Section Meeting

Wednesday February 21, 2018


Managing the Complexity of Global Supply Chain Partnerships
Have you ever heard someone say that their company offshored to country X and the quality was terrible, or that when the product was moved to country Y and the costs went up, or that country Z rips off our IP.  Is this done to us or do we allow it to be done unto us?

Supply Chain Management has become a global playing field in recent years.  The common view point is that there has been a race to the lowest common denominator, offshoring technology and intellectual property to Asia and moving us the consumers farther and farther away from the centre of the supply chain.  The concept of supply and demand are universal, the definition of quality and service are universal – providing the correct products at the correct price at the correct quality on time every time.  Our local needs and expectations may change however and we need to be able to reflect this cultural shift in our supply chains.  Add in to this ethical supply chains and our task of managing a complex supply chain becomes even more complex.

In this webinar we will address the central questions of (a) is globalisation a necessary constituent of modern supply chains and (b) what alternatives are necessary. We will look at the premise of ‘glocalisation’ in the supply chain environment – how can we apply the concepts of global supply chain management in a local environment.  Finally we will review tools and techniques for building complex supply partnerships and why partnerships whereby all elements of the supply chain are working in unison for the customers customer and everyone is s
haring the good fortune along the way

John Perigaut

John is an ASQ Fellow and CQE, CQA, CMQ/OE, and CBA.  His other certifications include:  Massachusetts Quality Award Examiner, Lean Certificate Degree, and Certified Train-the-Trainer from Motorola University.  He holds a BS in Industrial Engineering and an MBA in Finance.  Currently, John is the QMS Manager at Philips Health Systems in Andover, MA.  John is also an Adjunct Professor at Merrimack College.

In the course of his career, John has implemented ISO 9001 and Lean Manufacturing at various companies in various industries Worldwide.  He speaks on Quality and Change Management at World and Local ASQ Conferences.  John has also cerved as Chair for ASQMV.

Location (see map)
Holiday Inn Tewksbury –Andover
4 Highwood Dr
Tewksbury, MA 01876


5:30 - 6:00 Registration

6:00 - 7:00 Presentation

7:00 - 7:30 Dinner


American Society for Quality
Merrimack Valley Sec. 0102
PO Box 275
North Andover,  MA 01845-0275

SQMV Dinner Meeting

Thursday, February 7, 2019

ISO 13485:2016 Supplier Controls—Best Practices that Make Sustainable Change


Event Schedule:
Registration: 5:30 - 6:00
Buffet Dinner: 6:00 -6:45
Presentation: 6:45-7:45

The changes to ISO 13485:2016 have placed additional emphasis on Supplier Controls. As more companies outsource more of their processes or become virtual, the expectation are controls are implemented. What are the big problems found during the ISO audits? What are the best practices?
During this presentation, we will review the ISO Requirements and some of the best practices that are being used in industry. In addition, we will cover the use of proactive tools such as The Total Risk Factor™ and Total Cost of Ownership. These tools will not only help compliance, but they can reduce your overall Cost of Quality (appraisal). Key elements of the ISO requirements:

1. Documentation

Records of suppliers evaluation/selection/monitoring
Purchasing information documents and records, including a written agreement as applicable that the supplier notify the organization of changes in the purchased product prior to implementation of any changes that affect the ability of the purchased product to meet specified purchase requirements

2. Criteria

The criteria for the evaluation and selection of Suppliers shall be based on the Supplier’s ability to provide product(s) that meet the organization requirements, on the performance of the supplier and on the effect of the purchased product on the quality of the medical device. The standard also specifies that the evaluation and section criteria shall be proportionate to the risk associated with the medical device.

3. Risk-based approach

Both the above described Criteria and the actions implemented following the non-fulfilment of Purchasing requirements shall follow a risk-based approach, proportionate to the risk associated with the purchased product.

Presenter: James Shore

James “Gunny” Shore is the Chief Quality Officer at Quality Lean Solutions, consulting for Medical Device companies helping them improve in Compliance, Quality Systems, Operational and Lean Manufacturing. Jim has 25 years of quality and supplier management experience working in medical devices, semiconductor, aerospace and defense. His professional certifications include ASQ Certified Six Sigma Black Belt, ASQ Certified Quality Manager/Operations Excellence, Certified Quality Auditor and Certified Mechanical Inspector and ASQ Senior Member (joined in 1988). James is a Certified Welding Inspector and Test Supervisor for the American Welding Society.
James has served the ASQ Society as a Member Leader for over eighteen years; Boston Section Chair, Region Director (New England), Section Affairs Council Vice-Chair, Board of Directors, and Treasurer of the Biomedical Division. Currently, James is the 2019 Chair of the Biomedical Division and Deputy Region Director (New England).
James is the co-author of the book entitled “Proactive Supplier Quality Management in the Medical Device Industry,” which is published by Quality Press. 100% of the royalties are donated to Veteran service organizations. Jim served in the United States Marine Corps for 15 years and was Honorably Discharged at the rank of Gunnery Sergeant (E-7).

Call for Speakers

ASQMV is looking for subject matter experts!

Have you ever thought about giving a presentation on something you do well?  Do you have a case study that would be of interest to our colleagues?  Do you know someone who would be a great speaker? Think about joining me to be part of our innovative programs planning for the upcoming year.  Any ideas or interests please contact ASQMV Programs Chair at, or just discuss your thoughts at one of our upcoming meetings.