Can you imagine a site managing director within the pharmaceutical industry making that statement in front of a group of employees assembled to meet with the company president to discuss progress of FDA consent decree requirements? Can you believe that nothing happened in this organization as a result of this public confession of non-accountability and non-compliance? I hope this isnt your workplace, but unfortunately, this visible lack of commitment to one of the key components of any quality assurance and compliance system did take place recently within a consent decree site. And absolutely nothing happened “ unless you count the endless hours of wasted talk and negative speculation from employees and supervisors on the shop floor and in the quality labs. As you would expect, the level of trust and commitment to GMP compliance within this companys workforce declined. I dont have to mention the credibility that was lost by the senior executives gathered in the room. Contrast this inexcusable state of affairs with two other organizations marketing medical devices produced by world-class manufacturing operations with outstanding reputations for quality and compliance. GMP training “ whether its delivered as foundational training, refresher training, skills training, or cross-training, is considered sacrosanct “ a fancy term for we take it serious. There are no shortcuts to developing the attitudes, knowledge, and skills of operational, technical, management, and professional employees in these two companies. In looking at the success of their manufacturing operations, key managers from both organizations “ using similar concepts, but slightly different words - highlighted the following reasons for why training makes a difference in their workplaces: 1. We hold managers and supervisors accountable for training compliance and performance. In these organizations, work team leaders are tasked with the primary responsibility for ensuring people are trained, qualified, and certified prior to working independently on their own. GMP auditors double-check records for compliance on a monthly basis. Needless to say, performance is at 100%. 2. We link training outcomes with key operating metrics and business results. For these manufacturing operations, training is about performance, not just training hours, classes, or SOP reviews. The end result of training is 100% task or SOP performance within standards expected in daily operations. 3. We integrate training with other quality assurance functions, including document control, change control, and manufacturing or laboratory investigations. In these world-class manufacturing plants, the GMP training system is tightly linked to other quality processes. SOPs are not just cross-referenced as in other organizations. There is strong cross-functional teamwork and integration of information systems which produce records and reports. 4. We use training and career development to attract and retain top performers. In these organizations, training is considered an investment in people and improved performance versus an expense to be minimized. As might be expected, these operations experience above average retention levels and use training and career planning to maximize the contribution of top performers. 5. We use talent from the ranks to drive training system development and operation. The training function, whether centralized or decentralized, consists primarily of employees who have been there, done that. These individuals have the credibility, technical know-how, and savvy to keep training lean, relevant, and effective. They are supplemented by outside resources as necessary to learn new approaches to training or training system operation. If youre not taking the time for training, then youre missing out on an opportunity to improve performance in your workplace. If these world-class manufacturing organizations can figure it out, you can too!
