Preparing for an FDA Audit

    Posted by Chelsey Davis on Feb 19, 2015 10:46:07 AM

    FDA Audit

    As a result of the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA), food inspections are on the rise. Under FSMA, all high-risk facilities must be inspected by January 2016, repeating every three years; all other facilities must be inspected by January 2018, repeating every five years. With the added pressure for the FDA to come in and perform these inspections, it’s even more critical that food manufacturers be prepared before, during, and after an FDA audit inspection.

    Preparing for an FDA Audit 

    So how do you make sure you’re always prepared for an announced or even an unannounced audit? Here are a few tips to help you get started:

    1. Know the Latest in Standards and Rules

    Basically, you have to think of audits as a test in which all of the answers are provided. The standards and guidelines by which your facility has to adhere to are clearly laid out, it’s just a matter of making sure you are up-to-date with any changes that may have been made. Make sure to review these standards regularly in case you are presented with a pop quiz. 

    2. Conduct an Internal Audit Regularly

    To make sure you are always prepared for an unannounced audit, make sure you conduct one yourself regularly. To do this, have a checklist handy and schedule out some time for a daylong walk-through. If you’re in need of an updated FDA checklist, you can download one here. If possible, try to look at your operations from an outside perspective to really see if there are any concerns or issues you have to address.

    3. Manage Your Documents Efficiently

    The one thing an auditor will surely request from you will be documents, and often times, lots of them. Make sure your CoAs, invoices, product labels and any other supplier documentation are organized and ready to produce at any time. One way to tackle this issue is via automation, which can not only help with organization, but can also help to digitize operations and extract intelligence and critical data. Not only will this save you time, but it can also help point the way to where new opportunities are hiding and even help to shed light on where the gaps in your supply chain are. To learn more about the power of digitalization and automation, take a look at our Coffee Talk with John Paul Williams, Director, Enterprise Solutions and Market Development, Americas for Polycom.

    Document management and record-keeping are major components to ensuring you are audit ready 365 days a year. And preparing is only half the battle. To understand what needs to happen not only before, but during and after an FDA audit, make sure to download our FDA Audit Checklists to help guide you in the right direction.

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    Tags: FDA, Audit, Automation


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