Consultant Biographies - AQSN - A Quality Services Network

Bill is an operations consultant. He provides expertise for offshore manufacturing management, quality systems and Inventory control. He has guided remote manufacturing companies through new product development and Introduction from Intro to EOL. Bill has utilized ISO9000 criteria as the method of operation for all offshore manufacturing facilities. He has provided factory start-up instruction to factories in Ireland, Japan, Taiwan, China and the United States. Bill has more than 30 years experience in manufacturing operations from Printer Products, Hard disk drives, to Personal Computers. His latest assignment focused on cost reduction and Internet order entry procedures.

Included in his extensive experience, after receiving his BTEE from Oregon Institute of Technology, Bill was responsible for all stages of process test including; functional, download, configure to order and test equipment at OEM Portable Suppliers. He directed the inventory reduction program at the offshore suppliers facility-reducing inventory turns from 52 days to less than 10 savings of $5M annually were realized. He directed the inventory drop ship program, which required no more than a 3,000 DPM DOA level to succeed.

Bill was primary liaison with offshore suppliers for test suite, test specifications, process approval, problem resolution, and management of pre-production ramp schedule performance meeting deadlines and within budget. Bill managed turnkey supplier early ramp material for lead-time, cost, 2nd sourcing and availability. He Implemented state of the art innovations at overseas factories streamlining the PC assembly and test process from 24 hours to less than 8.

Bill was responsible for all stages of laptop computer products from definition, supplier selection, development, mass production through obsolescence. Working closely with the design team assessed components for ease of assembly and cost effectiveness increasing productivity and reducing product cost. Bill has completed 8 Portable Products starting in 1992 to the present. He deployed the above Laptop computer products to both OEM and domestic manufacturing facilities. Bill worked with the Portable Product Turnkeys international and domestic suppliers component sources on problem identification and resolution. He combined cross functional teams into a single team including design, materials, supply base managers, service and quality greatly reducing time to market increasing efficiency where by project cycle time was reduced from 18 months to 12 months.

Bill was responsible for directing a QA Department and providing for quality management activities. He implemented modern quality management methods and provided feedback to all levels of management to facilitate change. Responsibilities included Incoming Inspection, Process Audit, Quality Engineering and Reliability Engineering.

At Priam Corporation a manufacturer of state of the art Winchester hard disk drives Bill was Manager of Quality Assurance. Reporting to the Vice President of Operations. Responsible for organizing a QA Department and providing a direction for quality activities. Implemented modern quality management methods and provided feedback to all levels of management to facilitate change. Responsibilities included Incoming Inspection, Process Audit, Quality Engineering and Reliability Engineering. Implemented Quality training and certification program.

The quality of a product’s DNA is reflected as the quality of the product itself. The DNA, in a manufacturing environment, is the product’s documentation in the form of bills of materials (BOM), engineering drawings, specifications, procedures, work instructions, and other ancillary documents used in the manufacturing processes. Changes to the DNA can affect the manufacturing organization from supply chain to field support. Therefore, the change process must contain attributes that establish an audit trail of technical and business decisions. Document Control and Design Documentation Processes that conform to ISO or other industry standards are essential in developing and maintaining product DNA.

Sandy Casuga is an Engineering Documentation and Document Control Consultant in the A Quality Services Network, a network of quality professional resources specializing in Quality Systems, Supplier Management, and Customer Satisfaction solutions and implementations. His primary area of focus is working with clients to provide solutions to their quality systems relating to Engineering Documentation and Document Control in support of their corporate needs. The type of support provided, based on his background of over 30 years of industry experience in documentation and document control, includes customized new product introduction processes, engineering change processes designed to support the product at all lifecycle phases, and connections to product data management software implementation (Agile Software).

Sandy has provided his services to Varian Associates, ESL/TRW, Schlage Electronics/Ingersol-Rand, Corsair Communications, and Therma-Wave. The last 17 years, Sandy has managed a group of professionals in engineering documentation and document control.

Sandy’s experience includes implementation of new product introduction processes for captive and outsource manufacturing, development of change control processes for all product lifecycles phases, transition corporate documentation from paper to electronic data, and implementation of Agile Software as a PDM solution.

Team Based Problem Solver, General Manager, AQSN Business Process Improvement Manager for Costs, Profit, Customer Satisfaction, Cash flow from Renewable Energy Alternatives, On-time Delivery, Quality, Reliability.

NIGEL P.C. JOHNSON

An “end to end” strategic and tactical Supply Chain expert, embracing the notion of pragmatic “customer driven” holistic, business solutions with enabling supportive information system technologies. A talented team builder and a true believer in the critical role of continued learning and application of knowledge with a passionate and pragmatic “Vision to Action” approach applied to help customers, partners and employees. Very customer driven, supplier sensitive and drives for lowest total cost solutions best customer satisfaction solutions for Reclipse clients.

Previously, Founder and Chief Executive Officer of Eclipse Group Inc. (founded in 1994), a pragmatic end-to-end supply chain and global logistics professional services entity, headquartered in Silicon Valley, California. Eclipse held a constant place within the Top 50 fastest growing private companies in Silicon Valley and was the fastest growing professional services Company. Customers included Acer, Apple, Alcoa, Banta, BAX, DHL, Intuit, KLA, Phillips Medical, Tumbleweed as a sample set.

Educated in the UK, he served a 5-year technical apprenticeship with Wiggin Alloys (INCO) and earned a Higher National Diploma in Mechanical/Industrial Engineering and Information Systems. He earned a Management Services Diploma after 4 years of additional study.

Trained and mentored by some of the best thought and action leaders throughout his 30-year career with companies that include INCO, Rank Xerox, Diablo Systems (XEROX), Gavilan Computers, Visidata Corporation, Daisy Systems, Apple Computer, Inmac Corporation (now CDW), Eclipse Group Inc., Brocade Communications.

JANE DILLNER, C.P.M.

18+ years experience as a profit driven, business/functional Supply Chain Professional/Practioner with extensive global experience in “total cost of ownership” concepts supporting cost reduction and increased process efficiency. Utilizes well-honed analytical and communication skills with a talent for leading diverse cross functional teams in fast paced, challenging environments to streamline processes, accelerate efficiencies, reduce costs, and improve product quality. Supply chain career track record includes customer focus, supplier management, sourcing-global and domestic, outsourcing, procurement, strategic contracts, and materials.

Gary Zaro is a Quality Manager/Engineering Director with 30 years experience in quality and reliability engineering in production and new product development in diverse environments, including 16 years of Medical Device experience at Guidant Corp. He has an MS-Physics from San Jose State University, and is an ASQ Certified Quality Manager and Certified Quality Engineer.

As Quality Manager for Guidant Endovascular Solutions, Gary managed numerous quality programs, including evaluation of peripheral, carotid, neurological stent and embolic protection systems requiring CE Mark and Food & Drug Administration 510K approval and Investigation Exemption (IDE) submissions. He managed review and approval of new product development process validation and approved project risk analyses.

As Principal Quality Engineer for Guidant Endovascular, Gary completed a peripheral stent system project from concept phase to market release; he wrote the project risk analysis, quality plan, test methods, and filed test reports and protocols.

Earlier, as Engineering Director for Guidant Vascular Intervention, Gary managed evaluation of coronary stent systems requiring FDA Pre-Market Approval and Investigational Exemption (IDE) submissions. As Reliability Department head for Guidant Vascular Intervention, Gary managed evaluation of balloon dilatation catheters, guide wires, and accessories requiring FDA Pre-Market Approval (PMA), Investigational Device Exemption (IDE) and 510k submissions.

Gary’s earliest experience was in regulatory compliance, quality engineering and reliability engineering with Victor Technologies, Xerox, Acurex and Westinghouse Corp.

Most recently, Gary has been consulting in quality program management. Recent assignments included completing quality system corrective actions to close out audit action items and processing and investigating complaints for CryoVascular Systems.

Carl's expertise is in the development, implementation, and management of hardware test, quality control, and reliability-related programs. Throughout his 30-year career, Carl has spent much of his time working with Asian-based vendors. For the past 16 years, Carl has worked for Apple
Computer, based in California. In addition to working at Apple, Carl has also worked for Sun Microsystems, Daisy Systems, Corvus Systems, and Xerox.
Carl has received BS and MBA degrees.

Carl has performed and managed audits throughout the product design and build process including: manufacturing process, quality control, hardware test, reliability, field service, and repair depots. The majority of the audits were external to the Company, requiring extensive travel.

Reporting to the Director of Reliability Engineering, Carl developed a core reliability and continuation engineering team, responsible for the entire product life cycle of Apple's Imaging Division products (printers, scanners, and monitors). Carl provided the impetus to use the better suited Bellcore data and process for reliability predictions, and developed several statistical tools to assist the internal prediction process.

Carl developed and implemented a design margin test process, and a fundamentally different MTBF strategy that substantially reduced the amount of hardware and time required to quality product, and simultaneously improved product robustness and customer satisfaction. He developed a comprehensive test cross-functional plan and schedule, including all hardware and software activity, and has driven and tracked the completion of the tasks.

Carl was the cross-functional test leader and manager for all of Apple Computer products. Working with a team of 50 engineers, Carl provided a focal point to track and drive all hardware and software test activity, and corrective action, worldwide. Further, working with the field service organization, Carl used his expertise in formalizing the warranty prediction and spare parts depot inventory control process.

Carl was the reliability focal point for an entire portable computer division, which accounted for $2.5 billion in revenue. Within that division, Carl developed the reliability and testing paradigm for the entire product life cycle, developed test specifications, negotiated and coordinated test activity responsibilities. Carl implemented various reliability programs within the company, strategic manufacturing partners, third-party testing facilities, and vendors worldwide. Using this leveraged testing approach, Carl streamlined the hardware design and test activities,
and saved the company millions of dollars per year. The reliability of the portable products improved substantially, with the annualized failure rate dropping from 45% to 9% per year.

Carl lives in Bangkok, Thailand, and is available to travel worldwide.

Sentient Consulting Inc.

Global Supply Chain and Project Management, Six Sigma Implementations and Training,

Business Reengineering

Consulting for 15 years, Fred has excelled at re-engineering business and supply chain processes and concurrent information systems through cross-functional teams. Focused principally on the global Supply Chain, his approach to the project management phase has saved over $300 Mil. for companies mainly in biotech, high tech and regulated industries. His team approach uses Six Sigma, change management and empowerment tools at all levels. Fred has 30 years experience establishing and managing- global manufacturing, contract manufacturers, supply chains, and Quality and Materials organizations. Fred is a pioneer in establishing international facilities.

Consulting Achievements:

	Fitting Image – Supply Chain and project mgmt for a dental and medical design company using global contract manufacturing. Developed the project plan and managed the Asian sourcing effort for the CEO.
	Air New Zealand – Reengineered the supply chain for the maintenance function and materials operations focusing on outsourcing. Redesigned operations methodology in payload, fueling and crewing using 6 internal cross-functional teams.
	Kaiser Permanente – Redesigned the business and financial processes of $1 B in IT assets from planning to disposal using 5 internal cross-functional teams.Pacific Bell – Reengineered the processes from product development and sales through operations and support in the Call Management and IRV business ($30MM).
	Sun Microsystems – Developed and implemented a new process of Supply Chain management for global purchasing and qualification of externally purchased products.
	Inhale Therapeutics – Restructured purchasing and materials processes to meet cGMP requirements using a team approach. Key member leading team installing JD Edwards (JDE) MRP module including project manpower, capital, and expense tracking.
	Compaq– Program manager supporting 10 teams, developed project plan, schedules, timelines, milestones for the re-engineering of 5 supplier owned centers into three Compaq controlled international product centers; project manager for SAP and JDE implementation.

Corporate Achievements:

	Nektar Therapeutics – Managed purchasing and Supply Chain for pharmaceuticals and devices. Managed costs and authorized payments- of global contract manufacturers; $45 Mil for facilities construction, tooling and assembly vendors. Saved $2 Mil in European exchange rates. Restructured contracts in materials and services including software support saving $10 Mil. Completed two mock FDA audits and two ISO 9000 audits.
	Toshiba America – Managed quality and service for a $1Billion CD-ROM, floppy and hard disk division, including 4 manufacturing sites. Deployed a division-wide TQM and Quality Circle process. P&L and service strategy responsibility for service and configuration centers.
	Wyse Technology – Provided corporate direction and management for Asian facilities (3500 people). Developed Asian based manufacturing servicing global demand from $10 M to $1Billion. Managed the global Quality, Materials and Finance functions.
	Western Digital – Developed and imbedded the Six Sigma process throughout company of 10,000 at five sites. Overall governance of 80 cross-functional, self-directed teams in manufacturing, design and corporate functions saving over $100 Million.
	Kalok– Managed global contract manufacturers and materials and purchasing area into an effective supply chain. Restructured global vendor sourcing saving $10 million.
	Pfizer – Founded and managed a US plastics molding facility; and a Puerto Rican facility. Member of Warner Lambert’s and the industry-wide committee charged with responding to FDA initial Device Regulations developing cost and timing of compliance; member of the WL internal FDA audit response team.

Fred holds a M.S.in Management Science and Engineering from the Worcester Polytechnic Institute; a B.S. in Chemical Engineering, Plastics Specialty, from the University of Massachusetts; Certificate in Executive management from University of California.

Trained in Six Sigma methodologies at Motorola, and Quality Circles and Deming methodologies at Toshiba.

In addition to consulting, Fred has served as VP of Operations of Kalok Corporation, VP of Quality, Engineering and Continuous Improvement for Western Digital, VP Service & Quality for Toshiba America, Corporate Director of Quality, Manufacturing and Process Technology for WYSE Technology, Director of Operations for Miniscribe Corp and Director of Purchasing and Supply Chain for Nextar Therapeutics.

Fred completed certification through ASQ as a Six Sigma Black Belt (in Mar 05), completed the Project Management PMP requirements, completed the CCNA certification.