The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout the quality system, they are not limited to the distributed product alone. Preventive actions should also be simultaneously integrated in CAPA management for best outcome.
Corrective and preventive actions (CAPA) should seamlessly integrate with both the Clinical Evaluation Report (CER) and Post Market Surveillance (PMS) to ensure the greatest degree of safety and efficacy for both the patient and the user.
While the CER must detail preventive measures taken to ensure the safety and efficacy of the device under evaluation, PMS should include CAPA measures through Vigilance and Post market clinical follow up(PMCF), surveys etc.
However, there is a general lack of understanding between the different types of measures taken to address non-conformance such as corrections, CAPA and containment. Even experienced and knowledgeable quality experts can slip among these during the stress induced by a recently discovered nonconformance.
This article breaks down the concepts of Correction, Corrective and Preventive Action and explains how they tie together with the CER and PMS.
CAPA Management: Containment and Root Cause Analysis
In the event that a non-conformance is identified, the issue should be “contained” and it warrants a root cause analysis. Containment is basically the immediate process or measures taken to prevent further use or distribution of non-conforming material.
Here, all affected material is inspected and its status identified, such that non-conforming material can be quarantined to prevent further use (typically for a part or material) or distribution (typically for finished medical devices).
As a part of quality management and in order to determine the underlying cause of the non-conformance, a root cause analysis should promptly be performed upon identification of a non-conformance as it sometimes reveals an expanded scope of a problem and may possibly identify other affected product(s) to be contained or otherwise acted upon.
One or more of the following methods may be used to assess root cause: Is/not is assessment, fishbone diagram, flowcharts, brainstorming (use this technique in conjunction with the others), or the five why’s.
Since manufacturers may have to depend on a supplier for investigation, it may take considerable time and require appropriate action as and when information is discovered throughout the investigation.
Product and Quality Problems
Unfortunately, while working with sensitive medical devices, unwanted deviation from the ideal product quality and effectiveness is not rare and hence should be a part of quality management system. It is a part of CAPA management to take proper preventive action to make sure this doesn’t happen.
However, without identifying the product and quality problems a proper corrective and preventive action is not possible. So, regular analysis of the product effectiveness, investigation of the causes of failure and having appropriate quality management system in place will go a long way.
Proper statistical and non-statistical procedures should be in place to identify the quality problems and prevent their recurrence.
One of the steps to make sure of that is to ensure the data source are accurate and added in timely manners. Finding unfavorable trends in the data also should be a part of the quality management system.
Analysis of test results to detect any shifts of the data will help determine the source of performance failure of the product. When a mismatch in the data is identified, this information then can be used to specify the preventive actions and corrective actions.
Corrective and Preventive Action
The action taken to address non-conformance is defined as a correction and not a corrective action, since it only “fixes” the immediate non-conformance issue and does not address the root cause of the problem.
The EU MDR categorizes recalls and field notifications as “field safety corrective actions” (FSCA). While FSCA may help correct the problem in the field, it almost never addresses the root cause of the problem.
It is imperative for manufacturers to also implement a corrective action to prevent a recurrence of the non-conformance.
As explained previously, a root cause investigation should be conducted to adequately probe the sequence and interaction of events that led to the nonconformance.
Once the root cause is identified too, manufacturers should consider further evaluation to ensure the totality of root cause is identified and implement relevant and effective corrective action.
The action taken to eliminate the cause of potential nonconformities, prior to the occurrence of any event, is called preventive action.
Identification of preventive actions as part of a corrective action process designed for the handling of nonconformances is often a part of many quality management systems. Manufacturers should ideally use each nonconformance as an opportunity to identify potential nonconformances; however, the team should be trained on the principle of true preventive action and always identifying the potential for errors or other causes of nonconformances.
It is possible to identify potential nonconformances through internal audits, complaint investigations, monitoring and measurement of product or process and also during verification of training effectiveness.
How do I ensure compliant handling of nonconformance information?
- Ensure thorough and complete documentation of all containment actions, including the root cause investigation, corrections, corrective action and preventive action. Organized capa management approach is ideal.
- Assess and document whether the measures taken to enforce corrective and preventive actions are effective. In case processes are performed infrequently, there will be a significant delay in an opportunity to assess the effectiveness of any corrective or preventive action.
- Inform the personnel responsible for the quality of the product or process (or similar products and processes) and personnel who may prevent the nonconformance or (similar non conformances).
- Ensure that information relating to corrective and preventive actions is provided to the management, at least during a management review session. The outputs of your CAPA program must be evaluated for changes to your technical documentation to ensure compliance.
- In accordance with the EU MDR, distributors and importers too must maintain a quality management system. Thus, it is important to notify them about any corrective actions affecting the product so that they may follow the required procedures and maintain proper documentation at all times.
Integrating CAPA into PMS and CER
Under the EU MDR, corrective and preventive actions must be monitored through post-market surveillance. Thus, a post-market surveillance program must identify the need for corrective and preventive action and ensure that the defined procedures enforce these linkages.
The EU MDR also mandates that corrective and preventive actions be used as inputs to the periodic safety update report (PSUR). For all devices in classes IIa and above, manufacturers should create a periodic safety update report (PSUR) that must be maintained throughout the lifetime of the device and addresses the conclusions of the PMS data and associated CAPA.
Additionally, in accordance with the recent guidance, the CER must be updated at regular intervals, including when post-market surveillance data is received that has the potential to change the conclusion of the clinical evaluation report (CER).
If definitive measures are not taken to address non-conformance through preventive and corrective action, as elicited by insufficient PMCF or incomplete PMS, strict action may be taken against the manufacturer for non-compliance leading to costly product recalls.
Only through well-defined, appropriately linked procedures and thorough, complete documentation will manufacturers be able to identify the root cause of non-conformances and implement relevant and effective corrective action leading to a reduction and possible elimination in the occurrence of non-conformance.