raw material compositions of two different suppliers, though the final part from both suppliers will meet all the product characteristics. That is why i wrote that raw material composition is in directly control of suppliers.
 

Jim Wynne

Staff member
Admin
#15
Jim, the compounding is done on part of suppliers. Rubber compounding typically is mixing of rubber and other chemicals. Although, the suppliers use formula to finalize percentage of different chemicals to get the customer-provided characteristics, usually you will find a lot of difference in raw material compositions of two different suppliers, though the final part from both suppliers will meet all the product characteristics. That is why i wrote that raw material composition is in directly control of suppliers.
I understand. But to reiterate, the compounding of the material is no different from meeting other customer specifications--dimensional, e.g.--for a finished part.
 
N

ncwalker

#16
Here's an easy litmus test.....

If the customer has taken your print of the part, wrapped his title block around the image of your part print and released it in his system, you're probably design responsible.

If he has given you a print and said "make this" then he is.
 
V

vanputten

#17
I wonder about the posters approach to posting a question and then on posting #12 we find out the poster has an opinion on the question. It would have been nice to know in posting #1 what you wrote in posting #12. I feel sort of tricked or duped.

Now, back to the question. The first problem with the debate is the lack of operational definition on design. I alluded to this in my posting #5.

There are many types of design - product, process, manufacturability, environmental, end of life, etc.

I think you and your colleague are debating two different types of design responsibility - process (compounding) Vs product (the final thing provided to the customer that has characteristics the supplier cannot change.)
 

Miner

Forum Moderator
Staff member
Admin
#18
There is no blanket statement that covers all contingencies. Take some of the following examples from my past experience (15 years in automotive rubber manufacturing).
  • Automotive weatherstrips: The OEM gave us drawings of the weatherstrip with performance criteria. Dimensions were limited to gross characteristics such as length. No detail dimensions were provided. We designed the physical details and formulated the rubber compounds in order to meet the functional requirements. We designed the extrusion dies and the molds to manufacture the product.
  • Vibration Isolation (e.g., engine mounts, bushings, suspension links, etc.): The customer gave us drawings of performance criteria and key dimensions of mounting surfaces to mating parts. We designed all details and the rubber formulation to meet these criteria. We designed all tooling, inserts, stampings and weldments.
  • O-rings: The customer gave us drawings of performance criteria and physical dimensions. We designed the rubber formulations and tooling to meet these criteria.
In all cases, the design responsibility was shared to varying degrees. The OEM held us accountable for design related field issues. I remember one example where we proposed a weatherstrip with a vinyl base that was color matched to the interior trim. The customer approved it, but shortly after launch it became apparent that when the weatherstrip was exposed to the hot sun, it softened and fell off the sheet metal flanges. You better believe that the OEM held us design responsible for the cost of replacing the entire fleet.

I was involved with almost every rubber component used in a car, and was at least partially design responsible in the eyes of the OEM for all of them.
 

somashekar

Staff member
Super Moderator
#19
Design and development is always a shared responsibility. A rubber part in an automotive can be designed and developed by a tier 1/tier 2 supplier, but in the eye of the customer, every part is designed and developed by the automotive manufacturer.
An so the responsibility goes.
In a technical situation that comes under audit scope, you are design responsible. But you have no absolute authority, as you do not supply the rubber part directly to the end customer. In most business to business supply chain, design becomes shared responsibility.
 
V

vanputten

#20
Hello Someshakar

I couldn't disagree more with "but in the eye of the customer, every part is designed and developed by the automotive manufacturer."

Then why does TS 16949 have section 7.3?

All of my organization's parts are clearly designed by us, the manufacturer, and customers agree.
 
Thread starter Similar threads Forum Replies Date
A Auditing Design Organization - Auditor has to audit 7.3 and 7.5.1 / 7.5.2 separately? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N Design Churn - What industry has the most Design Churn? Benchmarking 2
D Full factorial design, 4 factors, each has its own # of levels. Using Minitab Software 6
GStough Risk Management Has to Begin Prior to Design Input, But... Design and Development of Products and Processes 10
S Multilevel Design in Minitab to conduct a DOE - 4 factors and each has 5 levels Design and Development of Products and Processes 4
Marc Design Control 4.4 - Design Engineering manager has no structured documentation Design and Development of Products and Processes 11
J How to keep MDD certificate valid when legal manufacturer has liquidity problem EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
G Special 510K possible? Only the packaging has changed Other US Medical Device Regulations 0
Louddogsbark When your 13485:2016 certificate has been pulled ISO 13485:2016 - Medical Device Quality Management Systems 2
lanley liao What shoud i do if our company top management has been changed. Oil and Gas Industry Standards and Regulations 8
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
L GRR for a tolerance that has changed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
D Partial FAI - AS9102 - One single drawing has 10 part numbers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 17
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 15
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
Sidney Vianna IAQG News IAQG has a new website - December 2019 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Richard Regalado ISO 22301:2019 has been published - Nov 2019 Business Continuity & Resiliency Planning (BCRP) 0
S FAIR - If we have not produced a part in over 2 years, but nothing has changed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Nicole Desouza Who has to be compliant with REACH Declarations? REACH and RoHS Conversations 11
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
A Would an MRP system that has been in use for over 10 years require validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Informational VDI 2017 - Medical Grade Plastics - German VDI has published a "Richtlinie" Other Medical Device Related Standards 1
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
U Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Has anyone heard of the 2 pan system? Manufacturing and Related Processes 6
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
I Who has had to move from ISO 9001:2015 to ISO 13485 and what were the challenges? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Informational UTC ASQR Rev.11 has a mistake; certification of distributors to IATF 16949 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
lilybef FDA and Biocompatability Testing - Reviewer has requested implantation testing Other Medical Device Related Standards 11
D Has anyone undergone a BARDA (HHS) audit as part of their grant process? Other Medical Device Regulations World-Wide 0
Sidney Vianna LinkedIn bug - Anyone has any idea of how to fix this? Posts not showing for me in a Group feed. Coffee Break and Water Cooler Discussions 2
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
C Has an amended version of IEC 60601-1-6 TRF been released for use in conjunction with IEC62366-1:2015? Human Factors and Ergonomics in Engineering 0
planB ISO 10993-1:2018 has just been published Other Medical Device Related Standards 2
S ISO 13485 Consultant Question - The company has 5 part time employees ISO 13485:2016 - Medical Device Quality Management Systems 1
K Has anyone used QAI for training? Training - Internal, External, Online and Distance Learning 7
Q MHRA has released a new guidance document related to 'GXP' Data Integrity EU Medical Device Regulations 3
B FDA Philippines has no check or balance outside the health department Supplier Quality Assurance and other Supplier Issues 3
S Doubts about SPC taken in Machining - Part has +-0.01 Tolerance Statistical Analysis Tools, Techniques and SPC 5
D Has anyone here had any experience with PQ-FMEA software? FMEA and Control Plans 1

Similar threads

Top Bottom