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?
Sources
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