Lean RAQA Systems’ unique approach to remediation goes beyond repairing quality system deficiencies to address underlying business systems and company culture, thus expediting resolution with the FDA, preventing recurrence, and improving overall organizational health.
Has FDA 483’s or a Warning Letter brought your company’s day-to-day business to a halt? Many companies do not realize that Warning Letters are more than just a piece of paper with bad news from the FDA. In fact, Warning Letters result from a series of 483’s that the FDA did not find adequately addressed. Through Warning Letters, FDA can prevent future product clearance, restrict international trade, and declare product misbranded and adulterated requiring market removal.
Costs can exceed $100,000 per 483 observation a company receives and over $1 million to remediate a Warning Letter, not counting the business impacts of the Warning Letter restrictions.1 Quality system remediation services include analyzing the results of the FDA 483 and/or FDA warning letter, formulating an effective response to a FDA 483 and/or warning letter, developing a remediation plan to identify all causes for deficiencies, responding to questions from the FDA, and implementing improvements to ensure compliance.
But what is remediation without addressing the real root cause? Once a company has received 483’s that escalate to Warning Letters, the company has systemic issues that reach beyond the Quality System and reflect the company culture toward quality. Not only are organizations dealing with the stress of business disruption due to non-compliance, but remediation also reveals the true root cause of non-compliance: negative company culture towards quality. Without addressing the behaviors at the root of the deficiency, repair of the quality system alone will be ineffective.
Many companies struggle with negative paradigms towards quality such as “quality is a necessary evil” and “quality are like the police.” These paradigms make successful, lasting remediation difficult and must be corrected in and of themselves for sustainable results. Further, integrating positive paradigms towards quality improves business strategy, product quality, and the efficiency of day-to-day operations.
Lean RAQA Systems offers a comprehensive set of organizational analysis tools to get at the root cause of quality problems related to company culture. These tools measure the negative impacts of FDA 483’s or a Warning Letter such as organizational stress, risk of attrition, and a multitude of other organizational dynamics. Executive management is empowered with information to know when, where, and with whom to intervene so a healthy organizational dynamic towards quality can be restored. Using these applied organizational and intervention tools, recurrences will be minimized and a solid foundation will be formed for lasting success.