Managing Process Change Rose Romeo, PhD, FACB Compare and Contrast Process Improvement Methodologies including Six Sigma and Lean Evaluate Case Study (Six Sigma & Lean) Organization Personnel Planning Describe Best Practices on implementation and rollout 18 th Century Europe: normal curve metric Walter Shewhart & 3 sigma deviation Motorola coins term Six Sigma http://www.sixsigmaonline.org/six-sigma-training-certificationinformation/articles/the-history-and-development-of-six-sigma.html 1
A Brief History of Lean Manufacturing Eli Whitney Invents the Cotton Gin (1794) and interchangeable parts Frederick Taylor published the Principles of Scientific Management (1911) Henry Ford invents the moving assembly line, and dozens of innovations between 1908 and 1913 Training Within Industry (TWI) developed to increase production in WWII. W Edwards Deming transfers info to Japanese companies in the reconstruction Taiichi Ohno, Kiichiro Toyoda and Shigeo Shingo invent mfg methods, JIT and SMED Womack and Jones Publish Lean Thinking in 1995 http://www.lean.org/whatslean/history.cfm; http://leanenvironment.com/lean-e/about- Lean.php ISO 15189? Other? Systems Approach GP26 A4/QMS01- A4? Lean? Six Sigma? Selection of Methodology HAACP?, Root cause analysis? Other Risk/Error Mitigations Improved Patient Outcomes Corrective/Preventiv e Action The Challenge: Design and Rollout integrated with sustained verification Systems & Systems & methodologies alone do not guarantee Quality http://www.huffingtonpost.com/2013/01/30/toyota-recall_n_2579685.html 2
Enterprise Wide ISO 31000 Patient/Operator Safety ISO 14971 (medical device manufacturer s) 3
Ineffective Improvements What s not working continues to not work (even if it moves faster) What s missing get s worse due to additional risks taken on as part of the change How do I select the right methodology? Short answer=it depends Needs What are the enterprise objectives What is the Design Strategy Phased In vs Direct Approach to System Implementation Single Method Hybrid Approach Executive Support Six Sigma vs Lean Endless Debate Specialized versus Hybrid models Other Options Risk Management Methodologies Failure Mode Effects Analysis (FMEA) Fault Tree/Fishbone Analyses Hazard Analysis Critical Control Point (HACCP) driven hybrids Valuable for Process Risk 4
Article emphasizing fit for Six Sigma and Laboratory Operations & Processes Definition (especially of the customer) Prioritization Itemization Completion Notes: Not all issues will be a fit for Six Sigma, but Six Sigma can be a very good fit for a Healthcare setting due to the repetition of processes http://www.sixsigmaonline.org/six-sigma-training-certification-information/articles/six-sigma-andit-use-in-healthcare.html https://www.aacc.org/publications/cln/articles/2015/march/this-is-not-a-drill http://www.epa.gov/lean/environment/methods/index.htm 5
Executive Support The opposite of micro management Illustrates understanding of Systems approach Supportive Who s Driving?? One needs the right people Owner & Delegates Need Leaders & Managers Open to Flexibility and Change Plan up front (Hybrid approach??) Drive by measurable desired outcomes RACI Matrix http://en.wikipedia.org/wiki/responsibility_assign ment_matrix Who s Responsible (aka who does the work) Who s Accountable (aka who s neck is on the line ) Who get s Consulted? Who is Informed? (but doesn t necessarily get a vote) Six Sigma- reduction of errors Classified by Belt Color White-Green-Black, etc Define-Measure-Analyze-Improve-Control (DMAIC) Lean- reduction of waste Multiple classifications 3P-5S-Kaizen etc etc See Combo versions as well 5S-3P-Lean-Six Sigma Risk Management Fault Tree Analysis, Failure Mode Effects Analysis, HAACP 6
Criteria for success for Black Belts (and the project) Strong interpersonal skills Able to influence/motivate teams Change agent Analytical/strong problem solver Advanced leadership skills Excellent project leadership Strong coach/mentoring skills Team player Integrates effectively with business teams Demonstrates prioritization ability Criteria for selecting Green Belts are: Functional expertise Able to influence/motivate teams Analytical/strong problem solver Ability to work with and influence cross functional teams Team player Demonstrates prioritization ability http://www.processexcellencenetwork.com/lean-six-sigma-business-transformation/articles/deploying-sixsigma-within-health-care-a-roadmap-t/ http://www.processexcellencenetwork.com/lean-six-sigma-businesstransformation/articles/deploying-six-sigma-within-health-care-a-roadmapt/ 5S 3P Workplace Organization Sorting Straightening Sweeping Standardizing Sustaining http://en.wikipedia.org/wiki/5s_(me thodology) Similar to Design Control Production Preparation Process http://www.epa.gov/lean/enviro nment/methods/threep.htm 7
Flowcharts of process and related subprocess What is the desired output? What are my metrics (and how will they be measured?) What are the acceptance criteria? Where do I want to verify (or validate)? What type of contingency, or the data suggests something else should have been measured? Is a custom methodology the best fit for my need; do I need one or many? Does my RACI matrix shift in different phases of the project? How to measure success? (patient outcomes, reduced costs, etc) 8-9 month project, multiple other reports 8
Clear Goals Customer Satisfaction Customer Safety Cost Savings Process Flow Charts Risk Management Methodology Example: Critical Control Points (CCP s) Improvement Methodologies Evaluate Interfaces (CCP s?) Project Plan Identification and Implementation Phased in with Phase Reports reviewed with all stakeholders SUSTAINABILITY & MONITORING PLANNING The 5S Methodology addresses A. Design processes B. Statistical assessment of error C. A & B D. All of the Above The 3P Methodology does NOT address design A. True B. False 9
Which of the following is a true statement: A. Methodologies for improvement are part of a Quality System B. A Quality System is part of the Lean Methodology C. 5S is a type of Lean Methodology D. A & C Ineffective design of Process Improvement Projects can lead to increased risk for inefficiencies and decrease in quality A. True B. False Q&A 10
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