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Operational Excellence including Lean Manufacturing Consulting

Operational Excellence Fact Sheet view pdf

Life science companies are increasingly concerned about their operational performance. Cost, throughput, and cycle time are now being seen as critical success factors in the industry. As regulatory requirements grow increasingly stringent, operational consistency and reliability can have a great impact on compliance. Variability not only results in compromised quality, but also causes disruption to upstream and downstream operations. Effective and reliable performance of operations beyond GMP requirements, in areas such as product launch, technology transfer, change control, supply planning and materials management, are crucial to meeting schedules and maintaining quality.

Maxiom Group helps clients build business and operational excellence through the application of programmatic, continuous improvement programs and by facilitating development of specific operational process improvements. While clients focus on their core capabilities of scientific and technical excellence, Maxiom Group assists in developing and implementing effective solutions for bringing products to market, ensuring reliable supply, assuring production efficiency, improving laboratory processes, accelerating and enhancing quality control practices, and improving other operational processes.

Maxiom Group focuses on Reliable Execution. We work with a client's organization to manage critical processes the way work is actually performed: across traditional functional boundaries, and across the entire supply network. Our experienced practitioners work either independently or can help facilitate your team in areas including:

  • Business process design and development
  • Cycle time reduction
  • Operational Excellence programs (lean and six sigma techniques)
  • Best practices assessment
  • Business process analysis and redesign
  • Enterprise metrics and performance management

A leading biotechnology product company engaged Maxiom Group to help increase its effective manufacturing capacity to support its growth and achieve better first-time quality to reduce cost, shorten cycle times and enhance compliance of its processes.

Maxiom Group designed an Operational Excellence (OE) program for the client and adapted our proven methodologies and tools to initiate continuous improvement in operations. We then led a pilot effort focused on risk-proofing batch records. We led five production teams in conducting Failure Mode & Effects Analyses (FMEA) to identify and mitigate process risks and mistake-proof batch records. The result of the pilot was a significant reduction in batch record errors and the wide adoption of the Operational Excellence process throughout the company.

Other OE processes facilitated by Maxiom Group with clients have achieved:

  • 20 – 32% reduction in batch release cycle time
  • 13 day annual reductions in manufacturing suite downtime worth $1.5M
  • 20 day reduction in QA disposition cycle times
  • 40% reduction in batch record verification steps