Inside This Issue BioFeedback BIOMEDICAL DIVISION NEWSLETTER Chair’s Message | James “Gunny” Shore Happy New Year! First, I’d like to start by thanking Teresa Cherry for her leadership as the chair of the division. She is a woman of great integrity, a great leader, and a great friend. We are very lucky to have her be part of this year’s plans, which will be explained later in this newsletter. Also, I’d like to thank the Leadership Team for 2018—Teresa, Karen Brozowski, and Lisa Grosskopf. I learned a long time ago that to be successful you surround yourself with smart people, and listen and learn from them. This team has been a pleasure to work with, and I’ve learned a great deal from them. I’m very excited about the plans the lead- ership team has put together for this year. If we are going to make a positive change, then there are some changes in our actions and activities. For the first time in a very long time, we had a face-to-face leadership planning session. Our intent was to rethink how we approach business planning—challenge all the activities we have been doing, identify those areas we are doing well, and stop doing activities that are not adding value to our members. Instead of just having the ritual “planning session,” this year we invested in the training of the leadership team and attended the “One Thing Workshop” led by Peter Chatel. We learned the value of focusing on the critical activities that generate the most benefit to our members. Not only did we learn to focus on the “critical few,” we actually put together this year’s business FEBRUARY 2019 | VOLUME 46, ISSUE 1 THE 10 VITAL LAWS OF SUCCESS 11 2019 Business Plan 3 6 th Annual ASQ San Diego Quality Conference 4 World Conference on Quality and Improvement 6 Information about ASQ Testimonial Award 8 ASQ Biomedical Division Mentoring Program 9 Certified Biomedical Auditor Body of Knowledge and Exam Being Updated 10 Vision To be the leading authority on quality issues related to the biomedical community. Mission To promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. asq.org/biomed The Planning Session Attendees with copies of the book, The One Thing.
Transcript
Inside This Issue
BioFeedbackBIOMEDICAL DIVISION NEWSLETTER
Chair’s Message | James “Gunny” Shore
Happy New Year!
First, I’d like to start by thanking Teresa Cherry for her leadership as the chair of the division. She is a woman of great integrity, a great leader, and a great friend. We are very lucky to have her be part of this year’s plans, which will be explained later in this newsletter.
Also, I’d like to thank the Leadership Team for 2018—Teresa, Karen Brozowski, and Lisa Grosskopf. I learned a long time ago that to be successful you surround yourself with smart people, and listen and learn from them. This team has been a pleasure to work with, and I’ve learned a great deal from them.
I’m very excited about the plans the lead-ership team has put together for this year. If we are going to make a positive change, then there are some changes in our actions and activities. For the first time in a very long time, we had a face-to-face leadership planning session.
Our intent was to rethink how we approach business planning—challenge all the activities we have been doing, identify those areas we are doing well, and stop doing activities that are not adding value to our members. Instead of just having the ritual “planning session,” this year we invested in the training of the leadership team and attended the “One Thing Workshop” led by Peter Chatel.
We learned the value of focusing on the critical activities that generate the most benefit to our members. Not only did we learn to focus on the “critical few,” we actually put together this year’s business
FEBRUARY 2019 | VOLUME 46, ISSUE 1
THE 10 VITAL LAWS OF SUCCESS 11
2019 Business Plan 3
6th Annual ASQ San Diego Quality Conference 4
World Conference on Quality and Improvement 6
Information about ASQ Testimonial Award 8
ASQ Biomedical Division Mentoring Program 9
Certified Biomedical Auditor Body of Knowledge and Exam Being Updated 10
VisionTo be the leading authority on quality issues related to the biomedical community.
MissionTo promote the awareness and use of quality principles, concepts, and technologies in the biomedical community.
asq.org/biomed
The Planning Session Attendees with copies of the book, The One Thing.
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BIOMEDICAL DIVISION NEWSLETTER | FEBRUARY 20192
plan and budget based on this learning. In addition to changing the paradigm of our past business plans, we are changing the titles of the objectives to value streams, and the chairs for these activities will be identified as value stream leaders. As more of these changes are solidified, we will share them with you. Bottom line—I think you will find that our objectives for this year are simple, focused, and effective.
In closing, as you all know, ASQ is going through a major transfor-mation and will be in a state of change for this year as well. We are all “change agents,” but we struggle within this professional group. There are more changes to come, so all I can tell you is we will be transparent and will communicate all the changes. Please understand that some of these changes are not within our direct control. We expect your constructive feedback and suggestions for improvement.
How can you make a difference? How can you get involved? Perhaps you don’t have a lot of time but would be interested in helping. Reach out to the value stream leaders and tell them about your ideas and your strengths, and try to engage in the division. Together we can make some positive changes to our division, our industry, and the members we serve.
As of the beginning of this year, Pam Goldstein and Beth Kelly have stepped down from division-level planning activities but will remain engaged in the New England Discussion Group. We acknowledge their work during the past years with our division conferences.
As part of our training with Peter Chatel and “The One Thing” Workshop, we focused on the 20 percent of the items that would give us 80 percent of performance. In order to identify those key items, we had to list all the ideas and prioritize them. After
narrowing down the list, we had to compare those ideas against the probability of completing them. That activity was difficult, but it helped us really focus on the 20 percent.
In addition to focusing our attention on those items, we put each one into a priority of high, medium, and low. That meant we would focus all our attention and resources to the high priority first before working on the medium and low priorities. Also, this meant we would not work on any activities that were brought up after we started the plans. If we did, that would distract our resources and attention to the original priorities. This is very similar to the approach Steve Jobs took during his leadership at Apple.
The other part of this plan was to break down the plan into a simple, easier presentation of the material. For those who know the business planning model from headquarters, that Excel file can be very overwhelming. This approach allowed everyone to better understand how their activities directly tied to the three objectives.
Each objective will be headed by a value stream leader and an assistant, and member leaders will be assigned to each objective. This way we will have focused effort on the activities.
Interested? Reach out to me or any of the division leaders to hear more!
2019 Business Plan for the ASQ Biomedical DivisionPriority 2019 Objectives Actions Action Plans Discussion Group Participation Ideas
High Professional development
1. Mentor program
2. Seminars, webinars, and podcasts
3. Tools and resources
1. a) Benchmark against other successful programs; b) Set up pilot program with small group of mentors and mentee; c) Schedule network events to obtain interested people.
2. a) Create database; b) Increase quality of recordings; c) Allow all division members access to the media; d) Provide CBA training.
3. a) Benchmark example of best practices; b) Survey members for feedback; c) Capture past programs for archiving; d) Update CBA course material and provide supplement material for current regulatory requirements.
Ideas to consider:
• Mentor people in this area – students, transitioning professionals, veterans.
• Record sessions or offer “remote site” viewing.
• Provide content for sharing.
• Offer CBA prep course or element of the BoK (which can be used to update the current BoK and training material).
Seminar list ideas:
• Risk management
• QMS/Software validation
• Cyber security
• Advanced process validation
Medium Outreach and collaboration
1. Partner with universities
2. Partner with industries
3. Partner with regulators
1. Identify the correct contacts and determine the best way to get involved based on the situation.
2. Ensure we are provided update and relevant content.
3. Collaborate with regulators and industry to participate in current updates.
4. Provide introductory relevant training and at the universities.
Ideas to consider:
• In addition to mass medic and RAPS, partner with a local college.
• Sponsor a student chapter at a local college.
Seminar list ideas:
• Technical file
• MDR
• EU update
• FDA update
Low Discussion group expansion
1. Grow one new discussion group
1. Identify new geographic location.
2. Solicit new leaders.
3. Set up meetings.
• Support new DG if speakers are needed.
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BIOMEDICAL DIVISION NEWSLETTER | FEBRUARY 20194
2018 SAN DIEGO QUALITY CONFERENCE EU MDR + Compliance, Quality, Culture Cohosted by the ASQ San Diego Section and Biomedical Division
6TH ANNUAL ASQ San Diego Quality Conference Lawrence J. Miller, ASQ San Diego Quality Conference Chair
The ASQ San Diego 2018 Quality Conference with the ASQ Biomedical Division was held October 19-20, 2018, at the Illumina, Inc. campus in the Sorrento Valley region of San Diego. This year’s conference was a great success in providing key member value to a broad cross-section of the ASQ community. The planning and execution of this conference was a dedicated collabora-tion, from the beginning, between the ASQ San Diego local section #703, the ASQ Biomedical Division, and Illumina, Inc. By taking this approach, we were able to deliver a diversity of content and resources, and reach a wider audience, than any of the three conference partners could have in isolation. The end result was a delighted conference attendance that was provided an array of valuable content, and eye-opening and favorable impressions of the quality profession, ASQ, and the professional communities we all represent.
The model that was used for the ASQ San Diego 2018 Quality Conference, by partnering between local ASQ Sections, ASQ Divisions, and industry, is one we will use for next year’s conference and going forward. It is an exemplary case that fits perfectly into the model of the new ASQ, with member-value focused communities of interest coming together to create a diverse quality offering. The conference kicked off on Friday morning
with a fresh offering of made-to-order breakfast burritos, leading into an opening address by James Shore, the ASQ Biomedical Division chair-elect, and the keynote address from Oliver P. Christ, who then conducted the full day of seminar and discussion about the MDR. Illumina was showcased by an eye-opening presentation from Kenny Ross, vice president of Illumina’s Factory of the Future, followed by a tour of some of Illumina’s consumables manufacturing facility. A delicious lunch of made-to-order tacos, completion of the MDR program, and a happy-hour mixer at San Diego’s famous Karl Strauss Brewery rounded out a great day of quality professionals learning, collaborating, and networking.
Saturday morning brought us to day two of the confer-ence, which had a program to address topics in quality compliance, tools, and culture. After another breakfast of made-to-order breakfast burritos, we were welcomed by an opening address from Gary Workman, vice president of Illumina’s Global Quality organization. Next up was an inspiring keynote address from Dr. Jerry Mairani, ASQ president emeritus, followed by a panel discussion between senior quality executives from several admired San Diego companies. We got great feedback about the panel discussion, and we will make sure to expand that feature in next year’s conference. After another delicious
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BIOMEDICAL DIVISION NEWSLETTER | FEBRUARY 20195
lunch of made-to-order tacos at our taco bar, we went into the second half of day two with an impressive offering of nine workshop seminars arranged in three parallel tracks. The conference team wishes to thank our sponsors for their generous support, Illumina for the use of its facilities, the conference planning committee for tireless hours of developing our speakers program, communicating, and planning logistics, and the ASQ volunteers who came together on the days of the conference to provide our attendees with a rewarding conference experience!
Biomedical Division at the October Conference
NoteThe San Diego Quality Conference program and presentation slide decks can be found here:
The World Conference on Quality and Improvement is ASQ’s flagship conference. Join a broad attendee base representing a wide array of industries and more than 45 countries from around the world to gain knowledge, improvement methodol-ogies, quality tools, best practices, and networking contacts. With more than 2,500 attendees, the World Conference is the ideal forum to meet quality professionals with a wide range of backgrounds and experiences.
2019 World Conference on Quality and Improvement Pricing
Early-bird Pricing Ends
April 11, 2019
Regular Pricing Starts
April 12, 2019
One-Day Pricing
ASQ Member: $1095 $1199 $599
Nonmember: $1299 $1399 $699
Group (3+) $999 $999 N/A
• All full conference (three-day) registration fees include lunch on both Monday and Tuesday as well as the Tuesday evening reception.
• Monday OR Tuesday (one-day) registration fees include lunch on the day you are attending (i.e., you have registered for Monday only, you will receive a Monday lunch ticket).
The Biomedical Division will have a booth, manned by division volunteers and featuring information about our mentoring program. In addition to the many outstanding benefits of attending WCQI, we have two seasoned speakers on the program. Don’t miss your chance to meet, greet, and learn.
Details about ASQ Biomedical Division presentations at WCQI are on the next page.
SHARPEN quality expertise,
GAIN knowledge,
IMPROVE methodologies,
LEARN best practices
Learn more TODAY!
May 20 – 22, 2019 Fort Worth, TX
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BIOMEDICAL DIVISION NEWSLETTER | FEBRUARY 20197
WCQITuesday, May 21, 2019 4:00 p.m. – 5:00 p.m.
T38: Compliance Does Not Equal Quality for Medical DevicesPresenter: David Manalan
Principal, INQC Consulting, Acton, MA
Level: Intermediate
Division: Biomedical
In 2011, the U.S. Food and Drug Administration (FDA) launched a case for quality (CfQ) initiative focused on improving product quality and patient safety by instilling a culture of quality into the medical device industry. This is shifting the medical device focus from regulatory compliance to sustained device quality for improved patient outcomes. The case for quality has evolved and expanded, and now includes the Medical Device Innovation Consortium (MDIC), the Capability Maturity Model® Integration (CMMI®), ASQ, AdvaMed, Xavier Health, and biomedical stakeholders—device manufacturers, physicians, hospitals, and patients. Metrics for use in the program and three dashboards are in the works. A pilot program involving a number of companies is underway, and initial results are strongly positive. The message for the future is clear: Measurable best practices in design and production are becoming the FDA’s and society’s expectations in the not too distant future.
Learning Objectives:
• Understand the benefits of FDA participating in a case for quality.
• Learn how the CMMI maturity level assess-ment is applied to medical devices.
• Access and use the critical to quality tools provided by AdvaMed and ASQ.
• Measure the benefits your organization can obtain from the case for quality.
WCQIWednesday, May 22, 2019 8:00 a.m. – 10:30 a.m.
W17: Auditing Your Risk Management SystemPresenter: Barrett Craner
MS+, MBA (with distinction), CQE, CRE, CQA, CBA, RAC(US), ASQ Fellow Principal Consultant, CQA Associates, Manteca, CA
Level: Intermediate
Division: Biomedical
All major quality system standards call for risk-based decision-making and a risk management system, and, as such, many auditors are practicing auditing aspects of risk management, including hazard identification, hazard analysis, failure mode and effects analysis (product and process), risk management file, risk management reporting, risk management planning, and even other less commonly used risk management tools like fault tree analysis and hazard analysis and critical control point. Are you ready for an audit of your risk management system and your analysis tools? One way to find out is to attend this informative session and check off the thoughts discussed, and during the Q&A, share your own additional thoughts. Attendees should include management, engineering, QA, regulatory, manufacturing, and project management, and attendees at all levels will benefit from this presentation and discussion.
Learning Objectives:
• Prepare for an audit of your organization’s risk management system, including its processes, procedures, planning, reporting, risk management analysis tools, and risk management file completion.
• Understand specific aspects of many risk management analysis tools potentially audited: hazard identification, hazard analysis, FMEA (product, process, and use), fault tree analysis (product and process), and others.
• Learn the “whys” of being audited on this major product and process development tool, including regulatory emphasis and direction.
• Gain a full grasp of the consequences of a risk management system under audit, and gain ideas for a risk management program structure.
• Get several sample workshops to take back to your company for use as actual workshops or as examples to create your own workshops to prepare for a risk management audit.
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Information about ASQ Testimonial Award• ASQ encourages recognition for outstanding
contributions in the field of quality or the allied sciences through service to the Society.
• The Testimonial Award is established to express appreciation to Society officers; members of the board of directors; divisions, sections, board, and committee chairs; or other members who served the Society with distinction for an extended period.
• There are no limitations of age, gender, or nationality.
• Other awards received by the individual will have no bearing on receipt of the Testimonial Award.
• An ASQ unit such as a section, division, or special interest group must petition the awards board.
• The awards board, under the authority and direction of the board of directors, is responsible for the review, approval, or disapproval of petitions for Testimonial Awards submitted to the awards board.
• The board of directors is responsible for the review, approval, or disapproval of all petitions for Testimonial Awards that are submitted without awards board review.
• The Testimonial Award is a framed, matted document with the ASQ seal that reads,
“With Appreciation from the Members and Directors of the
AMERICAN SOCIETY FOR QUALITY
This testimonial award is presented in recognition of Leadership and Distinguished Service to
<recipient’s name> <description of service and leadership specifics>”
and is signed by the chairman of the board and the awards board chair.
• Does your section or discussion group have one or more persons deserving of this award? Talk to your leadership about getting the process started.
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BIOMEDICAL DIVISION NEWSLETTER | FEBRUARY 20199
Mentoring relationships are an important element in personal and professional development. Your professional development and career can be greatly enhanced by high-quality mentoring relationships. These relationships provide you with an opportunity to openly share information with someone who works and shares your interests. Most people appreciate the benefits of mentoring in their career or professional journey, and many will tell you how much they have benefited from these relationships. Creating and cultivating mentoring relationships in your developmental network provides different experiences to learn from.
While there are many forms that mentoring can take, experiencing both the mentee and mentor roles increases your effective utilization of ASQ mem-bership, increases leadership capacity, leads to greater career satisfaction, and improves your overall effectiveness.
Our Mentoring Program
The ASQ Biomedical Division believes in the value of mentoring relationships. In addition to career-related benefits, Biomedical Division mentoring helps maximize your utilization of ASQ member activities, from certification choices to volunteer leadership opportunities. This
ASQ Biomedical Division Mentoring Program Sue Finneran, President of Regulatory Compliance Experts, Incorporated Vikram Gaonkar, Staff Development Quality Engineer at Abbott
A mentor might be helpful to you, if you:
• Wonder what ASQ certifica-tions might help you achieve your goals
• Could use a boost in achieving your professional development goals
• Are facing a career transition
• Are struggling to balance your career and personal life
• Are taking on a new job role or moving to a supervisory role
• Want to increase your impact
• Need some help improving working relationships or building effective teams
• Need to work more effec-tively with other departments in your organization
• Have relocated from another area and need help adjusting to a new culture
As you enter the relationship, consider:
• Any specific skills you would like to acquire or develop
• How participation in ASQ Biomedical Division leader-ship can help you develop these skills
• Any industry-specific learning goals you may have
• If you want to advance or change your career path
• If you are ready to respond positively to suggestions your mentor might make
• If you are willing to spend one to two hours a quarter to develop a good relationship with a mentor
• How you can take an active role in your devel-opment throughout the mentoring relationship
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BIOMEDICAL DIVISION NEWSLETTER | FEBRUARY 201910
mentoring program was developed for all interested division members.
Interested members will provide information about their interests and what they would like to get out of the mentoring relationship. Initial participants will get together for an overview of the program and an opportu-nity to connect with their mentor or mentee, if they have not done so already.
While mentor relationships vary in duration, the required commitment on the part of both the mentor and mentee is very manageable. During the initial face-to-face meeting, we suggest discussing expectations and goals for the mentoring relationship, and establishing a mutually agreeable frequency and location for future meetings.
A mentoring relationship should help you gain insight from someone with a wealth of experience who is willing to share their experiences.
Mentees have opportunities to interact with mentors in a private, non-judgmental, and non-threatening environment. Mentees receive guidance and encouragement, acquire knowledge and skills, and receive one-on-one feedback. Mentees can test ideas and talk openly to a mentor, something they cannot do with most managers.
There is currently a pilot program underway, and we’ll be looking for more mentors and mentees in coming months. Look for something before WCQI.
Certified Biomedical AuditorBody of Knowledge and Exam Being Updated
Scott Laman, the division liaison to the certification board, recently informed us there will be changes in the Certified Biomedical Auditor Body of Knowledge and exam. Keith Councell is the Certified Biomedi-cal Auditor (CBA) exam chair.
In 2019/2020, our division’s exam, Certified Biomedical Auditor, is planned to be updated. The process is described in detail in the November issue of Quality Progress. In summary, there will be six workshops for which volunteers who have the CBA certification will be needed. For the first two workshops, volunteers must also have no previous exam development workshop experience. Finally, trainers must steer free of conflict of interest and have to decide whether to teach prep courses or participate in the exam development process.*
In addition to generally recruiting for all kinds of diversity, Scott will be sending emails to those of you who meet all the require-ments to obtain some representation from division leadership in executing this important work.
2019
1. Job analysis (February 22 – 23)
2. Test specification (June 7 – 8)
3. Item writing (October)
2020
4. Item review
5. Exam review
6. Cut score
There have been many changes in regulations and standards since the last update to the body of knowledge. The EU MDR and IVDR regulations, the FDA UDI for labeling, the MDSAP and its requirements for Canada, the changes in ISO 13485:2016, ISO 14971:2018, ISO 10993-1, ISO 19011:2018, and ISO 9001:2015 come to mind immediately.
Once the new body of knowledge is established, there will be a need to update the Biomedical Auditors Handbook and the division will be soliciting assistance in that area.
*You must generally agree to not teach prep courses for two years.
For more information on ASQ certifications and the processes involved, see the November 2018 Quality Progress article, “The Gold Standard” by James Bossert.
BIOMEDICAL DIVISION NEWSLETTER | FEBRUARY 201911
Over the past few years, I have been reading and learning a great deal about what it takes to be successful in any business or career. Now, I define success as “getting what you want.” I have recently distilled my learning down to 10 vital laws of success. Yes, just like our physical world is in part governed by laws like the law of gravity, success is governed by laws as well. So here are my 10 vital laws of success:
1. You must know what you want in order to be successful. LAW OF CLARITY
2. Not everything matters equally—a disproportionally small number of things lead to a disproportionally large number of results. LAW OF PARETO (80/20)
3. Any, every, and all behaviors consistently demonstrated over time (habits) have a compounding effect. Law of Habits and THE DOMINO EFFECT
4. Working on more than one thing at any moment leads to a significant reduction in productivity and increase in waste. LAW OF FOCUS
5. The willpower to do what you need to do, and say no to everything else, is greatest when your mind and body are fully charged. LAW OF WILLPOWER
6. The most effective way to accomplish anything is to: a) develop a detailed description of the desired future state; b) accurately describe your current reality; c) clearly identify the gap between the two; d) develop a plan for closing the gap; e) implement the plan and make the necessary adjustments along the way based on results generated. LAW OF EXECUTION
7. Knowledge without action is never truly owned. LAW OF THE OWNERSHIP
8. Written goals and weekly accountability greatly increase the likelihood of successful goal achievement. LAW OF ACCOUNTABILITY
9. The people in your life as well as the environment within which you live your life have a profound impact on your success. LAW OF PROXIMITY
10. The quality of all your relationships, all your results, and indeed every aspect of your life are directly related to the quality of the questions you are asking and the order in which you are asking them. LAW OF QUESTIONS
Author
Peter Chatel from The Chatel Consulting Group shares information from the Biomedical Planning Session.
Let him know what you think about these laws. What other laws for success have you identified? How are you lever-aging these laws of success? [email protected]
