Why Should You Outsource Quality Audits?

Our Compliance Team review of the 2023 most frequently cited 483 findings identified heavy emphasis on a company’s ability to police itself through its internal, quality audit program. Prior to 2022, a company’s internal audit program did not appear in the Top 10 483 list, but both in 2022 and 2023, this matter has become a concern with the FDA.

Does The FDA Expect Internal Quality Audits?

In Compliance Team’s experience, a company actively working an open CAPA for a quality issue is less likely to receive a 483 for that issue than if an FDA inspector finds the issue first. Third-party quality audits are an essential tool to ensure that a quality system is effective.

Expectations For Pharmaceuticals

For pharmaceuticals, 21 CFR 210/211 does not specify a specific internal audit program. However, industry best practice suggests that internal audits are a necessary part of the duties for the Quality Unit. Both ICH Q9 and Q10, which are recognized by the FDA include expectations for internal audits, otherwise known as self-inspection.

A basic tenet of auditing prohibits auditors from evaluating their own work. While the reasoning is not spelled out in the standards, it stands to reason that auditors reviewing their own work have the advantage of not being sufficiently thorough, either because one would not want to incriminate oneself to management, or simply because the auditor is accustomed to performing a task incorrectly, thus failing to recognize their own errors.

Why Outsource Quality Audits?

So, it makes sense, with smaller companies, to employ external auditors to perform periodic quality audits. In this way, the auditing work avoids all conflicts of interest, and avoids the appearance of conflict when the organization is very small.

Certainly, larger companies have sufficient personnel to provide an unbiased review of work. Does this obviate the need for outside third-party auditors? While fewer external auditors (percentage-wise) may be needed than for a smaller firm, the challenges at a larger firm, most notably siloed departments, create the need for auditing from the angle of an outside perspective.

Larger companies tend to segment work into specializations. For example, a Quality Department at a small company may consist of one technician, one QA/Document control person, and a manager. At a larger company, These roles will be segmented into separate departments, such as Incoming Inspections, Supplier Quality, Laboratory Services, Manufacturing Quality Assurance, and Validations.

Each of these departments may exist at several locations at the company, and internal audits may either occur by trading personnel between sites to inspect a department, or by assigning a person from (for example) the validation department to audit the Incoming Inspections department.

This approach, which is effective at spotting employee mistakes, fails to focus on the larger issues that can cause concern during a regulatory inspection. Only an unbiased external auditor can view the organization from the lens of another external auditor. Specifically, limiting internal auditing to internal personnel yields the potential for two key gaps in the review.

Conformity To Best Practices

The first gap is that internal auditors rarely review procedures for conformity to industry best practices. An external auditor has seen numerous companies and has seen how the company performs when compared against similar operations, much in the same way that an FDA inspector will view a given department’s work.

So, while a larger company may feel that they meet the stated requirements, they may fall short when compared against the overall industry, particularly when compared to companies of similar size and operational experience.

Attention To Connection Points

The second reason a larger company may need outside auditors to perform regular quality system evaluations is that these audits tend to confine the scope of each audit to a particular department, leaving a gap in evaluating the corresponding connection points. Thus a communication issue between several separate, and potentially disjointed, departments fails to be revealed.

We are familiar with “us vs. them” thinking between siloed departments, and sometimes, personnel are quick to point the finger to another department when things go wrong. An outside auditor can take an objective view and see how information is either lost or miscommunicated during interdepartmental handoffs and provide a clearer assessment of the situation. Thus, the external observer can evaluate whether the company operates as a full, cohesive system, or if silos between departments have the potential to create quality problems.

The risk of missing these two crucial evaluations even exists for larger companies that have their own internal auditing department. Internal auditors, no matter whether they work “in the weeds” or not, may be subject to confirmation bias that assumes that industry best practices are being met and that successful manufacturing resulting from interdepartmental cooperation provides inherent evidence of effective communication.

While these assumptions may generally be true, it makes sense, at least once in a while, to challenge them. A system that may have operated perfectly well in the past may have broken due to changes in personnel, new processes, or shifting priorities.

Outside Perspective On Audit Program

To address this confirmation bias problem, Compliance Team suggests teaming with your company’s auditors to question some of the underlying assumptions in your audit program, assisting with periodic audits, reviewing your company’s auditing procedures and processes, and verifying the effectiveness of your company’s auditing program overall. In this way, your company can minimize your inspectional risks, by identifying issues before the inspector has a chance to find them first.

Do Third Party Audits Mimic FDA Audits?

The FDA is starting to notice that companies who police themselves have greater quality success, Third-party audits more closely mimic an FDA inspection, so it is advisable for pharmaceutical and medical device companies, both great and small, to incorporate them in their regular internal audit schedule, as it will reveal truths that will help companies survive their inspections.