Inspection Report: What Inspectors are looking for

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

Callum McLoughlin, inspector at the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Inspectorate has published a blog on his recent inspection experience. In the focus: CAPA and investigations. In his preamble, Callum McLoughlin points out that recently published data shows that "roughly 10% of deficiencies raised in that period were directly attributable to poor investigations". And that these "could also be the root cause of other deficiencies too".

So what do inspectors observe?

When inspecting, GMP inspectors are looking for "evidence that the investigation and Corrective and Preventive Action (CAPA) system is operating in a state of control". In the blog, symptoms are listed that indicate when this is not the case:

• Investigations being raised long after the event occurred or taking an unreasonable time to complete
• Root cause analysis being raised as a CAPA to enable premature deviation closeout
• A large proportion of CAPAs being overdue or being extended
• Human Error being listed as a frequent root cause

McLoughlin also sees the issue that a root cause is concluded only based on experience - leading rather to a theoretical assumption and not to the real evidence-based root cause.

What about Human Error?

Human Error can be a potential root cause. But before citing Human Error as the root cause, a thorough investigation is needed and all other system and process related variables should have been evaluated. And the true root cause could not only be caused by training deficiencies but also by (too) complex procedures or unnecessary distractions.

What inspectors like

• Effective investigations
• Risk assessments
• Consideration of patient safety
• Systematic root cause analysis
• A well-managed system