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Regular Checkups

Using a QMS internal audit program as strategic business tool

by Ally Baduel

There seems to be an underlying trend in the industry to view the quality management system (QMS) internal audit program as more of a box-checking activity rather than a strategic business tool. It’s odd that this would be the case because a majority of organizations are required either by regulation or various standards to establish a QMS internal audit program and to regularly conduct internal audits.

There is a great self-imposed disservice that is unknowingly being assumed by an organization that simply goes through the motions and spends the money to complete these activities without using the competitive advantage that internal audit programs can provide. After all, an organization that expends the resources to do something might as well do it with excellence and leverage the activity to its fullest.

Think of the internal audit program as being similar to that of a thorough physical exam. It provides feedback on how each part (organ) of the system performs individually, and how the system (body) performs as a whole. Think of all of the internal audits being performed throughout the year as mini checkups. The overall, in-depth physical exam results are delivered when all aspects of the QMS have been audited.

Healthy mix

In an effort to supplement internal resources, many organizations tend to perform a short, high-level exam of the system in the form of a full QMS audit, which is typically conducted by a third party over the course of five consecutive audit days. This approach helps serve as a benchmark on where the overall system is in terms of compliance, and it also can help to provide insight into the systems that are compliant but not operating at an efficient state.

It should be noted that overarching QMS audits that are performed as such should not be considered a deep dive into the system or a full view of its well-being. It’s more akin to the concept of a person having their vital signs checked at a local pharmacy to make sure that all critical features of the system are functioning properly and are in a state of baseline compliance.

This is one of the many reasons it’s so important to stress that the successful implementation of an internal audit program tends to rely on a healthy mix of audits executed by internal and external auditors. When applied correctly, the internal audit program can be leveraged as a strategic tool that can render amazing insight into the strengths and weaknesses of any organization.

The program can indicate not only what is or is not in a state of compliance, but it can also provide a critical insight and warnings similar to the concept of an oil light on a car’s dashboard.

It can proactively identify systemic issues before they become major issues. Identifying these issues ahead of time versus waiting until they become larger problems downstream allows the organization to avoid reactive activities and the greater costs associated with those types of activities.

In the end, an internal audit program should not only provide a read-out of an organization’s state of compliance, but it also should be used to identify the areas in which the systems are performing well.

The audit program also can be easily used to identify process integration points and systems not performing efficiently.This will help an organization determine which areas to focus its future continuous improvement activities on to receive the most return for its investment.


Ally Baduel is a senior regulatory affairs specialist and internal audit program manager at Inogen in Richardson, TX. She has an MBA from Amberton University in Dallas. An ASQ member, Baduel is an ASQ-certified quality auditor, biomedical auditor and manager of quality/organizational excellence.



Easily tracing to identify process integration points and systems not performing efficiently.This will help an organization determine which areas to focus its future continuous improvement activities on to receive the most return for its investment.
--Karikalan M, 03-31-2016

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