Design Responsible - Determining if Organization is Design Responsible

Sidney Vianna

Post Responsibly
Staff member
Admin
#11
Our organization is thinking there is no benefit to having design responsibility in the scope of our registration as it adds cost (audit days) and opens up more 'shalls' that we need to comply with.
It is not a matter of deciding whether you could simply remove the design aspect from your scope of certification. For TS, you either have product-design responsibility or you don't. It is an attribute. If you have design responsibility for the automotive products, then design must be a part of your QMS and the system audited against 7.3.

Now, if you are unsure if the automotive products you manufacture are done under your design or the customer's design, in other words, if there is uncertainty of whom is designing the product, there is a fundamental flaw in the business relationship. And, in the unlikely event of a product failure, leading to injuries or worse, and the ensuing legal actions, that uncertainty would be a mine field for your defense lawyers.
 
Elsmar Forum Sponsor

pondo

Registered Visitor
#12
Hi All,
This is my first posting so please bear with me :)

We have our TS re-registration coming up in early 2008 and are considering excluding design responsibility in our scope. I have been asked what the definition of "Design Responsibility" is to see if in fact we are responsible, by definition (ie. ISO definition). We offer full R&D and CAE capability if our customers need assistance, our customers always perform final validation.

Can anyone help me with an official definition? I have looked on IATF/IAOB websites and was unable to find a definition.

Thanks!
No definition but you are NOT design responsible.
 

Stijloor

Staff member
Super Moderator
#13
I have talked to our registrar and they pointed me to IATF/IAOB, which turned out nothing so far.
Hello CE2JD2,

You may want to take this issue up with your Registar/CB. They should be able to verify whether you are design responsible or not. Referring you to IATF/IAOB seems like an easy way out for them....

Based on what you described, you are not design responsible. Having said this, why was this issue not addressed during your initial certification audit?

Stijloor.
 
C

CE2JD2

#14
Hi All,
This question has had great responses and I appreciate everyone helping. Here is what I have learned since the original post:

What can be excluded if we are not Design Responsible:
- Anything related to “product design” can be excluded. Anything related to “process design” cannot be excluded (as Duke mentioned).
- therefore, 7.3.2.1 and 7.3.3.1 are the only two clauses that can be excluded.
- so as you can see most of 7.3 still applies, as "Manufacturing Process Design and Development"
- even if an organization is registered with 7.3 as an exclusion, then you get one contract as Design Responsible, the organization needs to re-register with all of 7.3 included asap.

Design Responsible Clarification:
There are only 2 options regarding “design responsible”.
(1) The client or supplier is responsible to design and manufacture the widget for a customer.
(2) The customer retains responsibility for the design and only contracts the supplier to manufacture the widget.

So, currently we do have one contract as design responsible, with one customer, so by default that means the scope of our registration needs to include all of 7.3. In other words 99% of our business is awarded as customer is DR, 1% is we are DR.

As Sidney mentions this is a go/no-go (or attribute) decision; and...we are DR. I have since talked with our registrar and they have helped clear all of this up for us too.

Initially, we had lots of DR work with our customers/OEM's and included 7.3 in our scope (before my time in this role) but since 2004 our business has changed drastically as has the entire North American automotive market. We were thinking there would be an advantage to exclude 7.3 "Product Design and Development" but now, based on all of this information, it seems like too much of a hassle to exclude being you only need one job as DR and you need to re-register again....a waste of everyone's time and money.

Thanks again all, I appreciate your great feedback.:applause:

Dave:agree1:
 

Helmut Jilling

Auditor / Consultant
#15
...What can be excluded if we are not Design Responsible:
- Anything related to “product design” can be excluded. Anything related to “process design” cannot be excluded (as Duke mentioned).
- therefore, 7.3.2.1 and 7.3.3.1 are the only two clauses that can be excluded.
- so as you can see most of 7.3 still applies, as "Manufacturing Process Design and Development"

You have done a very good job of summarizing, better than some of the posters who tried to help.

I did want to clarify one point -

therefore, 7.3.2.1 and 7.3.3.1 are the only two clauses that can be excluded.

In ISO 9001, the process and product design are so interwoven throughout 7.3, we generally don't attempt to exclude clauses. In your case, you were trying to exclude the process "Product Design." So, you wouldn't have excluded those two subclauses, you would have excluded product design form the whole clause 7.3.

But, if you have "some" Product design responsibility, then you have all of 7.3. But, you will only apply the product design requirements in those limited circumstances where you are doing product design.
 
C

CE2JD2

#16
Good Morning Helmut,

I think this still needs to be worked out with our 3rd party as to how we are going to handle (identify etc...). They have suggested what you mention but I am still not 100% clear on how we are going to segregate the DR vs. NDR programs, and further, how we are going to audit internally.

I will follow up in a few weeks once I have more information again.

Thanks for all of your help,
Dave
 
Thread starter Similar threads Forum Replies Date
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
C Advice on becoming a AS9100 Auditor - Need to audit organizations that are Design Responsible AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
J Not Design Responsible - Can we exclude all or parts of AS9100 clause 8.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M Design & Development - Only 1 Engineer - Who is responsible for Approval? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Definition Design Responsible - Good Definition in the context of AS 9100 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
A Design History File Maintenance - Who is responsible for the Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Configuration Management requirements if this facility is not design responsible AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
A Is a Distributor responsible for Design History Files 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
J Scope of Registration ? Design Responsible ? Outsource Design??? IATF 16949 - Automotive Quality Systems Standard 2
M IMDS Submissions for multiple parts requested, but not Design Responsible IATF 16949 - Automotive Quality Systems Standard 13
M Design Improvement, but not OEM or Design Responsible Design and Development of Products and Processes 6
D Quality Plan - Necessary for any Order? Mature Processes & Not Design Responsible Design and Development of Products and Processes 6
Z Suppliers: "Design Responsible", "Manufacturing" and "Service Suppliers" Design and Development of Products and Processes 5
T Design responsible? Tier 2 / 3 manufacturer of steel products - TS 16949 Design and Development of Products and Processes 6
S Seeking Internal Audit Plan - Design Responsible Manufacturing company Design and Development of Products and Processes 3
J More Design Questions - Parent Company Design Responsible Design and Development of Products and Processes 6
B TS 16949 for R&D Design Centre - What part are we responsible for? Design and Development of Products and Processes 3
T Not responsible for product design - Exactly which parts of 7.3 do not apply? Design and Development of Products and Processes 3
B My company makes product to order - Are we design responsible? Exclude 7.3? Design and Development of Products and Processes 17
R Design Responsible Design and Development of Products and Processes 2
B DESIGN RESPONSIBLE? Design and Development of Products and Processes 3
M Design Responsible? Design and Development of Products and Processes 5
DuncanGibbons Section 8.3 relevant for design organisations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
J Significant change related to design and intended use EU Medical Device Regulations 3
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
U NOC - What is considered a "design change" EU Medical Device Regulations 5
Q PPT used as Design Review ISO 13485:2016 - Medical Device Quality Management Systems 3
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 9
R DFA & DFM - Examples for Design for assembly and design for manufacturability Lean in Manufacturing and Service Industries 2
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
W Need for current design or process control FMEA and Control Plans 2
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3

Similar threads

Top Bottom