Root cause analysis

Root cause analysis

Root Cause is the fundamental cause, basis, or essence of something or the source from which something derives.

Root Cause Analysis (RCA) is a systematic process for identifying “root causes” of problems or events and looking for an approach for responding to them. ISO 9001:2015 (clause 10.2) requires organizations to react to non-conformities raised and to take action to control and correct them. Correction is defined as action taken to eliminate a detected non-conformity. The emphasis at the correction stage is on the immediate action taken.

Corrective action on the other hand is action to eliminate the cause of a detected non-conformity or other undesirable situation. This focuses on the long term elimination of non-conformities.

Once a nonconformity has been corrected or contained, the next step in the process is to determine WHY the nonconformity occurred, which is to determine the root cause.  The goal of an effective root cause analysis is to investigate the fundamental issue (the cause) that allowed the nonconformity to occur.

Quality management system deficiencies should be analyzed to detect patterns or trends to prevent them from reoccurring in the future. RCA seeks to answer;

  • What happened
  • How it happened
  • Why it happened…so that
  • Actions for preventing reoccurrence are developed.

Key steps of conducting a root cause analysis include

  1. Problem identification;  The information may be obtained by asking –

 What is the problem, How does it happen, where does it happen, when does it happen and how many times has it happened (as applicable).

2. Investigate to determine the cause; Use any of the root cause analysis tools & techniques to perform the analysis. Examples of these tools are the 5Whys – Root Cause Analysis (RCA), Fishbone analysis/Cause and Effects diagram Change Analysis, Causal Factor Tree Analysis, Pareto chart, Barrier Analysis, etc.

3. Come up with the solution (s);

Levels of knowledge

Awareness

Attitudes

Behavior

Resources

4. Evaluate the need for action to ensure that nonconformities do not recur;

Use your logic and choose the best possible way to solve the problem (effective and least expensive).

Take care to see that solutions/corrective actions do not induce any other or related unforeseen problems.

5. Evaluate the significance of the solution in the process and the final product.

6. Document the solution; Fill in the CAR form; the solution and the possible completion date of the corrective action. The completion date should be realistic.

7. Communicate the solution; inform the relevant staff members involved in the Corrective Action.

8. Implement the solution;

Undertake the corrective action. The process owner should supervise to ensure that the corrective action is undertaken within the stipulated time frame. In case the corrective action is found to be ineffective during its implementation, the process owner should go back to step 3 i.e. come up with a different solution.

9. Evaluate the effectiveness of the solution. During the next audit or the follow-up audit, evaluate the effectiveness of the corrective action to ensure that the nonconformity does not recur.

Implementing RCA will help an organization:

  • Identify barriers and root causes of the problems to help in getting a permanent solution and prevent re-occurrence.
  • Use data available in the organization to come up with a logical approach to problem-solving.
  • Identification of the current and future needs for organizational to work on improvement.
  • Establish repeatable, step-by-step processes, in which one process can confirm the results of another.

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