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WACE QMS - Quality Management System

WACE Enterprise Solution

WACE QMS - Quality Management System

Achieve zero-defect manufacturing with ISO 9001 compliant quality management. Leverage AI-powered inspections, real-time SPC, and closed-loop corrective actions for continuous improvement.

Core Features

ISO 9001:2015 Compliance Management

AI-Powered Visual Inspection & Defect Detection

Statistical Process Control (SPC) & Six Sigma Tools

CAPA (Corrective & Preventive Action) Management

Supplier Quality Management & Scorecards

Document Control & Training Management

Audit Management & Compliance Tracking

Risk-Based Quality Planning (FMEA, Control Plans)

Technical Specifications

Inspection Types

50+ configurable

SPC Charts

Real-time generation

Compliance Standards

ISO 9001, IATF 16949

Mobile Support

iOS, Android, Web

AI Models

Computer vision enabled

System Integrations

Vision Systems
CMM Equipment
Test Equipment
LIMS
ERP Quality Modules

Industry Use Cases

Automated Visual Inspection

AI-powered defect detection for surface quality and dimensional accuracy

90% reduction in escaped defects

Supplier Quality Management

Track and improve supplier performance with automated scorecards

35% improvement in supplier quality

Regulatory Compliance

Automated documentation and audit trails for FDA/ISO compliance

70% reduction in audit preparation time

QMS Digital Quality Architecture

Quality Intelligence Layer

AI-driven quality insights with predictive analytics and automated anomaly detection

Quality Dashboard
SPC Analytics
AI Inspection Portal
Mobile Quality Apps
Supplier Quality Portal
Customer Feedback Hub

Process Control Layer

Automated quality workflows ensuring consistent process execution and compliance

CAPA Management
Non-Conformance Handling
Document Control
Audit Management
Training Management
Risk Assessment

Quality Data Core

Centralized quality data repository with complete traceability and audit trails

Quality Records Database
Inspection Data Store
Certificate Management
Standards Library
Calibration Records
Supplier Quality Data

Integration & Compliance Layer

Seamless integration with production systems and regulatory compliance frameworks

MES/ERP Integration
Lab Equipment Interface
IoT Sensor Gateway
Regulatory Reporting
Standards Compliance
External Audit Interface

QMS Implementation Roadmap

2-3 weeks

Phase 1: Quality Assessment

Evaluate current quality processes and compliance requirements

Key Activities:

  • Quality process mapping
  • Compliance gap analysis
  • Risk assessment
  • System requirements gathering
  • ROI and KPI definition
4-6 weeks

Phase 2: Core QMS Setup

Deploy foundational quality management capabilities

Key Activities:

  • QMS platform configuration
  • Document control setup
  • Quality workflow design
  • User roles and permissions
  • Initial data migration
6-8 weeks

Phase 3: Process Automation

Automate key quality processes and integrate with production systems

Key Activities:

  • CAPA workflow automation
  • Inspection plan creation
  • SPC implementation
  • MES integration
  • Supplier quality module
4-6 weeks

Phase 4: Advanced Analytics

Deploy AI-powered quality analytics and predictive capabilities

Key Activities:

  • AI model training
  • Predictive quality analytics
  • Real-time monitoring setup
  • Quality dashboard deployment
  • Mobile app rollout
Ongoing

Phase 5: Continuous Improvement

Establish quality excellence culture with continuous improvement

Key Activities:

  • Quality metrics monitoring
  • Process optimization
  • Advanced AI deployment
  • Compliance updates
  • Regular audits and reviews

Quality Excellence Achievements

Global Pharmaceutical Manufacturer

Pharmaceuticals

FDA warning letter, manual quality processes, and 6-month batch release cycles

Solution:

Implemented validated WACE QMS with electronic batch records, automated CAPA, and real-time quality monitoring

-75%

Batch Release Time

Zero

FDA Findings

-85%

Quality Deviations

-$4.5M

Cost of Quality

Automotive Tier 1 Supplier

Automotive

IATF 16949 compliance, high PPM rates, and customer quality complaints

Solution:

Deployed WACE QMS with integrated SPC, AI-powered inspection, and supplier quality management

-90%

PPM Rate

-70%

Customer Complaints

98%

Audit Score

-60%

Warranty Claims

Medical Device Manufacturer

Medical Devices

ISO 13485 compliance, design control requirements, and post-market surveillance

Solution:

Implemented WACE QMS with design controls, risk management, and automated complaint handling

-50%

Design Transfer Time

-65%

CAPA Cycle Time

Zero

Recall Events

-45%

Compliance Cost

QMS Technology Stack

Quality Analytics

Statistical Process Control
Machine Learning QC
Computer Vision Inspection
Predictive Analytics
Real-time Dashboards

Compliance Framework

ISO 9001:2015 Engine
FDA 21 CFR Part 11
IATF 16949 Module
ISO 13485 Compliance
GxP Validation Suite

Data Management

PostgreSQL Database
MongoDB Document Store
Blockchain Audit Trail
Electronic Signatures
Encrypted Storage

Integration Tools

REST API Framework
HL7 FHIR Interface
EDI Connectors
IoT Data Pipeline
Cloud Integration Hub

Return on Investment

Defect Reduction

-85%

Through early detection and prevention

Inspection Time

-60%

Via automated and AI-assisted inspections

Compliance Cost

-40%

Reduced audit and documentation effort

Quality Savings

$3.2M/year

From warranty and rework reduction