Not Always From the Top Down

Manufacturing operators key to quality culture

By Susan Kheen, Contributing Editor

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Online video training (see sidebar) allows operators to watch daily or weekly short 5-10 minute videos that describe the thinking behind cGMPs. One of the training modules explains, for example, why it is important to move slowly and deliberately inside a cleanroom — because the airflow inside the room is designed for calm, methodical handling, not for quick motion and movement, or excited hand-waving while an operator shares the latest weekend football scores. The take-away: Disruption of the airflow too dramatically can be detrimental to the safety and efficacy of the products, by increasing the potential risk of contamination. Another module emphasizes that the medicines — the products being handled by the operators daily, are being ingested or injected by operators’ loved ones — parents, wives, husbands, sons and daughters. This module teaches that the job they do each day is always patient-centric, everything from gowning up, or putting on a hairnet properly. “It seems obvious, but developing a patient-centric philosophy and showing who will use the products being manufactured, go a long way toward driving the quality message,” says Creaner.

It seems intuitive to understand how training operators about why certain manufacturing practices make safer medicine, will lead to higher quality products, but that is not the full story about how manufacturing quality training can help organizations spot potential quality risks before they become issues.

Differences in customs and traditions can come into play when implementing a quality culture. In the Asian-Pacific region, manufacturing workforces represent a mindset which may emphasize deference to superiors, the importance of status within an organization, and an abhorrence of ‘losing face,’ and may result in operators and technicians being less likely to speak up about risks to the quality of the product or suggesting better ways of doing things than simply following the way it has always been done. Western cultures may not see it as a negative to speak up to a superior, but new operators would naturally defer to the tacit knowledge of the experienced ones or to the loudest voice in the room. However, experience has shown that if operators understand why a particular task is being performed in a particular way, then the likelihood increases that they will raise a hand when a task is being performed incorrectly or a potential problem of future risk is spotted.

It’s a good idea to educate operators about the science and good data needed when making suggestions and decisions about the process, so as to meet the intent of the GMPs. A great example of this concerns injectables:

Example: Teaching manufacturing operators and technicians the simple science behind SOPs comes alive when you talk about injectable products. Students are taught that injections bypass all the body’s defense mechanisms because the drug goes directly into the bloodstream. Creams, ointments and tablets on the other hand, benefit from the many of the body’s own defenses, with natural filters such as the skin, stomach, liver, etc., before entering the bloodstream. Learning the science behind Injectable Manufacturing SOPs makes routine procedures come alive.

Understanding the “real science,” as Creaner puts it, lessens the cultural taboos against bringing problems to the attention of superiors, because the operator understands he is questioning the science and the data as to why things have always been done in a particular way, and not that he/she is questioning the individual or his supervisor. So, education and training modules teach students how regulations, SOPs and cGMPs are based on simple, good science, which is the same approach that the regulators take when approving new drugs and auditing their manufacturing process. Understanding how a drug’s chemistry works in the process, and how the equipment is used to protect that process — the temperatures, mixing, agitation, reaction times — are simplified and explained. Understanding the real science leads to a clearer understanding of the Whys of GMP and fosters a quality culture.

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