Pharma Industry is a dynamic and highly regulated industry where mistakes, deviations are bound to happen. But what is expected from a quality conscious firm is not to hide the facts but to identify the mistake, report, investigate, identify root cause of the problem, take corrective and preventive actions and document the process as per Quality Management System.

For resolving any mistake or deviation and to ensure that the same is not repeated again, the most important action is to identify the root cause of the deviation. Genuine efforts, knowledgeable and experienced team, unbiased approach and appropriate tool is what you need to find the root cause. There are various tools that can be used to identify the root cause namely:

  1. Fishbone diagram or Ishikawa diagram
  2. 5 Whys
  3. Pareto chart
  4. Scatter Diagram
  5. Failure Mode and Effects Analysis (FMEA)
  6. Check Sheets
  7. Control Charts
  8. Histogram
  9. Flowchart

All the other techniques have already been explained in our previous articles. Current article is about understanding the concept, usage, advantages etc. of 5 WHY.

5 WHY is a Lean quality technique which is used for identifying the root cause of a problem, to ascertain the relationship among the causes and for improvement of the quality. Short term and long-term solutions can be addressed with the 5 WHY technique. This is an easy problem-solving technique for quick discovery of the problems root cause.

Sakichi Toyoda, a Japanese industrialist and inventor was the creator of this technique. This was initially used in the Toyota Corporation but is now used in almost every industry.

“The basis of Toyota’s scientific approach is to ask Why five times whenever we find a problem … By repeating Why five times, the nature of the problem as well as its solution becomes clear.” Taiichi Ohno

For successful implementation of the 5 WHY technique, understanding of the shop floor activities is a prerequisite. Personnel with experience of the process shall be assigned the responsibility to perform this technique as expertise in the area will be an asset to extract information from the problem. Cross functional team, i.e. team comprising of personnel from every department is usually preferred for performing the task. It has been seen that the problems considered as technical problems are usually process and human problems only. Therefore, finding the solution to such problems is required to avoid it from occurring again. 5 WHY technique is used:

  • For probing root cause of a problem
  • To help clearly explain the problem caused owing to its graphical communication strategy
  • When the problem to be analysed is confusing
  • When the problem analysis by a team is superficial

Procedure for performing the 5 WHY technique is as follows:

  1. Statement for the specific problem is developed whose root cause is to be determined to define the scope
  2. Ask the question “Why?” the problem occurred and list all the possible causes
  3. Each cause developed in step 2 now becomes the new statement for the problem. Again, ask the question “Why?”.
  4. Each cause is turned in a problem statement and the question “Why?” is asked at least five times. It is continued till the fundamental answer is reached, i.e.- solution for the root cause is attained
  5. Corrective action is then planned by the team and is applied on the root cause to prevent its recurrence
  6. The action planned must be monitored after a certain time to check its effectiveness, and if not found satisfactory then the same procedure is repeated till the desired result is reached.

The entire process needs to be documented and shall be available when required.

For example:

5 WHY technique

Tips:

  • The causes and problems are never linear, they usually branch out as a tree diagram
  • Main intention is to find the root cause of the problem
  • A problem can have more than one root cause
  • Mostly all problems are interrelated

Benefits of adopting the 5 WHY technique are as follows:

  • Root cause of the problem can be easily identified
  • Relationship between various root causes of the problem can be determined
  • It is a simple tool which does not use statistical analysis in the process
  • Not time consuming
  • Does not require substantial resources

5 WHY technique is a standalone tool but can also be used with other techniques for better results such as Brainstorming, Fishbone diagram & Failure Mode and Effect Analysis. 5 WHY technique is useful for continuous improvement of an organization. This technique can also be used in every management area as a problem-solving technique.