• Introduction

    This course covers 3 key elements of Laboratory Quality Management namely: Handling Non- Conformities, Root Cause Analysis, Corrective Action & Preventive Action (CAPA). 

    Handling Non-Conformities: Sessions will provide information on how to analyse laboratory data to identify actual and potential nonconformities.

    Root Cause Analysis: Sessions will provide the information required to effectively identify the underlying cause(s) of a problem so that action can be taken to prevent its recurrence.  

    Corrective Action and Preventive Action: Sessions will provide information on building proper corrective and preventive action processes.  The course has a description of general corrective action and preventive action analysis methodology and a set of basic tools necessary to implement it. 

     

    Learning Objectives

    This practical, hands-on course teaches participants how to use effective steps approach to correcting and preventing problems that exist in their laboratories. Specific objectives of the course include;

    a)   To develop the skills required to identify and properly define nonconformities. 

    b) To develop skills for determining and implementing effective corrective action and/or preventive action as a way of preventing its recurrence or occurrence. 

    c) To develop practical skills in trending laboratory data and information and reviewing the trends to identify sources of variation in the processes and requirements of the Quality Management System.    


    Intended Learning Outcomes (competencies)

    On completion of this course, participants will be able to:

    a)     Collect and analyse laboratory data to identify actual and potential non-conformities.

    b)     Investigate non-conformities and take appropriate corrective and preventive action

    c)     Verify the effectiveness of corrective action and preventive action processes

    d)     Analyze data to identify areas of improvement 


    Duration of the Course: 29.83 hours 

    Course Evaluation and Certification

    S/N

    Activity

    % Score

    1

    Quizzes

    15

    2

    Assignments

    30

    3

    Discussion contributions

    05

    4

    Final Exam

    50

     

    Total

    100


  • Module 1: Handling Nonconformities (NC)

    By identifying and recording problems (nonconformities) and the measures taken to solve the problems, we are better able to identify common and recurring faults and maintain a record of our experiences. Remember the English saying that “experience is the best teacher” which literally means that learning from your mistake is the most unforgettable experience.

    NC records are to capture NC and the actions taken to correct the problem(s) so that in future we can learn from them. NC records ensure that routine maintenance is appropriate and verify that the appropriate actions are used to efficiently maintain operations in the laboratory.

    In this module, you will learn how to proactively deal with potential nonconformities in order to eliminate the potential root cause(s) of nonconformities.

    Module Learning Outcomes

    Upon completion of this module, each participant will be able:

    a)     Clearly define and write a nonconformity

    b)     Determine extent of the nonconformity

    c)     Review NC trends and initiate Corrective action


    1 Forum, 2 Folders
  • Module 2: Root Cause Analysis

    The quality management system of an organization should define and document the process through which corrective actions are implemented. This module teaches key problem- solving techniques that will yield implementation of effective corrective actions. The module provides the skills to look for underlying causes of problems that impact an organization’s operations and ultimately its profitability.

    By performing exercises and group discussions, participants will develop a hands-on understanding that will facilitate the uncovering of true root causes of problems and the implementation of meaningful corrective actions to help the organization improve.

    Module Learning Objectives

    Upon completion of this module, each participant will be able to:

    1.  Apply different root cause analysis tools to investigate the cause of non conformities

    2. Conduct and document the root cause analysis for a given nonconformity

    1 Forum, 1 Chat, 1 Assignment, 1 Folder
  • Module 3: Corrective Action and Preventive Action (CAPA))

    In this module we will discuss corrective action and preventive actions which are improvements to an organisations processes taken to eliminate causes of non-conformities or potential non conformities. You will be engaged in exercises covering real life situations so that you will be confident of implementing CAPA requirements.

    Learning Objectives

    Upon completion of this unit, the participant will be able to:

    1. Differentiate between Corrective actions and Preventive actions

    2. Determine the most appropriate corrective action or preventive action that would address the non conformity or potential non conformity

    3. Implement corrective actions and monitor their effectiveness

    4. Implement preventive actions and monitor their effectiveness

    1 Chat, 1 Assignment, 1 Forum, 1 Folder
  • Course Wrap Up

    1 Assignment, 1 Quiz, 1 Feedback
  • Further Reading

    Reading Materials/Lists

    1.     ISO 15189 – 2012 Medical laboratories – Requirements for quality and competence