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• June 26, 2009:  ASQ Six Sigma Forum Discussion Group 1 hr Webinar on "Sample Size Determination"

• June 9, 2009: ASQSD Meeting pre-clinic speaker on "Success in Quality-Part 2". 

• May 13, 2009:  ASQ Palomar Key note talk on "Better Decision Making With EDX"

• May 12, 2009: ASQSD Meeting pre-clinic speaker on "Success in Quality-Part 1". 

• Feb. - Jun. 2009: SDSU BQS750 MS Bio-Med class on change & improvement

• Feb. - Jun. 2009:  UCSD class on Lean Six Sigma 

• Feb.11, 2009:  Talk to AeA SD on "Experimentation for Better Decision Making"

• Jan. 30, 2009:  PFMEA training for Safety Syringe, Inc.

• Jan. 28, 2009: INCOSE talk on "Experimentation for Systems Engineers"

• Nov. 13, 2008:  National University CQE course night on advanced statistics

• Nov. 12, 2008:  Moderated AeA SD Supply Chain Roundtable Expert Panel Event ("outstanding" evaluation scores)

• Oct. 14, 2008: ASQ SD Meeting pre-clinic speaker on a statistics teaching game. 

• Oct. - Dec. 2008:  UCSD course on Lean Six Sigma 

• Sep. 10, 2008:  AeA SD talk to ~100 people on ASQ for supply chain quality

• Sep. 10, 2008:  ASQ Palomar talk on Experimental Design (DOE)

• Sep. 9, 2008: ASQ SD Meeting pre-clinic speaker on Affinity diagram / Multi-voting. 

• July - Fall, 2008:  Overland Storage Green Belt Training, 18 employees, 14 weeks

• Aug. 12, 2008: ASQ SD Meeting pre-clinic speaker on job justification 

• June 11, 2008:  Expertbriefings.com talk on FDA487 red. via STAT implementation

• June 6, 2008: UCSD course on Lean Six Sigma;  Wrap-up - 8hrs.

• May 30, 2008: UCSD course on Lean Six Sigma;  Improve Statistics - 8hrs.

• May 29, 2008:  ASQ CQE Course night on test taking and CQE tough topics

• May 22, 2008:  ASQ CQE Course night on test taking and CQE tough topics

• May 9, 2008: UCSD course on Lean Six Sigma;  Analyze & Control Statistics - 8hrs.

• April 25, 2008: UCSD course on Lean Six Sigma;  Measure Statistics - 8hrs.

• April 11, 2008: UCSD course on Lean Six Sigma;  Define/Describe - 8hrs.

• April 8, 2008: ASQ SD Meeting pre-clinic speaker on Quality system stats. 

• March 10, 2008: SDSU BQS750 Week10; Wrap Up

• March 3, 2008: SDSU BQS750 Week9; Measurement & Variation

• February 26, 2008:  SSQ Meeting Speaker.  Change & Improvement for Software 

• Feb. 25, 2008: SDSU BQS750 Week8; Implementing Change Using Tools

• Jan. 7, 2008: SDSU BQS750 Week1; Change & Improvement Overview

• November 23, 2007: UCSD course on Lean Six Sigma;  Wrap-up - 8hrs

• November 16, 2007: UCSD course on Lean Six Sigma;  Improve - 8hrs

• November 13, 2007:  ASQ SD Meeting pre-clinic speaker on sample size selection 

• November 2, 2007: UCSD course on Lean Six Sigma;   - Analyze/Control - 8hrs.

• October 12, 2007: UCSD course on Lean Six Sigma;  Measure - 8hrs.

• September 28, 2007: UCSD course on Lean Six Sigma;  Define/Describe - 8hrs.

• September 11, 2007:  ASQ SD Meeting pre-clinic Panel Chair on outsourcing. 

• August 28, 2007:   Delta Design new managers (Cohu comps) on problem solving. 

• July 10, 2007:  ASQ SD Meeting change panelist. 

• June 22, 2007: UCSD course on Lean Six Sigma;  Wrap-up - 4hrs.

• June 12, 2007:  ASQ SD Meeting on PM/PdM/OEE

• June 8, 2007: UCSD course on Lean Six Sigma;  Control Statistics - 8hrs.

• May 25, 2007: UCSD course on Lean Six Sigma;  Improve Statistics - 8hrs.

• May 18, 2007: UCSD course on Lean Six Sigma;  Analyze Statistics - 8hrs.

• May 17 & 24, 2007:  ASQ CQE Course nights on test taking.

• May 4, 2007: UCSD course on Lean Six Sigma;  Measure Statistics - 8hrs.

• April 13, 2007: UCSD course on Lean Six Sigma;  Define Statistics - 8hrs.

• April 11, 2007:  Keynote speaker for ASQ Palomar; “Tips, Tricks, Methods, and Tools for Change and Quality Improvement Management”

• Mar. 20, 2007:  1+ Toastmaster talk; Chambers Club; Giving Praise. Won best spkr.  

• Feb. 1, 2007: SD SAMPE talk on Quality Improvement and Change Management. 

• Jan. 24, 2007: ASQ workshop on MSA / Gage R&R - 2hrs.

• Dec. - Jan 2007: 1 short Toastmaster talk; Chambers Club 

• Nov. 18, 2006:  Co-taught leads / supervisors with CMTC on Quality / Problem Solving at Delta Design - 3hrs.

• Nov. 17, 2006: UCSD course on Lean Six Sigma; Control Phase Statistics - 8hrs.

• November 5, 2006:   Delta Design training to new managers of all Cohu companies on situational leadership. 

• Oct. 26, 2006: ASQ workshop on DOE / Experimental Design - 2hrs.

• Oct. 20, 2006: UCSD course on Lean Six Sigma; Improve Phase Statistics - 8hrs.

• Oct.17, 2006:  Toastmaster talk; Chambers Club; Making toasts  

• Oct. 6, 2006: UCSD course on Lean Six Sigma; Meas/Anal Phase Statistics - 8hrs.

• Sept. 18, 2006:  ASQ workshop - Basic Statistics; 2hrs.

• Sept. 15, 2006: UCSD course on Lean Six Sigma; Define Phase Statistics - 8hrs.

• Sept. 14, 2006:  Experimental Design for Engineers at Delta Design - 1hr

• Sept. 13, 2006:  With CMTC on Quality / Prob. Solving for Mgrs. at Delta Design - 3hrs.

• Sept 5, 2006:  0:20 Toastmaster talk; Chambers Club; Leadership.  

• May 2, 2006:  0:20 Toastmaster talk; Chambers Club; Keynote on quality career.  

• March 18, 2006:  UCSD Six Sigma Black Belt  Lean module with Mitch Tarr

• March 2-4, 2006:  UCSD Six Sigma Black Belt  All statistics modules with Mitch Tarr

• Mar. 2, 2006:  BPS 3-hour Six Sigma Training Course at the Country Inns of SD

• Dec. - Jan 2006: 2+ Toastmaster talks; Chambers Club; acquired the CTM award! 

• Dec. 8-9, 2005: UCSD course on Lean Six Sigma Improve & Control

• December 2-3, 2005:  UCSD course on Lean Six Sigma Improve

• November 22:  1+ Toastmaster talk.  Chambers Club Escondido.

• November 18-19:  UCSD course on Lean Six Sigma Measure & Analyze

• Nov 7, 2005:  ASQ SD CRE Study Group Meeting - Experimental Design

• Nov 4-5, 2005:  UCSD Lean Six Sigma Black Belt Define and Measurement.

• Oct. 6, 2005:  BPS 3-hour Six Sigma Training Course at the CountryInns of SD

• Oct. 2005: Toastmaster talk.  Chambers Club Escondido.  Best Speaker Award.

• Sept. 15, 2005:  CSSBB course instructor & coordinator ASQSD - Mock Project.

• Sept. 13, 2005:  1hr. DOE / helicopter talk for ASQSD at the Country Inns of SD.

• Aug 25, 2005: CSSBB course instructor & coordinator ASQSD - DOE.

• Aug 24, 2005:  Co-taught Manager training with CMTC on Quality / Problem Solving.

• Aug 18, 2005: CSSBB course instructor & coordinator ASQSD - Improve.

• August 2005:  1+ Toastmaster talk.  Chambers Club Escondido.

• Aug 11, 2005: CSSBB course instructor & coordinator ASQSD - Measure.

• June - July, 2005:  1+ Toastmaster talk.  Chambers Club Escondido.

• July 21, 2005: CSSBB course instructor & coordinator ASQSD - Cust. focus.

• July 14, 2005: CSSBB course instructor & coordinator ASQSD - Bus. strategy.

• May 19, 2005:  CQA course instruction on Strategic Planning through ASQSD.

• May 11, 2005:  1hr. technical clinic DOE SPA talk for ASQ Palomar sect. 708

• May 7, 2005:  SD Northern District Toastmasters evaluation speech contest

• April 2, 2005:  Region 3 Toastmasters evaluation speech contest placed 2nd.

• Feb - April, 2005:  1+ Toastmaster talk.  Chambers Club Escondido.

• March 3, 2005:  BPS 3-hour Six Sigma Training Course at the CountryInns of SD

• February 10, 2005:  CQM course instruction on Project Management through ASQSD.

• January 19, 2005:  Lead 2hour presentation / discussion with SD ISO Users Group

• Dec - January, 2005:  2+ Toastmaster talks.  Chambers Club Escondido.

• Dec. 9, 2004:  CQM 3hr. course instruction on strategic assessments through ASQSD.

• Dec. 2, 2004:  CQM 3hr. course instruction on strategic planning through ASQSD.

• November 16, 2004:  International SAMPE Tech Conference (ISTC 36) talk on "Experimental Test Strategy For Six Sigma Levels of Process Improvement".

• November 16 - 30, 2004:  2+ Toastmaster talks.  Chambers Club Escondido.

• November 4, 2004: BPS 3-hour Six Sigma Training Course at the CountryInns of SD.

• November 3, 2004:  Taught 3hr CQE DOE & regression refresher course at Cubic.

• September 29, 2004:  Co-taught 3hr CQE Metrology refresher course at Cubic.

• September 23, 2004:  Taught 3hr CRE Data Collection & Analysis course at Encad. 

• August 31, 2004:  Half day SPC training to Gen-Probe at the CountryInns of SD.

• July 21, 2004:  Three hour workshop and combined modular course at Gen-Probe on Design of Experiments through ASQ San Diego Section 703.  See details.

• May 21, 2004:  BPS 3-hour Six Sigma Training Course at the CountryInns of SD.

• May 13, 2004:  ASQSD CQA Refresher course 3-hour Quality tools & Lean manufacturing module. 

• Feb. 11, 2004:  USD SCMA.  Career Insights Night "Supply Chain Management" "industry expert", speaker, and panel guest.

• Dec. 2003 - Feb. 2004:  Six Sigma Black Belt Overview Modular Course Developed & Taught through ASQ San Diego.  

• April 23, 2003:  ASQ SD Section 703 Workshop.  FDA V&V 3hr workshop guest presentation.  See details.

• March - June 2003:  Dale Carnegie class 1624.  Numerous presentations as a coach

• March 15, 2003:  ASQ Region 7 leadership conference; Co-presented workshop on "Section Communications" with Phoenix section webmaster.  

• Nov. 2002:  ASQ Palomar sect. 708 regular membership meeting (Gage R&R). 

• May 16, 2002:  UCSD’s Six Sigma Black Belt Certification Program.  DOE training with Dr. Leonard Perry.

• Jan 2002:  Six Sigma 3hr workshop guest presentation. 

• Spring 2001:  Dale Carnegie class 1610.  Numerous presentations (~20).  4x best speaker awards.

• Jan. 2001:  International ASQ Six Sigma Conference (Several 3 - 7min. introductions to large crowds). 

• June 2000:  Basic Statistics to Quality Personnel at Delta Design.

• May 2000:  International SAMPE Symposium #45 - DOE Implementation Techniques, Combining Statistics, 20 min. "International Webmaster Report" to large crowd of all international chapter officers.  See publications.

• Jan. 1999:  SAMPE San Diego Chapter (DOE and Manufacturing Gurus) 

• Jan. 1998:  ASQ San Diego Section 703 ("Ask the expert about DOE") 

Fall 2005 UCSD Lean Six Sigma Class Results:

Very similar results from:

• Spring 2002 UCSD Six Sigma BB class guest lecturer on case studies, co-taught with Dr. Perry and Keith Boyle
• Spring 2006 UCSD Six Sigma BB class co-taught with Mitch Tarr
• Fall 2006 UCSD LSSBB co-taught with Jane Marshall
• Spring 2007 UCSD LSSBB class co-taught with Jane Marshall
• Fall 2007 UCSD LSSBB class co-taught with Jane Marshall
• Spring 2008 UCSD LSSBB class co-taught with Jane Marshall
• Fall 2009 UCSD LSSBB class co-taught with Jane Marshall
• Spring 2009 UCSD LSSBB class co-taught with Jane Marshall

General Quality Biography:

Kim Niles has a master’s degree in Quality Science from California State University, Dominguez Hills, with emphasis in Six Sigma and Process Management. He received his Bachelor’s degree in 1984 in Applied Arts & Sciences from San Diego State University through the Industrial Technology Department.  He also has 4 certificates including a UCSD certified Master Black Belt. 

His career has specialized in improving quality, costs, & or productivity of complex, high volume, or problematic manufacturing systems using quality and statistical principles. He has personally performed more than 197 designed experiments producing an estimated hard savings to San Diego companies in excess of six million dollars (soft savings of ~ $500M). He has a wide range of work experience from medical, material science, semiconductor, rubber molding, and consumer electronics manufacturing companies.

Currently a Senior Quality Engineer with Alphatec Spine, Inc., Niles is an officer in three San Diego societies (ASQ703, SAMPE, SDEC). He also serves on advisory boards for SDSU's MS BioMed Quality Systems degree, UCSD’s Six Sigma Black Belt Certification Program, and formally with Palomar College’s Quality A.A. degree and certificate program.  He has authored or co-authored 39 article publications and given 199 talks.

Kim Niles is an adjunct instructor through San Diego State University and the University of California in San Diego (UCSD), as well as a quality and statistical consultant in San Diego.  He earned his master’s degree in quality science from California State University in Dominguez Hills. Niles is an ASQ-certified quality engineer and Six Sigma Black Belt, as well as a UCSD-certified Master Black Belt. He is a fellow of ASQ.

Kim Niles has a master’s degree in Quality Science from CSU Dominguez Hills. His career has specialized in improving quality, costs, & or productivity of complex, high volume, or problematic manufacturing systems using quality and statistical principles. He serves on three college advisory boards and has 39+ publications, and 4 certifications.

Instructors Biography  (110 word):

Kim Niles has a Masters degree in Quality Science with emphasis in Six Sigma, has taught approximately 1800 people, has studied under several related gurus, has performed over 197 designed experiments, and has completed projects with a combined total of $400M. He has written 39+ publications that have been circulated to over three million people via iSixSigma.com, ASQ’s Six Sigma forum, and other technical publications. He is teaching or has taught numerous related classes through Business Process Solutions, GQS, SDSU, UCSD, and ASQ San Diego.  He has given 199 talks to local technical societies. Kim serves on 2+ college advisory boards and works for Alphatec Spine, Inc. in Carlsbad, CA.

Kim Niles has a Master's degree in Quality Science from CSU Dominguez Hills and is currently teaching a class in "Change Management and Quality Improvement" through SDSU's Center for Bio/Pharmaceutical and Biodevice Development as part of their Masters degree and certificates program (see   http://interwork.sdsu.edu/cbbd/aboutus.htm).  He also is about to start his 8th wave of teaching Lean Six Sigma Black Belts through UCSD (see http://extension.ucsd.edu/programs/eng/leansixsigma.html).

Kim's career has specialized in improving quality, costs, & or productivity of complex, high volume, or problematic manufacturing systems using change management, statistics, and quality tools and methods.  He has a wide range of work experience from medical, material science, semiconductor, rubber molding, and consumer electronics manufacturing companies. 

Kim is also in a Roadmaps Institute think tank, has 39+ publications with over 3M circulations, has given 199 talks, and has received four certifications including a UCSD Master Black Belt certification, ASQ CQE, and ASQ CSSBB.  Find more information about Kim at www.KimNiles.com

Kim Niles, MSQA, has experience in applying statistical and quality principles to very difficult medical manufacturing processes improvement, research, and V&V applications. He is a member of the UCSD Six Sigma and SDSU Biomedical Quality Science MS degree program advisory panels.  Mr. Niles has consulted for companies such as Alaris Medical, Gen-Probe, Safeskin, Johnson & Johnson, Biomedical Technologies, and other device, pharmaceutical, and biologic manufacturing companies. He has also worked with LLNL (STTR), wrote and received a SBIR BK prosthetics NIH grant.

Kim Niles has a master's degree in Quality Science from CSU Dominguez Hills and is currently teaching a class in "Change Management and Quality Improvement" through SDSU's Center for Bio/Pharmaceutical and Biodevice Development as part of their Masters degree and certificates program (see   http://interwork.sdsu.edu/cbbd/aboutus.htm).

Kim's career has specialized in improving quality, costs, & or productivity of complex, high volume, or problematic manufacturing systems using change management, statistics, and quality tools and methods.  He has personally performed more than 197 designed experiments producing an estimated hard savings to San Diego companies in excess of six million dollars (soft savings of ~ $500M).  He has a wide range of work experience from medical, material science, semiconductor, rubber molding, and consumer electronics manufacturing companies. 

Kim also serves on the UCSD advisory board, teaches Lean Six Sigma through UCSD, is in the Roadmaps Institute think tank, has 39+ publications with over 3M circulations, has given 199 talks, and has received four certifications including a UCSD Master Black Belt certification, ASQ CQE, and ASQ CSSBB.  Kim currently works in Carlsbad for Alphatec Spine, Inc.  Find more information about Kim at www.KimNiles.com

Round Table Speaker Questions:

Change Management question ideas / condensed answers:

1. do you have any case studies of how companies handled change well or not well?
   • Heart of Change 100 case studies  
2. what roles are important in creating or controlling change?
   • change agent, guiding team, SSBB's etc.
3. name some change management related tools
   • See Harvard Rev article listing
4. name / explain some change management methods
   • See Leading change two  
5. do you know of any change management methodologies?
   • See Leading change 8steps
6. do you have any do/don't tips or personal techniques that can help facilitate change?
   • see harvard Rev article depends upon agreement matrix
7. what can the individual do to facilitate change?
   • use a model to guide / manage the effort
8. why doesn't ASQ make change management part of certifications?
   • there are bits and pieces in all such as conflict management
9. what's written in the literature about this subject?
   • provide my list of 25 books on CM that I own
10. are there consultants that specialize in CM?
    • yes but many are more specific to a particular method such as SSigma
11. how could a consultant help with a change effort?
    • provide structure, experience, guidance, insight, credibility, training
12. what models exist to help with change?
    • provide my list of 5 models
13. how can models help with change?
    • back track from symptom, planning all ingredients up front.
14. how does change management relate to quality?
    • both deal with controlling or creating change
15. how do methodologies help with the CM effort?
    • creates a process out of the effort.  Processes can be improved.
16. how can statistics be applied to change management?
    • better decision making.
17. what is the biggest barrier to change?
    • people
18. how do you get people to change?
    • see models; inspire their feelings; create convincing analysis
19. what makes a good change initiative?
    • large improvement, people on board, one that lasts, measured effectiveness, directly affects the customer, etc.

DOE question ideas / condensed answers: 

1. what is experimental design?
   • The most complex form of multivariable experimentation
2. why is it any different than any other form of experimentation?
   • It measures significance with confidence and captures interaction effects
3. how can it be used to improve manufacturing?
   • Extrapolation and interpolation of the entire design space at low cost
4. why are classes in DOE typically over 40hours long?
   • Its really advanced addition; a paradigm shift in thought is required
5. what are the biggest barriers to conducting DOE?
   • Mis-perceived costs; lack of training
6. how important is DOE to Lean and Six Sigma?
   • Its argued to be the heart of Six Sigma at many companies
   • Lean dictates priority for conducting DOE
7. are there any DOE methodologies?
   • Yes, several – cite my article
8. do you have any DOE case studies?
   • Yes, many …
9. how does this actually apply to me?
   • Electronics require continuous variables which are perfect for interactions. 
10. can DOE be implemented at a supplier?
    • Yes, cite many examples.  Usually saves the vendor cost, improves understanding, and improves customer delivery
11. what’s the history of DOE?
    • Fisher story
12. do you have any implementation tips, do’s / don’ts?
    • Cite my article.   

Six Sigma question ideas / condensed answers:

1. what is Six Sigma?
   • def. In the literature:  Power teams to solve large problem (project management), measure of variation in a process (metric), improvement philosophy (cont. improvement, strategy implementation, competition, etc.)
2. why is it popular?
   • It works; see comparison chart
3. is it really successful?
   • Cite billions claimed examples
4. how can it be used to improve manufacturing?
   • Problem solving, process understanding, process improvement
5. why is it different than Kaizen events?
   • Scope of projects and tools used
   • Focus on variation instead of waste
6. why do we need four full weeks of training to become a Black Belt?
   • Heavy stats and learning by doing
7. what’s the history of Six Sigma?
   • Cite iSS website … mikel Harry, et al.
8. what are the biggest barriers to implementing Six Sigma?
   • Top Management, change management, training, perceived costs
9. how can Lean and Six Sigma work together to improve manufacturing?
   • Lean to prioritize and first waste reduction, then SS variation
10. what are Six Sigma methodologies?
    • DMAIC, DMADV and others
11. do you have any Six Sigma case studies?
    • Cite Safeskin
12. how does this actually apply to me?
    • Team / improvement / statistics fits all
13. can Six Sigma be implemented at a supplier?
    • Cite current vendor success stories; Bodycote; Lydall
14. what does the 1.5 sigma shift mean?
    • explain
15. what are denominator metrics?
    • Explain dpmo
16. how can I implement Six Sigma at my company?
    • Cite different ways … Pande et al.

Project Ideas by Industry & Process Type:

Product Manufacturing:

1. Improve yield by breaking bottleneck barriers
2. Improve yield by breaking quality barriers
3. Improve yield by reducing the 8 wastes
4. Repeat for delivery, cost, flexibility, reliability
5. Reduce reliance on sole-source suppliers

Medical Service:

1. Improve fall & slip injury rates, costs, risks.
2. VAP - ventilation pneumonia 
3. Perioperative antibiotic timing 
4. Emergency department return rates
5. Medical error rates 
6. Patient and staff safety 
7. waiting times 
8. patient flow 
9. patient outcomes 
10. efficiencies / costs reductions 

Example: ED return rate control factors number of triage rooms average time to give aspirin percent of total admitted percent that arrive by ambulance wait time percent that left without screening number of patients outlier types of injuries nurse patient ratios