GPPQE flashcards
GPPQE · Build recall with a focused review session.
32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- PDCA cycle
- Plan-Do-Check-Act is an iterative improvement cycle: Plan establishes objectives and processes, Do implements, Check monitors against requirements, and Act improves performance.
- Quality policy
- A formal statement by top management of the organization's commitment to quality, including commitments to satisfy applicable requirements and to continual improvement.
- Management review
- A planned top-management activity to evaluate the QMS's continuing suitability, adequacy, and effectiveness, using defined inputs and producing improvement and resource decisions.
- Documented information
- Information required to be controlled and maintained by the organization, including records and documents, with controls for creation, update, access, retention, and disposition.
- Audit criteria
- The set of policies, procedures, standards, or requirements used as a reference against which objective evidence is compared during an audit.
- Audit evidence
- Records, statements of fact, or other verifiable information relevant to the audit criteria; evidence must be objective and traceable to its source.
- Third-party audit
- An audit performed by an independent external organization, such as a certification body, to assess conformity with a standard or regulation.
- Audit program
- A set of one or more audits planned for a specific time frame and directed toward a specific purpose, including scheduling, resources, and competence requirements.
- Pareto chart
- A bar chart ranking causes or categories by frequency or impact, used to identify the vital few contributors that account for most of the effect.
- Cause-and-effect diagram
- A tool that organizes potential causes of a problem into categories such as man, machine, material, method, measurement, and environment, without asserting causation.
- Control chart
- A time-ordered plot of a process statistic with a center line and control limits, used to distinguish common-cause from special-cause variation.
- Five Whys
- A root cause analysis technique that repeatedly asks why a problem occurred until the fundamental cause is identified, based on evidence rather than speculation.
- Corrective action
- Action taken to eliminate the cause of a detected nonconformity and prevent its recurrence; effectiveness must be verified with objective evidence.
- Correction
- Action to eliminate a detected nonconformity, such as rework or repair; it does not address the underlying cause and may be temporary.
- Risk treatment
- The process of selecting and implementing measures to modify risk, including avoidance, reduction, transfer, or acceptance, followed by evaluation of residual risk.
- Root cause analysis
- A structured investigation to identify the fundamental reason for a nonconformity, distinguishing root causes from contributing factors and direct causes.
- Supplier corrective action request
- A formal document issued to a supplier requiring investigation of a nonconformity, root cause analysis, corrective action, and verification of effectiveness.
- Approved supplier list
- A controlled record of suppliers authorized to provide products or services, based on defined selection criteria and periodic re-evaluation.
- Incoming inspection
- Verification activities performed on purchased products or materials before use or acceptance, based on sampling plans and defined acceptance criteria.
- Supplier scorecard
- A performance measurement tool that rates suppliers on quality, delivery, cost, and responsiveness to support monitoring and re-evaluation decisions.
- Verification
- Confirmation through objective evidence that specified requirements have been fulfilled, such as by inspection, test, demonstration, or analysis.
- Validation
- Confirmation through objective evidence that requirements for a specific intended use or application have been fulfilled under actual or simulated conditions.
- Process validation
- Documented evidence that a process consistently produces product meeting predetermined specifications, typically including installation, operational, and performance qualification.
- Control plan
- A document that identifies product and process characteristics, the controls applied, sampling frequency, and reaction plans for each production phase.
- Gauge R&R
- A measurement system analysis that estimates repeatability (equipment variation) and reproducibility (appraiser variation) as components of measurement variation.
- Cp and Cpk
- Process capability indices; Cp compares specification width to process spread (6σ), while Cpk accounts for process centering relative to specification limits.
- Type I error
- The probability (α) of rejecting a true null hypothesis, also known as producer's risk in acceptance sampling.
- Type II error
- The probability (β) of failing to reject a false null hypothesis, also known as consumer's risk in acceptance sampling.
- Stratified sampling
- A sampling method in which the population is divided into homogeneous subgroups (strata) and random samples are drawn from each stratum.
- p-value
- The probability of obtaining a result at least as extreme as the observed result, assuming the null hypothesis is true; compared with α to decide significance.
- Conflict of interest
- A situation where professional judgment could be influenced by personal, financial, or other interests; it must be disclosed and managed.
- Confidentiality
- The ethical obligation to protect client information from unauthorized disclosure, except when required by law or authorized by the client.