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CQE exam Format | CQE Course Contents | CQE Course Outline | CQE exam Syllabus | CQE exam Objectives

- 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 exam 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 Improve 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.

- demo integrity

- Identify and apply techniques for establishing and maintaining demo 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 demo 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 exam

- 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.

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