Janet Woodcock made headlines (again) by discussing the possibility of a quality rating system to aid transparency in her recent blog. But the devil is in the details when it comes to ratings for a site’s quality maturity.
Let’s take more of an everyday example to illustrate my point: if credit bureaus only assessed your credit worthiness once every three years based on just two days worth of financial data, how valuable would that rating be for potential lenders? Naturally, a great deal could change in a few days in terms of your credit worthiness. This points to the core issue with ratings systems like this, which are based on a mere snapshot of data.
But if the credit agency was able to capture a variety of data about you (like payment history, defaults, overall debt load) on a regular basis from all lenders/banks, the agency is now much better positioned to create a dynamic picture of your current standing. More importantly, they can now assess your trajectory (like are you in default or close to it today or how likely are you to default in the next quarter or year).
Back to the issue at hand, the FDA’s suggestion of a quality rating system is definitely a solid starting point for the critical discussion of improving quality among drug manufacturers, but is it enough to make this into a reality?
There are still big questions to be considered by the agency and those they regulate. For instance, would a standardized scoring system shared by all major regulatory agencies actually be welcomed? Or better yet, would larger pharma companies or auditees self report blinded audit results/data points? With these further discussions and answers, we can start to form necessary partnerships, actual buy in, and more complete data, all providing us a chance to fill in the gaps between significant inspections and paving a clear path of quality for manufacturers.
But the challenges are many and significant, such as:
- Getting agencies to agree on a shared approach is difficult and time consuming.
- Getting clients to share supply chain and audit data, especially for any kind of significant or critical vendor/contractor is very difficult.
- Understanding and somehow ‘handicapping’ for consistency of audits from one to the other is tough--e.g. the quality/experience of the auditor or the scope/complexity of the audit could really affect the outcome. At the very least you would need enough audits/daat for an auditee to manage outliers.
- Deciding what data/metrics to use? “Metrics can be dangerous” was a favorite quote from the audit VP of a top ten pharma companies, his point being if you incentivise/pay based on a metric (e.g. # of Deviations) it creates a strong incentive to possibly under-report minor/borderline incidents that should be reported and assessed if only for trending purposes.
I love this concept-- trying a launch transparent way to gauge a provider’s quality GxP compliance profile with the world was one of the original founding principles of ZenQMS, a leading quality compliance solution provider. We tried to initiate that quality credit bureau concept and spent years analyzing thousands of audits and related data to perfect a scoring system. Despite amazing insights analyzing audit data, when it comes down to it, companies are reluctant to share their data. I can’t blame them for being reluctant given the risks and moral hazards at play.
With or without the advance of these ratings and transparency, FDA’s strongest point in their latest post is that quality maturity plays a critical role in solving for today’s drug shortage problems, “a critical health care issue that reduces treatment options, limits access to medications, and can threaten the well-being of patients in need of important therapies.”
This viewpoint is shared among many of the quality experts we know here at ZenQMS, including Judy Carmody, founder and principal consultant of Carmody Quality Solutions. In reaction to Dr. Woodcock’s statement, Carmody responded:
Dr. Woodcock’s position that there is a ‘need for rewarding more investment in quality’ is appropriate and must go further. Shortages are just a symptom of larger issues. When a company lacks a culture of accountability, quality, compliance, and performance - all suffer. Many leaders need to embrace a deeper understanding that quality must be a strategic core cultural value. Only then will they stave off noncompliance issues – and build high-performing, innovative environments where drug shortages become a thing of the past.
Additional thoughts and recommendations from our team at ZenQMS, along with experts like Judy Carmody, are captured in our latest ebook featuring a multi-dimensional model for Quality Maturity. The model illustrates quality maturity as the strength of its people, processes and technology.
At ZenQMS, we encourage this continued dialogue and spotlight on the importance of holding up quality standards and are committed to working with agency and industry partners on this important issue.