Pharma Takes the Prize

Writing the site report, which is later sent to the host company, then takes another portion of a day, but examiners too learn a great deal. “Different experts bring different complementary strengths,” says Galsworth.

North Cove:
Refinement, Critical Mass

For Baxter North Cove, there had been no significant changes in direction or new points of emphasis within its existing continuous improvement program. Instead, the facility’s staff has been refining existing practices. “More team members have been through the training, so our critical mass is larger than it was seven years ago,” says plant manager Johnson. In addition, more operations, beyond manufacturing, have been integrated into the value stream.

The facility has staged Kaizen events with its suppliers, both internal and external to the Baxter corporate network. One of these sessions led to a change in the type of container used, from disposable to reusable, explains manufacturing director Smith.

Within the past two years, the facility’s teams have been focused on digitizing information, Johnson says, making necessary data available, from the most recent report on employees’ vacation time and attendance to manufacturing and business KPIs.

It’s important, Johnson advises, not to get hung up on the “prettiness” of the data display, because that tends to be directly proportional to the amount of care and feeding the system requires. “We didn’t want ‘monsters’ that we’d have to feed, so we selected systems where data were easily accessible but that wouldn’t take a lot of time to update,” he says. The facility measures OEE across every production line, using both manual and electronic methods, he says.

Baxter Cuernavaca started its Lean program in 2004, driven by the company’s overall quality leadership program. There are 800 manufacturing employees, but over 1,000 when distribution and other functions are included.

Visual Stream Mapping Is Crucial

Visual stream mapping (VSM) was the single most powerful tool that the facility used, says plant manager Alejandro Ochoa, to identify the key types of waste: overproduction, movement, inventory, rework and defects.

VSM directed all other efforts, from waste identification to plant layout changes and team assignments. “In the past, when looking at employee productivity, we were thinking of efficiencies but we didn’t see the whole process and such things as inventory levels,” Ochoa says.

Basic training was an important first step, says project leader Ivonne Nogueira-Flores. “We provided specific training, based on area requirements, whether Lean, Six Sigma, Kaizen, SMED (Single Minute Exchange of Die), Just in Time (Kanban) or Error-Proofing (Poka Yoke).” A number of different approaches and formats were used, she adds. In some cases, consultants helped set up a program; professors from local universities also assisted.

One of the most powerful training tools the facility has is a simple tour, Nogueira-Flores says. Conducted monthly or bimonthly, these tours invite people from different functional areas to see “how the other half lives.” For example, a packaging line professional will visit the quality lab or the manufacturing floor.

Poka Yoke and Visual Taken Seriously

Baxter Cuernavaca is taking mistake-proofing very seriously, and has a specific program in place designed to improve it, with process engineers assigned to it, Ochoa says. Options range, Nogueira-Flores notes, from use of sophisticated software to control mixing, to placing a small device in a sampling line to prevent the wrong connection.

On a filling line, for instance, where it is imperative that the right anticoagulants and additives be added to the right bag, Baxter uses different port sizes, with a different diameter tubing for each, to avoid mistakes. “It’s simple but effective,” Nogueira-Flores says. In sterilization, the facility uses barcoding with a software package that controls the movement of 1,000 trucks, or containers where product is placed to be sterilized, per day.

“Poka Yoke is not rocket science,” says North Cove’s Johnson. At his facility, mailbox flags are placed on the containers in which empty bags are moved from one location in the plant to another, to show whether they’re full (flag up) or empty (flag down). This system has the advantage of both functioning as a “pull,” signaling the need to produce when they’re empty, and preventing errors (flag up vs. down).

Similarly, flags have been put on some of the machines to indicate the status of production. “It’s the proverbial square-peg-in-the-round-hole approach,” Johnson says.

Visuality of data is also critical. It’s the key to employee involvement, says Cuernavaca’s Nogueira-Flores. “Without this information, they cannot succeed,” she says. “We used to meet once a week for about an hour with 20 pages of documentation on every batch and its status, but a lot of those batches were still there the following week,” says Terry Foxx, who is, along with Smith, a manufacturing director at North Cove.

The company set up a board where every batch is visually moved, depending on how many days it has been sitting there. “[Now] we meet at 8 a.m. every morning for 15 minutes, and are kept up to date on everything,” he says.

Plant manager Johnson also meets with staff every morning to talk about what happened during the previous day in terms of output, machine downtime and the key metrics that each line records. It’s a standup meeting that takes 10-15 minutes out in the center of the plant. “Anyone can walk over and report, and update the team on quality, uptime and output,” says Johnson. The data are also posted — and kept updated — on all the hallways that operators must walk through, adds manufacturing director Smith.

Baxter uses 6S (with the last S standing for security) as a basic platform from which to establish the commitment and discipline that employees will need to follow the procedures required for other aspects of OpEx such as Kanban, she says. “It’s also an excellent tool for good manufacturing practices (GMP), mandated by FDA,” she adds.

VSM led to changes in plant layout to minimize wasted motion, Ochoa says. One such change halved the distance that employees must travel in the plant.

Wasted time between batch changeovers was also addressed using Shingo’s “Single Minute Exchange of Die” method. For one sterile plastic sheet operation, it used to take seven hours to change the rolls, Ochoa says. It now takes 25 minutes. Similarly, in another area of the plastics plant, changing from a 6-L to a 1-L filling machine reduced changeover time from four hours to 20 minutes.

Cross-Training

Formal training is important at Baxter, which advocates the “Lean Six Sigma” approach, Ochoa explains. The facility currently has 20 to 24 green belts certified by Mexico University, but only one or two black belts.

Cross-training has been an essential part of Cuernavaca’s program, Ochoa points out. “In the past, employees specialized just in filling or packaging, but with Kanban they must be able to move to different lines,” he says. “We believe that each and every employee should be able to work in three different positions in three different lines.” Depending on the complexity of the position, that training can last from three weeks to six months.

For both applicants and judges, the Shingo Prize offers an opportunity to benchmark manufacturing operations and gain insights from outside the drug industry. North Cove’s Johnson has judged teams, and describes it as a very educational opportunity. Even if you haven’t won the prize, experienced professionals can apply to join the Board. For more information, visit www.shingoprize.org.