Our company is your best source for professional, value driven, low cost service. We provide services in two general practice areas:
I. Quality including FDA and Environmental Management Systems
e.g. ISO 9001, ISO 14001, BSI 25999, CFR 820
II. Lean Six Sigma Training and Coaching
Established in 1991, we have decades of collective and comprehensive knowledge and experience. We are able to provide the most value and innovation per your dollar spent. We are a customer focused, application oriented business made up of individuals who are simply the best at what they do. We specialize in process improvement, product improvement, customized training, auditing and coaching.
We provide a satisfaction guarantee for all services provided.
Dr. Victor Gray, Ed. D. , CQE, LSSMBB, BSI LEAD AUDITOR NO. 7039084-9784
Educator, consultant, entrepreneur, speaker and facilitator, Dr. Gray has many capabilities. With over 25 years of professional experience, Dr. Gray has been widely regarded as one of the world's leading experts in quality. He has worked directly with senior executives, has provided direct support to working teams and has provided direct support at the project level. His contributions have included assistance to leadership with the creation of corporate vision and goals, as well as, communication of leadership's vision throughout the organization. In addition to executive guidance, Dr. Gray has also provided tactical support which has included training and application of Lean and Six Sigma techniques, Voice of the Customer, 8D, SPC, Kaizen Design of Experiments, Quality Management Systems (ISO/TS/AS), Failure Mode Effects Analysis, Team Development, Measurement System Analysis, system audits and the solution of particularly troublesome quality problems.
Dr. Gray is a Fellow of the American Society for Quality (ASQ) and is a Certified Quality Engineer. He is certified as a Lead Auditor and trainer by BSI. Dr. Gray is also a Lean Six Sigma Master Black Belt and trainer. He holds a Doctor of Education Degree in Administration and Adult Education. He is Master Trainer for the Manufacturing Skills Institute, Richmond Virginia.
Some of our Associates:
Dr. Cal Morris, Ed.D., IRCA AUDITOR NO. A013760
Cal is President of The HR Group and assists clients in identifying training needs and designing programs to meet those needs. From 1993 to 2001 Cal was the Program Manager at the Center For Training And Work-force Development with Piedmont Virginia CommunityCollege (PVCC) in Charlottesville Virginia – promoted and provided customized training programs for business, industry, and government within PVCC’s region. ISO-9000 and Continuous Improvement programs were emphasized. Prior to 1993 he served in Command and staff positions within the United States Marine Corps and retired as
Lt. Colonel. He completed the requirements for the Doctor of Education from the University of Virginia in 1974.
Since 1994 his professional emphasis has been on ISO 9001 training, implementation, auditing and coaching.
David OrmsOver the past 28 years David has provided expertise and support in the development, implementation and auditing of organizations quality management systems. With over 18 years of auditing experience Mr. Orms is regarded as a highly qualified and effective quality auditing professional. Mr. Orms many capabilities include developing and training, consultanting. He has worked directly with senior executives providing direct support to working with teams and has provided direct support at the project level. His contributions have included assistance to leadership with the creation of corporate vision and goals, as well as, communication of leadership's vision throughout the organization.
In addition to executive guidance, Mr Orms has also provided tactical support which has included training and application of SPC, GMP, GLP, Internal Auditing (ISO\ FDA), Team Development, Measurement System Analysis, system audits and the solution of acute quality problems.
Mr. Orms is a member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor, and is a certified Plant Sanitarian through the American Institute of Baking (AIB). Mr. Orms certifications also include HACCP and Advance HACCP and Industrial Safety.
As Vice President for Environmental Solutions Inc. Harry is responsible for development and implementation of the ESI Strategic Plan and Environmental Management System (“EMS”) to advance the ESI mission to develop and commercialize technologies and processes that can be deployed in the implementation of innovative environmental solutions. His responsibilities include environmental technology development for the benefit of private industry and municipalities focusing on innovative beneficial use of waste streams, by-products, and residuals; and directing resources to promote sustainable principles and practices and pollution prevention. He has experience with Virginia DEQ and the EPA. Harry is a certified ISO 14001:2004 trainer, consultant and auditor.
Dr. Nat Ganesh, Ph. D, MBA, MBB-Six Sigma
Over the past 18 years, Nat has built a varied and progressively expanding corporate career in the US. Starting from and advancing as a technology leader with Fortune 100 firms such as Union Carbide Corporation (now Dow Chemical) and AlliedSignal, Nat specialized in leading the introduction and deployment of advanced automation systems and IT-based enterprise-wide systems applications. Based out of AlliedSignal’s business-cum-technology center near Colonial Heights, VA, Nat emerged as a Total Quality Management (TQM) Team Leader and led the deployment of operational efficiency enhancement initiatives in manufacturing facilities. At AlliedSignal, Nat received the Corporate Technology Achievement Award in 1999. He was the manager of the Enterprise Productivity Systems group. He was selectively sponsored by AlliedSignal to the full-time Executive MBA degree from Duke University’s Fuqua School of Business in 1998, wherefrom he graduated as Fuqua Scholar in 1999. Until 2000, Nat led business productivity enabling systems deployment, in the US and in Europe.
He then joined PricewaterhouseCoopers Consulting, where he became a Master Black Belt. Over the next several years, Nat handled various Six Sigma engagements, both as an Engagement Manager and a MBB, with broad responsibilities for delivering end-to-end Six Sigma and BPI services to client organizations in manufacturing, healthcare and service industries. He consulted for several global leaders including Johnson and Johnson, ServiceMaster, Verizon and IBM Financial Services. Internationally, his clients included the Formosa Group of Taiwan and POSCO Steel in S.Korea.
As a chemical engineer, Nat earned his MS in Chem. Eng. from the University of Virginia, Charlottesville, VA and his Ph.D from Carnegie-Mellon University in Pittsburgh, PA. Later, he earned an MBA from Duke’s Fuqua School of Business. Nat is an elected member of the Tau Beta Pi, National Engineering Honor Society and Sigma Xi, National Science Society in the US. He is also a member of the American Society for Quality (ASQ).
Robert L. Holloman Jr.
President of the Holloman Group, LLC, A Lean Consulting Firm, Mr. Holloman has over 19 years experience working with companies whose processes include, but are not limited to: printing, stamping, plating, assembly, painting, blasting, heat treat, automation, surface mounting, distribution, injection molding, welding, and metal forming. He has saved these companies millions of dollars by implementing lean manufacturing principles. Mr. Holloman has also worked with manufacturing companies as a Process Improvement Manager, Business Unit Manager, Engineering Manager, EH&S Manager, Quality Manager, and Lean Manufacturing Consultant.
Mr. Holloman holds an Industrial Engineering Degree from Virginia Tech University and has extensive formal training by the founders of the Toyota Production System, Shingijutsu Co. LTD (Japan). He also has extensive training and experience with the following: Training/implementing Kaizen Events (Process Improvement); One-piece Flow and Work Balancing; TPM/TQM Principles; Set-up Reduction (SMED); Value Stream Mapping; Establishing Kanbans; Cellular Manufacturing; Establishing a Visual Workplace (5S); Time Studies; Standard Operating Procedures; Lay-out Designs/Drawings; and Project Managing.
Industrial Experience over 19 years total:
Lean Manufacturing Consultant – The Holloman Group, LLC.
Process Improvement, Engineering, & Quality Manager – Rehrig International
Business Unit Manager, Project, Cost Down & EH&S Manager – Stanley Works
Industrial Engineer & Project Manager – Naval Air Station
Value Steam Mapping
Kaizen, Continuous Improvement
One-Piece Flow & Cellular Manufacturing
Education and Affiliations:
BS Industrial Engineering and Operations Research - Virginia Polytechnic Institute and State University
Over the past 19 years Darren has had a very successful business supporting orgnizations with a need to understand and use his knowledge in Quality and Regulatory consulting for the Medical Device & Pharmaceutical Industry and E-commerce company. He had provided Business, QA and RA advice and training to all size medical device & pharmaceutical companies.He has provided sterilization and process validation and engineering expertise.Some of his past experiences are:
Vice President, Quality & Regulatory, Surgical Group, Maxxim Medical; Medical Device Manufacturer (2000 Sales: $980 Million); Richmond, Virginia;
Director of Operations, Sterile Concepts, Inc.; Custom Healthcare Procedure Tray Manufacturer; Temecula, California;
In addition he has the following credentials:
- ISO Lead Auditor Course by BSI Training Services in Washington, DC., October 12-16, 1998 (Cert. No. 98-260US-50757).
- ISO Audit Training given by Grant Thornton ISO Consultants, Atlanta, Ga.; November 7-8, 1996.
- Management Representative for ISO 9002 Certification, Sterile Concepts, Inc., Richmond, Va. by the British Standards Institute (BSI). July 26-28, 1995.
- ISO Audit Training given by KPMG ISO Consultants, Richmond, Va.; October 27 and November 18, 1994.
- Developed CAPA Semniar for public presentation. October, 2004.
- Mastered Risk Management training concepts in accordance with ISO 14971. January, 2004.
- Developed quality system compliant with CMDCAS requirements. Successful registration March, 2003.
- ISO 13485:2000 two day training, BSI. July 7-8, 2003.
- Continuous training on QSIT through both industry and FDA, January-December, 1999.
- CE Marking for Medical Devices, MDD ‘98, Washington, DC; Washington Laboratories: May 5, 1998.
- Product compliance to the Medical Devices Directive (MDD) for CE Mark at 3 facilities; Feb., 1997.