Corrections, corrective actions and preventive actions are the “their, there, and they’re” for many medical device organizations. Confusing them is common, and even experienced and knowledgeable quality experts can slip with these during the stress induced by a recently discovered nonconformance. There is also confusion or a general lack of understanding around containment, another category of actions taken to address nonconformances. This article breaks down these principles in a step-wise fashion and explores the proper actions to address in compliance with 21 CFR 820, ISO 13485 and the EU MDR. While the EU MDR focuses heavily on field safety corrective actions for distributed product, these principles are used throughout the quality system and not only to correct distributed product. The activities described in this article may be completed within a process for handling nonconformances or a stand-alone process for corrective and preventive action.
Containment and Root Cause Investigation
When a nonconformance is identified, two things should be done immediately: Containment and initiation of root cause investigation. Containment is immediate action to prevent further use or distribution of non-conforming material. Containment usually consists of identifying the status of all affected material and quarantining non-conforming material within your organization’s control to prevent further use (typically for a part or material) or distribution (typically for finished medical devices).
Register for the EU MDR Implementation Strategies Workshop | November 27–28 | Attend in Washington, D.C. or virtually!A root cause investigation is performed to determine the underlying cause of the non-conformance. Sometimes, the root cause investigation also reveals an expanded scope of a problem and thus may identify other affected product to be contained or otherwise acted upon. For this reason, root cause investigation should begin promptly upon identification of a non-conformance. Use one or more of the following methods 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 (there are abundant resources online for these methods–see “Resources” at the end of this article). A root cause investigation may take considerable time, particularly when you are dependent on a supplier’s investigation. For this reason, be prepared to act on information as it is discovered throughout the investigation.
Correction is the action taken to correct the non-conformance. A correction is not a corrective action, as the correction simply corrects the non-conformance at hand and does not address the cause of the problem. Corrections include reworking, recalling, dispositioning non-conforming materials appropriately (e.g. rejecting), or other actions to address affected product. Of note, the EU MDR and MEDDEV both use the term “field safety corrective action” (FSCA) for recalls and field notifications. While an FSCA addresses a product problem that may cause an adverse event, a field action is actually a form of correction with respect to your quality management system, not corrective action as defined in the EU MDR (The definition of ‘corrective action’ in the EU MDR (2017/745) is action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation).. While an FSCA may address the root cause of a potential adverse event caused by a product, it does not address the root cause of the product problem. That is, you can correct the problem in the field but you must also implement a corrective action to prevent a recurrence of the non-conformance. A field safety correction alone is rarely, if ever, adequate to address a nonconformance, as it does not address the root cause of the nonconformance.
Corrective action is the action taken to eliminate the cause of nonconformities. To implement relevant and effective corrective action, the root cause investigation must adequately probe the sequence and interaction of events that led to the nonconformance. Even when you think you’ve identified the root cause, consider further evaluation to ensure the totality of root cause is identified. Your corrective action must remedy the entire root cause(s) of the nonconformance.
Preventive action is the action taken to eliminate the cause of potential nonconformities. A preventive action differs from corrective action in that no event has yet occurred but the potential has been identified. Many quality management systems only require employees to identify preventive actions as part of a corrective action process designed for the handling of nonconformances. You should use each nonconformance as an opportunity to identify potential nonconformances; however, you should not restrict the use of your preventive action process to only those times where a nonconformance has already occurred. Your organization should be trained on the principle of true preventive action and always identifying the potential for errors or other causes of nonconformances. When performing the following, look for opportunities for potential nonconformances:
- Internal Audits: Are there potential causes of nonconformance even when one has not yet occurred?
- Complaint Investigations: Even where a complaint investigation revealed there was no non-conformance, did the investigation reveal an opportunity for such a nonconformance?
- Monitoring and Measurement of Product or Process: Does data suggest “drift” that may result in out-of-specification product if not acted upon?
- Training: During verification of training effectiveness, is there evidence that a procedure or process may be confusing or prone to error?
The following actions are required to close out a nonconformance and to ensure compliant handling of nonconformance information:
- Ensure containment actions, the root cause investigation, corrections, corrective action and preventive action are all complete and documented. This includes the revisions to all applicable documents (e.g., procedures, forms, etc.).
- Verify that corrective and preventive actions are effective and document this assessment. For processes performed infrequently, there will be a significant delay in an opportunity to assess the effectiveness of any corrective or preventive action. In this case and when possible, consider a mock activity where you can demonstrate the effectiveness of a new or revised process in a simulated scenario.
- Notify personnel responsible for the quality of the product or process (or similar products and processes) and personnel who may prevent the nonconformance or (similar nonconformances). Consider documenting this notification in the relevant employees training files. Turn mistakes into training opportunities.
- Ensure that information related to corrective and preventive actions is provided to management, at a minimum during management review.
- Ensure the outputs of your CAPA program are evaluated for changes to your technical documentation.
- The EU MDR requires that corrective and preventive actions are monitored through post-market surveillance. In turn, your post-market surveillance program must identify the need for corrective and preventive action. Ensure your procedures enforce these linkages.
- Ensure distributors and importers of your products in the EU are notified of corrective actions affecting product. Under the EU MDR, distributors and importers are required to maintain a quality management system. They are required to maintain procedures ensuring they are notified by the manufacturer of corrective actions affecting product.
- Corrective and preventive actions are also required inputs for your periodic safety update report (a new requirement under the EU MDR). Ensure the appropriate procedure exists and that your processes are adequately linked.
- For each nonconformance affecting product already placed onto the market, ensure you have a cogent, risk-based evaluation for field safety corrective action (e.g., recall or field correction) that considers as the highest priority the impact on patient and user safety.
A customer reports a defective device. During an evaluation of a retain sample (representative samples of the lot retained for later evaluation, if needed) during the complaint investigation, the quality associate confirms the reported problem is present in the retain from the same lot. Containment actions performed at the manufacturer include quarantine of all units remaining in inventory from that lot. The root cause investigation is launched and, through a thorough root cause analysis using flowcharts, staff interviews, and the five why’s, the team discovers that the defect occurred during a critical assembly step. A recall of affected product was performed immediately (this constitutes a correction as described above and a field safety corrective action as defined in the EU MDR). During the root cause assessment, the team determined that the improper assembly was caused by a technician with insufficient prolonged grip strength to properly operate the assembly fixture over the entire course of the shift. To cope with decreased strength over the shift, the technician used uneven force and improper twisting motion to assemble the device, resulting in defective devices. A recall of affected product was performed as a correction and the EU distributor and Authorized Representative were notified of the recall as a Field Safety Corrective Action. Corrective actions implemented to address this nonconformance included ergonomic modifications to the assembly fixture and an additional QC inspection criterion. A verification of the corrective action included a process verification where devices were manufactured on the new fixtures by multiple employees and inspected for compliance to the specification. Employees were retrained on the use of the new fixture and the new inspection criterion. All assembly staff and quality control technicians were trained on the nonconformance and the resulting corrective and preventive actions. Technical documentation was updated to account for the new equipment and process and to capture the criticality of the assembly process on compliance of the finished device. To evaluate for preventive action, a review of other assembly processes was performed to identify similar situations. No other situations were identified where a technician-equipment interface may lead to a manufacturing error. For this reason, a justification was documented as to why preventive action was not warranted. The reported events and all actions taken to address the nonconformance were evaluated during both management review and post-market surveillance.
Heighten your organization’s awareness and understanding of these concepts. Encourage preventive action to truly prevent nonconformances, but ensure you have the required expertise to avoid non-value-added fishing expeditions for preventive actions. An efficient and effective preventive action policy will pay off in reduced nonconformances and resulting actions.
With the additional oversight granted to Notified Bodies, Competent Authorities, and your own EU Distributors and Importers under the EU MDR, now is the time to evaluate and improve your processes that eliminate and prevent nonconformances.