1. CAPA, Root Cause Analysis, and Risk Management
Documented by
Shubham Khandelwal

2. What is CAPA?
Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems.

3. CAPA is Part of the Seven Quality Subsystems

4. Terminology
Nonconforming Material or Process (Discrepancy) - Any material or process that does not meet its required specifications or documented procedure.
Correction – Refers to repair, rework, or adjustment and relates to the disposition of an existing nonconformity.
Corrective Action - To identify and eliminate the causes of existing nonconforming product and other quality problems.
Preventive Action - To identify and eliminate the causes of potential nonconforming product and other quality problems.

5. Nonconformance Control Steps
1. Identify
nonconforming
items.
2. Move items
away from
work area.
3. Decide
what should
be done.
4. Take
remedial
action.

6. Components Of Corrective Action
Collect and analyze data to identify nonconforming
product, incidents, concerns or other quality
problems that would be worth the effort to correct
Investigate and identify root cause
Implement the correct solution
Verify or validate effectiveness

7. Corrective Action (CA) Steps
1. Would the
correction be
worth the
effort.
2. Identify
root cause.
3. Change
the system.
4. See if it
worked.

8. Ascertaining Root Cause
Root cause and the “weed”:
Weeds can be difficult to remove once they
start to grow and spread.
On the surface, the weed is easy to see.
However, the underlying cause of the weed, its root, lies below the surface and is not so obvious.
To eradicate the weed you have to get below the surface, identify the root, and pluck it out.
Thus, you have to go beyond the obvious, ascertain an accurate route cause, so the appropriate corrective action can be pursued to prevent recurrence.

10. Tools for Ascertaining Root Cause
Include the following:
The five whys, a simplistic approach exhausting the question “Why?”.
Fishbone diagram, a cause and effect diagram also known as the Ishikawa diagram.
Pareto analysis, the 80/20 rule premised on a predefined database of known problems.
Fault tree analysis, a quantitative diagram used to identify possible system failures.
Failure modes and effects analysis (FMEA), which lists all potential failure modes and the potential consequences associated with each failure mode.

11. The Five Whys Technique
The 5 Whys technique is a simpler form of fault tree analysis for investigations, especially investigations of specific accidents as opposed to chronic problems.
The 5 Whys technique is a brainstorming technique that identifies root causes of accidents by asking why events occurred or conditions existed.
The 5 Whys process involves selecting one event associated with an accident and asking why this event occurred. This produces the most direct cause of the event.
Drill down further indicating if their were any sub-causes of the event, and ask why they occurred.
Repeat the process for the other events associated with the accident.

13. Disadvantages of the 5 Whys Technique
This time consuming brainstorming process may be tedious for team members trying to reach consensus. This is especially true for large teams.
Results are not reproducible or consistent. Another team analyzing the same issue may reach a different solution. The particular brainstorming process that was utilized may be difficult, if not impossible, to duplicate.
Root causes may not be identified. The 5 Whys technique does not provide a means to ensure that root causes have been identified.

14. Creating a Fishbone Diagram – Initial Steps
A fishbone diagram is a cause and effect diagram that looks much like a skeleton of a fish.
It is also called a Ishikawa diagram after the inventor of the tool, Kaoru Ishikawa who first used the technique in the 1960s.
To draw the diagram, first list the problem/issue to be studied in the head of the fish.
Label each bone of the fish. The major categories typically used are: The 6 M’s: Machines, Methods, Materials, Measurements, Mother Nature (Environment), Manpower (People).
Repeat this procedure with each factor under the category to produce sub-factors.
Continue asking, “Why is this happening?” and put additional segments under each sub-factor.

15. Simple Fishbone Diagram Bioburden Levels Out of Specifications

16. Creating a Fishbone Diagram – Further Steps
Continue adding sub-factors to your diagram until you no longer get useful information as you ask, “Why is that happening?”
Analyze the results of the fishbone after team members agree that an adequate amount of detail has been provided under each major category. Do this by looking for those items that appear in more than one category. These become the ‘most likely causes”.
For those items identified as the “most likely causes”, the team should reach consensus on listing those items in priority order with the first item being the most probable” cause.

17. More Detailed Fishbone Diagram

18. Interesting, right?
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