Interview #9: Vinay Goyal

Posted on by jimecalfa
A new interview of the QIC – Quality Interview Chain is here! Today let’s meet Vinay Goyal, a QMS professional with more than 30 years of experience. Enjoy the interview!

SHARE > Nominate > Connect > Learn

* YOURSELF / OCCUPATION: Who are you and what you do? 

Hi My name is Vinay Goyal, I was born and raised in India. I finished my BS in Electronic and Telecommunication from University of Roorkee India (Now called Indian Institute of Technology)


I am currently working for a Medical Device Company and take care of regulatory requirements related to Product Environmental Compliance and Stewardship.
I have worked mostly in electronics companies manufacturing products for commercial, military and medical applications, ranging from a very small company to very large corporations in various functions e.g. customer service, test engineering, manufacturing, quality, regulatory etc. 
I have received numerous awards and recognitions. 
Numerous presentations on quality and product environmental requirements in professional organizations e.g. ASQ, PSES, SME, etc. Published two reader guides on Regulatory Affairs for Medical Devices and Quality audits for Medical Devices.
Married, have two boys and two grandsons.

* CHALLENGES: What was the biggest challenge you faced in your job and how did you handle it?

The biggest challenge in any company for me was to make a place for myself and be the part of the team. I changed my jobs several times from design to customer services and marketing, test engineering to quality, reliability, regulatory, manufacturing, and now product environmental.
How did I handle it: Educate myself, becoming a better listener, educating myself as per the requirements, be hands-on, using quality tools e.g. visit where the problem occurs (Gemba), form a cross functional team, using Kaizen approach, come-up with short and long term solutions, be ready to make adjustments as needed and drive for the results. 
If not all 100% at least good 95% time, I was able to resolve the issue(s) successfully and once forever. 


* CONTINUOUS IMPROVEMENT: What are you doing to ensure you continue to grow and improve as a professional and/or as a person?

Educate yourself, use common sense, form a team of good resources at your disposal, analyze risks and associated pros and cons, do not be afraid in taking tough decisions, and take the ball and start running.

* QUALITY QUOTE: Which is your favorite quality quote?

Do it right the first time; Lead by the example, Do not follow where the path may lead. Go, instead, where there is no path and leave a trail.

* MOTIVATION / PASSION: What motivates you to do what you do? What are you truly passionate about?

Motivation: Having an opportunity where I can freely think, research, and share my thoughts in a team environment, implement and see encouraging positive results. Money is important but if you are good no matter wherever you go, you can make a place for yourself and money will come automatically depending on your fair market value.

* ADVICE / RECOMMENDATION: What advice would you pass along to others taking the same path as you? Any specific books/blogs/authors you would recommend?

Basic education is important but a good attitude e.g. be a good listener, be respectful and having a desire (hunger) for constant learning from both good and bad experiences. Education helps in boosting your confidence that you can do it and typically provides you a moderate success but may not provide ultimate inner satisfaction. Improving your common sense is very important but common sense is not common and it comes by listening, watching, practicing etc. and is an on-going process.

* FREE TIME: In your free time, what do you like to do to relax?
Listen music, singing, watch TV, research/reading latest activities related to my professional career, volunteer in professional and social organizations, teach in a college and professional organizations.

* HUMOR: I’m convinced that humor at work is the best remedy to reduce stress and help you with your productivity; do you have any funny stories/videos/pictures you would like to share with us?

It depends on each individual. Some people are very funny but are not good what they do. On the contrary some people are very introvert and quiet but do a super job. That does not mean that one is better than the other. I cannot recall anything funny but one incident I remember when in one of my previous companies as a Quality Manager I was giving the plant tour to our owner and CEO. He asked me how many people work for quality and I do not know why but my immediate response was 370. He looked pretty confused with my answer and repeated the same question couple of times, each time with more emphasis on every word. I gave him the same response. Then I clarified to him that we have total 370 employees and each employee is supposed to do a quality job. People directly reporting to me in QA department are there to assist other employees in achieving our collective policy and goals. 


Share > NOMINATE > Connect > Learn 

#1 Link: Bob Mehta: Quality Professional and very career oriented.

#2 Link: Dave Nagy: Professional and one of the most dedicated person.


Share > Nominate > CONNECT > Learn

Connect with Vinay Goyal through LinkedIn.

Share > Nominate > Connect > LEARN

Visit the QIC MAP to read and learn from other interviews.

Thank you so much Vinay Goyal for your participation in the QIC. Appreciate it!

SCRUM: the solution to organize your life – Green Card process example

Posted on by jimecalfa

Have you ever thought of incorporating quality tools into your daily life?

Consider this scenario: a family of 4 (mom, dad & boys), schools, extra school activities, doctor’s appointments, my husband’s job, house chores and running own businesses; in summary: LIFE. There are so many things going on in my daily routine, that if we as a family do not get organized, chaos is going to be a strong force managing our lives – instead of being the other way around. As I use to say, being a Quality Engineer I’m always looking for situations in my life to apply any of the quality tools I know. Added to that, being married to a Software Engineer, makes that search even more real and interesting.

One of the best solutions, after trying a few things to help us get organized, it is using a well known methodology called SCRUM.

Lots of people think that this type of methodologies are used in software development only or in a company environment. But I’ll show you that if you apply some of the concepts of SCRUM, you will be amazed of how your life goes smoother, you will be able to find ‘time’ that now seems so hard to have with all the things that are happening at the same time in your daily life. You will get things done and will not be able to tell anymore excuses like “I’ll do it tomorrow” or “I forgot about it”, and you will be more relaxed. I promise you!

For those of you who are not familiar with SCRUM, here is its definition:

“Scrum is an agile framework for completing complex projects. Iterative and incremental, flexible and holistic strategy where a self-organized development team works as a unit to reach a common goal.

It is lightweight and simple to understand (but difficult to master). It adopts an empirical approach accepting that the problem cannot be fully understood or defined, focusing instead on maximizing the team’s ability to deliver quickly and respond to emerging requirements.”

Keep in mind that SCRUM it is NOT a process neither a technique; it is a framework within you can employ any processes and techniques you know. That is why Scrum works well for any complex, innovative scope of work, and that includes any busy mom/dad/family life.

So, how do I use SCRUM at home? The example I want to share with all of you is the process of getting the USA Green Card (permanent resident status). My husband and I were born in Argentina, and after living in USA for 9 years, we’ve applied to get the green card in order to become permanent residents.

Let’s see first how Scrum works. Click the image to enlarge it.


1. Product backlog: A Product Owner (person responsible for maximizing the value of the product and the work of the Development Team) creates a prioritized wish list for the product called a Product Backlog. The product backlog helps the team to break the product into smaller, more manageable pieces and build it incrementally in a series of short time periods called Sprints.

2. Sprint planning: during this period the team pulls a small chunk from the top of the product backlog to create a Sprint Backlog, and then decides how to accomplish those items during the sprint.

3. The sprint: during the sprint, the team has a certain amount of time — a sprint (usually two to four weeks) — to complete its work; but it meets each day in a Daily Scrum, to asses progress and make necessary adjustments
– Along the way, the Scrum Master keeps the team focused on its goal, remove impediments for the team so everyone can focus and move forward with their work.
– At the end of the sprint, the work should be potentially shippable: ready to hand to a customer, put on a store shelf, or show to a stakeholder.
– The sprint ends with a Sprint Review of the product and a Sprint Retrospective of the team’s work process, relationships, and tools.

4. Next sprint: Once the sprint is complete, the team chooses another chunk of the product backlog and the next sprint begins.
– The cycle repeats until enough items in the product backlog have been completed, the budget is depleted, or a deadline arrives. Which of these milestones marks the end of the work is entirely specific to the project. No matter which impetus stops work, Scrum ensures that the most valuable work has been completed when the project ends.

Let’s see how we used Scrum for the Green Card process.

– Our Customer: The Government

– Our Product: all the papers and requirements fulfilled completely to send to the Government. 
– Product Owner: my husband. The green card process was possible through him, his background and his entrepreneur brain. There are few types of green card processes, our was called National Interest Waiver.
– The team: my husband, our lawyer and myself.

1. When we received all the information and requirements from the Government throughout our lawyer, my husband created the product backlog. 
NOTE: One of the best software to get organized using SCRUM methodology is called Trello. It is very easy to use, it is free and you can download its app to your smartphone for free access wherever you are. 

A good way to handle the backlog/requirements and all the progress you make, is to divide your project into columns, so what you are doing and your next steps get more visible. You can use a divided whiteboard with post-it notes or anything that works the best for you. We used the following columns names in Trello (click the image to enlarge it):


– Backlog: for the complete green card backlog activities
– To Do: for the activities to do in the current sprint
– On Going: for the activities in process during the current sprint
– Done: for the activities finished in the current and previews sprints.
(We later realized that a new column called Waiting was a good addition during this process).


2. During the first sprint, we have to gather and send to our lawyer all the information about ourselves: copies of passports, birth certificates, marriage certificate, and a lot more papers (can you imagine?); plus, get all the recommendation letters (this is required for this type of green card process. The person who applied has to have 8-10 recommendation letters from all his previews jobs, from HR to managers, to any person that can give good references working with him).

3. As a solid team we were working really hard to complete this sprint. We divided the activities in a smart way. My husband and the lawyer talked/email every Monday and Friday to check how everything was going, any doubts or questions we/her may have were addressed in those weekly scrums. My husband and myself discussed in our daily scrum (during breakfast) what we were going to do that day for the green card process and, at the end of the day (during dinner) we talked briefly about what we did during the day and if something went not as we expected.

Even when the government didn’t give us a time frame to present the papers, we put a date limit to send all the requested information.

4. Every sprint was different in this process, and of course we had a lot of new requirements that made our schedule shake; but looking backward of how we perform this project, we were so well organized that the process was smooth and we finally got product shipped on time sending everything to the government.

I’m not going to get into a lot of details of the green card process, I’l do it in another post for sure because is something that a lot of people are going through and is a stressful time while the process is on going; but I just wanted to show you that even in situations of your daily life you can apply this methodology to get organized in a manner that you will not missed anything and any new requirement/change will be handle it easily.

This is just an example, we have a complete board in Trello where we have all the activities to do during this month and for the next months until the end of the year.


Another example and tool use in daily life is shown in the last post of ASQ blog:
How Lean Helped Me Travel To Egypt With Just $500 by Sunil Kaushik. So worth it to read!


Now is your time! Share your stories with us!


RESOURCES

Interview #8 – Larry Pope

Posted on by jimecalfa
A new interview of The QIC – Quality Interview Chain is here! My pleasure to present Larry Pope, an Experienced Quality Professional with more than 25 years of experience in the pharmaceutical field. Keep an eye on his challenge story, so worth it. Enjoy it!

SHARE > Nominate > Connect > Learn

* YOURSELF / OCCUPATION: Who are you and what you do?

I began my journey in Quality 29 years ago. My experience has been focused on pharmaceutical manufacturing (sterile injectable, solid dose, topical solutions/creams/ointments). My first job in Quality was in the Quality Control Laboratory as a bench chemist. After 6 years in the lab, I moved to Quality Assurance providing guidance for sterile fill manufacturing. I then took a detour to the “Dark Side,” and spent 6 years in various operational roles. I returned to Quality Assurance and had various roles including Site Head of Quality. I am currently working as Senior Quality Manager for contract manufacturing. My journey has allowed me to live in 7 different states and travel to 7 foreign countries. I am very active in ASQ. I have been ASQ Certified Quality Auditor since 2002. In April 2015, ASQ published an article I wrote concerning internal auditing. My educational background includes a Bachelor of Science degree in Chemical Engineering and a Master of Business Administration.

* CHALLENGES: What was the biggest challenge you faced in your job and how did you handle it?

The biggest challenge that I have faced in my career, so far, happened several years ago. The company I worked for had a business partner that wanted to introduce their product to the Japanese market. In pharmaceutical market place, Japan ranks 2nd in the world; therefore, this would mean a great deal for both companies. My role at the time was site Compliance so I was tapped to prepare the site for the inevitable pre-approval inspection. Since no one at the site or at our corporate office had experience with this type of inspection, I had no choice but to “roll up the shirt sleeves” and dive right in.

I started by reviewing the Japanese regulations, finding any gaps, and filling those gaps. In this process, I learned that the inspection would be conducted in Japanese (by regulation) thus I needed to engage the services of interpreters. The interpreters were brought in a couple months in advance of the inspection as a “mock” inspection. This allowed for (1) practice for the inspection, (2) the interpreters to learn about site specific phrases that would be used during the inspection, and (3) site personnel to learn and practice cultural norms for the inspection. In the final days before the inspection, we purchased a Japanese flag to be flown in a place of honor next to our US and state flags.

The day of the inspection arrived and the site staff were confident and ready. After the traditional introductions and exchange of business cards, the inspection started. It lasted five days but was very successful. After the closing meeting, the lead inspector took me aside and spoke to me in English (for the first time in 5 days). He said “I hope you did not feel we were being especially hard on you and your staff. You must understand that my role is to protect the Japanese people and ensure that only safe and effective drugs make it to the market.”

The moral of this story is to rely on your quality tools to help you prepare for those difficult situations. Also remember to always keep the customer in mind when you are making those daily Quality-related decisions.

* CONTINUOUS IMPROVEMENT: What are you doing to ensure you continue to grow and improve as a professional and/or as a person?
I was lucky enough to have teachers in high school and college that instilled in me a passion for continuous learning. I am also fortunate to be living in a time where all I have to do is go to the internet and all the newest and brightest ideas can be found. I start each day reviewing the latest information from the FDA (Food and Drug Administration) website. I learn what issues other companies are having and apply that knowledge so to prevent that issue at my site. I attend webinars on topics of interest. Another great source of information is ASQ. The website contains news about Quality from many industries. Finally, I network with my Quality colleagues at local ASQ section meetings, seminars, and social media.

* QUALITY QUOTE: Which is your favorite quality quote?

“Quality is not something you install like a new carpet or a set of bookshelves, you implant it. Quality is something you work at. It is a learning process.” by Dr. W. Edwards Deming

* MOTIVATION / PASSION: What motivates you to do what you do? What are you truly passionate about?
In the first few days of my life, I developed a very serious eye infection. Luckily, there was a pharmaceutical solution that cured the infection and saved my eyesight. Many years later, I started my first job allowed me to help others by making sure that my company’s pharmaceutical products were safe and effective. So, I would say that I am passionate about help people.

* ADVICE / RECOMMENDATION: What advice would you pass along to others taking the same path as you? Any specific books/blogs/authors you would like to recommend?
Don’t be afraid to step out of your comfort zone. You’ll be amazed what you will learn. I have known people that would say “I’ll never work for a company under a FDA Warning Letter or Consent Decree.” I learned the most about quality by taking positions with companies that had issues with regulatory agencies and helping them to improve.

A book recommendation: Willful Blindness by Margaret Heffernan – she walks you through several examples how bad things happening when we become willfully blind (ignoring the obvious). As Quality professionals, we should never be willfully blind but ever vigilant to make the hard decisions.

* FREE TIME: In your free time, what do you like to do to relax?
Movies, movies, movies – I love to escape into a good story and be transported and forget about things for a few hours.

I also find enjoyment in the time I spend on my blog. The blog is a place for me to share Quality and Science articles, quotes, and news that I find interesting.

* HUMOR: I’m convinced that humor at work is the best remedy to reduce stress and help you with your productivity; do you have any funny stories/videos/pictures you would like to share with us?
I recall seeing a video during my MBA course work. In the video Gill Rider, Head, Civil Service Capability Group, UK Cabinet Office recounted an incident that has stuck with me. She was late for a meeting and was running down the hallway when she was stopped. The gentleman asked her what she was doing. She responded by saying she was late for an important meeting. The gentleman asked again what she was doing. After she repeated the same response given previously, the gentleman said “No, you are telling everyone that things are out of control.” Upon reflection, Gill agreed with the gentleman and said “You can’t talk your way out of what you behave your way into.” This is a good adage for any Quality professional to keep in their back pocket for use in those occasions when the operational procedures have been bent just about as far as possible.

Share > Nominate > CONNECT > Learn
Connect with Larry Pope on LinkedIn and through his Blog.

Share > Nominate > Connect > LEARN
Visit the QIC MAP to read and learn from other interviews.

Thank you so much LARRY POPE for being part of this project! I’ve really enjoyed your interview a lot!

The 2015 Future of Quality report

Posted on by jimecalfa

The 2015 Future of Quality report is here. It is entitled “Quality Throughout” and it is free for everyone. You can download it by visiting the ASQ website.

This year the report is a little bit different than the past ones. This is a compilation of essays from experts in their fields, from around the globe. You will find essays about the future of leadership, Internet, global aerospace and defense, quality, manufacturing, city planning, healthcare, education, energy, and customer experience, all from the perspective of Quality.

One of the essays talks about the FUTURE OF LEADERSHIP: From Efficiency to Adaptability. Stanley McChrystal and Rodney Evans express that “we now live, work, and lead in an environment where static targets rarely exist. Activities, people, and information are linked, moving, connected, and enabled in ways that produce outcomes and effects that are fundamentally impossible to predict… In this environment defined by speed and complexity, top-down leadership is no longer sufficient. The inspiring, directive, strategic leader at the top of the organizational pyramid is no longer the most effective model by which to mobilize and optimize the talent within an organization. So the answer to the critical question is to create leaders at every level of an organization.

Quality leadership for the future means that every individual in a system is empowered and inspired to own his or her “patch” of the place. CrossLead requires transparent leadership, a major investment of time into communication, and constantly forcing cross-functional collaboration. The result is that leaders can make fewer decisions, create ownership and accountability below their level, and have more whitespace for understanding the environment and proactively addressing new information. This requires a shift in mindset from “pyramid” to “network” leadership: the network leader doesn’t solve the problem himself or herself. Instead, he or she spends time pushing information into the system, and pulling together the nodes that have the right understanding to tackle the issue. Cross-functional teams spring up, collaborate, solve, and disband. And this can happen spontaneously because there is an understanding of the situation, the organization’s purpose, and the issue to be solved. This kind of adaptability will outpace efficiency any day. 


To make the shift from efficiency to adaptability, corporate leaders must possess certain fundamental skills. Typically, as leaders progress in their careers, they gain experience in various areas that develop their technical competence. But as they grow and progress, their reliance on these things becomes less critical and another, general skill set takes precedence. Adaptability comes from mastering this more general leadership skill set. Those who have mastery understand that “fundamentals first” is the only way to prepare for situations that can’t be anticipated. Only when an individual has mastery of these timeless leadership fundamentals will he or she become truly adaptable.“

And here is when I want to make a stop and think about what are those timeless leadership fundamental skills a leader has to have in order to be adaptable to any situation, and be able to work with his/her team in a collaborative way? Fortunately, they are very simple concepts, but sometimes hard to put on practice. Simon Sinek explains them in a clear way; he says that to be a successful leader you have to:

1) Know how and when to seize an opportunity.
2) Tell the truth. 
3) Ask for and accept help.
4) Take the risk to trust people. 
5) Remember who you are.

Here is his amazing speech:


Some phrases I want to highlight:

“One of the biggest failures of most leaders is the belief their leadership credibility comes from their intelligence. It doesn’t.”

“The people at the top have all the authority. The people at the bottom have all the information.”

“Leadership means: when everything goes right you give the credit away; when everything goes wrong, you take all the responsibility.”

The future of quality leadership is always getting back to the basic, to the fundamental timeless skills that will make you the best leader, no matter how the environment is changing around you. 

What are your thoughts? Share with us!

Interview #7 – John Hunter

Posted on by jimecalfa
The QIC – Quality Interview Chain is growing! My pleasure to present today ASQ Influential Voice John Hunter: Senior Facilitator at The W. Edwards Deming Institute, Senior Consultant at Hexawise and CEO of Curious Cat Ltd with more than 15 years of experience in management consulting, software development and internet consulting. Enjoy and learn from his experience!

SHARE > Nominate > Connect > Learn

* YOURSELF / OCCUPATION: Who are you and what you do? 

For the last few years I have travel around South-East Asia: doing some work for clients and managing web sites while delivering a few management seminars.

I write many blogs on things I like to explore and learn about. In my most recently blog I am covering topics related to a freelance nomad lifestyle and entrepreneurship. On my web site I provide links to other interviews and podcasts with me on the topic of management improvement.

I lived in Malaysia for 3 years and now am pursuing a nomadic lifestyle. Since leaving Malaysia I have spend a month or two in: Chiang Mai, Thailand; Luang Prabang, Laos; Siem Reap, Cambodia and Hoi An, Vietnam. Next will be Japan (I think) and likely more time in Kyoto than anywhere else but also more internal country travel than I have had so far.
* CHALLENGES: What was the biggest challenge you faced in your job and how did you handle it?
Isolated urgent challenges I don’t see as that big a deal. You figure something out and make it work if you have ability, critical thinking skill and an understanding of the work.
I think the biggest challenges is to change the management system so that it is much more robust and effective. Making that happen is pretty much what my blog has been about for over 10 years and is the theme of my book – Management Matter: Building Enterprise Capability.

Some blog posts that address this issue: 
– Circle of Influence 

* CONTINUOUS IMPROVEMENT: What are you doing to ensure you continue to grow and improve as a professional and/or as a person? 

I don’t do anything consciously to achieve that. I think if we retain a thirst for knowledge and curiosity and have a desire to do a good job we will do what is necessary. I follow my passion to learn largely through the internet (blog, webcasts, articles and podcasts). And I constantly question and experiment and adapt based on what I learn.

* QUALITY QUOTE: Which is your favorite quality quote?

There are so many I don’t have a favorite, more like 50 favorites. But here are four:

“The old-fashioned idea of a good manager is one who is supposed to know all the answers, can solve every problem himself, and can give appropriate orders to his subordinates to carry out his plans… A good modern manager is like a good coach who leads and encourages his team in never-ending quality improvement” by George Box – When Murphy Speaks, Listen

“Hire and promote first on the basis of integrity; second motivation; third capacity; fourth understanding; fifth knowledge; and last and least, experience. Without integrity, motivation is dangerous; without motivation, capacity is impotent; without capacity, understanding is limited; without understanding, knowledge is meaningless; without knowledge, experience is blind” by Dee Hock on Management

The common objection to seniority pay is, “It’s rewarding dead wood!” My response is, “Why do you hire dead wood? Or why do you hire live wood and kill it?” by Peter Scholtes on The Leader’s Handbook

“There are three ways to get better figures… Improve the system… Distort the system… Distort the figures” by Brian Joiner on Fourth Generation Management

* MOTIVATION / PASSION: What motivates you to do what you do? What are you truly passionate about?
I am most passionate about improving the system for long term success. Achieving some visible short term success is fine but really I mainly care about visible improvements as a lever to convincing people to make more systemic improvements. 

I also care about providing people good jobs – that provide them a good income and joy in work. I am happy when I feel I am contributing to others having good jobs. In a post on my management blog, The Importance of Management Improvement I talk more about some of these ideas.


* ADVICE / RECOMMENDATION: What advice would you pass along to others taking the same path as you? Any specific books/blogs/authors you would like to recommend?

I would recommend: W. Edwards Deming, Peter Scholtes, Russell Ackoff, George Box, Brian Joiner. I could go on with many more but really understanding these five would get you very far. And they are compatible with each other.


* FREE TIME: In your free time, what do you like to do to relax?
Travel, basketball, read, photography, invest, learn.
Share > NOMINATE > Connect > Learn 


Share > Nominate > CONNECT > Learn
Connect with John Hunter on Twitter, Google +, Blog and John Hunter online 

Share > Nominate > Connect > LEARN

Visit the QIC MAP to read and learn from other interviews.


Thank you so much JOHN HUNTER for being part of this project! I appreciate it!