The creation, tracking, and publication of quality metrics has long been a source of sensitivity and confusion. People may fear them because they feel that they don’t tell the whole story or that they may invite criticism and misinterpretation. Thus, quality metrics were held tightly close to the chest of business leaders. Deming identified this phenomenon in a quote, “Fear invites wrong figures. Bearers of bad news fare badly. To keep his job, anyone may present to his boss only good news” (here).
Recently, regulatory authorities have rightly accelerated their focus on the importance of data. The Pharmaceutical Quality System (PQS) used by each company is largely process-based; however, data is needed to “prove” that it is effective. On March 9, 2022, the FDA established a docket to solicit comments on changes to the previously proposed Quality Metrics Reporting program, and an article by Joanne S. Eglovitch of RAPS points out some of industry’s views, both positive and negative (here). This marks a major milestone in FDA’s journey to modernization, as described in its 2007 report, “Pharmaceutical Quality for the 21st Century-a Risk Based Approach” (here).
So, it seems that the time is now to recognize and leverage the conflation of the regulatory environment and good business practices. The FDA’s goals (here) are threefold:
- Obtain a more quantitative and objective measure of manufacturing quality and reliability at an establishment;
- Integrate the metrics and resulting analysis into FDA’s comprehensive quality surveillance program; and
- Apply the results of the analysis to assist in identifying products at risk for quality problems (e.g., quality-related shortages and recalls).
If good quality is good business, now is the time to start the journey. This should not be seen as a new concept but a natural progression of a company’s data governance journey as they manage their Data Integrity risks. There are three agreed-upon metrics which seem to have consensus, which are:
- Lot Acceptance Rate (LAR)
- Product Quality Complaint Rate (PQCR)
- Invalidated Out-of-Specification (OOS) Rate (IOOSR)
The regulatory environment wants to incentivize, industry has the tools, so where is your firm in this journey? Lachman has helped companies develop roadmaps to assist them in this journey to transform compliance into a competitive advantage using data integrity as the catalyst for change. Ask yourself- is your firm winning or losing? Lachman Consultants is happy to help your firm get back on course.