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Advertising Space for Rent | Espace publicitaire à louer Read More »
By Eric Hosking, Section Treasurer, Membership Chair, ASQ CQE, CSSBB and CQA and Samira Kazemi, Program Committee Member
CLIQUEZ ICI POUR LIRE L’ARTICLE EN FRANCAIS
Last month, in this column we featured Marcel Charbonneau, a very long time member of the ASQ. This month we are changing speed a bit. Some of our members are not necessarily long time members of the ASQ, but they are long time practitioners of Quality. They also come with a myriad of talents that have helped them have very successful careers inside and outside the Quality domain. Samira and Eric had the pleasure of interviewing Ruth Stanley, the ASQ’s former Regional Director for Canada and Greenland region. She described her career in Quality and her career as a leader. This is what we learned.
RUTH STANLEY – PRESIDENT, BOANN CONSULTING
Ruth Stanley has Ruth Stanley has 30 plus years in Quality working as a public servant in a number of branches of the Canadian Federal Government. While there she worked with ISO standards: 9001 for quality systems; 14000 for environmental standards; 17025 for laboratory information systems and 31000 for risk management.
Ruth became a member of ASQ in 2014 in the Ottawa Section. In 2017 she took the lead on organizing the first ASQ Canadian National Quality Conference which was hosted by the Ottawa Section. Following that she served as the ASQ Regional Director for Canada Greenland Region in 2019 and 2020, then stepping down to be Deputy Regional Director in 2021. From those positions, she was deeply involved in both the 2020 and 2021 ASQ Canadian National Quality Conferences hosted by Toronto Section and Montreal Section respectively.
Now retired from the Federal Government, she is far from retirement. She is an author, presenter, blogger and now founder of Boann Consulting.
Impressed by Ruth’s resume, Samira had a number of questions for Ruth:
What was the definition of Quality in your industry?
I’m in the Pharmaceutical industry and in my Quality role, the main focus has been mostly on complying with the requirements of national / foreign regulations. It is always interesting to me to know what Quality is in other industries, regulated or non-regulated. I was in the government industry where Quality was actually referred to as excellence. Quality meant acting with integrity and impartiality in providing the best value to Canadians while acting in accordance with statutes and regulations.
How did you get into Quality and how did your profession in Quality evolve over these many years in your industry?
My role changed over the years. My first role was as a Pensions Officer. I audited financial institutions that reported to the government. Quality meant compliance with the Income Tax Act. I was assessing pension plans and RRSP (Registered Retirement Savings Plan), RRIF (Registered Retirement Income Fund) and other financial instruments managed by those institutions.
As an Internal Auditor, I assessed the efficiency, effectiveness and economy of Revenue Canada internal processes. These were the Revenue Canada internal indicators of Quality at the time. Over the course of my time with the government, the tools of quality that we used changed. As a Planner/ Policy Officer, I followed the PDCA cycle to plan improvement activities, measure execution, assess achievements and update plans, following Treasury Board guidelines.
We introduced other tools along the way. We began with process mapping and triage for risk levels, then used a balanced scorecard and key outputs, then we moved to outcome-based key indicators with Canadians as the focus and a Baldridge-inspired excellence framework with elements of ISO standards. Later we changed our focus to risk-based thinking. Lean thinking, along with the move to value-stream mapping and a customer focus, was just getting going in 2016 when I left.
Did you always stay in the same industry?
More or less. I was with the government for a large part of my career, but in the different branches I dealt with different industries. I then devoted myself to service through ASQ and now I am in consulting. I have also authored a published book and I am working on my second book.
What made you successful in your Quality role?
I am a natural connector – ideas, things and people. I was able to distill large amounts of information into bite-sized pieces. I could facilitate and pull information out of people that they didn’t know they knew.
How long have you been with the ASQ and what kept you as a member for such a long time?
Since 2014, almost 8 years. I came to it late in my career. I was still learning about leadership outside the government and deepening my knowledge of quality methods and other very interesting topics. The ASQ gave me a chance to serve in a different way. I am very pleased with the friendships and contacts that I have made along the way.
How has ASQ membership helped or played a role in your career advancement and how have you benefited from being a member?
I really grew as a person and a leader/mentor and I got to try things that I would never have done in the government. The support I got from other people, encouraged me to become a writer, blogger and presenter.
What do you suggest could work / serve members better?
The real magic in ASQ Sections is the support that we give each other as members. Mentoring or twinning is something that the Sections should do more of. This is more personal than a webinar or a workshop. It could be an ongoing relationship, a sounding board for new members. This is something that I would have benefited from in my career.
You have worked with ASQ HQ. What are your impressions of that organization?
Staff are very dedicated and work hard. They are not on the ground, so they need our insights on current needs. They cannot be everywhere at once.
What would you say to any aspiring Regional Director candidate?
As a Regional Director, I was a therapist, problem fixer and sometimes an enforcer, but I would encourage an aspiring candidate to:
If you enjoyed this article, send your comments to the Membership Chair, and we will share them with the author.
Wisdom from our Wisest | Sagesse de nos plus sages Read More »
By Tooraj Khalili, ASQ member (French text follows)
Split personalities of QMS under FDA QSR, ISO 13485, & MDSAP – Medical devices industry regulations
(Les dualités d’un système QMS dans l’industrie d’appareils médicaux) with Michelle Lott on 30 March, 2022.
You were 47 participants to respond to our closing survey. It had an overall satisfaction rating of 98% and participants particularly appreciated the exchange with 98% satisfaction. As for the subject, the approach and the speaker, the satisfaction rate was 97% each.
The webinar began with a 30-minute networking period. In the webinar, Michelle discussed the strategies to manage regulations, risks, and audits in the medical device industry for the US & Canada. Also, there was exploration on the differences between ISO 13485, FDA and MDSAP audits and the impact on audit management and the structure of the quality management system.
It is important to note that this English webinar attracted people from Montreal and its surroundings (32%), while the rest of the participants were from the United States (42%), Canada (Toronto, Vancouver, Kingston), Brazil, Denmark, Mexico, New Zealand and Norway. I take this opportunity to tell you that it’s always a pleasure for the whole team to have such a diverse crowd.
A large majority of you would attend another event, which is why we invite you to our next bilingual event, the return of Pecha Kucha Night, hosted by Michael Bournazian on 27 April, 2022 at 19:00 with a Networking Opportnity starting at 18:30. Information | Reservations.
Vous étiez 47 participants à répondre à notre sondage de fermeture qui a obtenu un taux de satisfaction global de 98%. Les participants ont particulièrement apprécié l’échange avec 98% de satisfaction. Quant au sujet, l’approche et le présentateur, le taux de satisfaction était de 97% pour chacun.
Le webinaire a débuté par une période de réseautage de 30 minutes. Au cours du webinaire, Michelle a abordé les stratégies de gestion des réglementations, des risques et des audits dans l’industrie des dispositifs médicaux pour les États-Unis et le Canada. Elle a également exploré les différences entre les audits ISO 13485, FDA et MDSAP et leur impact sur la gestion des audits et la structure du système de gestion de la qualité.
Il est important de noter que ce webinaire en anglais a attiré des personnes de Montréal et de ses environs (32%), alors que le reste des participants provenaient des États-Unis (42%), Canada (Toronto, Vancouver, Kingston), du Brésil, du Danemark, du Mexique, de la Nouvelle-Zélande et de la Norvège. Je profite de l’occasion pour vous dire que c’est toujours un plaisir pour toute l’équipe d’avoir une participation aussi diversifiée.
Une grande majorité voudrait participer à un autre webinaire et c’est pour cela que nous vous invitons à notre prochain événement bilingue du retour de notre Nuit Pecha Kucha avec votre hôte Michael Bournazian, le 27 Avril, 2022 à 19:00 avec une opportunité de réseautage débutant à 18:30. Informations | Réservations.
Voici quelques prochains événements | Here are some future events:
♦ 25 May | Mai: “B Corp” certifications (Les certifications “B Corp”) with Dr Carolee Rigsbee (Webinaire en anglais | Webinar in English) Information.
♦ 15 Juin | June: Bilingual Networking event | Activité de réseautage bilingue.
Voice of The Customer | Voix du Client Read More »
By Raymond Dyer (committee member) for Dr. Farnoosh Naderkhani, ASQ Member, Assistant Professor @ Concordia, Student Outreach Committee Chair
Veronica Marquez, MSc, CSSBB, our past Student Outreach Committee Chair before Farnoosh, delivered an exciting presentation to university students at Concordia on the topic of green and sustainable supply chain design. This was part of a vision to bring industry experience into the classroom setting. Well done Veronica! For more information, see the LinkedIn posting by Farnoosh.
If you are from an educational setting and would like to have more industry exposure on Quality related topics, please reach out to us. We have a network of potential speakers that could interest you. I (Raymond Dyer) can also be reached directly in LinkedIn. Thanks!
Veronica Marquez, MSc, CSSBB, notre ancienne présidente du comité de sensibilisation des étudiants avant Farnoosh, a fait une présentation passionnante à des étudiants universitaires à Concordia sur le thème de la conception d’une chaîne d’approvisionnement verte et durable. Cette présentation s’inscrivait dans le cadre d’une vision visant à apporter l’expérience de l’industrie dans les salles de classe. Bravo Veronica! Pour plus d’informations, consultez la publication sur LinkedIn de Farnoosh.
Si vous faites partie d’un établissement d’enseignement et que vous souhaitez avoir plus de visibilité sur des sujets reliés à la qualité, n’hésitez pas à nous contacter. Nous disposons d’un réseau d’intervenants potentiels qui pourraient vous intéresser. Vous pouvez également me joindre directement sur LinkedIn (Raymond Dyer). Merci!
Student Outreach | Sensibilisation étudiante Read More »
Par Jean-Pierre Amiel, ASQ Senior, CQA Retraité, Secrétaire, Audits, Sites web (English text follows)
La section de Montréal de l’ASQ a créé un prix de 500$ en l’honneur de Denis Pronovost, décédé en juin 2015. Par sa contribution exceptionnelle à l’association, par son leadership et son implication, il a grandement participé à la promotion de la qualité en français au Québec.
Ce prix sera remis à un étudiant du Certificat gestion et assurance de la qualité de l’École de technologie supérieure, un programme multidisciplinaire qui permet d’acquérir une formation ou un perfectionnement en gestion et assurance de la qualité. Il permettra à un(e) candidat(e) de présenter des références tangibles telles que:
| 1. La constance de ses résultats académiques; 2. La présentation d’un sujet relié à la gestion de la qualité (ex. un stage relié aux techniques et outils de la qualité, un travail de recherche, d’étude de cas d’amélioration d’un processus, ou autre); 3. Sa participation, son attitude, son esprit d’équipe et son implication; 4. Le respect de la langue française dans ses textes et présentations orales. |
Rappellons que Denis avait une carrière de plus de trente années d’expérience de travail principalement en enseignement et consultation dans le domaine de la gestion, de l’assurance qualité et des audits. En 1990, avec Pierre Caillibot, il a fondé Academia Qualitas au Québec, où ils ont élaborés des cours et formé des professionnels de la qualité dans les secteurs de la fabrication, des services et des laboratoires. Denis a été membre du Comité consultatif canadien de l’ISO/TC 176, particulièrement actif dans le groupe de travail sur la terminologie, dans le groupe de travail sur les interprétations et dans le groupe de travail conjoint CCC/ISO/TC 176/CAC/ISO TC 207 sur l’audit et sur l’avenir de la norme d’audit ISO 19011.
Il était aussi auditeur principal de systèmes de management de qualité (SMQ) certifié par le Registrar Accreditation Board (Conseil d’accréditation des bureaux d’enregistrement, RAB) et membre senior de l’American Society for Quality (ASQ). Denis a été membre actif et président de la Section Montréal francophone de l’ASQ de 2012-14. Il a été conférencier et instructeur en Amérique du nord, Amérique centrale, Europe et Asie. Plus de cinq fois, il est venu à la section de Montréal nous présenter l’évolution du dossier des normes ISO 9000 et ISO 14000. En 2000, il a publié Internal Quality Auditing (Les audits internes de qualité), un guide pour réaliser des audits internes efficaces, édité par l’ASQ.
Nous avons hâte de vous présenter le gagnant de ce prix lors d’une prochaine activité de la section.
The ASQ Montreal Section has established a $500 award in honor of Denis Pronovost, who passed away in June 2015. Through his outstanding contribution to the association, his leadership and his involvement, he greatly participated in the promotion of quality in French in Quebec.
This award will be presented to a student in the Certificat en gestion et assurance de la qualité (Management and Quality Assurance Certificate) of the École de technologie supérieure, a multidisciplinary program that provides training or development in management and quality assurance. It will allow a candidate to present tangible references such as:
| 1. Consistency of academic performance; 2. Presentation of a subject related to quality management (e.g., an internship related to quality techniques and tools, a research project, a process improvement case study, or other); 3. His/her participation, attitude, team spirit and involvement; 4. Respect for the French language in the texts and oral presentations. |
Denis had a career of more than thirty years, mainly in teaching and consulting in the field of management, quality assurance and audits. In 1990, with Pierre Caillibot, he founded Academia Qualitas in Quebec, where they developed courses and trained quality professionals in the manufacturing, service and laboratory sectors. Denis was a member of the Canadian Advisory Committee to ISO/TC 176, particularly active in the Terminology Working Group, the Interpretations Working Group and the joint CAC/ISO/TC 176/CAC/ISO TC 207 Working Group on Auditing and the Future of the ISO 19011 Audit Standard.
He was also a lead auditor of quality management systems (QMS) certified by the Registrar Accreditation Board (RAB) and a senior member of the American Society for Quality (ASQ). Denis was an active member and Chair of the ASQ Montreal Francophone Section from 2012-14. Denis has been a speaker and instructor in North America, Central America, Europe and Asia. On more than five occasions, he came to the Montreal Section to present the evolution of the ISO 9000 and ISO 14000 standards. In 2000, he authored Internal Quality Auditing, a guide to conducting effective internal audits, published by ASQ.
We look forward to introducing you to the winner of this award at an upcoming section event.
Prix Denis Pronovost | Denis Pronovost Award Read More »
Split Personalities of the QMS Under FDA QSR, ISO 13485, and MDSAP(Les dualités d’un SMQ aux normes d’appareils médicaux FDA QSR, ISO 13485 et MDSAP)
By Raymond E. Dyer (Ray), ASQ Senior Member, CMQ/OE, & CQA (un texte en français suit)
Michelle Lott’s presentation on “Split Personalities of the QMS Under FDA QSR, ISO 13485, and MDSAP” on March 30th, 2022 was an excellent event. It was very well rated and for good reason. Michelle’s humour, delivery, evident expertise, and brutal honesty easily explained the satisfaction results.
Michelle explained the challenges of dealing with the FDA where medical devices almost seen as an afterthought compared to food and drug. She then discussed the ISO 13485:2016 Quality Management System certification for Medical Devices process and how that differed from the FDA approach. Then Michelle described the MDSAP (Medical Device Single Audit Program), its audit model, and how that compared to the FDA approach. Michelle ended the sessions with a very amusing discussion of Dos and Don’ts during an audit.
There were lots of good questions and exchanges from what was visibly a significant collection of Quality professionals from the Medical Device industry. It was easy to see how the expertise behind and the directness of Michelle’s responses led to such high satisfaction results.
Michelle showed great humour, e.g. when introducing her executive team of Morty the CEO (Chief Entertainment Officer), Chopper the CFO (Chief Fun Officer), and Lucy the CTO (Chief Therapy Officer). [Note to those that did not attend, these are Michelle’s dogs.] On the other hand, Michelle also demonstrated very obvious knowledge and shared extremely pertinent concerns and considerations regarding the medical device industry with the participants.
One of the participants I know very well, a francophone friend that can at times be a little critical and who was less familiar with this domain shared with me an excellent review of Michelle and her presentation. Just that alone is enough for me to confidently state, had you been there, you really would have enjoyed the learning experience.
La présentation de Michelle Lott intitulée “Split Personalities of the QMS Under FDA QSR, ISO 13485, and MDSAP” le 30 mars 2022 a été un excellent événement. Il a été très bien noté et pour de bonnes raisons. L’humour de Michelle, sa prestation, son expertise évidente et son honnêteté brutale expliquent aisément les résultats de satisfaction.
Michelle a expliqué les défis rencontrées pour traiter avec la FDA, où les dispositifs médicaux semblaient presque être considérés après coup par rapport aux aliments et aux médicaments. Elle a ensuite abordé le processus de certification du système de gestion de la qualité pour les dispositifs médicaux ISO 13485:2016 et la manière dont il diffère de l’approche de la FDA. Elle a ensuite décrit le MDSAP (Medical Device Single Audit Program), son modèle d’audit, et comment il se compare à l’approche de la FDA. Michelle a terminé les sessions par une discussion très amusante sur les choses à faire et à ne pas faire pendant un audit.
Il y a eu beaucoup de bonnes questions et d’échanges de la part de ce qui était visiblement une collection importante de professionnels de la qualité de l’industrie des dispositifs médicaux. Il était facile de voir comment l’expertise et la franchise des réponses de Michelle ont conduit à des résultats de satisfaction aussi élevés.
Michelle a fait preuve d’un grand sens de l’humour, par exemple lorsqu’elle a présenté son équipe de direction composée de Morty, le CEO (Chief Entertainment Officer), Chopper, le CFO (Chief Fun Officer) et Lucy, la CTO (Chief Therapy Officer). [Note à ceux qui n’ont pas assisté à l’événement: ce sont les chiens de Michelle.] D’autre part, Michelle a également fait preuve d’une connaissance très évidente et a partagé avec les participants des préoccupations et des considérations extrêmement pertinentes concernant l’industrie des dispositifs médicaux.
L’un des participants que je connais très bien, un ami francophone qui peut parfois être un peu critique et qui était moins familier avec ce domaine, m’a fait part d’une excellente critique de Michelle et de sa présentation. Ce seul fait me suffit pour affirmer en toute confiance que si vous aviez été là, vous auriez vraiment apprécié cette expérience d’apprentissage.
Our next webinar: ASQ Montreal: Pecha Kucha evening|soirée, 2022.04.27, 18h30 moderated by Michael Bournazian. Réservations
Had You Been There | Si vous étiez présent Read More »
By Raymond E. Dyer (Ray), ASQ Senior Member, CMQ/OE, & CQA (un texte en français suit)
How much information can you digest? Information comes from all kinds of sources: conversations, presentations, books, newspapers, magazines, television newscasts, emails, electronic newsletters, blogs, podcasts, and social media postings. In today’s world, we’re constantly bombarded, Quality professionals included, with all kinds of information, on all kinds of topics, using all kinds of media. The senders, ourselves included, often think, or at least hope, it’s important. The challenge is that more and more topics are being seen as important to share: the environment, climate change, conflicts, pandemics, human rights, the economy, etc. Furthermore, more and more individuals feel empowered to share their version of what they feel is important. Technology has gone a long way to enable this.
The sad part is that there is no guarantee the information is important, relevant, and/or even true. So how does one on the receiving end of all this information flow capture the essence of what’s important, relevant, and true? How does one stop wasting time on nonvalue added information and filter for use the useful and constructive information or, as Dr. Joseph Juran would say, “separate the vital few from the trivial many”?
Standard Quality tools like statistics and charting don’t really address this very human process of managing volumes of information. While technologies like artificial intelligence (AI) and machine learning (ML) might help treat digital information, most humans still rely on critical thinking capabilities and selective attention. Over time, we determine which sources are delivering the reliable, value adding information we need and eventually cut out those that don’t.
So why raise this? Because I’m painfully aware that our ASQ section is competing with these other information sources for your attention and would like to ensure our newsletters, website and social media postings, and events are seen as delivering reliable, value adding information for the Quality professional. If it’s not, I’d like to hear from you and have you share with us what you’d consider does add value to our profession. Thanks!
Quelle quantité d’informations pouvez-vous digérer? L’information provient de toutes sortes de sources: conversations, présentations, livres, journaux, magazines, journaux télévisés, courriels, bulletins d’information électroniques, blogs, podcasts et publications sur les médias sociaux. Dans le monde d’aujourd’hui, nous sommes constamment bombardés, y compris les professionnels de la qualité, par toutes sortes d’informations, sur toutes sortes de sujets, en utilisant toutes sortes de médias. Les expéditeurs, dont nous faisons partie, pensent souvent, ou du moins espèrent, que ces informations sont importantes. Le problème est que de plus en plus de sujets sont considérés comme importants à partager: l’environnement, le changement climatique, les conflits, les pandémies, les droits de l’homme, l’économie, etc. En outre, de plus en plus d’individus se sentent autorisés à partager leur version de ce qu’ils jugent important. La technologie a largement contribué à cette évolution.
Le plus triste, c’est qu’il n’y a aucune garantie que l’information soit importante, pertinente et/ou même vraie. Alors, comment faire pour que la personne qui reçoit tout ce flux d’informations puisse saisir l’essence de ce qui est important, pertinent et vrai? Comment arrêter de perdre du temps avec des informations sans valeur ajoutée et filtrer, pour les utiliser, les informations utiles et constructives ou, comme le dirait le Dr. Joseph Juran, “séparer les quelques informations vitales des nombreuses informations insignifiantes”?
Les outils de qualité standard, comme les statistiques et les graphiques, n’abordent pas vraiment ce processus très humain de gestion des volumes d’informations. Si des technologies comme l’intelligence artificielle (IA) et l’apprentissage automatique (ML) peuvent aider à traiter l’information numérique, la plupart des humains s’appuient toujours sur des capacités de réflexion critique et une attention sélective. Au fil du temps, nous déterminons quelles sources fournissent les informations fiables et à valeur ajoutée dont nous avons besoin et finissons par éliminer celles qui ne le font pas.
Alors pourquoi soulever cette question? Parce que je suis douloureusement conscient que notre section ASQ est en concurrence avec ces autres sources d’information pour attirer votre attention et je voudrais m’assurer que nos bulletins d’information, notre site Web, nos publications sur les médias sociaux et nos événements sont considérés comme fournissant des informations fiables et à valeur ajoutée pour les professionnels de la qualité. Si ce n’est pas le cas, j’aimerais que vous nous fassiez part de ce que vous considérez comme une valeur ajoutée pour notre profession. Merci!
Word from the Chair | Mot du président Read More »
By Michael Bournazian, Eng., Newsletter Editor, ASQ Senior Member, Quality Management Professional, CSSGB
Just a reminder that the ASQ WCQI for 2022 is coming up next month! The event will be taking place this year in Anaheim, California from May 15-18, 2022, although it is being billed as a “Hybrid” event.
CLICK HERE to get more information and register.
World Conference on Quality & Improvement (May 15-18, 2022) Read More »
By Jean-Pierre Amiel, ASQ Senior, CQA ret., Secretary, Web committee Chair and Audit Chair.
ASQ member since 1977, of the Leadership Team on/off for more than 40 years and still enjoying it.
Membre d’ASQ depuis 1977, de l’équipe de direction depuis plus de 40 ans et je m’y plait toujours.
On Being a Member Leader | Être un membre de direction Read More »
By Michael Bournazian, Eng., Newsletter Editor, ASQ Senior Member, Quality Management Professional, CSSGB
My days have been pretty busy for the past number of weeks, so you will forgive me if I have not taken any QUALITY time to think about what to write about here this month.
Did you happen to watch the QUALITY movie I recommended to you last month? If you did, I hope you enjoyed it.
Another question for you: have you signed up for our next QUALITY webinar later this month?
This will be our 6th Pecha Kucha Night event since 2014 and I will be hosting again. Myself and our speakers will do our QUALITY best to make sure the evening is entertaining and educational for everyone. If you have not yet signed up, CLICK HERE and do so.
Wow, I was worried I would have nothing of QUALITY to speak of 😉
EDITOR’S NOTE: Neither the “C” word nor the “P” word were used during the writing of this article.
**********************************************
Any feedback? Click on the link and let me know.
ALSO . . . Please contact me or any one else on the Leadership team if you would like to:
1) Write and submit an article to be published in the Newsletter.
2) Write a review of one of the upcoming monthly webinars for the “Had You Been There” section.
Thank you, all the best and none of the worst.
The Editor’s Corner | Mot de l’éditeur Read More »
