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Lean manufacturing is becoming prominent in the Life Sciences industry. The model has seen much success in a variety of other industries. This blog series will focus on revealing how Enterprise Asset Management (EAM) can drive lean. We will shed light on lean in the Life Sciences industry; digging deeper into the understanding of how lean manufacturing correlates with Current Good Manufacturing Practices (cGMP).

Today’s Life Sciences manufacturing landscape brings about many challenges. Most companies have embraced streamlined processes; yet face fierce competition, strict regulation, and great customer demand for top-quality products.

What is Lean?
Lean manufacturing consist of continuous efforts to reduce and eliminate waste. Its core purpose is to maximize customer value while minimizing waste; reducing resources. Lean permits corporations to thrive in an increasingly competitive market while enhancing productivity, profitability and quality.

Many benefits of lean manufacturing include:

  • Streamlined workflows
  • Reduced error and waste
  • Improved productivity and profitability
  • Environment for continuous innovation and improvement
  • Reduced manufacturing costs

Why should a Life Sciences company implement a lean model?

FDA regulations are not the only reasoning behind a lean model. Corporations that have lean manufacturing currently implemented are driving quality in their production and increasing profitability. This is creating a higher level of competition among those lacking a lean model.

Lean is all about guaranteeing product quality.

Companies are constantly investing in new equipment, yet they often fail to update maintenance plans and activities. These tend to go undocumented. Equipment records are not always easily accessible, therefore resulting in machinery that falls short at the most critical times. Investing in top notch equipment alone is not enough to guarantee high product quality. Proper implementation of a lean manufacturing model ensures proper maintenance on equipment; increasing lifetime and efficiency.

In order for a company to get their highest return on investment, they need to reduce maintenance expenditures.  They can do so by increasing technician productivity and reducing paper trails and administrative work with a lean manufacturing model.

What does the lean model look like in practice in the Life Sciences industry?

EAM is the foundation for an efficient manufacturing process. Life Sciences companies must have an EAM in place that serves as a backbone to their complete manufacturing process in order to meet cGMP standards and FDA regulations.

Mckinsey & Company has reported that pharmaceutical companies that have embraced lean manufacturing have made significant improvements to their production system. Service and maintenance operations have also been enhanced. This report concludes that successful lean programs save companies money while allowing for more flexibility and better service.

  • The application of lean techniques can save a company from 20% to 50% in warehousing and up to 40% in transportation.
  • Successfully eliminating waste has reduced their costs up to 50% in the process.

Lean manufacturing allows companies to meet FDA regulations and thrive in an increasingly competitive market. While many corporations are able to comply with cGMP standards using their traditional business models, adopting a lean manufacturing model that encompasses an EAM system gives way to the enhancement of productivity, profitability and quality.

Our next blog in this series will discuss how lean manufacturing and cGMP fit together. Stay tuned!

Sources/Additional Information:

“Lean and Mean: How Does Your Supply Chain Shape Up?” by Knut Alicke and Martin Losch, McKinsey & Company

http://www.pharmtech.com/lean-manufacturing-practice-cgmp-environment

http://www.lean-manufacturing-junction.com/lean-manufacturing-principles.html

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm

http://www.automationworld.com/batch-manufacturing/new-pharma-factory

https://pharmout.net/downloads/white-paper-10-problems-with-pharma-plant-maintenance.pdf

http://www.pharmtech.com/lean-manufacturing-practice-cgmp-environment

https://pharmout.net/downloads/white_paper_lean_pharma_manufacturing.pdf

http://searchmanufacturingerp.techtarget.com/definition/enterprise-asset-management-EAM

http://www.reliableplant.com/Read/25421/EAM-managing-sustainability-industries

http://www.genesissolutions.com/effective-asset-management-enhances-lean-manufacturing-principles-and-processes/

http://www.lean.org/WhatsLean/