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Never Stop Learning

In ISO 14971, Medical Device, QA, Quality, Quality Management Systems, Risk Management, Training on April 2, 2011 at 2:30 pm

One of my family’s favorite songs is “Come on Get Higher” by Matt Nathanson. Two years ago I tried to purchase this for my wife as a Christmas present. Unfortunately, I couldn’t remember who sang the song. I tried searching the web for the lyrics and found out that Sugarland sings it. I remembered the logo on the album cover, went to the store and bought the album. After I got home I realized that the song wasn’t on the album. Back to the store I went and found another version of the album with some live versions of songs—including “Come on Get Higher.” Just to make sure I had the right song, I decided to open the package and play it. My music video selection for this blog is what I heard. I guess we never stop learning, but I did fall in love with Country music at the age of 38…

I am in Canada, it’s almost midnight, and this client has me thinking so hard that I can’t sleep. I am here to teach the company’s Canadian facility about ISO 14971:2007—the ISO Standard for Risk Management of medical devices.

                Most of the companies that request this training are doing so for one of two reasons: 1) several of their design engineers know almost nothing about risk management, or 2) they have several design engineers that are quite knowledgeable with regard to risk management but these engineers have not maintained their credentials and their last risk management training was to the 2000 version of the Standard. This company falls into the second category.

                I always tell students that I learn something by teaching each course. From this company, however, I have learned so much. This company has forced me to re-read the Standard a number of times and reflect on the nuances of almost every single phrase. I have learned more about this Standard in one month than I learned in the 3.5 years since I first took the course I am now teaching.

                I have developed a model for learning that explains this phenomenon. I call this model the “Learning Pyramid.” At the base of the pyramid there are “Newbies.”

               This is the first of four levels. At the base, students read policies and procedures with the hope of understanding.

                In the second level of the pyramid, the student is now asked to watch someone else demonstrate proper procedures. One of my former colleagues has a saying that explains the purpose of this process well, “A picture tells a thousand words, but a demonstration is like a thousand pictures.” This is what our children call “sharing time,” but everyone over 40 remembers this as “show and tell.”

                In the third level of the pyramid, the student is now asked to perform the tasks they are learning. This is described as “doing,” but in my auditing courses I refer to this process as “shadowing.” Trainees will first read the procedures for Internal Auditing (level 1). Next trainees will shadow the trainer during an audit as a demonstration of proper technique (level 2). During subsequent audits, the trainees will audit and the trainer will shadow the trainee (level 3). During this “doing” phase, the trainer must watch, listen and wait for what I call the “Teachable Moment.” This is a moment when the trainee makes a mistake, and you can use this mistake as an opportunity to demonstrate a difficult subject.

                Finally, in the fourth level of the Learning Pyramid we now allow the trainee to become a trainer. This is where I am at—so I thought. I am an instructor, but I am still learning. I am learning what I don’t know.

                The next step in the learning process is to return to the first level. I am re-reading the Standard and procedures until I really understand the nuances that I was unaware of. Then I will search for examples in the real world that demonstrate these complex concepts I am learning. After searching for examples, I will test my knowledge by attempting to apply the newly acquired knowledge to a 510(k) or CE Marking project for a medical device client. Finally, I will be prepared to teach again.

                This reiterative process reminds me of the game Chutes and Ladders, but one key difference is that we never really reach the level of “Guru.” We continue to improve, but never reach our goal of perfection…For further inspiration try reading “Toyota Under Fire.”

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  1. Rob, This is a very insightful and useful post, regardless of what business or industry we’re in. Your concept of learning is universally applicable in my opinion. What I particularly like about it is the humility of accepting that we never really ‘know it all’. The engineers you train are fortunate to have a teacher who is enlightened enough to view education as a collaborative process. Keep writing. Loved the tune, too. Never heard Sugarland before and they’re really good to listen to.

    • Thank you so much for the positive feedback Ellie. I have noticed that the students that take my courses are the most frequent visitors to my blog and the most popular blogs are about training. The universal applicability of training topics must be the reason for the increased interest. I’m looking forward to reading some of your recent postings too. I learn a lot from the way you communicate to your audience and I try to adopt some of those techniques in what I do.

  2. I enjoyed it as well. You did, however, touch a nerve with me on the music. Sugarland is far from country (keep in mind I’m a Texas guy). Do a search for anything by Aaron Watson, especially “Barbed Wire Halo” or “Off The Record”, or Josh Abbott Band, “End of a Dirt Road” or “She’s Like Texas”. For more mainstream country, listen to anything by Miranda Lambert or Brad Paisley’s “This is Country Music”. The best song about what is going on in country music is “Murder on Music Row” by George Strait and Alan Jackson.

  3. Thank you for the comments JB. I’m growing my appreciation for country slowly. I’ll be sure to check out some of your suggestions, but it might take me a few years to become a country guru that earns the respect of a Texan.

  4. […] Last year I published a blog titled “Never Stop Learning.” […]

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