The Basics of Non-Conforming Event Management for Clinical Laboratory Services

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Lisa Dewey, BS, MT(ASCP)
Reviewer: Jack A. Maggiore, PhD, MT(ASCP)

One fundamental element of a quality management system (QMS) includes the management of non-conforming events (NCEs). Its general purpose is to cultivate an environment in which problems or occurrences can be used in a positive way to improve the quality of laboratory services. This course discusses the importance of non-conforming event management as a means of achieving laboratory quality objectives. Various data and tools used in managing corrective and preventive actions along with a list of the basic steps for a typical non-conforming event process are described by the authors of the course.

Continuing Education Credits


  • Recognize the importance of non-conforming event management as a means of achieving laboratory quality objectives.
  • Understand the purpose of corrective actions and preventive actions, including distinguishing between the types of actions.
  • Identify various data and tools used in managing corrective and preventive actions.
  • List the basic steps of a typical non-conforming event process.
  • Demonstrate an awareness and understanding of compliance concerns.

Course Outline

  • Introduction to NCE Management
      • The Laboratory Quality Management System and Non-Conforming Events (NCEs)
      • Nurturing a Culture of Open Communication
      • Compliance
      • NCE Programs
  • Terms Used in a NCE Management Program
      • Reportable Events
      • Other Reportable Events
      • Corrections, Corrective Actions, and Preventive Actions
      • Corrective Action / Preventive Action
      • Risk
      • Root Cause
      • How do corrective actions/preventive actions (CAPA) improve the quality of laboratory services?
      • A laboratory has ordered 500 disposable lab coats, but only receives 450 in the shipment. The shipping department immediately sends the laboratory the...
  • Regulatory and Accreditation Requirements
      • Requirements for Management
      • CLIA '88 Requirements
      • Accreditation by the College of American Pathologists (CAP)
      • American Association of Blood Banks (AABB)
      • COLA
      • The Joint Commission (TJC)
      • Det Norske Veritas Germanischer Lloyd (DNV GL)
      • Laboratory-Developed Tests and the Food and Drug Administration (FDA)
      • Clinical and Laboratory Standards Institute (CLSI)
      • Non-conforming event management procedures are not required by some accrediting agencies.
  • Sources of Information About Non-Conformities
      • Sources of NCEs and Prioritizing Based on Risk
      • NCEs of External Origin
      • Examples of NCEs of External Origin
      • Examples of NCEs of Internal Origin
      • The Laboratory Director has been notified by the Risk Management department that a physician suspects his patient’s laboratory results caused a ...
      • The laboratory's Quality Committee is evaluating its quality monitor for QC failures on a test system that has a history of poor performance. A trend ...
  • Using Corrective Actions vs. Preventive Actions in the Correct Scenarios
      • What to Report?
      • Distinguish Between Corrective Action and Preventive Action
      • Some NCE Scenarios
      • A nurse calls from the floor to state that he does not believe the laboratory report on his patient is accurate. The medical laboratory scientist (MLS...
  • Basic Steps of a NCE Management Program
      • Management of Non-Conforming Events
      • Identification
      • Identification, continued
      • Reporting Form
      • Investigation
      • Analysis
      • Five Whys
      • Analysis: Cause and Effect Diagram
      • Analysis: Possible Root Causes
      • When analyzing NCEs, you may want to detect which of the following trends?
      • Implementation
      • Implementation, continued
      • Verification of Effectiveness
      • Verification
      • Verification, continued
      • Verification: Evidence
      • Why Verification May Fail
      • Communication
      • Communication, continued
      • Management Review
      • Documentation
      • New procedural steps have just been implemented in the Hematology laboratory in response to a non-conformity. What must be done next?
  • Reporting Systems for Non-Conforming Events
      • Non-Conformity Reporting
      • Status Tracking
      • Trend Analysis
      • Trend Analysis: Pareto Charts
      • In the Pareto chart shown, which NCE shows the greatest frequency?
      • In the same Pareto chart, the amount of risk associated with each category is shown to be the highest for corrected reports.
      • Summary
  • References
      • References

Additional Information

Level of Instruction: Basic to intermediate
Intended Audience: The target audience for this course is laboratory professionals who act in an administrative capacity or would like to increase their knowledge regarding laboratory administrative issues. The course is also appropriate for Clinical Laboratory Science students. 
Author Information: Lisa Dewey, MT(ASCP) has been a Medical Technologist since obtaining her Bachelor’s degree in Clinical Laboratory Science from the University of Illinois at Chicago. Lisa has experience working in various specialties in hospital and clinic laboratories, research & development, and commercial laboratories specializing in dried blood spot testing. She has held positions as a bench technologist, supervisor, and manager. She is currently the Quality Manager at Doctor's Data, Inc., a specialty reference laboratory. As an active Board Member of her CLMA chapter, Lisa is working to promote education and awareness in the Laboratory Science Industry.
Reviewer Information: Jack A. Maggiore, PhD, MT(ASCP) serves as the Assistant Laboratory Director of Chemistry and is Head of Research and Development at Doctor's Data, Inc. in Saint Charles, Illinois. Dr. Maggiore is a medical technologist, certified by the ASCP, with a Master of Science in Clinical Chemistry and Doctorate in Pathology from the University of Illinois. His expertise includes clinical instrumentation, method development and validation, quality assurance, medical device clinical trials, and scientific regulatory affairs. His clinical research interests include development of novel biomarkers for chronic diseases using blood spots and other non-conventional samples. Dr. Maggiore holds several medical device patents, has authored more than fifty peer-reviewed and invited publications and textbook chapters, and has presented his research findings at international scientific society meetings. Dr. Maggiore's mission is to work with health care professionals to empower consumers to take a more active role in their health maintenance. 

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