[Video] Get It Right with The Gemba

By Katie Anderson, Chief Editor, Pharmaceutical Online

You have a contamination control strategy in place; one that you believe to be solid and holistic. No matter how great it is on paper, observing the shop floor on a regular basis is an invaluable part of the strategy, according to Herman Bozenhardt, president of Bozenhardt Consulting Services.

In an April Pharmaceutical Online Live on Proactive Contamination Control Strategies in Aseptic Fill/Finish, Bozenhardt emphasized the importance of physically visiting the shop floor and performing regular Gemba walks.

The idea of the Gemba walk originated after World War II in Japan, specifically in relation to automotive production at Toyota. The word can be translated to “the real or actual place,” referring to where the work takes place—in the case of pharma or automobiles, on the factory floor.

Gemba walks involve operations/QA/QC production leads visiting the production floor, making observations, communicating those observations with the team, and making corrections to fix and prevent those errors from occurring again. Bozenhardt breaks it down into discovery, educating the operators and then reinforcing that in documentation.

Discovery During Gemba

A contamination control strategy can’t just be on a piece of paper; it must be live, according to Bozenhardt. “You got to keep reinforcing it. It can't just be on a piece of paper. You have to know it, you have to see it, and it has to be live,” he explained during the panel.

Though there are training programs on conducting Gemba walks with the Parenteral Drug Association and ISPE, a close eye on the process is all that you need to make important observations. “As I do the Gemba walks, I look at everything. I do the white glove on everything, I check and look at everything. Some of it is so common and obvious. If you see subsections of the decking in the isolator, and it's got a coating of red,” added Bozenhardt.  

When you make observations during the Gemba, it is important to ask questions.  “When you see things that are obviously wrong, you ask a question like, "Why are you doing that? Why do the star wheels have a stain on them or why does the cap perhaps some rouging on it?” explained Bozenhardt. He continued that when there aren’t answers to these questions, it tells you that the operators do not know what good looks like. It is then that we need to educate them on what good does look like.

See Something, Say Something

Educating the operators should include taking picture of the flaws in the process and communicating with education on how to prevent it in the future. “People have got to be in the position of when they see something, say something. If it doesn't look right, stop it and say, ‘no, this doesn't look good,’ added Bozenhardt.

Bozenhardt recommends taking a picture of the problem and putting it on a poster board with an explanation of why it isn’t good. These observations and education can’t just be left to operators alone. It has got to be a team effort and understanding, involving sterility assurance, quality assurance, and quality control. “Everybody's got to be able to have an eyes open approach. Sometimes you see the QC people doing the sampling wrong. Sometimes you see them where they're taking the wrappers off their settling plates in the isolator, and this guy tosses it, or they're working with tools that are rusted. If you see something, say something,” emphasized Bozenhardt.

No matter who observes the issue in the process, they should not be afraid to speak up. Bozenhardt notes that we need to create an environment where employees, no matter their role, are not afraid to highlight an issue in the process. “One of the things that we also have to do in this business is get away of being afraid, afraid of bringing something up, afraid of the operator telling the supervisor he's doing wrong, or telling the head of QA, ‘Hey, I think you really should take a look at that.’ We have to learn to express ourselves, and we have to learn to tell like it is,” added Bozenhardt.

Team Education and Documentation

Saying something is only half the battle. The team must then be educated, and documentation must be updated to reflect that issue.

“Gemba walks tell you the number of things that you find there. You wonder why you have contamination in an isolator, and you see that there's threaded fittings inside the isolator, right at different corners on the deck. Why are there threaded connections? "Oh, well, we changed this out and changed that out, and we left it." Well, that's not a good idea. You have to keep reinforcing what looks good and what looks bad,” explained Bozenhardt.

After posting the issue to a board and communicating it with the team, the resolution should be incorporated in the CCS documentation. This promotes a culture of not only quality, but continuous improvement. Not only does this reduce error in the future, but it will also improve efficiency.