Management Review Panel Discussion

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 MoyseowiczWith over 30 years in manufacturing quality, he is presently implementing an

ISO9001 compliant QMS at Benchmade Knife Co.

Tom RaabWith 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 WilsonDuring the last 14 years as a quality manager at Coca Cola, he has

implemented ISO22000, ISO9001, ISO14001, and ISO18001.

ISO9001 Quality Management RequirementsTop 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 RequirementsReview 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 RequirementsReview 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 CabakQuality Manager

Garmin

Management Review ExperienceUnderwriters Laboratories 1985 – 1996:• BS5750 (UL/BSI Collaborative Certification)• ISO/QS/EN/TS Qualified Lead Auditor • Quality Registration Systems Group LeaderCommonCents Solutions 1996 – 2006• Business Management Consulting • ISO/QS/TS Implementation• Adjunct Software Quality Assurance ManagerGarmin 2006- 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 “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 MoyseowiczQuality 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 closedHow 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 RaabQuality ManagerBiAmp Systems

Pete WilsonQuality Manager

Coca Cola

ISO9001 Quality Management Requirements

Classified - Internal useClassified - Internal useClassified - Internal use

ISO9001 Quality Management Requirements

Classified - Internal useClassified - Internal useClassified - Internal use

ISO9001 Quality Management Requirements

Classified - Internal useClassified - Internal useClassified - Internal use