"Remediation" is often synonymous with maximum stress: Notified bodies or authorities such as the FDA have discovered significant deviations that must be remedied with the highest priority and without regard to the workload of employees or budgets.
This article will help you to complete such "remediation projects" in such a way that
The term "remediation" is common in the regulatory field, but no legal definition exists. The Cambridge Dictionary defines the term as follows:
“the process of improving or correcting a situation”
For manufacturers of medical and pharmaceutical products, remediation involves eliminating (regulatory) problems.
Deviations are identified by notified bodies, authorities such as the FDA, or the companies themselves during internal/external audits or inspections. Remediations are, therefore, neither limited to the FDA nor one specific area of law.
Some companies only talk about remediation once a certain level of escalation has occurred, such as the threat of a warning letter from the FDA.
Remediation aims to bring a system, process, or product back into compliance before serious consequences such as fines, criminal charges, import bans, or poor reputation can occur.
This goal is similar to that of corrective actions. However, remediation should be seen as a more comprehensive overarching process than a single corrective or preventive action (CAPA).
Typically, several CAPAs are processed, grouped, and implemented as part of a remediation project. Therefore, organizations should start a remediation project immediately if several systemic problems have been identified whether in an internal audit or during an FDA inspection.
The FDA almost always oberserves that procedures were not adequately defined or not followed.
The following procedures are particularly frequently affected (see Fig. 1):
The FDA documents deviations (“inspectional observations”) on a form with the number 483. In case of major violations, a warning letter can be issued.
There are no legal requirements for remediation. However, there are requirements for corrective and preventive actions, e.g., in chapter 8.5 of ISO 13485 or 21 CFR 820.100.
The authorities and notified bodies also set deadlines. Manufacturers should adhere to these.
Legal area | Deadlines |
USA / FDA | Response to a 483 deviation report and warning letter: 15 working days |
Typically 15 days to create a plan and 30 to 90 days to implement it (depending on criticality) | |
15 days until the submission of a remediation plan. 30 days until implementation of the remediation plan for non-conformities of grade 4 or 5 |
Typically, the process starts with the identification of a significant regulatory problem by
In this case, manufacturers must act immediately due to the deadlines mentioned above:
The next step is to work together to identify the root causes of the problems. Use the CAPA process for this (if it is not affected by the non-conformity).
Find the actual causes. The fact that someone has not complied with a process is not a "root cause." The real problems usually lie deeper:
Once the non-conformities and their causes have been fully identified and understood, the next step is to plan the remediation. The plan should include:
Communicate your plan to the notified body or authority (see also best practices).
Companies should continuously monitor the plan's implementation to react promptly, for example, in the event of delays. This task is typically the responsibility of a project manager.
Once the actions have been implemented, the effectiveness check phase begins. This can last for different lengths of time. For an objective evaluation, the respective process often has to be run through several times in order to assess whether the cause of the problem has been eliminated.
For processes that are rarely run, e.g., vigilance processes, it can be helpful to evaluate the effectiveness of the actions and the process's conformity using a simulation.
The organizations typically are obliged to report the remediation completion to the notified body or authority.
The commitment of top management and all those responsible is one of the most important success factors in a remediation project. It will be difficult if management does not understand how critical the situation is.
Use the help of Professor Johner and his team to do the necessary persuasion work. This has always been helpful to companies. Get in touch.
The root cause analysis should be system-wide and not limited to a specific process. This is the only way to identify the real root causes.
There must be no taboos in the analysis. It is not about finding the culprits but about finding the root cause. As long as companies do not find them, the next remediation is only a matter of time.
Respond to non-conformity reports or warning letters promptly and always within the set deadlines.
However, you should not react too hastily if you want your plan to be accepted. A good and well-founded remediation plan takes time because all those responsible must be involved, not just the Quality or RA manager.
Where possible, companies should define suitable preventive actions. These could be actions in other areas of the QM system or for processes that have not been objected to and that are currently (still) compliant. However, jf similar root causes could also apply to those processes and potential non-conformities could occur in the future, a preventive action might be suitable.
The process for the mandatory reporting of incidents is legally compliant and is implemented in accordance with the company's own QM procedures. However, it has been noticed that for several events the specified deadline for evaluating incidents is only just being met (negative trend).
In the simplest case, the cause is a lack of resources. However, it could also be a systemic problem (e.g., the process is too complicated, or too many people are involved). In this case, a preventive action may be useful.
The response to the authority or notified body should include the remediation plan. It is useful to formulate your intention to comply with the law and remain so in the future, preferably with the signature of top management.
A vague response to the authority should be avoided. For example, do not mention that you are working on a solution without giving specific deadlines and responsibilities.
Systemic problems can only be solved if the cause is eliminated. Treating a symptom usually only helps in the short term or not at all.
Remediation actions are implemented and trained. However, the evaluation of effectiveness is often inadequate. Take the necessary time for this and choose suitable methods.
It is not sufficient to simply document a complaint retrospectively. Instead, the organization should find out how it came about. The 5 Why method, for example, can help with this.
One possible cause is an incorrectly configured or unsuitable ticket system that leads to user errors. Or users may lack the necessary training.
In some cases, it is advisable to call in external help:
External experts can help with almost all steps:
There is no second chance with remediation projects! In most cases, there is no possibility of extending the project. It is, therefore, essential to find the right partner.
When choosing a partner, make sure that your ideal partner ...
Get in touch and find out how the Johner Institute can support you with inspections and remediation projects.
Violations of the law or standards uncovered by audits or inspections can have serious consequences. In order to avoid this, it is imperative to have:
The right partner will ensure that resource and competence bottlenecks are eliminated and that the actual causes are eliminated. In this way, you will complete your remediation project to the authority's or notified body's satisfaction.
Remediation has thus achieved another goal: better organization.
The Johner Institute's team of experts has quickly implemented countless remediation projects and helped to prevent more serious regulatory actions or warning letters from the FDA. This success is based not least on clever communication with authorities and notified bodies.
Whether you need help interpreting a non-conformity report or warning letter or an entire "remediation squad," The Johner Institute team will assist you with all activities or take them over completely if you wish.
The only decisive factor is that you get in touch quickly if an inspection or audit is pending or has already led to a suboptimal result. If we start together within a few days, it is easier to achieve the desired result: The authority or notified body closes the case successfully.