SUSTAIN Quality & Compliance Improvements

Sustainability

What is “Sustainability”?  In the context of business initiatives and investment, and more particularly in the context of quality and compliance remediation activities, sustainability can be defined as the process of maintaining that which you’ve created, repaired, or invested in.   According to Dictionary.com, one definition for sustainability is: “to keep up or keep going, as an action or process.”

Many if not most compliance remediation projects are temporary in nature, and are intended to “reset” the balance point with respect to under-attention and under-investment of compliance-related activities.   See our article on a cost-effective approach to compliance remediation.   While compliance remediation projects take time – often significant amounts of time – and money – all of that investment can be easily wasted if there is not an early focus on and planning for long-term sustainability.

Sustaining a high-level of business performance is extremely difficult.  Business priorities take precedence;  priorities change;   Budgets shrink; and "stuff happens."  What you have the best intentions about one day, are superseded by more important priorities when situations change.   For FDA-regulated manufacturers however, sustainable compliance is of paramount importance.  The FDA can walk through your door (with certain exceptions) at any time.  If you haven’t invested in your systems and practices, and if you haven’t sustained these systems and practices, you just won’t be ready – period.     As evidenced by our industry’s abysmal compliance track record, it appears that many companies have not only failed to perform the proper remediations, but have altogether failed to focus on sustainability.

Achieving Sustainability

For companies that have invested in quality and compliance remediation programs, or that already have high-performing quality and compliance programs,  how can sustainability be achieved, enabling the company to continue to reap the fruits of their significant investment, and ensure that they are ready when the FDA Investigator walks through the door?

The following eight (8) actions are key to significantly improving the likelihood of sustainable outcomes:

  1. Ensure leadership ownership of improvements and establish a positive tone at the top leading sustainability activities;
  2. Measure / assess and continually improve organizational culture, with focus on continual improvement and staff candor;
  3. Embed operational excellence approaches into manufacturing and quality operations to ensure daily results-focused reviews;
  4. Approach inspection readiness as an "ever-ready" activity, not a crisis to be "managed";
  5. Prevent death by 1000 cuts by creating incentives for robust infrastructure and eliminating the quality function as a target cost area for budget cuts;
  6. Ensure adequate staff quality and numbers through focus on talent management while guarding against aggressive cost-cutting;
  7. Create safe-zone Management Reviews to ensure frank, open discussions of quality system performance; and
  8. Maintain well-architected quality systems through focus on fit to business model and periodic re-engineering.

The foregoing steps are not easy.   Each involves significant cross-organizational stakeholder buy-in, and recurring effort to achieve sustainable outcomes — and not to just move onto some flavor of the month project.