To implement a Robust Training System for the Operations department.
The organization already had an existing training program that was in the process of being modified. The VP of Operations was not satisfied that the program would meet FDA expectations.
While the client was cited for numerous quality systems issues, they were also in a serious back-order situation. To mitigate customer demand for product, additional shifts were created that resulted in huge waves of new hires needing to get to up to speed quick. To add to the mix of challenges, the VP of Operations mandated that new hires would be qualified properly before being released to task.
Simultaneously work on their FDA commitments and close the back order situation.
HPI Method in Use – Gap Analysis
HPIS Consulting was brought in to expedite the Training Quality System makeover and mentor the program owner. The project followed the Assess – Redesign – Implement – Monitor phases and was coordinated with the SOP redesign project deliverables.
Biggest Challenge – What Wasn’t Working as Expected
- The training program owner did not report to VP Operations and the relationship was constrained.
- There was a strong attachment to the existing program.
In short period of time, the site went from owner controlled to being managed by a holding company with the intent to sell once an attractive IPO (initial public offering) could be achieved.
In essence, the site was in a state of flux with multiple critical priorities, all pulling for the same set of resources. And knowing eventually they’d be sold.
HPIS Solution / End Results
The solution that best mapped back to the identified causes was to improve process and structure of existing training program.
- The existing training program was overhauled to an Employee Qualification program leveraging the best from the existing program and incorporating new needed quality system elements.
- Existing trainers were re-qualified with the newly designed Qualified Trainers Workshop complete with their own performance demonstration for qualifying their peers.
- 3rd Party Auditors reported that the new program was one of the best in the industry reaching World Class status; which delighted the VP of Operations.
- IPO was successful. The Company was sold and the Employee Qualification program is still in place today.
Lessons Learned By the Client
- The client experienced rapid growth and did not keep up with the need to upgrade all their quality systems. They were “too busy putting out fires”.
- Modifications to existing systems were constantly being delayed due to increasing corrective actions demands. Client finally hired external consultants to off load the burden.
“This is by far, the best training program I’ve ever seen”.VP of Operations
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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?
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