QRM Process

Alza: Kaizen, 5-S Drive Development of Combination Product

Alza relies on its operators and standard quality methodologies to facilitate commercialization of a drug-device product.

TEAM OF THE YEAR FINALIST, SMALLER-SCALE PROJECTS:
ALZA&rsquoS IONSYS MANUFACTURING TEAM

A new drug-device product was proceeding through clinical trials at ALZA Corp. With commercial production on the horizon, a team was needed to transition production to commercial readiness at the company&rsquos PSGA West site in Vacaville, Calif. Former production manager Stacy Malueg and current production supervisor Arvin Balram made a key decision to put the process on the shoulders of the 16 operators who would eventually be running the production line.

They set up five kaizen teams, each involving the production supervisor and manager, plus several operators. The teams were charged with improving safety, documentation, spare parts control, equipment start-up and shutdown, and implementation of a 5-S program.

They also set up four distinct manufacturing teams, each comprising four operators with one as leader. These teams would be charged with getting all members qualified on multiple unit operations so that teams could seamlessly rotate from operation to operation on the plant floor. Cross-training would be one of the keys to the product team&rsquos success.

The smaller teams were necessary for commercial scaleup, but Malueg had the alternative motive of getting the operators ready to run the show. &ldquoI wanted them to be more confident, to work together and evolve into a cohesive unit,&rdquo she says.

They have more than met her expectations. In the past, the operators may have waited for an engineer to be present to make a key decision, or might not have immediately sought to resolve a problem, believing these responsibilities were outside their realm. Now they readily take ownership of problems and offer opinions on how processes can be improved. When commercial production begins, possibly late this year, Malueg believes the team will be ready.

An extreme challenge

The team is paving the way for the IONSYS transdermal system, a drug-device combination product that relies on a small electrical current to drive a drug molecule, contained in a gel, through the skin.

The challenge of the IONSYS team was to transform the entire department from an R&D outfit to a commercial-ready one. This included upgrading equipment, improving the manufacturing process itself, and preparing employees along the line for process validation and commercial-scale manufacturing.

Balram and four process operators had been laying groundwork since 2000. Early last year, however, in preparation for process validation and commercial production, a cross-functional team of 16 process operators, a new production manager, as well as support personnel from engineering, QA and maintenance, was formed.

The initial response was lukewarm. &ldquoAt first I was wondering how far we were going to go with it,&rdquo says process operator Roy Bernardi. &ldquoWould we be just talking about it, or actually following through?&rdquo

Since that time, the new approach has been extremely successful:
  • Equipment startup/shutdown time has been reduced by 50%. Inspection throughput has increased by 20%.

  • Equipment upgrades and process improvements helped increase yields 20% and reduce variability. Equipment throughput has risen by more than 20% as well.

  • All process operators have been trained and qualified on multiple unit operations. All team members have opportunities for input and leadership.
Process improvements focused on creating visual systems and error-proofing methods throughout the process. Specific examples include diagrams of equipment parts for training, labeled locations for tools, equipment, documentation and materials, and daily set-up kits. The spare parts kaizen team put all parts into two cabinets, in marked containers, which was so simple it felt strange. &ldquoIt was a little unsettling at first because we didn&rsquot know where things were,&rdquo jokes Bernardi.

Operators making a difference

The operators have been thoroughly engaged in each step, particularly in helping to formulate new SOPs. Team members now talk about having a greater understanding of the product and a sense of pride at being instrumental in bringing it to market. &ldquoIt was great to see our input actually become part of the process,&rdquo says Bernardi.

Participating in planning and implementation has led to documented increases in job satisfaction. Surveys show that team members have a much greater sense of job satisfaction than before.

One member talked about reaching a state of &ldquomental 5-S.&rdquo Previous habits and attitudes have changed so that safety, compliance and efficiency have become top priorities.

The teams have bonded as well. It&rsquos not unusual for one to provide lunch for the others, or to give others credit for a job well done. The 5-S kaizen team recently honored the spare parts team by displaying members&rsquo photos on the newly organized parts cabinets. The joke is that if some small wrinkle or improvement has been instituted, &ldquoThe 5-S people were up to this.&rdquo

Other workers at PSGA West, Vacaville have taken notice. &ldquoA lot of people from different departments are now looking at IONSYS,&rdquo says Martha Gutierez, another operator on the team. &ldquoThe rest of the plant wants to know what we&rsquove done.&rdquo

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