As per the US Federal Agency, Food and Drug Administration (FDA) observations, many companies in the healthcare sector fail to establish and maintain the Standard Operating Procedures (SOPs), in their production or manufacturing processes. In a sense, knowingly or unknowingly, pharmaceutical and medical device manufacturers are violating the basic component of current Good Manufacturing Practices (cGMPs).
Following SOPs is not only a regulatory requirement, but also improves the quality of your business and ensures consistency in employee performance. Training your employees on SOPs is a major challenge, apart from framing them. It’s quite a daunting task to train employees on procedures and regulations. Taking the aid of technology can lighten your burden, particularly, using eLearning to train your employees on standard operating procedures. Let’s check how that’s effective.
What are compliance SOPs?
FDA regulations state that there should be a set of formal Standard Operating Procedures for the production of life saving medicines. Hence, following SOPs is critical for pharmaceutical and medical device companies. They adhere to stringent SOPs for getting the defined quality, purity, and strength in drugs production or medical device manufacturing. SOPs are a must in precision driven industries, to perform the essential jobs correctly, with consistency, according to approved internal procedures.
For example, maintaining standards when cleaning, sterilizing drug product containers; sampling and testing of in-process materials in drug production, etc.
Embed the Context with Scenario-Based Learning
Simply telling ‘do this’, ‘don’t do that’, or ‘what to follow’, may not work effectively in training your employees on standard operating procedures. Yes, there are rules, but telling them directly may not yield the needed results. You have to tell employees the importance of the rule and the context behind the procedure, so that they can understand the seriousness of complying with it.
Taking the daily work scenarios is the best way to train your employees on SOPs. Scenario-based eLearning places your employees in the midst of a scenario and gives them the option to take decisions. This helps to give them feedback if they select the incorrect choice; if they take the right decision, appreciation would encourage them to complete the learning with enthusiasm.
Scenario-based learning helps set the context or background for compliance SOPs, also to show the consequences of SOP violation incidents.
A test on compliance SOPs is really a test for your employees. You can make it lighter, yet effective, through gamification. This helps your employees effortlessly learn while playing.
- Get your employees’ attention
- Make them interactive and motivate employees to actively participate in the learning
You can gamify assessments with simple plots and avoid high-end animations and complex game plots. Designing a crossword puzzle is a simple example of gamifying assessments. In this, you give questions and the options in the form of hints.
You can link assessments virtually to any game. For example, take a soccer game; selecting the right option to a multiple choice question can be represented as a goal. You can design assessments in courses with the backdrop of cricket, golf, hockey, archery, bowling, and more.
Integrate Procedural Videos
Pharmaceutical and medical device manufacturing are precision driven, so stringent quality measures, and meticulous work procedures are required to get accuracy. Showing ‘How to’ videos on compliance SOPs will help your employees understand the procedures and processes clearly. A step-by-step demonstration impresses the order of process upon employees’ mind.
Support with Job-Aids
Though employees get trained on compliance SOPs, they miss out little details and tend to forget the procedures after some time. Giving them job-aids is helpful to performing crucial procedures without confusion. They act as performance support tools for your employees to increase productivity.
For example: Giving the steps of sterilizing a drug container to remove the pyrogenic properties in a flash card comes in handy to check while doing the procedure.
Hope using these techniques and strategies of eLearning will help add the much needed liveliness to your compliance SOPs training. More than that, your organization will stay compliant and the overall performance and productivity will go up to new levels.
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