Design for Six Sigma / Robust Design

B

BRoyal

#1
Here's a definition I scribbled down from a Harry Mikel column in ASQ's Quality Progress magazine, August 2000.

"Designing for Six Sigma - focused on abating the various forms fo risk attributable to the design of a product, system or process, regardless of its nature.

"First, it is concerned with reducing the extent of risk exposure inherent to the funcational performance and physical attributes of a design (customer satisfaction).

"Second, it is concerned with reducing the risks associated with the business and operational viability of a design (provider satisfaction issue).

"The goal is to exercise the Breakthrough Strategy to such an extent that each critical value risk point associated with the functional properties and process-ability of a design is limiteds to no more than 3.4 risk exposures per million opportunities for such risk."

Ben
 
Elsmar Forum Sponsor
K

Ken K.

#2
I was wondering if you could help me understand specifically is meant by Design for Six Sigma. What topics/techniques are usually covered in the training?

Also, any help in identifying sources of Robust Design/DFSS related information would be greatly appreciated.

Does anyone know of on-line or CD-ROM based training in this area?
 
G

GaryC

#3
Ben,

Go ask Mikel how many products he has seen that meet this definition. If you get an honest answer it will be zero.

That good ole boy cowboy is master of confusion and intimidation. Does that definition actually explain something to you?
 
K

Ken K.

#4
Gary,

That was the opinion I quickly formed after a meeting with him over 10 years ago - a meeting that you helped arrange (thanks again).

My intent was to meet wtih him for some specific business-related assisatance, but instead he let go with a lecture about lack of stability in data, chaos theory, and how worthless statistics is.

From what I hear not much as changed.

Ken K.
 
B

Benjamin

#5
Gentlemen,

I am the BRoyal who provided the definition from Mikel above (I am writing from work; my password is at home).

Geeez, guys, I was just putting down what Mikel wrote in an article a while back, not a defense of his worldview or bank account.
 
K

Ken K.

#6
No offense taken or implied (except maybe toward M.H. himself).

I try never to shoot the messenger. You contribution is very appreciated.

Ken
 
Thread starter Similar threads Forum Replies Date
S Example of a DFSS (Design for Six Sigma) Project or a Case Study Six Sigma 4
C DFSS (Design for Six Sigma) project or SSBB project? Six Sigma 8
T Six Sigma (DfSS in Design & DMAIC in Production) Maturity study Six Sigma 1
M Design for Six Sigma to be applied for different types of Manufacturing Processes Six Sigma 1
N Implement the Best Format and Set of Tools for Design For Six Sigma Six Sigma 7
P Design For Six Sigma (DFSS) Example For Pump Design and Tolerance Quality Assurance and Compliance Software Tools and Solutions 2
J Call for Speakers - Leading Annual Design for Six Sigma Conference Six Sigma 3
I Can a small design and six sigma consulting company be ISO 9001 certified? Design and Development of Products and Processes 4
M Six Sigma in Design - Product Development Six Sigma 17
A AS9102B - 3.6 Design Characteristics and form 3 AS9100, IAQG 9100, Nadcap and related Aerospace 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
R Design and Manufacture Guidelines for Surface Mount Technology Misc. Quality Assurance and Business Systems Related Topics 8
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Relabeler for patent expired product - design control responsibilities? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Supplier of design and manufacture process ISO 13485:2016 - Medical Device Quality Management Systems 10
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A Design process goal for ISO 9001 Manufacturing and Related Processes 21
Z Definitive definition of design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Design FMEA for Industrial Machinery FMEA and Control Plans 3
M Design Development MDR Design and Development of Products and Processes 0
L Contracted Manufacture Company wanting to be able to design and manufacture own product. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
C Essential Design Output(s) and Design transfer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
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
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
D Design Verification - Is testing required? Design and Development of Products and Processes 5
D DHF Responsibility after design handover Document Control Systems, Procedures, Forms and Templates 4
K Completing Design Controls after 510(k) Clearance Other US Medical Device Regulations 11
C Design and implementation of process audits as defined within IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
C Design Control - Ways of capturing inputs from manufacturing Other Medical Device Related Standards 5
R Design verification for interim design outputs - sampling rationale ISO 13485:2016 - Medical Device Quality Management Systems 2
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 5
R No design history file or device master record ISO 13485:2016 - Medical Device Quality Management Systems 5
R Suggestions for putting together a DHF (Design History File) ISO 13485:2016 - Medical Device Quality Management Systems 2
M One clinical design: Russia and Europe Other Medical Device and Orthopedic Related Topics 0
H New 510K VS Documents about design change. Other US Medical Device Regulations 1
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
M Medical Device Design Control Auditor Recommentations General Auditing Discussions 19
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
C Design Transfer Review - Before or after PQ validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Similar threads


















































Top Bottom