Both 21 CFR 820 and ISO 9001 require a company to have control over their non-conforming product. According to the FDA, “each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements.” Essentially, a company must have a procedure in place that addresses the identification, documentation, evaluation, segregation and disposition of product that is determined to be non-conforming. This procedure should also identify how you are going to trend, or monitor, non-conformances.
A non-conformance program is defensive by nature. The main goal is to identify non-conformities as soon as possible, and prevent them from making it to the customer. In order for a non-conformity to exist, at least one of the following situations must be present:
- Formal verification activities are not part of the manufacturing process.
- A non-conforming product does not get removed from the normal production flow.
- Scrap or waste looks identical to a conforming product.
- The risk to the organization (business risk or potential liability) is significant enough to treat a product as non-conforming.
The key to controlling non-conforming product is to make sure it is immediately identified and segregated to prevent the customer from receiving such product. Another critical aspect of identifying non-conformances is to identify and eliminate the root cause of the situation. Evaluation and investigation of the non-conformance needs to be documented, along with any explanation for not performing an investigation.
It is important to identify who has the responsibility and authority to address non-conforming product. Who can identify material as being non-conforming? Who has the role to move or handle this product? Which individual, or group, can authorize the disposition of the material? Who can make sure the disposition is achieved?
There are three possible disposition outcomes:
- Take action to eliminate the identified non-conformity. This can be done by repairing the product, reworking it, or reprocessing.
- Take action to avoid its original intended use. The possibilities for this option include scrapping, recycling, reprocessing, or regrading.
- Authorize its use under a concession. The product does not meet the original intended use, but the decision has been made to accept the product anyway.
Once a non-conforming product has been identified, a company is required to take action to correct the situation. In most instances, this will generate a Corrective Action.
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