Supplier and Internal Quality Audits

Monday November 20, 2017
5:30 pm - 8:00 pm

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The presentation focuses primarily on Supplier Qualification and Process audits, and includes key components required for a successful internal audit program.  It will provide advice on strategies that may not be in the “Manual”, from pre-audit planning to closure, avoiding time consuming tactics, and what’s most important to look for when limited for time.  

Location

3041 N Mayfair Road, Milwaukee, WI

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Speaker

KASHYAP MALKAN BIO

“Kashyap enjoys using his diverse background in assessing, improving and executing remediation for quality management systems for organizations of varying sizes for ISO 9000 and 13485. For over 15 years, Kashyap has been hands on with companies implementing and transitioning ISO QMSs in the medical and automation realms. Kashyap has been sharing his technical and organizational competencies with small to mid-sized companies while managing suppliers for multi-billion companies such as GE Healthcare, Carefusion (BD), Rockwell Automation that develop a range of products from complex medical devices to microscopic electronic components.


Kashyap has holds a Master in Engineering Management, Masters in Quality Engineering, Bachelors in Computer Science from Marquette University. He is certified as a Lead Auditor, PMP, Lean and Six Sigma blackbelt. He loves to coach First Lego teams with STEM concepts to children in every chance he gets! “

 

PAUL RICHARDS BIO

Paul Richards is a Senior Member of ASQ, a Certified Quality Auditor, and a Certified Manager of Quality and Organizational Excellence. He is a Supplier Quality Lead Engineer and Senior Auditor at GE Healthcare in Waukesha, WI. Paul also performs an internal audit service for smaller medical device companies and is a Lead Auditor with Malkan Solutions, a consulting group focused on providing supply chain and quality solutions.

He began working in the printing field after obtaining an Associate degree in Printing and Publishing from Milwaukee Area Technical College and eventually became the Quality Manger for a company that produces medical packaging. He earned a Bachelor’s degree in 2006 from Ottawa University.

In 2007 GE Healthcare offered an opportunity in Waukesha, WI for a Quality Engineer which Paul accepted. In 2010 he moved on to become a Supplier Quality Lead Engineer in the Services group.

He has also taken on responsibilities as a Calibration Auditor and Training Auditor at GE Healthcare.

Paul resides in Wauwatosa, Wisconsin with his wife Kathie and two teenage children.

Roundtable Discussion

November 2017 Roundtable Discussion Topic

“ISO 9001:2015 Implementation at Harley-Davidson”

We are fortunate to have Scott Waligora and Bob Della from Harley Davidson.  They will be co-presenting the past years activities that surround Harley-Davidson’s Quality Management System transitioning to compliance with the ISO9001:2015 standard. They will provide an overview of the implementation of the standard across the Motor Company’s 6 global sites. They will also cover the new requirements and share how we were able to leverage current business practices to meet these new requirements.    

Scott has had an exciting career in Quality with roles in technical problem solving, supplier quality, manufacturing quality, and auditing across the automotive and medical device spaces. He is currently the Corporate QMS Manager at Harley-Davidson. Bob is a Harley-Davidson veteran with past roles in logistics, project management, continuous improvement, manufacturing quality, and QMS. Bob is currently a Sr. QMS Leader at Harley-Davidson.

The presentation will begin at 5:30; we will distribute RU slips at the tables at 5:45.  If you arrive after 5:45 please participate but understand that you will not receive RUs for the event.

We will finish up at 6:15 leaving ample time to register for the meeting.

Roland Chaloupka

Roundtable/Pre-Meeting Chairperson