GAP DISCOVERY / IMPROVEMENT OPPORTUNITY
Miguel finished his preliminary assessment of the company’s quality systems as part of his first 90 days task list. The Training Quality System was the last one on his list. He sighed. This is not going to be easy, he said to himself. With so many systems needing to be updated, I cannot do this alone, he concluded. So he clicked on his laptop and located a recent congratulations email from a LinkedIn contact who happened to be a performance consultant (PC). In the subject line, he typed, “I need your help, got time to chat?”.
Miguel explained to Cara the PC, that he was recently hired as VP of Quality. His first major initiative was to get the organization ready for a comprehensive systems-based inspection. They had been successfully producing products with sales above forecasted targets for several years now. Previous regulatory inspections were favorable and did not indicate GMP compliance issues that could not be mitigated with a few minor procedure updates. “So, the Board of Directors decided it was time to launch a new product line and become a commercial manufacturer”. He took a breath and continued.
“What I am finding is that they have very basic rudimentary systems for making OTC supplements, but without upgrading the quality systems, they (we) will not pass a full-blown inspection, I’m afraid,” Miguel said.
To which, Cara asked, “What about training? What’s in place?”
“Nothing, really. I mean they have a procedure and all, but it’s not like what you did for me last time. It’s no where close to today’s standards”.
Current State of Affairs
Miguel then went on to describe the small QA Training staff, their reporting structure and then asked when Cara could be on site. She refreshed Miguel on her approach and reiterated that an assessment of the current state was in order. He gave her the contact information for his Quality System Manager and ended the call relieved that his PC was available and interested in helping him succeed with his initiative.
After two days of back-to-back interviews and a review of the requested documents, Cara wrote the report with recommendations and arranged for a conference call with Miguel and his site trainer. With observations confirmed, the remainder of the discussion focused on a review of the project phases in which the recommendations would be implemented. Cara requested an on-site meeting with the primary stakeholders to debrief the findings and provide an overview of the Robust Training System (RTS) project. Together they were going to be asking for a team of cross-functional resources. Miguel agreed it was a good idea and they set a date and time.
Is training really a priority?
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