My company makes product to order - Are we design responsible? Exclude 7.3?

B

Brian B

#1
#1
I have a question of whether I can exclude 7.3. My company makes product to order.

Customers send me 2 types of drawings: TypeI dwgs are very specific, give exact dimensions. I specify suitable materials, I determine the appropriate mfg. processes etc.

Type II dwgs from my customers provide overall dimensions. Our engineering dept. calculates internal part size, specifies suitable materials and determines appropriate mfg methods.

My question is: Do we design our product, or not?
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
D

Dan Larsen

#2
#2
If you were simply making to print I'd say not. But you mention that you "specify suitable materials". From a metallurgical point of view, materials selection is generally part of the design process. Just one opinion.
 
A

Al Dyer

#3
#3
Your use of the word "specify" leads me to think that you are design responsible.

What do your customers think?

ASD...

[This message has been edited by Al Dyer (edited 17 April 2001).]
 
N

newbie

#4
#4
Quote :
'Type II dwgs from my customers provide overall dimensions. Our engineering dept. calculates internal part size, specifies suitable materials and determines appropriate mfg methods.'

Keywords :calculate / specifies.

It's like your customer said : I want a box for shipping easter eggs - he gives you the overall dimensions, but it does not specify how to and from which type of material you must manuf. that box - so it seems like design.
 
D

db

#5
#5
Design exclusions

This is an old thread, but there is some new information from one of my registrar contacts (NSF)

Accreditation bodies are scrutinizing registrations with exclusions. The most common exclusion is 7.3 Design and Development. A widespread practice for organizations was to exclude design when the company provided a service or had not designed a product for a long period of time. These are no longer permissible exclusions and the auditor must verify the justification during site visit…

In the pas, it was acceptable to simply state “no design activities” in your quality manual. The guideline [4.2.2 Quality manual] requires registered clients to provide an explanation of the exclusion. ISO/TC 176 has issued several documents to help organizations determine if their justification and documentation is appropriate. The documents are available on the web at http://www.iso.ch/iso/en/ISOOnline.frontpage
Click to expand...
Just thought you would like to know.
 
A

Anton Ovsianko

#6
#6
Re: Design? Yes and NO

Brian,

Brian B said:

... TypeI dwgs are very specific, give exact dimensions. I specify suitable materials, I determine the appropriate mfg. processes etc.

Type II dwgs from my customers provide overall dimensions. Our engineering dept. calculates internal part size, specifies suitable materials and determines appropriate mfg methods.

My question is: Do we design our product, or not?
Click to expand...
Type I: customers provide you with design out output, you can use as one of inputs to manufacture beside materials, equipment etc. (If we consider design as a process previous to manufacture)

Type II: customers provide you with design input, you can use together with other inputs like engineering skills and knowledge, CAD, PC's etc. to design and develop products (read to produce design output, you shall be able to use as one of the inputs of manufacture... and so on.

That is with type II drawings you definitely are responsible for design.

IMHO,

regards,

Anton
:smokin:
 
M

msrazak

#8
#8
hi there i am new here and i am also making an effort to REALLY understand the requirements after reading the standard a couple of times.

anyway, in my opinion i think if you just produce direct from your customer request than there's no design involved, but if there is some input form you into the customer request than that would surely involve design.

and the next question here is up to what extend? this is where you explain how deep are you involved in the deisgn activities of the product.

comments from anyone on the above are most welcomed.
 
Q

QHSE

#9
#9
In my opinion there are very few companies who can say that they don't (according 7.3) design.
"Design" is very broad scope and covers a multitude of activities performed in the workplace.

John
 
D

db

#10
#10
:bigwave: Welcome to the Cove msrazak and John! Reading the information from the registrar, I think you are both pretty close. It will be much harder to exclude design than previously. I think one of the keys will be whether the organization is involved with the different aspects of design (planning, design input/output, review, verification, validation and the organization's input in changes. I think there will be a significant number of companies that are not going to be happy.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Medical Device Regulations in South Africa - Company makes thousands of Products Other Medical Device Regulations World-Wide 1
Q Sister Company makes Cables & Wires - Design & Development Exclusion Design and Development of Products and Processes 1
QMMike Looking for a company that makes check fixtures (N.E. Ohio area) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
H Exempt from FDA Registration or not? Company that makes parts for medical devices ISO 13485:2016 - Medical Device Quality Management Systems 11
Marc Company Makes Hiring Mistake, Sues Employee To Get Money Back Career and Occupation Discussions 11
R Can PLM be in the OEM position for another company? EU Medical Device Regulations 1
L Acquiring software from 3rd party company IEC 62304 - Medical Device Software Life Cycle Processes 8
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 3
H Starting my own 3rd party inspection company Service Industry Specific Topics 6
Kevin_Hall Becoming a successful manager of a spacecraft company Human Factors and Ergonomics in Engineering 11
Ed Panek Which choice of the following most closely matches the MDR compliance of your company? EU Medical Device Regulations 0
J How many majors is one company allowed ? IATF16949 Manufacturing and Related Processes 16
A Outsourcing registration to a local company China Medical Device Regulations 0
D Technical Standard aggregator company suggestions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Transferring a calibrated counting scale to a sister company Calibration Frequency (Interval) 2
A Quality's Authority - Company Moving In ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
J Validity of CE mark on distributed product when company ceases trading EU Medical Device Regulations 3
M Must a company be 17025 accredited to perform internal calibrations? ISO 17025 related Discussions 7
S Business Number versus Company ID? Canada Medical Device Regulations 3
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A AS9100D - Clause 8.1 Operation - Coating service company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
L Have been purchased by a corporate company ISO 13485:2016 - Medical Device Quality Management Systems 7
R Advice needed: Shall I report my not complying company to NB / competent Authority (Europe) EU Medical Device Regulations 6
lanley liao What shoud i do if our company top management has been changed. Oil and Gas Industry Standards and Regulations 8
S Malcolm Baldrige Company Dashboard Quality Tools, Improvement and Analysis 3
T IATF Rules for sharing production space with another company IATF 16949 - Automotive Quality Systems Standard 10
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
R MDEL and company affiliate Canada Medical Device Regulations 5
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
M QMS for a repair/servicing company ISO 13485:2016 - Medical Device Quality Management Systems 2
C Internal Audits in a tiny Dx Company Internal Auditing 33
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
F Quality manual for trading company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Implementing the PRRC role in a company EU Medical Device Regulations 8
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 17
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom