Audits can be a stressful time for a company. Even if it is known in advance when the audit will occur getting ready can still prove a challenge. A company may be audited by one of several regulatory bodies depending on the market their product is being sold in and the type of product being sold. In the US the FDA is the body responsible for setting compliance standards and will often be the one conducting the audit.

The FDA will inspect many aspects of a company, including its quality system. The audit of the Quality System of device manufacturers is referred to as the Quality System Inspection Technique or QSIT for short.[1] A QSIT audit is divided into four sections with multiple subsections and is conducted in a top-down manner.[2] The Audit starts by looking at the overall quality system and then dives deeper into the records. The FDA provides guidance on what goes into a QSIT audit. Apart from the quality system the FDA also audits computer systems, facilities, and more.[3]

To be ready for an audit at any time a company should try to use the always ready approach. Essentially instead of preparing for an audit just before it is conducted the company is ready at all times. This can be done by figuring out which regulations apply to the product and ensuring that all standards are being met at all times. Putting compliance systems in place can be challenging, ensuring that they are always being met by every team member is as well. To help achieve always readiness a company should attempt to foster a culture of regulatory compliance, encouraging all team members from senior management down to practice routines and procedures that are in line with the goal of compliance. With this method, there will be no scramble to cover multiple non-compliance issues or get documents sorted when an audit is approaching. Instead, all the company will have to do is identify any of the small remaining gaps and ensure those are covered.

Ensuring systems are in place for audit readiness can consume a lot of resources. A helping hand can go a long way in achieving compliance. EMMA International can provide that helping hand. Our team of consultants can help build and establish compliant quality systems no matter what standard or standards it needs to be compliant with. From start to finish EMMA International’s full service consulting can help reach the market and stay on the market. Give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.

[1] FDA (August 2014) Quality Systems, Retrieved 11/28/2021 from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/quality-systems

[2] FDA (August 2014) Performing Subsystems Inspections, Retrieved 11/28/2021 from https://www.fda.gov/performing-subsystem-inspections

[3] FDA (March 2021) Inspection Guides, Retrieved 11/28/2021 from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-guides

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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