Applying Continuous Improvement (CI) Manufacturing - - BioPharm International

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Applying Continuous Improvement (CI) Manufacturing


BioPharm International


Traditionally, continuous improvement (CI) activities at Lonza were carried out and managed by staff who were also responsible for the delivery of product to internal and external customers. The CI projects usually competed for resources with product delivery. To address this issue, the potential benefit of having dedicated resources focused on improving working practices and procedures was often discussed. Separating direct accountability for product delivery from CI efforts alleviated this conflict.

In May 2003, Lonza restructured the manufacturing department and created two full-time, dedicated positions focused on CI activities in manufacturing. The new roles provided a resource for CI projects designed to achieve specific business goals. To highlight the importance of the projects, the CI leads reported directly to the head of operations.

The CI lead role was envisaged as a long-term secondment, allowing the skills and knowledge obtained from executing CI projects to ultimately be transferred back to the product delivery teams. This was done to ensure that CI did not become just the job of the CI leads, although the CI leads were responsible for driving and ensuring successful project execution. To allow the CI leads to be successful in their roles, training and coaching on CI techniques was provided by an in-house Six Sigma Master Black Belt. As well as executing projects, part of the CI lead's role was promoting the CI philosophy and encouraging the use of various CI techniques throughout the organization. By exposing as many staff as possible to the philosophy, Lonza hoped that CI would become part of the staffs' everyday work to ensure that the company continues to deliver value to its customers.

Lonza's CI philosophy is based on five main principles.


Figure 1. This control chart shows a shift in the process performance (a reduction in the mean number of deviations generated per batch) after implementing an on-plant review of documents. New control limits will remain temporary until more batches are completed using the new process.
1. Understanding Process VariationThe first principle of the philosophy is understanding process variation and emphasizing on-target performance with minimal variation. Control charts are useful tools for monitoring process variation over time and determining if a process is in control (stable, predictable, and exhibiting only random, "common cause variation") or out of control (unstable, unpredictable, and showing "special cause variation").1 Traditionally, the number of deviations reported from one manufacturing batch was compared to the number reported for the previous batch. If the current batch generated more deviations than the previous batch, an investigation was carried out to try to understand why. Conversely, if the number of deviations generated was less than the previous batch, the teams were considered to have performed particularly well. In the past, there was no way to determine the typical level of variation in the process and, therefore, how many deviations could be expected. Control charting is now used to monitor the number of deviations generated by each batch. This has allowed Lonza to target investigations at batches that truly have special cause variation rather than wasting time investigating random and expected variation.


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