Introduction:

Quality auditing is an essential component of any organization’s quality management system (QMS). It ensures that processes and products meet the required standards and comply with both regulatory and internal requirements. This course offers participants a comprehensive understanding of quality auditing principles, techniques, and tools, focusing on how to effectively plan, conduct, and follow up on audits in various environments. Participants will also learn how to turn audit findings into actionable improvements, ensuring long-term quality sustainability.

Course Objectives:

By the end of this course, participants will:

1. Understand the fundamentals of quality auditing, including principles, processes, and best practices.
2. Learn to plan, conduct, and report audits efficiently across different functions.
3. Gain proficiency in identifying non-conformities and opportunities for improvement.
4. Develop skills for using audit tools, checklists, and techniques to ensure compliance with standards.
5. Be able to translate audit findings into actionable steps for continuous improvement and organizational development.

Who Should Attend?

This course is ideal for:

• Internal and External Auditors
• Quality Managers and Compliance Officers
• Process Improvement Specialists
• ISO Certification Consultants
• Operations Managers and Supervisors
• Professionals in industries such as manufacturing, healthcare, automotive, and food safety

Day-by-Day Outline:

Day 1: Introduction to Quality Auditing

• What is a Quality Audit? Purpose, scope, and types of audits (internal, external, second-party, and third-party)
• Audit Standards and Frameworks: ISO 9001, IATF 16949, FDA, and other relevant regulations
• The Audit Process Overview: Planning, conducting, reporting, and follow-up
• Key Auditing Principles: Objectivity, independence, evidence-based findings, and confidentiality
• Audit Criteria and Audit Scope: Setting clear audit objectives and defining the scope
• The Role of Auditors: Responsibilities, ethical considerations, and communication skills
• Workshop: Reviewing a sample quality management system (QMS) and identifying key audit areas

Day 2: Audit Planning and Preparation

• Audit Planning: How to prepare for audits, including defining objectives, scope, criteria, and resources
• Audit Checklist Development: Creating checklists and audit protocols to guide the audit process
• Document Review: Reviewing procedures, work instructions, and previous audit reports
• Sampling Techniques: Selecting appropriate samples for process audits
• Risk-Based Approach to Auditing: Identifying high-risk areas and focusing audit efforts on critical processes
• Hands-On Activity: Developing an audit plan for a specific department or process

Day 3: Conducting the Audit

• Opening the Audit: Conducting an effective opening meeting and setting the tone for a productive audit
• Gathering Evidence: Interviewing personnel, observing processes, and reviewing documentation
• Audit Techniques: Effective questioning, verification of evidence, and identifying non-conformities
• Effective Communication During Audits: Maintaining professionalism and impartiality while addressing issues
• Audit Recording and Reporting: Properly documenting audit findings and observations
• Audit Non-Conformities and Non-Conformance Reports (NCRs): Categorizing, documenting, and communicating issues
• Workshop: Conducting a mock audit and documenting findings

Day 4: Audit Reporting and Corrective Actions

• Audit Report Structure: Writing clear, concise, and objective audit reports
• Audit Findings and Non-Conformity Reports (NCRs): Defining and documenting findings, categorizing severity
• Root Cause Analysis: Investigating the root causes of non-conformities
• Corrective and Preventive Actions (CAPA): Developing actionable and sustainable solutions
• Audit Follow-Up: Ensuring corrective actions are implemented and sustained
• Reporting to Management: Communicating audit findings to senior management and other stakeholders
• Case Study: Reviewing a sample audit report and proposing corrective actions

Day 5: Continuous Improvement and Sustaining Audit Quality

• Building a Continuous Improvement Culture through Audits: Using audits as a tool for long-term organizational improvement
• Audit Program Management: Developing and managing an audit program across multiple departments
• ISO 9001 and Other Standards Compliance: Ensuring ongoing compliance and continuous improvement through audits
• Audit Competency and Training: Ensuring auditors maintain expertise and certifications
• Future Trends in Quality Auditing: Automation, AI, and digital tools in auditing processes
• Final Workshop: Creating an audit program plan for a department or organization and presenting it for feedback.