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The Dread of Human Errors
CTDO Magazine

The Dread of Human Errors

Friday, September 14, 2018

Organizations can maintain compliance through training and emotional connections between employees and their roles.

Why is compliance a cause of angst? Compliance is a necessary component of any successful regulatory environment and quality management system. Standard operating procedures, policies, regulations, guidelines, law, control, risk, standards, and requirements combine as the tools used to create a compliant environment. Responsibility and accountability for actions and behaviors are the human element that create a compliant environment. If an organization doesn't maintain regulatory compliance, it can run into the danger of an audit finding, which can have a negative impact on the company internally and externally.


It sounds simple, right? You have all these elements in place, provide a written process or procedure to employees, train employees on the process, and expect employees to follow the procedures. Why, then, is "Procedures not followed" the number 1 training—related audit finding? Standardizing the work processes should eliminate errors in compliance if employees follow those standards.

But we're dealing with humans. Why do humans deviate from a process they have been trained on? Here are some of the causes:

  • distractions or interruptions
  • fatigue
  • lack of focus
  • forgetting the steps in the procedure or policy
  • lack of aptitude
  • self—doubt or lack of confidence
  • not seeing the relevance of what they are doing
  • past negative experiences
  • too much information at one time
  • fear of asking questions
  • tight timelines.

Because of these and other reasons, employees make errors, and the regulatory environment can quickly fall out of compliance.

Changing employee behavior and creating a mindset for compliance

An interactive approach to compliance training can shift behavior and help build a cultund a vare of accountability and responsibility. A combination of adult learning theory ariety of media are available to train employees to create an engaging experience that will connect the employee to the task and make the task meaningful and sustainable.

Research from Malcom Knowles, one of the founding fathers of adult learning theory, describes adults as relevancy— and goal—oriented and that they must see a reason for learning something. Learning must be applicable to their work to be of value to them. Adults need to be actively involved in the learning process and understand how the process will help them reach their goals. Because they have accumulated experience and knowledge in life, they need to connect learning to that experience.

Meeting employees' learning styles will drive the behavior that will help them maintain compliance. Employees will then take more responsibility for the task they are performing, be more aware of their affect, and hopefully take ownership.

Three areas for a big impact in training that meet adult learning theory are:

  • using interactive hands—on learning experiences
  • explaining the "why"
  • creating an emotional connection.

Communication is a thread throughout these three impactful areas. Good communication between supervisors in a manufacturing area and in operations can keep employees abreast of issues so they can be reactive when issues arise. Daily communication is essential to adults—this is demonstrated in many industries with morning stand—up meetings and visual dashboards with critical statistics.

Use interactive, hands—on learning experiences

Technology has played a vital role in advancing and improving compliance training. Simulations can immerse learners in a situation that engages them, and videos can clearly show a procedure and explain the detail, making the learning engaging. Videos are also good for refreshing employees on tasks where significant time has passed between performing them.

Online learning enables participants to learn at their own pace, making it more effective for them to absorb complex material. These types of media have the visual element that helps make learning more engaging and improves retention. Online training has created a means for making content more accessible globally for companies that need greater bandwidth. Further, all employees receive a consistent training message or learning point. Many online software packages enable organizations to build interactive and engaging training. Keeping up with regulation updates and revision training can be a demanding task. Document management systems and learning management systems have greatly improved over the years, providing an audit trail system to manage regulatory documents and training.

Microlearning is an in—demand technique, because there is so much information to absorb on a regular basis. This bite—size learning offers employees information in small chunks that focus on one topic or part of the process, which enables them to grasp the concept. This type of learning is effective and efficient. Once learners grasp that concept, the next bite—size learning takes place to add to their existing knowledge bank. This also helps employees focus on what they are learning. They can then more easily comprehend small bits of information, which is useful in today's environment where information comes in large volumes and at high speed.

Explain the "why"

Clearly explaining the reason why process and procedures are performed and linking the end result or the goal back to the learners' performance can help create ownership, especially if you can tie an association with the learners' role and the task. Don't focus on wrong or right; rather, use the end result to explain why employees need to follow a specific step—by—step process to complete the task.

For example, a learner who works in operations in a manufacturing environment hand—assembling caps on bottles of medications will gain a better appreciation for her role knowing that it is critical to bring drugs to market to help people. The end result of her role is inspiring and motivating. And coupling the explanation with hands—on activities in an environment that enables learners to touch and feel the product and equipment is a powerful method for them to learn and understand the importance of regulations and compliance.


Create an emotional connection

If employees understand the impact they make each day in their lives and on the world, that provides fulfillment, which can create a behavior change and thus accountability and responsibility in the workplace. Taking the extra step to explain to employees the reason behind the task and process can help drive a culture of inspiration.

For example, in a manufacturing environment, exposing an operations employee to the end result of his work can have a positive impact on him, helping him appreciate the role he plays and creating an emotional connection. This type of personal contact with the end customer or patient can be done by having a customer or client visit a workplace to tell her success story to employees and provide that direct personal contact, which creates an understanding of how important the employees' role is in that patient's success. I have seen this done successfully with life science companies as well as the affect it has had on employees finding meaning in their role in routine manufacturing job.

Because many manufacturing operations employees aren't exposed to the end user, this is a powerful way to make an emotional connection to a job role. Some companies in the life sciences industry create a CD of touching stories of customers who have benefited from a drug or treatment that the company produces. In a large organization, this can also help employees learn more about the products the company manufactures and create an informed culture. Interactive and engaging learning can also come from case studies or board games.

Recently, I have used two custom—built board games in training to provide shared learning among participants. The game concept provides a team—building experience, and interactive board games are another fun way to create learning with light—hearted competition.

The use of 3—D glasses can be another tool to engage learners on the importance of a quality culture that drives compliance. For example, an organization could distribute 3—D glasses that have a picture of a warehouse. By looking through the glasses, employees can gain a panoramic view that includes items that can cause the site to be out of compliance and make the environment unsafe. This brings the learner into the environment with an easy, effective tool for a powerful learning experience.

It is important that learning is continuous and provides repetition and constant reinforcement. Investing in training to ensure best—in—class performance can help relieve the uneasiness of compliance and become a competitive edge for any organization. Good regulatory compliance also helps to create a quality culture of good moral and high performance. A culture that embraces quality and lives the regulations set forth in a quality culture is an essential element in reducing compliance angst.

Read more from CTDO magazine: Essential talent development content for C-suite leaders.

About the Author

Marie Casarella has more than 20 years of experience in Leadership Development and Operations Training. Marie has a passion for creating learning and development cultures and has trained globally in Asia Pacific, S. Africa, Europe and South America. She has led numerous teams and has been in the Pharma industry for more than 10 years. In her current role, Director, GMP Training, Thermo Fisher Scientific, Pharma Services Group, Clinical Trials Division, Marie leads the division’s Global GMP Training function. This is a newly created role that is focused on driving a global operations training strategy, enhancing employees knowledge of GMPs, global regulations and driving a quality culture to enable the business to deliver safe products to customers worldwide.

Previously, Marie was the Director of Learning & Development for the Bio Pharma Services Division where she developed leaders. Prior to Thermo Fisher Scientific, Marie worked for B. Braun Medical and built the B. Braun University. Marie was also the Principle owner of Casarella Consulting with a focus on driving peak performance and coaching. Marie earned a Masters Degree from Clemson University in Industrial Education and Adult Learning Theory, and a BBS from Denver University. Marie has held numerous adjunct faculty positions and board positions including the Vice President of Marketing for the Eastern PA Chapter of the Associate for Talent Development.

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