COURSE OVERVIEW:

The meaning of this course lies in the evolution from reactive error correction to proactive risk management within the modern analytical laboratory. In the current iteration of ISO/IEC 17025, "Risk-Based Thinking" is no longer an optional concept but the fundamental lens through which all laboratory processes must be viewed. This program provides the advanced analytical tools and strategic mindset required to identify, evaluate, and mitigate risks that could compromise the validity of laboratory results or the safety of personnel.

The scope of the training addresses the identification of technical risks throughout the "Analytical Lifecycle," from sample receipt to the final reporting of data. It covers the application of established risk assessment methodologies, such as FMEA (Failure Mode and Effects Analysis) and SWOT analysis, specifically tailored for the laboratory environment. Participants will explore how to balance "Risk and Opportunity," ensuring that resources are allocated to the areas of greatest technical vulnerability while maintaining operational efficiency.

The coverage includes a comprehensive investigation into risks associated with impartiality, measurement uncertainty, equipment failure, and personnel competency. The course emphasizes the development of "Risk Registers," the calculation of "Risk Priority Numbers" (RPN), and the integration of risk mitigation into the Laboratory Quality Manual. By mastering these advanced risk management protocols, participants will be able to safeguard their laboratory's accreditation, protect their technical reputation, and foster a culture of resilience and continuous improvement.

COURSE OBJECTIVES:

After completion of this course, the participants will be able to:

• Define the core principles of Risk-Based Thinking in ISO/IEC 17025:2025.
• Distinguish between "Technical Risks" and "Management Risks."
• Conduct a formal "Risk Assessment" using the FMEA methodology.
• Identify potential threats to laboratory "Impartiality" and "Confidentiality."
• Quantify risks using "Risk Matrix" and "Severity-Likelihood" scoring.
• Develop a comprehensive "Laboratory Risk Register."
• Implement effective "Risk Mitigation Strategies" for equipment and methods.
• Link risk management results to the "Management Review" process.
• Identify "Opportunities for Improvement" through risk analysis.
• Evaluate the effectiveness of "Corrective Actions" from a risk perspective.
• Lead "Risk Awareness" workshops for laboratory technical staff.
• Document "Risk-Based Decisions" to satisfy accreditation assessors.

TARGET AUDIENCE:

This course is intended for Quality Managers, Technical Managers, Laboratory Directors, and Senior Lead Auditors.

TRAINING COURSE METHODOLOGY:

A highly interactive combination of lectures, discussion sessions, and case studies will be employed to maximize the transfer of information, knowledge, and experience. The course will be intensive, practical, and highly interactive. The sessions will start by raising the most relevant questions and motivating everybody to find the right answers. The attendants will also be encouraged to raise more of their questions and to share in developing the right answers using their analysis and experience. There will also be some indoor experiential activities to enhance the learning experience. Course material will be provided in PowerPoint, with necessary animations, learning videos, and general discussions.

The course participants shall be evaluated before, during, and at the end of the course.

COURSE CERTIFICATE:

National Consultant Centre for Training LLC (NCC) will issue an Attendance Certificate to all participants completing a minimum of 80% of the total attendance time requirement.