Internal auditing is an important activity for life science organizations not just during product development, but through the overall product life cycle as well. It allows your business to self-monitor according to the necessary quality management system (QMS) rules and requirements laid out by FDA and other regulatory bodies. But some organizations might find themselves struggling with this compliance aspect: how do you ensure your internal auditing is up to standard? Here are four steps you can take to improve your auditing capabilities and efficacy.
In order to have a successful internal auditing program at your life science organization, you need to make sure you have well-established policies and procedures in place; they need to be developed, implemented, and maintained, plus routinely updated. They incorporate your team’s current capacities, resources, and needs, and must hold up the quality standards your organization has instituted. Investing the time into documentation that produces meaningful results at the end of your audits is worth it, and is the necessary first step in improving your internal auditing capabilities.
Either way, it’s important to take the tasks that comprise your auditing activities and appoint them accordingly. SOPs/WIs are only effective if the processes and procedures they document are assigned to personnel responsible for carrying them out. This encourages a greater level of accountability for the internal auditing process. Furthermore, it fosters a culture of quality in your organization.
Still, it’s important to think about how often you should be auditing. Given all the variables, you want to determine the frequency with which auditing can have the most impact. Too often, and you risk losing time to market and lost resources overinvested in auditing. Too few, and you could run the risk of postmarket issues and QMS breakdowns that would have serious consequences for your organization.