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Quality/Analytics

SPC (Statistical Process Control)

Analyzes and monitors manufacturing process data using statistical techniques to identify process anomalies early and support continuous improvement.

IATF 16949 Core ToolsISO 11462 (Statistical Process Control)
01

Are you facing these challenges?

1. Process anomalies are discovered only after the fact

When control charts are maintained manually or managed in separate SPC software, deviations are not detected in real time. Defective products frequently pass to downstream processes before the problem is recognized.

2. SPC and the quality system are disconnected

Even when a deviation is detected on a control chart, the result does not naturally flow into an NCR or CAPA. In a structure where SPC personnel must separately contact the quality department or send emails, response delays are inevitable.

3. Periodic process capability evaluation is difficult

Cpk and Ppk values need to be periodically recalculated and their trends managed, but the sheer number of items and characteristics makes manual execution impractical. Preparing evidence for initial process capability (Cpk 1.67 or higher) required by IATF 16949 customers also takes considerable time each time.

4. MSA (Measurement System Analysis) management lacks structure

When Gage R&R results are managed in spreadsheets, follow-up actions after an unacceptable determination (equipment calibration, operator retraining) are not properly carried through. Presenting MSA history immediately during customer audits is also difficult.

5. Advanced analyses (DOE, non-normal process capability) are hard to access

Separate statistical software like Minitab must be purchased and training provided, and the process of feeding analysis results back into the SPC system is cumbersome. In most cases, there is no connection between Design of Experiments (DOE) results and control chart application.


02

Here is how we solve it

Detect process anomalies in real time and respond immediately

With WebSocket-based real-time streaming, measurement data is reflected on control charts the instant it is entered. Nelson Rules (all 8) and Western Electric Rules are applied simultaneously, automatically detecting not only simple control limit violations but also patterns such as trends, shifts, and mixtures.

  • Zone classification (A/B/C) for each measurement point enables visual position verification. Even within control limits, pattern anomalies (e.g., 7 consecutive rising points, 9 consecutive points on one side of the center line) are detected proactively.
  • Upon deviation detection, depending on severity, responsible personnel are notified, a CAPA is automatically generated, or a production hold event is issued. Warning-level and immediate-action-level responses are distinguished to set response priorities.
  • 3-level escalation: If the primary responsible person does not respond within a set time, the issue is automatically escalated to a higher-level manager. An automatic rejection feature is also included, preventing unresponsive states from persisting.
  • Shop floor POP screens: Measurement values can be entered via touch on the manufacturing floor, or data automatically collected from equipment can be reviewed. Even in offline environments, up to 500 records are queued and automatically synchronized when the network is restored.

Practical scenario: On a production line measuring automotive brake pad thickness, an X-bar/R control chart is monitored in real time. When 7 consecutive points show an upward trend, a Nelson Rule #3 violation is detected and an immediate alert is sent to the responsible engineer. The engineer records equipment wear (Machine) as the cause in the 6M root cause analysis form and registers a mold replacement action as a CAPA.

SPC deviations lead directly to quality actions

When a deviation is detected on a control chart, it automatically links to the QMS CAPA process. Without manual intervention, the full cycle of root cause analysis (6M: Machine/Material/Man/Environment/Method/Measurement) through corrective action to effectiveness verification proceeds.

  • CAPA effectiveness verification: Cpk, defect rate, and alarm frequency are automatically compared before and after corrective action to confirm improvement in quantitative terms
  • SPC emergency alarm to production hold event linkage supports the IATF 16949 requirement of "suspect product quarantine"
  • Control limit change history is separately preserved, ready for immediate use as evidence during customer audits

Automate process capability evaluation and manage it systematically

Beyond Cp, Cpk, Pp, and Ppk, the system also calculates Cpm/Cpmk (Taguchi method), Cnpk (non-normal distribution), Z.bench, and PPM. Periodic evaluations can be automatically executed through CRON-based timer workflows, ensuring that even hundreds of control characteristics are managed without omission.

  • 5 normality tests (Anderson-Darling, Shapiro-Wilk, Kolmogorov-Smirnov, Ryan-Joiner, D'Agostino-Pearson) are performed automatically. Cases where data does not follow a normal distribution are handled appropriately.
  • Non-normal data processing path: normality test, distribution identification, transformation (Box-Cox/Johnson), Cnpk-based determination. Even without statistical expertise, the system guides personnel to the appropriate analysis path.
  • IATF customer-required Cpk determination criteria are reflected in the workflow. General characteristics use Cpk 1.33 as the threshold, and special characteristics (safety/regulatory) use Cpk 1.67, with automatic determination and improvement action requests issued upon non-compliance.
  • Cpm/Cpmk (Taguchi method) is an index reflecting process center deviation from the target value, evaluating not just whether a process is within specification but how close it is to the target. It is useful for processes where precision is critical.
  • Quality KPI snapshots: Process capability indices are automatically recorded on daily/weekly/monthly intervals to track trends over time. Visualization is available through 17 dashboard widgets.

Practical scenario: On the 1st of each month, a timer workflow runs to automatically recalculate Cpk for 200 registered control characteristics. When characteristics falling below Cpk 1.33 are found, the responsible process engineer is automatically notified and an improvement action request is generated. When OEM customers require quarterly Cpk reports, Cpk trend data for the relevant period can be immediately exported from the system for submission.

Perform MSA systematically with follow-through to corrective actions

All core study types from the AIAG MSA Manual 4th Edition are supported. Gage R&R (ANOVA and X-bar/R methods), Bias, Stability, Linearity, and Attribute Agreement (Kappa/Fleiss Kappa/Kendall W) analyses can be performed.

  • GRR% determination: Automatic 3-way branching in the workflow gateway for below 10% (acceptable), 10-30% (conditional), and above 30% (unacceptable)
  • ndc (Number of Distinct Categories) of 5 or higher: automatic determination
  • Unacceptable determination triggers follow-up workflow: equipment calibration/repair or operator retraining
  • Automatic MSA report generation with file attachment capability

Connect from Design of Experiments (DOE) to control chart application

6 types of DOE (Full Factorial, Fractional Factorial, Taguchi, RSM-CCD, RSM-BBD, Screening) can be performed, and a workflow reflects the derived optimal conditions on control charts. Confirmation experiment Cpk is linked to ensure the flow from experimentation to production application is uninterrupted.

Practical scenario: When shrinkage defects recur in an injection molding process, RSM (Response Surface Methodology) is used to derive the optimal conditions for mold temperature, injection pressure, and holding time. The derived conditions are set as new control limits on the control chart, and when the confirmation experiment achieves Cpk 1.67 or higher, they are applied to production. Control limit change history is automatically recorded, preserving the rationale for why the control limits were changed.


03

Global standards this solution follows

The SPC field has international standards and industry guidelines for control charts, process capability, and measurement system analysis respectively. These standards serve as the basis for demonstrating your SPC capabilities during customer audits, IATF certification, and export activities.

ISO 7870 Series -- Control Charts

Why does this standard matter? ISO 7870 is the international standard for control charts, providing criteria for determining whether a process is in a state of statistical control. When a customer asks "What criteria are your control charts operated under?", being able to cite ISO 7870 compliance enhances credibility.

How is it applied in VEXPLOR?

ISO 7870 PartWhat it means for your operationsVEXPLOR approach
Part 1: General guidelinesStandardizes basic control chart concepts and terminologyTerminology and structure of 7 control chart types defined per ISO 7870
Part 2: Shewhart control chartsOperating criteria for the most widely used control charts (X-bar/R, X-bar/S, I-MR)X-bar/R, X-bar/S, I-MR control charts implemented
Part 3: Acceptance control chartsUsed when integrating acceptance criteria into control chartsIndirectly addressed through sampling plans
Part 4: CUSUMAdvanced control charts that cumulatively detect subtle process variationsCUSUM, CUSUM V-Mask supported
Part 5: EWMADetects process variation by weighting recent dataEWMA, EWMA Lambda parameter supported
Part 6: Multivariate control chartsNeeded when multiple quality characteristics must be monitored simultaneouslyHotelling T2, MEWMA, MCUSUM implemented

ISO 22514 Series -- Process Capability

Why does this standard matter? ISO 22514 is the international standard for process capability indices including Cp, Cpk, Pp, and Ppk. Process capability data is essential evidence for IATF 16949 certification audits, customer PPAP submissions, and new process approvals. Following this standard ensures your process capability data is recognized under the same criteria globally.

How is it applied in VEXPLOR?

ISO 22514 PartWhat it means for your operationsVEXPLOR approach
Part 2: Short-term process capability (Cp/Cpk)Evaluates how stably a process operates within specificationCp, Cpk, Cpl, Cpu automatic calculation
Part 3: Long-term process performance (Pp/Ppk)Evaluates total process variation over extended periodsPp, Ppk, Ppl, Ppu automatic calculation
Part 4: Non-normal process capabilityProcess capability must be evaluated even when data does not follow a normal distributionCnpk calculation, normality determination (is_normal), distribution type (distribution_type) automatic identification
Part 7: Cpm (Taguchi)An index reflecting process center deviation from the target valueCpm, Cpmk calculation
Part 8: PPM/Sigma levelEvaluates processes in terms of defects per million and sigma levelZ.bench (within/overall), PPM (3 types: observed/predicted) calculation

AIAG SPC Manual (4th Edition) -- Automotive Industry SPC Guide

Why does this standard matter? The AIAG (Automotive Industry Action Group) SPC Manual is one of the Core Tools under IATF 16949, making it a mandatory SPC operating guideline for automotive parts manufacturers. "Are you operating SPC according to the AIAG Manual?" is a fundamental question in customer quality audits.

How is it applied in VEXPLOR?

AIAG SPC RequirementWhat it means for your operationsVEXPLOR approach
Chapter 2: Variable control chartsControl charts for measurable characteristics such as length, weight, and temperatureX-bar/R, X-bar/S, I-MR supported
Chapter 3: Attribute control chartsControl charts for count data such as defect counts and defect ratesp, np, c, u control charts supported
Control chart interpretation rulesPattern anomalies must be detected even within control limitsNelson 8 Rules + Western Electric Rules applied simultaneously (exceeds AIAG requirements)
Subgroup compositionMeasurement frequency and subgroup size must be rationally configuredsubgroup_size, sampling_frequency configuration functions
Chapter 4: Process capability analysisCp/Cpk/Pp/Ppk calculation and histogram analysisAutomatic process capability index calculation + normality testing + histogram
OCAP (Out-of-Control Action Plan)What to do immediately upon deviation must be predefinedFull OCAP implementation via deviation detection-root cause analysis-corrective action-effectiveness verification workflow

AIAG MSA Manual (4th Edition) -- Measurement System Analysis Guide

Why does this standard matter? For SPC data to be trustworthy, the measurement system itself must first be reliable. MSA (Gage R&R) results are required for IATF 16949 certification and PPAP submissions. If a measurement instrument's GRR% exceeds 30%, the reliability of all SPC data measured with that instrument is called into question.

How is it applied in VEXPLOR?

AIAG MSA RequirementWhat it means for your operationsVEXPLOR approach
Gage R&R (ANOVA)Quantitatively analyzes measurement equipment and operator variationBoth ANOVA and X-bar/R methods supported
Bias analysisEvaluates how far measurement values deviate from the reference valueDedicated analysis with study_type = 'Bias'
Stability analysisVerifies whether the measurement system produces consistent results over timeDedicated analysis with study_type = 'Stability'
Linearity analysisVerifies whether bias is consistent across the full measurement rangeDedicated analysis with study_type = 'Linearity'
Attribute agreement analysisEvaluates judgment consistency for attribute data such as visual inspectionKappa, Fleiss Kappa, Kendall W supported
GRR% determination criteriaBelow 10%: acceptable / 10-30%: conditional / Above 30%: unacceptableAutomatic 3-way determination at workflow gateway
ndc >= 5 criterionThe measurement system must be able to distinguish at least 5 categoriesAutomatic ndc calculation and criterion determination

04

How it differs from existing tools

Compared to specialized SPC software (Minitab, InfinityQS, WinSPC)

ItemSpecialized SPC SoftwareVEXPLOR SPC
Control chartsBasic to advanced supportBasic 7 types + CUSUM/EWMA + multivariate (Hotelling T2)
Process capabilityCp/Cpk/Pp/Ppk focusedExtended to Cpm/Cpmk/Cnpk/Z.bench/PPM
DOEMinitab supports; others do not6 types of DOE + automatic SPC control chart application workflow
QMS integrationMostly standalone products, difficult to integrateNCR/CAPA/8D automatic linkage, management review data automatic collection
MES/ERP integrationSeparate interface development requiredDirect reference to equipment, lot, and item information
CAPA effectiveness verificationNot supportedAutomatic before/after comparison of Cpk/defect rate/alarm frequency
Shop floor inputPartial supportPOP shop floor screens, touch-optimized, offline capable
Code-free configurationConfiguration GUI providedCanvas-based visual configuration of control charts/rules/alarms

Specialized SPC software has strengths in the depth of statistical analysis functions. VEXPLOR SPC focuses on connecting SPC data with quality management processes (QMS), manufacturing execution (MES), and resource management (ERP) within a single system. Without transferring data between separate systems, deviations on control charts can be seamlessly processed through to corrective actions.


05

How does it compare to global solutions?

If your company is currently using or evaluating Minitab, InfinityQS, WinSPC, or SAP DMC, the following comparison may be helpful.

Detailed feature coverage comparison

Feature AreaMinitabInfinityQSWinSPCSAP DMCVEXPLOR SPCWhat this means for you
Basic control charts (7 types)SupportedSupportedSupportedSupportedSupportedX-bar/R, X-bar/S, I-MR, p, np, c, u all available
CUSUM/EWMASupportedSupportedPartialPartialSupportedCapable of detecting subtle process variations
Multivariate SPC (Hotelling T2)SupportedPartialNot supportedPartialSupportedAddresses processes requiring simultaneous monitoring of multiple characteristics
Cp/Cpk/Pp/PpkSupportedSupportedSupportedSupportedSupportedAll basic process capability evaluations available
Cpm/Cpmk (Taguchi)SupportedPartialNot supportedNot supportedSupportedEvaluates deviation from target (useful for precision-critical processes)
Non-normal process capability (Cnpk)SupportedPartialNot supportedNot supportedSupportedAppropriate process capability indices calculated even for non-normal data
Normality tests (5 types)SupportedPartialPartialNot supportedSupportedAD, SW, KS, RJ, D'Agostino-Pearson all available
Gage R&RSupportedSupportedSupportedSupportedSupportedMeasurement system analysis based on AIAG MSA Manual
Attribute agreement (Kappa)SupportedPartialNot supportedNot supportedSupportedEvaluates measurement reliability for attribute data such as visual inspection
AQL sampling inspectionPartialSupportedSupportedSupportedSupportedIncludes ISO 2859-1 automatic switching rules
DOE (Design of Experiments)SupportedNot supportedNot supportedNot supportedSupported6 types of DOE with results linked to control chart application
Real-time streamingNot supportedSupportedSupportedSupportedSupportedWebSocket-based real-time control chart updates
Nelson 8 Rules + WESupportedSupportedSupportedPartialSupportedSimultaneous application of both rule sets enhances detection sensitivity
Escalation alarmsNot supportedSupportedPartialSupportedSupported3-level automatic escalation with automatic rejection for non-response
CAPA integrationNot supportedPartialPartialSupportedSupportedDeviation detection triggers automatic QMS CAPA generation
Cross-solution integration (ERP/MES/QMS)Not supportedPartialNot supportedSupportedSupportedEquipment/lot/item information referenced without separate interfaces
POP shop floor screensNot supportedPartialSupportedSupportedSupportedTouch-optimized with offline queuing (500 records)
CAPA effectiveness verificationNot supportedNot supportedNot supportedPartialSupportedAutomatic before/after comparison of Cpk/defect rate/alarm frequency
Automatic periodic Cpk evaluationNot supportedSupportedPartialSupportedSupportedCRON-based timer for automatic recalculation of hundreds of characteristics

Feature coverage ratio: Minitab approximately 77%, InfinityQS approximately 73%, WinSPC approximately 55%, SAP DMC approximately 68%, VEXPLOR SPC 100%.

Compared to Minitab

Minitab is a specialized statistical analysis tool that supports a broader range of advanced statistical functions including regression analysis, reliability analysis, and others compared to VEXPLOR. Conversely, Minitab does not support real-time streaming, escalation alarms, CAPA integration, or cross-solution integration (ERP/MES/QMS).

Available in Minitab but not yet in VEXPLOR: Regression analysis, reliability analysis, advanced ANOVA analysis, and other statistics-specific features.

Available in VEXPLOR but not provided by Minitab: Real-time WebSocket streaming, 3-level escalation, automatic QMS CAPA integration, direct ERP/MES reference, CAPA effectiveness verification (before/after comparison), POP shop floor screens, automatic periodic Cpk evaluation timer.

VEXPLOR SPC unique strengths

Differentiating FeatureDescriptionCompetitive product status
DOE-to-SPC linked workflowAutomatically reflects experimental optimal conditions on control chartsMinitab supports DOE but lacks automatic SPC control chart application workflow
3-tier cross-solution integrationDirect connection with QMS/MES/ERPInfinityQS/WinSPC are standalone products where ERP/MES/QMS integration is difficult
CAPA effectiveness verification (before/after comparison)Automatic comparison of Cpk/defect rate/alarm frequency before and after actionsNo SPC product provides automatic before-after comparison
Automatic periodic Cpk evaluation (Timer)CRON-based periodic automatic recalculationOnly InfinityQS offers similar capability; other products require manual execution
No-Code SPC configurationCanvas-based visual configuration of control charts/rules/alarmsCompetitive products provide configuration GUIs but not at the no-code level

06

Expected benefits after implementation

Faster process anomaly response

  • Real-time monitoring delivers immediate alerts upon deviation detection. Response time can be significantly shortened compared to after-the-fact discovery.
  • The full cycle from deviation through root cause analysis, corrective action, to effectiveness verification is trackable within the system.

Systematic Cpk management

  • Automatic periodic evaluation enables monitoring Cpk trends for hundreds of control characteristics without omission.
  • Initial process capability evidence (Cpk 1.67 or higher) required by IATF customers can be output directly from the system.

Measurement system reliability assurance

  • Systematic management from MSA execution through determination to follow-up actions (calibration/retraining) enhances measurement data reliability.
  • MSA history and reports can be presented immediately during customer audits.

Data-driven process improvement

  • The linkage from DOE to optimal condition derivation, control chart application, and Cpk confirmation creates a structure where experimental results are actually applied to production.
  • Accumulated deviation history, cause classification (6M), and CAPA effectiveness data can be utilized to identify root causes of recurring process problems.

07

Solution component summary

AreaKey Features
Control ChartsBasic 7 types (X-bar/R, X-bar/S, I-MR, p, np, c, u) + CUSUM/EWMA + Hotelling T2/MEWMA/MCUSUM
Process CapabilityCp/Cpk/Pp/Ppk/Cpm/Cpmk/Cnpk + Z.bench + PPM + 5 normality tests + non-normal distribution processing
MSAGage R&R (ANOVA/X-bar) + Bias/Stability/Linearity + Attribute agreement (Kappa) + ndc determination
Sampling InspectionAQL-based + ISO 2859-1 automatic switching rule automation
Real-time MonitoringWebSocket streaming + Nelson/WE rule real-time detection + escalation alarms
DOEFull Factorial/Fractional/Taguchi/RSM-CCD/RSM-BBD/Screening + confirmation experiment linkage
Dashboard17 widgets, quality KPI snapshots (daily/weekly/monthly), gauge/trend/distribution charts
Documents/Reports4 document template types with automatic generation, PDF export

08

Key workflows

Control chart operation flow

Control characteristic registration -> Specification (USL/LSL/Target) setting -> Control chart type selection -> Alarm rule configuration (Nelson/WE)
  -> Measurement data collection (POP input or equipment auto-collection) -> Real-time Zone classification (A/B/C)
  -> [Normal] -> Data accumulation, KPI snapshot
  -> [Deviation detected] -> Severity determination -> [Minor] Personnel notification / [Major] Automatic CAPA generation + production hold

Process capability evaluation flow

Measurement data collection -> Normality testing (select from 5 types or automatic)
  -> [Normal] -> Cp/Cpk/Pp/Ppk/Cpm/Cpmk calculation
  -> [Non-normal] -> Distribution identification -> Box-Cox/Johnson transformation -> Cnpk calculation
  -> Cpk determination -> [>=1.67] Special characteristic compliant / [>=1.33] General characteristic compliant / [<1.33] Improvement needed
  -> Result report generation -> KPI dashboard update

MSA execution flow

MSA plan development -> Gage R&R execution (ANOVA/X-bar method)
  -> GRR% calculation -> [<10%] Acceptable / [10-30%] Conditional / [>30%] Unacceptable
  -> ndc determination -> [>=5] Acceptable / [<5] Measurement system improvement needed
  -> [Unacceptable] -> Equipment calibration/repair or operator retraining -> Re-evaluation
  -> Automatic MSA report generation

DOE to production application flow

Process problem identification -> DOE type selection (6 types) -> Experiment design -> Experiment execution -> Results analysis
  -> Optimal conditions derived -> Confirmation experiment (Cpk verification) -> [Compliant] -> Control chart control limit update
  -> Control limit change history automatically recorded -> Production application
09

Suitable companies

  • Automotive parts manufacturers: Companies that must systematically manage SPC and MSA per IATF 16949 requirements and regularly submit Cpk data to customers
  • Precision manufacturing: Companies producing parts with tight tolerances where process capability management and real-time monitoring are essential
  • Companies needing quality system integration: Companies seeking to automate process anomaly response by connecting SPC data with QMS, MES, and ERP

10

Frequently asked questions

Q. We currently use Minitab. Do we need to replace it? Minitab has strengths as a specialized statistical analysis tool, while VEXPLOR SPC focuses on real-time monitoring on the manufacturing floor and integration with the Quality Management System (QMS). Parallel use is possible — continue using Minitab for advanced statistical analyses (regression, reliability analysis, etc.) while running daily control chart operations and process capability management in VEXPLOR SPC. VEXPLOR SPC calculates beyond Cp/Cpk/Pp/Ppk to include Cpm/Cpmk/Cnpk/Z.bench/PPM and supports 6 types of DOE, covering most routine SPC work.

Q. We have hundreds of control characteristics. Can all be monitored in real time? Yes. WebSocket-based real-time streaming settings and timer-based periodic evaluations can be configured differently for each control characteristic. Typically, critical special characteristics (CTQ/CTP) are set for real-time monitoring, while general characteristics are evaluated on daily/weekly periodic schedules.

Q. Can process capability be evaluated for non-normal distribution data? Yes. Normality testing (5 types) is performed automatically, and when data is determined to be non-normal, the system guides through the path of distribution identification, Box-Cox or Johnson transformation, and Cnpk-based determination. Even personnel without statistical expertise can obtain appropriate process capability indices by following the system guidance.

11

Solutions that work well together

SolutionIntegration Details
QMSAutomatic NCR/CAPA generation on control chart deviations, management review data integration
MESEquipment data, lot information integration, production hold events
ERPItem information, specification data reference

Try it yourself

Apply the SPC (Statistical Process Control) template on the canvas, and data models to screens are auto-generated.

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