| Many pharmaceutical manufacturers are considering | | | | direct changes that back the Lean models. |
| Lean Manufacturing and Six Sigma, two reputable | | | | The transition team has to identify what |
| management approaches, to transform manufacturing | | | | management tools, IT systems and communication |
| operations and to boost quality. These methodologies | | | | means included are necessary for the company to |
| have positively changed other industries like the | | | | change. |
| electronics and automotive businesses. | | | | Another important thing the company must consider |
| Lean manufacturing concentrates on getting rid of | | | | is how it will define or determine success by |
| waste, with the intention of influencing manufacturers | | | | establishing Key Performance Indicators (KPIs) at |
| to be more open to customer demands and market | | | | diverse levels of production, and it is also crucial to |
| changes. | | | | create a highly visible problem solution system to |
| Six Sigma is an approach that deals with business | | | | guide and institutionalize change. |
| processes and works on minimizing product and | | | | All of these capabilities have to be put into practice |
| process variation with the intention of reducing | | | | and scaled so that they reach over the whole value |
| product defects. | | | | chain. This value chain is in many cases |
| According to the methodology, one standard | | | | overwhelmingly complex and can go beyond |
| deviation from the mean is one sigma; thus, | | | | traditional organizational limits. |
| manufacturers who operate at (+ or -)6 sigma are | | | | 3. Mindsets and behaviors |
| doing so at 99.9997% compliance. | | | | The most difficult part of change for the majority of |
| Pharmaceutical manufacturers who put Lean and Six | | | | pharma companies is the transformation of mindsets |
| Sigma approaches into practice possess a strong | | | | and behaviors. |
| method to help them improve quality, compliance, | | | | People normally fear change, and thus, resist it |
| productivity, costs, and speed, resulting in them | | | | strongly; and when talking about the pharmaceutical |
| offering better products to the market in a faster | | | | manufacturing industry, which until not so long ago, |
| and more cost-effective way. | | | | flourished in spite of its focus on preserving the |
| In order to move to a Lean Six Sigma environment, | | | | status quo, this is a truth that is set in stone. |
| companies have to center on change at three levels: | | | | When moving to a Lean Six Sigma environment, the |
| 1. Operating systems | | | | management team has to identify and communicate |
| 2. Management systems | | | | a coherent mission, vision, and value system all |
| 3. Mindsets and behaviors | | | | through the organization, never losing focus on the |
| 1. Operating systems | | | | customer. |
| At the level of operating systems, manufacturers | | | | The transition team has to center on achieving |
| have to comprehend demand levels, must design lean | | | | top-down acceptance by lining up resources to help |
| production systems around material and information | | | | build and convey momentum across the company. |
| flow analysis, should create tactical implementation | | | | Last but not least, pharmaceutical consulting firms |
| plans, and must develop consistent work charts and | | | | agree that training is a must. There must be an ample |
| instructions. | | | | strategy that offers training opportunities at different |
| 2. Management systems | | | | points during the transition as a way to gain higher |
| Management systems have to be assessed at | | | | acceptance and expertise both from management |
| various different levels, and pharma companies must | | | | and other staff. |