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- Quality Philosophies and Foundations
- continuous improvement tools
- lean
- Six Sigma
- statistical process control (SPC)
- total quality management.Understand how modern quality has evolved from quality control through statistical process control (SPC) to total quality management and leadership principles.

- The Quality Management System (QMS)
- Strategic planning Identify and define top managements responsibility for the QMS- including establishing policies- and objectives- setting organization-wide goals- and supporting quality initiatives.

- Deployment techniques Define- describe- and use various deployment tools in support of the QMS such as:
- Benchmarking (Define the concept of benchmarking and why it may be used.)
- Stakeholder (Define- describe- and use stakeholder identification and analysis.)
- Performance (Define- describe- and use performance measurement tools such as cost-benefit analysis.)
- Project management (Define- describe- and use project management tools- including Gantt charts and the responsible- accountable- consulted and informed matrix (RACI))

- Quality information system (QIS)
- Identify and describe the basic elements of a QIS- including who will contribute data- the kind of data to be managed- who will have access to the data- the level of flexibility for future information needs- and data analysis.

- ASQ Code of Ethics for Professional Conduct
- Determine appropriate behavior in situations requiring ethical decisions.
- Leadership Principles and Techniques
- Analyze various principles and techniques for developing and organizing teams and leading quality initiatives
- Facilitation Principles and Techniques
- Roles and responsibilities
- Describe the facilitators roles and responsibilities on a team.
- Facilitation tools
- Apply various tools used with teams- including brainstorming- nominal group technique- conflict resolution- and force-field analysis.

- Communication Skills
- Identify and distinguish between specific communication methods that are used for delivering information and messages in a variety of situations across all levels of the organization.
- Customer Relations
- Define- apply- and analyze the results of customer relation tools such as customer satisfaction surveys.
- supplier Management
- Techniques
- Apply various supplier management techniques- including supplier qualification- certification- and evaluation.
- Improvement
- Analyze supplier ratings and performance improvement results.
- Risk
- Understand business continuity- resiliency- and contingency planning.

- Barriers to Quality Improvement
- Identify barriers to quality improvement- analyze their causes and impact- and implement methods for improvement.
- The Quality System
- Elements of the Quality System
- Basic elements
- Interpret the basic elements of a quality system- including planning- control- and improvement- from product and process design through quality cost systems and audit programs.
- Design
- Analyze the design and alignment of interrelated processes to the strategic plan and core processes.

- Documentation of the Quality System
- Document components
- Identify and describe quality system documentation components- including quality policies and procedures to support the system.
- Document control
- Evaluate configuration management- maintenance- and document control to manage work instructions and quality records.
- Quality Standards and Other Guidelines
- Apply national and international standards and other requirements and guidelines- including the Malcolm Baldrige National Quality Award (MBNQA)- and describe key points of the ISO 9000 series of standards. (Note: Industry-specific standards will not be tested.)

- Quality Audits
- Types of audits
- Describe and classify the various types of quality audits such as product- process- management (system)- registration (certification)- compliance (regulatory)- first- second- and third party.
- Roles and responsibilities in audits
- Identify and define roles and responsibilities for audit participants such as audit team (leader and members)- client- and auditee.
- Audit planning and implementation
- Describe and apply the stages of a quality audit- from audit planning- including assessing risks through conducting an audit.
- Audit reporting and follow-up
- Apply the steps of audit reporting and follow-up- including the need to verify corrective action.

- Cost of Quality (COQ)
- Identify and apply COQ concepts- including cost categorization- data collection- reporting- and interpreting results.
- Quality Training
- Identify and apply key elements of a training program- including conducting a needs analysis- preparing curricula and materials- and determining the programs effectiveness.
- Product- Process- and Service Design
- Classification of Quality Characteristics
- Define- interpret- assess- and classify quality characteristics for new and existing products- processes- and services.

- Design Inputs- Techniques- and Review
- Inputs
- Classify design inputs such as customer needs- regulatory requirements- critical to quality- and risk assessment into robust design using techniques such as failure mode and effects analysis (FMEA).
- Techniques
- Apply Design for X (DFX)- Design for Six Sigma (DFSS)- and requirements traceability.
- Review
- Identify and apply common elements of the design review process- including roles and responsibilities of participants.

- Technical Drawings and Specifications
- Interpret specification requirements in relation to product and process characteristics and technical drawings- including characteristics such as views- title blocks- dimensioning and tolerancing- and geometric dimensioning and tolerance symbols (GD&T).
- Verification and Validation
- Interpret the results of evaluations and tests used to verify and validate the design of products- processes and services- such as installation qualification (IQ)- operational qualification (OQ)- and process qualification (PQ).

- Reliability and Maintainability
- Predictive and preventive maintenance tools
- Describe and apply the tools and techniques used to maintain and Strengthen process and product reliability.
- Reliability and maintainability indices
- Apply indices such as mean time to failure (MTTF)- mean time between failure (MTBF)- mean time to repair (MTTR)- availability- and failure rate.
- Reliability models
- Classify and apply the basic elements of reliability models such as exponential- Weibull- and bathtub curve.
- Reliability/Safety/Hazard Assessment Tools
- Define- construct- and interpret the results of failure mode and effects analysis (FMEA)- design FMEA (dFMEA)- process FMEA (pFMEA)- use FMEA (uFMEA)- failure mode- effects- and criticality analysis (FMECA)- and hazard analysis.

- Product and Process Control
- Methods
- Implement product and process control methods such as control plan development- critical control point identification- and work instruction development and validation.
- Material Control
- Material identification- status- and traceability
- Define and distinguish between these concepts- and describe methods for applying them in various situations.
- Material segregation
- Describe material segregation and its importance- and evaluate appropriate methods for applying it in various situations.
- Material classification
- Assess and classify product and process defects and nonconformities.
- Material review board (MRB)
- Describe the purpose and function of an MRB- and evaluate nonconforming product or material to make a disposition decision in various situations.

- Acceptance Sampling
- Sampling concepts
- Apply the concepts of producer and consumer risk- and related terms- including operating characteristic (OC) curves- acceptable quality limit (AQL)- and lot tolerance percent defective (LTPD).
- Sampling standards and plans
- Identify- interpret- and apply ANSI/ASQ Z1.4 and Z1.9 standards for attributes and variables sampling.
- sample integrity
- Identify and apply techniques for establishing and maintaining sample integrity.

- Measurement and Test
- Measurement tools
- Select and describe appropriate uses of inspection tools such as gage blocks- calipers- micrometers- optical comparators- and coordinate measuring machines (CMM).
- Destructive and nondestructive tests
- Identify when destructive and nondestructive measurement test methods should be used and apply the methods appropriately.

- Metrology
- Apply metrology techniques such as calibration- traceability to calibration standards- measurement error and its sources- and control and maintenance of measurement standards and devices.
- Measurement System
- Analysis (MSA)
- Calculate- analyze- and interpret repeatability and reproducibility (gage R&R) studies- measurement correlation- capability- bias- linearity- precision- stability and accuracy- using MSA quantitative and graphical methods.

- Quality Control Tools
- Select- construct- apply- and interpret the following quality control tools:
- Flowcharts
- Pareto charts
- Cause and effect diagrams
- Control charts
- Check sheets
- Scatter diagrams
- Histograms (Analyze)

- Quality Management and Planning Tools
- Select- construct- apply- and interpret the following quality management and planning tools:
- Affinity diagrams and force field analysis
- Tree diagrams
- Process decision program charts (PDPC)
- Matrix diagrams
- Interrelationship digraphs
- Prioritization matrices
- Activity network diagrams

- Continuous Improvement Methodologies
- Define- describe- and apply the following continuous improvement methodologies:
- Total quality management (TQM)
- Kaizen
- Plan-do-check-act (PDCA)
- Six Sigma

- Lean tools
- Define- describe- and apply the following lean tools:
- 5S
- Value stream mapping
- Kanban
- Visual control
- 8 Wastes
- Standardized work
- Takt time
- Single minute exchange of die (SMED)
- Overall equipment effectiveness (OEE)

- Corrective Action
- Identify- describe- and apply elements of the corrective action process- including problem identification- failure analysis- root cause analysis- 5 Whys- problem correction- recurrence control- and verification of effectiveness.
- Preventive Action
- Identify- describe- and apply various preventive action tools such as error proofing/poka-yoke- and robust design- and analyze their effectiveness.

- Collecting and Summarizing Data
- Types of data Define- classify- and compare discrete (attributes) and continuous (variables) data.
- Measurement scales Define and describe nominal- ordinal- interval- and ratio scales.
- Data collection methods Describe various methods for collecting data- including tally or check sheets- data coding- automatic gaging- data automation- database integration- and identify the strengths and weaknesses of the methods.
- Data accuracy and integrity
- Identify factors that can influence data accuracy such as source/resource issues- flexibility- versatility- inconsistency- inappropriate interpretation of data values- and redundancy to ensure data accuracy and integrity.

- Data visualization techniques
- Apply and interpret data visualization techniques using dashboards- and select the appropriate metrics for dashboards.
- Descriptive statistics
- Describe- calculate- and interpret measures of central tendency and dispersion- apply the central limit theorem- and construct and interpret frequency distributions- including simple- categorical- grouped- ungrouped- and cumulative.
- Graphical methods for depicting distributions
- Apply and interpret diagrams such as probability plots for normal and other distributions.
- Quantitative Concepts
- Terminology
- Define and apply quantitative terms- including population- parameter- sample- statistic- random sampling- and expected value.

- Drawing statistical conclusions
- Distinguish between numeric and analytical studies. Assess the validity of statistical conclusions by analyzing the assumptions used and the robustness of the technique used.
- Probability terms and concepts
- Describe concepts such as independence- mutual exclusivity- multiplication rules- complementary probability- and joint occurrence of events.
- Probability Distributions
- Continuous distributions
- Define and distinguish between these distributions such as normal- uniform- exponential- lognormal- Weibull- Students t- and F.
- Discrete distributions
- Define and distinguish between these distributions such as binomial- Poisson- hypergeometric- and multinomial.

- Statistical Decision-Making
- Point estimates and confidence intervals
- Define- describe- and assess the bias of estimators. Calculate and interpret standard error- tolerance intervals- and confidence intervals.
- Hypothesis testing
- Define- interpret- and apply hypothesis tests for means- variances- and proportions. Apply and interpret the concepts of significance level- power- type I- and type II errors.
- Define and distinguish between statistical and practical significance.
- Paired-comparison tests
- Define and use paired-comparison (parametric) hypothesis tests and interpret the results.
- Goodness-of-fit tests
- Define and use chi square and other goodness-of-fit tests and understand the results.
- Analysis of variance (ANOVA)
- Define- use- and interpret ANOVA and interpret the results.
- Contingency tables
- Define and use contingency tables to evaluate statistical significance.

- Relationships Between Variables
- Linear regression
- Calculate simple linear regression models. Illustrate hypothesis tests for regression statistics. Use linear regression models for estimation and prediction.
- Simple linear correlation
- Calculate the correlation coefficient and its confidence interval and illustrate a hypothesis for correlation statistics.
- Time-series analysis
- Define- describe- and use time- series analysis- including moving average to identify trends and seasonal or cyclical variation.

- Statistical Process Control (SPC)
- Objectives and benefits
- Identify and explain the objectives and benefits of SPC.
- Common and special causes
- Describe- identify- and distinguish between these types of causes.
- Selection of variable
Identify and select variable characteristics for monitoring by control charts.
- Rational subgrouping
- Define and apply the principles of rational subgrouping.
- Control charts
- Identify- select- construct- and use various control charts- including X-R- X-s- individuals and moving range (ImR or XmR)- moving average and moving range (MamR)- p- np- c- and u.
- Control chart analysis
- Read and interpret control charts and use rules for determining statistical control.
- Short-run SPC
Identify and define short-run SPC rules.

- Process and Performance Capability
- Process capability studies
- Define- describe- calculate- and use process capability studies- including identifying characteristics- specifications and tolerances- developing sampling plans for such studies- and establishing statistical control.
- Process performance vs. specifications
- Distinguish between natural process limits and specification limits- and calculate percent defective- defects per million opportunities (DPMO)- and parts per million (PPM).
- Process capability indices
- Define- select- and calculate Cp- Cpk- Cpm- and Cr- and evaluate process capability.
- Process performance indices
- Define- select- and calculate Pp and Ppk- and evaluate process performance.

- Design and Analysis of Experiments
- Terminology
- Define terms such as dependent and independent variables- factors- levels- response- treatment- error- and replication.
- Planning and organizing experiments
- Identify the basic elements of designed experiments- including determining the experiment objective- selecting factors- responses- and measurement methods- and choosing the appropriate design.
- Design principles
- Define and apply the principles of power and sample size- balance- replication- order- efficiency- randomization- blocking- interaction- and confounding.
- Full-factorial experiments
- Construct full-factorial designs and use computational and graphical methods to analyze the significance of results.
- Two-level fractional factorial experiments
- Construct two-level fractional factorial designs and apply computational and graphical methods to analyze the significance of results.

- Risk Fundamentals
- Risk terminology
- Define- describe- and apply risk terminology such as risk- risk management- severity- occurrence- detection- and risk-based thinking.
- Types of risk management
- Understand and apply various types of enterprise (strategic- software- business- regulatory- medical- audit)- operational (supplier- supply chain- safety- project- manufacturing- operations- service- quality system)- and product (design- process- use- safety) risk management.

- Risk Planning and Assessment
- Risk management plan
- Analyze and interpret a risk management plan and its components (objectives- risk criteria- stakeholder identification- and team member roles/responsibilities) to identify and prioritize risks.
- Risk assessment
- Apply categorization methods and evaluation tools to assess risk such as failure mode and effects analysis.
- Identify and apply evaluation metrics including the use of risk matrices- risk priority numbers- and acceptability criteria.

- Risk Treatment- Control- and Monitoring
- Identification and documentation
- Identify risks- gaps- and controls and document with tools such as a risk register.
- Risk management system evaluation
- Apply auditing techniques and testing of controls to evaluate a risk management system.
- Risk treatment strategies
- Understand and apply risk treatment strategies- such as avoid- mitigate- transfer- and accept.
- Risk monitoring
- Apply risk monitoring techniques such as- complaint tracking- trending- and post-market surveillance.
- Mitigation planning
- Apply and interpret risk mitigation plan.