Is Prototyping Design Output or Design Verification?

Manix

Get Involved!!!
Trusted Information Resource
#11
Is the prototype not an output of the initial design process and an input into the validation process? IMO this is where Quality Management Systems tend to let us all down. We become consumed by the semantics and don't focus on the real issue of what value is added, regardless of what it is called.

I like the security and sense of "order" as much as anyone, but how much time do we spend trying to structure and pigeon hole certain aspects of what we do.

That said, please don't think I don't see this as a valuable question, we all need clarification, my opinion is that if your system effectively translates the requirements of whatever customer you have (internal or external), via your design process, your designs are validated against these requirements and the process is deemed effective and efficient to your organisation, then you can call the prototype whatever you like!
 
Elsmar Forum Sponsor

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#12
Dyeysi,

I’d like to present my viewpoint by combining a few of the thoughts already posted here. I’ll start with Mark’s comments regarding FDA’s view. FDA does not make a clear distinction between what are design requirements and design specification, especially in the realm of software. Essentially, they view Design Specifications as final design inputs. So, in this instance, the Product Specification is a Design Input deliverable, not a Design Output. It is true that other industries view it differently as do some other standards bodies.

Paul and Yodon make good points in that regardless of what we are telling you – what does your design model look like? In ours we have a process we call engineering test, which is where a design engineer does ‘sniff testing’. This is not considered formal design verification as the design is in a fluid state but essential to the development process. When an engineer is dialed in, at least to a rather solid state, he/she will develop design verification and validation test protocols to verify the design requirements and validate the user needs.

From what you describe in your latter post, the data you are collecting will be used for design verification and validation. From that perspective, your prototype should be coming from a latter stage in you design model. Perhaps first and second run prototypes are used for engineering test and third prototypes are used for most of your design verification and validation activities. Take a look at your model and confirm the point of development you are in and decide.

Regards,

Kevin
 

al40

Quite Involved in Discussions
#13
Is the prototype not an output of the initial design process and an input into the validation process? IMO this is where Quality Management Systems tend to let us all down. We become consumed by the semantics and don't focus on the real issue of what value is added, regardless of what it is called.

I like the security and sense of "order" as much as anyone, but how much time do we spend trying to structure and pigeon hole certain aspects of what we do.

That said, please don't think I don't see this as a valuable question, we all need clarification, my opinion is that if your system effectively translates the requirements of whatever customer you have (internal or external), via your design process, your designs are validated against these requirements and the process is deemed effective and efficient to your organisation, then you can call the prototype whatever you like!

Good call,

We have written a procedure specificaly calling out what a prototype is and how it should be handeled i.e. if it's used for marketing then we don't go through steps ABC, but if it may be used to validate a design aspect we go through steps ABC. Again you want to add value in everything you do so we decided that the procedure would serve this process it has also helped new engineers adapt moe qucikly in R&D.

Best regards,

al40
 
Thread starter Similar threads Forum Replies Date
J Design Control & Rapid Prototyping - Medical Device Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Do suppliers of prototyping components need to undergo supplier qualification? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Remote Support Location Audit - Engineering prototyping and process evaluation Internal Auditing 2
S Supplier Quality with Prototyping Parts with no Part Number or Drawings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Product Development and Prototyping Company - Nonconforming material or not? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
F ISO 9001 implementation at a prototyping shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
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 5
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
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
L Design & Development of a SERVICE Service Industry Specific Topics 13
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A AS9102B - 3.6 Design Characteristics and form 3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Design FMEA - Detection Rating criteria ISO 14971 - Medical Device Risk Management 3
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
T Design Input detail & specificity ISO 13485:2016 - Medical Device Quality Management Systems 4
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
D Design Transfer Template capturing Customer Specific Requirements Other Medical Device Related Standards 3
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom