How to Structure Your Internal Audit Program

With the mandate for internal audits, the last thing that you want to do is forget about it. By year's end, you have many things going on. Holidays are clumped together and you have many people out of the office. This is a poor time to remember that you have to do an internal audit.

These should be well structured and rigorous and are one of the hardest things to be performed by the company. Internal audits are highly important because they're meant to keep your company (and you) prepared by means of evaluating your progress. There are ways to make this process go more smoothly in addition to preparing your internal audit early on.

1. Spread It Out
2. If your company has 35 different processes that make up your SOP's you should try and separate them into sections. Separate them up into groups and each group done over different quarters. This will help to spread things out over the course of the year.
3. Audit Schedule Structure
4. Don't choose arbitrary dates. Spreadsheets, while useful in many ways, are not the best idea to use in an effort to toss out dates and ideas because it limits the ability for good collaboration. creating and planning out an internal audit workflow is going to be one of your better options when it comes to really facilitating a plan. Cover what to do and when it needs to be done. For quality and compliance, being connected is a major key factor.
5. Opportunity In Audits
6. An internal audit does not have to be seen as a stress filled horrible experience for you or your company. While an internal audit can vary depending on the companies size, it's important to learn from the findings. This will allow your company to grow and for you to learn and become even greater than you are now. Even if you find issues during your internal audit, don't panic. This is the time that you need to take to work on any issues that you're facing before the FDA and the auditor even arrives.
7. Teamwork
8. If you contact and bring in a consultant, most of the time those consultants do not have the internal knowledge needed for noting everything. When you use your own team during an internal audit, you may be able to uncover a lot of issues that might, otherwise, go unfound until it's too late. Consider a training program for team members so that you know that the process will be done at peak level.

Don't wait until the last minute to conduct your internal audit. Be the company that steps up to the plate instead of the company that starts to panic in the 12th month of the year. Treat the process as just another learning tool that is implemented by your company.

Mitch Robbins is the Managing Director at The Anthony Michael Group, helping Medical Device, Medical Technology, Digital Health, and Diagnostics organizations to build best in class Technical (Regulatory, Quality, Engineering, R&D, Manufacturing teams across the USA while helping candidates progress their careers. He is also the host the RA/QA Today podcast on iTunes and Sound Cloud.

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