Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429, mobile: 513-484-2012, tpviggiano@zoomtown.com Executive Summary of Thomas Viggiano: Business acumen and a manager with a passion for manufacturing, operations management, purchasing - supply chain, and engineering with a master black belt in both lean and six-sigma. I help manage operations that increase profits to companies on average over $40,000,000 per year, every year for the last 20 years and lately much more. At times I have managed groups of over 400 people. Results: I have a proven track record of exceeding goals and increasing bottomline probability to about $40,000,000/year on average. I consistently make good decisions through a combination of business acumen, wisdom, experience, and good judgment. I am business acumen and have the ability to balance the delivery of programs against the realities of a budget along with good problem solving, project management, and creative resourcefulness. Sensei (a waste eliminator and profit generator) and Master Black Belt in both Six-sigma and Lean. I am skilled to help with the transitional experience of training, facilitating and mentoring of people and programs. Transforming waste to millions of dollars of increase profits. I am a United States of America Citizen. Education: Masters of Science in Operations Management (MSOM), Kettering University, Flint, MI, Graduated in 2003 with a GPA of 3.9 Masters of Science in Manufacturing Management (MSMM), Kettering University, Flint, MI, Graduated in 2012 with a GPA of 3.8 Bachelors of Science in Engineering (BSE) - Mechanical Engineering, University of Cincinnati, Cincinnati, OH, and Graduated in 1996 with Cum Laude honors with a GPA of 3.6 Associates in Applied Sciences (A.A.S.)- Mechanical Technology, Westchester Community College, Valhalla, NY, Graduated in 1982, GPA of 2.5 Experience Summary: Project Manager Sub-Section Manager Sr. Project Manager Sr. Program Manager Supply Chain Manager Master Black Belt Six-sigma and Lean Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com This is a one page resume: The following pages are supporting documents to the first page. “Increasing profits of companies by an average of over $40,000,000/year, and managing groups of over 400 people” Continued Experience Summary from first page: Business Analysis Sr. Efficiency Engineer Sr. Industrial Engineer Sr. Machine Design Engineer Intergraph, Pro-Engineering Sr. Mechanical Engineer Sr. Product Engineer LINDO and LINGO and MS Project Performance Engineer Quality Control Engineer Sr. Assembly Line Engineer Technical Writer CAD/CAM-SDRC IDEAS/CAEDS Designer/Draftsman Operations Engineering Cost Engineer Consultant Safety Process Engineer Reliability Engineer Asset Manager Finance Director Sr. Value Engineer Shainin approach Sr. Manufacturing Engineer Liaison Engineer Sr. Statistical Engineer Sr. Project Engineer Sr. Quality Assurance Engineer Risk, Issue and Opportunity Management Systems Management AutoCAD, Minitab Tool & Die Maker, Machinist Safety Engineering Consultant Cost Improvement Manager Cost Czar Commodity Performance Management Specialist Environmental, Health and Safety Engineer Complaint Engineer Work Experience: Tyco Electronics, TE Connectivity under contract November 2014 to August 2015 Middletown, PA Senior Quality Engineering, Research and Development to Production Consultant Managing the coordination of activities: Consultant in Advanced Quality Engineering and mentoring management at all levels at the client and their customers. Winner of New Innovation Award while giving Extraordinary Customer Experience (ECE). There was significant improvement in our Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com delivery times, lead times and responsiveness in order to exceed customer expectations every time. Help move a semi-production project from the research, development phase with in the United States to full production work in the China. Help train the China workers for the production phase of the project. At times worked as a Master Black Belt in Lean and Six-sigma and used many techniques to help expedite the program schedule at the lowest cost. The main plan is providing data analysis and developing designs for data communications, cable fiber optics and high speed cables for servers. Help within the design and development to production of the new products. I trained both the customers and the internal staff on Design for Manufacturing (DFM), Cost Reduction, Value Added and Non-Value Added, Irreversible Corrective Action (ICA), Advanced Product Quality Planning (APQP) approaches. • Review customer quality specifications. • Provide design input on critical dimensions and methods of inspection • Facilitate Failure Mode and Effect Analysis (FMEA’s) for Design & Process including periodic updates • Help develop error proofing techniques on all designs and processes. • Develop and maintain QIP’s for components and assemblies • Arrange for the design and fabrication of gages and inspection tooling. • Verify repeatability and reproducibility of measurements. • Provide data analysis and statistics summaries for parts produced on new tooling and help identify where process or tool changes may be needed to meet specifications. • Support process validation studies for special processes. Be a resource for design of experiments (DOE) and capability studies. • Evaluate suitability of inspection methods and recommend alternative devices to improve repeatability and reproducibility of measurements. • Perform gage studies on critical measurement devices. • Develop and facilitate plans to verify process performance when tools are transferred to an alternate manufacturing location. • Facilitate cause and corrective action responses related to customer complaints. • Support compliance to Quality Management policy (QS-9000 etc.) for new product introductions. • Provide special reports and data summaries as required by key customers to gain their approvals of new products. Measurement Capability and Analysis (MCA) and Correlation. Gauge Repeatability and Reproducibility (Gauge R&R) and Accuracy testing. Making chip to input output (I/O) cable assemblies with 25G per channel data transfer that involves data communication for end-customers with targeted high-end servers. Use JMP11 a statistical software package. Enterprise Resource Planning (ERP) System, SAP, GUI, Version 7200 Inspection Data Collection System (IDC) Increase profits and opportunities to over $93,423,000/year. Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Hill-Rom Inc. Under contract August 2014 to September 2014 Batesville, IN Complaint Investigation Engineering Consultant Managing the coordination of activities: Analyze design related complaints, evaluate product (component) returns, complete root cause analysis on returns, complete engineering investigations and write a technical report. Govern by: CHAPTER I--FOOD AND DRUG ADMINISTRATION (FDA), DEPARTMENT OF HEALTH AND HUMAN SERVICES. Use many Master Black Belt 6-sigma and Lean techniques to resolve issues. Used: People-soft, Agile, Product Life Cycle Management and IBM rational DOORS. Quality Assurance / Regulatory Affairs (QAC/RA), Corrective and Preventive Action (CAPA), FDA 21 CFR 820, ISO 9001, ISO 13485, ISO 14001,ISO 17025 and European Union Medical Devise Directive (93/42/EEC), Healthcare Canada Medical Device Regulations (SOR/98-282), Japanese Medical Devise QMS, Ministerial Ordinance No. 169 ad No. 2. Food and Drug Administration (FDA) Part 820 – Quality Systems Regulation – Subpart M – Records – 820.198 Complaints. Current Good Manufacturing Practice (CGMP). This is a medical device company. Help to avoid a Food and Drug Administration (FDA) shutdown and penalties of over $80,000/day. Increase profits an additional $32,000/day from other issues. Increase net profits gain of $112,000/Day. This is a gain profit rate of $40,000,000/year. The Doncasters Meco, Integrated Energy Technologies, Inc. Under contract Paris, IL May 2014 to May 2014 Quality Engineering Consultant Managing the coordination of activities: Prepares advanced quality planning documents and participates in quality planning activities; including Failure Mode and Effect Analysis (FMEA’s), Process Flow Diagrams, Control Charts, and Gage Repeatability and Reproducibility (Gage R&R) and capability studies. Using Epicor software to manage projects. Performs technical and statistical investigations and analysis on production, quality, process, and equipment issues using standard NAL problem solving method Coordinates the resolution of quality issues and implementation of countermeasures with other NAL departments and suppliers Serves as the primary liaison between NAL and customers on all quality related issues Performs other duties as assigned o Technical knowledge in statistics and/or QC tools inspection methods o Computer Aided Design (CAD), Geometric Dimensioning and Tolerancing (GD&T), and Advanced Product Quality Planning (APQP) Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com International Traffic in Arms Regulations (ITAR) Export Administration Regulations (EAR) Foreign National Export License Help to regain access to self-release parts and increased profits over $600,000/year. The Coca Cola Company Under contract Atlanta, GA Manager, Reliability Engineering Consultant October 2013 to February 2014 Manage the coordination of activities with The Coca Cola Company and vendor’s base out of India and others. Manage the design and reliability of new equipment and be the liaison manager for the company. Manage consultants, designers, engineers and coordinators. Product Implementation Manager. I am a Master Black Belt in Lean and Six Sigma using the skill-sets: Design of Experiments (DOE), Design for Six Sigma (DFSS), Reliability, and Statistical Process Control (SPC) statistical analysis on this project. Worked with New Product Development (NPD) and Integrated Product Development (IPD) Teams. Build Reliability block diagrams and reliability predictions, reliability testing and field failures analysis. Design Failure Mode and Effect Analysis (DFMEA) and Reliability Allocation: Agree Method, ARINC apportionment method, equal apportionment method. Product Life-Cycle Management (PLM, PLCM), Change Management (CM). Unit shall be in accordance with applicable safety and regulatory requirements (2006/42/EC for the EU) and risk assessment per EN12100. Manage the cost, time and deliver of the project. I preformed data analysis to estimate and then generate risk analysis. Govern by: CHAPTER I--FOOD AND DRUG ADMINISTRATION (FDA), DEPARTMENT OF HEALTH AND HUMAN SERVICES. Used Windchill. I helped saved $150,000,000 in issues and opportunities in service reduction by redesigning the units with irreversible corrective actions and in cost reduction of high risk issues. Xerox Under contract April 2013 to June 2013 Middletown, OH Environmental, Health and Safety Process Engineering Consultant Assist in developing the process for the warehouse manufacturing operations to obtain a Responsible Recycling (R2) certification building on the existing ISO14001 documentation already in place. Work to the BS-OHSAS-18001 and ISO-18001 Occupational Health and Safety Management Systems Requirements. Create an Environmental Health and Safety (EHS) Management System (EHSMS). Design processes and equipment related to the creation of products or services that are cost effective and in keeping with the given budget. Work life cycle management including end of life management programs. Implement process designs, creating prototypes, testing, making necessary modifications where required and commissioning the process. Help address the Heating Ventilation and Air-condition (HVAC) systems and lighting systems issues with in the facility. Assess environmental health and safety requirements Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com and ensure that these are integrated into the process. Work closely with other professionals such as upper management, scientists and other engineers on development and research projects. Integrate new technology or environmentally friendly practices into existing processes. Ensure Product Life-Cycle Management (PLM) (PLCM). Used Master Black Belt (MBB) Lean Six-sigma approaches: Define Measure, Analyze, Improve and Control (DMAIC): A standard approach for re-engineering existing processes. Overview examples are shown below. Define Measure, Explore, Develop, and Implement (DMEDI): Ideal for optimizing new processes. Design for Lean Six Sigma (DFLSS): Used, with specialized tools, for customer-driven design of new technologies and services. I facilitate Kaizen events that produced estimated cost of savings of about $400,000/year. Spirit Airways under contract Kinston, NC Program Manager January 2013 to February 2013 Program Management: Working within the Aerospace industry using earned value management (EVM), and Microsoft project systems. Manager - Product Implementation, Project Managers and Program leads. Projects are using composites and aircraft assembly for Airbus 350 products. Production, supply chain, value engineering, cost engineering, quality, Lean, Six-sigma and contracts are the prime areas of focus. Also leading the staffing teams for the programs that are issues and working with Human Resources to resolve them. Clean room: Airbus Specification: AIPS03-02-019 Control Contamination Area Requirements. EN ISO 14644-1, Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness. EN ISO 14644- 3, Cleanrooms and Associated Controlled Environments – Part 3: Test Methods. AIMS 1200-000 Ancillary Materials Type A and Type B. They make use of a 4 square charts: picture, situation, target and proposal. Work to help reduce estimated projected losses of $1,500,000,000 worth of issues for life of the program. We facilitate Kaizen events: workshops, deep dives, design changes and proposals which yielded a target estimated increase in profits and opportunities of over $1,500,000,000 for the life of the project. United Technologies Corporation, Corporate Headquarters (Third time) under contract September 2012 to November 2012 Farmington, CT Commodity Performance Management Specialist Work on a series of high level high priority projects. Contract Lifecycle Management Planning, Sourcing Process, Passport (gated review) Process, Factory Executive Leadership Council Planning, Factory Ops Council Planning, Senior Supply Review Board (SSRB) Document and Process Management, Supply Management Analytics, Financial Planning and Analysis, Change Management, New Initiative Planning, Project Management, Communications, Leverage Available IT Solutions, Performance Tracking Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com and Reporting, and Market Feedback Analysis. Planning and Organizing: structures, staffs and plans work effectively to meet program requirements. Lay out the form of the organization (team structure) that is needed to execute the program, and identifies the key people for the core team. Involve key players in front end planning (e.g., manufacturing, marketing, suppliers, etc.). Anticipate changes in program requirements over time and adjusts program staffing to meet these requirements. Scopes programs and sets accurate expectations to ensure success. Understands the critical skill and ability requirements of key jobs and matches the right people to these assignments. Communication Skills: expresses ideas effectively to establish self as a credible and capable leader. Actively listens to what others are saying in order to understand situations, issues or problems from their perspective. Communicates with program partners, teams, customers, and senior management on a frequent basis to keep them informed on what's happening with the program. Solicits and considers the input of critical team members before making key decisions. Facilitate communication among key people across project teams and functions within the program. Use simple graphics that capture the essence of a complex system or structure when communicating. Analytical Thinking: takes a systematic and logical approach to analyzing problems. Break down large and complex tasks into manageable tasks and milestones. Ask incisive questions to surface key issues or information needed to make decisions. Insist on objective evaluation of situations by focusing on facts and data rather than subjective feelings and opinions. Clearly identifies the critical path requirements and dependencies at the front end of the program. Drive relentlessly to find root causes. System Thinking: understands the complex interrelationships of the multitude of factors affecting system structure and performance. Identify the most important priorities in the context of all the technical, financial, schedule, organizational, political, people and customer issues that exist at any given time. Able to cognitively manage the complexity of details about the program and the people working on it, without getting bogged down in the details. Set priorities on problem-solving (e.g., solutions that solve multiple problems) based on understanding the entire system and its interdependencies. Understands how the component projects affect and fit in with each other in a complex program. Stay focused on the broad array of system issues and problems while surfacing and addressing short-term (or most visible) problems/issues. Global General Procurement, Non Product Commodity Performance: Energy, Plant consumables, Facilities, Office Products, Gas Chemicals. Management Tools: Risk analysis, Strengths, Weaknesses, Opportunities and Threats (SWOT) and Achieving Competitive Excellence (ACE). Target estimated increase in profits and opportunities of over $120,000,000/years. Boeing Company Second time under contract Everett, WA Project Management and Lean Consultant July 2012 to September 2012 Conduct a research and design study for communicating objectives and scope for the 787 Final Assembly program for a consulting group. Perform manpower analysis with Human Resources and Industrial Engineering. Conducted surveys with program Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com management: Superintendents, Human Resources, Industrial Engineering and Lean managers. Experience in project management and strong in workload management. Benchmarking Oobeya rooms: strategy, risk, opportunities, issues and lessons learn within Program Management and Final Assembly Management. Help to mentor many managers and engineers and others with the teaching of: master black belt in lean and 6sigma techniques with an emphasis on risk management and risk mitigation for assembling aircraft 787 Program. Help development of plans in order to minimize or eliminate potential adverse program impacts. We facilitate Kaizen events that target estimated increase in profits and opportunities of over $300,000,000/year. Humana Corporation, RightSource under contract August 2011 to February 2012 West Chester, Ohio Manager, Project Manager Job Description: Project management: collaborate with internal teams to develop project objectives, business requirements, financial feasibility studies and deliverables. Manager of Product Implementation, Project Managers and Program leads. This is within the Advance Manufacturing Systems group. One of the projects was to create an Over the Counter (OTC) operations mail order factory. I developed a financial supply curve for a supply and demand diagram, for their new Over the Counter (OTC) factory. This helps directs marketing and sales to know where the loss, break-even and profit prices will be and to find the maximum price point to yield the maximum profits. I also developed a feasibility study for the new OTC factory. They were on a course of losing over $4,000,000/year before I presented them with the supply curve and financial feasibility study. Created and maintained project schedules, developing project plans, risk management, estimating time requirements, allocating resources, establishing deadlines and monitoring milestones completion. Track all phases of the project lifecycle and provide timely reporting of issues that impact project progress. Pro-actively coordinate actions and resolve conflicts and/or remove obstacles as necessary. Work with business users to integrate new technologies and applications into operations and redefine and streamline processes as necessary. Develop and maintain relationships with internal and external customer. Co-author of technical specifications with developers to create value streams. Conduct project meetings and provide central point of contact for assigned projects. I developed a business model: Supply and Demand Charts for the new plant wide, of over the counter items. Develop implementation templates that allow for standardized and repeatable processes. Serve as subject matter expert on all assigned projects using my Master Black Belts in Lean and Six-sigma techniques. Address the Heating Ventilation and Air-condition (HVAC) systems and lighting systems and power systems issues with in the new facility. Experience in project management and strong in workload management. Execute troubleshooting on systems to drive resolution and prevent future issues. Obtain buy-in from user base by incorporating their inputs and keeping them updated on progress and changes. Humana RightSource is a medical, pharmaceutical, pharmacy, Rx, mail order and over the counter direct orders company. Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Govern by: FOOD AND DRUG ADMINISTRATION (FDA), DEPARTMENT OF HEALTH AND HUMAN SERVICES. Projects worked on are over $20,000,000. John Maneely Corporation (JMC) Steel Group, Wheatland Tube, Atlas Tube under contract March 2011 to May 2011 Warren, OH Safety Engineering Consultant, Project Engineering, Master Black Belt Lean and SixSigma, Responsible for safety engineering, improvement and cost savings projects at multiply plants in Ohio and Pennsylvania. Work within the Environmental Health and Safety (EHS) group. Help reduce cost while improving safety. Reduce issues, by improving their Sorting, Simplifying, Sweeping, Standardizing, and Self-Discipline (5S), issues. Increase the Return on Investments (ROI): Created and completed tasks using Safety Management System (SMS) Intelex, Software and Risk and Hazard Assessment Reports. Summary Plans, directs, and implements organization safety program at the plant to ensure safe, healthy, and accident-free work environment and is involved with establishing, promoting, and maintaining the plants security and property protection programs by performing the following duties: Leads plant investigation of accidents and injuries and cooperates in the preparation of material and evidence for organization use in hearings, lawsuits, and insurance investigations. Inspects the plant to detect existing or potential accident and health hazards, determines corrective or preventative measures where indicated, and follows up to ensure measures have been implemented. Work with management and the United Steel Workers (USW) Union. Directs activities of workers involved in safety programs at the plant level. Plans and implements plant safety policies and procedures in compliance with local, state, and federal Occupational Safety and Health Administration (OSHA) rules and regulations. (29 CFR Part 1910) Plan and implement programs to train managers and employees at the plant in work site safety practices. Address the Heating Ventilation and Air-condition (HVAC) systems and lighting systems issues with in their many facilities. Prepare plant studies and analyses of industrial accident causes and hazards to health for use by company personnel and outside agencies. Works with Managed Care Organization (MCO), third party administration (TPA), and Bureau of Workers Compensation (BWC) on handling of injury claims. Estimate cost of savings of about $2,200,000/year. General Electric Energy, Aero Energy. Fifth time under contract July 2010 to November 2010 Houston, TX Cost Czar, Cost Engineering, Master Black Belt Lean and Six-Sigma, GE Advanced Programs within GE Energy Packaging. Cost Czar. Responsible for costing activities associated with advanced programs aeroderivative gas turbine and generator package systems, and auxiliaries. Balance Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com component cost out opportunities against reliability, availability and maintainability targets. Drive and coordinate costing activities and deliverables across various systems and perform trade-off analysis for overall cost optimization. Evaluate and process various cost out proposals from each system owner ensuring accuracy of estimate and communicate interaction of change as it relates to other systems. Communicate effectively with all system leads for idea generation, cost input as well as to update on impact of change to other systems. Ensure cost out effort is executed using sound engineering principles and adheres to business standards, practices, procedures and product/program requirements. Provide cost out suggestions/advice to system owners and drive them to look at all possible alternatives. Coordinate all engineering cost out efforts with sourcing and supply chain to ensure alignment. Work with sourcing and suppliers to identify all possible cost out ideas and work with the systems owners to implement. Provide costing support to systems owners and others within the Engineering teams. Make recommendations based on preferred solutions utilizing analytical costing tools. Performed cost optimization, component selection and design to cost methodology to set product cost. Work with electrical and mechanical components related to gas turbine Package systems and auxiliaries or equivalent. The scope includes fuel systems, water injection systems, lube oil systems, hydraulic systems, air inlet treatment, structures, enclosures, generators, piping, cabling, junction boxes, etc. Experience working with multi-disciplinary engineering teams, technical experts and specialists, suppliers and manufacturing personal to draw out and implement best cost out ideas. Use AutoDesk, Enovia, COGNOS, Kronos, AutoCAD and Foxtrot and Oracle an Enterprise Resource Planning (ERP) system. I have strong written and oral communication skills, interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. I have strong familiarity with manufacturing techniques and experience using cost out tools/ methodology. Target savings were over $18,000,000/year. CompuCom Company Under contract February 2010 to February 2010 Blue Ash, OH Project Management Specialist Project Description Master Black Belt in Lean and 6-sigma working in a Project Management Specialist position. Serve as a change agent and mentor for management. Maximize project results in their Performance Management System. Work in the deployment depot evaluating the processes and performing process mapping. Responsible for ensuring the customer (General Electric Medical division) needs are satisfied by providing specific deliverables. Ensure good practices in standard methodologies and processes are used to deliver an integrated solution. CompuCom is an IT solutions company. Found and suggested $330,000/year savings while lowering risk. Accomplishments: The major emphasis is the coordination of tasks. Perform computer programming, software development, systems analysis, professional engineering, consulting and technical writing. This position serves as a single point of Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com contact and acts in a liaison capacity to facilitate problem resolution and technical developments. Rolls Royce Aerospace Company Under contract October 2008 to December 2008 Indianapolis, IN Cost Engineering, Master Black Belt Lean and Six-Sigma, Operations Engineering Cost Improvement Management Project Description Cost Engineering working within the Operations Engineering Cost Improvement team. Program Manage the Integrated Product Teams (IPT) to design, verify and enable validation of the components and systems to achieve customer requirements and cost targets. Support the aircraft turbine engine development program and manage change, throughout to production readiness. Program Planning and Control (PPC) and Financial Control (FC) tools and procedures. Coordinated cost savings using international efforts with United Kingdom, Germany, Italy, China, the United States of America and others. Accomplishments: Ensure that the design definition process follows the design to target cost process. Management and technical corporation easements, from systems to specification, design to manufacturing. Assesses risks and opportunities identified, translates into cost risks and opportunities and based on this influence decisions to minimize life cycle cost. Develop component life cycle cost program for all stages of product life cycle with all relevant parties (e.g. Program, Finance, Purchase, Service Organization, etc.) Evaluate and assess the new aircraft turbine engine performance and its cost to their requirements. Estimated savings from loss prevention where: $3,300,000/year. Project Technologies Master Black Belt, Design for Six Sigma (DFSS) and Elimination of Non-Value Added Activities and More. The Design for Six Sigma is a team-based program designed to achieve business results and provide a framework in which to think and design in a statistical manner. Plan and facilitate Design for Manufacturing (DFM). Used Enterprise Resource Planning (ERP). Boeing Company First time under contract May 2007 to September 2008 Everett, WA Program Manager and Systems Engineer Project Description Program management role, manager of risk, opportunities, issues and lessons learn within Program Management and Systems Engineering management. Manage Product Implementation, Project Managers and Program leads. I mentored many managers and Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com engineers and others with the teaching of many Master Black Belt techniques with an emphasis on risk management. Program Management and Systems Engineering, perform risk management and mitigation planning, which includes performing risk and opportunity management addressing critical technical, cost, schedule and performance parameters and development of mitigation plans in order to minimize or eliminate potential adverse program impact. Support Program, Project, Technical and Finance Management. Develop and manage requirements, which include the identification and definition, integration and prioritization, documentation, allocation and flow-down (with linked trace ability) of product-level, stakeholder, and regulatory requirements. Plan, organize, and monitor information that affects product design (e.g., Customer Integration Integrated Product Team (CI-IPT), customer needs, regulatory requirements, performance, cost constraints, Boeing Production System (BPS) enterprise capability and capacity). Synthesize, integrate and manage design interfaces, which include formulating, synthesizing and assessing alternative system architectures consistent with requirements and product strategy. Conduct requirements validation and verification of design solutions, which involves validating that customer needs, requirements, expectations, and constraints as expressed in the established requirements and architecture are satisfied through the use of incremental reviews, demonstrations, and operational tests. Work IT Project Management. In part I worked on the Heating Ventilation and Air-condition (HVAC) systems and lighting controls systems issues for both the assembly of the planes and within the planes. Help in building the automation technologies of building the planes. Verify design compliance and ensure safety and quality by conducting and documenting tests, demonstrations, simulations, analyses or inspections. Accomplishments There was an estimated savings of over $60,000,000/year while reducing risk in the process. Reduce cycle time of building airplanes. I received many awards: Achievement Award, Accomplishment Award, Appreciation Award and Exceptional Performance Awards and others. Resolve quality issues and reduce cost. Incorporated a Lessons Learn Database within Boeing. Experience in project management in application support and strong in workload management. Project Technologies Master Black Belt Six-Sigma and Lean approach. I used and taught Boeing Opportunities, Risk and Issues System (BORIS). Taught Irreversible Corrective Actions techniques Taught Root Cause and Corrective Action techniques Increase customer enthusiasm. MS Office (Outlook, Excel, Access, Word, and PowerPoint), MS Project, MS Visio BAE Systems Second time under contract Minneapolis, MN February 2007 to April 2007 Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Business Analysis Project Description Business Analysis, using a Master Black Belt approach to improving processes from: Product Development to: Production. Systematically gathering, analyzing and documenting business requirements for moderately complex systems. I was working within Systems Engineering within Armament Systems Division. Military projects. Accomplishments Develop and document a management system that will release to manufacturing. Anticipate, research, identify and develop solutions to customer problems. Act as a liaison between customers and their support groups to identify business process, systems, and information systems. Develop business processes, quality and engineering services tools. Initiate measures to eliminate non-value-added activities through process improvement. There was an estimated savings of over $16,000,000/year while reducing risk in the process. Develop Statements of work (SOW). Used Critical Path Method (CPM) Project Technologies Used: Master Black Belt 6-sigma, process approach. Product Lifecycle Management (PLM) Ensure deliverables to customers. Naval Surface Fire Support (NSFS) Light Towed Howitzer (LTH) Massive Ordnance Penetrator (MOP) Program level Systems Requirements Document (SRD) and program level Statement Of Objectives (SOO) MS Office (Outlook, Excel, Access, Word, and PowerPoint), MS Project, MS Visio PACCAR Inc. Under contract June 2006 to December 2006 Cincinnati, OH Sr. Quality Engineering Consultant Project Description Sr. Quality Engineering Consultant, using a Master Black Belt approaches to improving projects. I observed vendors performing first article inspections, verification validations, and Production Parts Approval Process (PPAP) audits. PACCAR is a truck manufacture company and the parent company of Peterbilt Motors Company and Kenworth Truck Company. Accomplishments Anticipate, identify and develop solutions to customer problems. Act as a liaison between the quality, engineering, customer and vendors. Identify quality process, problems and solutions. Reduce risk of non-conforming parts. Project Technologies Used: Master Black Belt 6-sigma, process approach. Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Ensure quality deliverables to customers. Consolidated Edison Inc. Under contract October 2005 to May 2006 New York, NY Finance Specialist Director Project Description Finance specialist Director, Asset Utilization Manager and Business Analysis position. Work as a project specialist using probabilistic, statistical and reliability system analysis along with financial components to create an asset management system for asset utilization. I’m a master black belt and manager in a role using reliability, engineering, financial and management skill sets at a utility company: electric, steam and gas. Accomplishments: Develop and document a management system algorithm that will provide a process based on asset performance to prioritize capital funding. Optimize asset utilization, along with predictive failures analysis and equipment replacement for reliability improvements. Help prevent system failures in management by using Design for Six Sigma (DFSS) Probabilistic, statistical, reliability, algorithm and asset management to save about $32,000,000. Project Technologies Used an asset management, master black belt, and reliable approach to ensure deliverables from outside consultant firms are accurate, completed and timely. Honeywell Aerospace, Sixth time under contract February 2005 to September 2005 Phoenix, AZ Manufacturing Integration Engineer Project Description Manufacturing Integration Engineering, and Master Black Belt, Risk management at a turbine engine manufacturing company. Presented white paper to the Material Review Board (MRB), and develop Statements of Work (SOW) Accomplishments Found and saved over $37 Million of cost savings at risk. I help increased reliability while reducing cost. Worked with the Material Review Board (MRB) and created engineering white pages for the Material Review Board Manage supply chain local, international and worldwide. Wrote a few Export license Manufacturing License Agreement (MLA) and Technical Assistance Agreement (TAA), Amendment Data Collection, ITAR, and conforming to Arms Export Control Act. Project Technologies Master Black Belt skills, Design for Six Sigma (DFSS) are a team-based program designed to achieve business results and provide a framework in which to think and design in a statistical manner. Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Resolve quality issues and reduce cost. Used Enterprise Resource Planning (ERP) software tools. Mentor six sigma black belts and green belts Used risk management to reduce the risk, which prevented millions of dollars of waste. MS Office (Outlook, Excel, Access, Word, and PowerPoint), MS Project, MS Visio Goodrich Aerospace a United Technologies Company Second time under contract June 2004 to January 2005 Dublin, GA Supply Chain Management Manager Expert Project Description Supply Chain Management Manager Expert, International working vendor management and procurement. Work with primary actuation, systems suppliers, which should deliver quality systems on time to Airbus. Work closely with Parker Aerospace for their servovalves, Rexnord and other vendors. Develop Statements of Work (SOW) Accomplishments Help prevent $500,000/day late shipment charges. Work with management in teaching Design for Six Sigma (DFSS) First Article and procurement activity I helped increased reliability while reducing cost in manufacturing. Management and technical corporation assessments, from systems to specification, design to manufacturing. Project Technologies Master Black Belt, Design for Six Sigma (DFSS) and Elimination of Non-Value Added Activities and More. Champion in manufacturing excellence leadership. Mentor six sigma black belts and green belts. The DFSS is a team-based program designed to achieve business results and provide a framework in which to think and design in a statistical manner. MS Office (Outlook, Excel, Access, Word, and PowerPoint), MS Project, MS Visio Pratt and Whitney a United Technologies Company First time under contract October 2003 to April 2004 East Hartford, CT Supply Chain Management, Sr. Program Manager Project Description Supply Chain Management, Sr. Program Manager, process assessments of suppliers of both local and international procurement. A Master Black Belt (MBB) Achieving Competitive Excellence (ACE): evaluator, trainer and mentor. Accomplishments Design for Six Sigma (DFSS) Found over $12 million of savings. Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Project Technologies Using Master Black Belt, Design for Six-Sigma (DFSS) and Elimination of Non-Value Added Activities and More. I was train in Achieving Competitive Excellence (ACE) and champion manufacturing excellence leadership while working in procurement. The DFSS is a team-based program designed to achieve business results and provide a framework in which to think and design in a statistical manner. This material helps you learn more about your designs, and combines the basic Black Belt tools. DFSS is a systematic methodology to manage variation in the product design process so all customer expectations can be met and so the product can be produced at 6s quality levels. Honeywell Aerospace Fifth time under contract October 2002 to September 2003 Phoenix, AZ Sr. Program Engineer Project Description Sr. Program Engineer, Master Black Belt, Design for Six Sigma (DFSS) and Elimination of Non-Value Added Activities, Material Review Board. (MRB), Develop Statements of Work (SOW) When I first came to this facility they had issues with making turbine components. The machines were repeatable to 0.0002 inches and the engineer proved it with Statistical Process Control (SPC). The problem was putting out product with errors as much as 0.010 out of specification. After reviewing the process and machines outputs: I review the tooling and found the tooling was not in control. We put in place requirements of Cp of 2.0 or better and Cpk of 1.75 or better for the tooling. This change saved over $12,000,000 in scrap. Accomplishments Design for Six Sigma (DFSS) Found over $24 Million of savings at risk. Material Review Board. (MRB) Created engineering white pages for the Material Review Board Project Technologies The DFSS is a team-based program designed to achieve business results and provide a framework in which to think and design in a statistical manner. This material helps you learn more about your designs, and combines the basic Black Belt tools. DFSS is a systematic methodology to manage variation in the product design process so all customer expectations can be met and so the product can be produced at 6s quality levels. General Electric Aircraft Engines Forth time under contract June 2001 to Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com January 2002 Cincinnati, OH Consultant - Performance Engineer Project Description Consultant - Performance Engineer, Design for Six Sigma (DFSS) and Elimination of Non-Value Added Activities Accomplishments Design for Six Sigma (DFSS) Found over $24 million of savings. Project Technologies The DFSS is a team-based program designed to achieve business results and provide a framework in which to think and design in a statistical manner. This material helps you learn more about your designs, and combines the basic Black Belt tools. DFSS is a systematic methodology to manage variation in the product design process so all customer expectations can be met and so the product can be produced at 6s quality levels. Performance Engineer and Numerical Propulsion System Simulation Engineer. Coordinating efforts for performance and certifications of turbine engines, for the Aircraft Engine Business Group. Design for six-sigma. Support multiple engine programs, liaison engineering, certification and reliability. Technical writer: to help write the Federal Aviation Regulations (FAR) reports. Created FAR-25 and FAR-33 reports. Supporting National Aeronautics and Space Administration (NASA) and commercial turbine engine programs. Used MS Project to manage projects. $24,000,000/year savings project. Paxar Under contract April 2001 to May 2001 Dayton, OH Sr. Statistical Engineer and Consultant Lead, train, and mentor the current staff and implement statistical methods to reduce waste. Create a lean process with quality products. Optimize processes with current equipment and suggest advance manufacturing methods and equipment. Using Minitab (statistical software), and Statistical Process Control (SPC) techniques. Design for six sigma, control charts, process improvement cycle and process control, and process measurement systems analysis etc. Estimated findings of cost savings to be more than $2,320,000+/month. Harley-Davidson Motor Cycle Company Under contract June 2000 to December 2000 York, PA Sr. Assembly Line Engineer, Consultant and Master Black Belt Six Sigma and Lean. Coordinate the implementation of equipment for current and new generation of Softail motorcycle line. Help to optimize assembly lines and mentor the current engineering Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com staff. Maximize utility using Design for six-sigma and lean manufacturing concepts. I helped create over 300 Continuous Improvement events (Kaizen events) that saved over 7,000,000/year. Increased safety and reliability while reducing cost and improved the first run operations by more than 40%. Improve lighting systems and mounts. Help in building the automation technologies of building the motor cycles. Ergonomic engineering to reduce ergonomic and safety cost. Estimate budgets. Estimated cost savings of more than $7,000,000/year. Praxair Trialigaz Ozone Company Under contract March 2000 to April 2000 Cincinnati, OH Project Engineer Consultant Coordinate the implementation of Ozone equipment for a water treatment project. The Two-treatment plants are in the Las Vegas area. The average project is about $13,000,000 per project. Ozone is used to purify the water for drinking and other uses. Estimated cost savings of more than $100,000/month. Formica Corporation Under contract January 2000 to February 2000 Cincinnati, OH Engineering Consultant Value Engineering, working to reduce and eliminate scrap, increase production rates and a focus for on time deliveries to customers. Suggesting ideas for the other sister plants in California and Canada with similar process to reduce scrap waste and increase their productivity as well. Gave them some advance technology breakthroughs for their processing areas within their manufacturing area. Estimated cost savings of more than $2,000,000/yr after implementation. Navistar International Transportation Second time under contract May 1999 to December 1999 Springfield, OH Sr. Industrial Engineer / Consultant / Master Black Belt Working in the Advance Manufacturing Engineering Group. Closed and consolidating assembly plants and re-engineering their facilities to maximize utility using and lean manufacturing concepts. Incorporated ergonomic and engineering cost reduction methods to reduce millions of dollars within ergonomic and safety cost. Gave them technology breakthrough in manufacturing process improvements, design for six-sigma and in product design. Increased: safety and reliability, while reducing cost. Estimate a saving of more than $7,000,000/yr. Develop Statements of Work (SOW) Clippard Instrument Laboratory May 1998 to April 1999 Cincinnati, OH Sr. Machine Design Engineer / Consultant Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Tool, test equipment, machines design engineering. Workings to reduce scrap and promote value engineering. Within the first 3 months, I've completed over 50 projects to reduce time cycles and improve ergonomic conditions. This has lead to average time reduction savings of more than 20% per job. General Motors, Truck Group, Moraine Assembly Third time under contract May 1997 to April 1998 Moraine, OH SR. Project Manager / Engineering Consultant Work in the Plant Support Consulting Team, directing problem-solving efforts using statistical engineering techniques, and design for six-sigma. Shainin, Deming, DOE, DFSS Facilitate engineering changes and implement a quick fix and then permanent resolutions. Facilitate trial run-on new parts and new processes. Help in building the automation technologies of building the vehicles. In part I worked on the Heating Ventilation and Air-condition (HVAC) systems and lighting controls systems. Support variation reduction activities, and process improvements. Identify customer concerns and evaluate concern resolution for both the customer and the process. Gave them advance breakthrough in technology within design and manufacturing process improvements. Average a savings of more than $12,000,000. Navistar International Transportation Frist time under contract April 1997 to May 1997 Springfield, OH Consultant project management. Analysis strengths and weakness of management team for movement of some operations to Mexico. General Motors, Delphi chassis Systems Second Time under contract November 1994 to April 1997 Dayton, OH Sr. Manufacturing Engineer Duties include but not limited to consulting, manufacturing processes, upgrading, and design for six sigma, reducing chronic waste in scrap and production losses. Address ergonomic problems, preventive maintenance, and vibration analysis, designing of new products and processes. Help in building the automation technologies of building of clutch plates. Work to obtain the Quality System Requirements of QS-9000. Production Parts Approval Process (PPAP). I gave them advance breakthrough technology for within the manufacturing process for improvements. I incorporated irreversible corrective actions to improve their quality and processes for their manufacturing line. When I first came to this site they were having 75,000 to 150,000 parts per million (PPM) Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com rejects. This was their normal process for 25 years. I conducted a Continuous Improvement event (Kaizen events) after taking to operators and engineers I suggested changing the process to stop the machine if it detected and out of place part before it makes the first bad part. We went down to 1 part per million (PPM) rejects within 3 months and 0 parts per million (PPM) rejects within the 4th month. Used then used Statistical Process Control (SPC) with a Cp of 2.0 or better and a Cpk of 1.67 or better as our new standard. Accomplishments have increased profit margins from 11% to 182% along different product lines an averaging a cost savings of $4,289,000 per year. General Motors, Delphi chassis Systems First time under contract September 1994 to November 1994 Dayton, OH Sr. Efficiency Engineer Combine diagnostician, manufacturing, mechanical designing, value and cost engineering skills into one. Used Shainin statistical engineering techniques and design for six-sigma. Applied a project-by-project approach to quality improvement and achieve a chronic scrap reduction of up to 42%. This yielded total savings of $2,092,000 per year. Parker Aerospace, ABEX/NWL Aerospace Under contract June 1994 to September 1994 Kalamazoo, MI Sr. Quality Assurance Engineer Responsible for monitoring and providing quality plans, failure analysis, program control, test certification inspection, planning, process review and drawing change control. ABEX manufactures actuators, pumps, rotors, manifolds and valves, both electric and hydraulic equipment. Reduce operating cost up to 36%. U.S. Testing company/SGS Industrial Services Under contract December 1993 to June 1994 Part time. Cincinnati, OH Quality Engineer ISO-9000, source inspecting, U.L listed, F.M. approval, quality reports and advisement to managers and clients. MAC Tools Inc/Stanley Mechanics Tool Division Under contract August 1993 to November 1993 Washington Courthouse, OH Engineering Consultant / Sr. Manufacturing Engineer / Liaison Engineer Consulted in coordinating a multi-plant restructuring. Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Controlled the operations of engineering and of new and existing products, hand tools, wrenches and ratchets, etc. Maintained MRP-2 cost routing, forging, mold making, CNC, turning, grinding, fixtures, casting, assembly, inspection, ISO-9000, reporting, trouble shooting and advising. Designing and modifying equipment to prevent losses, increase safety and reliability. Netted cost savings of 12% - 38% in the manufacturing processes. U.S. Postal Services Second Time under contract August 1993 to February 1994 Part time. Cincinnati, OH Engineering Consultant, part time. Advise vendor and trained personnel how to trouble shoot while overseeing many projects. Increase productivity in total quality, designing, scheduling, safety and reliability. Work with conveyor systems, material handling equipment, packaging machinery and system integration. Net a cost saving of 46%. U.S. Postal Services First time under contract February 1993 to August 1993 Cincinnati, OH Quality Assurance Specialist and Design Engineer First article inspection, reporting, trouble-shooting and advising. Design and modified equipment to prevent infield damage to components, increasing safety and reliability. Used solid modeling, 3D IDEAS, finite element analysis, optimization, CAD/CAM, to produce conveyor systems, material handling equipment, packaging machinery and system integration equipment. Net a cost savings up to 28%. ILC Dover / NASA / Hamilton Sundstrand Under contract June 1992 to December 1992 Frederica, DE Project Engineer, Space Shuttle Engineering Department Directed the design and upgrading of National Aeronautics and Space Act (NASA's) space suits, liquid cooling ventilation garments, EMU (Extravehicular Mobility Unit) and other space shuttle engineering projects. In part I worked on the Heating Ventilation and Air-condition (HVAC) system. Managing about ten projects at a time and overseeing approximately fifty people. Many improvements increased reliability, safety and efficiency. Generating cost savings up to 37%. General Electric Aircraft Engines Third time under contract. February 1990 to December 1990 Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Cincinnati, OH Controls Component Design Engineer. Designed a nacelle chimney vent actuation system and all of its components for the longrange antisubmarine warfare capability aircraft for the U.S. Navy. Designed cables, thermocouples, valves and pumps. Implemented a continuous improvement program based on the Deming theory and Work-Out. (A Jack Welch theory.) Designed and developed the state-of-the art aircraft actuation system while increasing the performance levels by 16%. General Electric Aircraft Engines Second time under contract December 1989 to February 1990 Cincinnati, OH Fluid System Component Design Engineer Designed state-of-the-art nacelle anti-icing valves, pneumatic actuators and published detail design specifications. Designed pneumatic systems powered from the turbine engine bleed air system, which increased the performance by 13%. Work the Heating Ventilation and Air-condition (HVAC) systems. Honeywell International Inc, Aerospace Forth time under contract June 1988 to October 1989 Teterboro, NJ Senior Mechanical / Thermodynamic Design Engineer Design state-of-the-art equipment, interfacing with purchasing and vendors creating engineering change notices (ECN) working within military and DOD specifications, U.S. Work the Heating Ventilation and Air-condition (HVAC) systems within the test units. Air Force specifications and increased system performance by 17%. Honeywell International Inc., Aerospace Third time under contract May 1987 to March 1988 Teterboro, NJ Industrial Engineer / Facilities Engineer Duties included operating procedures, troubleshooting, time studies, probability and statistical analysis of military components for COR TEAM. Work the Heating Ventilation and Air-condition (HVAC) systems within the test units. This yielded a cost savings of 7-49% per process for the Test Systems Division. Honeywell International Inc, Aerospace Second time under contract March 1987 to May 1987 Bridgeport, CT Quality Engineer/Product Quality Engineer Designed and set-up a company wide standards program for visual acceptance criteria. Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com AVCO manufactures turbine engines powering aircraft, trucks, tanks, helicopter and U.S. Navy Amphibious assault crafts for the Department of Defense and commercial use. Increased the total acceptance rates 2 to 5%. General Electric Aircraft Engines First time under contract July 1986 to January 1987 Cincinnati, OH Sub-Section Manager, Supply Chain Management and Procurement Manage consultants, liaison engineers and coordinators, for the Aircraft Engine Business Group. At times managing over 400 people directly. Efforts were to support engine programs, vendor liaison engineering and material input programs for both military and commercial usage. This yielded a net savings of more than $60,000,000.Material Review Board. (MRB) experience. Honeywell International Inc, Aerospace First time under contract April 1986 to July 1986 Teterboro, NJ Sr. Mechanical Engineer Test Systems Division. Military Project. Work the Heating Ventilation and Aircondition (HVAC) systems within the test units. Duties included trouble-shooting, documentation review and product design engineering, efforts increased performance by 11%. BAE Systems. First time under contract November 1985 to February 1986 York, PA Manufacturing Engineer Wrote government work instructions for military vehicles, including the self-propelled Howitzer M109A2 (Tank). Reviewed manufacturing and quality documentation, inspection procedures, time schedules, etc. Yielded a cost saving of 9 to 46% for each part process. Metal Form August 1985 to November 1985 Boca Raton, FL Quality Control Inspector for a precision sheet metal company. Duties included working in the flat, inspection reports for incoming and outgoing and first article inspection yielding a 32% cost savings in manufacturing processes. Unisys – Burroughs Second time under contract November 1984 to January 1985 Coral Springs, FL Quality Assurance Engineer Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Maintained quality standards and was technical advisor of quality assurance department. Conducted short training programs for employees, which increased productivity by 23%. IBM Second time under contract July 1984 to August 1984 Fishkill, NY Manufacturing Engineering, Model Maker Duties included keeping manufacturing line up and running while designing and developing new tooling. Design and build machining equipment and laboratory experiments. One major accomplishment was converting a 7-week backlog to a 3-week bank in production by implementing better product designs and processes. Yield cost savings of 18% in production. James River Corporation Second time under contract May 1984 to June 1984 Fairlawn, NJ, Mechanical Consultant, Model Maker Research and Development in the Dixie Division Manufacture paper products and heavy-duty equipment. Projects included running experiments for lift, drag, power, torque, coefficient of friction, etc. for high and low speed equipment. Designed new equipment to perform at a 76%greater speed and improved the system. Unisys – Burroughs First time under contract April 1984 to May 1984 Coral Spring, FL Quality Control Troubleshooter and Manager Started up and ran a second shift in quality control incoming and receiving inspection department. By combining efforts and organization skills, a backlog of nine weeks was decreased to one and 1/2 weeks. A record-breaking productivity month of 29% over all previous months of quality control history was achieved. This corporation deals with computers and banking instruments. James River Corporation First time under contract July 1983 to August 1983 Fairlawn, NJ Mechanical Consultant, Model Maker Duties included mechanical consulting to division managers. This is where I invented a new product line and the manufacturing process for Dixie Living-ware. By completing a project more than 12 weeks in advance and implementing my new design ideas to the project, the company increased profits by 1,880% and achieved a $43,000,000/year of net profits. EXXON Office Systems under contract May 1983 to July 1983 Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Stanford, CT Quality Control and Quality Assurance Started up and ran a second shift in the quality control / quality assurance department of the research and development division. Applied geometric tolerance techniques aided by computer assisted digital television and optical comparative equipment for quality control inspection. Manufactured high-speed copy and office equipment. Increased the productivity by about 23%. PRD Harris Under contract September 1982 to December 1982 Long Island, NY Mechanical Technologist, First Class Machinist Worked on hybrid testing systems and other government projects in their Instruments Products Division. Introduced new methods to reduce manufacturing production time by 38%. IBM First time under contract April 1982 to July 1982 Boca Raton, FL Mechanical Technologist. Quality Control and Quality Assurance. Worked for specialized engineering design and build departments. Help in building the automation technologies of building the assembly of computers. Model maker involved with creating the arms of robots and automated machine system in the robotics division. Reduced manufacturing production time by about 34%. Perkin Elmer Under contract July 1981 to January 1982 Stanford, CT Model Maker. Microlithography Division. Worked in their research and development laboratory. Help develop components to be used in optical and computer equipment. Increased the productivity by about 21%. Hubble telescope and light measuring equipment. Permclip Products February 1981 to March 1981 Buffalo, NY Model Maker. Project involved designing of a roll bar for a glue press machine. The new design cut operating expenses by 23% and manufacturing time by 56%. This new design was easier to replace and/or repair, and was used on all old and new glue press machines. Farrand Optical Company July 1979 to July 1980 Valhalla, NY Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Prototype Machinist Assisted engineers in the design and modification of flow cells, lens housings, etc.. Work to government specifications and with tolerances to one ten-thousandth of an inch for medical and optical testing equipment. Increased the productivity by about 23%. Gamma Enterprises Second time March 1979 to June 1979 Mount Vernon, NY First Class Machinist. Involved heat treating of plastics, making of fixtures, and machining alloys for: blood auto analyzers and other medical testing equipment. Develop new processes to improve output by 27%. National Diamond Laboratory Third time April 1978 to December 1978 Peekskill, NY, Tool and Die Specialist, Designer, Draftsman and Salesman for a specialized diamond tool corporation. Increased output by about 31%. Singer Kearfott (Marine Division) January 1978 to April 1978 Mount Vernon, NY General Machinist. Manufactured parts for submarines battleships etc. Increased output by about 23%. National Diamond Laboratory Second Time Peekskill, NY Machinist, Tool and Die Specialist. Manufactured specialized diamond tools. Changed processes to increased output by 18% August 1977 to December 1977 Western Union Teleprocessing June 1977 to August 1978 Mahwah, NJ Prototype Machinist. Assisted engineers in the design of new equipment increased output by about 16%. Gamma Enterprises First time March 1977 to June 1977 Mount Vernon, NY First Class Machinist. Involved heat treating of plastics, making of fixtures, and machining alloys for: blood auto analyzers and other medical testing equipment. Develop new processes to improve Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com output by 27%. Harrison Machine and Tool September 1976 to March 1977 Harrison, NY First Class Machinist. Manufactured medical testing equipment. Increased output by about 12%. National Diamond Laboratory First time June 1974 to September 1976 Peekskill, NY Machinist, Tool and Die Specialist. Manufactured specialized diamond tools. Training Over 30 years of college and graduate level classes from over 10 different colleges and universities. I have taken company courses at: Boeing, UTC Pratt & Whitney, General Electric, Honeywell, General Motors, Delphi, Navistar, Tri State Technical, Xerox, HillRom and The Coca Cola Company as well as courses at universities and colleges: Kettering University, University Cincinnati, State University of New York (S.U.N.Y.) at Westchester, S.U.N.Y. at Buffalo, Iona College, Mercy College, Palm Beach Community College, Florida Atlantic University, Cincinnati Technical College, Raymond Walters College and many others with in the last 30 years. Six Sigma Technology Breakthrough Statistical Process Control (SPC) Design of Experiments (DOE) Total Quality Management (TQM) Just In Time (JIT) Continuous Improvement Theory of Constraints (TOC) Lean Manufacturing X-Bar R-Bar Charts Pareto Charts Flow Charts Process Mapping Thought Process Map Cycle Time Reduction Performance Metrics Variation Reduction Gantt Charts Supply Chain Optimization Elimination of Non-Value Added Activities Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Systems, Methods and Tools Used: Technology Breakthrough, Raised Production, Deming, Shainin, Workout, Kaizen, Juran, Taguchi, Shewart, Plan Do Study Act (PDSA) Cycle, Process Re-engineering, Six Sigma, Statistical Process Control (SPC), Design Of Experiments (DOE), Design for six sigma (DFSS), Program Planning and Control (PPC), Financial Control (FC), Response Surface Method (RSM), Pull Approach, Push Approach, Total Quality Management (TQM), Just In Time (JIT), GD & T, QC Circles, Zero Defects, Continuous Improvement, Cellularization, Benchmarking, Single-Minute-Change-Of-Dies, Dedicated Flow Lines, Flexible Manufacturing Systems (FMS), Theory of Constraints (TOC), Flowcharts, Decentralization, Cell, Directing and Motivating, Focused Factory, Performance Report, Throughput, Lean Manufacturing, X-Bar R-Bar Charts, Pareto Charts, Flow Charts, World Class manufacturing, Production Parts Approval Process (PPAP), Continuous Flow Manufacturing (CFM), Process Mapping, Cycle Time Reduction, Maximo, Quality Function Deployment (QFD) Key Product Characteristic (KPC), Key Control Characteristic (KCC) Control Plan, Reaction Plan, Control Charting, Quality Gates Simulation, Linear Regression, Lean Manufacturing Fishbone Cause and Effect, Scatter Diagrams, Error Proofing, Capability Design and Process, Performance Metrics, Variation Reduction, Decentralization, Kanban Systems, Directing and Motivating, Performance Reports, Company Wide Quality Control (CWQC), Customer Orientation, Total Quality Assurance (TQA), Total Factor Productivity, Budgets, DOE Factorial Design, Value Added Engineering, Bottleneck Systems, Constant Work In Process (CONWIP), Gantt Charts, Manufacturing Cycle Efficiency (MCE), Delivery Cycle Time (DCT), Manufacturing Cycle Time (MCT), Management by Exception, Velocity of Production (VOP), Inventory Turnovers, Maynard Operation Sequence Technique (MOST) Work Measurement Systems, Relaxing the Constraint, Ergonomics, Supply Chain Optimization, Manufacturing Cells, Reduce Setup Times, Flexible Work Force, Deming Wheel, Process Re-engineering, Simplification and Elimination of Wasted Effort, Elimination of Non-Value Added Activities, Decentralization, Benchmarking, Task Analysis, Task Management, Scientific Management, Failure Report Analysis and Corrective Action System (FRACAS), Rationalization, Life Cycle Engineering Development units (LCEDS), Feedback Analysis, Probability Theory, Threshold Phenomenon, Key Event, Activity Base Costing, Allocation of Scarce Resources, innovation Performance, Core Competencies, Result Control, Innovation, Variability Reduction Methodology, Probability, Statistics, Process Capability, Hypothesis Testing, Analysis of Variance, Regression Analysis, Measurement System Analysis (Gage R&R), Process Management, Project Management, MS Project, LINDO, LINGO, Out-of-Control-Action-Plans (OCAP), Critical Path Analysis, Bill of Material (BOM), Contemporary Management Approach, Occupational Safety and Health Act (OSHA), Thought Process Map, Process Mapping, FMEA (Failure Modes & Effects Analysis) Quality Function Deployment (QFD) Statistical Process Control (SPC)/NEM Capability Analysis), Multi Variance Analysis/ANOVA/COV (Components of Variation) MSE (Measurement System Evaluation) Full and Fractional Factorials Confidence Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Intervals/Hypothesis testing/Sample Sizing Regression Analysis 5S/Mistake Proofing, Control Plans, Supports improvement teams Builds and shares knowledge, Identifies opportunities and advises, Ensures technical integrity of training Achieves and sustains measurable results Trains/Mentors Green Belts and Black Belts Advanced tools in the following: Data Analysis Tools: Regression/General Linear Models, Advance Measurement Systems, Attribute (Kappa, ICC) Distributions, Statically Tolerancing, Transformations, Auto/Lag Cross correlation analysis, Advanced DOE: Strategies of Experimentation (RSM,…), Taguchi/Robust Design & Noise, Split Plot, Restricted Randomization (FRD), Variance Components, DOE Models and Diagnostics, Project Lifecycle Management Processes (PLMP), ANOVA Extensions, Faulty DOEs and their Analysis of missing data, Lean Enterprise, Design Track (Design for Six Sigma, History of Lean/Lean Principles/Seven Types of Waste Site/Cell Baseline Analysis Project, Product Lifecycle Management (PLM), Critical Path Method, Planning/Team Design, Value Stream Mapping, Activity of the Operator, Set-Up Reduction, Multi-Cycle Analysis, Standard Work, Line Balancing/Design/Layout, Intelex Software, Work Station Design/Ergonomics, Materials Kanban Design and Calculations, Design To Cost (DTC), Life Cycle Cost (LCC), Boeing Opportunities, Risk and Issues System (BORIS), Technical Performance Measurement (TPM), System Engineering Management Plan (SEMP), Integrated Master Plan (IMP), Integrated Master Schedule IMS), Contract Work Breakdown Structure (CWBS), Risk Reduction Metrics (RRM), Good Manufacturing Practices (GMP), Production Scheduling, Visual Controls, Lean Metrics, Organization Structure, Kaizen Strategy, Applies lessons learned to other areas, Draws and focuses resources, Builds and transfers knowledge, Achieves and sustains measurable results, Integration with other initiatives, Takt Time, Production, Preparation and Process (3P), Accelerated Improvement Workshop (AIW), Sorting, Simplifying, Sweeping, Standardizing, Self-Discipline (5S) , and Safety (6S), Tools/Methodology, life-cycle balanced system of systems, Safety Management System (SMS) Intelex, Drum Buffer Rope (DBR) system, Master Production Schedule (MPS) Drum, Protective cushion (Buffer), Capacity Constraint Resources (CCR) rope, Methodology for DFSS, (Understand Customer Needs, Define Initial Solution, Model Design Performance, Optimize for Value, Verify Design & Models, Control) (UDMOVC), (Suppliers/Inputs/Process/Outputs/Customers) (SIPOC), Systems Management, Jidoka (Autonomation), Chaku-Chaku (Load-Load) status, Poka-Yoke (Mistake proofing), Wasteology: the total elimination of Waste (Muda), Baya-yoke (Machine Sensors), Kaikaku (Revolution), Perform safety, reliability, maintainability, testability, human systems integration, survivability, vulnerability, susceptibility, system security, regulatory, certification, lift safe – basic principles for overhead crane and hoist operations, Strengths, Weaknesses, Opportunities, Threats (SWOT), Material Review Board (MRB), Computer Aided Design (CAD), Computer Aided Engineering (CAE),Computer Aided Manufacturing (CAM), product assurance; system performance (requirements), integrates technical parameters, and assures compatibility of all physical, functional and program interfaces to optimize total system of systems, Design Object Oriented Requirements System, (DOORS), Statement of work (SOW), Quick Reaction Capability (QRC), Computer Integrated Manufacturing (CIM), Product Lifecycle Management (PLM), Product Data Management (PDM), economic Order Quantity Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com (EOQ), Material Requirements Planning (MRP), Manufacturing Resource Planning (MRP II), Manufacturing Planning and Control (MPC), Master Production Schedule (MPS), Capacity Requirements Planning(CRP), Sensei – expert in waste elimination MS Office (Outlook, Excel, Access, Word, and PowerPoint), ″ MS Project, MS Visio and much more. Advanced Product Quality Planning (APQP), A3 is a paper size, typically 11″ x 17 and is a problem solving method made popular by Toyota. Toyota 5S System: Sort (Seiri), Straighten (Seiton), Scrub ((Seiso)(Spic and Span or Shine)), Systematize (Seiketsu), Sustain ((Shitsuke)(Way of life, Safety, Order and Cleanliness)), Continuous Improvement ((Kaizen) Map things as they are, Measure, Eliminate what does not add value, Flow the process and train, Measure again, celebrate the accomplishments, Map things as they are.), Earned Value Management (EVM), and much more. (Define, Measure, Analyze, Improve and Control) (DMAIC): A standard approach for reengineering existing processes. Systems Development Life Cycle (SDLC), also referred to as the Application Development Life-Cycle, (ADLC), (Define, Measure, Explore, Develop, Implement) (DMEDI): Ideal for optimizing new processes. (Design for Lean Six Sigma)(DfLSS): Used, with specialized tools, for customer-driven design of new technologies and services. Visio, Share point, MS project, Design Failure Mode and Effect Analysis (DFMEA), Reliability Allocation: Agree Method, ARINC apportionment method, Equal apportionment method. Corrective and Preventative Actions (CAPA), Geometric Dimensioning and Tolerancing ASME Y14.5M Strategic Sourcing: 1) Preform Market Analysis / Suppliers, 2) Develop Sourcing Strategy, 3) Generate Supplier Portfolio, 4) Develop Solicitation & Visit Supplier, 5) Evaluate Supplier Proposals, 6) Select Competitive Suppliers, 7) Negotiations and Contract Approval, 8) Manage Implementation Plan. Eliminate 7 types of waste: 1) Defects, 2) Over Production, 3) Transportation, 4) Waiting, 5) Inventory, 6) Motion, and 7) Processing. 5 principles of Lean: 1) Specify value in the eyes of the customer, 2) Identify the value stream and eliminate waste, 3) Make value flow at the pull of the customer, 4) involve and empower employees, 5) Continuously improve the pursuit of perfection. A PARTIAL LISTING OF SOME Food and Drug Administration (FDA), OSHA, MILITARY, INDUSTRY AND OTHER SPECIFICATIONS: DODISS MIL-Q-9858 MIL-STD-15 MIL-H-45374 MIL-STD-8 DOD-D-1000 ANSI/, AWS A2.4 MIL-STD-961 MIL-1-45208 MIL-STD-461 DOD-STD-100 ANSI X.3.5 MIL-STD-490 MIL-M-85337 MIL-STD-34 DOD-STD-480 ANSI-Y-32.16 MIL-STD-454 MlL-E-5400 MIL-STD-120 DOD-STD-1476 ANSI-Y-32.2 MIL-STD-17B-2 MIL-S-45180 MIL-STD-105 MIL-C-5541 ANSI-Y-14.5 MIL-STD-45662 MIL-HDBK-333 MlL-STD-810 MIL-M-98680 ANSI/ASME B46.1 MIL-STD-462 MIL-HDBK-189 MIL-STD-704 ASTM-E380 ANSI/IEEE-STD-268 MlL-STD-721 Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com MlL-HDBK-141 MIL-STD-1806 MIL-D-8510 MIL-STD-1345 GMGP-8 MIL-STD-1521 FED-STD-H28 Dl-R-706S MIL-STD-12 MIL-HDBK780 MIL-STD-109 MS-51835M Dl-R-7064 MIL-STD-481 MIL-HDBK-251 MIL-STD-1528 MMM-A-1617 MIL-STD-1520 MIL-STD-482 MIL-HDBK-221 MIL-STD-1472 UDI-T-20340 MlL-STD-8100 MIL-STD-83 MIL-HDBK63038 MIL-STD-1519 UDI-T-23934 MIL-STD-17B-2 MIL-STD-1806 MILHDBK-759 MIL-STD-1132 MIL-T-31000NATRICK/TR-89/044 ANSI-ASQC Q90 MIL-HDBK-1472 MIL-STD-882 TS 16949 MIL-HDBK-881 MILHDBK-245 ASME Y14.5M ANSI-ASQC Q91 ANSI-ASQC Q92 ANSI-ASQC-Q93 ANSI-ASQCQ94 ISO-9000 ISO-9001 IS0-9002 IS0-9003 IS0-9004 ISO/TS16949 IS0-8402 QS-9000 AS-9000 GM-GP-3 ANSI/ASME B46.1 IPPAP PPAP FAR-25 FAR-33 MIL-TFP-4AC Geometric Dimensioning and Tolerancing ASME Y14.5M People-soft, Agile, Product Life cycle Management. Quality Assurance / Regulatory Affairs (QAC/RA), Corrective and Preventive Action (CAPA), FDA 21 CFR 820, ISO 13485, ISO 14001,ISO 17025 and European Union Medical Devise Directive (93/42/EEC), Healthcare Canada Medical Device Regulations (SOR/98-282), Japanese Medical Devise QMS, Ministerial Ordinance No. 169 ad No. 2. Department of Defense Index of Specifications and Standards (DODISS) International Traffic in Arms Regulations (ITAR) Export Administration Regulations (EAR) Foreign National Export License Foreign Corrupt Practices Act ("FCPA") POL-2, "Ethical Business Conduct" POL-15, "Supplier Management" PRO-6, "Offering of Business Courtesies" PRO-8, "Acceptance of Business Courtesies" PRO-9, "Proper Relationships with Suppliers" PRO-3712, "Compliance with Anti-Kickback Law and Regulations" Standard Industrial Classifications (SIC) codes Occupational Safety and Health Act (OSHA) TITLE 21--FOOD AND DRUGS Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com CHAPTER I--FOOD AND DRUG ADMINISTRATION (FDA) DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C--DRUGS: GENERAL PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 22 21 C.F.R. Part 211 Subpart I--Laboratory Controls 211.160 - General requirements. 211.165 - Testing and release for distribution. 211.166 - Stability testing. 211.167 - Special testing requirements. 211.170 - Reserve samples. 211.173 - Laboratory animals. 211.176 - Penicillin contamination. Subpart J--Records and Reports 211.180 - General requirements. 211.182 - Equipment cleaning and use log. 211.184 - Component, drug product container, closure, and labeling records. 211.186 - Master production and control records. 211.188 - Batch production and control records. 211.192 - Production record review. 211.194 - Laboratory records. 211.196 - Distribution records. 211.198 - Complaint files. Subpart K--Returned and Salvaged Drug Products 211.204 - Returned drug products. 211.208 - Drug product salvaging. Subpart A--General Provisions 211.1 - Scope. 211.3 - Definitions. Subpart B--Organization and Personnel 211.22 - Responsibilities of quality control unit. 211.25 - Personnel qualifications. 211.28 - Personnel responsibilities. 211.34 - Consultants. Subpart C--Buildings and Facilities 211.42 - Design and construction features. 211.44 - Lighting. Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com 211.46 - Ventilation, air filtration, air heating and cooling. 211.48 - Plumbing. 211.50 - Sewage and refuse. 211.52 - Washing and toilet facilities. 211.56 - Sanitation. 211.58 - Maintenance. Subpart D--Equipment 211.63 - Equipment design, size, and location. 211.65 - Equipment construction. 211.67 - Equipment cleaning and maintenance. 211.68 - Automatic, mechanical, and electronic equipment. 211.72 - Filters. Subpart E--Control of Components and Drug Product Containers and Closures 211.80 - General requirements. 211.82 - Receipt and storage of untested components, drug product containers, and closures. 211.84 - Testing and approval or rejection of components, drug product containers, and closures. 211.86 - Use of approved components, drug product containers, and closures. 211.87 - Retesting of approved components, drug product containers, and closures. 211.89 - Rejected components, drug product containers, and closures. 211.94 - Drug product containers and closures. Subpart F--Production and Process Controls 211.100 - Written procedures; deviations. 211.101 - Charge-in of components. 211.103 - Calculation of yield. 211.105 - Equipment identification. 211.110 - Sampling and testing of in-process materials and drug products. 211.111 - Time limitations on production. 211.113 - Control of microbiological contamination. 211.115 - Reprocessing. Subpart G--Packaging and Labeling Control 211.122 - Materials examination and usage criteria. 211.125 - Labeling issuance. 211.130 - Packaging and labeling operations. 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 211.134 - Drug product inspection. 211.137 - Expiration dating. Subpart H--Holding and Distribution Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com 211.142 - Warehousing procedures. 211.150 - Distribution procedures. Food and Drug Administration (FDA) Part 820 – Quality Systems Regulation – Subpart M – Records – 820.198 Complaints 21 C.F.R. Part 820 – Quality System Regulation TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES - PART 820 QUALITY SYSTEM REGULATION Subpart A--General Provisions 820.1 - Scope. 820.3 - Definitions. 820.5 - Quality system. Subpart B--Quality System Requirements 820.20 - Management responsibility. 820.22 - Quality audit. 820.25 - Personnel. Subpart C--Design Controls 820.30 - Design controls. Subpart D--Document Controls 820.40 - Document controls. Subpart E--Purchasing Controls 820.50 - Purchasing controls. Subpart F--Identification and Traceability 820.60 - Identification. 820.65 - Traceability. Subpart G--Production and Process Controls 820.70 - Production and process controls. 820.72 - Inspection, measuring, and test equipment. 820.75 - Process validation. Subpart H--Acceptance Activities 820.80 - Receiving, in-process, and finished device acceptance. 820.86 - Acceptance status. Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Subpart I--Nonconforming Product 820.90 - Nonconforming product. Subpart J--Corrective and Preventive Action 820.100 - Corrective and preventive action. Subpart K--Labeling and Packaging Control 820.120 - Device labeling. 820.130 - Device packaging. Subpart L--Handling, Storage, Distribution, and Installation 820.140 - Handling. 820.150 - Storage. 820.160 - Distribution. 820.170 - Installation. Subpart M--Records 820.180 - General requirements. 820.181 - Device master record. 820.184 - Device history record. 820.186 - Quality system record. 820.198 - Complaint files. Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. Subpart N--Servicing 820.200 - Servicing. Subpart O--Statistical Techniques 820.250 - Statistical techniques. Code of Federal Regulations (C.F.R.) C.F.R. Title 29 OSHA form 300 OSHA form 301 OSHA form 200S Forms OSHA Form 200/301 OSHA Publication 2056 OSHA publication 3047 Consultant services for the Employer OSHA Voluntary Protection Programs (VPPs) 29 C.F.R. 1903.2(a) OSHA Poster OSHA Poster 2203 29 C.F.R. 1903.16(a) Posting of OSHA Citations 29 C.F.R. 1904.2 Injury/Illness Log 29 C.F.R. 1904.4 Supplementary Records 29 C.F.R. 1904.5 Annual Summary 29 C.F.R. 1904.6 Lifetime of Records OSHA 200/300 Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com 29 C.F.R. 1904.7 Access to Records 29 C.F.R. 1904.8 Major Incident Report 29 C.F.R. 1904.11 Change of Ownership 29 C.F.R. 1910.20(d) Medical/Exposure Records 29 C.F.R. 1910.20(e) Access to Medical/Exposure Records 29 C.F.R. 1910(g) (1) Toxic Exposure 29 C.F.R. 1910.20(g) (2) Distribution of Materials 29 C.F.R. 1910.20 OSHA’s Records Access Standard Subpart D: 1910.21 1910.22 1910.23 1910.24 1910.25 1910.26 1910.27 1910.28 1910.29 1910.30 1910.31 1910.32 Subpart E: 1910.35 1910.36 1910.37 1910.38 1910.39 1910.40 Subpart F: 1910.66 1910.67 1910.68 1910.69 1910.70 Subpart G: 1910.49 1910.95 1910.96 1910.97 1910.98 1910.99 1910.100 Subpart H: 1910.101 1910.102 1910.103 1910.104 1910.105 1910.106 1910.107 1910.108 1910.109 1910.110 1910.111 1910.114 1910.115 1910.116 1910.119 1910.120 Subpart I: 1910.132 1910.133 1910.134 1910.135 1910.136 1910.137 1910.138 1910.139 1910.140 Subpart J: 1910.141 1910.142 1910.144 1910.145 1910.146 1910.147 1910.148 1910.149 1910.150 Subpart K: 1910.151 1910.153 Subpart L: 1910.155 1910.156 1910.157 1910.158 1910.159 1910.160 1910.161 1910.162 1910.163 1910.164 1910.165 Subpart M: 1910.169 1910.170 1910.171 Subpart N, Subpart O, Subpart P Subpart Q Subpart R Subpart S Subpart T Subpart Z Part 1926 United States Department of Labor Occupational Safety and Health Administration Regulations (Standards - 29 CFR) PART 24 Procedures for the Handling of Retaliation Complaints under Federal Employee Protection Statutes PART 70 Production or Disclosure of Information or Materials PART 70A Protection of Individual Privacy in Records PART 71 Protection of Individual Privacy and Access to Records under the Privacy Act Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com of 1974 PART 1901 Procedures for State Agreements PART 1902 State Plans for the Development and Enforcement of State Standards PART 1903 Inspections, Citations, and Proposed Penalties PART 1904 Recording and Reporting Occupational Injuries and Illness PART 1905 Rules of Practice PART 1906 Administration Witness and Documentations in Private Litigation PART 1908 Consultation Agreements PART 1910 Occupational Safety and Health Standards PART 1911 Rules of Procedure for Promulgating, Modifying or Revoking OSHA Standards PART 1912 Advisory Committees on Standards PART 1912A National Advisory Committee on OSHA PART 1913 Rules Concerning OSHA Access to Employee Medical Records PART 1915 Occup. Safety and Health Standards for Shipyard Employment PART 1917 Marine Terminals PART 1918 Safety and Health Regulations for Longshoring PART 1919 Gear Certification PART 1920 Procedure for Variations under Longshoremen's Act PART 1921 Rules of Practice in Enforcement under Section 41 of Longshoremen's Act PART 1922 Investigational Hearings under Section 41 of the Longshoremen's and Harbor Workers' Compensation Act PART 1924 Safety Standards Applicable to Workshops and Rehab. Facilities PART 1925 Safety and Health Standards for Federal Service Contracts PART 1926 Safety and Health Regulations for Construction PART 1928 Occup. Safety and Health Standards for Agriculture PART 1949 Office of Training and Education, OSHA PART 1952 Approved State Plans for Enforcement of State Standards PART 1953 Changes to State Plans PART 1954 Procedures for the Eval. and Monitoring of Approved State Plans PART 1955 Procedures for Withdrawl of Approval of State Plans PART 1956 Plans for State and Local Government Employees without Approved Plans PART 1960 Basic Program Elements for Federal Employees OSHA PART 1975 Coverage of Employees under the Williams-Steiger OSHA 1970 PART 1977 Discrimination against Employees under OSHA Act of 1970 PART 1978 Procedures For The Handling Of Retaliation Complaints Under The Employee Protection Provision Of The Surface Transportation Assistance Act Of 1982 (STAA), As Amended PART 1979 Procedures for the Handling of Discrimination Complaints under Section 519 of the Wendell H. Ford Aviation Investment and Reform Act for the 21ST Century PART 1980 Procedures for the Handling of Discrimination Complaints under Section 806 of the Corporate and Criminal Fraud Accountability Act of 2002, Title VIII of the Sarbanes-Oxley Act of 2002 PART 1981 Procedures for the Handling of Discrimination Complaints under Section 6 Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com of The Pipeline Safety Improvement Act of 2002 PART 1982 Procedures for the Handling of Retaliation Complaints Under the National Transit Systems Security Act of 2007, Enacted as Section 1413 of the Implementing Recommendations of the 9/11 Commission Act of 2007, and The Federal Railroad Safety Act, as Amended by Section 1521 of the Implementing Recommendations of the 9/11 Commission Act of 2007 PART 1983 Procedures for the Handling of Retaliation Complaints under Section 219 of The Consumer Product Safety Improvement Act of 2008 PART 1986 Procedures for the Handling of Retaliation Complaints under the Employee Protection Provision of the Seaman's Protection Act (SPA), as Amended. PART 1990 Identification, Classification, and Regulation of Carcinogens PART 2200 OSHA Review Commission PART 2201 Regulations Implementing The Freedom of Information Act. PART 2202 Rules of Ethics and Conduct of Review Commission Employees PART 2203 Regulations Implementing The Government In the Sunshine Act PART 2204 Implementation of the Equal Access to Justice Act PART 2205 Enforcement of Nondiscrimination on the Basis of Handicap in Programs or Activities Conducted by the Occupational Safety and Health Review Commission PART 2400 Regulations Implementing the Privacy Act SAFETY MANAGEMENT SYSTEM (SMS) Intelex Know your Rights: While a mutually respectful relationship between safety staff and Compliance Safety and Health Officers (CSHO) should be maintained during any inspection, it is also important to know that you have rights. When a CSHO arrives, politely ask him or her for their credentials. Ask why they are visiting your worksite, and if it is a complaint-related matter, ask to see the complaint. Also, don’t hesitate to ask for time to get your team in order, and to prepare whoever will be assigned to accompany the inspector around your site. Don’t use this time to scramble to cover up any safety-related gaps. Use it to ensure a smooth, seamless inspection and to remind union reps that they are entitled to be present when an inspector requests to speak with any employee one-onone. NIOSH Workers Compensation Food and Drug Administration FDA: 21 CFR Part 11, CGM, 12 CFR Parts 210 and 211 Current Good Manufacturing Practices (CGMP) Regulations Final Rule, 21 CFR Parts 808, 812, 820 Defense Trade Controls Licensing Title 22 – Foreign Relations, Chapter 1 – Department of State: Parts 120 – Purpose and definitions Parts 122 – Registration of manufactures and exporters Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Parts 123 - licenses for the export of defense Parts 124 - Agreements, off-shore procurement and other defense services Parts 125 – Licenses for the export of technical data and classified defense articles Parts 126 – General policies and provisions Parts 127 – Violations and penalties Parts 128 – Administrative procedures Parts 129 – Registration and licensing of brokers Parts 130 – Political contributions, fees and commissions Department of State, International Traffic in Arms Regulations (ITAR) Department of Commerce, Export Administration Regulations (EAR) Technical Assistance Agreements (TAA) Manufacturing License Agreement (MLA) Arms Export Control Act (AECA) Export Administration Act (EAA) Clean room: Airbus Specification: AIPS03-02-019 Control Contamination Area Requirements. EN ISO 14644-1, Cleanrooms and Associated Controlled Environments – Part 1: Classification of Air Cleanliness. EN ISO 14644-3, Cleanrooms and Associated Controlled Environments – Part 3: Test Methods. AIMS 12-00-000 Ancillary Materials Type A: In contact with uncured structural materials and Type B: ancillary materials that are not in direct contact with the uncured structural material. EN ISO 14644-1 class 8. Professional Affiliations (current and former): Golden Key National Honor Society (GKNHS) Phi Theta Kappa International Honor Society American Society of Mechanical Engineers (ASME) Society of Manufacturing Engineers (SME) Mu Pi Kappa (Engineering Honor Society) Society of Automotive Engineers (SAE) Society of Aerospace Engineers (SAE) American Society for Quality (ASQ) American Society for Quality Control (ASQC) American Institute of Aeronautics and Astronautics (AIAA) American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc. (ASHRACE) Institute of Industrial Engineers (IIE) Boy Scouts of America (Life Scout) Realtor, Real Estate Salesman was license in New York, New Jersey and Ohio Real estate appraising and advance appraising United States of America Citizen USA Citizen Active Passport Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio 45429 513-484-2012 (mobile), tpviggiano@zoomtown.com Salary History and Expectations: About 150 times return on investment is what I have been returning to my clients. My salary is a small price to pay for such a large return on investment. How does that compare to the return on investment of your other employees? Each position will have different demands and the salary request will be evaluated by those demands and the location and cost of living within the area to where the work is to be performed. Salary history and expectations are about 4 to 20 times the Per Diem Rates as listed in the IRS Publication 1542, (http://www.gsa.gov/portal/content/104877) for the area in the country in which the work is to be preformed. Or Salary request will be within the upper quartile of similar jobs for any position, normally within the six-figure range about Two Lakh. However I will consider other offers as well. Just call me at: 513-484-2012 (cell). Please call Thomas P. Viggiano at 513-484-2012 (Cell) for the particulars of your requirements. If I do not answer please leave a message and a return telephone number. Please call Thomas P. Viggiano at 513-484-2012 Cell so that we may start to resolve your company’s needs. Thomas P. Viggiano, MSOM, MSMM, BSE, AASMT 5240 Denise Drive, Dayton, Ohio, USA 45429 513-484-2012 Cell Email: tpviggiano@zoomtown.com