Education

How do you demonstrate training competence?

Anyone can sign and date training records, but how do you demonstrate the effectiveness of training and competence?
%name How do you demonstrate training competence?

What are the requirements for training?

The requirements for training are found in ISO 13485:2016, Clause 6.2 (i.e., Human Resources). Auditors and inspectors usually only ask for training records, but the requirement for records is the last item in the clause (i.e., “6.2(e) – maintain appropriate records of education, training, skills, and experience (see 4.2.5).”). The first four items in Clause 6.2 all include one word, but it’s not “records.” The most critical word in the requirements is “competence.”

What is the difference between training requirements, training records, training effectiveness, and training competence?

  • Training requirements define the “appropriate education, training, skills, and experience.” Specifically, what degree(s) is required, if any? What training curriculum needs to be completed? What skills are needed to perform the work? And how many years of experience are needed?
  • Training records are documented evidence that all training requirements have been met. Records may include a job application, resume, individual training records, group training records, or a training certificate. Records may also include the results of any quizzes to demonstrate training effectiveness and any evaluation of training competence.
  • Training effectiveness is how well a person understands the information communicated during training. Using terms from human factors engineering (i.e., the PCA Process), the person must have the correct perception and cognition. Cognition can be evaluated by giving people quizzes or asking them questions. Written and verbal exams may also include pictures and/or video. Performing these types of tasks on a quiz or exam are “knowledge tasks.”
  • Training competence is possessing the skill or ability to perform tasks. To demonstrate competence, someone that is already competent (i.e., a subject matter expert) must observe the trainee performing tasks. A person that once possessed the skill or ability can also judge competency, and a person that does not possess the skill or ability can be trained to evaluate skill and ability (e.g., an Olympic Judge or referee). Skills and abilities can be physical or cognitive, but there are also social skills. Examples of each are provided in the table below:

List of abilities and skills 1024x495 How do you demonstrate training competence?

What keeps me awake at night? (a story from April 2, 2011)

I am in Canada, it’s almost midnight, and I can’t sleep. I’m here to teach a Canadian client about ISO 14971—the ISO Standard for Risk Management of medical devices. Most companies requesting this training are doing so for one of two reasons: 1) some design engineers have no risk management training, or 2) the engineers have previous training on risk management, but the training is out-of-date. This Canadian company falls into the second category, and engineers with previous training ask the most challenging questions. This group of engineers forced me to re-read the Standard several times and reflect on the nuances of almost every single phrase. While teaching this risk management course, I learned more about risk management than I ever knew.

The four levels of the Learning Pyramid

The image at the beginning of this blog is a learning model that explains my experiences training Canadian design engineers. 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, hoping to understand.

The student is now asked to watch someone else demonstrate proper procedures in the second level of the pyramid. 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.” Our children call this “sharing time,” but everyone over 50 remembers this as “show and tell.”

The student is now asked to perform their tasks in the third level of the pyramid. 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 to demonstrate the 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 complex 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. I am an instructor, but I am still learning. I am learning what I don’t know.

Teaching forces you back to the bottom of the Learning Pyramid

After teaching, the next step in the learning process is to return to the first level. I re-read the Standards and procedures until I understood the nuances I was unaware of. Then, I search for examples in the real world that demonstrate the complex concepts I am learning. After searching for examples, I tested my knowledge by applying the newly acquired knowledge to an FDA 510(k) or De Novo submission for a medical device client. Finally, I 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.

Where is training competence in the Learning Pyramid?

Most people feel that a person is competent in a position when they can consistently perform a task. However, the ISO 13485 standard uses the phrase “necessary competence” to suggest that competency for any given task might not be the same for all people. For example, in some cases, it may be sufficient to perform a task with written instructions in front of you, while an instructor might be expected to perform the task without written instructions. The speed at which a person performs a task might also differ. For example, a secretary might be required to touch type at a speed of 60+ wpm with a QWERTY keyboard, while a stenographer must be able to use a STENO keyboard and write at 225 wpm. The accuracy requirements may differ for those two positions as well. Therefore, your company may decide that the training competence requirement for a design engineer is that they can pass an exam on risk management. However, the training competency requirement for the design project lead or Engineering Manager might include teaching inexperienced design engineers to apply the basic risk management principles. Demonstrating the ability to teach inexperienced design engineers might be demonstrated by an auditor interviewing members of your design team.

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Time management to prevent work overload: Top 10 ideas

This article lists my top 10 ideas for time management to help prevent work overload–including suggestions for apps and other resources.

Handling Work Overload 1 Time management to prevent work overload: Top 10 ideas

I am a workaholic and I don’t recommend it–unless overweight, out of shape, friendless and divorce sounds like a great life plan. I work with regulatory affairs and quality assurance managers at every client, and 100% of them have insufficient resources. Expectations internally and externally never decrease. The saying used to be, “Do more with less.” Now it feels like we have one egg, one basket and we are expected to save the world.

Stop feeling sorry for yourself. Every department manager feels this pressure. If you don’t believe me, look around you. Everyone is popping 400mg of ibuprofen and stressed to their limit.

So what can you do to make things better?

That question is critical. It shows that internally you acknowledge that you can do something to make things better. I obviously don’t have all the answers, but I have found some tools in the past year that really made a magnificent difference in helping me with time management. 100% of these ideas were suggested by others that appear to be more at peace and happier than I was last year.

#1 Get some sleep

Two years ago I woke up after 3-4 hours of sleep every night. Last year I was almost up to 6 hours of sleep on a good night. Now I am consistently getting 6-8 hours of sleep, and once I slept for 9 hours. There are lots of suggestions for how to get more sleep, and I’ve tried them all. What works for me is: 1) no alcohol or coffee within 4 hours of bedtime, 2) melatonin just before bed, 3) exercise every day, 4) eating well, and 5) a habit of reading each night to calm myself and relax. I also use a white noise app on my phone.

#2 Budget your time management

You will never get everything done. It’s a fact. Just like money, you can always spend more. Instead, decide how much of your life you want to spend doing things. Don’t micromanage your time. Think of the big picture. There are 168 hours in a week, and >42 hours should be spent sleeping. 40-50 hours a week will be spent working. 5-10 hours per week will be spent getting to work. More than two-thirds of your life is spent sleeping and work-related–if you’re not a workaholic. Be very selfish of how you budget the remaining third of your life. I like to re-read habit #3 from Steven Covey’s book “7-Habits of Highly Effective People.” It will help you remember what’s important. Your priorities should be physical health, mental health and your family. If you devote an hour a day to each of those, you might have time left for eating, grooming and reading a book. Yes, you need vacations too!

#3 Minimize multitasking

Some people believe time management is managing multiple tasks at once, but it is actually less efficient to multitask. Picking something up, putting it down, picking it up again…didn’t you learn from your lean manufacturing training that motion, waiting and queue are all muda (i.e., waste). You need to start a task, finish that task and then start the next task. If you want more advice on this topic, try reading “Getting things done” by David Allen. This one was recommended to me by an uber-productive orthopaedic surgeon.

#4 Don’t forget to “sharpen the saw”

This is the seventh habit from Covey’s book. You should never stop improving. For example, entrepreneurs need to learn marketing. I don’t have time for an executive MBA to learn marketing. Instead, I teach myself every day while I’m working out. I have a bicycle on a trainer set-up in front of my TV. The TV is only connected to the internet. If I need a break, I watch Netflix while cycling. However, usually I’m listening to podcasts, watching YouTube videos about marketing and software tools or I’m reading books on my Kindle. I also purchase a lot of audiobooks that I listen to in the car while driving my children to rock climbing, soccer, plays and during my two-hour ride to and from the nearest airport. This is the only kind of multitasking I’m good at.

#5 Just say no.

You need to put first things first (i.e., habit #3). On a scale of 0-10, how important is it. Is it important to you, your boss, your spouse, your children or your best friend. If not, why are you wasting your precious time on it. Say no. If it’s a 9 or 10 to your spouse, say yes–even if it’s a 2 on your scale. If you have a time conflict with two items that are high on the scale, then you need to find a win-win (i.e., habit #4). This is why communication skills and empathic listening (i.e., habit #5) are the most important skills you will ever learn.

#6 Don’t read your emails “real-time”

You should have a plan for what you are going to do each day. Reading your emails throughout the day will result in reactive behavior that will always result in time management failure. Be proactive (i.e., habit #1). Read your emails just before lunch in a batch and just before you go home in a batch. You should also read “Getting things done” by David Allen. He has fantastic advice for how to process emails. This is an area I’m still working on, but I get 400+ emails a day and that doesn’t include spam, social media or promotions. You should also tell people you work with, “Call me or text me if it’s important.” Good advice for any client of mine. For example, you should probably text me if the FDA is coming on Monday and you need my help.

#7 Use productivity apps for time management

Microsoft seems to have a strangle hold on corporate America, but Outlook is a horrible tool for managing your tasks and time. You need something for personal time and personal tasks, because you have less time available for the things that are more important in your life (i.e., health, family and friends). If I empty the milk carton, I grab my phone and add milk to my “Out of Milk” app. I also use this app for planning what I need for trips, meetings and Christmas present ideas for the kids. Evernote is an uber-app. It organizes everything. Website links, blog ideas, business cards, photos, an address, directions, photos of the person I’m meeting and I use it for lists too (if I already have it open instead of Out of Milk). If you want to know how the most productive people in the world use apps like Evernote, John Lee Dumas includes apps like Evernote in every entrepreneur interview he does–1,303 podcasts and counting.

#8 Block off time to get work done

Some people believe that time management only involves scheduling meetings. You schedule weekly meetings with your boss. You schedule lunch meetings. You should also block off some time for getting work done–without interruptions. You might try blocking off every day from 11:30-Noon for emails, Noon-1pm for a lunch and a walk and 4:30-5pm for emails. If you need to review complaints each day for the need to report as an adverse event, block off some time for that each day. My advice would be to devote time to reviewing CAPAs, complaints and MDRs every day. These are the most critical areas for FDA inspections and you can’t afford to let these tasks fall behind. If you have these tasks assigned to you, then you work on the most urgent task and get it done. Then you schedule the next step for that CAPA, complaint or MDR and go onto the next task you scheduled. If you manage these processes, then you should block off time for reviewing metrics and investigate the exceptions. If it seems like you never have enough time in your schedule for all the tasks, maybe you need to delegate some of those tasks to other departments or people in your department.

#9 Schedule shorter meetings

Not all meetings deserve 1 hour. Some things can be done in 15 minutes, 30 minutes or 45 minutes. Learn about good meeting etiquette, make an agenda and manage the meeting so it’s done on-time or early. Make sure you show up on-time and get it done on-time or early. If people leading meetings are poor at time management, do not let them lead the meeting.

#10 Schedule breaks too

Outlook will allow you to schedule back-to-back meetings from 7am to 7pm (or longer). That doesn’t mean that you should, and that is definitely not good time management. Time management needs to create windows of time where you can rest too. I drive a lot. In order to survive 50,000 miles of driving a year with a congenital spine defect (i.e., L5 fused to pelvis one one side), I need to take breaks and stretch. When I don’t do this I pay dearly. The same thing happens to me when I try to work 12 hours straight without a break. You will be more focused and productive if you take a break once and while.

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