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Quality Standards - Coggle Diagram

- - - - Decision Matrix
      - Multivoting
      - Case Studies
- - - - The Certified Six Sigma Black Belt is a professional who can explain Six Sigma philosophies and principles, including supporting systems and tools. A Black Belt should demonstrate team leadership, understand team dynamics and assign team member roles and responsibilities. Black Belts have a thorough understanding of all aspects of the DMAIC model in accordance with Six Sigma principles. They have basic knowledge of Lean enterprise concepts, are able to identify non-value-added elements and activities and are able to use specific tools.
    - - The Six Sigma Green Belt operates in support of or under the supervision of a Six Sigma Black Belt, analyzes and solves quality problems and is involved in quality improvement projects. A Green Belt is someone with at least three years of work experience who wants to demonstrate his or her knowledge of Six Sigma tools and processes.
    - - The Six Sigma Yellow Belt Certification will be aimed at those new to the world of Six Sigma who have a small role, interest, or need to develop foundational knowledge. Yellow belts can be entry level employees that seek to improve their world or executive champions who require an overview of Six Sigma and DMAIC. This certification will adopt the approach of advancing the concept and potential of using Six Sigma tools and methodologies within an organization.
    - - The ASQ Master Black Belt (MBB) certification is a mark of career excellence and aimed at individuals who possess exceptional expertise and knowledge of current industry practice. Master Black Belts have outstanding leadership ability, are innovative, and demonstrate a strong commitment to the practice and advancement of quality and improvement. Obtaining an ASQ MBB is acceptance and recognition from your peers.
  - - - The Certified Biomedical Auditor is a professional who understands the principles of standards, regulations, directives and guidance for auditing a biomedical system while using various tools and techniques to examine, question, evaluate and report on that system's adequacy and deficiencies. A biomedical auditor analyzes all elements of the system and reports on how well it adheres to the criteria for management and control of process safety.
    - - The Certified Food Safety and Quality Auditor (CFSQA) is a professional who understands the standards and principles of auditing a Food Safety and HACCP-based (or process-safety) system. A CFSQA uses various tools and techniques to examine, question, evaluate and report on that system's adequacy and deficiencies. The CFSQA analyzes all elements of the system and reports on how well it adheres to the criteria for management and control of process safety.
    - - The Certified Pharmaceutical GMP Professional understands the GMP principles as regulated and guided by national and international agencies for the pharmaceutical industry. This covers finished human and veterinary drugs and biologics, ectoparasitacides, and dietary supplements (alternatively called nutraceuticals where regulated as drug products, as well as their component raw materials (includes active pharmaceutical ingredients (APIs) and excipients), and packaging, and labeling operations.
    - - The Certified Quality Auditor is a professional who understands the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating and reporting to determine a quality system's adequacy and deficiencies. The Certified Quality Auditor analyzes all elements of a quality system and judges its degree of adherence to the criteria of industrial management and quality evaluation and control systems.
- - - - Analyze
        
        Define #
        
        Voice of the customer to understand feedback from current and future customers indicating offerings that satisfy, delight, and dissatisfy them
        
        Value stream map to provide an overview of an entire process, starting and finishing at the customer, and analyzing what is required to meet customer needs
        
        Project charter to define the focus, scope, direction, and motivation for the improvement team
        
        Measure
        
        Capability analysis to assess the ability of a process to meet specifications
        
        Pareto chart to analyze the frequency of problems or causes
        
        Process map for recording the activities performed as part of a process
        
        Root cause analysis (RCA) to uncover causes
        
        Failure mode and effects analysis (FMEA) for identifying possible product, service, and process failures
        
        Multi-vari chart to detect different types of variation within a process
        
        Improve
        
        Design of experiments (DOE) to solve problems from complex processes or systems where there are many factors influencing the outcome and where it is impossible to isolate one factor or variable from the others
        
        Kaizen event to introduce rapid change by focusing on a narrow project and using the ideas and motivation of the people who do the work
        
        Control
        
        Quality control plan to document what is needed to keep an improved process at its current level
        
        Statistical process control (SPC) for monitoring process behavior
        
        5S to create a workplace suited for visual control
        
        Mistake proofing (poka-yoke) to make errors impossible or immediately detectable
- - - - How upper management leads the organization, and how the organization leads within the community.
    - - How the organization establishes and plans to implement strategic directions
    - - How the organization builds and maintains strong, lasting relationships with customers
    - - How the organization uses data to support key processes and manage performance.
    - - How the organization empowers and involves its workforce.
    - - How the organization designs, manages, and improves key processes.
    - - How the organization performs in terms of customer satisfaction, finances, human resources, supplier and partner performance, operations, governance and social responsibility, and how the organization compares to its competitors.