EDITOR’S NOTE: This blog post is part of an ongoing series, Quality Manager Tip of the Month, to provide the latest tips from experts in the field to help readers keep up with changes in the quality industry.
Deviations and nonconformances resulting from human error are increasing or higher than expected.
Employee training and development systems designed with feedback loops and that constantly intersect with an employee's regular work allow employees to continually improve and minimize deviations or nonconformances caused by human error.
Continuous improvement for processes and products has been well accepted within the medical device and pharmaceutical industry. This same approach can extend to personnel resources.
The on-boarding process for a new employee—as well as the training and development time spent on current employees—has evolved beyond the dull “read and understand the document" type of training that once dominated the industry.
Training and development, at every level, should involve some amount of interaction between the trainee and the trainer (or training content).
For the necessary document training—which includes standard operating procedures, company policies and other documented tools, such as work instructions and guidance—methods to engage the trainee with the training content may include:
Multiple training methods should be used to ensure the maximum level of employee competence. Creative training methods are also necessary for refresher training. For an employee already familiar with the content, training must go above and beyond simply presenting the subject matter.
Learning by Experimenting: Performing something in practice is a learning style that uses all of an employee’s senses, resulting in a more complete level of memory and recall. This type of approach involves trial and error.
Learning by Observing: This training method involves the trainee observing a subject matter expert (SME) perform a particular task, followed by him attempting to perform it himself. This is a very interactive and successful method of training because the trainee is given the devoted focus and time of the trainer.
As a quality manager, would you bet on employees memorizing processes, or employees achieving high performance levels to reduce human-error caused nonconformances and deviations? Rather than memorizing and regurgitating content, an employee's ability to use all available tools to achieve a high performance level is more effective.
Achieving a high performance level should include focusing on a variety of approaches, and at minimum, these three guidelines:
It is likely that your employees are not underperforming on purpose. Evaluate all the inputs to the task that is causing the deviation or non-conformance, and identify where potential problems might be. Steps that are too complicated or a lack of sufficient instruction may be to blame.
A training and development program that is influential to employees and collaborative in nature is a reliable method for the continuous improvement of people. When employees are showing continual improving at their assigned tasks, there are typically fewer instances of human error, followed by an overall reduction in deviations and nonconformances. A training and development program that is focused on employee performance and uses multiple training methods will embrace a variety of learning styles and instill a culture of continuous self-improvement in employees.
Jake Walton is the corporate operations and quality manager at MasterControl. Jake has worked in the quality and regulatory industry for over 10 years and is a Certified Quality Auditor, as well as a Certified Quality Process Analyst (CQPA) with the American Society for Quality (ASQ). Well-versed in medical device, laboratory, pharmaceutical and ISO regulations, he has been a featured speaker at the ASQ Annual Symposium and the Utah Technology Council’s regulatory conference. Throughout his tenure, he has hosted over 250 external audits by customers, the U.S. Food and Drug Administration (FDA), European Qualified Persons (QPs), notified regulatory bodies (ISO), Taiwan FDA, and the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA).
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