SBS - The best value in QMS software

What are the Design Factors in APQP?

jelly1921

Quite Involved in Discussions
#1
In introduction of Chaper 2 of APQP, it says: All design factors should be considered by the organization in APQP even if the design is owned by the custormer or shared.

What is it? and how to "consider" the design factors? Is it conflicted with requirements of ISO/TS 16949 the exclusion of product design and development if the organization has no responsible for the product design ?

Thanks!

Jelly
 
Last edited:
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#3
In introduction of Chaper 2 of APQP, it says: All design factors should be considered by the organization in APQP even if the design is owned by the custormer or shared.

What is it? and how to "consider" the design factors? Is it conflicted with requirements of ISO/TS 16949 the exclusion of product design and development if the organization has no responsible for the product design ?

Thanks!

Jelly
Jelly,

Being as you are not responsible for product design you may think you have no input to product design.

But product designers are concerned about the ease of manufacture of the item (perhaps in a design for six sigma sense). Perhaps the designer is asking your organization to input its expertise on how the product design could be improved.

So, at what point do you plan to review the product's design information and provide that input?

John
 

jelly1921

Quite Involved in Discussions
#4
I found text in APQP which could explain the question:
Appendix B Design for manufacturability and assembly: Esign for Manufacturability and Assembly is a simultaneous engineering process designed to optimize the relationship between design function, manufacturability, and ease of assembly. The enhancement of designs for assembly and manufacturing is an important step. Plant representatives should be consulted early in the design process to review components or systems and provide input on specific assembly and manufacturing requirements.
Here Plant could be considered as supplier, I think.
 
Thread starter Similar threads Forum Replies Date
J Selecting factors for screening DoE design Statistical Analysis Tools, Techniques and SPC 8
J DoE (Design of Experiments) - Multiple responses with different factors Using Minitab Software 2
H Minitab 15 - Factorial Design - 3 factors: 4x3x2 - How to? Using Minitab Software 4
A How do I create a 3^k factorial design with factors be treated as continuous where I Using Minitab Software 0
S Taguchi Design with ANOVA - 3 factors each with 3 levels Quality Assurance and Compliance Software Tools and Solutions 13
Y Taguchi Design with 6 levels and 3 factors in Minitab Using Minitab Software 11
R Taguchi design for 3 level 4 factors Using Minitab Software 12
V Selection of Design - 8 Factors, almost sure about Target Levels Using Minitab Software 8
E 5^2 DOE (Design of Experiments) with 3 Replications, 5 Levels 2 Factors Statistical Analysis Tools, Techniques and SPC 6
D Resolution V Factorial Design with 5 factors (3 numerical and two text) Using Minitab Software 1
S New Draft FDA Guidance - Human Factors & Usability Engineering for Med Device Design US Food and Drug Administration (FDA) 0
J DOE (Design of Experiments) Dependent Factors Using Minitab Software 1
C DOE (Design of Experiments) with 'Uncontrollable' Factors Using Minitab Software 5
R Taguchi Design - Degree of freedom for l27 in 4 factors 3 level (Minitab) Using Minitab Software 15
D Design of Experiments (5 factors with 3 levels) - How to proceed with Minitab? Using Minitab Software 41
D Full factorial design, 4 factors, each has its own # of levels. Using Minitab Software 6
M DOE (Design of Experiments) with 3 factors with levels of 3,3 and 5 Quality Tools, Improvement and Analysis 3
A What factors must be considered during gauge design?what are VG points ? Design and Development of Products and Processes 1
S Multilevel Design in Minitab to conduct a DOE - 4 factors and each has 5 levels Design and Development of Products and Processes 4
Tim Folkerts DOE: Choosing a Design - Factors that affect the choice of design The Reading Room 0
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 4
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

Similar threads

Top Bottom