Urgent Request: To design and implement a training and qualification program.
Problem: The client could not defend the effectiveness of their training “program” during an extensive FDA inspection.
During the inspection, Inspectors observed multiple departures from SOPs routinely. When they inquired about the training, training records were produced. The Inspectors then asked, “How do you know your training was effective”? They had witnessed firsthand the performance gap between the set of written instructions and the signed training records. What then did the operators sign for, the reading of the SOP or that I’m trained to do the task as written?
- The client wanted to create a training department whose primary responsibility was to centralize training records and manage a training database.
- They also wanted an “effective” training system. (They didn’t know what that looked like.)
HPI Method in Use – Gap Analysis and Workplace Analysis:
A high-level policy document was generated containing a description of the 6 key quality system elements of an effective training system (GMP Training, Planned OJT for Procedures, Use of Qualified Trainers, Employee Qualification Process, Training Documentation Process, and Training Effectiveness Measures). For each of the 6 elements, “how-to” process maps and procedures were created.
Biggest Challenges – What Was Not Working as Expected:
- The transition from decentralized control to centralized record-keeping and complying with standardized training procedures developed outside their “local” departments created separation anxiety for their training records and control fears over assigning training requirements.
- Acceptance that “old-timers” could not be grandfathered into qualification. They, too, had to demonstrate their ability to perform the current procedure. There was no backing down from this expectation.
- A false belief that as long as you “signed for an SOP”, that was adequate training documentation.
- Challenging the knowledge, skill and acquired experience of old-timers was taboo; it was easier to “give him a pass”.
- The only process that was formally captured via SOP was how to assemble and complete employee training binders and every department had its own version of that original SOP.
HPI Solution – End Results:
Of the six categories for Human Performance Improvement Solutions, the solution best matched from the causes was to improve the structure and process for an Effective Training Quality System.
- Client achieved “Acceptable GMP Status” and was able to launch new products again.
- Within 2 years, all operations employees were qualified (via documented checklists) by Qualified Trainers.
- Training curricula were right sized and reviewed/signed for on a quarterly basis to keep up with SOP revisions.
- Two internal promotions for Qualified Trainers:
- One became a full time trainer in the Training Department
- One become a first line supervisor
- FDA stopped asking to see training history records, when everyone could answer their question – “how do you qualify someone”? It didn’t matter who they asked, everyone responded consistently.
- Training program adopted into QA Inspection, Analytical Lab, Maintenance, Validation, and then to other company sites after they were acquired.
Lessons Learned by Management
The company was not keeping up with regulatory trends and industry practices regarding FDA expectations for OJT of SOPs. They lacked a dedicated training manager who was part of industry training groups and could implement newer trends.
“Vivian, you indeed changed our training culture”, VP of Quality.
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Who is Vivian Bringslimark, the Author?
So You Want a Robust Training System? But are you really ready for what you want?
(c) HPIS Consulting, Inc.