Introduction

In an increasingly complex global marketplace, ensuring product safety and quality is not merely a regulatory obligation but a fundamental pillar of consumer trust, brand reputation, and long-term business sustainability. As supply chains become more intricate and consumer expectations soar, the need for advanced, rigorous product safety and quality compliance audits has become paramount for mitigating risks, preventing recalls, and safeguarding market access. This essential training course focuses on Product Safety and Quality Compliance Audit (Advanced), equipping professionals with the specialized knowledge and sophisticated methodologies to conduct in-depth assessments of product lifecycle processes, from design and manufacturing to distribution and post-market surveillance. You will learn to navigate intricate international standards, pinpoint systemic vulnerabilities, and provide robust assurance that products consistently meet stringent safety and quality benchmarks.

This intensive training course delves into the advanced aspects of product compliance auditing, covering critical areas such as risk-based auditing techniques, advanced root cause analysis for quality deviations, and the verification of complex supply chain controls. We will explore key international standards and regulations (e.g., ISO 9001, relevant industry-specific directives, consumer protection laws), and discuss how to audit their effective implementation within diverse manufacturing and service environments. Participants will gain hands-on experience in evaluating product design controls, manufacturing process validations, quality management systems (QMS), and the integrity of post-market surveillance data. By the end of this training course, you will possess the expertise to confidently lead and execute advanced product safety and quality compliance audits, providing invaluable insights that drive continuous improvement and ensure sustained market leadership.

Target Audience

• Quality Assurance & Control Managers
• Product Safety Officers
• Internal & External Auditors
• Regulatory Affairs Professionals
• Supply Chain Auditors
• Manufacturing Managers
• Risk Management Professionals
• Compliance Officers (Product Focus)

Course Objectives

• Understand the advanced concepts of product safety and quality compliance in a global context.
• Learn about the interplay between product design, manufacturing, and distribution for compliance.
• Master advanced methodologies for risk-based auditing of product safety and quality controls.
• Develop skills in auditing complex Quality Management Systems (QMS), including ISO 9001.
• Understand the role of process validation and verification in ensuring product integrity.
• Learn about techniques for auditing supply chain quality controls and supplier performance.
• Explore best practices for auditing post-market surveillance, incident reporting, and recalls.
• Master techniques for performing root cause analysis and corrective/preventive actions (CAPA) for quality issues.
• Understand the requirements of major international product safety regulations (e.g., CE Marking, FDA).
• Learn about preparing comprehensive product safety and quality compliance audit reports.
• Apply advanced Product Safety and Quality Compliance Audit strategies to complex real-world scenarios.

Duration

5 Days

Course Content

Module 1: Advanced Principles of Product Safety & Quality

• Defining advanced concepts of product safety and quality compliance.
• Exploring the evolution of global expectations for product integrity.
• Understanding the lifecycle approach to product safety from concept to disposal.
• Overview of critical success factors for a robust product quality system.
• The role of audit in achieving and maintaining excellence.

Module 2: International Product Safety Regulations & Standards

• Learning about key international product safety regulations (e.g., EU Directives for CE Marking, US CPSC, FDA for specific industries).
• Understanding the application of ISO 9001:2015 and other relevant QMS standards.
• Exploring industry-specific regulations and certifications.
• Navigating cross-border product compliance requirements.
• The impact of non-compliance on market access and reputation.

Module 3: Auditing Product Design & Development Controls

• Mastering methodologies for auditing product design and development processes.
• Assessing risk management in design (e.g., FMEA).
• Techniques for verifying design inputs, outputs, and review processes.
• Ensuring compliance with safety critical design requirements.
• Auditing design validation and verification activities.

Module 4: Advanced Manufacturing & Process Quality Audit

• Learning how to conduct advanced audits of manufacturing processes for quality and safety.
• Understanding process validation (IQ, OQ, PQ) and its audit.
• Techniques for assessing in-process controls, testing, and inspection.
• Evaluating the effectiveness of production environment controls.
• Auditing equipment calibration, maintenance, and process capability.

Module 5: Supply Chain Quality & Supplier Audits

• Exploring the complexities of supply chain quality management.
• Mastering techniques for auditing supplier quality systems and performance.
• Assessing inbound material quality controls and supplier qualification.
• Understanding the role of supply chain transparency in product safety.
• Mitigating quality risks throughout the extended supply chain.

Module 6: Post-Market Surveillance & Incident Management

• Best practices for auditing post-market surveillance systems.
• Understanding requirements for product defect reporting and adverse event tracking.
• Mastering techniques for auditing recall management processes.
• Performing root cause analysis (RCA) and implementing corrective and preventive actions (CAPA).
• Evaluating customer feedback and complaint handling processes.

Module 7: Audit Reporting, Data Analytics & Continuous Improvement

• Strategies for preparing comprehensive and impactful product safety and quality compliance audit reports.
• Using data analytics to identify trends and potential issues in product quality data.
• Communicating audit findings and recommendations to senior management.
• Developing a framework for continuous improvement in product safety and quality.
• The role of audit in fostering a culture of excellence and responsibility.

Training Approach

This course will be delivered by our skilled trainers who have vast knowledge and experience as expert professionals in the fields. The course is taught in English and through a mix of theory, practical activities, group discussion and case studies. Course manuals and additional training materials will be provided to the participants upon completion of the training.

Tailor-Made Course

This course can also be tailor-made to meet organization requirement. For further inquiries, please contact us on: Email: info@skillsforafrica.org, training@skillsforafrica.org  Tel: +254 702 249 449

Training Venue

The training will be held at our Skills for Africa Training Institute Training Centre. We also offer training for a group at requested location all over the world. The course fee covers the course tuition, training materials, two break refreshments, and buffet lunch.

Visa application, travel expenses, airport transfers, dinners, accommodation, insurance, and other personal expenses are catered by the participant

Certification

Participants will be issued with Skills for Africa Training Institute certificate upon completion of this course.

Airport Pickup and Accommodation

Airport pickup and accommodation is arranged upon request. For booking contact our Training Coordinator through Email: info@skillsforafrica.org, training@skillsforafrica.org  Tel: +254 702 249 449

Terms of Payment: Unless otherwise agreed between the two parties’ payment of the course fee should be done 10 working days before commencement of the training.