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It’s a popular term that is especially associated with Risk Management. This term is in several guidelines such as PICs GMP Guide, ICH Guideline, and mentioned in FDA and ISO standards. etc.


Root Cause term is frequently used in the PICs GMP Guide - Annexes especially under Annex 20 Quality Risk Management - Appendix II. These guidelines have very similar content with ICH Guideline Q9 - Quality Risk Management. They can be useful for choosing the proper tool and performing the analysis in order to find the correct root cause. It is important to note that tools should be selected according to the situation in which a quality risk management procedure is used.


Why is it so important?

Root cause analysis (RCA) is the crucial step of non-conformity (or CAPA) management. When all the information associated with the non-conformity is gathered, an analysis should be performed in order to find the underlying root cause.

Although ISO standards for Quality Management Systems (such as ISO 9001, ISO 13485) and FDA guidelines (21 CFR 820.100) don’t include the exact term, they mention determining and eliminating the cause of nonconformity under the title of Corrective and Preventive Actions.


Here are the most common root cause analysis tools:

  1. Cause and Effect Diagrams
  2. Pareto Chart
  3. The 5 Whys
  4. Scatter Diagram
  5. Failure Mode and Effects Analysis (FMEA)
  6. Fault Tree Analysis

The most well-known tool for root cause analysis is “Cause and Effect Diagrams” (which is also called an Ishikawa diagram or fishbone diagram) Even if it can be adaptable to most situations, avoid using the same tool for every situation and consider that the other tools might be more appropriate for the current situation.

Would you like to read further about risk assessment tools, please check the article 5 Risk Assessment tools used by Life Sciences Companies.

Alternatively, brainstorming can be adapted for root cause analysis. It’s performed by a multidisciplinary team that creates as many ideas as possible in a short time.

For instance; elicit both individual and group creativity in one session.

In addition to those, the Root Cause Analysis term is in the PICs GMP Guide Part I. under Chapter 8 - Complaints and product recall. It’s stated that as follows:

  • An appropriate root cause analysis should be performed during the investigation. If it’s not possible to find the root cause, the most likely root cause(s) should be identified and justified.

  • The most common root cause is human error. But there might be another underlying root cause(s) that can be addressed by the quality defects. Possible causes might be procedure, process, system-based errors, so make sure that all possibilities are not overlooked, analyzed, and justified.

  • After root cause analysis is performed, proper CA and PA should be taken to eliminate the root cause. And the effectiveness of these actions should be monitored and verified.

  • Quality defect records should be reviewed and trend analyses should be performed regularly for any indication of specific or recurring problems requiring attention.

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