Course Overview


This interactive, instructor-led course is designed for ISO/IEC 17025 laboratory personnel responsible for conducting investigations and implementing corrective actions. Delivered in a remote, hands-on format, the course focuses on performing technically sound and compliant investigations into nonconforming work, out-of-specification results, and other laboratory events.
Participants will learn how to structure and document laboratory investigations in alignment with ISO/IEC 17025 requirements, including defining clear problem statements, evaluating technical validity, assessing measurement uncertainty and method performance, and identifying true root causes. Emphasis is placed on distinguishing between immediate causes, contributing factors, and systemic issues to ensure effective corrective action.


The course integrates practical application of proven tools, such as the 5 Whys, Fishbone (Ishikawa) diagrams, Pareto Analysis, and FMEA, within the context of laboratory operations, calibration, and testing environments.

 

Through guided exercises, breakout activities, and real-world case studies, participants will actively practice investigation techniques, develop defensible conclusions, and design corrective actions that meet ISO/IEC 17025 expectations for effectiveness and continual improvement.

Learning Objectives:

By the end of this course, participants will be able to:


  • Explain ISO/IEC 17025 requirements related to nonconforming work, corrective action, and continual improvement
  • Develop clear, concise, and technically accurate problem statements for laboratory  investigations
  • Differentiate between immediate causes, root causes, and contributing factors in laboratory  events
  • Apply root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA, Pareto, fault tree) to laboratory-specific scenarios
  • Evaluate the impact of nonconformities on test results, calibrations, and data validity
  • Identify appropriate corrective and preventive actions based on investigation findings
  • Document investigations in a manner that is compliant, traceable, and defensible during 
    audits
  • Collaborate effectively in remote investigation settings using structured tools and techniques



Learning Outcomes

Upon successful completion of this course, participants will be able to:

  • Conduct a complete laboratory investigation into nonconforming work in alignment with ISO/IEC 17025 expectations

  • Produce well-documented investigation reports that clearly justify conclusions and decisions

  • Demonstrate the ability to identify true root causes rather than symptoms

  • Recommend and justify effective corrective actions that address systemic issues and prevent recurrence

  • Assess the effectiveness of corrective actions using objective evidence

  • Defend investigation approaches and conclusions during internal or external audits

  • Apply investigation techniques consistently across a variety of laboratory scenarios (e.g., OOS results, method failures, equipment issues)

  • Actively participate in and contribute to remote, team-based investigation exercises

Course Curriculum

    1. Root Cause Analysis Presentation

    2. Root Cause Analysis (Notes)

    3. Five Whys Template

    4. Fishbone Diagram Template

    1. Course Completion Survey

About this course

  • $549.00
  • 5 lessons
  • 0 hours of video content

  • Certificate of Attendance

    All attendees receive a certificate of attendance upon course completion.

  • Who Should Attend

    Quality assurance personnel, laboratory management, and laboratory staff.

  • Group Discounts

    Group discounts available. Contact us to receive a unique group discount code.

Meet Your Instructor

Senior Instructor Gretchen McAuliffe

Labtopia co-founder and Principal, Gretchen is expert at developing integrated systems for regulated industries. She specializes in providing QA support to ISO and GxP manufacturers, laboratories, and distributors, as well as managing and conducting domestic and international audits for such organizations. Additional areas of expertise include quality management systems, technical writing, business process mapping, database requirements and implementation, document control, and laboratory compliance.

When facilitating, she draws on her analytical capabilities, attention to detail, and cross-sector professional experience, providing richly informative, immediately actionable instruction to her learners.

Registering a group?

Get your group discount code and assistance with registering your group.

Discover your potential, starting today

Enroll today