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Operational Excellence including Lean Manufacturing Consulting

Operational Excellence Fact Sheet view pdf

LabSense™ 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

NEW!

The Power of Workplace Organization in Improving Lab Operations

Maxiom Group partnered with a client on a 5S implementation targeted to achieve these and other benefits in the area of sample retains management.


Improving Business Process Integration Post-Acquisition

Maxiom Group led multiple biologics development groups through a series of Strengths, Weaknesses, Opportunities and Threats (SWOT) initiatives aimed at assessing and improving integration between two newly merged organizations.


Risk-Proofing Biologics Manufacturing Operations

Maxiom Group led cross-functional teams to conduct Process Failure Mode & Effects Analysis (PFMEA) of eight Purification batch records to identify process risks and develop mitigation solutions.


Lean Assessment of Site-Wide Indirect Costs

Maxiom Group conducted site-wide assessment of indirect resources and costs at a vaccine manufacturer in the European Union (EU) to align operations with the production "rhythm." Then developed improvement recommendations in the areas of site processes, site staffing, and cross-site consolidation.


5S for Sample Retains

Maxiom Group led a client team through implementation of a 5S program in the sample retains management area, resulting in reduction in storage space and cost requirements as well as time to locate samples.