QMS (Quality Management System)

Convert audit preparation time into actual improvement activities

Documents and records required for ISO 9001 certification audits are automatically generated as part of daily operations. Inspection records, NCR/CAPA histories, and management review input/output data accumulate simply by performing routine work, eliminating the need for separate preparation before audits.

• Management Review: Inputs required by ISO 9001 Clause 9.3 (audit results, customer feedback, process performance, nonconformity and corrective action status, follow-up actions from previous management reviews, etc.) and outputs (improvement decisions, resource needs, etc.) are automatically collected in parallel from 5 areas. There is no need to send data requests to each department and consolidate responses.
• Internal Audit: Audit plans, checklists, and findings are connected in a single workflow. Turtle Diagrams and VDA 6.3 process audit forms are supported, with findings directly linked to corrective action requests.
• Document Control: Revision history, distribution, and expiry management following a 4-tier document hierarchy (manual-procedure-instruction-form) is available. Expiry timers ensure document review deadlines are never missed, and electronic signatures enable approval workflows.

Practical scenario: If your annual ISO surveillance audit is scheduled for March, you can instantly retrieve the past year's management review records, NCR/CAPA status, internal audit results, and document revision history from the system and present them to auditors without any separate preparation.

Respond immediately to customer requirements

IATF 16949 Core Tools (APQP, PPAP, FMEA, MSA, SPC) are connected within a single system. Once customer-specific CSRs are registered, the corresponding inspection criteria and PPAP requirement levels are automatically reflected in related work.

• PPAP: Levels 1-5, an 18-element checklist, PSW (Part Submission Warrant), and dimensional results are managed on a single screen. Customer disposition history (approved/conditionally approved/rejected) is also tracked.
• FMEA: The AIAG-VDA 2019 AP Score (Action Priority) method is applied, with Design FMEA and Process FMEA managed separately. Automatic RPN (Risk Priority Number) calculation is also supported.
• CSR: Inspection criteria and PPAP requirements for 16 OEMs including Hyundai, Kia, GM, and Ford are mapped bidirectionally. When an OEM changes a CSR, related inspection criteria and PPAP elements can be verified at once.
• APQP: New product development deliverables are systematically managed through a 5-phase gate approach (Planning/Design/Process Design/Product Validation/Production). Gate reviews and CFT (Cross-Functional Team) member management are supported at each phase.

Practical scenario: If Hyundai requests PPAP Level 3 for a new part, you can check Hyundai's requirements from the CSR database and automatically populate the checklist with the elements required for that level from the 18 PPAP elements. Since FMEA, control plans, dimensional results, and MSA results are linked within the system, you can quickly assemble the PPAP package.

Process NCR through CAPA and 8D seamlessly

When a nonconformance occurs, the flow from NCR creation to CAPA (corrective/preventive action) to 8D report is a single continuous process. Assignment of responsible personnel, deadline management, and escalation at each stage are automated to prevent missed actions.

• Disposition Decision: When selecting rework, scrap, concession, or return, subsequent processes automatically branch accordingly
• Root Cause Analysis: Tools such as 5 Why, cause-and-effect diagrams, and FTA are available directly within the system
• Horizontal Deployment: Preventive actions for similar processes or products are managed together within CAPA
• Cost Aggregation: Costs incurred for nonconformance handling are automatically tallied, facilitating cost-of-quality tracking

Achieve consistency and efficiency in inspection operations

Incoming inspection (IQC), in-process inspection (PQC), and outgoing inspection (OQC) data are managed within a unified framework. ISO 2859-1 switching rules (tightened/normal/reduced) are automatically applied, reducing the burden on inspectors for inspection level management.

• Incoming Inspection: Inspection quantities are automatically calculated based on AQL sampling plans. Concession management and supplier certificate of results (SCR) integration connect the full context of incoming inspection work. Automatic switching to reduced inspection after consecutive acceptances and to tightened inspection upon rejection efficiently allocates inspection resources.
• In-Process Inspection: First article, patrol, and final inspection types are supported. Inspectors can view SPC mini-charts while entering inspection data on shop floor POP screens, enabling real-time process status monitoring. When anomalies occur, 4M (Man, Machine, Material, Method) change reports can be created immediately.
• Outgoing Inspection: COC (Certificate of Conformance) / COA (Certificate of Analysis) are issued automatically and integrated with ERP shipping processes. Hold/release management prevents shipment of products that have not completed quality verification.
• Offline POP: In environments with unstable networks, up to 500 inspection records can be stored locally and automatically synchronized (queue-and-sync) when the network is restored.

Practical scenario: When raw materials from Supplier A are received, the inspection quantity is automatically calculated based on the item's sampling plan. If the inspection passes, receipt processing proceeds; if it fails, an NCR is automatically generated and the disposition decision process (return/concession/scrap) begins. If a concession is decided, the concession rationale and approval history are recorded, enabling subsequent quality tracking of that lot.

SPC deviations lead directly to quality actions

Bidirectional integration with the SPC solution is provided. When a Nelson Rules violation is detected on a control chart, a CAPA is automatically generated or an alert is sent to the responsible person depending on severity. SPC mini-charts are embedded in the in-process inspection POP screen, allowing real-time process status verification on the shop floor.

Compared to Excel/document-based management

Compared to general-purpose ERP QM modules

Compared to specialized QMS software

Specialized QMS products such as ETQ Reliance, MasterControl, and Veeva Vault have strengths in document management, audit management, and regulatory compliance (especially for medical devices and pharmaceuticals). In contrast, VEXPLOR QMS differentiates through tight integration with the manufacturing floor (SPC integration, POP shop floor screens, ERP/MES integration). It is particularly well-suited for environments where IATF Core Tools and shop floor inspection/SPC are critical, such as automotive parts manufacturers.

Streamlined audit response

• Time previously spent on certification audit preparation can be significantly reduced. Daily operational data can be directly used as audit evidence.
• Time spent gathering management review materials is shortened through automatic parallel collection.

Faster nonconformance resolution

• Lead time from NCR occurrence to CAPA completion can be shortened. Automatic 3-level escalation prevents action delays.
• Horizontal deployment and lessons learned records for similar nonconformances accumulate, contributing to reduced repeat defects.

Strengthened customer audit response capability

• When OEM customers change CSRs, related inspection criteria and PPAP requirements are updated in sync, preventing missed responses.
• PPAP submission documents are consistently managed within the system, enabling immediate submission upon customer request.

Data-driven decision making from inspection data

• Integrated IQC/PQC/OQC inspection data enables quality trend analysis by supplier, process, and product.
• Linked SPC control chart deviations and quality actions accelerate response to process anomalies.

Quality management flow from incoming inspection to shipment

Raw material receipt -> Incoming Inspection (IQC) -> [Pass] -> Production input -> In-Process Inspection (PQC) -> Finished goods -> Outgoing Inspection (OQC) -> [Pass] -> Shipment
                                                  -> [Fail] -> NCR generated -> Disposition (return/concession/scrap) -> Supplier corrective action request

Nonconformance handling flow

Nonconformance detected -> NCR registered -> Containment action (lot quarantine) -> Disposition
  -> CAPA request -> Root cause analysis (5 Why/cause-and-effect diagram/FTA) -> Corrective action plan -> Execution -> Effectiveness verification
  -> [Ineffective] -> Re-analysis/re-action -> Re-verification
  -> [Effective] -> CAPA completed -> Lessons Learned -> Horizontal deployment

PPAP submission flow (automotive parts manufacturers)

Customer PPAP request -> CSR verification -> PPAP Level determination -> 18-element review
  -> FMEA completion confirmed -> Control plan confirmed -> MSA (Gage R&R) completion confirmed -> Dimensional results confirmed
  -> PSW prepared -> Customer submission -> Customer disposition (approved/conditional/rejected) -> Result recorded

Q. We already have ISO 9001 certification. Do we need to change our existing procedures? You can leverage the system while maintaining your existing procedures. The system's workflows are designed based on ISO 9001 requirements and naturally align with your existing QMS procedures. However, a transition period is needed to migrate manually managed records (inspection logs, NCR logs, CAPA management logs, etc.) to the system.

Q. Can we use only some of the IATF 16949 Core Tools? Yes. APQP, PPAP, FMEA, MSA, and SPC can each be used independently and adopted in phases as needed. For example, you can start with PPAP and FMEA first, then add SPC integration later.

Q. Can it support medical device (ISO 13485) or aerospace (AS9100) certification? Foundational data structures are implemented (medical devices: DHF, UDI, clinical evaluation, FSCA, PMS / aerospace: FAI, counterfeit parts, configuration management, Nadcap). However, advanced requirements for these industries (medical device regulatory submissions, aerospace OASIS DB integration, etc.) are under development as extension packs.