Quality Assurance / Management Consultants: 7

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

View Mark McFarland's Expert Witness Profile.

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

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)

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 19 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.

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. 

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

View David Sinai'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.

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.

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.