Engineer Quality Management flashcards
Engineer Quality Management · 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.
- ISO 9001 clause 9.2
- Requires internal audits at planned intervals, considering process importance, changes affecting the organization, and prior audit results, with documented results reported to management.
- Documented information
- ISO 9001:2015 term covering both documents that must be maintained, such as procedures, and records that must be retained as evidence of results.
- Process approach
- Managing the organization as a system of interrelated processes with defined inputs, outputs, sequence, interaction, owners, and performance indicators, rather than as isolated functions.
- Hoshin kanri catchball
- The negotiation step in policy deployment where targets and means are discussed and agreed between management levels before commitment, aligning objectives with operational reality.
- Quality function deployment
- A planning method that converts customer requirements into technical requirements using a relationship matrix, competitive assessment, and correlation roof, commonly called the house of quality.
- APQP phases
- Five phases: plan and define, product design and development, process design and development, product and process validation, and feedback, assessment, and corrective action.
- Cp and Cpk
- Cp equals specification width divided by six sigma and ignores centering. Cpk uses the nearer specification limit divided by three sigma and reflects both spread and off-centering.
- Western Electric rules
- Signal rules for control charts: one point beyond three sigma, two of three beyond two sigma, four of five beyond one sigma, eight consecutive on one side.
- p versus c chart
- A p chart tracks the proportion defective with variable subgroup size. A c chart tracks the count of defects per unit with constant opportunity.
- Rational subgrouping
- Selecting subgroups so that variation within a subgroup reflects only common causes while variation between subgroups captures shifts, maximizing chart sensitivity.
- GR&R
- Gauge repeatability and reproducibility study that estimates variation from repeated measurements by one appraiser and variation between appraisers, expressed as a percentage of study or tolerance variation.
- Number of distinct categories
- A gauge discrimination index computed as 1.41 times process variation divided by gauge variation; values of five or more indicate the gauge can resolve process changes.
- Linearity
- The change in measurement bias across the operating range of an instrument, assessed by regressing bias against reference values.
- Resolution rule of ten
- Measurement resolution should be at most one tenth of the tolerance or process variation, so rounding does not distort capability indices or acceptance decisions.
- Resolution IV design
- A fractional factorial design in which main effects are clear of two-factor interactions, but two-factor interactions are aliased with each other.
- Taguchi loss function
- A quadratic function stating that quality loss grows with the square of the deviation from target, so any deviation causes loss even within specification.
- FMEA RPN
- Risk priority number computed as severity times occurrence times detection, used to rank failure modes for action, with severity considered separately for high-risk cases.
- Blocking in DOE
- Grouping experimental runs to remove known nuisance variation, with randomization applied within blocks and block effects tested before factor effects are interpreted.
- Correction versus corrective action
- A correction fixes the detected nonconformity itself, while corrective action eliminates its root cause to prevent recurrence.
- Effectiveness check
- Objective verification over a defined period that a corrective action actually eliminated the nonconformity and prevented recurrence, required before closing a CAPA.
- Fault tree analysis
- A top-down deductive method starting from an undesired event and using AND/OR gates to identify combinations of basic causes that produce it.
- Producer and consumer risk
- Producer risk alpha is the probability of rejecting a good lot; consumer risk beta is the probability of accepting a bad lot in acceptance sampling.
- AQL
- Acceptable quality level in sampling standards, the quality level corresponding to a specified low probability of lot rejection; it is not a defect target.
- PPAP
- Production part approval process requiring evidence such as process flow, PFMEA, control plan, MSA, dimensional results, and material tests before production release.
- Skip-lot inspection
- Reducing incoming inspection frequency after a defined number of consecutive accepted lots, suspended immediately when a lot is rejected.
- Audit finding structure
- A finding must state the requirement, the objective evidence observed, and the gap between them; opinions or undocumented observations are not findings.
- Third-party audit
- An audit performed by an independent certification or regulatory body, distinct from first-party internal audits and second-party supplier audits.
- Auditor impartiality
- The requirement that auditors not audit their own work or have operational responsibility for the area under review, preserving objectivity.
- DMAIC
- Six Sigma improvement sequence: Define, Measure, Analyze, Improve, Control, applied to existing processes, while DMADV applies to new designs.
- OEE
- Overall equipment effectiveness, computed as availability times performance times quality, measuring equipment output against ideal cycle time.
- Takt time
- Available production time divided by customer demand, setting the pace at which a process must produce to meet customer requirements.
- TIMWOODS wastes
- Eight lean wastes: transport, inventory, motion, waiting, overproduction, overprocessing, defects, and skills underutilization.