Engineer Quality Management study materials
Engineer Quality Management study resources

Engineer Quality Management cheat sheet

Engineer Quality Management · Keep the key ideas within reach.

Quick reference

Quality Management Systems and Standards

  • ISO 9001:2015 is built on seven quality management principles: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.

  • ISO 9001:2015 has 10 clauses: 1 Scope, 2 Normative references, 3 Terms and definitions, 4 Context of the organization, 5 Leadership, 6 Planning, 7 Support, 8 Operation, 9 Performance evaluation, 10 Improvement.

  • Clauses 4-10 contain the auditable requirements; clauses 1-3 are informational and cannot be used for nonconformity findings.

  • The process approach requires identifying process inputs, outputs, sequence, interaction, owners, and performance indicators; the PDCA cycle and risk-based thinking are applied to each process.

  • Documented information replaces the old terms 'documents' and 'records': retain records as evidence of results, maintain documents as instructions or rules.

  • ISO 9001:2015 clause 6.1 requires planning actions to address risks and opportunities; there is no separate formal risk-management standard required, and no requirement for a documented risk register.

  • ISO 9001 certification is issued by an accredited certification body (third party); internal audits are first party and supplier audits are second party.

  • ISO 19011 provides guidance for auditing management systems: principles include integrity, fair presentation, due professional care, confidentiality, independence, and an evidence-based approach.

  • ISO 9000:2015 contains the fundamental terms and definitions; ISO 9004 gives guidance for sustained success and is not a certification standard.

Quick reference

Quality Planning and Strategic Deployment

  • Hoshin kanri (policy deployment) cascades annual objectives from top management to operational levels; the catchball step negotiates targets and means between levels before commitment.

  • A X-matrix links long-term objectives, annual objectives, improvement priorities, and targets with correlation symbols, giving one-page traceability of strategy to action.

  • QFD translates customer requirements (the 'whats') into technical requirements (the 'hows') using a relationship matrix; the roof matrix records interactions among technical requirements.

  • In QFD, importance ratings are computed as the sum over customer requirements of (customer importance x relationship weight); relationship weights are commonly 9 strong, 3 medium, 1 weak.

  • The house of quality sequence is: customer requirements, competitive assessment, technical requirements, relationship matrix, technical targets, and correlation roof.

  • A quality plan per ISO 10005 defines the specific procedures, resources, responsibilities, and timing for a product, project, or contract.

  • APQP is a five-phase product quality planning structure: plan and define, product design and development, process design and development, product and process validation, feedback and corrective action.

  • Strategic deployment must be measurable: each objective needs a metric, baseline, target, owner, and review cadence; unassigned targets are the most common deployment failure point.

  • Cost of poor quality splits into internal failure, external failure, appraisal, and prevention; prevention spending typically reduces total quality cost more than appraisal spending.

Quick reference

Statistical Process Control and Process Capability

  • Control chart selection: variables data uses X-bar/R (n=2-9) or X-bar/S (n>=10); individuals data uses I-MR; attributes use p, np, c, or u charts.

  • p chart = proportion defective, variable subgroup size; np chart = number defective, constant subgroup size; c chart = count of defects per unit, constant opportunity; u chart = defects per unit, variable opportunity.

  • X-bar chart limits use A2 x R-bar; R chart limits use D3 x R-bar and D4 x R-bar; constants depend on subgroup size n.

  • Western Electric rules: 1 point beyond 3 sigma; 2 of 3 consecutive points beyond 2 sigma; 4 of 5 beyond 1 sigma; 8 consecutive points on one side of the centerline.

  • Cp = (USL - LSL) / (6 sigma); Cpk = min[(USL - mean), (mean - LSL)] / (3 sigma). Cpk accounts for centering, Cp does not.

  • Pp and Ppk use the overall sample standard deviation; Cp and Cpk use within-subgroup sigma estimated from average range or average standard deviation.

  • Process capability requires a stable process; calculating Cpk on an out-of-control chart produces a meaningless index.

  • A Cpk of 1.33 corresponds to roughly 63 defects per million opportunities for a centered normal process; 1.67 corresponds to about 0.6 ppm.

  • Attribute capability uses defect rate p and the binomial or Poisson distribution; a Poisson model is valid when defects per unit are rare and independent.

Quick reference

Measurement Systems Analysis and Metrology

  • GR&R studies decompose variation into repeatability (equipment variation) and reproducibility (appraiser variation); total gauge variation combines both.

  • Percent GR&R = 100 x (GR&R standard deviation / total study variation) or as a percentage of tolerance; AIAG guidance: under 10% acceptable, 10-30% conditionally acceptable, over 30% unacceptable.

  • Number of distinct categories (ndc) = 1.41 x (process variation / gauge variation); ndc of 5 or more is generally required to use a gauge for process control.

  • Bias is the difference between the average measured value and the reference value; linearity is the change in bias across the operating range.

  • Stability is the change in bias over time, evaluated with a control chart of repeated measurements on a reference standard.

  • Resolution should be at most one tenth of the tolerance or one tenth of the process variation to avoid rounding-induced capability errors.

  • Attribute agreement analysis reports within-appraiser agreement and agreement versus a known standard; kappa adjusts for chance agreement.

  • Calibration establishes the relationship between instrument readings and a reference traceable to national or international standards; verification checks that calibration remains valid.

  • Measurement uncertainty is reported as an interval about the result, typically using a coverage factor k=2 for approximately 95% confidence.

Quick reference

Design of Experiments and Quality Engineering Methods

  • DOE objective hierarchy: screening (many factors, few runs), characterization (main effects and interactions), optimization (response surface), and robust design (tolerance to noise).

  • Full factorial with k factors at 2 levels requires 2^k runs; a fractional factorial 2^(k-p) uses a resolution equal to the smallest sum of generator words.

  • Resolution III designs alias main effects with two-factor interactions; Resolution IV alias two-factor interactions with each other; Resolution V alias main effects with four-factor interactions, so two-factor interactions are clear.

  • Randomization protects against nuisance factors; blocking removes known sources of variability; replication provides an independent estimate of pure error.

  • ANOVA in DOE partitions total sum of squares into model and residual; a factor is significant when its p-value is below alpha and its effect exceeds practical importance.

  • Taguchi methods use orthogonal arrays, signal-to-noise ratios, and loss functions; smaller-the-better, larger-the-better, and nominal-the-best SN ratios are the three standard forms.

  • The quality loss function L = k(y - T)^2 shows loss grows quadratically with deviation from target, so conformance to specification alone understates loss.

  • FMEA uses severity, occurrence, and detection ratings (typically 1-10) with RPN = S x O x D; action priority should consider severity even when RPN is moderate.

  • Poka-yoke prevents errors at the source through physical or design constraints rather than relying on operator vigilance.

Quick reference

Root Cause Analysis and Corrective/Preventive Action

  • Correction fixes the symptom; corrective action removes the cause of a detected nonconformity; preventive action removes the cause of a potential nonconformity.

  • The 5 Whys must follow the physical or causal chain, not opinions; each 'why' answer becomes the subject of the next question until the systemic cause is reached.

  • Fishbone (Ishikawa) categories in manufacturing are commonly Man, Machine, Material, Method, Measurement, and Environment (6M).

  • Fault tree analysis works top-down from an undesired event using AND/OR gates; FMEA works bottom-up from failure modes.

  • A Pareto chart identifies the vital few contributors; root cause analysis should start with the largest contributor unless safety or regulatory risk dictates otherwise.

  • A good problem statement includes what, where, when, how much, and the gap versus standard, and contains no cause or solution language.

  • Verification confirms the implemented action was done as planned; validation confirms the action actually eliminated the nonconformity or prevented recurrence.

  • Effectiveness checks require objective evidence over a defined period; closing a CAPA without an effectiveness check leaves recurrence risk unaddressed.

  • Is/is-not analysis narrows the problem by contrasting where the defect occurs versus where it does not, revealing distinguishing factors.

Quick reference

Supplier Quality and Incoming Material Control

  • Supplier selection criteria typically include capability (Cpk), quality system certification, capacity, financial stability, and past performance.

  • Incoming inspection sampling plans follow ANSI/ASQ Z1.4 (attributes) or Z1.9 (variables); the plan is defined by lot size, inspection level, and AQL.

  • In the OC curve, producer's risk (alpha) is the probability of rejecting a good lot; consumer's risk (beta) is the probability of accepting a bad lot.

  • AQL is the quality level that corresponds to a specified low probability of acceptance; it is not a defect target for the supplier.

  • Skip-lot inspection reduces inspection frequency after a defined number of consecutive accepted lots; it must be suspended immediately after a rejected lot.

  • A supplier quality agreement defines specifications, change notification, traceability, audit rights, and nonconformity response times.

  • PPAP requires submission of design records, engineering change documents, process flow, PFMEA, control plan, MSA, dimensional results, material tests, and a part submission warrant.

  • First article inspection verifies the first production parts against all drawing characteristics before full production release.

  • Supplier scorecards combine quality (PPM, nonconformities), delivery, and responsiveness; scores should drive escalation or development actions.

Quick reference

Auditing, Inspection, and Compliance

  • Audit types: first-party (internal), second-party (supplier), third-party (certification or regulatory); each has different independence requirements.

  • An audit finding must cite the requirement, the objective evidence, and the gap; opinions or undocumented observations are not nonconformities.

  • Nonconformity grading commonly distinguishes major (system failure or risk of escape) from minor (isolated lapse); repeat findings are usually escalated.

  • The audit process follows ISO 19011: objectives, scope, criteria, team selection, document review, opening meeting, evidence collection, findings, closing meeting, report, and follow-up.

  • Sampling in audits must be justified by risk and process volume; convenience sampling alone is weak evidence of system effectiveness.

  • Inspection can be receiving, in-process, or final; inspection alone cannot create quality and should be reduced as process capability improves.

  • Gauge calibration records, control plans, and traceability records are the highest-frequency audit evidence requests.

  • Regulatory compliance differs from voluntary certification: noncompliance can carry legal penalties, while ISO 9001 certification is contractual and market driven.

  • Auditor competence includes sector knowledge, audit technique, and communication; impartiality requires excluding auditors from auditing their own work.

Quick reference

Continuous Improvement and Lean Six Sigma

  • DMAIC phases: Define, Measure, Analyze, Improve, Control; DMADV (Design for Six Sigma) applies to new processes and products.

  • Lean waste categories (TIMWOODS): Transport, Inventory, Motion, Waiting, Overproduction, Overprocessing, Defects, and Skills underutilization.

  • Value stream mapping distinguishes value-added time from lead time; the ratio of value-added time to total lead time is the process cycle efficiency.

  • Kaizen is continuous incremental improvement by the people doing the work; kaizen events are time-boxed and target a specific process area.

  • 5S steps: Sort, Set in order, Shine, Standardize, Sustain; the fifth step is the one most often missing and determines durability.

  • OEE = Availability x Performance x Quality; it measures equipment effectiveness against ideal cycle time and is not a substitute for capacity planning.

  • Takt time = available production time / customer demand; it sets the pace, not the actual cycle time.

  • Kanban limits work in process and pulls material only when downstream consumption signals demand.

  • A control plan in the Control phase specifies the metric, sample size, frequency, owner, and reaction plan for each key process characteristic.

Quick reference

Continuous Improvement and Lean Six Sigma (Supplementary)

  • Six Sigma corresponds to 3.4 defects per million opportunities when the process mean shifts 1.5 sigma over time.

  • A SIPOC diagram defines Suppliers, Inputs, Process, Outputs, and Customers at the Define phase boundary; it is a scope tool, not a detailed process map.

  • Hypothesis testing in Analyze uses a p-value compared to alpha; failing to reject the null is not proof that the null is true.

  • Measurement system validation must precede capability analysis in the Measure phase; a poor gauge invalidates both baseline and improvement claims.

  • Standard work documents the current best method with cycle time, work sequence, and standard inventory, and is the baseline for further improvement.

  • Poka-yoke and jidoka (stop at defect) support built-in quality rather than inspection-based quality.

  • A3 problem solving captures background, current condition, target, root cause, countermeasures, and follow-up on one page to force concise thinking.

Quick reference

Quality Management Systems and Standards (Supplementary)

  • ISO 9001:2015 clause 9.2 requires internal audits at planned intervals considering process importance, changes, and prior audit results.

  • Clause 8.5.1 requires controlled conditions for production, including availability of work instructions and monitoring equipment.

  • Clause 10.2 requires retaining documented information on the nature of nonconformities, actions taken, and results of corrective action.

  • Clause 7.5 requires documented information to be controlled for availability, protection, and retention; version control is the most common audit finding.

  • The certification cycle is a three-year cycle with annual surveillance audits and a recertification audit before expiry.

  • A nonconformity cited in a certification audit must be corrected within a defined period, and the corrective action must address root cause, not only the finding.

Quick reference

Quality Planning and Strategic Deployment (Supplementary)

  • The control plan is a planning deliverable that lists product and process characteristics, specifications, measurement methods, sample sizes, frequencies, and reaction plans.

  • A feasibility commitment in APQP records whether the supplier can meet capacity, tolerance, and timing requirements before design release.

  • A design review is a planned, documented examination of design outputs against requirements at defined stages; it is not a sign-off formality.

  • Quality function deployment should be re-run when customer requirements change materially; a stale matrix misdirects resources.

  • Balanced scorecard links quality, delivery, cost, and people metrics so that quality objectives are not traded away for output.

  • Annual quality objectives must be consistent with the quality policy and measurable; clause 6.2 requires planning who, what, resources, timing, and evaluation.

Quick reference

Statistical Process Control and Process Capability (Supplementary)

  • A process in statistical control has variation from common causes only; special-cause variation appears as a signal on a control chart.

  • Control limits are computed from process data and are not specification limits; specification limits come from design requirements.

  • Rational subgrouping minimizes variation within a subgroup and maximizes variation between subgroups so that shifts are detected.

  • The average run length (ARL) describes how many points are plotted before a signal; ARL0 applies to a stable process, ARL1 to a shifted process.

  • For a centered process, Cpk equals Cp; any off-centering makes Cpk smaller than Cp.

  • A Cpk below 1.0 means the process produces nonconforming output even when stable; process improvement is required, not tighter inspection.

Quick reference

Measurement Systems Analysis and Metrology (Supplementary)

  • A Type 1 study evaluates repeatability of one gauge against a reference standard with one appraiser.

  • A linearity study regresses bias against reference values; a significant slope indicates the gauge reads differently across its range.

  • Destructive testing uses nested GR&R designs because parts cannot be measured repeatedly by the same appraiser.

  • Calibration intervals should be set from drift history and criticality, not copied from a default calendar.

  • Traceability chain: working standard, reference standard, national standard, and SI definition; each link must be documented.

  • Attribute gauges require agreement studies because GR&R in the variables sense does not apply to pass/fail decisions.

Quick reference

Design of Experiments and Quality Engineering Methods (Supplementary)

  • A screening design should not be used to estimate interactions unless resolution permits; follow with a characterization design.

  • Center points in a 2-level design test for curvature; a significant curvature term means the response is not linear and a response surface design is needed.

  • Confounding means effects cannot be separated; aliasing structure is read from the design generators.

  • Robust design places the design point where the response is least sensitive to noise factors, not necessarily at the response maximum.

  • A confirmation run at the predicted optimum is required before adopting DOE results into production.

  • Sample size in DOE depends on the effect size to detect, the noise standard deviation, alpha, and power; underpowered experiments produce false negatives.

Quick reference

Root Cause Analysis and Corrective/Preventive Action (Supplementary)

  • Human error is usually a symptom; look for the process conditions that made the error possible or undetectable.

  • Containment actions protect the customer immediately and are temporary; they must be replaced by permanent corrective action.

  • A CAPA record should link the nonconformity, root cause, action, owner, due date, verification, and effectiveness evidence.

  • Recurrence of the same nonconformity indicates the root cause was not addressed or the effectiveness check was inadequate.

  • Brainstorming and cause-and-effect diagrams generate candidate causes; data analysis is required to confirm which cause is real.

  • Change control must be applied to corrective actions that alter a validated process, drawing, or specification.

Quick reference

Supplier Quality and Incoming Material Control (Supplementary)

  • Critical characteristics should be identified on the drawing and control plan and verified at receiving when supplier capability is unproven.

  • A supplier corrective action request (SCAR) requires containment, root cause, corrective action, and verification of effectiveness from the supplier.

  • Incoming inspection records must include lot identity, sample size, acceptance criteria, results, and disposition.

  • Supplier development differs from supplier selection: development raises capability through training, audits, and joint improvement projects.

  • A certificate of conformance is a supplier declaration, not independent evidence; it should be supplemented by periodic verification.

  • Approved supplier list maintenance requires periodic re-evaluation based on performance data, not only initial qualification.

Quick reference

Auditing, Inspection, and Compliance (Supplementary)

  • The audit program must consider risk and prior results when setting frequency and scope.

  • Audit evidence includes records, interviews, and observation; interviews alone are weaker than records plus observation.

  • The closing meeting presents findings and agrees on corrective action timing; the audit report is issued afterward.

  • A surveillance audit focuses on changes, previous findings, and continued conformity rather than a full system review.

  • Inspection planning should define the characteristic, method, sample, acceptance criterion, and reaction to nonconformance before inspection begins.

  • Compliance to customer-specific requirements is audited separately from ISO 9001 and often carries stricter evidence expectations.

Quick reference

Continuous Improvement and Lean Six Sigma (Supplementary)

  • A root cause verified in Analyze must be linked to a countermeasure in Improve; unrelated improvements break the DMAIC logic.

  • The Control phase must include a response plan for out-of-control signals, otherwise gains decay after the project closes.

  • Statistical significance does not guarantee practical significance; effect size and cost determine whether a change is worth implementing.

  • A pilot run validates the improvement before full deployment and exposes unintended side effects.

  • Project charters define the problem, goal, scope, team, and business case, and prevent scope creep during DMAIC.

  • Standardizing the improved method and retraining are required to sustain gains after the project team disbands.

Quick reference

Quality Management Systems and Standards (Additional)

  • Risk-based thinking in ISO 9001 does not mandate a formal risk methodology; the organization defines its approach and retains evidence of planning.

  • Outsourced processes must be controlled and their conformity ensured; the control method depends on the risk the process presents.

  • The quality policy must be appropriate to purpose, include commitment to requirements and improvement, and be communicated and available.

  • Top management must demonstrate leadership by ensuring resources and integrating quality requirements into business processes, not only by delegating to a quality manager.

  • Clause 8.7 requires control of nonconforming outputs with documented information on the nonconformity, actions, concessions, and identification of the authority deciding the action.

  • A concession is permission to use or release nonconforming product under specified limits, usually with customer agreement and limited duration.

Quick reference

Quality Planning and Strategic Deployment (Additional)

  • Deployment matrices translate top-level objectives into department and team targets; gaps between rows indicate unowned objectives.

  • A quality plan should reference the applicable control plan, inspection plan, and acceptance criteria rather than restating them.

  • Design for manufacturability reviews reduce downstream variation by aligning tolerances with process capability during design.

  • Cost of quality reporting should separate prevention, appraisal, internal failure, and external failure so improvement priorities are visible.

  • Strategic quality objectives should be reviewed at management review with trend data, not only pass/fail status.

  • A project quality plan for a contract defines deliverables, acceptance criteria, and inspection points agreed with the customer.

Quick reference

Statistical Process Control and Process Capability (Additional)

  • Out-of-control signals must be investigated for assignable cause before any capability index is computed.

  • The moving range chart for individuals data uses the average moving range of consecutive points; limits use E2 and D4 constants.

  • A p chart with a small average number of defectives per subgroup (np under about 5) is unreliable; use a c or u chart for counts instead.

  • Process capability studies require at least 25 subgroups or 100 individual points to estimate sigma reliably.

  • Specification limits placed inside control limits indicate the process cannot meet requirements even when stable.

  • Capability improvement should target centering first when Cpk is much lower than Cp, then variation reduction.

Quick reference

Measurement Systems Analysis and Metrology (Additional)

  • GR&R as a percentage of tolerance is the correct metric when the gauge is used for acceptance decisions against specifications.

  • Reproducibility is influenced by appraiser technique and training; repeatability is influenced by the gauge, fixture, and part variation.

  • A gauge that passes GR&R but has poor stability over time will produce drifting capability results.

  • Calibration certificates should state the reference standard, uncertainty, environmental conditions, and the as-found and as-left readings.

  • Out-of-tolerance calibration results require an impact assessment on product measured since the last valid calibration.

  • Resolution finer than needed increases cost without improving capability; resolution coarser than one tenth of tolerance introduces measurement error into decisions.

Quick reference

Design of Experiments and Quality Engineering Methods (Additional)

  • Interaction plots show whether the effect of one factor depends on the level of another; parallel lines indicate no interaction.

  • Main effects plots show the average response at each factor level, ignoring interactions, and can mislead when interactions are strong.

  • A response surface design such as central composite or Box-Behnken estimates quadratic effects and locates an optimum.

  • Blocking should be randomized within blocks, and block effects should be tested before interpreting factor effects.

  • The power of a DOE increases with the number of replicates and decreases with noise; pilot runs estimate noise before the full experiment.

  • Factor levels should span the actual operating range; levels too close together produce effects indistinguishable from noise.

Quick reference

Root Cause Analysis and Corrective/Preventive Action (Additional)

  • The 8D method proceeds through team formation, problem description, containment, root cause, corrective action selection, implementation, prevention, and recognition.

  • A root cause must be both necessary and sufficient to explain the observed nonconformity; a plausible cause that cannot reproduce the effect is not confirmed.

  • Detection failures are causes too: a defect that escapes inspection points to a control-plan or gauge weakness.

  • Corrective actions should be prioritized by risk reduction, not by ease of implementation alone.

  • Preventive action can be triggered by trend analysis, risk assessment, or FMEA, not only by an actual nonconformity.

  • Lessons learned should be fed back into FMEA, control plans, and standard work to prevent recurrence across similar processes.

Quick reference

Supplier Quality and Incoming Material Control (Additional)

  • Supplier audits should focus on the processes and characteristics that affect the supplied product, not only on documentation completeness.

  • Incoming sampling plans must state the lot definition; mixed lots invalidate the sampling assumption.

  • A rejected lot requires documented disposition: return, rework, sort, or concession with customer approval.

  • Supplier process capability data should be verified by the supplier's own MSA before being accepted as evidence.

  • Change notification requirements should cover process, material, sub-supplier, and facility changes.

  • Long-term supplier agreements should include quality targets, escalation paths, and audit access.

Quick reference

Auditing, Inspection, and Compliance (Additional)

  • Audit criteria are the set of requirements used as a reference; findings must be traceable to a specific criterion.

  • Opening meetings confirm scope, criteria, schedule, and confidentiality, and give the auditee a chance to raise constraints.

  • Audit trails should be sampled from records back to the process, not only from the process forward to records.

  • Findings should be written so the auditee can verify the evidence independently; vague findings cannot be closed effectively.

  • Follow-up audits verify that corrective actions were implemented and effective, not merely planned.

  • Auditor independence is compromised if the auditor has operational responsibility for the area being audited.

Quick reference

Continuous Improvement and Lean Six Sigma (Additional)

  • The Define phase should quantify the business case and the gap between current and target performance.

  • The Measure phase establishes a validated baseline; without it, improvement claims cannot be substantiated.

  • The Analyze phase should confirm causes with data rather than accepting the team's first hypothesis.

  • The Improve phase should pilot and verify the effect with the same measurement system used for the baseline.

  • The Control phase transfers ownership to the process owner with a documented monitoring plan.

  • Lean and Six Sigma complement each other: Lean removes non-value-added flow waste, Six Sigma reduces variation in value-added steps.

Quick reference

Quality Management Systems and Standards (Final)

  • Management review inputs include audit results, nonconformities, performance trends, resource adequacy, and risks; outputs include improvement and resource decisions.

  • Competence requirements in clause 7.2 require determining necessary competence, ensuring it, and retaining evidence.

  • Customer property must be identified, protected, and safeguarded, with records of loss or damage reported to the customer.

  • Monitoring and measuring resources must be suitable and maintained; when found unfit, the organization must assess the validity of prior results.

  • Documented information from external providers must be controlled to the extent necessary for conformity.

  • The process approach requires performance indicators for processes, not only for final product.

Quick reference

Quality Planning and Strategic Deployment (Final)

  • Hoshin kanri reviews use monthly and quarterly checkpoints to adjust means while keeping annual targets stable.

  • A strategy map links learning and growth, process, customer, and financial perspectives so quality improvements connect to business outcomes.

  • Quality planning should identify special characteristics early, since late discovery forces costly design or process changes.

  • Deployment without resource allocation is a plan, not a commitment; budgets and staffing must follow the objectives.

  • Risk assessment during planning should consider both threats and opportunities, with actions proportional to impact.

  • Customer requirement reviews before acceptance of orders prevent later nonconformity and disputes.

Quick reference

Statistical Process Control and Process Capability (Final)

  • A control chart distinguishes common-cause from special-cause variation; reacting to common-cause noise increases variation.

  • Control limit recalculation is justified only after a documented permanent process change.

  • A process can be in control and still incapable; control and capability answer different questions.

  • The Cpk target should be set by criticality: safety-critical characteristics often require 1.67 or higher.

  • Attribute control charts are less sensitive than variables charts and need larger samples to detect shifts.

  • Capability studies must use a measurement system with acceptable GR&R, or the index reflects gauge error.

Quick reference

Measurement Systems Analysis and Metrology (Final)

  • GR&R study design: 10 parts spanning the process range, 3 appraisers, 3 trials, randomized order.

  • The range method of GR&R is quick but cannot separate repeatability from reproducibility.

  • ANOVA GR&R can detect appraiser-by-part interaction, which the average and range method cannot.

  • A gauge used only for sorting may tolerate higher GR&R than one used for process control.

  • Measurement error adds to observed variation; observed capability is worse than true capability when the gauge is poor.

  • Calibration traceability must be documented for every gauge used to accept product.

Quick reference

Design of Experiments and Quality Engineering Methods (Final)

  • A 2^(k-p) design has p generators; the defining relation determines the alias structure and resolution.

  • Resolution IV designs are appropriate for screening when two-factor interactions may exist but main effects must stay clear.

  • Folding a Resolution III design over creates a Resolution IV design that separates main effects from two-factor interactions.

  • Randomization order must be recorded and followed; reordering runs invalidates the statistical assumptions.

  • Response surface methodology uses steepest ascent to move toward the optimum, then a quadratic model to locate it.

  • Tolerance design sets component tolerances from the loss function and the sensitivity of the response to each component.

Quick reference

Root Cause Analysis and Corrective/Preventive Action (Final)

  • A problem description should include the defect, location, time pattern, quantity, and the standard it violates.

  • Cause verification can use designed experiments, stratified data, or reproduction of the defect under suspected conditions.

  • Corrective action should address the systemic cause, such as a missing control or unclear standard, not just the individual error.

  • Effectiveness verification should run long enough to cover the conditions under which the problem originally occurred.

  • CAPA metrics such as open age, recurrence rate, and overdue actions indicate system health.

  • A corrective action that creates a new risk requires risk assessment before implementation.

Quick reference

Supplier Quality and Incoming Material Control (Final)

  • Supplier qualification should include a capability assessment, not only a certificate review.

  • Incoming inspection levels should be adjusted based on supplier performance history and criticality.

  • A first article inspection report should cover every drawing characteristic with measured values, not pass/fail only.

  • Supplier nonconformity data should feed back into the approved supplier list and sourcing decisions.

  • Incoming material must be identified and segregated until inspection status is known.

  • Supplier process changes require revalidation of PPAP elements affected by the change.

Quick reference

Auditing, Inspection, and Compliance (Final)

  • Audit sampling should cover all shifts, lines, and shifts of staffing where the process operates.

  • Records must be legible, retrievable, and retained for the defined period; missing records are a common major finding.

  • Inspection results must be recorded against the characteristic and the acceptance criterion used.

  • Compliance audits against regulations require knowledge of the applicable legal requirements, not only the management system standard.

  • Findings should distinguish system nonconformity from product nonconformity because corrective action paths differ.

  • Audit reports should be distributed to those responsible for corrective action and tracked to closure.

Quick reference

Continuous Improvement and Lean Six Sigma (Final)

  • Value stream maps should distinguish current state and future state with a dated implementation plan.

  • Setup reduction (SMED) separates internal from external setup activities to cut changeover time.

  • Total productive maintenance builds operator ownership of equipment care to prevent unplanned downtime.

  • Mistake-proofing should be designed into the process, not added as an inspection step at the end.

  • A kaizen event should have a defined scope, measurable target, and follow-up audit after the event.

  • Improvement projects should be prioritized by impact on customer, cost, and risk, not by ease alone.