Pharmaceutical Root Cause Analysis Training

  • Overview
  • Benefits
  • Why Work With NSF?

Our pharmaceutical root cause analysis (RCA) training ensures that personnel involved in conducting investigations understand the RCA tools and have practical knowledge to drill down to the root cause(s) of an event. We cover structured brainstorming techniques such as 5 whys, 6 Ms, and cause and effect diagrams. We introduce concepts and tools commonly used to assess risk, and ensure investigators are comfortable handling data sets.

In addition, because so many investigations are attributed to human error we have included human error training in the NSF program. We cover the principles of why people make mistakes and provide tools for analyzing the contributing factors associated with human error. Our philosophy is that human error should be the starting point of an investigation and not the root cause.

Benefits

Through the use of case studies and hands-on exercises, the educational component of our program provides investigators the appropriate training to conduct in-depth investigations and generate investigation reports that will “stand the test of time.”

Why Work With NSF?

This case study illustrates the benefits of working with NSF.

Problem
A corporate-wide assessment identified major gaps in quality systems, including the CAPA system. Investigations were inadequate. The scope was usually not defined or did not explore whether other batches, processes, products or sites were potentially affected. Risk assessment was inconsistently applied and did not explicitly address patient risk. There was no formal system to escalate non-conformances into the CAPA system. Root cause analysis was weak and usually stopped at operator error. Corrective actions were frequently limited to retraining. There were no effectiveness checks.

Objectives

Our goals for helping this company were to:

  1. Customize and strengthen training materials for root cause analysis
  2. Deliver training to 300 company staff, including investigators and reviewers/approvers
  3. Conduct formal third-party review of completed investigation reports
  4. Mentor and coach investigators with feedback from third-party reviews

Approach/Methodology

We developed a fully customized two-day hands-on training course on root cause analysis. Training sessions were limited to about 15 attendees to maximize teamwork and interaction with the instructors. We delivered 25 sessions at nine sites and developed a formal scoring rubric with six focus areas:

  • Problem statement
  • Risk assessment
  • Root cause analysis
  • Data analysis
  • Overall report quality
  • Robust CAPA with effectiveness check

We implemented the scoring rubric and third-party reviews, and rolled out one-on-one feedback and coaching sessions. Investigators become “certified” once they submit three acceptable investigation reports.

Outcomes/Benefits to Client (ROI)

A formal, objective risk assessment and scoring rubric are in place. Non-conformances are escalated based on risk. Investigators have numerous new tools to identify root cause and develop effective corrective actions. Nearly 120 reviews have been completed and feedback sessions are well received. The quality of the investigations is significantly improved. Prior to the training and coaching, only 18 percent of the investigation reports were acceptable. After the training, approximately 70 percent of the reports are acceptable. The average score continues to climb.

Early results reflect the immediate impact of the training sessions. Recent results add the substantial benefit of one-on-one feedback and higher standards demanded by the reviewers/approvers.

With strengthened systems in place, regulatory risk is greatly diminished. With improved identification of root cause and effective corrective/preventive actions, the frequency of non-conformances is diminishing rapidly, from about 40,000 per year in 2015 to under 20,000 in 2017. A separate COQ analysis shows the net financial benefit is over $3 million. Benefits will continue to accrue as new issues are encountered and effectively managed by the new system.

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