Posts Tagged ‘Quality Assurance’

Great Instructors and the Power of a SNICKERS

In Canadian Medical Device Regulations, CMDCAS, Training on November 13, 2012 at 3:57 am

I guess there are still some instructors out there that need to be reminded that we can all read the regulations on our own. We don’t need to pay $1,000+ per day in order to have someone read stuff for us. If that’s what you want, my 10-year old son is a fantastic reader. He’ll record anything you want, in any media format, for a much smaller dollar figure.

If you want to learn something that is worth at least as much as your investment of time and money, then you need to find an instructor that can teach effectively. There are four prerequisites for a great instructor:

1. The instructor must be an expert.

2. The instructor must inspire participation.

3. The instructor must provide practical examples for each student.

4. The instructor must get everyone’s attention–and keep it.

The most important determining factor of training effectiveness, however, occurs after the course is over.

You may have read my other posting with two songs by the lead singer of Pink Martini–China Forbes. However, China was unable to sing for a period of time and Storm Large was the guest singer that helped keep their tour going. Storm is larger than life and so passionate, but this performance is only one side of her personality…

When you are teaching quality assurance and regulatory affairs, you must develop your ability to inspire and engage students to Olympic medalist proportions. “Blah, blah, blah…” and “Death by PowerPoint” will get you fired. Don’t read your slides, don’t turn your back on the audience (or they’ll attack), and PLEASE don’t ever ask someone to read the definition of nonconformity out loud to the rest of the group. When I teach a class you demand my best. I’m six-foot, six inches tall and I have a loud booming voice. My mother has red hair and she was an opera singer. I’ve got the voice to fill any auditorium, and the stage presence to match. But if you even start to nod off in class, I may just have to throw a Snickers bar at you.

This is an essential tool for any instructor. It functions as a tool to prod sleeping students awake, is small enough to cause minimal injury when thrown, serves as an emergency food supply, and it’s gluten free.

If legal council recommends against using projectiles to encourage class participation, you might also consider one of my all-time genius ideas. I was scheduled for a 2-day course in Ottawa, but the day before I needed to perform an audit in Pennsylvania. Therefore, my flight was the last flight into Ottawa–arriving at approximately 1 am. My flight was delayed more than an hour and the person in front of me was trying to smuggle an extra carton of smokes into the country. Just before 4 am my taxi arrived at the Albert at Bay Suite Hotel. Class started at 8 am. I made it to class on time, and excessive consumption of several pots of black coffee helped get me to lunch. Then my legs started getting a little wobbly. Fortunately, there was a convenience store next door that sold my favorite chocolate–the Dark Aero bar! After four of these monstrous organisms of cacao, and another pot of coffee, I could have listened to the lecture on Canadian Medical Device Regulations all night.

The closest chocolate companies have come to selling the body of Christ.

Hershey’s copied them, but the result was a mere shadow of the Nestle’s greatness. Canadian’s know how to make junk food, tell a joke and play hockey!

Despite the physical handicap of sleep deprivation, I still learned a ton from my course in Canada. Here’s why:

1. The instructors were experts. Both instructors were regulatory experts and Canadian. Both instructors taught this course twice a year for multiple years, and one of the instructors actually worked for Health Canada.

2. The instructors were blessed with the perfect audience that was hyper-motivated to pass the course. Everyone in the class worked for a Notified Body that had sponsored them to take the course. In order to stay employed and get a raise, I needed to pass that course. If I failed the exam, I had to absorb the cost to travel back to Ottawa and retake the course in February (BRRRR!).

3. Everyone has different experiences and therefore not every example makes sense to us. Therefore, instructors need to use practical examples that are actionable. In  this course, the instructors brought more than a dozen medical devices to the class. We studied the labeling and the intended use of each device. Even students from Japan, Europe and Australia were familiar with some of the products. This was critical, because we all needed to be able to identify incorrect Canadian labeling.

4. The greatest asset of all was the humor of the instructor from Health Canada. He was hilarious. He had everyone laughing at his jokes for the entire course. Most of the jokes were not funny enough for a stand-up routine, but this was a mandatory regulatory course on Canadian regulations. Who would even expect a chuckle.

Despite the strengths of these instructors, there is only one reason why I know the Canadian Medical Device Regulations (CMDR) as well as I do. I use them every single week.

Here are some examples of how I used the CMDR:

First, I had to audit 162 days for BSI in 2011. Ninety percent of those 162 days were for companies that required a Canadian Medical Device License. Therefore, I started auditing companies to the Canadian regulations immediately after the course.

Second, I was also consulting for companies at the same time I was auditing for BSI. Consulting clients hired me to prepare and submit Canadian Medical Device License Applications for them. I also had to revise and create new procedures specific to the Canadian regulations. I spent another 60+ days in 2011 doing consulting.

Finally, I was one of BSI’s instructors that taught the a regulatory comparison course that compared the regulations of the USA, Canada, Europe, Australia and Japan. Therefore, at least once a month I had a classroom of 6-20 people asking me challenging questions about how to interpret and apply the regulations from each of these countries to their products.

I used every bit of knowledge I learned in that course in Ottawa and I started using that knowledge immediately after the course. I had peers, superiors, clients and students challenging my knowledge of these topics every day. This is what makes you an expert.

If you need to learn something about Quality Assurance or Regulatory Affairs, a one-hour webinar is not enough. Reading a blog is not enough. Taking a 5-day class is not enough. Shadowing another more experienced person is not enough. In the end, all of the above will get you to barely competent!  If you want to learn, you need a great instructor. Then you need to use everything you learned at every opportunity for several years.

Some say, “If you can’t do, teach.”

I say, “Bring a SNICKERS bar and throw it at them for faking it.”

For those of you that are brave enough, Storm will perform an encore that shows you a little of the wild side that we all need to unleash from time to time (even us regulatory geeks). I think she might have had more than one candy bar before this performance.


The Quality Police

In Consulting, International Standard, ISO, Medical Device, QA, QC, Quality, Quality Management Systems on November 11, 2010 at 12:24 am

            A few years ago I was in the process of resigning from my job as Director of Quality from ConforMIS. My boss at that time paid me a kind complement that provided me with a perspective that I had not had prior to that moment. I don’t remember the exact wording, but his basic message was: Quality Managers that work cooperatively with operations are rare and highly sought after. He described my approach to Quality as modern and progressive. Over time I have learned to articulate this as the difference between Quality Control (QC) and Quality Assurance (QA). The word “control” is the key difference between these two responsibilities. QC is responsible for verifying that product is “good.” Often this creates friction between manufacturing personnel and inspectors. It doesn’t help that the people often have the same title as our favorite FDA employees—the Inspectors.

            We might as well give the QC folks a uniform, a badge and a gun. They act like they are the Quality Police. Progressive companies have changed their organizational structure and integrated the Inspectors into the production lines. Now we have U-shaped cells instead of lines. Operators are now referred to as “team members,” and everyone takes a turn at inspection as a normal part of job rotations. This modern and progressive approach is difficult for “old school” Quality Managers to accept. They feel uncomfortable with this approach, because they remember when manufacturing didn’t care about Quality and would just “ship it.” Some of these managers are quite young. Unfortunately, these Quality Managers were taught methods for achieving quality that are thousands of years old.

            The 21st century is not “out of control.” We merely upgraded our risk controls. Once we relied upon the Inspectors. Now we rely on process validation, automation, and statistical analysis of process variable that are Critical to Quality (CTQ). Many people use rules of thumb to estimate the effectiveness of visual inspection. At best visual inspection is capable of catching 98% of the problems. Validation, automation and statistical analysis each have the capability of exceeding 98% effectiveness by themselves. When we combine each of these methods together, we improve the certainty of making good product to Sigma Quality levels of 5 and 6-sigma. At this level of quality, the importance of visual inspection begins to evaporate. It is in the context of a highly automated and robust process that modern Quality Managers are implementing “radical” changes. We don’t need the Inspectors. We need Quality Engineers that can help us implement the new risk controls.

            When I first started at ConforMIS, I was interviewing candidates for a new QA Associate. I used this title to differentiate it from QC Inspectors. One of the design engineers argued that we needed to hire an inspector that was more qualified at performing measurement of implants. I argued that we needed good suppliers to do this for us. We also needed to have strong supplier controls such as process validations, supplier audits, process risk management, and a physical presence on-site at the supplier. Being the hiring manager, I got my way (I’m also 6’6”).

            During the interview process, I asked each person to describe their role in their current position. One candidate actually described himself as the “Quality Police.” I stopped the interview immediately and showed him the door. Coincidentally, the design engineer thought this candidate was great. When I finally hired someone for the job, I made a point of telling him this story. The person I hired had no experience in the medical device industry and he knew little about measurement techniques. He was also the oldest candidate that interviewed for the job. What won him that job was that his mindset was the most modern and progressive of the people we interviewed. He may also be the first QA person in history to have the customer service department rave about him. I miss working with him, but I know a company in Massachusetts that is very lucky to have him.

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