root cause analysis by using a 5 Whys method

laboratory root cause analysis by 5 whys

1. Root Cause Analysis

2. What is a Root Cause
Analysis(RCA)
–A system of problem solving methods aimed at
identifying the root causes of problems or
incidents.
–Predicated on the belief that problems are best
solved by attempting to correct or eliminate root
causes, as opposed to merely addressing the
immediately obvious symptoms.
–By directing corrective measures at root causes, it
is hoped that the likelihood of problem recurrence
will be minimized.

4. 4

5. Philosophy of Root Cause analysis
–Each problem is an opportunity (“golden nugget”)
because it can tell a story about why and how it
occurred.
–It is critical that everyone take a personal and active
role in improving quality.
–The “true” problem must be understood before
action is taken.
–Problems are often masked for a variety of reasons
–To do this well, we must be
•Both focused and open-minded
•Both patient and quick

6. What the ISO 15189 Says:
•4.10 Corrective action
•The laboratory shall take corrective action to eliminate the
cause(s) of nonconformities. Corrective actions shall be
appropriate to the effects of the nonconformities encountered.
•The laboratory shall have a documented procedure for:
a) reviewing nonconformities;
b) determining the root causes of nonconformities;
c) evaluating the need for corrective action to ensure that
nonconformities do not recur;
d) determining and implementing corrective action needed;
e) recording the results of corrective action taken (see 4.13);
f) reviewing the effectiveness of the corrective action taken (see
4.14.5).
•NOTE Action taken at the time of the nonconformity to mitigate
its immediate effects is considered “immediate” action. Only
action taken to remove the root cause of the problem that is
causing the nonconformities is considered “corrective” action.

7. Principles of root cause
analysis

8. Principles of Root Cause
Analysis
Must be performed systematically as an
investigation.
–Not a blame game
–Not looking for the immediate fix
–Dig deeper
–Establish a sequence of events or timeline
–Understand the relationships between
contributory factors

9. Symptom Approach vs. Root
Cause
Symptom Approach
•“Errors are often a result of
worker carelessness.”
•“We need to train and motivate
workers to be more careful.”
•“We don’t have the time or
resources to really get to the
bottom of this problem.”
Root Cause
•“Errors are the result of defects
in the system. People are only
part of the process.”
•“We need to find out why this is
happening, and implement
mistakeproofs so it won’t happen
again.”
•“This is critical. We need to fix
it for good, or it will come back
and burn us.”
If we do a poor job of identifying the root causes of our problems, we
will waste time and resources putting band aids on the symptoms of
the problem.

10. Tools and Techniques for RCA
•FiveFive WhysWhys
•CauseCause andand EffectEffect
•BrainstormingBrainstorming
•Pareto analysisPareto analysis
•Control chartsControl charts
•Many more othersMany more others

11. FISHBONE TECHNIQUE

12. Fishbone Diagram
•The Fishbone Diagram
is a technique to
graphically identify
and organize many
possible causes of a
problem (effect).
•Also known as the
Cause & Effect
Diagram or Ishikawa
Diagram

13. Fishbone Diagram
–Fishbone Diagrams help identify the most
likely ROOT CAUSES of a problem. They can
also help teach a team to reach a common
understanding of the problem.
–This tool can help focus problem solving and
reduce subjective decision making.

14. Cause and effect Diagram
14

16. Fishbone technique

17. Basic elements of Fishbone
Diagram
•The 6Ms:
1.Man: Anyone involved with the process
2.Machine: Any equipment, computers, tools, etc.
required to accomplish the job
3.Methods: How the process is performed and the
specific requirements for doing it, such as policies,
procedures
4.Materials: Raw materials, reagents, parts, pens,
paper, etc. used to produce the final results
5.Mother Nature: The conditions, such as location,
time, temperature, and culture in which the
process operates
6.Measurements:

18. Possible Issues with 6Ms
•Materials
–Defective raw materials
–Wrong type for job
–Lack of raw material
•Machine/Equipment
–Incorrect instrument
selection
–Poor maintenance or
design
–Poor equipment or
instrument placements
–Defective equipment or
instrument
•Environment(Mother
Nature)
–Workplace
cleanliness/clutter
–Layout of work area
–Maintenance of work area
–Techniques or demands of
task
–Forces of nature
•Methods
–No or poorly written
procedure
–Practice not same as
written procedure
–Poor communication

19. Possible Issues with
6Ms
•Man
–No or poor management
activity
–Inattention to task
–Task hazards not
guarded properly
–Other - Skill set not
defined - Not trained for
task
–Stress demands or undue
pressure
•Results in improper
practice
•Measurements
–Calibrations
–Allowable errors (UM)

20. Group Exercise
•Conduct the given exercises in your
groups
•Present as powerpoint

21. Group Exercise
•Review the following EQA performance
and give comments
•State the problem (NC) if there’s any
•Use Fishborne technique to conduct root
cause analysis
•Suggest probable corrective action/s

22. FIVE WHYS

23. Five Whys Technique
•Explore cause/effect relationship
Tendency to stop at symptoms rather than
going to lower level root causes
Lack of support to investigate real problem
Lack of training to identify cause/effect
relationship
•Asking Why five times
Nature of the problem becomes clear
Helps get to true cause of problem

24. Five Whys Analysis
Helpful in tracing the chain of events (starting with
the nonconformance and working backwards)
Asking Why five times
•NB: 5 is just a guideline not a hard and fast rule
Nature of the problem becomes clear
Helps get to true cause of problem

25. Benefits of 5 Whys
–Easy to teach and
–Easy to use.
–It introduces people to problem solving
–Prevents “band aids”

26. Drawbacks of 5 whys Analysis
–Its not a repeatable tool, does not involve
the use of data. Different people can come
up with different results.
–Results may be biased.
–Limited to personal experience
–Doesn’t account for multiple causes
–Doesn’t work well for complicated problems

27. Group Exercise
•Conduct the given exercises in your
groups
•Present as powerpoint

28. Exercise
•An old version of the temperature
monitoring form F034 version 1 was used
to monitor the room temperature for the
Immunology lab room for the month of
March 2016 while the lab has a new
version 2 indicated in the master list
index.
•Perform root cause analysis using Five
Whys

29. …Exercise continued
•Why: The hard copies in the immunology file
were the wrong version
•Why: Because the version of the form that came
from the quality officer was wrong one.
•Why: Because the deputy quality officer printed
the forms from a wrong folder.
•Why: Because she saved copies in her on folder,
when the master was updated, hers was not
updated.
•Why: Because employees aren’t required to
access required to access forms from just one
central location.

30. Assignment
•At the time of the assessment, it was
noted that the lab management did not
complete action items from the 2019
Management Review meeting within the
agreed upon timescale.

31. Questions?