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Root Cause Analysis Project at Major Pharma

About the Company

As of 2023, this major pharmaceutical had over 100k employees. The company is one of the world's largest biotech companies and focuses on a range of solutions for oncology, immunology, infectious diseases and opthamolgy.

The Challenge

The project run for this internationally renowned pharmaceutical company was investigating deviations due to a mixture of quality in the Filling Line. Deviations were addressed using an RCA methodology and were documented in a Quality Document Repository.

The knowledge and skill was within the team, but it did not always lie with the people who needed it, the result of this was that some RCAs were skillfully completed and documented, but the majority simply were not. It had been noticed that regulatory authorities that there were RCAs that did not meet the required standard.

Company

Major Pharma Company

Industry

Life, Science & Health

Size

100,000 Employees

Revenue

>USD 50 Billion

What We Did

We developed an approach which meant the lead investigators were typically drawn from a small group of compliance experts so concentrated effort with this group would make it possible to achieve a visible overall impact on the results.

The impact was made visible by using a learning tool that evaluated each Deviation/RCA Robustness with a maximum score of 3.0 and acceptable score of >2.7.

Our approach was to:

Use the Learning Tool to review Deviations / RCAs in the Quality Document Repository, initially to establish a baseline and there after to track progress
Set up regular weekly meetings with the Compliance Experts to review each individual Deviation with the owner and identify positives and “work ons”
In parallel all of the Compliance Experts as well as other potential Deviation leads received training on how to address.
Investigators were encouraged to visualize the work with an emphasis on team makeup, and a logical flow from problem description to Gemba walk, Root Cause, Solution Identification and Implementation
Investigators were encouraged to visualize the work with an emphasis on team makeup, and a logical flow from problem description to Gemba walk, Root Cause, Solution Identification and Implementation

Results

Lead investigators motivated to improve their own Deviation scores, attendance at reviews very high
Over 95% of Deviations now have an attachment in the Quality Document Repository detailing the working of the RCA team
RCA process has become more visual with a clear logical flow and increased use of Gemba
Teams are typically now more “right sized” but small teams still following best practice
Median Robustness score exceeds the 2.7 target for 11 of the last 13 weeks

Framework

Lean Training
Consultancy
Problem-Solving

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