QMS 1 - MANAGEMENT RESPONSIBILITY
1.3.2-2 Risk Management
Illuminating the Path to ISO 15189 (SLMTA 3) e-Learning Course Download Video
- Overview
- Resources
PURPOSE:
All laboratory work is a series of connected processes. Therefore, to adequately perform root cause analysis and risk assessment, management must first identify and understand the processes involved.
In this activity, document control processes are used to explore the benefits of applying processes in problem resolution efforts. Working with the document control process, participants will be better prepared to support their QMS improvements and the accompanying documentation changes at their site.
KEY MESSAGES:
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A laboratory can best reduce errors by understanding and documenting its processes.
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The actions necessary to meet requirement compliance should be built into the process during the quality design phase.
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The time to begin identifying and managing risk is during the quality design phase.
SELF ASSESSMENT:
Can you:
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Describe a Fit-for Purpose process?
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Read a process map?
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Understand the connection between Quality Planning, Quality Control, and Quality Improvement?
- 1-16 - Handout_Excerpts from a Management of Records Procedure.docx
- 1-17 - Worksheet_Generic Analyzer Examination Process.pdf
- 1-18 - Job Aid 1_Process Control Process.pptx
- 1-19 - Job Aid 2_ Diagraming Processes.pptx
- 1-20 - Job Aid 3_Understanding Risk Managment.pptx
- Homework- Designing Fit-for-Purpose Processes Quiz.doc
Instructor(s)
Elde Mel Paladar
Mr. Paladar led the redesign of the classroom-based SLMTA 3 curriculum for on-line delivery and will serve as an instructor and facilitator of the e-learning course. Based in Malawi, he is a Project Manager at Adventist Health International, as well as Assistant Professor at the Department of Clinical Laboratory Science, Loma Linda University. Mr. Paladar has a Master of Science in Biochemistry and Molecular Biology. He is a SLMTA master trainer and has trained numerous laboratorians in the past decade.