Tuesday, February 4, 2014

Lean Techniques and Quality Management in Pharmaceuticals

Applying lean techniques within the field of pharmaceuticals, as was done at Baxter’s BioPharma Solutions, can generate productivity, improved workflow efficiency and significant cost savings.


At Baxter, for the facilitation of the implementation of the lean process, employees at the BioPharma Solutions facility were trained on the major lean manufacturing tools and their applications. A team was built within the chemical and microbiological divisions to set consistent standards in each lab area and to complete the following 6 S steps!


1. Sort Out

2. Set in Order

3. Shine

4. Standardize

5. Safety

6. Sustain


Sort Out: All items in the company’s labs which are no longer used are removed at the beginning of the process, and then placed into a separate area for three months before disposal, making space for new improvements and orders.


Set in Order: the individual analytical processes are examined and set in an order suited to the relevant processes and space.


Shine: cleansing and sterilization of products and putting them into a well maintained status are necessary.

Standardize: This process indicates where things belong and identifies a location for the item to be returned after work was completed. This reduces tedious and time-consuming search activities.

Safety: This is crucial for a lab which handles carcinogenic and toxic substances.


Sustain: The entire process is managed by the European Baxter Lab Council and the company’s manufacturing facility through regular 6S audits carried out by lab supervisors and the lab manager who check the status and make suggestions for future improvements.


Also, the implementation of Kanban systems as visual indicators for the material stock ensured that the stock was ordered early enough to prevent any “out of stock” situations. This improves the level of customer service by preventing delays.

Upon this foundation, a Pareto analysis of the contract manufacturing batches planned for the corresponding year helps to identify potential opportunities for improvement in the product portfolio, taking into account:


  • The number of batches produced of each item
  • The analysis times per batch
  • The number of operators involved in the lab
  • The potential for standardization


This team-based approach created deeper process knowledge for all members of the company. The flow of information also became more homogeneous and structured, with trends occurring on the shop floor level traced daily. Based on the understanding of those specific processes, a more general approach focusing on the total lead time was implemented.


A swim lane diagram including all functional areas involved was created and was helpful in providing the insight for the allocation of potential for eliminating late corrections and establishing efficient information flow and prioritization.


As a result of this approach, the analysis time for some products has been reduced by up to 25%. Also, previously independent releases of products from the chemical and microbiological labs were synchronized, which, for example, helped to ensure all tests were completed on the day sterile testing was reviewed.


The application of lean techniques throughout the Baxter laboratory created a deeper process understanding by all employees involved and a direct, positive impact on Baxter’s customer service level as a result of decreased lead time. This success has meant that this approach may be applied throughout the facility and globally across Baxter Quality Control laboratories.


In which other large pharmaceutical manufacturing companies have lean techniques also been used to achieve significant results in quality control and management?



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