If your company is regulated, then you know that it’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work.
|For many companies, quality is a concept manifested
largely in paper, instead of electronically. Which do you use?
“Training is what helps turn the theory of quality into reality,” said Dave Hunter, product management director at MasterControl (1). “Effective training should be a fundamental part of a company’s quality management strategy as it can help prevent many quality problems from ever occurring.”
Yet, for most regulated companies, quality is a concept manifested largely in paper— through policies, SOPs, work instructions, manuals, and other materials—instead of training.
Drawing from his long experience working with regulated companies, Hunter identified five common problems in managing a training control process. These problems are magnified in companies without an automated system.
This article is related to the Whitepaper: How Effective Training Management Can Help You Prevent Quality Issues. If you’re interested in reading more about Hunter’s practical strategies for addressing the issues mentioned below, please download your free copy.
(1) Negative Impact of Scale and Complexity: A company typically has SOPs for various areas of its operations. If, for example, a company has 12 SOPs that apply to 100 employees, that means a total of 1,200 training tasks for this group of employees and this particular set of SOPs alone. This can be a daunting scenario, doubly so if the company uses a paper-based or hybrid (part paper and part electronic) or home-grown system. It would entail sending out training materials and tasks via email; tracking training attendance and task completion via spreadsheets; and conducting the actual training and testing in person or online.
(2) Document Revision Not Connected to Training:Any change to a document or process typically requires retraining on the updated process. When the document revision process is not connected to the training process, tasks are easily missed and employees could still be performing their jobs based on an outdated understanding of the SOPs, manuals, and other documents. This problem is prevalent in companies that use paper-based processes or disparate systems for document revision and training management.
(3) Unnecessary Administrative Burden: Training coordinators are typically responsible for the creation and preparation of the curriculum and the implementation of the training program. In a manual process, they spend most of their time and energy in the distribution, follow up, escalation, and tracking of training tasks. They spend equal amount of time conducting testing, verifying results, and tracking completion of training tasks.
(4) Unprepared for Audits and Inspections: In terms of audits by customers or regulators, the most common concern when it comes to training is making sure you have compliant training records. Many companies are caught unprepared when an auditor looks at their organizational chart and asks for a random employee’s training record.
(5) Ineffective Competency Assessment: Assessing competency can be tricky. Many companies fail to create and implement testing that captures the essence of their training program. With a manual system, a training coordinator spends so much effort with routine matters that he or she has little time to concentrate on the content of the curriculum.
Training is an integral part of product quality and safety. This is the reason why various standards and regulations, such as FDA 21 CFR Part 211.25 for pharmaceutical companies, FDA 21 CFR Part 820.25 for medical device manufacturers, and ISO 9000 2000 for general manufacturers and other businesses require training as part of the quality management system.
Whether your company is trying to establish a training management process from scratch or improving your existing process, you should integrate your training requirements with your overall compliance and business goals. If you are using manual or home-grown processes, consider switching to an automated system (2). Take advantage of the latest technology when choosing a training platform. The time, effort, and resources you invest in establishing and maintaining an effective training management process will add value to your operations over the long haul.
(1) Dave Hunter joined MasterControl in 2002. His extensive technology experience includes working for Microsoft, EDS, Intel, and TenFold for over 20 years. He received his bachelor’s degree in electrical engineering and his MBA from Brigham Young University.
Cindy Fazzi is the editor of MasterControl Insider, a monthly publication for MasterControl users. She writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.