Dr. Thomas Agrait is the actual CEO and Senior Partner of Lean Enterprise Consulting Inc. He has over 30 years of experience as an independent management consultant/Coach in Lean Six Sigma, technical, regulatory affairs, and compliance to pharmaceuticals, medical devices, biotech, healthcare institutions/companies, and various government agencies with an emphasis on establishing efficient processes, sustainable compliance, quality levels, and validation environments. Through his work, Mr. Agrait has been affiliated with the Regulatory Entities- regulated industry for more than 25 years in the areas of QA, Quality Engineering, Manufacturing, Supply Chain, compliance, and Corporate / Operations Management and employed on behalf of well-known, globally recognized manufacturers and service providers.
Among his major accomplishments are:
• Increased the number of consultants on his team from 3 at the beginning to over 50 subject matter experts at this moment.
• Branding the firm outside Puerto Rico with the result of becoming a worldwide service provider with offices in Fort Lauderdale, FL., Barcelona-Spain, and Ahmedabad-India.
• Exponentially increased the monthly billable hours from an average of $50,000 in 2005 to $450,000.
• Instituted the Professional Development Academy, an internal professional development training program that improved the performance of our consultants by improving their competency level.
• Improved the morale of the team by developing, selling, and getting the commitment of the team through the establishment of a “Cultural Contract”.
• Diversified the client portfolio from a pharmaceutical-focused firm to an enterprise focus. Reached pharma, biotech, medical devices, banking, hospitals, insurance, retailers, and government agencies, among others.
• Integrated the “BOK – Project Management system to the deliverables of our project.
• Developed the PALMS System© for People Engagement

Mr. Agrait’s areas of interest and expertise include, but are not limited to, deploying and implementing Process Improvement Initiatives like Total Quality Systems, Lean Six Sigma, Supply Chain, Validation Programs, supplier/vendor qualification, auditing, Executive Coaching, QMS policy and procedure development/implementation from cradle to grave, Project Management, Risk Assessment and Management, Quality / Statistical Tools and Techniques, CAPA, Six Sigma / Lean Enterprise assessment and project execution, FDA Mock Inspection, and PAT.
He has held various managerial positions, from manufacturing to quality and logistics, with multinational Hi-Tech, pharmaceutical, and electronics companies like Raychem US-France, Owens Illinois-Specialty Packaging, Johnson & Johnson, Baxter, Novartis, Bard, Ciba Vision, Ocular Sciences, Wyeth, Amgen, The Clorox Company, Precision Monolithic in California and Cutler-Hammer/Eaton Corp-US, among others.
Mr. Agrait currently serves on the Faculty Board of the UPPR and FIU – Engineering School and has been an invited professor at FIU-Miami, Villanova University Engineering School in Pennsylvania, and at the Technology University of Costa Rica.
He is currently dedicated to Total Quality Management, Lean Manufacturing, and Lean Six Sigma program, Validation and Regulatory Consultant, and Human-Centered Assets Development for companies in Mexico, Brazil, Spain, India, Venezuela, Colombia, Puerto Rico, Jamaica, Europe, and the USA.
Some of the firms being serviced are:
• Amgen
• St. Jude Medical
• Boston Scientific
• Owens Illinois – LatinAmerica/USA
• Peldar – Colombia
• Vitro –Mexico, Canada
• American Standard
• Vitro Packaging - Texas
• Johnson & Johnson - Puerto Rico / USA/ Europe
• Ethicon-England, USA
• Ortho McNeil
• Pall Life Sciences
• Watson Laboratories
• Cardinal Health
• The Werner Company
• Medtronic • Procter & Gamble – Jamaica
• Sara Lee
• Comar
• Avon Latin America
• Nestle
• Raychem - France, Ireland, U.S.A.
• Intel
• WYETH Pharmaceuticals
• Baxter
• Bristol Myers Squibb
• Baxter
• Ortho-McNeil
• Boston Scientific
• OSCOR
• Bard
• Technoaerospace-Fl
As a quality/management consultant, Mr. Agrait assists customers in reducing defects and improving cycle time through analytical process management techniques. He has worked with clients on a variety of issues that impact the performance of a process, i.e. defects management, inventory control/record, production control, SPC, DOE, strategic planning, creative thinking and problem-solving, safety, and other managerial and organizational development aspects. In addition, has assisted many organizations with Quality Awards Certification.
Mr. Agrait is the author of various publications, including training manuals for SPC, DOE, Project Management, Creative Thinking, and Problem Solving that have been used to educate personnel from all organizational levels. Some other publications include topics like Master Production Scheduling, Sampling, Logistic Planning, Team Building and Structure Problems, and Design of Experiments, among others.
Mr. Agrait’s academic degrees include Engineering, Operation Research, and Organizational Development. He holds a B.Sc. in Industrial Engineering and a B.B.A. in Economics from the University of Puerto Rico, a master’s in business administration – Operation Research & Management from InterAmerican University in Puerto Rico, and a Doctoral Degree from LSU and he is pursuing a Post Doc in Neuroscience from the Massachusetts Institute of Technology, (MIT) Boston, Mass.