Design and Development Validation at the Customer's Location

M

Mario Alberto83

#1
Good afternoon

I would like to have you input for the following scenario.

We are a small mechanical design company and our procedures have controls for validating design outputs with customer engineering department or designee.

The stuff we design is actually sent to our customer?s customer directly.
I would like to know if there is any problem if we do not validate the design with our customer, but directly with the end customer due to they know exactly what they want.

Based on the note saying that we have to validate design with customer engineering department or designee, I would think in those cases, that designee is the end customer.

As we are about to gather records for the certification process, I would like to know if this situation would become a gap during the certification audit, I do not see any restriction in the standard to proceed per my assumption.

Thank you in advance
 
Elsmar Forum Sponsor

Big Jim

Super Moderator
#2
I do not see any restriction in the standard to proceed per my assumption.

Thank you in advance
Neither do I. The one thing I can see to be careful of is to make sure there are no holes in your customer designating their customer to work with you on design validation.

Another option would be to reword your procedure so that no mention of who helps you with validation is made or perhaps to more fully explain potential designees.
 
M

Mario Alberto83

#3
Hello Big Jim

I guess I will take your advice on full explanation for designees as a reference information so it is clearer during tasks performance.

Thank you and regards
 

somashekar

Staff member
Super Moderator
#4
I would like to know if there is any problem if we do not validate the design with our customer, but directly with the end customer due to they know exactly what they want.
The requirement is design and development validation.
Where and how and who does it is a matter of a plan. Please put it in the design and development planning, that gets approved and then you are just fine ...
 

Mikishots

Trusted Information Resource
#5
Good afternoon

I would like to have you input for the following scenario.

We are a small mechanical design company and our procedures have controls for validating design outputs with customer engineering department or designee.

The stuff we design is actually sent to our customer?s customer directly.
I would like to know if there is any problem if we do not validate the design with our customer, but directly with the end customer due to they know exactly what they want.

Based on the note saying that we have to validate design with customer engineering department or designee, I would think in those cases, that designee is the end customer.

As we are about to gather records for the certification process, I would like to know if this situation would become a gap during the certification audit, I do not see any restriction in the standard to proceed per my assumption.

Thank you in advance
There doesn't appear to be a restriction in the standard, but is your direct customer (the middleman, if you will) OK with this arrangement? I'm putting myself in their shoes; I would not be particularly comfortable with my vendor dealing directly with my customer, when I'm the one that is responsible for verifying that the product meets the requirements of what I ordered; I'm left completely out of the loop.
 
Last edited:
M

Mario Alberto83

#6
...is your direct customer (the middleman, if you will) OK with this arrangement? I'm putting myself in their shoes; I would not be particularly comfortable with my vendor dealing directly with my customer, when I'm the one that is responsible for verifying that the product meets the requirements of what I ordered; I'm left completely out of the loop.
I would agree with you in some sense Miki, but it depends on the service/product provided, I would not be comfortable either if we were dealing with manufactured products (engineering already defined); however in this case, we are dealing with engineering definition (starting from concepts or ideas that could easily be wronged due to intervention of middlemen).

My direct customer initially took part of this validation, however it was a mess because my company has competent and knowledgeable personnel for dealing with engineering requirements and activities, while my customer does not.

Then, when our designs were approved by our direct customer, the end customer rejected; that?s why the communication channel was widen to end customer participation in the validation points.

Regards
 
Thread starter Similar threads Forum Replies Date
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
J Where does process validation fit within design & development? Design and Development of Products and Processes 7
M Design and Development Outputs Approval, Verification and Validation IATF 16949 - Automotive Quality Systems Standard 4
S Design and Development - Review vs. Verification vs. Validation Design and Development of Products and Processes 15
Randy Clause 7.3 Design and Development - Verification and Validation Design and Development of Products and Processes 3
eternal_atlas Design and Development - Verification & Validation (Cl 7.3.5 & 7.3.6) Design and Development of Products and Processes 1
C Design & Development Validation - I need know the meaning Design and Development of Products and Processes 6
H Design and Development Review 7.3.4 - Planned intervals for outputs and validation Design and Development of Products and Processes 3
K Design & Development - Exclusion of Clause 7.3.6 - Design and Development Validation Design and Development of Products and Processes 6
D 7.3.6 Design and Development Validation Design and Development of Products and Processes 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
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
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 5
L Design & Development of a SERVICE Service Industry Specific Topics 13
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
M Design Development MDR Design and Development of Products and Processes 0
O How can I justify excluding the R&D group and the design and development clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 5
A Design and development of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S ISO 9001 Clause 8.3 - Design & Development for training course center ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S ISO 9001:2015 & ISO 14001:2015 - I need a format for Design & Development planning ISO 14001:2015 Specific Discussions 2
AlienraverX Design and Development Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
V Who should define and own the Design and Development Plan and how to maintain the updates and revisions. ISO 13485:2016 - Medical Device Quality Management Systems 2
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
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
S Waterfall model or v-model design and development ISO 13485:2016 - Medical Device Quality Management Systems 2
JoshuaFroud Design and Development of Software under 13485:2016 or 62304? ISO 13485:2016 - Medical Device Quality Management Systems 6
M IATF Clause 8.3 - Design and Development IATF 16949 - Automotive Quality Systems Standard 5
K Design and Development Exemption/NA confusion Design and Development of Products and Processes 6
C AS9100 8.3.5.e Design and Development Outputs - Key Characteristics / Critical Items AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
L Software Medical Device - 7.3.8 - Design and Development Transfer ISO 13485:2016 - Medical Device Quality Management Systems 4
S Purchasing for Design and Development Organization ISO 13485:2016 - Medical Device Quality Management Systems 3
qualprod Development separated from design? ISO 9001 cl. 8.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Design and development of user centric audit report visualisation tool Design and Development of Products and Processes 5
D IATF 16949 Design and Development Planning IATF 16949 - Automotive Quality Systems Standard 1
M IATF 16949 Cl. 8.3 - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 1
P Design and Development Clause ISO 9001:2015 Exclusion for Medical Services Design and Development of Products and Processes 3
A ISO 13485:2016 Certification for Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 0
H IATF 16949 Cl. 8.3 - Design and Development Exclusion Question IATF 16949 - Automotive Quality Systems Standard 4
R Development of Design FMEA - Functional Requirements FMEA and Control Plans 1
G ISO 9001:2015 8.3 Design and Development (in Civil Engineering) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M AS9100D excluding Design and Development - Small Job Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
Moumen H API Spec Q2 Design and Development Requirements for Service Providers Oil and Gas Industry Standards and Regulations 11
T Design Changes - Updating the Design and Development File EU Medical Device Regulations 5
Y ISO 9001 Cl. 8.3 - Design and Development of Products and Services not applicable ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J ISO 9001:2015 8.3.2 f) - Interfaces between Persons in Design & Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom