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A Kaizen Transformation roadmap will help you balance two worlds- the 'right now' and the 'next future'.
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Born at Toyota, Lean is a lighter, leaner way to achieve results. A Lean process is ruthless about getting rid of errors, steps, processes and people that don’t add value to a company’s products or services.
Lean is all about focussing on customer needs, reducing defects, creating waste-free processes that result in maximum ROI and Customer value.
Although Lean defined Toyota Production System (TPS) in 1940s, with time, Lean has been extended to other manufacturing verticals such as- electronics, cement, construction, food & beverages, pharmaceuticals, personal products, engineering etc.
The best part about Lean is that, Lean brings in a 3:1 rate of returns for any organization regardless of industry sector, that implements Lean correctly.
Learn more about how Lean can help your organization at our Workshops & Webinars:
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Which companies can use Lean?
LEAN can be implemented by Manufacturing as well as Service based companies.
LEAN is best for incremental improvements, organizations that focus on their people and culture, companies that want a less mathematical and more flexible approach than Six Sigma. But you can strive for a break-through Six Sigma improvement by eliminating waste Lean-style.
In the next part of this article series I shall discuss another time-tested business improvement methodology; TQM
Lean Innovation, Hoshin Kanrii and Six Sigma (as DFSS) for Product Design, Development and Manufacture via 3D Printing; a Case Study
Lean Innovation, Hoshin Kanrii and Six Sigma (DFSS- design for six sigma) for product design, development and manufacture via 3D Printing (i.e. Additive Manufacturing) Case Study by Dr. Shruti Bhat, gives benefits of applying Hoshin Kanrii, DFSS and Lean Innovation techniques to a drug product design, development and manufacture via 3D Printing.
The study findings however can be extended to product development across other industry verticals.
Some of the benefits of applying continuous improvement methodologies such as Lean, Hoshin Kanrii and Six Sigma to research and product development include-
The study uses Isosorbide dinitrate (ISDN) as model drug, although other drugs can also be used in this therapeutic platform.
2x3 Factorial Design of Experimentation (DOE) was used to design drug beads. The results were evaluated for regression analysis, Main and interaction effects of parameters, Contrast Column Dispersion effects, Normal Probability Plots, Pareto and Process Capability Analysis.
The drug beads were further used as ‘starter’ seeds to develop MUPS (multi-unit particulate system) anti-angina ‘rate-programmed’ drug product.
The pharmacokinetic- pharmacodynamic (PK-PD) modeling was done using Doebrinska- Welling equation. MUPS were developed using 3D Printing technology via a 12- Run Plackett Burman DOE.
All hardware, software applications involved in the study were pre-validated. All qualifications i.e. Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for each experimental run was done as per USFDA guidelines. Data was analysed statistically using Paired ‘t’ test. Reliability Testing was conducted as per ICH current Good Clinical Practices (cGCP) guidelines.
Product prototype and Reference listed drug (RLD) were compared for bioequivalence compliance. The prototype is ready for commercialization.
This study also gives benefits of using 3D Printing technique for pharmaceuticals and how the technique can be applied to product development across other industry verticals!
For details on how to apply Lean Innovation, Hoshin Kanrii and DFSS to product design, development and manufacture, watch the video …
To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp
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Shruti is true Thought Leader with over 10 years of demonstrated accomplishments, industry awards, certifications, books, patents and several publications in peer reviewed journals.
Shruti is appreciated for her knowledge, integrity, innovation, and collaborative team approach with effective mentoring as her organizational leadership style.
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