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: BS5750 (UL/BSI Collaborative Certification) ISO/QS/EN/TS Qualified Lead Auditor Quality Registration Systems Group Leader CommonCents Solutions 1996 – 2006 Business Management Consulting ISO/QS/TS Implementation Adjunct Software Quality Assurance Manager Garmin Present Quality & Manufacturing Engineering Manager

Industry Experience 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 Address the “So What?” Aligned Right audience Meaningful Specific Realistic Metric-centric Apply “P 2 DCA” 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