HPISC Client Impact Stories

From Dept. SME to Qualified Trainer: one roll out at a time


We need to upgrade our Trainer Qualification process.  Can you help us?


The organization was not able to adequately defend its current process for determining who was qualified to train employees on SOPs.

Background Situation

After an extensive FDA inspection, the Leadership Committee committed to upgrading their trainer process.

Performance Objectives

First and foremost, the client wanted to complete their regulatory commitments and be able to comply with the approved modifications.    In order to follow the revisions in the procedures, the site needed to ensure that the process modifications could be followed by the employees.  They were not interested in revising SOPs just to close the inspection report and then later receive 483 observations for failure to follow the revised SOPs. 

HPI Method in Use – Influence Analysis: Workplace Factors and Support Systems

Client recognized that they were not ready to launch into an Employee Qualification program.  The project team took a staggered approach instead.  After conducting a “Back to GMP Basics” training program, the training group then focused on the process to qualify existing department subject matter experts (SMEs).

Biggest Challenges – What Wasn’t Working as Expected

  • During the project, the site underwent significant leadership changes resulting in scope changes and project delays.
  • The client was so risk averse, that getting them to expand their process enough to be considered an upgrade was a challenge.   They constantly reverted back to not wanting to be non-compliant as soon the SOP was released. 


  • Training was not a major focus and therefore not budgeted for.   To meet productivity quotas, training was either short-changed or did not happen at all.
  • As long as they could “produce a training record”, that was considered training on SOPs.
  • A trainer was someone who was already trained; which meant, they had a training record for that SOP in their file.  There were no additional criteria required.

HPI Solution(s) / End Results

Of the six categories for Human Performance Improvement Solutions, the solution best matched from the causes was to improve process and structure for Qualifying SMEs as Trainers.

  • A modified Qualified Trainers Workshop was developed to meet the client’s needs.
  • A focus group-type activity was conducted for initial sessions that resulted in parking lot issues for Leadership Committee to follow up.
  • Leadership Committee approved a full-time training position to follow through on the continuation of the staggered approach towards an Employee Qualification program.
  • Follow up FDA visit was successful.
  • Full-time Trainer leveraged the new cadre of Qualified Trainers to overhaul curricula.
  • QT refresher sessions were delivered as “Lunch n Learns” to provide on-going support for QTs. 

Value Added for the Client

  • Site leadership did not keep up with implementing regulatory trends and industry practices regarding FDA expectations for OJT of SOPs.
  • Training is an important quality system that needs to be adequately resourced with people and a minimum budget.   
  • Stretch goals are important for growth and improvement while not creating a sense of failure at the onset. 
From Dept. SME to QT
PDF VERSION: Alignment of 4 levels of Organizational needs map included.

HPISC Library has articles, impact stories and white papers.

Nominating Your SMEs as Qualified Trainers Abstract: This article explores what it takes to really qualify your SMEs (subject matter experts) to become qualified as an OJT Trainer.

Who is the Author, Vivian Bringslimark?

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