For too many FDA-regulated companies, internal audits are just another procedural item to check off. It may get onto the calendar, but rarely gets circled as a high priority. The result? A moment of panic when you realize you only have a few weeks to complete your program.
This mindset ignores the reason regulators require internal audits in first place—to help you teach yourself how to identify and address issues before they need to do it for you.
A well-run internal audit doesn’t just provide protection, it lets you revisit your quality system and compare it to current regulations.
Have new requirements created gaps in your system that need to be addressed?
Are there opportunities to be more efficient?
These are the advantages of building an internal audit process that gives you valuable information in return for the work you invest in it.
To help you get more out of your audits while ensuring they’re adequately protecting you from compliance problems, we’ve highlighted six essential actions all FDA-regulated companies should consider.
1. Create Dedicated Procedures for Your Auditing Process
Defining clear procedures for each process speaks to a basic best practice. But especially for companies who don’t place internal auditing particularly high on their list of priorities, this can present very real problems if not closely followed according to what’s required.
Before laying out the details of how your audits are conducted, start by clearly identifying the scope of the regulations as they apply to your product. Make sure this scope is defined within your procedure so you can build an auditing process that focuses squarely on what you need to do without wasting resources satisfying requirements that don’t apply.
2. Write a Detailed Audit Plan
Especially for companies expanding manufacturing processes to new sites, it’s absolutely critical to standardize the internal auditing process and make it easy for new facilities to adopt.
Having a clear and concise audit plan also helps to prevent the tendency to put it off until teams are forced to rush through it by eliminating the unknown factors that scare teams into procrastinating.
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Plan what needs to be done, how long each activity should take, and schedule your audit ahead of time. In addition to being better organized, you'll also send a message that these audits aren’t the mundane intensive tasks they’re made out to be., but rather a chance for your team to revisit the quality system to find new ways to make it more efficient—saving them time in the long-run.
3. Always Be Ready
Interestingly, people tend to turn into their perfect selves in the run-up to an audit.
While it’s important to be prepared beforehand, FDA doesn’t always give you the luxury of a warning before they show up. Rushing to organize and change behavior just before a scheduled audit is a sign you probably aren’t fully prepared for FDA investigators if they decide to knock on your door out of the blue. That’s a serious risk.
Although quality experts have been telling companies to “always be ready” for decades, drug and device manufacturers are still getting burned by regulators as a result of poor preparedness—underscoring just how valid of a concern it really is.
But how do companies actually stay fully prepared 24/7? The simplest and most effective solution is to simplify.
Quality systems should be thorough, but they should also be efficient. Do everything you can to simplify your quality system and make it easier to use. Preparedness will come naturally from letting your staff focus on what matter most.
4. Compare Existing Procedures Against Current Regulations
Procedures should routinely be checked against current regulations to ensure they’re up to specifications. Have any activities become unnecessary as a result of new laws? Have new regulations been addressed?
The second piece to this point is taking a closer look at your records themselves. Determine whether testing was completed correctly and that all the files you’ve generated have been verified and are easily accessible.
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5. Make Your Internal Audits More Rigorous Than FDA’s
The advantage here is obvious. By going over and above what you can expect from FDA’s investigators, you can be confident you’re fully prepared for them.
But putting such a program in place can seem like a tall order, especially when audits don't exactly bring instant gratification.
Checklists can help a great deal when crafting a super-powerful audit program. Examine each of your applied regulations and standards and create actions that can be checked off as they’re completed and verified.
6. Don’t Let the Person Who Wrote the Procedures Conduct the Audits
This problem is common among smaller companies and startups, but certainly isn't exclusive to them.
Along with being a major ISO and FDA violation, separating the writer from the auditor is also common sense. The person responsible for doing a good job shouldn’t be the one evaluating what’s been done.
Once you’ve identified an objective auditor, make sure they’re sufficiently trained. While certifications like RAPS and ASQ are preferable, independent firms can provide valuable training and oversight to regardless of certification.