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    ISO 13485 & MDR Blog

    ISO 13485:2016 nonconforming product – How to approach the post-delivery actions

    Medical instruments are critical healthcare and life-saving devices that are meant for surgeries, implantation, and other medical objectives. Many medical instruments are reused after they have gone through the sterilization process. Any non-conformity in a medical device is simply not acceptable, even after its use or after delivery. Therefore, ISO 13485:2016 addresses the management of non-conformity in a medical device even after its use or after its delivery.

    The management system covered within the scope of ISO 13485 deals with production, delivery, and supplies of sensitive healthcare devices that are critical to life; hence, the likelihood of releasing a non-conforming device is addressed exclusively in ISO 13485:2016.

    ISO 13485:2016 Standard’s Requirements

    Clause 8.3 of ISO 13485:2016 addresses control of nonconforming product. The standard under clause 8.3.3 addresses the risk of releasing a nonconforming product, and thus addresses actions to be taken after delivery. According to clause 8.3.3, an organization is required to detect nonconformity after use or delivery, to act against nonconformities with records, and to establish a procedure of advisory notices with records on its proceedings.

    Detection of non-conforming products after use & after delivery

    The organization is required to detect nonconforming products after release or after use. It’s possible that a nonconforming product is released to the market because the sample-based inspection plan did not detect it during in-house processes. For example, some lots, i.e., WIP (Work in Process) were identified with a particular defect because of an error in raw material. That specific batch of raw material was also used in some identified shipped lots that were not detected in sample-based in-process and final inspections. All those shipped lots are detected after the issue is traced out and analyzed. Therefore, in the non-conformance report, not only in-process lots are identified, but also the ones being shipped.


    Actions to address adverse effects of non-conformances

    The organization is mandated to take appropriate measures to eliminate the adverse effects of its products. Appropriate measures for a nonconforming product being shipped depend upon multiple factors, for example:

    • Situation 1: Non-conformance does not pose a health hazard, but is unacceptable to regulatory authorities.
    • Situation 2: Non-conformance does not pose a health hazard, and is acceptable to regulatory authorities.
    • Situation 3: Non-conformance poses a health hazard.

    In Situation 1, where it is unacceptable to regulatory authorities, the organization must issue a return shipment for reversing nonconforming products back. The organization should analyze the root cause and take a corrective action. The organization is required to clearly tag, label, and quarantine all nonconforming material and, if needed, dispose of it. The effectiveness of the corrective action that is taken should be measured (e.g. nonconformance is checked in the next three shipments for measuring effectiveness of the corrective action).

    In Situation 2, where it is acceptable to regulatory authorities and no health risk is assessed – the organization can communicate with the customer regarding monetary compensation, reworks, etc. If the customer agrees, then the organization takes the measure immediately. However, it is better for the organization to analyze the root cause and take a corrective action so as to avoid this non-conformity in the future.

    In Situation 3, where it poses a health risk, it means it is unacceptable for the customer as well as for regulatory authorities; the organization is required to issue a withdrawal from the market or a recall of the product. The organization must analyze the root cause and take corrective action. The effectiveness of the corrective action will be measured. Advisory notices, addressing the nonconformity and recall status of the devices, are issued to the relevant stakeholders, e.g.: customers, health care practitioners, regulatory authorities, etc. Non-conforming products are clearly tagged, identified, placed in a quarantine area, and disposed of if the issue cannot be corrected. When a product is recalled, a health hazard evaluation is conducted by regulatory bodies – for example, the Food and Drug Administration (FDA) in the U.S. The FDA also classifies the recall as Class 1, Class 2, or Class 3 based on the health hazard posed by the non-conformity.

    Maintain records of actions taken

    All those actions that are being taken must be recorded and maintained. All the records starting from the identification of the non-conformity to the root cause analysis, and from the root cause analysis to all measures for corrections and corrective actions – have to be maintained. In the (above-mentioned) Situation 2, when the customer agrees to a concession, the standard specifies an additional requirement: to keep records of the agreed concessions.

    Procedure of advisory notices

    The organization needs to develop and clarify a procedure of advisory notices. An advisory notice is initiated to send information regarding what proceedings should be undertaken in the implementation, servicing, disposal, or return of a medical device. The procedure should require the committee who issues advisory notices to answer the following questions:

    • What is the magnitude and kind of health hazard involved?
    • If there is a recall notification, what should be the scope and magnitude of the recall?
    • What is the medium of notices to consignees, e.g.: letter, email, fax, telephone, or multiple media?
    • What is the content (recommendations) of the advisory notice to consignees?
    • How is the effectiveness of advisory notices and recalls measured?

    Maintain records of proceedings following advisory notices

    Maintain a record of the proceedings held when advisory notices are distributed – issuance and receipt records of these notices should be maintained, along with their traceability. Proceedings on advisory notices include records of completed recommended actions provided in the notices, the records of measuring effectiveness of the notices, etc.

    Taking care of the product

    The new version of ISO 13485:2016 specifies a new requirement to maintain records of actions relating to the issuance of advisory notices, and even records of concessions. This is all done to ensure safe business and medical processes for all customers, suppliers, medical practitioners and, ultimately, the patients. Record keeping creates a win-win situation for all stakeholders, whereby every process for post-delivery non-conformances is recorded and every concern is addressed.

    The benefit of implementing this part of the standard is a hallmark of your organization’s commitment to patients’ safety, product conformance, and adherence to regulatory bodies. Your organization will gain an increased level of trust in the eyes of customers, and this trust will bring more business opportunities and will open new ventures.

    To see which documents are required for nonconforming products, check out this free Checklist of Mandatory Documentation Required by ISO 13485:2016.