Typical Case Descriptions
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Some client identities are deleted from the
following case descriptions to protect confidentiality. Client
information is not disclosed without explicit authorization.
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Large
Engineering Projects
- Ontario:
Consultant to prime contractor for proposal and startup of York
University Busway design/build project.
Developed ISO 9001 compliant QMS, trained auditors and led initial
audits.
Alberta: Quality
System development and management for design, construction and
operation of the Anthony
Henday South East Ring Road by Access Roads Edmonton Limited (AREL).
The project is a Private Public
Partnership with the Government of Alberta. Work commenced January,
2005, with traffic availability October,
2007, and ongoing operations and maintenance contracted to AREL for 30
years. The Quality System complies
fully with ISO 9001:2000. Roles include development of Quality response
in proposal; development, training and
implementation of Quality Systems for AREL and its Design, Build and
Operations partners; auditing of all
quality systems and quality management of the project for AREL.
- New
Brunswick: Quality System Implementation and management
for Maritime Road Development Corporation
(MRDC). The QMS was ISO 9001 compliant and closely integrated with
environmental and safety management
plans, for 195 km, $584M, design-build-operate Fredericton-Moncton
Highway Project; opened to traffic in 2002.
Roles included drafting the quality management components of the
winning proposal in 1997, completion of the
quality documentation leading to final negotiation and signing of the
contract, and managing the Quality Systems
of the MRDC Construction Joint Venture, Engineers Joint Venture and
Operations Corporation from 1998 to
2000. This project
received a 2003 Canadian Consulting Engineering Award of Merit for
design, quality control and environmental management.
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Health
Care
- Needs assessment, training program design and
delivery for Sunnybrook-Osler Centre for Prehospital Care and
Ontario Base Hospitals Group including custom training delivery for 27
base hospital and EMS managers and
medical staff in team methods and basic statistical tools for quality
improvement. Syllabus was aligned to the
American Society for Quality (ASQ) Certified Quality Improvement
Associate body of knowledge. Several of the
group subsequently registered for and passed the examination for this
credential.
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Medical Devices
- Consultation, coaching and documentation
preparation for several medical device manufacturers and distributors
to obtain or retain registration to ISO 13485 as required by the
Canadian Medical Devices Regulations. Product
types include in-vitro diagnostics (drug of abuse, cancer and cardiac
markers, fertility, pregnancy, menopausal
tests), blood pressure and blood sugar monitoring systems, needle free
insulin injectors, orthopaedic implants and
surgical tools, procedure kits and operating room communication
systems. Clients include local designer- manufacturers,
virtual manufacturers using off shore design and production facilities,
and private labelling
manufacturers and distributors.
- Registration has been successful in all cases
and generally attended by noticeable improvements in business
control systems.
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Custom
Manufacturing
- Facilitation of ISO 9001:2000 registration for
custom store furnishings manufacturer. Project included training,
process analysis and improvement, policy and procedure documentation,
internal auditing and conduct of
management reviews.
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Construction
and Contracting
- Developed Quality Management system for a major
Ontario road construction firm in compliance with Ministry
of Transportation quality system requirements. Project included
development of the documented system and
training and leading internal auditors through the initial cycle of
quality system audits.
- Provided quality auditing and sampling
applications to project to develop MTO Design Assessment Checklists
and Procedures.
- Worked extensively with Applied Industrial Floor
Systems Ontario Ltd. to design and document their Quality
Management System in line with ISO 9002:1994. The company specialized
in high quality polymeric flooring for
a variety of industrial applications, including food processing and
medical environments.
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Other
projects and disciplines
Quality
systems
- Training and consulting to prepare five medical
device manufacturers for registration to ISO 13485 in
compliance with new Canadian Medical Devices Regulations under HRDC
productivity program.
- Business case assessment for bio-tech startup to
support Federal Funding application.
- Facilitated recovery of QS 9000 registration for
a Tier 1 automotive parts manufacturer.
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Quality
management and engineering
- Developed process documentation and deployment
methodologies for an international consumer product
manufacturer.
- Coordinated capability studies, recommended
practices, trained quality manager and clarified
subcontractor requirements for new automotive part project.
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ISO 9001/QS
9000 registration
- Consultant and trainer in implementation and
registration projects for: ISO 9001:2000 – Medical Device
importer/distributor, Chemical formulator/reseller, ISO 9001:1994 -
Leading Canadian designer and
manufacturer of metal roll forming machinery, Designer/producer of
consumer packaging; ISO
9002:1994 - Major Ottawa plastics mould maker and injection moulder,
Toronto area roll former, Printed
circuit board producer, Multi-plant pigment and chemical manufacturer;
QS 9000 - Tier-1 automotive
electronics manufacturer.
- Also conducted pre-registration assessments for
companies in paper, software, textiles, electronics,
automotive parts, household products, pigments, chemicals and packaging.
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Improvement
programs
- Lead consultant for productivity and quality
improvements for custom orthotics manufacturer.
- Advised and coached management of a window
products company in a participative, company-wide, continuous
improvement program featuring improved results reporting, increased
employee participation and
benchmarking exchanges.
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Training
- Author and trainer for CSA ISO 13485:2003
Essentials and Transition courses, 2003 - 2007.
- Developed and delivered training in quality
improvement for Canadian medical device manufacturer.
- Wrote and delivered public and in-house courses
on Internal auditor training, ISO 9001:2000 & 1994,
ISO 13485:2003 & 1996, QS 9000, Statistical Process Control
(SPC), Quality Improvement, Team
Problem Solving, and Quality Function Deployment for clients in various
industries, including medical,
engineering, aerospace, automotive, packaging, chemicals and foods.
- Contributing author to the CSA-ISTC Course on
Environmental Management - 1993.
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