FDA Quality System Regulation:

FDA QSR Non Conforming Product

Information & Training. | Medical Devices


FDA QSR Non Conforming Product  – Requirements.

The FDA has detailed that when product at any stage in a process is identified as “non-conforming”, it needs to be segregated and dispositioned per defined procedures. An investigation then needs to be performed into the reasons for the non-conformance. This investigation needs to be performed in accordance with the organization’s corrective and preventative action process, to ensure measures are implemented to prevent re-occurrence.

Non-conforming Product

Validation. Classification. Regulation. Requirements. Current best practices.
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Where the non-conformance is to be corrected, then there needs to be defined rework and re-test procedures to ensure the non-conformances are addressed.

Where non-conforming material is to used in the manufacture of a medical device, then the details of the non-conformance and impact on the finished product needs to be assessed and documented. Approval must be given by competent individuals for the use of non-conforming materials or processes. For example, consider components of a medical device that have only cosmetic requirements. In the event of the components failing to meet such specified cosmetic requirements a determination may be made that there is no functional finished product impact. Therefore, the non-conforming materials may be approved for use in the manufacture of the finished device, however such a decision making process and “acceptance for use” determination need to be recorded in a defined deviation acceptance procedure.

Medical Device Validation & Compliance … more details …



FDA QSR Non Conforming Product – Regulations.


Subpart I–Non-conforming Product
a) Control of nonconforming product. Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of non-conformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the non-conformance. The evaluation and any investigation shall be documented.

(b) Nonconformity review and disposition. (1) Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use.

(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and re-evaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and re-evaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.


Reference: FDA QSR’s

Information & Training.

Medical Device:

      • Validation. Classification. Regulation. Requirements. Current best practices.
      • FDA cGMP’s. EU MDR’s / MDD’s.
      • FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
      • FDA Medical Device Classification. The FDA approach to Medical Device Classification.
      • EU Medical Device Regulation and Classification (per MDD’s).
      • New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
      • Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
      • Quality System requirements to maintain compliant Validations.
      • Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
      • Medical Device Software Validation.
      • Medical Device Design Validation.
      • Electronic Signature, Electronic Records.
      • Life Cycle Approach to Validation.
      • Risk Identification. Documentation. DHR’s. DMR’s.
      • Etc. Etc. …
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