Design Exclusion Text - Will an auditor buy this?

B

Bob_M

#1
Design Exclusion Text - Comments? Will the auditor buy this?

OK hopefully this will be my last design related post for awhile...

Based on a suggestion from Richard Olson, I'm going to TRY to exclude 7.3 Design for our Pre-Assessment (need to email documents by 7/28/03 at the LATEST), and re-include it only if we HAVE TO. (I'm also working on a basic design form to cover our :ca: just in case. :ko:

I'm looking for comments (good and bad), and I need opinions if this might work with our auditor (BSI).

OK this is what I'm putting into our manual.
(Additional comments about scope verbage also welcome).
---------------
1.0 Scope

This quality manual provides an outline of the ISO 9001 Quality Management System requirements. The manual also provides references to policies, procedures, processes and documentation that have been implemented to comply with the requirements of VDI, our customers, our products, and the ISO 9001 Quality Management System requirements.

VDI has excluded section 7.3 Design and Development from the applicable requirements of ISO 9001, due to the nature of the organization and its products. This exclusion does not affect VDI's ability to provide product that meets customer and applicable regulatory requirements.

The scope of VDI's Quality Management System covers:
The manufacture, assembly, and distribution of product for
Heavy-Duty Truck Axle and Brake Components and Kits and,
Vent Assemblies and Components for the Mobile/Modular Home Industry.
----------------------
7.3 Design and Development

This portion of the ISO 9001:2000 standard does not apply to VDI. VDI is not currently designing its own products. Therefore this portion has been excluded.

All current truck (and automotive) product designs are customer owned and controlled. Production Part Approval Process (P.P.A.P) submissions are made as required. Product approval and validation is the responsibility of our customers. New products are planned for and conformity is verified as required by customer directed and/or internal quality plans.

Vent assemblies and components distributed by VDI are based on older public designs that have been modified to meet our customer’s needs. New and revised designs for these product lines are directed by our customer requirements and inputs. Product approval and validation is the responsibility of our customers. New products are planned for and conformity is verified as required by customer directed and/or internal quality plans. Addition testing and final product certification is performed and obtained by our customers and is not the responsibility or VDI.

Production of additional new products and revisions to other miscellaneous products shall be directed and approved by our customers. Product introduction and process changes directed by our customers or required internally to meet customer and product requirement are managed within our Engineering Change Control procedure.

Supporting Documentation
QOP-04-02 Engineering Change Control – Procedure
QOP-04-02-A Engineering Change Control Matrix – Procedure Matrix
-----------------
 
Elsmar Forum Sponsor
D

David Hartman

#2
I was with you right up to the part where you started describing the controls for handling the above quoted portions of your process. This appears to be defining design activity.
 
B

Bob_M

#3
bob_m said:
Vent assemblies and components distributed by VDI are based on older public designs that have been modified to meet our customer’s needs. New and revised designs for these product lines are directed by our customer requirements and inputs. Product approval and validation is the responsibility of our customers. New products are planned for and conformity is verified as required by customer directed and/or internal quality plans. Addition testing and final product certification is performed and obtained by our customers and is not the responsibility or VDI.

Production of additional new products and revisions to other miscellaneous products shall be directed and approved by our customers. Product introduction and process changes directed by our customers or required internally to meet customer and product requirement are managed within our Engineering Change Control procedure.

Supporting Documentation
QOP-04-02 Engineering Change Control – Procedure
QOP-04-02-A Engineering Change Control Matrix – Procedure Matrix


ddhartma said:
I was with you right up to the part where you started describing the controls for handling the above quoted portions of your process. This appears to be defining design activity.
OK I agree the first re-quoted paragraph does not sound right for non-design... I'll see what I can come up with. We DON'T redesign the products, we just apply minor customer requirement to existing products. Example: Make OUR tube 2in longer than the stanadard. No design involved, create new part number, control plan, and inspection sheet as needed. Production - Cut blank 2in longer. Is that design?

Our Engineering Change Procedure technically pre-dates any ISO oriented QMS. This is how we internal track and notify people of changes and assign tasks. I'll attach our ECN matrix. Let me know what you think after that, keeping in mind our CUSTOMER's own and direct any "design" changes...
 
D

David Hartman

#4
Bob,

In a previous life I worked as a Quality Manager at a defense contractor to the DoD. We were provided with product requirements that were for either production of current products, production of products that were modifications of current products, or development and production of "new" products. In all cases we maintained our own drawings and assorted production documentation (assembly instructions, inspection and test instructions, etc.). Contracts for the production of products that were modifications of current product designs, required revision of current drawings with the assigment of new part numbers and verification that these revisions once made to the drawings agreed with what the customer had requested. Production documentation was then modified accordingly and the first pieces of product produced were validated to ensure that they met the customer's requirements.

Totally "new" products were handled in the same fashion (although all new drawings were created to reflect the customer's requirements).

BTW: The DoD always maintained that they were the sole owners of these designs and they had final approval on most revisions or design releases (in-fact they could have taken the drawings that we had developed and procured the products from another source at any point in time).

From your ECN matrix it appears that a similar process is currently being implemented at your company (drawings and production processes revised or developed as necessary). And it appears that for the most part your organization may be currently meeting at least most of the 7.3 requirements (you just need to develop an upper-level document that states what your doing, and include the design review/verfication/validation steps that you're probably already accomplishing in some fashion).
 
B

Bob_M

#5
OK we MAY be covering MOST of the 7.3 requirements in our ECN matrix. But based on your DoD past and our similar way of doing business are we really "Designing" them or are we just going thru the motions of product realization and planning, and JUST verifying that the finished part is dimensionally within the customer's drawing/requirements?

Maybe my definition of ISO Design is to narrow. I'm trying to make things simplier here, not continue to bog myself down with design review stages/paper work when all we need to do is make a part based on the CUSTOMERS DESIGN OR PRINT.

Am I confused or lost in the forest here?
 
M

M Greenaway

#6
If your customer says 'make me one of them, but two inches longer' that is the requirement of the order, and is a specification in itself. If you have to update a drawing to reflect this requirement it, in my opinion, comes under document control.

If however the requirement of the order is 'to make one of them long enough to fit XYZ' then you are into design, but only just.

If the order requirement is 'to make something that will do this, that and the other under these conditions for this length of time' then you are into real design.

A pure dimensional change to a clearly defined customer requirement isnt design, in my opinion. The customer has effectively designed and made an exact specification.
 
B

Bob_M

#7
M Greenaway said:
A If your customer says 'make me one of them, but two inches longer' that is the requirement of the order, and is a specification in itself. If you have to update a drawing to reflect this requirement it, in my opinion, comes under document control.

B If however the requirement of the order is 'to make one of them long enough to fit XYZ' then you are into design, but only just.

C If the order requirement is 'to make something that will do this, that and the other under these conditions for this length of time' then you are into real design.

D A pure dimensional change to a clearly defined customer requirement isnt design, in my opinion. The customer has effectively designed and made an exact specification.
OK I'll address this one comment at a time.

A - I agree. And IMO making an internal drawing does not need to be a function of design. (I can fall under product realization, work instruction, and general document control).

B - Just only I think is covered by our ECN procedure, and the INPUT and Validation is still our customer's responsibility.

C - I agree.

D - I agree, this also would fall under ECN and/or a new part number (original part is not unique to one customer).
----------------------
My main problem with INCLUDING design is un-necessary paperwork/records for something we've done ONCE in the 7+ years I've worked here.
--------
We were asked to take an existing Gas Vent Assembly (inner exhaust tube) Design and make something "similar" in overall shape,size,appearance but now it had to be a relatively low-leak exhaust and intake assembly. Input came from customers, I created sketches, prototype, prints, lots more prototypes, and customer VALIDATED product WITH the water heat but have CSA certify the entire product (water heater and OUR vent tubes).
This was a long project that could have been made easier with some "design" procedure on our end...
BUT...
We do not forsee making any such design for a long time.
(That customer was bought out, and we're merely a tiny supplier now).
--------------
WE don't and WON'T design products for the Truck industry so no design there, just submitting PPAP...

SO if we DON'T plan or forsee the need to FULLY design a product, why would we want to be audited to part of the standard, we may never have records for???
 
J

Jimmy Olson

#8
The key thing to remember in all of this is who is responsible for the design. Even if you have input or make suggestions to the design, if the customer has final aproval and responsibility, then you can exlude design from your scope.

We do several things here that are design related, but we still exclude all of 7.3.
 
D

David Hartman

#9
Richard Olson said:
The key thing to remember in all of this is who is responsible for the design. Even if you have input or make suggestions to the design, if the customer has final aproval and responsibility, then you can exlude design from your scope.

We do several things here that are design related, but we still exclude all of 7.3.
Be careful when making general comments like this. I have worked for several defense and NASA contractors where the customer was the ultimate approval and owner on all drawings, but the contractor was responsible for the R&D efforts (with requirements for compliance with the ISO 9001 clauses for design control).

Many times the contractor would present to a government agency a new product NOT even thought of by anyone within that agency, with the intent of selling them on the advantages and necessity of procuring said product - the contractor's original design, but utimately the drawings/design would be "owned" by the government). Once the government agency "procured" said design, authority for approval of revisions and release of "new" drawings for that product were the responsiblity of the government agency.
 
J

Jimmy Olson

#10
ddhartma said:
Be careful when making general comments like this. I have worked for several defense and NASA contractors where the customer was the ultimate approval and owner on all drawings, but the contractor was responsible for the R&D efforts (with requirements for compliance with the ISO 9001 clauses for design control).

Many times the contractor would present to a government agency a new product NOT even thought of by anyone within that agency, with the intent of selling them on the advantages and necessity of procuring said product - the contractor's original design, but utimately the drawings/design would be "owned" by the government). Once the government agency "procured" said design, authority for approval of revisions and release of "new" drawings for that product were the responsiblity of the government agency.
The difference here is what you are being asked to do. If a contractor is asked to do the design, then yes, the contractor is design responsible. If the contractor is provided the design and told to build to the design, then the contractor is not responsible.
 
Thread starter Similar threads Forum Replies Date
B Exclusion of Design - Problem if we were to design? & Sample exclusion Text Design and Development of Products and Processes 18
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 5
K Design and Development Exclusion Quality Management System (QMS) Manuals 1
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
P Design exclusion in AS9100D for commercial products AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
P Design and Development Clause ISO 9001:2015 Exclusion for Medical Services Design and Development of Products and Processes 3
H IATF 16949 Cl. 8.3 - Design and Development Exclusion Question IATF 16949 - Automotive Quality Systems Standard 4
4 Adding a new Company - ISO 9001 Design Exclusion Design and Development of Products and Processes 1
D IATF 16949 Design Exclusion Clauses which can be N/A IATF 16949 - Automotive Quality Systems Standard 7
I ISO 9001 Scope - Exclusion of Design in an engineered solutions company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
B AS9100 - Exclusion for 7.3 Design and Developement as we do not design AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Design and Development Procedure with Design Exclusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Can Design & Dev (7.3) Be An Exclusion For A Facilities-based Service Company? Service Industry Specific Topics 7
M TS16949 Design Exclusion when Design is done in a different Facility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P ISO9001 Scope Exclusion Verification in a Design Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J Justification for Exclusion of Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 8
A We do not design anything brand new from scratch - Design Exclusion? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D Consultancy company - ISO 9001 Implementation and Design Exclusion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
somashekar Exclusion of Design and Development Controls for Class 2B Medical Devices EU Medical Device Regulations 8
Y Clarification on ISO 9001 - Exclusion of Design and Development, Clause 7.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A ISO 9001 Clauses 7.5.1 and 7.5.2 - Exclusion for Design Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Service Provider in NC Programing and Design - Exclusion clause in AS 9100 Rev C Quality Manager and Management Related Issues 5
B ISO 13485 Class I Medical Device Design Exclusion ISO 13485:2016 - Medical Device Quality Management Systems 10
B Design and Development Exclusion - ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J ISO 13485 Requirements - Design Exclusion - Predicate Products Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 8
Q Exclusion of clause 7 design sub clauses? Service Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Design and Development, Support parts - Clause 7.3 Exclusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Design Validation - Justifiable Exclusion for an Electrical Engineering Consultancy Design and Development of Products and Processes 11
A Can this be a case for Design and Development Exclusion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 64
D Do we need to include ISO 9001 Clause 7.3? Design and Development Exclusion Design and Development of Products and Processes 8
S Design Exclusion - Drawings with Material Specifications from Outside Source AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 38
quality1 Sister Company makes Cables & Wires - Design & Development Exclusion Design and Development of Products and Processes 1
R Design and Development exclusion? We repair and refurbish electric motors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Design & Development in Food and Beverage Services - Permissible exclusion or not? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Casana Exclusion of 8.3 for Design only scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J TS 16949 - Design Exemption - Seeking a procedure/exclusion verbiage IATF 16949 - Automotive Quality Systems Standard 3
N Design: To claim exemption, or not to claim exemption (exclusion) Design and Development of Products and Processes 23
H Exclusion of Design and Development Requirements (7.3 & sub-clauses) in TS16949? Design and Development of Products and Processes 9
A Exclusion of Purchasing Process - Consumer Electronics Product Design House Design and Development of Products and Processes 1
J Design Exclusion for AS9100B and not ISO 9001 - 7.3 Design conflicts Design and Development of Products and Processes 16
M Exclusion of Design and Development - Construction and Renovation of Premises Design and Development of Products and Processes 11
Q Exclusion of Design and Development Controls - ISO 13485 Section 1.2 Design and Development of Products and Processes 6
D Company doesn?t design product - Exclusion of clause 7.3 Design and Development of Products and Processes 14
S EN AS 9100 Permissible Exclusion and Provision - Aerospace design and development Design and Development of Products and Processes 4
C ISO 9001:2000 clause 7.3 Design & Development Exclusion - Collagen casing for sausage Design and Development of Products and Processes 19
I Design & Development - Exclusion of 7.3 - We Manufacture to Customer Prints Design and Development of Products and Processes 14
K Design & Development - Exclusion of Clause 7.3.6 - Design and Development Validation Design and Development of Products and Processes 6
T TS 16949 Clause 6.2.2.1 - Product Design Skills Exclusion Design and Development of Products and Processes 1
L Scope and Exclusion of 7.3 - No Product Design - 7.3.1.1 Multidisciplinary Approach Design and Development of Products and Processes 3

Similar threads

Top Bottom