|Learn five tips for addressing common training gaps.|
by Stephanie Jones, Senior Professional Services Consultant, MasterControlIf you follow GxP Lifeline regularly, you’ll notice that we’ve been talking a lot about the concept of closed-loop quality recently, and here’s why. In the face of an increasingly competitive business environment, manufacturers are discovering that traditional approaches to quality management are no longer working (and haven’t been for quite a while). Treating compliance as a series of data or process silos that vary with department or product lifecycle stage simply won’t cut it anymore. A closed-loop approach is what’s needed today because it provides a more holistic view of product and process quality throughout the value chain as well as a considerable competitive advantage.
Closed-Loop Quality SystemFor those of you who are unfamiliar with the term, a closed-loop quality system is a system which ensures that quality events are acted upon in a visible manner from problem to solution; it includes key process, review and verification steps to attest to the efficacy of the solution. The steps are: identify the problem; contain the problem; analyze the problem; correct the problem; prevent the problem; report on the corrected/prevented problem; and finally, analyze the reported data, which could potentially bring you back to identifying an entirely new problem.
Additionally, a closed-loop quality system is not a single closed-loop process but a number of closed-loop processes working together to close gaps. The processes might include quality event processes (e.g., forms and templates), documentation processes (e.g., SOPs and work instructions), training processes (e.g., competencies and skills) and reporting and analytics processes (e.g., tracking, trending, reports for management review). All of these processes working together close the loops typically found in a quality system and make all components congruent.Potential Training Gaps
Similar types of training gaps can occur in quality event management, documentation and training processes in the form of not training the right people, not training on the right content, not testing effectively, or the worst case scenario of not training at all. In terms of reporting and analytics, some typical training gaps would include failing to track who’s trained on what, not trending on the effectiveness of testing, and not providing management with sufficient training data or reports.
Tips for Addressing Training GapsOnce you’ve identified your training gaps, the next step is to develop a plan to resolve them and prevent reoccurrence. Your plan should define: who needs training; what the course content will cover; where the training will take place (e.g., electronically or face-to-face); when the training will occur (e.g., one time or periodically); and how the training will be delivered (e.g., job codes).
When deciding how to address the gaps that may occur in the closed-loop steps through training, consider the following:
- Nine out of 10 training gaps are related to a quality event;
- Training the right people, on the right content, at the right time/frequency (e.g., new hire/transfer training versus recurring training) can help you solve the problem as well as prevent future occurrences;
- Training reports and analytics are critical to identifying a problem within your quality events, documentation or training processes;
- Reports and analytics can help you determine which trainees need to be contained (i.e., prevented from working on a particular task or process) until they have been retrained and/or which training content needs to be contained (i.e., not delivered to trainees) until it has been clarified or corrected; and
- Reports and analytics can help you analyze the problem in terms of who needs help with what.
The bottom line is that training the right people, on the right content, at the right time, combined with continual reporting and analytics, will close your training gaps, resulting in a firmly closed-loop quality system.
To learn more about what MasterControl's Professional Services Team can do for you, call 1-800-825-9117 and ask for Inside Sales, or send email to firstname.lastname@example.org.Stephanie Jones joined MasterControl in 2011 as a professional services consultant. She has more than three decades of experience working with enterprise systems. Stephanie’s skills include project management, business systems analysis, software implementation, data conversion, and computer system validation and compliance. Stephanie’s real-world expertise, particularly in the pharmaceutical and food manufacturing industries, and exceptional problem-solving and interpersonal skills, have helped her complete hundreds of successful implementations for companies both large and small.
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