PathWise Blog

Archive for November, 2009

Thoughts on Adult Learning

Monday, November 23rd, 2009

I love a profound quote. A teacher explained how she’s gotten better at her craft. Her response “The longer I teach, the less I talk.”

Can you relate?

If you’ve been training for a while, you most likely have considered Adult Learning Principles in the delivery of your workshops. In Adult Learning Principles, To Truly Educate, You Have To Understand How Employees Learn, Elizabeth Millard identifies five tips for achieving greater success when teaching adults.

Set Expectations Accordingly

“The biggest error that companies make when training adults is in having unrealistic expectations about what employees will be getting out of the education,” says Ron Perry, a professor of information technology at the Rochester Institute of Technology who has also done corporate training.

To prevent this lack of alignment between education and expectation, Perry suggests that companies be realistic in how much they can train adults in a single training session and also give students plenty of time to practice what they’ve been taught.

Understand Learning Styles

There are three types of ways that adults learn, and most people display a combination of the styles with one being dominant, says Dave Minutella, vice president of educational services at training firm TechTrain.

We talked about this in a previous newsletter.

Spark Discussion

Adult students collaborate and seek help from their colleagues much more often than college kids and tend to solve problems through questions.

Mind The Age Gap

When mixing employees, no matter what the departments, it’s likely that there will be a range of ages, which can be a challenge. Older adults may feel anxious about keeping up in technical subjects with tech-savvy whippersnappers, and younger adults may be impatient if a trainer has to slow down to accommodate those learning at a less speedy rate.

Make It Fun

If an employee enjoys a training session, she’s more apt to remember what she learned,

“Some trainers think they have to be serious because they’re in a corporate environment…” “But when people relax and enjoy themselves, the material sticks in their minds. And isn’t that the goal of training?” (Perry)

To access the entire article, click here.

Ms. Millard is addressing technical training, which is not too different from the topics you deliver. These principles work across the learning spectrum. What kinds of activities, practices and techniques have you used that can help the rest of us to apply these principles.

Please feel free to share your experiences by commenting below.

What’s Wrong? Why Do We Have So Many Repeat CAPA Investigations?

Monday, November 9th, 2009

Repeat CAPA investigations are arguably one of the largest areas of concern for Life Science organizations today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as up to 30% of all open investigations- or 1 in every 3. What’s going wrong? Why is this happening to so many of us?

There are many reasons this phenomenon occurs; two of the most common areas that organizations misstep are outlined below. The initial steps of the investigation process are performed too quickly. As a best practice, investigators are asked to scope out exactly what the problem is and outline it in a problem statement. Far too often this step is done improperly or rushed, and the problem is not captured with a true scope and specifications. For example, problem statements that describe the issue using simple descriptors, such as “failed assay” or “improper installation,” lack rich information and can be interpreted in many different ways. Without a clear and concise description of the problem, it is difficult for the investigator to determine the underlying issue- or even know where to begin searching.

When the problem statement is mislabeled, the symptoms of the problem and not the problem itself tend to be treated. This scenario often results in the investigator identifying a “quick fix” solution to the symptom that never addresses the root cause of the underlying issue. In this case, the investigation will have a corrective action that eliminates the symptoms of the problem for a short time, but the problem ends up resurfacing with a new set of symptoms. Therefore it is beneficial to spend time up front in clearly identifying what the scope and specifics of the problem truly are. The second area that can cause repeat investigations is incomplete effectiveness checking. In many cases, once the effectiveness checking process begins, it is not carried through all the way to the end. Once it is noticed that the problem is going away and/or complaint rates decreasing then the CAPA is subsequently closed. This is an example of inadequate measurements for effectiveness checking. Effectiveness checking should show a formal plan to measure the elimination
of the underlying problem to ensure that it will not reoccur.

To eliminate a future repeat of the same problem, it is recommended to have a formal process for effectiveness checking ,making sure that proper verification and validation takes place, as well as ongoing monitoring of the situation until closure. If an incorrect root cause was identified or an incorrect corrective action was implemented, a strong, well-maintained effectiveness checking plan would be able to catch it.

By addressing and developing a formal problem scoping and effectiveness checking plan, quality managers should see a decrease in repeat investigations and an overall improvement of their CAPA system.

How would you rate the Effectiveness Checking within your CAPA Investigations?

Monday, November 9th, 2009

A surprising amount of companies do not have a formal method for effectiveness checking, and many do not even know what one looks like.

How would you rate the Effectiveness Checking measures within your CAPA Investigations?

Highly Effective
Moderately Effective
Not Effective
We do not have a process for Effectiveness Checking.
What is Effectiveness Checking?

Responses welcomed.

Why is it difficult to get to the Root Cause of a CAPA?

Monday, November 9th, 2009

1. Investigators or management make rash decisions or “quick fixes”
2. We have limited resources to investigate them
3. Individuals are not trained adequately on how to conduct a root cause analysis
4. We mistake trial and error activities with root cause analysis
5. We have difficulty differentiating between a symptom of the cause and the root cause itself

Vote at http://bit.ly/rXuwq

46% of respondants say that their employees are not trained adequately on how to conduct a root cause analysis. Do you agree?

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