As a regulatory agency, the FDA expects that organizations that they audit will take appropriate measures to ensure that they remain in compliance with the regulations. In the event that the FDA determines that a particular organization consistently gets reprimanded for non-compliance, they will likely look into the Quality System of the organization to make recommendations to amend the ongoing problems that the FDA has noted. Most of the FDA audit observations that I have seen are circled around the following: “on-going problems…”, “failed to thoroughly investigate…”, “without adequate justification or scientifically sound statistical analysis…”
When a particular organization has repeated compliance concerns, it indicates poor and ineffective quality system. FDA expectations are that the Quality Department is competent enough to identify problems when they arise, and investigate them as they arise. Repeat citations from prior inspections indicate that the quality system is either not appropriately exercising its responsibilities or does not have the authority to carry out its responsibilities. The Quality Department is the protective umbrella under which any regulated business can survive and thrive. A Quality Department that fails to do this, fails at its purpose within the firm.
Repeat warnings or citations by the FDA indicate that a firm’s own Quality Department is either incapable or unwilling to correct the identified issues. Basically, this shows that the Quality Department cannot be trusted to take matters into its own hands. Thus, in the event that the FDA recognizes such a shortcoming of an organization’s Quality Department, they may recommend that the firm solicit the assistance of a third party consultant to initiate the improvements that the firm’s own Quality Department has failed to implement.
When the FDA sees no option but to issue a Warning Letter or a Consent Decree, it shows a “vote of no confidence” in the quality system of the organization. In order to prevent a Quality Department from becoming ineffective, management should work with their Quality Department to ensure that concerns are eliminated by long term solutions, rather than ignored or worked around. Long term solutions mean that root cause analysis has been done to fully address the issue, rather than simply correcting superficial problems.
Extra time and effort spent on finding long term corrections in a timely manner will ensure that a firm demonstrates the ability to handle problems on its own, ultimately saving time and money. Responsible management and oversight by the Quality Department ensures that penalties are avoided and that third party consultants are not recommended to take over the duties that were continuously neglected. The FDA must be confident that a regulated firm will be able and willing to thoroughly and effectively address compliance concerns.
My personal advice to those who are facing the same challenge at their work place is to battle “unwillingness” by finding another line or work where there is less effect on the lives of other people, or Battle “inability” by competence and the courage of conviction.
Please tell us what kind of compliance issues you are facing at your current/previous work?