Quality problems are rising in the pharmaceutical industry, often to the point of crisis. But remediation is no simple matter. If not handled effectively, it can be extremely cumbersome and expensive, often without even fully meeting its main goal: reducing patient risk. Delayed or ineffective efforts can also bring on drug shortages, which hurt patients and the industry as a whole — not to mention creating greater financial risk.
It’s time for companies to devote more attention to effective remediation initiatives. Empirical evidence demonstrates that an intensive investment early on, following a structured approach to problem solving and project management, can make remediation run much more smoothly. Indeed, properly managed remediation efforts can not only restore operations to normalcy, but also strengthen a company’s quality systems and operating culture to help forestall future crises.
The good news is that companies entering a remediation can learn from those that have navigated their own quality crises. The leaders of those successful pharmaceutical companies have found ways to implement focused and time-sensitive fixes while laying the groundwork for better quality systems for the future. We’ve distilled seven foundational principles from the successes of those companies (Exhibit 1).
1. Align & Commit the Whole Organization
To ensure successful remediation, the entire organization must be committed to the effort. Typically, quality and compliance problems that are large enough to require remediation are complex, with root causes that are difficult to identify and resolve. Sophisticated solutions cannot be implemented solely by the quality staff or even the entire operations organization. Successful remediators make it a company-wide commitment, requiring the wholehearted engagement of top management, the allocation of necessary organizational resources, and cross-functional collaboration focused on finding and eliminating the root causes.
A remediation program requires significant resources. Without intervention from the top, managers are stuck with the untenable burden of carrying out remediation activities and simultaneously completing day-to-day tasks. So companies should identify the necessary resources from the earliest stages of any remediation program. At a minimum, they should establish a strong project management office (PMO) tasked with coordinating remediation activities, tracking progress and measuring key performance metrics. For larger and more complex remediation efforts, it is prudent to set up an entire remediation organization led by a senior executive with sufficient technical and management resources on hand — including targeted infusions of staff from other divisions or from external contractors, when needed.
The hard work of remediation starts with a structured approach to root-cause problem solving — not simply by jumping on first- or second-order diagnoses. Ideally, the problem solving should be cross-functional. In one company, the sessions included personnel not only from the engineering, manufacturing and quality groups, but also from HR. That inclusive approach helped to pinpoint the fact that some production workers were not following established operating procedures.
Cross-functional collaboration is just as important once the root causes are clear. Quality and manufacturing must align on solutions and adjust their operating priorities consistent with the remediation program. Procurement and other functions might need to get involved, too. IT may need to step in to build systems that can capture more data or better analyze trends. And it may even be valuable for the R&D group to join in, postponing unrelated work in order to focus on solutions that change the product lineup, for instance.
2. Make Performance Management Transparent
The work of remediation differs so much from that of the core business that it requires a very different approach to managing performance. The most successful companies establish balanced scorecards to track remediation activities and overall company metrics; they also create a robust forum to properly review this performance, and they aggressively manage the performance of third parties such as remediation consultants brought in to provide interim controls.
Balanced scorecards are essential to provide visibility into both the remediation efforts and key day-to-day activities — and to shine a light on the performance of all of those activities. This requirement seems simple, but many companies fail to carry it out. They may lack the available data to be able to set up a scorecard; they may not have the resources needed to collect and manage the metrics. The companies that do commit to tracking performance management should set up simple scorecards that include such measures as remediation activities completed, regulatory external commitments met, first-pass quality, deviation and CAPA closure, and amount of back ordered product (Exhibit 2).
The PMO can be the appropriate forum for tracking performance as well for helping to coordinate and execute remediation activities. But we have found that the most successful remediation initiatives establish a fully equipped “control tower.” This is a dedicated, cross-functional forum for leaders at both the corporate and plant levels that can track improvement projects, make fact-based decisions, and drive the collaboration needed for cross-project initiatives.