Quality Assurance / Management Consultants

Eric Kimberling, MBA, is one of the most recognized and respected independent Enterprise Resource Planning (ERP) systems experts in the world, giving 100% unbiased advice to clients for more than 20 years.

Throughout his career, Mr. Kimberling has helped hundreds of high-profile enterprises worldwide with their ERP initiatives, including Nucor Steel, Petro Masila, the Yemen Government, the City of Charlotte, NC, Fisher and Paykel Healthcare, Kodak, Samsonite, Coors, Boeing, Duke Energy, Filson, and Lucent Technologies, and the Alaskan Native Tribal Health Consortium, to name a few. 

Mr. Kimberling has helped manage ERP implementations and reengineer global supply chains in countries as diverse as China, India, Singapore, Hong Kong, Australia, New Zealand, South Africa, Lebanon, and the United States. He has won numerous industry awards for his experience and contributions, including Supply Chain Pro to Know and Best Independent ERP Blog award from ERP Focus.

Consulting Services:

ERP Software Selection SAP, Oracle, Microsoft Dynamics, Epicor, Infor, and other ERP Systems Organizational Change Management Implementation Project Management Independent Verification and Validation

Project Recovery Merger and Acquisition Business Integration via Strategic Planning Business Process Reengineering Six Sigma Enterprise Strategy

Mr. Kimberling has dedicated himself to giving keynote speeches at industry conferences and universities worldwide, and has been quoted in thousands of articles in newspapers, magazines, and books, including the Wall Street Journal, CIO Magazine, and Fortune. He has authored, published, and presented more than 50 ERP articles and white papers, and is the author of Panorama’s series of ERP Reports, quoted in dozens of publications per year. He is also the author of the acclaimed book, “Lessons from 1,000 ERP Implementations.”

Mr. Kimberling holds an MBA with an emphasis in operational strategy and a Bachelor of Science in business administration from Daniels College of Business at the University of Denver. He is also Six Sigma certified and a certified practitioner of multiple ERP solutions, including SAP, Siebel, Oracle, Microsoft Dynamics, Epicor and Infor, among others. He has won numerous industry awards for his experience and contributions, including Supply Chain Pro to Know and Best Independent ERP Blog from ERP Focus.

View Eric Kimberling's Expert Witness Profile.

Summit Associates of Bedford is a Materials and Manufacturing firm offering growth strategy, operations improvement, and international sourcing to commercial clients ranging in size from $3 to $150 million.

Summit Associates has a record of fixing troubled organizations and driving growth in complex technology based operations. Skilled at positioning small and middle market companies for sustained growth, they have commercial experience in ten countries, including creation and oversight of global partnerships in Europe and India and acquisition, sale, and licensing of fifteen technologies in seven countries.

Consulting Services:

Turnaround Leadership Organizational Change and Alignment Accelerated New Product / Market Development Product Launch

Lean Manufacturing Technology Acquisition Sale and Licensing International Partnerships Technology Valuation

Principal, Thomas W. Caldwell, PE, has over 40 years of experience in Materials Research and Development, Process and Product Development, and Manufacturing Operations in the Precision Cast and Machined Products industry.

Mr. Caldwell has designed and manufactured components for consumer and industrial products, including safety-critical applications such as aircraft landing gear brakes, seat belt lockup devices, windshield wiper, and window lift motor systems. He has experience creating and guiding technology development and manufacturing partnerships in Europe and Asia, licensing and selling intellectual property and creating supply chains in China.

Mr. Caldwell has lectured in the USA, Germany, Switzerland, and India on manufacturing premium quality metal products and manufacturing processes, and was a technical paper peer reviewer for 20 years for the Society of Automotive Engineers. A United States patent holder, he has published peer reviewed research in electrochemistry and materials processing, and has written and spoken numerous times on the subject of Materials Selection.

View Thomas A. Caldwell's Expert Witness Profile.

Q9 Consulting partners with its clients to develop and implement effective risk management procedures to successfully commercialize and sustain safe and effective products. Q9 Consulting, Inc. was founded in 2007 by Mike Wakshull. The name originates from ICH Q9, Quality Risk Management for the pharmaceutical industry. Mike managed Corporate Quality Risk Management for Amgen, the world's largest biotechnology company. Mike's experience with medical device product risk management has focused on implementation of ISO 14971. Mike was a technical editor and primary contributor to the 2nd edition of the risk management chapter 11 of the Guide to the Project Management Body of Knowledge (PMBoK Guide). This is an ANSI and ISO standard for project management. He has contributed to the risk management chapter of the 4th edition of the PMBoK Guide.

Services offered include:

• Expert witness testimony
• Project Management Consulting
• Risk Management Consulting
• Project Management Training
• Risk Management Training
• Forensic Document Examination

In 1999 Mike wrote the first 4-day Project Risk Management course for Learning Tree International. In 2002 he presented 2 4-day risk management classes for PMI Seminars World. Mike teaches project risk management for the University of California at Irvine's Extension University. He wrote and presented globally the internal Product Quality Risk Management training classes at Abbott Vascular. Q9 Consulting, Inc. serves Southern California counties of Riverside, San Diego, Orange, San Bernardino, and surrounding regions. Work is accepted from all other locations. 

Areas of Expertise:

• Managing large information systems projects
• Project risk management
• Pharmaceutical product quality risk management
• ICH Q9
• Medical Device product quality risk management
• ISO 14971
• Training classes
• Public speaking

View Mike Wakshull's Expert Witness Profile.

Petroleum & C-Store Management Group® is a bonded and insured full-service Clerk Management & Operating Company, providing quality services to Gasoline Stations, Car Washes, and Convenience Stores with over 24 years of field experience in managing, operating, and designing innovative, efficient and profitable businesses.

Petroleum & C-Store Management Company® has competitive international purchasing power with major oil companies such as: Chevron, ConocoPhillips, Shell, Mobil, Texaco, Citgo, BP /Arco, Exxon, Valero, and unbranded refineries. They also have established relationships with convenience store distributors for purchasing beverages, groceries, candies, snacks, alcohol, automotive merchandise, health and beauty products, and more at discounted prices to benefit the facility.

Services Include:

• Full Employment Management - Employee training, cash registers, inventory, vendors, payroll, cash management, branding, accounting, permitting, and accounting
• Receivership - Bank receiverships, court receiverships, property management, strategic plan implementation and management preserve and enhance the value of the business
• Consultation - Management, operations, solutions, results
• Merchandising - In-store merchandising, stocking, product rotations, seasonal support

CEO, David Sinai, actively manages a ground team that works seamlessly with clients to enable a smooth take-over of facilities. These clients include banks, private owners, dealers, private investors, oil companies, and attorneys. He has managed and operated over 200 locations monthly, with totals exceeding 5,760,000,000 gallons of gasoline / diesel products and $2,936,000,000 of convenience store products. 

Mr. Sinai also manages the sourcing process (development of RFPs/RFQs, evaluation, negotiation, contract award) for material and equipment not covered by existing category management strategies.  He designed, project managed and built over 145 gas station and car wash facilities in North America, Canada, and Mexico    

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Mechanical Solutions, Inc. (MSI) provides new equipment design, computer-aided analysis, installed equipment field testing and problem solutions. MSI staff performs these tasks for all types of Pumps, Compressors, Fans, Turbines, and Motors. For pumps and compressors, expertise includes both centrifugal and positive displacement (e.g. reciprocating or screw) configurations.  Turbine knowledge and experience include hydraulic turbine generators (“hydroturbines”) as well as aircraft gas turbine engines and land-based gas or steam turbine power generation systems. Applications include green energy, power, process, petrochemical, paper, and water resource industries.

MSI uses advanced finite element analysis (FEA), rotordynamics, and torsional analysis tools, and uses computational fluid dynamics (CFD) to analyze 3-D steady or unsteady fluid flows and heat transfer, enabled by its 230 high speed processor supercomputer. MSI also uses top-of-the-line testing equipment, including multichannel FFT analyzers (up to 200 simultaneous channels) to accurately read the outputs of various vibration, stress/strain, and pressure sensors, as a function of both time and frequency. As a unique additional test capability, MSI uses motion magnification video cameras to amplify and display scene vibration by 1000x. MSI uses calibrated exciters while equipment remains running, to locate structural, rotor, and acoustic natural frequency resonances as they exist at any particular operating point, without interfering with machinery operation.  In addition, MSI performs stress, acoustic, dynamic pressure pulsation, electric current spectrum, and aero/hydraulic performance testing. 

MSI also has been project team leader in the development of advanced rocket turbopumps, as well as turbopump diagnostics, for the U.S. Air Force and NASA Marshall Space Flight Center. MSI is funded for several large projects with the U.S. Navy and Air Force involving vision-based systems that automatically evaluate and display/amplify machinery or system dynamic events.  As a result of these projects, MSI has developed its VibVue® vibration motion magnification system, which can magnify vibration 1000x in the full field-of-view of the equipment.  This system is available as a service, or for purchase.

Mechanical Solutions has a staff of approximately 30 technical professionals, many of whom are well known internationally in the area of pumps, compressors, and turbines.  For example, MSI’s Dr. Edward Bennett won the ASME Gopalakrishnan award for best pump fluids technologist, and was later awarded another ASME medal for CFD.    MSI’s Paul Boyadjis has won the Hydraulic Institute 2021 Standards Partner of the Year award. Since its founding in 1996, MSI has strived to provide best-in-class service throughout the world.

William D. Marscher has over 50 years of experience in the field of Fluid Systems and their rotating and reciprocating machinery, particularly large turbines, generators, compressors, and pumps.  His typical work responsibilities include design, analysis, and testing of all types of plant machinery, as well as other types of fluid and mechanical systems.   

Mr. Marscher received a B.S.M.E. from Cornell University in 1970, and a Master Eng. (Mech. Des.) in 1972, when he was a NASA Fellow and the lead graduate student for the original Mars Rover Design project.  In 1976, he received an M.Sc. in Engineering Physics from Rensselaer Polytechnic Institute. He is a registered and licensed Professional Engineer, State of New Jersey Lic. No. 40626.

For 25 years, Mr. Marscher has been one of the U.S. voting representatives on the ISO (International Standards Organization) TC108 committee, and has been the US Coordinator concerning, among other issues, machinery dynamics of centrifugal pumps and hydraulic turbine generators. He is past president of the Society of Tribologists & Lubrication Engineers (STLE), the primary technical society worldwide for the study and design of bearings, seals, wear, and erosion issues in machinery.  For the past 45 years he has been a voting member of the ASTM Fatigue Standards Committee E9, as well as the ASTM Wear & Erosion Standards Committee G2.  He is also the past Board of Directors Chairman for the Machinery Failure Prevention Technology Society (MFPT), and has been active in the Vibration Institute.   Mr. Marscher is a 23-year member of the Texas A&M Turbine-Pump Users Symposium Advisory Committee (essentially the Board of Directors for the Symposium).   For ASME, Mr. Marscher was Chair of the Predictive Maintenance committee, and was Organizing and Presiding Chair of the 1993 RoCon Rotating Machinery Conference and the 1995 Tribology Conference.

Mr. Marscher has written thirteen handbook chapters for various major engineering handbooks, which have focused on turbomachinery mechanical issues, including dynamics, and bearing and seal design   In previous employ, he was a senior engineer Pratt & Whitney Aircraft Engines, and Director of Mechanical Engineering for Worthington HQ (pumps, compressors, and turbines), and for Dresser Worthington Division after their acquisition of Worthington.   Later, he was VP of Concepts NREC, from which 30 years ago he spun off Mechanical Solutions, Inc. as an independent turbomachinery technology company.  He has since become a charter Standards Partner for the Hydraulic Institute (HI), the trade association for the pump industry, became Vice Chair of the vibration technical committee for HI, and was HI Standards Partner of the Year for 2018.   He also won the 2019 Vibration Institute MFPT Frarey Award for Diagnostics Excellence.

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mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

OUR APPROACH

We utilize the following three part approach to providing high quality services to our clients:

Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients

Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment

Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)

Rudolph Johnson, PhD, is a Chemical Toxicologist who brings over 25 years of experience bridging scientific leadership, program management, and strategic advisory work across government, industry, and international organizations. Early in his career at BASF Corporation, he managed the end-to-end development of high-margin industrial and pharmaceutical products, led competitive analysis and product lifecycle planning, and directed the scale-up of laboratory innovations into large-scale production — gaining hands-on experience bridging R&D, manufacturing, and market strategy across sites in Michigan, Massachusetts, and North Carolina.

Dr. Johnson has built a track record of high-level strategic and operational leadership, directing multimillion-dollar programs and budgets at the CDC, the US Department of Veterans Affairs, and the Wisconsin State Laboratory of Hygiene. He has developed laboratory facilities, operations, and laboratory networks. His international advisory experience includes work with the Organization for the Prohibition of Chemical Weapons (OPCW), the Biological Weapons Convention (BWC) and the United Nations. 

Domestically, he has advised the White House Office of Science and Technology Policy on multiple topics, the National Academy of Sciences, and the FBI, and has briefed senior government leadership including the President's National Security Council. This blend of private-sector business acumen and large-scale public and international program leadership positions him to advise organizations on strategy, regulatory navigation, and operational scale-up in complex, high-stagnant-stakes environments.

Consulting Services - Dr. Johnson's clients are those setting up technical operations or manufacturing a new product that requires chemical or toxicological support.

Consulting Expertise:

Strategic and Business Leadership Strategic Planning Product Lifecycle Management Competitive Analysis Market Strategy Industrial Scale-Up R&D-to-Manufacturing Translation Business Development Customer Engagement National Engineering Support Program & Operations Management Budget Management (multimillion-dollar)

Operations Management Laboratory Operations Interlaboratory Network Development Staffing and Logistics Standard Operating Procedures Resource Allocation Quality and Regulatory Assurance Leadership and Governance Funding and Grant Management International Collaboration Government Relations Crisis / Emergency Response

Siegfried Guggenmoos, B.Sc.(Agr.), P.Ag., Principal of Ecological Solutions, Inc. is a Professional Agrologist, with over 30 years of experience in the electric/gas utility corridor vegetation management business.

Mr. Guggenmoos has designed, implemented and provides assessments of utility vegetation management programs. In evaluating the prudence of vegetation management programs Mr. Guggenmoos has developed methodologies to assess their efficacy by predicting the impact of vegetation management program as practiced, on the future costs and reliability of electric systems.

Areas of Consultation:

• Storm hardening electric transmission and distribution systems to quantitatively manage tree-caused service interruptions
• Advise and develop protocols for assessments of power line tree exposure and mitigation
• Advise on least cost vegetation management by synchronizing economics and ecology
• Advise on impacts of vegetation management program alternatives, modifications
• Provide context for vegetation management, greenhouse gas mitigation measures in a competitive energy market
• Facilitate for management, staff, contractors and stake holders an actionable understanding of ecological principles and their impacts on vegetation management needs and costs
• Provide project management; expert review of programs and proposals
• Develop and advise on quantification, monitoring and verification of biotic greenhouse gas mitigation measures

Discovery Engineering is a private Engineering Firm based in Boulder, Colorado, performing investigations into Electrical, Electronic, and Communications Systems.  Discovery Engineering also works with management to analyze risk, improve quality, and understand variability processes.  Clients include industrial, commercial, research, legal, government, and private entities.

Mark McFarland, PE, Founder & CEO, is an Licensed Engineer and Statistician with over 25 years of extensive education and experience in applied statistics, statistical learning, artificial intelligence, electrical engineering, and communications. His practical experience includes the design, analysis, and testing of satellite, cellular, LTE, Internet, wireless, Wi-Fi, RADAR, networks, data communications, communication protocols, standards, public safety communications systems, GPS, instrumentation, and control systems. 

Mr. McFarland understands variability is crucial to improving and controlling processes.  He brings scholarship and practical experience in Statistics and Applied Research to help clients understand variability and improve outcomes.

Applied Research and Analytics Consulting Services:

Data Mining, Inference, and Prediction Quality Improvement and Control Risk Analysis Root Cause Analysis

Research Methods Experimental Design Statistical Engineering Electrical Investigations

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