Thomas Viggiano Summary:

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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.
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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
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