“The ideal supervisor-to-operator ratio is 1:8. At some pharma plants, it’s now closer to 1:100 or 1:250.”
—Johnny Guerra (independent consultant, formerly with FDA)
Ah, spring. The crocuses are blooming. And for those of us who didn’t get them over with last December, performance evaluations are in the air.
This March, FDA broke new ground with the mother of all performance evaluation programs. The Agency’s Transparency Initiative aims to have OPS and other offices within FDA track the efficiency of its processes, and eventually make this information available to the public. (For more on this topic, listen to an interview with Helen Winkle, Director of OPS, on PharmaManufacturing.com).
Transparency is clearly a goal for any company doing business today. Unfortunately, even though all companies say they value it, there is still a tendency to muddy the waters and blame individuals for problems that are really caused by systemic failures within organizations. When an issue comes up with FDA, many organizations are only too happy to point the finger at some operator, quality person or manager who didn’t do his or her job.
Individual accountability is important, but when does pointing the finger amount to blaming the victim?
One wonders whether the operators, managers and executives replaced at Genzyme’s Allston plant, which is soon expected to enter into a Consent Decree with FDA, were truly responsible for the problems there.
Clearly, the economic recession has had some impact on regulatory compliance, across all industries. Now, the government is even questioning plant safety and OSHA claims that U.S. workplace injuries had fallen by 96% in the U.S. between 1994 and 2009. Turns out, some employees were failing to report workplace injuries, to avoid losing their jobs, while some employers were keeping mum to avoid higher insurance premiums.
At Interphex Puerto Rico last month, consultant and former FDA specialist Johnny Guerra and industrial psychologist Ginette Collazo discussed human error from an FDA perspective. “When we talk about the validated state,” Guerra said, “we’re not only talking about equipment, OQ, IQ, and PQ, but the human factor.” Viewing human error as the root cause of noncompliance neglects to look into preventive measures, and, all too often means that the error will be repeated, Guerra said.
Many companies are still taking the “personal” approach to human error, which appeals to the individual’s sense of fear. A systemic view, instead, assumes that some degree error is inevitable and puts systems in place to detect, prevent, and correct it.
Training is used 80% of the time when a problem is traced to human error, Ms. Collazo said. Unfortunately, it only cures 5% to 10% of human errors. More than half of these errors can be traced to faulty procedures and involve experienced and trained people.
A strong human error prevention program is not an OpEx “nice to have.” It’s really the law, and is covered in depth within the cGMP provisions for data integrity, employee and supervisor training, and supervision requirements. The cGMP’s even cover human factors in system development.
Assess your resources, Guerra continued. Is the ratio of supervisors to operators okay? Mr. Guerra pointed out that downsizing and other efforts have eliminated or changed the supervisory role so that the ideal supervisor-to-operator ratio of 1:8 is now diluted to 1:100 or even 1:250 at some plants. “Employee empowerment is a nice topic for philosophical discussions,” Mr. Guerra said. And don’t point the finger at the quality department. “QA is not responsible for performing supervisory functions,” Guerra said. In the final analysis, said Jackelyn Rodriguez, president of Monarch Quality Systems, the first step toward continuous improvement is like the first step in the “12 step” program popularized by AA: admitting the fact that there is a problem. Unfortunately, many organizations today have yet to take that step.
Here are some examples of systemic failures from KV Pharma, Ranbaxy Laboratories, and Mylan Laboratories.
