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
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.
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.