Definition - Correction, Corrective Action, Preventive Action (CAPA) Structured problem solving (PDCA) Root Cause Analysis (5 Whys, Cause and effect, Pareto)

1. STRUCTURED PROBLEM
SOLVING
(CORRECTION, CAPA AND RCA)
Dr. Lallu Joseph
Quality Manager
CMC, Vellore

2. Every problem has a
solution. You just have to
be creative enough to
find it.
Travis Kalanick, Co-founder of Uber

3. OVERVIEW OF THE PRESENTATION
 Definition - Correction, Corrective and
Preventive Actions
 Structured Problem Solving
 Tools and Techniques - Structured Problem
Solving
 Implementation and follow up

4. CONTINUAL IMPROVEMENT
 Perfection of systems does not happen overnight
 Quality management strives to achieve continual
improvement
 Essence of continual improvement is effective
problem solving

5. CORRECTION, CORRECTIVE AND
PREVENTIVE ACTION
 Correction- Action to eliminate a detected non-
conformity
 Corrective action- Action to eliminate the cause
of a detected non-conformity.
 Preventive action- Action to eliminate the cause
of a potential non-conformity.

6. CORRECTION
Correction- Action to eliminate a detected non-
conformity
 Correction is like a first aid
 Instant action taken to correct the problem
 Action to reduce the impact of the problem

7. CORRECTIVE ACTION
Corrective action- Action to eliminate the cause of
a detected non-conformity.
 Reactive
 Considered as ‘Problem Solving’
 Focuses on root cause/ causes
 Steps taken to remove or eliminate the causes of
a non-conformity or undesirable situation
 Intent is to ensure non-conformity or undesirable
situation do not re-occur (to avoid recurrence)

8. PREVENTIVE ACTION
Preventive action- Action to eliminate the cause of
a potential non- conformity.
 Proactive
 Undesirable situation has not happened
 Need to anticipate risks that may occur
 To be identified proactively, against the
potential non-conformities, risks or defects
 To prevent occurrence

9. EXAMPLES – C, CA, PA
Food served cold to patient, replaced with hot food
when complained
C
Metal detector at the entrance of MRI room PA
Alcohol based hand rub kept at the bedside of
patients as the hand hygiene compliance of doctors
and nurses was inadequate
CA
Patients monitored post endoscopy in the recovery
area
PA
Inj. Avil administered to the patient as he developed
C

10. FIRE DUE TO OLD WIRING AND POOR
INSULATION
Correction : Put off the fire immediately
Corrective Action : Change the old wiring in the area
Preventive Action : Thermographic testing of the
electrical wiring at
predefined intervals
Thermography is a non-destructive test method to detect
poor connections, unbalanced loads, deteriorated
insulation in energized electrical components. Heat
generated is related to the amount of current flowing and

11. WRONG PATIENT SENT TO
OPERATION THEATREKumar. V for angiogram sent to CTVS OT for CABG instead of Kumar.
S from the same ward. Identified at the receiving bay by the
Anaesthetist & Nurse, while checking the identity, procedure using the
surgical safety checklist (Pre-op check).
Correction : Patient counselled by the doctor and sent to the
CATH lab
Corrective Action : Systems to alert the medical staff in wards when
patients with same name, or similar sounding names are admitted.
Colour tagging with different coloured bands and double checking.
Preventive Action : Surgical safety checklist is used to prevent wrong
surgery, wrong patient and site, which has worked in this case.
However, the PA based on this experience is to ensure that the same
cause cannot be a potential problem in other areas. For example,

12. BABY SUSTAINED BURNS
Four month old baby for cardiac surgery at 7.30 am was given bath
by night duty nurse at 5.30 am with hot water as part of pre-op
preparation. Nurse checked the temperature of the hot water with
her gloved hands by pouring water on her gloved wrist. Baby
sustained burns.
Correction : Treatment provided to the baby
Corrective Action : Temperature checking of the hot water for bath
to be
done with thermometer.
Preventive Action : Temperature checking made mandatory with
bath
thermometer in wax bath, foot therapy for

13. PREVENTION EMPHASIZED THROUGH RISK
BASED THINKING!!
 Previous versions of ISO 9001 included correction,
CA and PA
 No mention of PA in ISO 9001:2015
 ISO 9001:2008 didn’t mention risk and 2015
mentions risk in various forms and contexts
 Clause 6.1 of ISO 9001:2015 has new requirements
to risk when planning QMS
 It also requires evaluation of the effectiveness of
the actions to address risk.

14. STRUCTURED PROBLEM SOLVING
TRADITIONAL APPROACH STRUCTURED APPROACH
PROBLEM PROBLEM
SOLUTION
(QUICK FIX)
SOLUTION
(PREVENT
RECURRENCE/
OCCURRENCE)

15. TRADITIONAL VS STRUCTURED
PROBLEM SOLVING…
TRADITIONAL
APPROACH
•Jump to conclusions
•Treating the symptoms
•Not evidence/ data
driven
•Short term focus
•No follow up
STRUCTURED APPROACH
•Identifying root cause
•Identifying all associated
causes
•Evidence/ data driven
•Long term focus
•Follow-up of
recommendations and

16. FORMING THE RIGHT TEAM..
• Team better than individual
• Multidisciplinary group with members from area
that experienced problem
• Small team, knowledge about the system
• Administrator/ decision maker, client of the
process, quality team member
• Clear purpose, roles
• Mutual accountability, complimenting each
other

17. ACT PLAN
DOCHECK
PDCA – APPROACH TO PROBLEM
SOLVING

18. STEPS IN PDCA PROBLEM SOLVING
ANALYZE THE PROBLEM
GENERATE SOLUTIONS
SELECT THE SOLUTION
IMPLEMENT
EVALUATE THE RESULT
STANDARDIZE
DEFINE THE PROBLEM
PLAN
DO
CHECK
ACT
1
2
3
4
5
6
7

19. 1. DEFINE THE PROBLEM
 Most difficult and most important step.
 Problem well defined is problem half solved
 Involves situation diagnosis to focus on real problem and not
symptoms
 Written down, clear, specific
 Details of who, what, where and when.
 GEMBA- Walk the area, look for potential causes, observe, take
inputs, pictures
 Careful defining provide raw material for successful identification of
root cause.
(Appropriate tools include brainstorming, fishbone, flow chart, Pareto

20. 2. ANALYZE THE PROBLEM- RCA
SYMPTOMS
• Problem reported
CAUSES
• Reasons of the problem
• Root

21. ROOT CAUSE ANALYSIS
 Weed is the problem, which is above the surface and
easy to see
 Root is beneath the surface, its obscured and difficult to
get to
 Mistake in understanding is that RCA is to identify the
root cause of the problem
 Analysis is actually breaking down into parts
 Root is a system and a combination of parts
 RCA is to understand all the pieces that contribute to the
problem

22. 5 WHY ANALYSIS
 Called the two year old approach
 Often used to solve simple or moderate
problems
 Simple tool that helps to get to the root
immediately
 Made popular in 1970s by the Toyota
production system
 Involves asking repeated “Why”
 Answer to the first “why” leads to the second

23. 5 WHY ANALYSIS- NEEDLE STICK
INJURY
Housekeeping staff sustained needle stick injury while transporting
the sharps to the temporary storage area
WHY 1: Why did the HK staff
sustain needle stick injury?
Box was overflowing
WHY 2: Why was the box
overflowing?
Short supply of puncture proof
boxes
WHY 3: Why was the short supply?
Order was not placed by stores on
time
WHY 4: Why was it not placed on
time?
Store keeper was on leave

24. PATIENT LATE TO OT
Patient arrives late to OT from the ward. Surgeon,
anaesthetist and the team had to wait
WHY 1: Why did the
patient arrive late to OT?
Patient had to wait for the trolley
WHY 2: Why did the
patient wait for the
trolley?
Replacement trolley had to be brought
from the other ward.
WHY 3: Why did the
patient need a
replacement trolley?
Screws of the side rail came off and
dislodged.
WHY 4: Why did the
screws come off?
They have not been checked
periodically.

25. CRITICISM OF 5 WHY ANALYSIS
1. Tendency to stop at symptoms rather than
going on to root causes
2. Inability to proceed beyond the investigators
current knowledge
3. Results not repeatable- different people
using 5 whys come up with different causes
for the same problem
4. Isolate single root cause, when there could be
many root causes

26. CAUSE AND EFFECT
DIAGRAMS
Dr. Kaoru Ishikawa
Cause & Effect Diagram (Fishbone or Ishikawa
diagram)
 It is a schematic way of relating the causes of
variation in a process
 A drawing to organize the contributing causes to a
problem in order to prioritize, select, and improve the
source of the problem
 Problem (Effect) on the right side and the possible
causes on the left side

27. WHEN IS IT USED?
 When identifying possible causes for a
problem.
 Identifies areas for collecting data
 When analysing complex problems
 Useful for teams: focusing a discussion and
organizing large amounts of information coming
from a brainstorming session.
 Especially when a team’s thinking tends to fall
apart and concentration is lacking

28. CAUSE AND EFFECT DIAGRAM
Registration
time too
long
People /Man
Plant / MachineProcedures / Methods
PoliciesMaterial
Staff can cut the queue
Registration at any time
Irrespective of appointment
time
Manual registration- No
computers
Inadequate signage /
instruction
FIFO not followed
Unnecessary information
being collected at the reg.
counter
New staff
Aggrieved Staff
Inadequate
stationeries
Separate line for men and
women

29. PARETO CHARTS
Pareto charts are used to identify and prioritize
problems to be solved.
Vilfredo Pareto, 1800, Italian economist noted “80% of
wealth was held by 20% of population”
Juran applied the Pareto Principle, stating that 80%
variation in process is by 20% of the variables
“Vital few” as opposed to “Trivial many”
80/20 rule
Need not be 80/20, could be 75/25 or 70/30 or even
65/35
The concept is to prioritize and address the issue.

30. WHEN IS IT USED?
 Looking at data on the frequency of problems
or causes.
 When there are too many problems or causes
and you want to focus on the significant ones.
 When you want to analyze broad causes by
looking at their specific components.
 To effectively communicate to others about
the problem/ data.

31. # Reasons
Number
of
patients
In %
(N=400)
Cumulativ
e
frequency
7 Registration time too long 111 28 % 28%
3 Inadequate number of doctors 100 25 % 53%
4 Inadequate number of counter staff 93 23 % 76%
2 Problem mixing with ‘follow-up’ patients 25 6 % 82%
6 Too many patients at the same time 21 5 % 87%
1
No mike or display board to know the
token number
15 4 % 91%
8 No name boards of the doctors 13 3 % 94%
5 Staff not following the Queue 12 3 % 97%
9 Others 10 3 % 100%
10
DISSATISFACTION OF PATIENTS IN
OPD

32. 28%
53%
76%
82%
87%
91% 94% 97% 100%
0%
20%
40%
60%
80%
100%
0
20
40
60
80
100
120
Registration
Time too
long
Insufficient
Doctors
Insufficient
Counter Staff
Problem
mixing with
‘follow-up’
patients
Too many
patients at
the same
time
No mike or
display
board to
know the
token
number
No name
boards of the
doctors
Staff not
following the
Queue
Others
Number of patients Cumulative frequency
Addressing these 3 issues out of 9, will solve 76% of
the problems

33. 3. GENERATE SOLUTIONS
 Brainstorm solutions

34. 4. PRIORITIZE/ SELECT SOLUTIONS
PLAN
NOW
DO
NOW
DON’T
DO
DO
LATER
DIFFICULT EASY
SMALL
LARGE
Impact
Ease of implementation

35. 5. IMPLEMENT THE SOLUTIONS
 Involve the stakeholders
 Appropriately communicate to the stakeholders
and create ownership
 Draw up the implementation plan and the
timelines
 Identify the implementation champion/ leader
 The RCA team should be involved in
implementation for better results
5a. Verification- Did the solution get

36. 6. EVALUATE THE RESULT
Conduct a pilot study to assess the following:
 The changes after implementation
 Effectiveness of the solution and whether any
further solution needs to be implemented
 Validation- Has the solution produced the
desired results?
 Whether the stakeholders and the RCA team are
satisfied with the solution and implementation

37. 7. STANDARDIZE

38. IMPLEMENTATION AND FOLLOW UP
 Role of Quality Team is critical in follow up
 Continuous audits for a certain period
 Periodical audits after the standardization is
achieved

39. REFERENCES
1. Where is preventive action?, John E. Jack, Charles A. Cianfrani,
http://asq.org/quality-progress/2016/03/standards-outlook/where-is-
preventive-action.html
2. CAPA Process (Corrective Action & Preventive Action), Bill Greenwood,
www.thebcma.org
3. Root cause analysis processes and methods, http://asq.org/learn-about-
quality/root-cause-analysis/overview/conducting-root-cause.html
4. TQM in the Service Sector, R.P Mohanty & R.R Lakhe, Jaico Publishing House
5. Total Quality Management, V.S Bagad, Technical Publications Pune
6. Juran’s Quality Handbook, 6th Edn, Joseph M. Juran & Joesph A. De Feo, Tata
McGraw-Hill
7. Learn Quality Tools, http://asq.org/learn-about-quality/quality-tools.html
8. Quality Improvement tools & techniques, Peter Mears, McGraw-Hill
9. Root cause analysis – A Tool for Total Quality Management, Paul F.
Wilson, Larry D. Dell, Gaylord F. Anderson