QMSR Complaints and Nonconforming Product

QMSR Complaints and Nonconforming Product

Our previous post discussed the Suppliers’ control requirements for the Quality Management System Regulation (QMSR). This post will focus on QMSR Complaints and Nonconforming Product requirements. The final QMSR rule can be seen here.

QMSR Complaints Control

During the QMSR review process, some industry members claimed that 21 CFR 820.100(a)(6) and (7) of the QS regulation, which requires that information related to quality problems or nonconforming products be shared with the responsible quality person, is not explicitly listed in ISO 13485. In addition, relevant information on quality problems and corrective and preventative actions needed for the management review are not mentioned. FDA agreed with these remarks but disagreed that the content of such provisions is not part of ISO 13485 and, thus, it is included in QMSR.
FDA specified that medical device manufacturers or other parties that want to apply QMSR should follow ISO 13485 Clauses 8.2.2, Complaint Handling 8.5.2, Corrective Action and 8.3.1 General requirements of Control of Nonconforming product to meet the following criteria:

• Need for investigations of complaints
• Sharing relevant information between the organization and any external party involved in the complaints
• Determining the need to investigate nonconformities and any need to notify an external party responsible for a nonconformity and
• Evaluating any need for actions to ensure that nonconformities do not recur.

FDA has clarified that use error may be a type of nonconformity and may require investigation, as appropriate.
Complaints are often directly reported to importers or distributors, not manufacturers. Therefore, these operators must clearly understand their duties and responsibilities. Consider consulting EU-MDR Articles 13 and 14 for general obligations of importers and distributors, respectively, especially if you are also marketing your products in the EU region.

QMSR Nonconforming Product Requirements

A nonconforming medical device is a product that does not conform to product requirements and should be identified and controlled to prevent its unintended use or delivery. It is a rare but unfortunate scenario when a manufacturer doesn’t define product requirements carefully. Accordingly, all their products may fall under the definition of nonconformity.

All nonconforming products discovered before or after distribution should be investigated proportionately to the significance and risk of the identified nonconformity, consistent with Clause 8.3 of ISO 13485, Control of nonconforming product, and its subclauses.

All organizations should have a procedure to define the controls, related responsibilities, and authorities for the identification, documentation, segregation, evaluation, and disposition of nonconforming products. The records of the nature of the nonconformities and any subsequent action taken shall be properly documented and documents maintained.
According to ISO 13485 (8.3.2), if the nonconforming product is identified before delivery, the manufacturer should apply one or more of the following ways:

• act to eliminate the detected nonconformity
• act to preclude its original intended use or application
• authorizing its use, release or acceptance under concession

The organization shall ensure that a nonconforming product is accepted by concession only if the justification is provided, approval is obtained, and applicable regulatory requirements are met. FDA clarified that the justification should be based on scientific evidence, which a manufacturer should prepare and be ready to provide upon request. Concessions should be on a case-by-case basis, closely monitored, and not become accepted practice.
If the nonconforming product is detected after delivery, the company shall take action appropriate to the nonconformity’s effects or potential effects.

Consistent with Clauses 8.2.5 Monitoring and measurement of processes and 8.2.6 Monitoring and measurement of the product of ISO 13485, it is mentioned that the requirement for measurement and monitoring applies to process and quality system nonconformities and product nonconformities. Quality system nonconformities is an important concept and manufacturers should find an integrative approach to link detection of quality system nonconformities to Risk Management and Corrective and Preventive activities in the company.

BioReg Services

Don’t hesitate to contact us for assistance with FDA QMSR complaints, nonconforming product issues, or QS—QMSR Gap Analysis. Our team can provide cost-effective help with all ISO 13485 Transitions or other Quality and regulatory Consulting tasks.

BioRegards,

Daniel