By applying lean tools, such as 5S and visual management, Roche Carolina laboratories set the standard for quality control and help the company respond to market demand for critical drugs like Tamiflu. Read below and answer the following questions.

Sort During the initial 5S implementation, the defining question is, Do we need it, or not? The question is asked of equipment, materials or consumables. If the answer is no, its disposed of. We freed up so much space because everything was all over the place, recalls Taylor. We discarded a bunch of stuff, and found stuff we didnt know we had. This included many high performance liquid chromatography (HPLC) columns that are used to separate drugs from impurities, which cost upward of $600 each.

Set in order During the sort process, if the answer is, Yes, we need it, the equipment and materials are moved to a logical place and labeled or otherwise identified This is where taped lines on the floor and shadow boards for frequently used tools often come in. In the labs they moved gloves, which people had been hoarding in various cabinets and drawers, to a standard location in each of the five labs, and they mounted the HPLC columns on wall racks.

Shine Roche implemented the cleaning and housekeeping aspect of 5S through daily, weekly and monthly audits in each laboratory. Detailed checklists included dusting shelves and cleaning floors, as well as maintenance items such as requesting repairs to lights and fans that arent working. Guest inspectors from elsewhere on the Roche campus brought a fresh set of eyes and offered their comments and feedback. The key when we first started was that management was involved, says Taylor the manager. It wasnt just the analysts. My director came on audits, made comments and was very involved to show how important it was.

Standardize Instrument status log books record equipment qualification, maintenance, repairs, and operational data. When they started to implement 5S in the labs these log books were incomplete, they were stored in different locations, and some needed data was stored elsewhere. As part of the standardization process, they bought new log

Sustainability Anyone can go in and do 5S, but if they dont have the sustainability part of it, theyll be doing it again and again. Its a continuous process; you dont just do it and forget about it, says Taylor. After six months, Roche cut out the weekly audits and rolled those activities into the daily and monthly checklists. Making a 5S project part of every analysts annual objectives has been another key to sustainability. One of the important parts of 5S is accountability, he adds. If youre working in a laboratory thats clean, you will have more ownership. You will be more accountable for keeping it clean. I dont have to go in the lab and tell people to pick up their stuff. It has become self policing.

1) Were the lean tools used by Roche Carolina the right ones, were they effective? Comment on each of the 5S steps.

2) Do you think the improvements at Roche are sustainable? Explain your reasoning.