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Advancing Human Performance, Learning, and Improvement

The Operational Learning Institute develops investigation capability in GMP, QA, and EHS professionals — through evidence-based programs grounded in Human and Organizational Performance.

Why this Program? 

Traditional root cause analysis — 5-Why, Fishbone, single root cause thinking — consistently fails to identify the real causes of deviations and safety events. The result: ineffective CAPAs, repeat deviations, and mounting regulatory risk.

 

OLI's Investigator Foundations Certificate Program shifts the mental model from blame and human error to systems thinking, causal analysis, and operational learning.

 

The result: investigations that find real causes and produce corrective actions that actually work.

The 3-Layer Model

3 Layer model.png

Investigations must go beyond behaviors to address system and workplace factors.

37%

Overall deviation reduction

44%

Manufacturing deviation reduction

<1%

Human error designation

$1.5M+

Estimated Annual Savings

Proven Results

Results achieved by a global pharma manufacturer following program completion.

The Investigator Foundations Certificate Program

8 modules · Live virtual · 16 weeks · Certification included

1. Human Performance & Systems Thinking

2. Thinking Differently About Investigations

3. Event & Causal Factor (E&CF) Analysis

4. Operational Learning & Psychological Safety

5. Problem Definition & Is/Is Not Analysis

6. Bias & Decision Quality in Investigations

7. Facilitation of Effective Investigations

8. Reporting & Communicating Investigation Outcomes

01

Kickoff

Introductions, expectations, first case study

02

Live Sessions

8 modules, real cases, applied tools

Your Certification Journey

03

Applied Work

Apply tools to real events between sessions

04

Peer Learning

Review, feedback, and coaching

05

Assessment

Demonstrate competence and complete exam

06

Community

Ongoing peer community post-certification

Who Should Attend?

If your work involves investigating deviations, incidents, or safety events, this program is for you.

  • GMP Investigators and Quality Assurance professionals

  • EHS and Safety professionals

  • Operations, Engineering, and MSAT leaders​

  • QC and Regulatory Affairs professionals

  • Team leaders and managers responsible for deviation and safety investigations

  • Anyone who leads or participates in investigation teams

"I just want to say you guys are changing the way I view investigations for quality and safety completely… Great work!"

— Technical Leader and Six Sigma Black Belt Current IFCT Participant

Advanced Investigator Certification

Deeper practitioner development through coaching, peer review, and a portfolio-based designation.

HOP Consulting

Advisory support for organizations building Human and Organizational Performance capability.

Learning Teams Facilitation

Structured facilitation of learning team events to surface operational insights after events.

Operational Learning  Consulting

Advisory support to help organizations apply operational learning principles and build sustainable HOP capability.

Beyond the IFCT

OLI offers a growing suite of programs and services for organizations serious about operational learning.

Get Started

Contact us to discuss open enrollment cohorts, dedicated company programs, or OLI consulting services.

Jim Ball | Founder, Operational Learning Institute

jimballcoaching@gmail.com

(603) 812-7526

www.jimballcoaching.com

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©2026 by Jim Ball Coaching, LLC.

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