Quality Improvement Tools

ISO 9001 - Chen & Cheng, 2012)
1. Quality Management system design influences
  1. Environment
  2. Size & Structure
  3. Product or service
  4. Quality objectives
  5. Abilities of employees
  6. Changes in environment
  7. Risks in environment
2. Strategic decision of the organization
3. Assess ability to meet requirements
  1. Customer
  2. Regulatory
  3. Organization
4. Internal & External parties
5. Quality management principles
  1. Customer Focus
  2. Leadership
  3. Involvement of people
  4. Process approach
  5. System approach to management
  6. Continual improvement
  7. Factual approach to decision making
  8. Mutually beneficial supplier relationships
Lean/Six Sigma - Schweikhart, S. A., Ph. D., & Dembe, A. E., Sc. D. (2009, October)
1. Lean
  1. Designing, improving, and managing processes
  2. Improve effieciency and eliminate waste
    1. Resources that do not add value
      1. Mistakes needing rectification
      2. Unneeded process steps
      3. Movement of materials or people without a purpose
      4. Unnecessary waiting
      5. Creation of goods not needed by end users
  3. Application
2. Six sigma
  1. Improve quality and efficiency of processes
  2. Makes processes more uniform and precise
  3. DMAIC
    1. Define
    2. Measure
    3. Analyze
    4. Improve
    5. Control
  4. Application
    1. Healthcare
      1. Making deliverables more discrete and measurable
      2. Retaining strong customer focus
      3. Quantifying results
      4. Deliver quality improvements in a designated timeframe
    2. Lab Sciences
      1. Reduce auto-verification errors
      2. Ensure sufficient volume of samples
      3. Assure repeatability and reproducibility or tests
      4. Establish continuous and efficient workflow
Plan Do Study Act - (Setting a Course for Change - Part 3 of 3, 2015)
1. Study
  1. Did the results match predictions
  2. Compare results to previous performance
  3. What did you learn
2. Plan
  1. Describe test
  2. How to know it is improvement
  3. What does change impact
  4. Predict what will happen
3. Do
  1. Carried out as planned
  2. Record data and observations
  3. Observations not part of plan
4. Act
  1. Adopt? - Select changes to implement
  2. Adapt? - Improve change / Continue testing
  3. Abandon? - Discard change and try different plan

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Quality Improvement Tools

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