Click on the orange Eventbrite link to view all the current

ASQ-Raleigh live events, and to register. It is

recommended that you bookmark it in your browser.

Inside This Issue

1...... Eventbrite link

2...... Upcoming Events

........ Member Re-Certifications

3...... Certification Opportunities

........ Career Opportunities

4...... Recertification tip

........ ASQ Dinner Meeting

Cancellation Policy

........ ASQ Raleigh Social Media

5-6 .. 2016 Raleigh Section

Leadership Council

7-10 Executive Roundtable

Series

11 ... Food Bank Volunteer

Opportunity

12 ... ASQ Raleigh Community

Good Works

ASQ Raleigh Sect ion, P.O. Box 5589, Cary, NC 27518

www.asqraleigh.org

ASQ Raleigh Section Newsletter

June 2016

Inside This Issue

1...... Eventbrite link

2...... Upcoming Events

........ Member Re-Certifications

3...... Certification Opportunities

........ Career Opportunities

4...... Recertification tip

........ ASQ Dinner Meeting

Cancellation Policy

........ ASQ Raleigh Social Media

5-6 .. 2016 Raleigh Section

Leadership Council

7-10 Executive Roundtable

Series

11 ... ISO 9001 Workshop

12 ... ISO 13458 Workshop

13 ... Food Bank Volunteer

Opportunity

14 ... ASQ Raleigh Community

Good Works

ASQ Raleigh Section Newsletter Page 2

Member Re-Certifications May 2016

Robert Carter ..................... CQE, CMQ/OE, CSSBB

Stephen Barfoot ................. CQE, CMQ/OE, CQA

Pritesh Majmundar ............ CSSBB, CMQ/OE

Dustin Smith ........................ CQA

Upcoming Events/Conferences

June 10, 2016 ASQ Sponsor of the Executive Roundtable Series hosted by SAS

August 4, 2016

Workshop - Using Your ISO 9001:2008 QMS to Plan for the ISO 9001:2015 Changes

Register Here

Workshop - What’s new with ISO 13458:2016 for Medical Devices?

Register Here

September 8, 2016 ASQ Sponsor of the Executive Roundtable Series hosted by BASF

September 20, 2016 Tutorial and Dinner Meeting – 3D Solid Printing Overview and Applications (such as

mechanical, pharmaceutical, & medical devices) Register Here

September 24, 2016 ASQ Food Bank Volunteer Opportunity

October 15, 2016 ASQ Food Bank Volunteer Opportunity

October 18, 2016 Tour

November 5, 2016 ASQ Food Bank Volunteer Opportunity

November 15, 2016 Tour

December 8, 2016 ASQ Sponsor of the Executive Roundtable Series

December 13, 2016 Tutorial and Dinner Meeting

Is a local company employing interesting or cutting edge technology? Are they on the front lines of quality

toolkit implementation? Send us your ideas for tours!

ASQ Raleigh Section Newsletter Page 3

Certification Opportunities

ASQ is moving to a computer-based testing model for certifications. No more certification exams will be

hosted by the local section. The exams will be taken at Prometric locations that the examinee will choose.

There will still be application deadlines and testing windows for each exam; the first one is for exams to be

scheduled at Prometric locations between September 1st and October 14th, with an application deadline

of August 12th. The change will enable six testing windows for each exam every year, rather than two

dates. The testing windows will still alternate exams, with each exam offered approximately every other

month. More information at http://asq.org/cbt/; more information on Prometric available at https://

www.prometric.com/en-us/Pages/home.aspx.

Career Opportunities

Post Your Resume

ASQ Raleigh Section members may post their resumes on the ASQ Raleigh page by contacting Placement

Chair Angie Lucas at angela.lucas@grifols.com and placement@asqraleigh.org

If your company has a position it would like to list with the Raleigh, North Carolina ASQ Section send your listing

to Placement Chair Angie Lucas at angela.lucas@grifols.com and placement@asqraleigh.org

Local Job Opportunities posted on the ASQ Raleigh Website:

Jobs

Quality Engineer II - Rexnord Ind., LLC - Sanford, NC

QMS Training Professional (Part Time Consulting)

TrackWise / Validation Specialist - Quintiles - RTP

Process Quality Professional / Quality Technician - Oxford, NC

Performance Excellence Contributions

If you would like an opportunity to apply your skills and collaborate on items and activities related to the

Performance Excellence program, please contact Mark Morton mortom01@nc.rr.com for more information.

ASQ Raleigh Section Newsletter Page 4

Recertification tip:

Just a reminder to check your recertification due dates. Recertification applications can be submitted up

to six months in advance of the recertification due date. There is also a six month grace period for

submission of recertification applications after the recertification due date.

When claiming training classes in the Professional Development category of your Recertification Journal, it is

required to have listed as evidence the total number of actual training time performed. This is required in

order to calculate the ASQ RU credit. If your certificate does not tell the number of hours, an agenda that

reflects the training hours will work too. To qualify, all training must correlate to the Body of Knowledge for

your particular certification and remember you can receive .1 RU for every hour of qualified training. This is

the most common issue seen when reviewing Recertification Journals.

ASQ Dinner Meeting Cancellation Policy:

Cancellation notification must be received no later than 48 hours prior to the start of the event in order to

receive a full refund. To request a cancellation, please send an email to ASQ at info@asqraleigh.org

Registration for Dinner Meeting Events after Registration is closed in Eventbrite:

To register for an event after the deadline, please send an email to ASQ at info@asqraleigh.org. ASQ Raleigh

can only accept cash or checks when paying at the door. Credit or debit cards are not accepted.

ASQ Raleigh is Getting More Social

You will notice increased activity on the ASQ Raleigh social media sites.

Twitter

If you have a Twitter account, follow @ASQRaleigh and retweet interesting notes. If you don’t have a Twitter

account, ASQ Raleigh tweets can be reviewed with these steps:

Type search.twitter.com in your browser

Enter @asqraleigh in the search box

Remember that Twitter posts have a 140 character limit.

FaceBook

If you have a FaceBook account, “Like” us and comment on posts.

ASQ-related information can be posted on Twitter and FaceBook by sending write-ups and photos to:

pamschodt@gmail.com

LinkedIn

Members of the ASQ Raleigh LinkedIn group can submit posts directly. Membership is open.

ASQ Raleigh Section Newsletter Page 5

2016 ASQ Raleigh Section Leadership Council

Chair Mark Morton

Past Chair Joanne Mayo

Chair-Elect Kelli Collin

Vice Chair/QMP Chair Joey Martin

Arrangements Lilli Abdullahi

Certification Heather Payne

Education Open

Membership Kelli Collin

Recertification/Examining Fred Rich

Communications

Communications Chair

Sukonya Gogoi

Newsletter Subcommittee

Sandy Waddell and Bryan Ambrose

Website Manager, Web Page Updates, and Website Calendar

Open

Eventbrite, Social Media

Pam Schodt

Six Sigma SIG Byron Wingerd

Food Bank

Jim Murrell

Mary Chris Easterly

ASQ Raleigh Section Newsletter Page 6

Executive Quality Round Table Carol Poindexter

Treasurer Joy Young

Secretary Wendy Haines

Audit Bob Carter

Community Good Works Bill Michaud

Historian Doyle McGlone

Mentor Committee Chair Joanne Mayo

Nominations Jim Murrell

Placement Angie Lucas

Programs Doug McCorquodale

Publicity Helen Sims

Quality Conference Mike Porter

Student Advisor Ralph Van Aken

Scholarship Wendy Haines

VOC Chair Joey Martin

Interested in joining the Raleigh Section Leadership Council? Contact Mark Morton or any of the leaders. We

welcome new talent and ideas. It’s a perfect opportunity to develop leadership skills and build relationships.

Come join us.

COME SEE THE NEW AND IMPROVED ASQ RALEIGH WEBSITE!

http://asqraleigh.org/

ASQ Raleigh Section Newsletter Page 7

American Society for Quality Raleigh-Section 1113 Executive

Quality Roundtable “Café Process”

Sponsored by Biogen

April 21, 2016

On Thursday, April 21, 2016, American Society for Quality (ASQ) Raleigh section kicked off the first Executive

Quality Roundtable (EQR) meeting for 2016. ASQ Raleigh gathered twenty executives that represented

manufacturing, software (business and data management), local university, pharmaceutical, banking, and

laboratory testing services, quality and compliance services, and state government offices throughout the

Raleigh Durham area.

We would like to thank Biogen for sponsoring this meeting and also providing an overview on Human

Performance. Below is an example of the discussions.

What is Human Performance?

How is it applied?

Biogen’s Vision & Implementation

Quality Systems Considerations

Human Performance is fundamentally about managing operational risk. Goal: Reduce the frequency and

minimize the severity of events triggered by human performance.

In other words…

Increase the frequency of the activities that go right the first time

Enhance system robustness

The key objectives for the ASQ Executive Quality Roundtable series are as follows:

Provide an ongoing venue for executives to network and share Continuous Improvement best practices

Collaboratively identify opportunities to drive improvements in our community

Enhance the value and relevance of ASQ Raleigh to meet your collective expectations

Carol Poindexter opened the meeting welcoming all to the 1st 2016 ASQ Raleigh Executive Quality

Roundtable meeting. Carol introduced Jeff Soper as the facilitator for the meeting. Currently, Jeff is

Executive Director of the International Strategic Business Partner Institute (ISBPI) located in Tampa, Florida,

and Lausanne, Switzerland. Jeff is a “seasoned warrior” with extensive industry, consulting and academic

work experience spanning a variety of industries and functional areas.

Jeff kicked off the meeting by asking each person to introduce themselves with their name, company name

and title, then their favorite movie and why.

continued on next page

ASQ Raleigh Section Newsletter Page 8

Why are the challenges different for Top CEOs vs Top Quality Executives?

Top CEO Challenges (external focus)

Business Disruption by Competitor Innovation

Disrupting Competitors via Innovation

Team Member Excellence

Changing Governance and Compliance Landscape

Work-Life Balance

Top Quality Executive Challenges (internal focus)

Maintaining Leadership Emphasis on Quality

Ensuring Message Credibility

Encouraging Peer Support

Increasing Employee Ownership and Empowerment

The Café Process began with the following topics and the purpose was to identify multiple topics and

identify the topics of interest to the executives.

Talent Management

Globalization

Future of Quality and Continuous Improvement

The participants broke up into 3 small groups for each of the three topics and each time the topic changed

the group members changed, which provided an opportunity to meet and have discussions with other

executives.

1. Talent Management.

Afterwards each group presented their ideas to the other groups. Ideas were shared to invest in

development engagement and retention of employees. This may be accomplished in times of slow growth

by identifying what motivates people. Other challenges included turning technical experts in to managers;

what is the cost of hiring; engaging and providing a vision; developing employees by communicating a

clear vision and demonstrating from the top-down a hands-on leadership approach.

New technology and the integration into the workforce is always a challenge and having a strategic plan

and a workforce that feels valued and are loyal and are involved early in the process with a clear plan and

communication are key components to success. What skills sets are required for your organization to

succeed over the next 5 years?

Identify the skill sets required for your organization’s success. Ideas discussed included: Salary-experienced

professionals; identify people with potential; build a training/mentoring program; don’t limit career path;

retain talent; keep your workforce engaged; and develop soft skills.

continued on next page

ASQ Raleigh Section Newsletter Page 9

2. Globalization

In the next break-out session each of the three groups rotated team members for this session to discuss

Globalization and some of the challenges. After completion one person from each group presented the

findings of their group.

Globalization of companies has an impact due to locations, particularly if global. Ideas included different

regulations, cultures, expectations, talent and cost. Developing productive working relationships due to

language barriers, cultures, different electronic systems, time zone fatigue with teleconferences meetings all

together impede the success of a project and it becomes very challenging to accomplish the goal. It is

important to have the processes clearly defined and the use of consultants or translators to learn more

about the culture in different countries as well as the regulatory aspects that may impact the business. It is

important to have an awareness of the impact of social media on a business by developing policies that

are clearly communicated to all employees.

3. of Quality/Continuous Improvement

The third break-out session began with the question: What does the future of continuous improvement (CI)

look like for the business community? What alternatives to CI look viable in the future? Does Quality have a

future and what does it look like? What do we need to do to prepare for the future you envision?

Quality leaders have to speak the business language. Quality plays a larger role in business especially if

there is poor quality in the products or services provided especially the reputation of a company. Poor

quality can cause death or serious injury and how do you put a price on a life. It is important to transition

from a Quality Group to a larger Quality Culture within an organization. Quality is the responsibility of

everyone.

The future of CI is about Risk Management not just key performance indicators (KPI). Continuous

improvement has to be part of social responsibility. CI starts on the shop floor and must be integrated in to

problem solving. Quality is more than a program or department and for it to work well it has to be an

integral part of behavior of all involved in the process and move beyond bureaucracy.

concluded on next page

ASQ Raleigh Section Newsletter Page 10

To prepare for the future it is important that all understand how to do good stewardship. Good stewardship

includes the 4 following principles:

1) Ownership; 2) Responsibility; 3) Accountability; 4) Reward

Stewardship – the careful and responsible management of something entrusted to one’s care.

There are many areas where understanding is imperative that support the future of quality and continuous

improvement. Here are a few listed below:

Understanding cultural challenges in a global world

Regulatory/Compliance varies per country

Time zones impact transportation, meetings, etc.

Global Accreditation

Systems and interfaces

Data privacy

Managing import/exports for customers

Counterfeit

Serialization

Tax implications

Social media

Anticipating impact

In closing the team voted on the most important topic of the day and identified how they wanted to

proceed with the next meeting. Talent Management was the winner and subtopics included: 1) Strategic

workforces planning; 2) Recruitment/Retention; 3) Succession planning/talent pool; 4) Tap into unused

talent. We look forward to ongoing discussions and opportunities to learn from each other’s experience.

The next EQR meeting will be held on Jun 10, 2016 and will be sponsored by SAS at their location.

ASQ Raleigh Section Newsletter Page 11

Using Your ISO 9001:2008 QMS to Plan for the ISO 9001:2015 Changes

NCSU McKimmon Conference & Training Center

August 4, 2016 8:30 - 11:30 am

Session Overview:

The much anticipated revision of ISO 9001 arrived in September 2015. During the history of ISO 9000, there’s

only been one other significant change – the first of its type, from the 1994 to 2000 versions. Many

organizations weren’t properly prepared for the significance of that change and, as a result, missed the

opportunity to realize the full benefits the change brought.

To prepare your organization for the changes it is necessary to utilize your existing quality management system

to plan for and implement the changes – in order to maintain the integrity of the system, certification and

customers’ perception. This workshop takes a high level look at the background and content of the2015

version of ISO 9001 and how the various “tools” in an existing, ISO 9001:2008 compliant, quality management

system can work together to accomplish the important task of managing the changes, using the popular

“P.D.C.A” cycle.

Key requirements will be reviewed and break-out activities will examine key ISO 9001:2015 requirements in the

context of a plan to migrate the organization from a 2008-compliant quality system.

Session Leader:

Andy Nichols Auditor, Author, Speaker & ASQ Member

Andy has been a quality professional since the late 70’s. His experience crosses a variety of roles including

Supplier Quality, Product Design Assurance, Certification Body auditor, Senior Consultant and Trainer.

He has trained hundreds of people who attended his implementation and auditing courses over a period of

16 years. His clients have included Ford, GM, Chrysler, HP, GE, the Army, Navy, Airforce, FDA and many other

well-known organizations.

As an author, his books on the “Myths of ISO 9001” and on Internal Audits as a Risk Management Tool are

published by IT Governance.

Previously, an IRCA and RABQSA certified Lead Auditor and a member of the UK’s CQI, Andy has been a

member of the ASQ since 1985 and often presents to ASQ sections.

Register Here - This class is for ASQ Raleigh members only

ASQ Raleigh Section Newsletter Page 12

What’s new with ISO 13458:2016 for Medical Devices?

NCSU McKimmon Conference & Training Center

August 4, 2016 1:00 - 4:00 pm

Session Overview:

The next, and much anticipated, revision of ISO 13485 was released in February of this year. There’s been

much speculation about the content of the changes and its alignment with other ISO Management Systems

requirements and recent changes affecting them.

This session will review the ISO 13485:2016 requirements, including key changes and the impact on

organizations wishing to upgrade their management systems. In addition, the timeline for completing the

changes as viewed from the Certification Body’s will also be considered.

The presentation and break-out activities will examine key ISO 13485 requirements, an implementation

strategy and a time line for managing and accomplishing implementation of the new and modified

requirements.

Session Leader:

Andy Nichols Auditor, Author, Speaker & ASQ Member

Andy has been a quality professional since the late 70’s. His experience crosses a variety of roles including

Supplier Quality, Product Design Assurance, Certification Body auditor, Senior Consultant and Trainer.

He has trained hundreds of people who attended his implementation and auditing courses over a period of

16 years. His clients have included Ford, GM, Chrysler, HP, GE, the Army, Navy, Airforce, FDA and many other

well known organizations.

As an author, his books on the “Myths of ISO 9001” and on Internal Audits as a Risk Management Tool are

published by IT Governance.

Previously, an IRCA and RABQSA certified Lead Auditor and a member of the UK’s CQI, Andy has been a

member of the ASQ since 1985 and often presents to ASQ sections.

Register Here - This class is for ASQ Raleigh members only

ASQ Raleigh Section Newsletter Page 13

ASQ Food Bank Volunteer Opportunity

Help us give back to our community! The ASQ Raleigh Section has scheduled three volunteer opportunities at

the Food Bank of Eastern & Central North Carolina in 2016. These opportunities will be held in Raleigh on Sept.

24th, Oct. 15th, & Nov. 5th on Saturdays from 9am-12pm. View the Event Calendar for events and our section

monthly newsletter for dates. Registration is now available for the three events in Raleigh.

$57 and 19 pounds of food were collected at the QIT Food drive. The QIT Food Drive provided 301 meals for

people in need in our area. Great job ASQ Raleigh!

We invite you to join us in helping the hungry in our state. Family and friends are welcome; children must be

12 or older and accompanied by an adult. If you register and later find out you are not able to participate,

please contact Jim Murrell at jmurrell.asq@usa.net

Activities May Include: Warehouse volunteers help to sort and repackage Food Bank's warehouse inventory.

We may also help with: sorting fresh produce into smaller containers; repackaging products from food

manufacturers and distributors; and/or putting bulk items into family size portions.

Location: Food Bank of Central and Eastern North Carolina, Raleigh events will be held at 3808 Tarheel Drive,

Raleigh, NC 27609.

Recertification Units adhoc: 0.2

CAUTION: Please wear closed toe shoes and clothes that can get dirty. You may want to dress in layers it may

be cool in the warehouse.

ASQ Raleigh Section Newsletter Page 14

The Community Good Works Team (CGWT): Wake Enterprises, Inc.

and the Flexopower Project

The CGWT has connected with Wake Enterprises to help bring our chapters’ strengths, expertise, and

altruistic spirit to the community.

About Wake Enterprises, Inc.

Wake Enterprises, Inc. (WE) is a private, nonprofit organization whose mission is to assist people with

disabilities achieve their maximum level of independence. WE is about all members of the community

having a place

In addition to being a human service agency, WE is also a business dedicated to providing quality

subcontracting, outsourcing, and fulfillment services at a fair price. Participants receive job training in areas

such as electronic subassembly, corrugated box and insert assembly, shrink-wrapping, and more. Our team

and section is helping establish a more robust QMS.

The Project

In March, a kick-off meeting was held with WE. The meeting was geared toward helping WE prepare for a

new customer contract, Flexopower.

We are assisting with the quality planning, risk mitigation, quality documentation development, setting up

workstations, and establishing standards.

A special thanks to Matt Demko and Doyle McGlone who particularly impressed the executives at WE with

their deep understanding of quality.

About Flexopower

Flexopower is a South African company and recognized as a pioneer in the solar energy industry. They

create solar energy solutions for mobile and high-risk applications where glass solar panels are not suitable

and fail.

How you can get involved

If helping in the community interests you please contact - billmichaud@att.net.