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Business Improvement Team

Brian Balzer
Brian Balzer
Focus Areas:
Brian has successfully combined his experience in systems, processes and product quality to help companies achieve their business goals and process improvement objectives. These have been primarily focused in the areas of ISO 9000, ISO/TS 16949 and ISO 14001. Additionally, he has conducted numerous independent industry related surveys, customer satisfaction surveys and benchmarking studies for various clients.
Additional Skills/Expertise:
Brian’s expertise is in the area of process improvement and includes Lean, Kaizen, Six Sigma, International Quality Standards.
Joe Barckett
Joe Barckett
Focus Areas:
Joe is an experienced Master Black Belt and teaches/coaches the Six Sigma methodology, Statistical Process Control, Design of Experiments including Taguchi methods, the Malcolm Baldrige National Quality Award criteria, and ISO 9000 quality system standards. Joe has also taught at the university level. He was an instructor/coordinator for Northeastern University’s College of Engineering program, Pre-NUPrime, a mathematics program for high school students pursing an engineering career.
Additional Skills/Expertise:
Joe has the proven ability to analyze a situation and determine an implementation approach appropriate for the business environment. He is able to train and interact with all levels of an organization, establish and motivate teams to process improvement, and lead company-wide programs that result in significant cost reduction.
Ron Belmont
Ron Belmont
Focus Areas:
Ron is the Vice President of the Healthcare/Telecomm Practices and has led SAI Global’s regulatory program (medical device, pharmaceutical, biotech) for over 16 years. He has utilized his engineering education and in depth experience in R&D, product safety, product management and regulatory affairs in the development and implementation of effective quality systems that not only comply with domestic/international regulatory requirements and standards, but enhance overall business operations and improve the bottom line.
Additional Skills/Expertise:
Ron has trained thousands in areas such as quality management systems (ISO 13485, ISO 9001), FDA cGMPs/QSR, international regulatory requirements (EU Directives, CMDCAS), internal and lead auditing, design control for medical devices, risk management / ISO 14971 for medical devices, risk analysis/FMEA for medical devices, corrective / preventive action as well as many other areas.
Sal Girifalco
Sal Girifalco
Focus Areas:
Sal provides consulting and training support to help clients meet business goals through process improvement utilizing a wide set of tools. This support includes assisting organizations to implement ISO 9001 and TL 9000 Quality Management Systems. He addresses direct process improvement with methodologies that include root cause problem solving, process mapping, process management, and Lean/Kaizen. Of these, Lean/Kaizen has the proven capability of yielding the most significant performance improvement (breakthrough goals), in a short time.
Additional Skills/Expertise:
In addition to management consulting, Sal has considerable experience in conducting Customer surveys to support Customer satisfaction efforts. Utilizing an interview technique and a survey customized to the organization, Sal determines customer perception of an organization’s performance in a way that enables improvements to be planned and executed so that bottom line performance can be improved. He also performs both ISO 9001 and TL 9000 Internal Audits for some of his clients.
Jim Kolka
Jim Kolka
Focus Areas:
Jim specializes in strategic planning in several areas. He has developed integrated regulatory compliance programs for medical devices for both the EU (CE marking) and the US (FDA's Quality System Regulation). He also has developed programs utilizing ISO 9001 and ISO 13485 as risk management platforms for reducing product liability exposure for the US and EU as well as working with companies on developing an Enterprise Risk Management Program (ERMP). For the EU he has developed CE marking programs for constructing Technical Files and applying risk assessment/risk analysis to products covered by the Medical Devices, Machinery, Toy Safety, Personal Protective Equipment, Low Voltage, Electromagnetic Compatibility, Pressure Vessels, and Explosive Atmospheres (ATEX) Directives. For the US, he has developed programs utilizing ISO 9001 and ISO 14001 to reduce liability exposure in the manufacturing and service sectors in both regulated and nonregulated industries.
Additional Skills/Expertise:
For the past 17 years, Jim has been working in the quality, environmental, forensic law and preventive law fields, writing articles, books and giving presentations throughout the US. As an attorney and international legal consultant, he has served as legal expert in lawsuits involving ISO 9001, FDA’s QSR, ISO 13495, QS9000, ISO 14001 and CE marking in the US and EU. He has developed a comprehensive preventive law program using ISO 9001 as a risk management platform to reduce liability exposure in the US and EU as well as apply that same platform to disaster preparedness. Presently, Jim and his colleagues at SAI Global are applying these same preventive law principles to product liability audits for life science firms and developing tailored programs for product liability avoidance.
Carmine Liuzzi
Carmine Liuzzi
Focus Areas:
Carmine is Vice President and Automotive Practice Leader for SAI Global. He has continued to refine his process management skills and techniques since joining SAI Global 15 years ago. He has assumed the leadership role in several key projects including the development and coordination of international work teams tasked with reengineering core business processes, starting with strategic long range product planning through the entire product / process design, manufacture, sales, service and product phase out. Carmine’s approach has always remained on the “bigger business picture” in order to ensure maximum benefit and value to the entire enterprise.
Additional Skills/Expertise:
Carmine has acquired a unique combination of expertise in development and implementation of integrated management systems. By utilizing a practical and beneficial approach to business improvement, Carmine has been very successful at generating internal acceptance to needed changes to enhance core business processes. Emphasizing that the business processes should serve the organization and its customers, Carmine has been a leader in identifying opportunities to reduce hassle and bureaucracy within each organization.
Martha Miller
Martha Miller
Focus Areas:
Martha is a regulatory professional with extensive experience in domestic and international regulatory affairs and quality assurance. Her career in the healthcare arena spans over 30 years, and includes experience in the design, development, manufacturing and sale of medical devices as well as auditing of clinical sites for devices, pharma/device combinations and testing labs. Responsible for clinical trials, including initial and on-going site audits, compiling and analyzing data and submission of findings to FDA and international governments for approval to market new products.
Additional Skills/Expertise:
Martha has designed and incorporated programs for the implementation of quality systems for compliance to both ISO 13485 and ISO 9001 requirements as well as the FDA current Good Manufacturing Practices Quality System Regulations(cGMP). Martha has audited clinical sites for compliance to clinical study requirements, including both FDA requirements (cGCP) and international standards. Martha is a registered Medical Device Lead Auditor and has worked with a Notified Body for many years in certifications of companies to both quality systems to the ISO Standards (9001 and 13485) as well as certification to the Medical Device Directive/CE Marking of products.
Glen Mondani
Glen Mondani
Focus Areas:
Glen is adept at implementing and integrating various management system elements within an organization’s culture and priorities, effectively utilizing international standards (including ISO 14001, ISO 9001, OHSAS 18001) to add value to an organization’s existing business systems, while protecting the environment and creating a safer workplace. These skills, plus his in-depth work with large, dynamic environments, make him a valuable part of a client’s liability and cost reduction plans.
Additional Skills/Expertise:
Glen has more than 20 years experience in domestic and international management systems, including implementation, auditing and training. He has worked at the plant level to integrate quality management, environmental management and regulatory compliance, creating a unified business management system. Glen’s assignments include working as an Application Expert (Black Belt) to lead improvement teams in solving critical problems.
Steve Obolewicz
Steve Obolewicz
Focus Areas:
One of Steve’s strengths is his ability to link design engineering practices to manufacturing. He has implemented these links in both hardware and software development environments, helping to streamline the introduction of new products. Steve has provided customers with the direction how to integrate ISO 9001 or ISO13485 into business processes to create value and integrity.
Additional Skills/Expertise:
For our Medical Device manufacturing customers, he has advocated the proper use of FDA QSR per the Safe Medical Device Act. He has also assisted several Medical Device companies with Risk Management in accordance with ISO 14971:2000. Steve is a subject matter expert (SME) in TL 9000. He is a participant in the QuEST Forum teams (since 1998) for both TL 9000 handbooks, is an active member on sub-teams, and has been the key developer of the QuEST Forum sanctioned TL 9000 training courses. He has trained registrars, telecom service providers, and suppliers, as well as providing consulting services for some of the industries top suppliers.
Al Rollins
Al Rollins
Focus Areas:
Al has extensive experience in providing management system implementation support for companies striving to enhance their business effectiveness. With his support, SAI Global’s customers gain the ability to incorporate the standard’s requirements while enhancing their management systems without losing their individual corporate identities. His strengths lie in his proven ability to work throughout diverse organizations establishing management systems that significantly improve process effectiveness and organizational results.
Additional Skills/Expertise:
His work has achieved significant business improvement by way of initiating and encouraging major system and cultural change. His current work is with organizations that are applying AS9100, ISO 9000 and ISO 9000-based quality management systems (including ISO/TS 16949 and TL 9000), as well as integrated ISO 9000 and ISO 14000 quality management systems, to improve their business processes.
Sonny Sahi
Sonny Sahi
Focus Areas:
Sonny has solid skills and extensive knowledge and experience in auditing, SPC and project engineering, which allows him to help our customers reach their business process improvement goals quickly and efficiently. Sonny offers a valuable dual perspective: he understands an auditor’s perspective of how systems can be optimized and how to find improvements through the evaluation of engineering designs, cost reduction proposals and best manufacturing methods.
Additional Skills/Expertise:
Sonny has assisted clients in developing and implementing quality management systems based on ISO 9001, ISO/TS 16949 and ISO 14001. As part of the implementation activities, he has performed quality awareness training, including SPC and FMEA. In addition, he has conducted numerous third-party certification audits that covered a range of design activities.
Suzanne Sessoms
Suzanne Sessoms
Focus Areas:
Suzanne has hands-on experience in several industries including the telecommunications, chemical/ petrochemical, pulp and paper, electronics, automotive and agriculture. Suzanne’s diverse chemical and manufacturing engineering experience allows her to quickly understand and evaluate process control systems for product quality, environmental and/or health and safety compliance. One of Suzanne’s specialties is the development of environmental health and safety management systems including compliance strategies, risk management and pollution prevention. In addition, Suzanne is instrumental in applying and optimizing air and wastewater control technologies.
Additional Skills/Expertise:
She continued to demonstrate her ingenuity by assisting with the development of the first ISO14001 registered EMS for a major swine producer. She has extended these capabilities to include OHSAS 18001 and fully integrated management systems that are tailored to client needs to improve performance.
 
 

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