Design & Development Validation - I need know the meaning

C

Carlos Soler

#1
I need know de meaning of Design & Development validation in the ISO/TS
16949. I work in a company that make piston pins


Please , some example
 
Elsmar Forum Sponsor
#2
design and development validation is different from design and development verification.

In layman terms, the verification is more like confirming the input meets the outputs, or in other words, whatever you have planned to design / develop, you are able to do it.

meanwhile, validation is a task / function whereby you run a series of tests to the product which you have designed to see if the product meet its intended functions, i.e. functionality tests, etc
 
S

Sonjia

#4
Thanks Howard!
There was an interesting statement made in one of the links. Someone had inserted a statement into their documentation stating: "design validation is the responsibility of the customer".
I almost got excited because I have been wrestling with this a bit, however... In TS 7.3.6 NOTE 2 says "The requirements of 7.3.5 and 7.3.6 above apply to product and manufacturing processes."
We manufacture stamped parts for our customers. No assemblies. Just single component parts. No product design.
So, I know I cannot validate the product. But TS still requires me to validate my processes, correct?
So, would the verification of my process outputs such as the product meeting internal and/or customer requirements, and the performance of my processes meeting my requirements from the planning stages, satisfy my process validation?
Thanks,
Sonjia
 
D

D.Scott

#5
It sounds to me like you are right on track Sonjia. Be sure you document your validation.

Dave
 

Howard Atkins

Forum Administrator
Staff member
Admin
#6
Sonjia said:
So, I know I cannot validate the product. But TS still requires me to validate my processes, correct?
So, would the verification of my process outputs such as the product meeting internal and/or customer requirements, and the performance of my processes meeting my requirements from the planning stages, satisfy my process validation?
Thanks,
Sonjia
In fact PPAP is the validation of the process
 
#7
Validation = Beta Testing

In addition to our own physical testing, our validation includes a production pilot run (to validate the process) BEFORE product is released. The parts produced in the production pilot are sent to customers for actual installation in vehicles. In TS parlance this would be your PPAP run.

We call these BETA units. The ALPHA units are the Engineering Prototypes used for VERIFICATION. Verification can also include CAD simulations, calculations, etc. VALIDATION is done with real world parts.
-ICY
 
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 Validation at the Customer's Location Document Control Systems, Procedures, Forms and Templates 5
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
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 6
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