|
Mark Kaganov
|
|
|
Table of contents:
|
|
|
|
Русский
|
|
English
|
|
|
Short biography:
|
>
back to the top |
|
 Mark Kaganov was born and raised in Moscow, Russia. He graduated from Moscow University of Radio-electronics and Automation where he earned his Bachelor and Master's degrees in design and technology of electronic equipment. While attending the university, he worked for
Institute of Plastics, the former USSR's leading organization in
research and development of plastic materials. Mr. Kaganov designed plastic
materials and developed test equipment and processing methods for automotive, aerospace,
medical, agricultural, consumer and other industries. In the late
1970s he was an active member of the group representing the USSR on the ISO Technical Committee
(TC) 61 that developed test methods for plastics for ISO standards.
In 1981, Mr. Kaganov immigrated to the US and continued his professional career in Quality Assurance and Research and Development in the plastics, electronics, and medical device manufacturing industries. He has worked for major
international corporations such as Capitol Records, RCA, COBE Laboratories,
Medtronic and British Standards Institution (BSI). During his professional career, Mr. Kaganov has published a number of technical articles in the areas of
research of plastics, the economics of manufacturing,
ion-selective electrode technology and quality and environmental
management systems . He has also authored numerous international patents.
Since 1990, as a
Director of Operations, Mr. Kaganov manages Quality Works. The company
specializes in providing businesses with consulting and
publications in the areas of
development and implementation of quality
management systems (QMS), environmental management systems (EMS), optimization of manufacturing and service
processes and design of custom software.
From 1996 to 2001, Mr. Kaganov
worked for British Standards Institution (BSI), Inc., one of the world's leading registrars and notified bodies as
a Client Manager and a
Lead Auditor. His qualifications include ISO 9000,
ISO 14000, AS 9100, ISO 13485, EN 46000 and Medical Device Directive 93/42/EEC for CE marking. In early 1998, Mr. Kaganov led an assessment for the first registration in North America to the ISO 13485 standard.
Mr. Kaganov has over 20 years experience in the development, implementation and management of quality
management systems. His industrial experience covers numerous areas such as plastics, electronics, optics, defense and medical equipment manufacturing. Working in the ISO
9001 and ISO 14001 registration arena, Mr. Kaganov has assisted dozens of North American, European and Asian companies in registering their
quality and environmental systems.
Mr. Kaganov is certified as
a QMS Lead Auditor with the International Register of Certificated Auditors
(IRCA), England and as an EMS Lead Auditor with Registrar Accreditation Board (RAB),
USA.
Mr. Kaganov is a
public speaker
and contributor of
articles to conferences and professional publications.
In
January 2005 Mr. Kaganov joined WSI as an
Internet
Business Consultant. In this capacity he
provides Internet
consulting, education and Internet business solutions to small and medium size
businesses. He offers companies economical results-oriented Internet
solutions including, Website development, advanced promotional programs to
generate high site traffic, economical hosting, on-line audio, video and
multimedia, secure e-commerce, e-learning and full service consulting and
education in the area of e-business.
|
|
|
Professional
experience:
|
>
back to the top |
|
MK
Internet, LLC, Lakewood, CO, 2004 to present (www.wsiallwebsolutions.com)
President
-
Purchased
and maintains a WSI Internet Business Consulting franchise with full
P&L responsibility.
-
Developed
and implemented a Business Management System for the company to ensure
its effective operation.
-
Conduct
business development activities to acquire and maintain client base.
-
Develop
and deliver client Internet business solutions to establish and
improve client’s Internet business with measurable ROI.
-
Coordinated
and implemented short and long-term business objectives with
responsibility for achieving the organization’s financial
goals.
|
|
|
QUALITY
WORKS, Lakewood, CO, 1990 to present
Director
of Operations, Author
Established
and manages Web-based E-commence consulting business with focus on
development of QMS and general Business
Management. Managed
staff of
up to 4 associates and coordinated workflow to ensure timely delivery of
services. Responsible for meeting company's financial goals and
objectives.
-
Developed and implemented
QMS and EMS for
clients to achieve ISO 9001, ISO 13485 and ISO 14001 certification.
-
In
cooperation with Moscow-based software development company, developed
and implemented custom distributor management software for a medical device
manufacturer.
-
Provided
Business Management consulting to start-up companies. Developed
business and marketing strategies and business plans.
Developed, validated and maintains customers' Web sites to support
their business presence on the Internet.
-
Wrote and
published numerous books and papers in the areas of ISO 9001, ISO 14001,
ISO 13485, EN 46001 standards, Medical Device Directive 93/42/EEC and the
US FDA Quality System Regulation to assist readers in understanding
complex requirements and regulations.
-
Made numerous public presentations
to promote company's services and establish its competitive position on
the market.
|
|
|
INTERTEK
SYSTEMS CERTIFICATION, Boxborough, MA January 2003 – March 2004
Contract
Auditor / Auditor
Provided
domestic and international customers with timely ISO 9001, ISO 13485,
CMDCAS, MDD 93/42/EEC CE-mark and ISO 14001 registration services.
Conducted pre-, certification, surveillance and special assessments to
assist clients in obtaining and maintaining their registrations and
improving their quality and environmental management systems.
|
|
|
TUV AMERICA, Boulder, CO January 2002 - March 2003
Project
Manager
/ Medical Device Auditor
Provided domestic and international customers with timely ISO 9000, ISO 13485, EN 46000, ISO
14000, CMDCAS and CE Mark registration services. Conducted pre-, initial, continuous and
special assessments to assist clients in obtaining and maintaining their
registrations and improving their quality and environmental management
systems.
Developed and taught
ISO 13485:2003 public course.
|
|
|
BSI
(BRITISH STANDARDS INSTITUTION), Inc., Reston, VA,
April 1996 to August 2001
Client
Manager
Provided domestic and international customers with timely ISO 9000, ISO 13485, EN 46000, ISO
14000, AS 9001 and CE Mark registration services, generating annual
revenue in excess of $250,000. Conducted pre-, initial, continuous and
special assessments to assist clients in obtaining and maintaining their
registrations and improving their quality and environmental management
systems.
-
Achieved
qualifications of lead assessor for Quality Management Systems
(QMS) for ISO 9001, EN 46001, ISO 13485 and Medical Device
Directive (MDD) 93/42/EEC for CE marking. Led
an assessment for the first registration in North America to ISO 13485:1996
standard. Achieved qualification
of assessor for Environmental Management Systems (EMS) for ISO 14001 standard.
-
Designed
a Microsoft Access-based Assessment Management software system to
computerize assessment reporting to improve accuracy and quality of
documentation and to increase assessment efficiency.
-
Conducted
market research in Russia to assess business opportunities and to
identify BSI's competitors' positions. Submitted business
development plan to BSI QA and BSI Testing management
groups.
-
In
addition to assessment responsibilities, conducted marketing and sales
activities to promote BSI's services. Generated additional revenue
in excess of $100,000. Developed and taught EN 46001 course to BSI,
Inc. staff.
|
|
|
EMCO
(ENGINEERING MEASUREMENT COMPANY), Longmont,
CO, May 1995 to April 1996
Quality
Assurance Manager
Directed activities of the Quality Assurance organization for an ISO 9001 certified
flow meter manufacturing facility. Managed QA and Documentation Management
groups to support business in timely production of high quality products
meeting budgetary requirements and customers' expectations.
-
Directed
implementation of company-wide Quality Management System and
manufacturing documentation to reduce operating costs and to enhance
compliance with ISO 9001 Standard.
-
Developed
and introduced Balanced Scorecard and trend analysis software to
define and monitor key business performance indicators and
objectives.
-
Implemented
effective corrective and preventive action, MRB, internal auditing and
calibration programs. Performed training in ISO 9000 standards,
internal auditing, SPC and TQM. Developed and implemented effective
design management, servicing and documentation change programs to
improve compliance with ISO 9001 Standard and to increase effectiveness of
QA organization.
|
|
|
MEDTRONIC
HEMOTEC, INC.,
Englewood,
CO, March 1991 to November 1994
Quality
Assurance Engineer
Coordinated activities of incoming, in-process and final QA organizations to meet
regulatory requirements and product delivery schedules for medical
equipment manufacturer.
-
Led QA function for introduction of new products
by designing and implementing product validation protocols. Developed and
implemented supplier certification program.
-
Reduced
incoming inspection cost 50% by revising part drawings to identify
critical functional attributes for instruments and disposable product
operations. Cut in-process failure rate 50% by leading
multi-functional corrective action team to identify and eliminate root
causes of non-conformities. Designed and implemented MS Access-based
failure analysis software system to support this task and to comply
with FDA QSRs and ISO 9001 Standard.
-
Established
conformance with FDA QSRs and ISO 9001 Standard by implementing and
coordinating supplier certification program to improve quality of
incoming materials. Conducted numerous supplier and internal audits
per QSRs and ISO 9001 Standard.
-
Designed
and implemented SPC program at supplier's facility which reduced
failure rate of incoming parts from major supplier 40%. Saved more
than $25,000 annually by eliminating in-process inspection and
transferring assembly and product verification functions to production
personnel. Developed complete structure of manufacturing procedures
for instrument product line.
-
Designed
and implemented Environmental program for recycling of packaging material
including location of subcontractors accepting card board and
packaging foam. Established recyclable material collection centers
and trained personnel in handling recyclable materials.
|
|
|
COBE
LABORATORIES, INC.,
Lakewood,
CO, June 1987 - October 1990
Quality Assurance Engineer
III, Group Leader
Led
QA activities for CentrySystem3
product line (nephrology equipment) meeting required quality standards and
FDA QSR regulatory requirements. Managed staff of up to seven employees
with responsibilities for project management, hiring, employee development
and performance evaluation.
-
Realized
7X improvement in MTBF of major
product line by analyzing and improving customer satisfaction and
product performance through design and implementation of field failure
tracking system with audit centers.
-
Established
compliance with GMPs by designing and implementing failure analysis
system for manufacturing facility identifying and solving production
floor problems.
-
Played
an active role in implementation of Just-In-Time (J-I-T) program for
Nephrology division to increase throughput 300% and reduce
Work-In-Process (WIP) by 90%
|
|
|
COBE
LABORATORIES, INC., Lakewood,
CO, June 1986 to June 1987
Quality Assurance Engineer
III, Project Leader
Designed
and validated conceptually new pH combination electrode for Nephrology
equipment. Led development, validation and implementation of differential
pH circuit which resulted in tenfold improvement of electrode's lifetime.
Project led to estimated increase in sales of $ 1,000,000, significant
savings in warranty cost, two technical publications and five US and
international patents.
|
|
|
COBE
LABORATORIES, INC.,
Lakewood,
CO, June 1985 to June 1986
Quality Assurance Engineer
III
Conducted
reliability studies of disposable sets for blood component technology (BCT)
equipment. Designed and validated various prototypes of sets to
select and qualify final design to meet equipment specifications and FDA
QSR requirements.
|
|
|
COBE
LABORATORIES, INC.,
Lakewood,
CO, June 1984 to June 1985
Quality Assurance Engineer
II
Performed
root cause analysis of field failures and customer complaints for
Nephrology equipment to provide R&D group with suggestions for
improvement of reliability and performance of equipment. Analyzed failures
of printed circuit boards, hydraulic and electro-mechanical components to
resolve customer complaints
|
|
|
RCA
CORPORATION, "SelectaVision" Division,
Indianapolis,
IN, November 1982 to December 1983,
Quality
& Reliability Engineer
Developed
and implemented test methods for assessment of in-process and final
quality of PVC video disks to improve process efficiency and quality of
final product. Developed a mathematical model of material flow for
automated PVC compounding facility to establish correlation between
quality of the final compound and lots of raw materials. Developed and
implemented operating procedures for PVC compounding facility
|
|
|
CAPITOL
RECORDS, INC.,
Jacksonville,
IL, November 1981 to November 1982
Engineer
Coordinated
activities of Incoming Quality laboratory. Developed and implemented test
methods for assessment of incoming, in-process and final quality of
PVC audio records.
-
Developed
clear and concise specifications for raw materials to improve
communication with suppliers.
-
Conducted
design of experiments on production equipment to optimize process
settings and improve process efficiency and quality of final
product. Defined relationship between record audio quality and such
processing parameters as blending cycle, extruder temperature profile
and pressing cycle to reduce scrap and product cost.
-
Led
product cost reduction program by optimization of PVC compound that
resulted in reduction of cost of raw materials by $8,000 per year
|
|
|
INSTITUTE
OF PLASTICS, Moscow,
USSR, December 1975 to April 1981
Senior Engineer
Led
design and development of non-standard testing equipment and methods
for various plastic materials and finished products to evaluate new and
existing materials and technological processes.
-
Characterized
thermoplastic and thermoset materials by such properties as tensile
and compression strength & strain, shear, stiffness, impact
strength, tear, hardness, etc.
-
Implemented
and conducted environmental and accelerated aging studies for
materials and finished products used in various industries.
-
Designed
plastic materials, and developed test equipment and processing methods
for automotive, aerospace, agricultural, consumer and other
applications
-
Participated
in activities of the group representing the USSR on the ISO Technical
Committee (TC) 61 that developed test methods for plastics for ISO
standards.
|
|
|
INSTITUTE
OF PLASTICS,
Moscow,
USSR, October 1968 to December 1975
Technician
Maintained
Instron and Zwick test equipment to assist research personnel in timely
completion of projects. Designed and constructed specialized high
and low temperature test equipment for characterization of materials for
application in aerospace and automotive industries. Maintained high speed
(up to 1,000 m per second) impact test equipment to assist research
personnel in qualifying materials for defense applications
|
|
|
INSTITUTE
OF CHEMICAL MACHINERY,
Moscow,
USSR, October 1966 to October 1968
Associate Technician
Assembled,
installed and tested pressure, temperature and humidity control circuits
to assist engineering staff in evaluating prototypes' performance for
optimization of industrial chemical processing methods.
|
|
|
Education:
|
>
back to the top |
|
Moscow University of Radio Electronics and Automation, Moscow, USSR
-
M.S.
Design and Technology of Electromechanical
Equipment, 1975
-
B.S.
Design and Technology of Electromechanical Equipment, 1971
|
|
|
Languages:
|
>
back to the top |
-
Russian,
native,
fluent spoken and written
-
English.
fluent spoken and written
-
Spanish,
beginner, self-study
|
|
|
Professional
certifications
and affiliations:
|
>
back to the top |
-
IQA International Register of Certificated Auditors (IRCA), UK
QMS
Lead Auditor, Certification No. A008436
-
Registrar Accreditation Board (RAB), USA
EMS Lead Auditor, Certificate No. E052617
-
Health Canada
CMDCAS Auditor, Certificate No. M-1233
-
American Society for Quality (ASQ)
Member 1994 - 2006
|
|
|
Publications:
|
>
back to the top |
-
ISO 9001:2000 - A Process Interaction Matrix -
A Case Study
Mark Kaganov, Quality Progress,
October
2004, p 194.
You can
download a .pdf version of
this publication from this Web site.
(14)
-
Transition Checkup for ISO 13485:2003
Mark
Kaganov, Quality System Update (QSU),
June 2004, pp 12-14.
You
can
download a .pdf version of
this publication from this Web site.
(13)
-
ISO 9001:2000 - A Quality
Manual For the Transition and Beyond
Mark
Kaganov, Quality Progress, March 2003, pp 27-31.
You can
download a .pdf version of
this publication from this Web site. (12)
-
Keep Your Web Site Under
Control
- This case study shows how effective Web
site management can help you establish compliance with
ISO 14001 and ISO 9001:2000
Mark
Kaganov, Quality Progress, November 2001, pp 51-56.
You can
download
a .pdf version of this publication from this Web site. (11)
-
Checklists - A Perfect
Tool to Tune-up Your Quality Manual
Mark Kaganov,
Quality Progress, October 2000, pp.37-41. You can
download an updated version
of this publication from this Web site. (10)
-
EN 46001 / ISO 13485 - A
Practical Approach to the Development and Implementation of a
Quality Manual
Mark Kaganov,
Quality Works, 1999,
Quality Works Store
(9)
-
ISO 9000
- A Practical Approach to the Development and Implementation of a
Quality Manual
Mark Kaganov, Standards &
Quality, Moscow, 1999 (Russian) (8)
-
ISO 9000 - A Practical
Approach to the Development and Implementation of a Quality Manual
Mark Kaganov,
Quality Works, 1998,
Quality Works Store,
1998 (7)
-
Monte
Carlo Approach to Assessment of the Accuracy of Ion-Selective
Circuits
Mark Kaganov, American Laboratory, September
1996, pp. 46-51 (6)
-
Ground
Loop Current: The Achilles' Heel of Ion Measurement
Mark Kaganov, American Laboratory, March 1992,
pp. 59-62, Part I; October 1992, pp. 17-23, Part II (5)
-
A
Practical Approach to Measurement of pH Glass Resistance
Mark Kaganov and Ken Maydew, American Laboratory, June 1988, pp.
68-78 (4)
-
Processing Economics: Here's a Simple Way to Make Comparisons
Mark Kaganov, Plastics Technology, June 1984,
pp. 71-73 (3)
-
The Properties of New Low Temperature Resistant
Polymers
Yakutsk, USSR, 1977, pp. 233-235 (Russian) (2)
-
Evaluation of
Viscoelastic Tensile Properties for Several Polymer Films
Rostov-Don, USSR, 1976, pp. 34-36 (Russian) (1)
|
|
|
Patents:
|
>
back to the top |
|
"Safe Failure Ion-Selective Combination Electrode,"
Mark Kaganov,
-
Germany, Patent No. 40 21
853, March 9, 1995
-
Canada, Patent No. 2,019,728, January 17, 1995
-
Italy, Patent No. 1,240,484, December 17, 1993
-
Great Britain, Patent No. 2,233,768, January 5, 1993
-
USA, Patent No. 5,096,565, March 17, 1992
|
|
|
Continuing
education:
|
>
back to the top |
-
Internet
Business Consulting
WSI, Torontro, Canada, October 2005 -
January 2006
-
Project
Management Certificate Program
Colorado State University, Denver, CO, September 2004 - February 2005, (6.0 CEUs / 60
PDUs)
-
The
Rosetta Stone Language Library, Spanish 1
Self-study CD course,
February 2002 to present
-
Canadian
Medical Devices Regulations
Academia Qualitas, Montreal, Canada, June
2001
-
Aerospace
Auditor Training Course AS 9001
Bureau Veritas, BSI, July 2000
-
Advanced
EMS (ISO 14000) Lead Auditor Course
CEEM, Reston, VA, July 1999
-
Effective
Negotiating
Karrass, Denver, CO, October 1997
-
Think
& Talk Spanish
Berlitz self-study course, August 1996 to present
-
ISO
9000 Lead Assessor of Quality Systems
Perry Johnson, Inc.,
Southfield, MI, September 1994
-
Statistical
Process Control
QINAS, Inc., Englewood, CO, June 1989
-
Design
of Experiments Utilizing Taguchi Concepts
QINAS,
Inc., Englewood, CO, February 1989
-
How
to Work with People
Fred Pryor Seminars, Denver, CO, August
1988
-
Interact
- Interpersonal Problem Solving
COBE Laboratories,
Inc., Continuous Education Program, Lakewood, CO, June 1988
-
Supervisory
Skills
Mountain States Employee Council, Inc.,
Denver, CO, March 1988
-
Just-In-Time
Manufacturing
J-I-T Institute of Technology, Inc.,
Parker, CO, December 1987
-
Managing
Conflict
AT&T Organization Effectiveness
Group, Aurora, CO, December 1986
-
Design
of Experiments
RCA Engineering Education Course,
Indianapolis, IN, Spring 1983
-
Programming
in BASIC
MacMurray College, Jacksonville, Il, Fall
1982
-
Manufacturing
Economics
Institute of Plastics, Moscow, Russian
Federation, 1976 - 1977
|
|
|
Public presentations and courses:
|
>
back to the top |
-
Need Leads? Check the Internet
Business Excellence Forum, Denver
Metro Chamber of Commerce, January 24, 2006
-
Does
your Website Bring you Money?
Denver
Metro Chamber of Commerce, September 11, 2006
-
ISO 13485:2003 -
Overview and Transition Strategy for Medical Device Personnel
A two-day public course for The Center for Professional Innovation
& Education, Southeastern, PA, April 25-26, 2005
-
Checklists - A Perfect Tool to Tune-up Your
Quality
Manual"
ASQ Rochester Section, 57th Annual Quality Conference,
Rochester,
NY, March 28, 2001
-
Checklists - A Perfect Tool to Tune-up Your
Quality
Manual
ASQ Salt Lake City Section, Salt lake City, UT, January 18,
2001
-
Assessors' Secrets
ASQ Salt Lake City Section, Salt lake City, UT, January 18,
2001
-
Trend
Analysis System for ISO 9001
ASQ Denver
Section, Denver, CO, January 1994
|
|
|
