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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.
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
By identifying and recording problems (nonconformities) and the measures taken to solve the proble...1 Forum 2 Folders
The quality management system of an organization should define and document the process through whi...1 Forum 1 Chat 1 Assignment 1 Folder
In this module we will discuss corrective action and preventive actions which are improvements to a...1 Chat 1 Assignment 1 Forum 1 Folder
1 Assignment 1 Quiz 1 Feedback
1. ISO 15189 – 2012 Medical laboratories – Requi...