Mixed Deck — All CQE Topics Flashcards

The standard design for a crossed Gauge R&R study per AIAG MSA guidelines typically includes:

Answer: 2 or 3 operators, 10 parts, and 2 or 3 measurement trials per part per operator

AIAG recommends 2–3 operators, 10 parts, and 2–3 trials, providing sufficient data to estimate both repeatability and reproducibility while remaining practical to conduct.

Risk-based thinking in ISO 9001:2015 primarily aims to:

Answer: Prevent undesirable outcomes and pursue opportunities proactively

Risk-based thinking enables organizations to determine factors that could cause their processes and QMS to deviate from planned results, taking preventive action and exploiting opportunities.

During a quality audit, the auditor finds that a corrective action was implemented but the root cause was not verified as eliminated. This is BEST classified as:

Answer: An ineffective corrective action requiring follow-up

Corrective actions must address root cause and be verified for effectiveness; unverified actions represent an ineffective CAR requiring follow-up.

Which tool is used to systematically evaluate and rank alternative solutions using weighted criteria?

Answer: Decision matrix (weighted criteria matrix)

A decision matrix applies weighted scores to each alternative against defined criteria, enabling objective comparison and selection.

In Failure Mode and Effects Analysis (FMEA), the Risk Priority Number (RPN) is calculated as:

Answer: Severity × Occurrence × Detection

RPN = Severity × Occurrence × Detection, and is used to prioritize which failure modes require corrective action.

A quality engineer is conducting a gage R&R study. A high percentage of variation attributed to reproducibility indicates:

Answer: Different appraisers are measuring inconsistently

Reproducibility variation reflects differences between appraisers using the same gage, pointing to operator-related measurement inconsistency.

Which type of control chart is most appropriate for monitoring the number of defects per unit when the sample size varies?

Answer: u chart

The u chart tracks defects per unit and accommodates variable subgroup sizes, unlike the c chart which requires constant sample size.

What is the primary purpose of a Fault Tree Analysis (FTA)?

Answer: To identify combinations of events that could lead to a top-level undesired event

FTA is a top-down, deductive analysis that uses Boolean logic to identify all possible combinations of hardware failures, human errors, and external events that could cause a specific undesired top event.

Which sampling plan standard is most commonly referenced for attribute sampling in the United States?

Answer: ANSI/ASQ Z1.4

ANSI/ASQ Z1.4 is the primary US standard for attribute sampling inspection by attributes, widely used in manufacturing and procurement.

SIPOC stands for what?

Answer: Supplier Input Process Output Customer

SIPOC stands for Supplier, Input, Process, Output, Customer. It is a visual tool used in process improvement and Six Sigma methodologies to map out the high-level view of a process.

Which of the following best describes 'audit sampling' in quality auditing?

Answer: Selecting a representative portion of records or activities to evaluate the whole

Audit sampling involves examining a representative subset of records, transactions, or activities to draw conclusions about the overall conformance of the system being audited.

A quality team uses a cause-and-effect diagram. Which of the following best describes its primary purpose?

Answer: Identify root causes of a problem

The Ishikawa (fishbone) diagram organizes potential causes into categories to identify root causes of a quality problem.

Which of the following quality authorities is opposed to individual bonuses and merit pay? He was against objective-based management and staff performance reviews.

Answer: Dr. Deming

Dr. Deming is the quality authority who had a negative view on merit pay, individual bonuses, management by objectives, and performance evaluations for personnel. He was a prominent figure in the field of quality management and is known for his contributions to the development of Total Quality Management (TQM) principles. Dr. Deming emphasized the importance of focusing on system-level improvements, teamwork, and intrinsic motivation rather than relying on individual incentives or evaluations. He believed that the responsibility for quality improvement lies with management and that individual rewards and punishments can be counterproductive to achieving overall organizational success.

What is the purpose of a Design of Experiments (DOE) in quality and reliability improvement?

Answer: To systematically vary input factors and measure effects to understand cause-and-effect relationships

DOE efficiently identifies which input variables significantly affect process outputs by systematically varying multiple factors simultaneously, enabling optimization with fewer experiments than one-at-a-time testing.

In a Measurement System Analysis (MSA), 'reproducibility' refers to variation caused by:

Answer: Different operators measuring the same part

Reproducibility measures the variation introduced when different operators use the same instrument to measure the same part, reflecting operator-to-operator inconsistency.

Juran's Quality Trilogy consists of three processes. Which of the following is NOT one of them?

Answer: Quality assurance

Juran's Trilogy consists of quality planning, quality control, and quality improvement — not quality assurance.

A company tracks customer complaints, field failures, and returned goods. These metrics primarily measure which cost of quality category?

Answer: External failure

Customer complaints, field failures, and returns occur after product delivery, making them external failure costs.

In acceptance sampling, the Lot Tolerance Percent Defective (LTPD) represents:

Answer: The quality level at which lots should be rejected with a high probability (consumer's risk protection)

LTPD (also called Rejectable Quality Level) is the poorest quality level the consumer is willing to accept with only a small probability (typically 10%), defining the consumer's risk point on the OC curve.

What is the purpose of a Quality Function Deployment (QFD) House of Quality?

Answer: Translating customer requirements into technical product characteristics

QFD's House of Quality is a planning matrix that translates customer 'voice' (requirements) into specific technical characteristics and engineering targets for product design.

What is the key difference between validation and verification in product development?

Answer: Verification confirms the product meets user needs; validation confirms design outputs meet input requirements

Verification confirms that design outputs meet design input requirements (are you building it right?), while validation confirms the product meets customer needs in its intended use (are you building the right thing?).