In a warning letter sent earlier this year to a maker of over-the-counter skin-care products, FDA wrote: “You failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or combination thereof, to enable that person to perform their assigned functions.”

The letter continues: “For example, your ‘QC/ R&D Chemist’ has not been trained to perform specific tasks such as microbial limits testing . . . Your response is inadequate because you have not established completion dates and training programs for current good manufacturing practices and SOPs.”

The admonition is not unlike many found in warning letters from the past year. Better get used to it, experts say. Employee training—and the documentation of it—is on FDA’s radar.

FDA “is trying to get to the root cause of a lot of the problems they’re finding” during investigations, says consultant Michael Gregor, president of Compliance Gurus, Inc. Whether these problems lie in Quality Control or elsewhere, the Agency wants to know whether manufacturers have the right people doing the right jobs, and that they can prove it. Meanwhile, Gregor says, FDA is intensifying scrutiny of issues related to 21 CFR Part 11—including training records and electronic signature authorizations—and sending dedicated Part 11 investigators on inspection visits.

Bill Ciambrone, senior VP for technical operations at Shire Human Genetic Therapies, has also noticed the Agency’s change. ”They recognize that there are so many deviations that are related to training,” he says. “I would venture to say that in many instances, manufacturing failure is oftentimes due to a failure to properly train personnel. It’s one thing that comes up when we look at deviations and investigations—have our people been appropriately trained so they can perform their functions adequately?”

Another issue of consequence is the effectiveness of training. In its August 30, 2010, letter to Bristol-Myers Squibb regarding its Manati, Puerto Rico facility, the Agency wrote: “Please provide a plan that evaluates your training program, specifically the program's effectiveness and your assurances of personnel compliance to aseptic processes prior to certification to work in an aseptic area.”

The upshot: Manufacturers, like it or not, need to reevaluate the training records of their employees, how they manage and monitor training, and whether or not it produces its intended consequences.

Not a Good Time

FDA’s renewed emphasis comes at a time when manufacturers are struggling to manage their workforces and ensure that the right people are doing the right jobs. With mergers and acquisitions rampant, and manufacturers cutting costs and “leaning” their operations (i.e., fewer people doing the same amount of work), maintaining a consistently competent workforce is a challenge.

Nowhere is this better exemplified than at J&J’s McNeil division, whose quality control and personnel problems have been well documented. Many of them derive from the fact that products in question were brought over in the purchase of Pfizer’s consumer health care division, and their production transferred, on the cheap, to McNeil’s now notorious Fort Washington, Pennsylvania facility.

“There were no wholesale layoffs in quality control,” wrote Mina Kimes in a recent Fortune article. “Instead experienced staffers were repeatedly laid off and replaced with newbies who mostly lacked technical pharmaceutical experience. By 2008 the analytical laboratory, formerly staffed almost entirely by full-time scientists, was half-full of contract workers, according to a former manager there.”

“Those product handoffs are expensive and difficult,” says regulatory consultant John  English. “And when you move, you lose the collective memory or oral history” that production personnel have of a product.

Add to that the fact that a lot of the industry’s expertise is retiring (or being forced to do so), and you’re left with fewer plant-floor operators and other professionals who really know what they’re doing. Meanwhile, training and travel budgets have been slashed. No longer can manufacturers afford to take personnel off the lines for a week or two of seminars and certification programs.

Most warning letters of late reference poor or inadequate training, English has noticed. “The tea leaves would say it’s an issue,” he adds. “It’s always been an issue, but backwards. If there were problems at a manufacturer, the company would say that they’ll train their workers [to address the problems]. But I always ask, how good were their training systems in the first place?” And it appears FDA has this interest, too, he says.

The Necessary Evil

Management buy-in is at the core of successful employee training. And yet at many drug manufacturers, training is at best a “cost center” and at worst a “necessary evil.” Kimes’ article chronicles how training and personnel development were far from the top of J&J management’s priority list.

FDA has signaled that it will begin to hold executives accountable for what happens at their facilities, and those of contract partners as well—“you are ultimately responsible for the quality of your products” regardless of who manufactures them, the Agency has repeatedly said of late. This position is bound to get management’s attention.

Shire’s Ciambrone has heard the “necessary evil” tune before. “Most companies spend an awful lot of money on plant facilities,” he says. “I find it bizarre to not also invest in training, as if somehow you’re naturally going to get qualified employees off the street. You can’t rely on the old, “follow me around for a couple days and we’ll do on-the-job training.” That’s what you would see in factories 20 years ago. These products are highly complex, the processes highly automated, there’s lots of computer interface. People are a key resource that we invest in, and it’s only good business to make sure that they’re adequately trained.”

“Good training is a literal cornerstone of good GMP,” he continues. “Not just because it’s required by the regs, but because we are relying upon the employees to execute a function. In our case, our product is extraordinarily expensive.”

Ciambrone is encouraged by what he sees as a “wave” of renewed interest in training. “Best practice should change,” he says. “That’s the whole idea. So as people get better at [training], as the bar gets raised, so will performance. It’s not going to happen overnight, but will happen with inspection cycles and as the technology is there to institute a robust training program.”

Technology to the Rescue?

The technology is there, as a matter of fact, and making training more automated and efficient will be critical to future training efforts. “Drug manufacturers are excellent at measuring and monitoring everything—except the workforce,” says John Frehse, partner and owner of Core Practice LLC. “Although software and other forms of technology have been heavily implemented to improve quality, consistency, and the supply chain, many management teams are still using Excel, pencil and paper to manage shift workers.”

“It just doesn’t make sense,” Frehse continues. “Few can identify labor best practices, top performers, and detailed labor inefficiencies and are left managing to the status quo. The laggards are too comfortable with current practices and will not change unless they are hit with a catastrophic event. Of course at that point, it is too late.”

The future will bring with it what Frehse and others call real-time management of a workforce. “Management teams can look at effectiveness throughout the day and not just a week later when reports have been tabulated,” Frehse says. “It allows management teams to look at key performance and productivity measures and understand success while also making immediate course corrections as employees deviate from best practices.”

In short, Frehse says, automated workforce management is a way to maintain labor quality at all times. The question of “how many” and “how fast” have been augmented, but not replaced, by “how well.” “This is the key to managing quality and not just cost,” he says.

As manufacturers struggle to train their workers, expect vendor companies to ramp up their training solutions offerings as well. When the economic crisis hit in 2008, Emerson Process Management was forced to adapt, says Jim Siemers, Manager of Educational Services. As travel and training budgets at clients were slashed, Emerson had to make training available remotely to professionals who previously would journey to its Austin, Texas training center.

Clients “still really needed the training,” he says, “but they needed a lower-cost option.” Emerson set up a remote classroom in Austin, by which students anywhere in the world could view instructors via live video feeds, access PowerPoint slides, ask questions, chat with other students, take tests, and mirror the experience that they’d have were they right there in Austin. Most critical was the ability of trainees to access Emerson systems remotely and perform fundamental simulation activities. Siemers says Emerson’s simulation training business has doubled in the past three years.

Is training a competitive advantage for vendor companies? Absolutely, says Bill Sicari, Manager of Festo Corp.’s Didactic group, a separate profit-making arm of the automation company. Didactic offers general technical training for the process industries. Like Siemers, Sicari says manufacturers just can’t afford to send their top workers offsite for days or weeks to get the skills they need. As such, Didactic conducts web-based assessments, factory-based seminars, and even has a 53-foot tractor trailer that it drives around and uses to train up to 20 people at a time.

How to convince manufacturers that the training is needed? It’s not just a matter of having skilled personnel, Sicari says. It’s also getting the most bang for their buck in terms of exploiting the products and technologies that they have purchased. “Training closes the loop in automation technology,” he says.

Measuring Success

A still greater challenge is to measure the success or failure of training over time.

Manufacturers must try to measure both hard and soft aspects of performance and competence, says Shire’s Ciambrone. “We measure both process success—for example, tracking the number of deviations and investigations and how they relate to employees and training—but we also try to measure employee engagement. And one of the most critical questions is, ‘Do you have what you need to do your job?’ We measure that continually. Every year we look at our employees and ask, do they have their basic needs met?”

Production teams can pick up signals that training is or isn’t working by looking at the success of their operations in terms of, for example, manufacturing output, customer complaints, investigations, or rejected material.

Lean metrics (OEE, etc.) provide visibility into the entire manufacturing process, and thus the people who execute it, says Gregg Gordon, senior director of manufacturing industry marketing at workforce solutions firm Kronos, Inc. “Was the workforce more productive after the training than before? And if they are, how often should this training be repeated to account for the slow loss of lessons learned through turnover and the eventual return to less than ideal practices?”

By mapping training events over time against production key performance indicators, Gordon says, “a comparison of the impact to production efforts are visible and ROI can be calculated. If training occurs on a productivity improving topic and throughput for that group of employees does not increase, then however popular the training session was, the company yielded no benefit from that investment.” 

Lean manufacturing, while it may reduce work staff, can also be done with an eye towards easing the burden of training, adds consultant English. “One of the advantages of Lean is doing something in the same way,” he says, citing a new Novartis facility which uses only one type of bottle on its production lines. The packaging line would remain essentially constant, he says, with the same bottler, labeller, sorter, and so on. “The only thing that changes is what pills go in, so one set of training is all you need,” he says.

“Lean allows you to focus your training,” says English. “You can train on what is necessary and it will always be current.”

Where to from Here?

That manufacturers are being pressured to take training more seriously can only be a good thing, since product quality is ultimately at stake, says Michael Gregor. Drug companies “should definitely be concerned” by FDA’s newfound attention to training, he says, recommending that each step back and re-evaluate workers’ credentials and whether training programs are addressing gaps in skills or credentials. Some immediate steps:

• Make sure to have all resumes and job descriptions on file, including—to the degree possible—those of key personnel at supply partners. (Auditing partners’ training records is a “nice to have,” Gregor says, but depends on the size of the CMO or supplier.)
• Undertake a review of all employee training records. Make sure records are up to date and reflect the current status of workers’ training accomplishments and certifications. Do workers’ job descriptions fit what they are doing, and vice-versa? Have they received training regarding their own SOPs, as well as external training (webinars, conferences) about current trends and practices?
• Maintain documentation properly via hard-copy records or an electronic database such as a Learning Management System (LMS). Keeping electronic records and databases is “the way to go,” Gregor says, though he cautions that a lot of solutions that promise to be “Part 11 Compliant” have not been thoroughly tested as such. 
• Hire external auditors to review certifications, training records, and training practices, as an additional measure of confidence and compliance.

The optimal solution to the “training issue,” of course, is to be proactive and ensure that the value of training is part of a company’s culture. Shire, for example, has recently contracted with an outside company to do focused quality training, to improve quality leadership and groom leaders of the future. The program is module-based, notes Ciambrone, covering specific quality-related aspects of pharmaceutical chemistry, formulation, analytics, microbiology, and more. After three years of training, “students” are eligible for a master’s degree.

It’s a win-win, says Ciambrone. The individuals get the career development they need and desire, and the company gets increasingly competent leaders who do not have to go outside the organization for their training and development.

One final thought: training should not be viewed as a panacea for deep-rooted manufacturing issues, says John English. What FDA wants to know, he says, is “what needs fixing—the employee or the procedure/ process as it is currently being performed? We need to first acknowledge that the underlying cause needs to be identified and addressed before we ‘fix the operator error’ by re-training on a procedure that doesn’t work.”