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Follow the 7 Steps of Root Cause Analysis Posted: June 9th, 2011 | Author: | Filed under: CAPA | Tags: , , , | No Comments »

Root Cause Analysis (RCA) is one of the continuous improvement elements of a quality management system. Its purpose is to identify a problem and its causes, resolve the problem and improve performance. It should be used as soon as a problem has been identified and the RCA process should not be delayed until a problem becomes too large and unwieldy.

The Root Cause Analysis process should follow these 7 steps:

1.  Describe the Problem: A business always has issues so it is a question of prioritising and dealing with the ones involving the most risk. It is important to be specific, keep the scope narrow and resolvable.

2.  Collect Data: Put a team together made up of representatives of all effected areas. Collect all the information you can about the problem using any tools available including statistical tools.

3.  Identify Possible Causes: This can be done in a brainstorm session. Start with the problem definition and ask “why?” it happened. Keep on asking “why?” repetitively until you have found the root cause. An example could be:

  • The delivery window for product Y was missed – why?
  • Because the delivery truck was late leaving the warehouse – why?
  • Because the planned service had run over schedule – why?
  • Because it was a new mechanic who lacked experience or because the wrong tools were taken out in preparation of the scheduled service etc…

Once “why?” has been asked as often as possible and all possible causes have been identified then the process of developing the solutions can start.

4.  Test Possible Causes: When the possible causes have been identified, run tests on each of them to see that they actually contribute to the problem. Make sure that everybody is involved in this process.

5. Identify the most effective Solutions: Review the results of the tests and select the solutions that are the most effective at resolving the problem and that do not create additional problems. Make sure that the solutions are within the control of the organisation in other words that the solutions can actually be implemented.

6.  Determine Corrective & Preventive Actions (CAPA): Identify exactly the corrective and preventive measures that need to take place and who should be responsible for their implementation.  Make sure that all concerned are involved in this process as well as areas that are not affected but could learn from the solutions, such as areas that run similar equipment but have not experienced the same problem. Update the relevant procedures.

7.  Implement and verify the Corrective & Preventive Actions: Implement the Corrective and Preventive Actions and check to make sure that they are followed and are effective in resolving the problem. In most cases the solutions are of a permanent nature so it is a good idea to revisit the problem at a later date to make sure that the CAPA items are still in place and permanently implemented.

The Root Cause Analysis process will help determine which processes may need to be modified, what documents and forms will need updating, who in the organisation will require training or re-training, and a slew of other considerations that go into a typical problem resolution process.

It is important that the root cause analysis process is followed by an effective corrective and preventive action plan as performing one without the other could mean that the problems do not get resolved and therefore repeat themselves.

 


Related posts:

  1. Corrective versus Preventive Action
  2. The Role of CAPA (Corrective Action and Preventive Action) in Continuous Improvement