I came across this article that discusses quality issues and their relations to drug shortages. This quote stopped me short:

“In this [FDA] report, the agency presents persuasive evidence to indicate that drug shortages are most often caused by quality issues in the production plants (almost two-thirds) versus other causes such as planned discontinuation.”

This FDA Group blog post, “FDA Warning Letter & Inspection Observation Trends [Updated 2022],” which covers FY2017-FY2021 cumulative trends of cGMP FDA inspectional observations further supports the idea of quality issues being central to citations. For example:

1. The top reason for citations in this period (543 of them), were due to violations of 21 CFR 211.22(d)—Quality control unit procedures (written and followed).
2. The second top reason for citations in this period (523) were due to violations of 21 CFR 211.192—Investigations of discrepancies.
3. Another top reason was companies lacking written procedures—21 CFR 211.100(a).

To recap: The Top 10 list for warning letters in this timeframe, were all due to quality issues—not following requirements for GDP, SOP, CAPA, and training. Six of the top 10 violations noted lack of written procedures in one form or another.

It appears we have a growing epidemic: a lack of focus on quality issues. That’s the bad news.

The good news is that we can mitigate this epidemic quickly if we focus on the true root cause to address the issue — culture. Although there aren’t going to be any silver bullets, if companies focus first and foremost on culture, quality system compliance will result.

Shift The Thinking

It is time for a shift in thinking—altering the perception of quality as only a “policing function” responsible for completing checkbox exercises and creating procedures that burden the organization. Such thinking slows progress and adds to the cost of doing business.

It is time to see quality as something everyone owns. The quality function can be a partner collaborating with stakeholders to produce efficient processes and innovative quality solutions which accelerate time to market and reduce costs while protecting patients. This is a Voluntary Quality Assurance (VQA)® Culture realized. A VQA® Culture centers on:

1. Collaboration rather than confrontation.
2. Proper training and education.
3. Setting proper expectations.
4. Imparting accountability through reinforcement.

This approach creates a safe environment for the free flow of ideas and concerns that brings people together, provides them with tools to be successful, and empowers them to do the right thing. It breaks down the “us-vs.-them” mentality, which is vital to create the all-important foundation for building all downstream systems.

Want to learn more about implementing a VQA® Culture at your organization? Contact us here. We look forward to working with you to shift the thinking.