Root cause analysis plays an important role in implementation of Corrective and preventive action of laboratory medicine.

1. Root Cause Analysis
By
Raveesh C Pandey

2. Requirements of RCA
ISO 15189:2012 (clause 4.9) holds clinical labs accountable to have: “a
documented procedure to identify and manage nonconformities in any
aspect of the quality management system, including pre-examination,
examination or post-examination processes.”
What is Nonconformities:
“Nonfulfillment of a requirement”
Some example of nonconformities are accidents, errors, events,
incidents, and occurrences.

3. Requirements of RCA
Clause 4.12 states that
 Requires Continual Improvement Process
 Requires identification potential sources of non-conformance
 Requires improvement to those areas, review, and monitoring

4. When should RCA be used?
• Corrective or Preventive action
• When instruments are not maintained
• Lab error
• Internal quality control out of range
• Proficiency testing outlier

5. The 7 Steps of RCA

6. Three basic type of causes:

7. How to Identify Root Cause
 The 5 Whys
 And for potential nonconformities conduct
 Fishbone diagram analysis
 Fault tree analysis

8. The 5 Whys

9. Cause analysis – the 5 Whys

10. Fishbone diagram
 The fishbone diagram or Ishikawa diagram is a cause-and-effect diagram that
helps managers to track down the reasons for imperfections, variations,
defects, or failures.
 Also known as Cause and Effect Diagram
 The diagram looks just like a fish’s skeleton with the problem at its head and
the causes for the problem feeding into the spine.
 Once all the causes that underlie the problem have been identified, managers
can start looking for solutions to ensure that the problem doesn’t become a
recurring one.

11. Example of Fishbone Diagram

12. Fault Tree Analysis(FTA)
 Fault tree analysis (FTA) is a top-down, deductive failure analysis
 Fault tree analysis (FTA) was originally developed in 1962 at Bell
Laboratories by H.A. Watson.

13. Example of Fault Tree Analysis(FTA)

14. Thanks