QMS 4 - EVALUATION & CONTINUAL IMPROVEMENT

4.1.5-9 RCA Activity Assignments

Illuminating the Path to ISO 15189 (SLMTA 3) e-Learning Course Download Video
  • Overview
  • Resources

PURPOSE:

Beneath every problem lies a cause for that problem.  If the cause is reduced or eliminated, the risk is also reduced. 

In this session, participants solve a complex problem, which entered the corrective action process, using the Root Cause Analysis (RCA) methodology, a structured problem-solving approach.  

KEY MESSAGES:

  • Prioritization is the key so that laboratories apply their problem-solving resources where they are needed the most.
  • Root cause analysis is a consistent and disciplined problem-solving process that focuses on systems and processes and not individual performance. 
  • Understand the process, and then ask WHY.

SELF ASSESSMENT:

Can you:

  • Understand the importance of selecting the right problem for RCA?
  • Perform RCA given a nonconformity?
  • Relate the ISO15189 4.10 Corrective Action standards with the RCA model?

Instructor(s)

Janet Scholtz

Ms. Scholtz helped redesign the classroom-based SLMTA 3 curriculum for on-line delivery and will serve as an instructor and facilitator of the e-learning course. Ms. Scholtz is a Quality Manager, Regional Western and Northern Cape, at National Health Laboratory Services (NHLS), South Africa. She is a certified auditor for The South African National Accreditation System (SANAS). Ms. Scholtz has a Medical diploma in Biomedical Technology. She is a SLMTA master trainer and has trained numerous laboratorians in the past decade.


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