Understanding Waste From A Lean Biopharmaceutical Perspective

/// By Niranjan Kulkarni

As pressure to cut costs continues to grow, CRB Operations Improvement specialist, Niranjan Kulkarni, PhD, assists manufacturers in implementing Lean and Six Sigma methodologies to eliminate waste and maximize profits.

As pressure to cut costs continues to grow, companies need to reflect on their current practices and identify any possible sources of waste. Lean and Six Sigma methodologies can be used to help identify non value adding (NVA) activities and eliminate the causes of waste, along with variability in supply, demand or processing.

Though wastes differ by products, processes, facilities, etc., there are some common traits.

  • Waste, irrespective of type, negatively impacts productivity, flexibility and profitability.
  • Waste will not be always 'visible'. Obvious waste is easy to reduce/eliminate. However, it is the unseen waste that poses the real threat. This type of waste needs to be identified and eliminated.
  • Waste can be concealed even in the (so-called) value added activities.
  • Wastes are not always independent of each other. One type of waste can lead to another. E.g. Overproduction could increase chances of defects, increase inventory, transportation, etc.
  • Some NVA activities are mis-categorized as ENVA activities. Some are due to legacy practices no longer applicable with the use of new technologies and better process understanding. Proper identification of Critical Quality Attributes will lead to a lean Quality Program based on risk to patient.

Overcoming the initial hurdle of admitting a process is not perfect can be the hardest part. There is a perceived high cost to re-validate a process. Many times, the benefits gained from process improvements can overcome the cost of re-validation within the first year. The savings can be realized as increased capacity or reduced inventory in a warehouse. The benefits are not limited to cost savings, but may include quality improvements and increased flexibility.

When one takes a step back, and looks at the process from a different perspective, many forms of waste and unnecessary costs can be seen. A company striving for manufacturing excellence must identify their customer and determine what is absolutely necessary to manufacture the product the end users desire. Once this is done and the waste has been removed, a company can start to see the true variation built into their process and begin to control it using Six Sigma methods. Only then can a process be truly lean and profits can be maximized.

Email Dr. Kulkarni for a copy of his white paper entitled: Understanding Waste From A Lean Biopharmaceutical Perspective.

About the Author

Niranjan Kulkarni, PhD

Niranjan Kulkarni, PhD

Niranjan Kulkarni, PhD, is Director of Operations Improvement at CRB in our Boston, Massachusetts office.


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