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Program Overview and Foundations

Program Introduction and Learning Path

Quality Fundamentals and Regulatory Context

Core Configuration and Supplier Quality

Master Data and Configuration Design

Incoming Inspection and Supplier Quality Management

Shop‑Floor Execution and Corrective Actions

In‑Process and Final Inspection Workflows

Nonconformance, CAPA, and Corrective Workflows

Traceability, SPC, and Visual AI

Traceability, Genealogy, and Recall Management

Test and Measurement Management with SPC

Visual Inspection and AI‑Assisted Quality

Analytics, Integration, and Assurance

Reporting, Analytics, and Compliance Readiness

Integration, Extensibility, and Deployment Assurance

Testing and Release Assurance for Quality Systems

Capstone Project, Review, and Certification Exam

Quizzes and Knowledge Checks

Quiz: Fundamentals and Regulatory Context

Quiz: Master Data and Sampling Strategies

Quiz: Supplier Quality and Incoming Inspection

Quiz: In‑Process and Final Inspection Controls

Quiz: NC, Root Cause, and CAPA Effectiveness

Quiz: Traceability and Recall Execution

Quiz: SPC and Measurement Systems

Quiz: Integration, Automation, and Release Assurance

Build an end-to-end, audit-ready quality program that scales from supplier receipt to final release. Enterprise Quality Control and Assurance: End‑to‑End Implementation Mastery is a practical, 40-hour, hands-on course for manufacturers who need measurable, compliant results—not just theory. You’ll design master data, craft inspection plans for discrete and process flows, operationalize incoming and in-process controls, and execute NC/CAPA workflows tied to root cause and risk. Then you’ll extend your system with traceability and recall management, real-time SPC, and AI-assisted visual inspection. Finally, you’ll connect it all to ERP, analytics, and CI/CD testing so changes deploy safely and predictably. The program balances regulatory rigor (ISO 9001, ISO 13485, GMP, 21 CFR Part 11) with pragmatic execution: operator-friendly UIs, IoT data capture, evidence packaging, and robust integration patterns for D365 FO/BC. Through guided labs, quizzes, and a capstone, you’ll leave with a working, demonstrable quality solution, full documentation, and a portfolio-ready test report—equipping you to improve FPY, reduce cost of poor quality, and pass audits with confidence.

Enterprise Quality Control and Assurance: End‑to‑End Implementation Mastery

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            <p>Enterprise Quality Control and Assurance: End‑to‑End Implementation Mastery equips experienced quality leaders, ISO auditors, and manufacturing practitioners to design, implement, and sustain a compliant, data‑driven quality system across discrete and process environments. Anchored in ISO 9001 and extended to ISO 13485, GMP, and FDA 21 CFR Part 11 expectations, the program balances prevention and detection through robust master data, risk‑based sampling, SPC, digital traceability, and audit‑ready evidence management. The learning path spans five intensive days (40 hours) with guided self‑study, blending lectures, instructor notes, labs, quizzes, and a graded capstone. Roles including quality engineers, QA/QC leads, production supervisors, MES/ERP integrators, test engineers, and implementation consultants will find explicit success criteria and role‑mapped outcomes, supported by sandbox access and curated resources. Prerequisites include familiarity with ISO 9001 principles, ERP foundations in Microsoft Dynamics 365 (FO/BC), web application concepts, and Git/Azure DevOps for testing pipelines.</p>

<p>The curriculum progresses from foundations and regulatory grounding to core configuration and supplier quality, then moves through shop‑floor execution, nonconformance and CAPA rigor, and end‑to‑end traceability with recall readiness. Participants will design master data structures—products, inspection methods, quality plans, and sample plans—linking them to BOMs, routings, and recipes with effective dating and internationalization. Supplier quality is operationalized via PO‑linked sampling, SCAR lifecycles, scorecards, and cost‑of‑non‑quality analytics. On the shop floor, guided inspections, barcode/RFID enablement, e‑signatures, and IoT data capture underpin hold/release controls and conformance documentation. Measurement management and SPC are addressed through calibration, MSA context, control charts, and capability indices (Cp/Cpk/Pp/Ppk), while visual AI modules introduce imaging practices, human‑in‑the‑loop validation, and edge/cloud inference patterns. The program culminates with analytics and compliance readiness, ERP and API‑based integrations with resilience and reconciliation strategies, and testing/release assurance using CI/CD pipelines and traceability matrices. Labs, timed drills, and scenario assessments lead into a capstone where learners deliver a complete quality workflow—including NC/CAPA effectiveness verification, genealogy, recall documentation, dashboards, audit evidence, and an integration test report—demonstrating implementation mastery aligned to regulatory and operational excellence objectives.</p>
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