Alphapharm is one of Australia's leading pharmaceutical companies, developing, manufacturing, marketing and distributing prescription medicines, pharmacy-only medicines and medicines only available at pharmacies. Alphapharm's speciality is bringing generic medicines (patent-expired medicines) to market.

The 60,000m2 facility located at Carole Park in Ipswich is Alphapharms' Manufacturing and Product development Site and as such, is home to a research, production, packaging, laboratory and distribution operation. It is where a focused and highly dedicated team concentrates on the manufacture of solid dosage forms – tablets, coated tablets and hard shell capsules.

In 2005, 3 billion tablets and capsules were supplied to some 5,000 customers in Australia, as well as to customers in more than 40 export markets. Alphapharm's quality assurance systems ensure the highest Australian and international standards are maintained. The operation at Carole Park consistently meets or exceeds Australian, EU, UK, US, Canadian and New Zealand standards of Good Manufacturing Practice.

With a consistent focus on manufacturing best practice, Alphapharm conducted a global company meeting in 2004, where the Group Operations Director presented concepts on Lean Manufacturing. Queensland's supply chain manager saw Lean Manufacturing as a key concept to undertake and integrate at Alphapharm's Carole Park plant. At the same time, a TPM (Total Preventative Maintenance) program was also being developed and the management team saw Lean Manufacturing as a hand-in-glove fit with the facility's mission and something that could deliver results that TPM couldn't.

Alphapharm also realised that TPM alone wouldn't raise manufacturing efficiency as the laboratory teams weren't engaged by a program that they saw was about machines and the factory and not about their scientific labs.

Through a workshop conducted by QMI Solutions at the State Development Centre in Ipswich, Alphapharm realised that engaging QMI was the perfect opportunity to employ some of the Lean Manufacturing principles they'd been introduced to at the company's global meeting.

From the beginning, the company had wanted to change many of their processes at a higher level. A QMI Solution consultant met with the management team at Alphapharm to examine the work flow, particularly to see what could and should be changed. The consultant worked closely with the quality group coordinator and the teams in the QA lab to restructure what they were doing and set systems in place. He and the Alphapharm team also went through value stream mapping processes to further clarify work flows, transport flows etc.

"During my walk throughs and examination of the work flow at the Alphapharm lab, I felt that something wasn't quite making sense in production," explains the QMI consultant. "There were some tight time frames and bottlenecks going on, so I suggested that the management team walk the plant's process flow backwards with me."

Afterwards, the team white boarded their walk-through and mapped out their discoveries.

"One of the most surprising things to us was some of the information flows in the plant," explains Alphapharm's Plant Director, Robert Elliot. "We discovered that the illogical information flows and paperwork being undertaking was hindering the work flows, but that the problems were largely historical as well, so they'd been going on for quite some time."

"We found that the same information was being passed around many different points before ending up at its intended destination. The process was far too convoluted: Too many people were being involved in information work flows and this needed to be seriously streamlined."

"The main point that was highlighted to us was the convoluted information flow, more so than the material flow. In many of the cases we couldn't change the material flow because of the location of equipment or facilities," explains Brian Wood, the senior manager for quality assurance.

The ramifications of the poor flow of information were not only constraints on time management but also resources, machinery and equipment. Often a document could take up to 2 days to clear, despite the fact that a batch could go through its quality control process and clear in a fraction of that time.

"This was a real issue for us, because in our industry, if a document isn't signed off, then you can't sell anything," said Elliot.

"The document mapping exercise was incredibly significant to us," Wood expanded. "It was where we decided that a number of changes had to be introduced immediately."

In the laboratory, the storage location for documents was moved, as was the location of a 'release' work team from the main building to the laboratory. As part of the process the document mapping exercise was fully completed, enabling the whole team to understand the documentation process and the manner in which documents and paperwork were completed and stored.

Elliot readily admits that the changes brought about some initial resistance from within certain workgroups. Understandably, after years of implementing their own processes and document flows and feeling somewhat territorial about their own areas, staff had to be convinced of the benefits to them and their area before embracing the new systems, lab layout and restructuring of teams. Some staff felt that their job importance relied on certain documents and processes and the work units needed to undergo a slight culture change in the early days before feeling comfortable with their new roles and responsibilities.

"I guess what QMI convinced us of, was that the new work teams needed to be process focused, not product focused. It meant that we got a lot of parallel work done. As a result of those changes, we were able to bring a fairly significant amount of the work that we had previously contracted out back in-house and see something in the order of a 27% improvement in productivity in the quality control area," explains Elliot.

Wood goes on to expand, "We would contract out up to $20,000 worth of testing per month, but the restructuring that QMI assisted us with enabled us to bring that testing work back in-house. In measurable terms, this was the most significant thing we saw. However we think there were plenty of other wins as well, such as increases in efficiency, validation and turn-around times."

Validation processes and their corresponding gains in efficiency are particularly important to a company such as Alphapharm. In the pharmaceuticals industry, every time a change is made to how a drug or product is made, extensive testing needs to be carried out to ensure that the mixing of the product is correct through the entire process and that the product is performing exactly the same way in terms of release of the drug, uniformity etc. Far more testing is conducted for validation testing than for quality control (QC) release testing. A typical QC release would take approximately 3 days. A validation test would take up to 8 days, making any gains in the validation testing process significant.

While Alphapharm haven't fully measured the gains in validation testing that have occurred since the restructuring, they have since taken on enormous increases in validation through taking product transfers from with the company, launching the products that have been developed in-house and also taking products from another plant in another part of the world – all without increasing their resources at the Brisbane plant and still successfully managing the workload.

The first manufacturing microscope conducted in 2005 identified 3 main areas of concern. They were pull, improvements in quality at source and visual factory layout.

The Manufacturing Microscope, part of the PROBE suite of diagnostic tools, compiles a report through asking cross-functional and multi-level teams to score results via a self-assessment questionnaire with the guidance of an independent facilitator. The finalised scores are calculated against a world class model of manufacturing excellence developed by the London Business School and the IBM Consulting Group, and benchmarked against a cross-section of international companies within the data set. Intended as a management summary, the Manufacturing Microscope report expands and reinforces findings from the facilitated discussion with the company.

The Alphapharm, Carole Park site's overall practice index at 67% leads its overall performance index at 64% putting it into the 'CONTENDERS' sector of the world class model.

Alphapharm have already addressed the first area of concern (pull) with the quality control team by ensuring that they can support a full system going through the factory. The factory manager worked closely with QMI to implement such things as improving scheduling within the lab and making that scheduling more visual and also Kanban across certain areas.

Visual Factory is also critical within the plant and lab, and Alphapharm are striving towards implementing a highly visual system that allow anyone at any given time to ascertain what is going on where, rather than printing out a full report that contains extraneous information.

Alphapharm will be relying on a Six Sigma system to develop improvements in their 'quality at source' issues. Stronger supplier agreements and supplier contracts will be formulated to bed down their raw and bulk material needs. A big part of quality at source is vendor assurance of the materials being supplied. This typically means a huge amount of testing of products and then sign-off from the government authorities that any given product or material meets stringent standards. Vendor assurance can obviously be a huge issue in the manufacturing process and streamlining this as much as possible will prove to be a bonus to Alphapharm.

Three Blitz Teams were formed under QMI's guidance. A "Right First Time" team, a documentation team and "5S" Team.

"By far the most successful of these blitzes was the 'Right First Time" team," says Wood. "Over the last 15 months our Right First Time percentage has gone from 84% to 95%. In economic terms, it's given us approximately 10% more capacity because were not doing 10% of jobs again."

"When we talk about 27% improvement in productivity gained from the processes QMI have helped us implement, about one third of those gains are simply from getting it right the first time," says Elliot.

Alphapharm have been invited to join the Best Practice Manufacturing Consortium – a group that meets regularly to examine and learn about other Queensland companies that are 'getting it right.'

"The Consortium has exposed us to a host of great and novel ideas from other companies – particularly some excellent visual ideas. It's important to us to get the vision and values of the organisation across to our team and imparting these in visual terms is certainly the most efficient and effective way," says Elliot.

"The other major message we've learned about World Class Manufacturers is that in their factories, nobody runs around. There's a sense of calm about the place."

"The Consortium has also allowed us to highlight some of the things we do well too," Wood goes on to say. "The feedback we can give to our own team is that we do an excellent job in some areas and that plenty of additional opportunities exist."

"One of the most positive things for us that has come out of the QMI experience is that we bite off more than we can chew," says Elliot. "We've identified that through our change control process and project management in the past we've had a pattern of undertaking too many projects and too many changes at once, which all get half done. We tie up too many resources in the process and then we see a net improvement of zero. Our experience with QMI was vastly difference. We took things in manageable bite-sized chunks. Or simply speaking…. We slowed down to speed up."

Find out more about Alphapharm at www.alphapharm.com.au