Management Review
Panel Discussion
Portland Section Dinner Meeting
December 11, 2012
Panel Members
Carrie Cabak
With 27 years of quality experience as a lead auditor, teacher, business
consultant, and quality manager, she has worked at Garmin for almost 7
years.
Bogdan Moyseowicz
With over 30 years in manufacturing quality, he is presently implementing an
ISO9001 compliant QMS at Benchmade Knife Co.
Tom Raab
With over 20 years experience in manufacturing engineering and 5 years as
a quality manager, he works at Biamp Systems, developing the QMS and
gaining ISO9001 certification.
Pete Wilson
During the last 14 years as a quality manager at Coca Cola, he has
implemented ISO22000, ISO9001, ISO14001, and ISO18001.
ISO9001 Quality Management
Requirements
Top management shall review the
organization's QMS, at planned intervals,
to ensure it continuing suitability,
adequacy and effectiveness. This review
shall include assessing opportunities for
improvement and the need for changes
to the QMS including the quality policy
and quality objectives.
ISO9001 Quality Management
Requirements
Review Inputs
Results of audits
Customer feedback
Process performance and product conformity
Status of preventive and corrective actions
Change that could affect the QMS
Recommendations for improvement
ISO9001 Quality Management
Requirements
Review Outputs
Decisions and actions related to:
Improvement of the effectiveness of the QMS
and it processes
Improvement of product related to customer
requirements
Resource needs
Carrie Cabak
Quality Manager
Garmin
Management Review Experience
Underwriters Laboratories 1985 – 1996:
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BS5750 (UL/BSI Collaborative Certification)
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ISO/QS/EN/TS Qualified Lead Auditor
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Quality Registration Systems Group Leader
CommonCents Solutions 1996 – 2006
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Business Management Consulting
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ISO/QS/TS Implementation
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Adjunct Software Quality Assurance Manager
Garmin 2006- Present
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Quality & Manufacturing Engineering Manager
Industry Experience
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Paper/Paper Products
Electronics Manufacturing
Hi-Power Electrical Equipment
Medical Devices
Metal Forming
Plastics
Software/Database Development
Regulatory Experience
• UL/Product Safety
• FDA – Medical Devices
• FAA - Avionics
Keys to Success
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Address the “So What?”
Aligned
Right audience
Meaningful
Specific
Realistic
Metric-centric
Apply “P2DCA”
Live the Quality Policy!
Things that don’t work…
• Use this time to air complaints about the
organization, system, processes,
procedures
• Use this time to push “personal agendas”
• Use this time to train
• Deviate from agreed-upon meeting
rules/protocol
• Stick to “one meeting/year” when more is
needed.
Bogdan Moyseowicz
Quality Manager
Management Review Experience
Involved with ISO 9000 series since
1990 in the following industries:
•Commercial Electronics
•Silicon wafer manufacturing
•Metal forming and stamping
•Sporting, Military and Law Enforcement
knives
Keys to Success
Management Review:
•The person at the top needs to own it
•It’s NOT a “Dog-and-Pony” show!
•There has to be open and honest
discussion of issues at hand
•Don’t allow anyone to play the blame
game
•Actions must follow the review
Educate Senior Management on
their role
•To own the QMS, its institutionalization
and continuous improvement
•To ask probing questions about its
–Suitability
–Adequacy
–Effectiveness
•Support it as an integral part of the
company culture
Educate Senior Management on
these Key Concepts
•Suitability
– Is the QMS suitable and appropriate for the
business and its processes?
•Adequacy
– Is it adequate to ensure customer
satisfaction from source to customer?
•Effectiveness
– Does it do the job it was designed to do?
Metrics for Management Review
Look for metrics that address the
question of effectiveness
Often, focus is only on status:
•Number of CA’s open and closed
How about:
•Time to close CA’s
•Related PA’s initiated
QMS Improvement & Resources
Discuss and decide on specific actions
to make improvements in the QMS
Recognize and address any resource
limitations
Follow through with regular updates on
MR Action Items
Don’t wait until next MR to bring up
issues or lack of progress
Tom Raab
Quality Manager
BiAmp Systems
Pete Wilson
Quality Manager
Coca Cola
ISO9001 Quality Management
Requirements
Classified - Internal use
ISO9001 Quality Management
Requirements
Classified - Internal use
ISO9001 Quality Management
Requirements
Classified - Internal use