CAPA - The Foundation of Continuous Improvement

CAPA - Corrective and Preventive Action is the most basic and the most important Tool for Continuous Improvement. When implemented effectively CAPA leads to significant gains in Productivity, Quality and Cost Efficiency. 


You can boast of Kaizens and Gembas and anything else that you think helps to showcase your Plant – but they are all just Noodles if your Workforce is not habituated to this essential ingredient of Continuous Improvement.

Allow me to deviate a little to deliberate on the difference between Kaizen / Gemba etc on one hand and Continuous Improvement or Lean Thinking on the other. The former are like tyres and the latter your driving skills (or your Driver’s). If all you have is a swanky shiny car with a set of Made In Japan wheels that outshine sunshine but have no driving skills – you know your car is not going anywhere, any time soon!

Why bring this up ? Because if CAPA is not a part of the way your workforce thinks – your plant is not going very far on the Road to Continuous Improvement or Competitiveness.

Sometimes I feel CAPA has suffered the same fate as the much derided Garlic. Both have tremendous healing power and yet remain unutilized or underutilized at best. 

In addition to being a typical “Low Hanging fruit” for getting a higher ZED Score, CAPA oriented workplaces reduce Cost, improve Customer Satisfaction and most importantly free up Leadership Time for focusing on more important things such as Strategy, Customer Acquisition or even Productivity enhancement. 

We solve problems every day. Some of us solve a different problem every day, while some solve the same problem every time it happens. Every time we are faced with a problem, we solve it, and move on. Every new problem requires us to think through the possible solutions. It is a time consuming effort sometimes but eventually we get there sooner or later and then we get better and better at solving those problems when they occur again. 

How many of us take time to figure out Why did this problem occur in the first place and What can we do to make sure it does not happen again? If you are one of those who spend time and effort on finding ways to make sure you never have to face the same problem again, Congratulations! You have what it takes to implement CAPA with minimal effort.

CAPA is an integral part of ZED across many parameters such as:

• Safe Working Environment
• Daily Works Management
• Process Capability 
• Process Validation
• Process Control
• Material Handling Systems
• Environmental Performance
• Safety Score

CAPA comprises of the following elements: 
A. Problem/Event Description
B. Corrective Actions
C. Root Cause Analysis
D. Preventive Actions
E. Risk Mitigation
F. Effectiveness Review

We detail each one of these to help you implement an effective CAPA mechanism in your organization. A suggested CAPA format is also provided for you to use in your organization - CAPA & Risk Mitigation Format.


A. Problem/Event Description

It is important that the issue be described in detail to enable further review of the actions taken. Date, Time, Location (or machine) are some details that come to mind apart from a detailed description of the incident or problem.  

Example: 
The S1 Separator equipment stopped suddenly at 11.20 AM on 01-12-2017 due to Bearing overheating caused by damage to the O ring. The O ring was replaced at 12.20 AM and operations were resumed. This resulted in a 15% production loss for the shift.

B. Corrective Action

Corrective actions means what is done to address the problem at hand and resolve the immediate issues. Usually Corrective action takes the form of replacement, rework, resolution, first-aid or hospitalization etc. It is Priority 1 when anything goes wrong.

If I cut my finger while sharpening a pencil with a blade – applying first aid is Corrective Action. It will not ensure that this will not happen again, but this needs to be done as Priority 1.

Example of Corrective actions in the preceding problem: 

• Separator opened and emptied.  
• O ring replaced.
• Unprocessed material replaced in Separator.

C. Root Cause Analysis

Every Problem has a Root Cause - that factor (or factors) which have led to the problem. If this Factor (or Factors) were not to happen, the Problem would not have occurred at all.  A thorough Root Cause Analysis (RCA) is the first step to taking effective Preventive Action. 

The Root Cause will almost always point to a flaw in one or more of the following - Process, Person, Environment, Equipment, Material or Measurement. 

There are two popular tools for carrying out Root Cause Analysis
a. 5 Whys 
b. Ishikawa Diagram (or Fish Bone Analysis). 

The two approaches will be detailed in another article. Stay tuned!!

Establish Root Cause(s)

After you have listed the possible causes suing the 5 Why or FishBone Analysis, review them to establish the likelihood of each cause being a source of the Problem. Then list all established Root Causes

For our Example above the outcome of analysis looks like this

D. Preventive Actions 

Once all Root Causes have been identified, you need to eliminate these so that the failure / deviation does not recur. 

• For each Identified Root Cause identify Actions which will ensure that this problem does not recur.
• Monitor progress on regular basis to ensure all planned actions are completed.

A sample Preventive Action Plan is provided for reference

Steps A to D will only get you to a certain level in ZED Framework. From a Business Perspective as well as ZED perspective you should progress to the next Level - Risk Mitigation.

E. Risk Mitigation

Risk Mitigation means preventing problems from happening before they happen. In other words Anticipate what can go wrong and fix it BEFORE it goes wrong.

We need to evaluate the possibility of the Root Cause or problem occuring elsewhere. Review all areas / Operations / Work Groups and Product Lines/ Categories and verify the likelihood of this problem occurring or other problems occuring on account of the Root Cause. 

Steps in Risk Mitigation are as follows:

1. Risk Assessment

List all Work Areas / Operations / Functions in the Plant and check for the possibility of this problem occurring in those areas. Assessment of the possibility of occurrence in each area should me marked as follows:

• A. Yes – There is a possibility of occurrence
• B. Not Sure – Occurrence does not appear to be likely but cannot be out.
• C. No – There is no possibility of occurrence.

For our example above the Risk Assessment is as follows - Note that though Administrative & support functions do not have any equipment they too can face similar problems because of the nature of the Root Cause.

2. Risk Management 

Prepare and implement Preventive Actions for all cases having a definite potential for occurrence or where you are not sure.

Use the CAPA Format and monitor progress to ensure all planned actions are completed. Every month the plans & progress for Risk Mitigation must be reviewed by the MD/CEO along with Senior Team members on a monthly basis. 

For our example above the Risk Mitigation Action Plan would look as follows:

F. Effectiveness Review

Monitor effectiveness of Preventive Actions. Ideally this should form a part of a Monthly Leadership Review of all CAPAs.

• If the problem does not occur for 6 months, consider revising your SOPs & Work Instructions to incorporate the Preventive Actions into your Work Practices. 
• If there is any recurrence of the same Problem or similar Problem in any work area – conduct Root Cause Analysis again and repeat Preventive Action Planning Cycle. 

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