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Old view of "Quality Control"
-time, cost, quality-- choose any two.
-QA function to independently check up on and "control" production.
-Remove and rework defective products through inspection P/F
-Cost of quality, optimal inspection and rejection.
New Concept of Quality Management
-Taguchi loss function.
-99.9% Quality is not good enough
-6 sigma-->less cost of failures
-Cost of failure underestimated
-Cost of quality not understood
-Increased quality eliminates waste.
-Quality is free.
99.9% is not good enough
-1 hour of unsafe drinking water every month.
-2 unsafe plane landings per day at O'Hare Airport Chicago
-16,000 pieces of mail lost by USPO every hour.
-20,000 incorrect prescriptions every year
-50 babies dropped at birth every day.
-22,000 checks deducted from wrong bank account each hour.
-32,000 missed heart beats per person each year
Bill Smith
Reliability engineer, Motorola Corp.
Six Sigma
-increasing complexity of systems and products used by consumers created higher than desired system failure rates.
-holistic approach to reliability and quality and developed a strategy for improving both.
-this was done bc better quality is cheaper.
Goal of six sigma
to reach 3.4 defects per million opportunities over the long term.
Six sigma seeks to reduce what?
variability present in processes
1 sigma
690,000 defects- 30.90% yield
2 sigma
308,000 defects- 69.20%
3 sigma
66,800 defects- 93.30%
4 sigma
6,210 defects- 99.40%
5 sigma
320 defects- 99.98%
6 sigma
3.4 defects- 99.9997%
What is six sigma?
structured data driven methodology for eliminating waste from processes, products, and other business activities while having a positive impact on financial performance.
Six sigma perceptions
-perceived to be a business system that improves the bottom line.
-perceived as fitting naturally into the business systems of most companies.
-perceived as being more easily and more successfully launched than traditional Total Quality Mgt programs.
Total Quality Mgt system is perceived as
a technical system owned by technical specialists.
Six sigma system
-highly focused problem-solving system (DMAIC)
-focus on profits
-tools include SPC, DOE, FMEA
-project mgt, benchmarking
-3.4 defects/million
-focus on metrics
Quality Systems
-highly focused problem-solving system (PDSA)
-focus on improving organizational performance including profit
-Tools include SPC, DOE, FMEA, capability studies
-theory of constraints
-measures of performance
Benefits of adopting Six Sigma Methodology
-enhanced ability to provide value customer.
-enhanced understanding of key business processes.
-reduction of waste
-improved profit performance
Six Sigma Methodology focuses on
-Customer knowledge (CTQ info)
-Core processes (key business processes that deliver value directly to the customer)
-Accurate performance measures of both
Six sigma methodology is based on
-statistical process control techniques
-data analysis methods
-project mgt techniques
-systematic training of participants.
Six sigma is data drive AND
profit focused
An improvement in just 1 sigma can result in...
a 10 fold reduction in the number of defects.
improvement at 3 sigma...
66,800 defects= $668,000
improvement at 4 sigma...
6,210 defects=62,100
How are six sigma projects selected?
Based on their ability to contribute to and enhance an organization's financial performance.
What projects does six sigma seek out?
Sources of waste: overtime, warranty claims, production backlogs, customer issues.
5 phases of six sigma
1. define
2. measure
3. analyze
4. improve
5. control
Define
-identify the problem/project
-define the requirements
-establish the goals to be achieved
Measure
-gather info about the current process (define and measure key process steps and inputs)
-Refine the problem statement and goals.
Analyze
-identify potential root causes of the problem
-validate the cause and effect relationship
-identify the vital few root causes.
Improve
-implement solution to address root causes of problem
-test solutions
-measure results
Control
-evaluate and monitor improvements (make adjustments as needed)
-establish standard procedures.
8 essential tools of Six Sigma Methodology (used with DMAIC)
1. process maps
2. cause and effect diagrams
3. failure modes and effects analysis
4. measurement system analysis
5. process capability studies
6. multi-variate studies
7. design of experiments
8. process control plans
Green belts
-Operate in support or direction of black belts.
-trained to analyze and solve quality problems.
-two weeks of training in methods and basic statistical tools.
-complete a cost savings project ($10,000+)
Black belts
-team leader on six sigma projects.
-capable in the explanation of six sigma philosophies and principles.
-training in time leader ship (more advanced) 4-5 weeks
-knowledge of lean
-complete cost-savings projects ($100,000+)
Master Black belts
-expert in six sigma methods and tools
-extensive training. Responsible for training others to green and black belts.
-responsible for maintaining integrity
-highest certification
-assists the champion with deployment
-complete cost-savings projects ($1,000,000+)
APQP
Advanced Product Quality Planning
CTQ
Critical To Quality
DFSS
Design For Six Sigma
DMAIC
Design, Measure, Analyze, Improve, Control
DPMO
Defects Per Million Opportunities
DPU
Defects Per Unit
FMEA
Failure Modes and Effects Analysis
KPIV
Key Process Input Variable
KPOV
Key Process Output Variable
Process Owners
The individuals responsible for the process and what it produces
Reliability
Measured as mean-time to failure
Quality
Measured as process variability and defect rates.
In order to successfully adopt the Six Sigma Methodology, and org must have:
-visible mgt commitment
-visible mgt involvement
-clear definition of customer requirements
-understanding of key business processes
-sound measures of performance
-discipline
-rewards
Who is doing Six Sigma?
-Motorola
-G.E.
-DuPont
-Ford
-AlliedSignal
-Texas Instruments
-Honeywell
Six Sigma for the smaller company:
-is scaleable (ideas and concepts are viable regardless of size or type of industry)
-requires participation and training of black belts (time consuming-4to12 months, expensive- 10 to 15k)
Six Sigma focuses on defects while other quality improvement methodologies emphasize:
nonconformances
When the org says no more improvement is possible...
remember Six Sigma has a 2 pronged approach:
1. fix the existing problems
2. design six sigma into processes, products and services
Six sigma is about results. Enhancing profitability through...
improved quality and efficiency.
Yellow Belt
-Professional who works on project.
-awareness of six sigma but no training
-anyone
Champion role
-translate the company's vision, mission, goals and metric
-make resources available and remove road blocks.
-resolves cross-functional issues.
Executive role
-establish strategic focus
-ensure six sigma within the context of the org's culture and vision.
Criticism
-Need aggressive performance tracking and accountability for results.
-EE's need to be willing to use statistical tools.
-Pay more attention to steps than the actual result.
-Cost of infrastructure.
-Cost of training for belts (MBB at least $17,000 alone)
-A pacemaker needs higher standards than six sigma
Phase 1: Define
Goal: define the projects purpose and scope and get background on the process and customer.
Output: clear statement of intended improvement and how its to be measured.
-high level map of process
-list of what's important to customer
Phase 2: Measure
Goal: Focus improvement effort by gathering info on current situation.
Output: Data that pinpoints problem location or occurrence.
-baseline data on current process sigma
-more focused problem statemeny
Phase 3: Analyze
Goal: Identify deep root causes and confirm them with data.
Output: A theory that has been tested and confirmed
Phase 4: Improve
Goal: Develop, pilot, and implement solutions that address root causes.
Output: ID of planned, tested actions that should eliminate or reduce the impact of the identified root causes.
Phase 5: Control
Goal: Used data to evaluate both solutions and plans.
-validate that all changes adhere to all operating company change control, GMP, and compliance requirements.
-maintain gains by standardizing processes.
-outline next steps for ongoing improvement
Output: before and after analysis
-monitoring system
-completed documentation of results, learnings, and recommendations.