ISO 9001’s subclause 8.3 is intended to prevent inadvertent use or installation of nonconforming product. A primary requirement of this subclause is to ensure effective implementation of processes that prevent unintended use or delivery of product that doesn’t conform to requirements. This simple requirement makes business sense because one of the worst things an organization can do is unwittingly provide its customers with product that doesn’t meet requirements. Organization must devise processes to accomplish this objective in a way that encourages personnel to address product nonconformity rather than find ways to avoid identifying and controlling such product.
This clause requires an organization to establish processes to ensure that nonconforming product is identified and controlled to prevent unintended use or delivery. This is also one of the few clauses for which the standard requires the organization to develop, implement, and maintain a documented procedure. That procedure must describe the activities that the organization will take to deal with nonconforming product. The organization should consider documenting a process for addressing the disposition of nonconforming product and, where appropriate, reverifying the product. The organization should also consider documenting the process for communication with customers, where appropriate, concerning product nonconformity. The process for dealing with major product problems or recalls should be documented, outlining the items top management should consider and actions they may need to take in such situations. This can be particularly important for consumer items where the organization’s very existence may rest on how well it handles a major recall. These communication processes may be documented in the procedure on control of nonconforming product or in separate communications procedures.
The organization should document a process for addressing situations where nonconforming product is detected after delivery to, or use by, a customer.
Also, the organization needs to ensure that nonconforming product is corrected and subject to reverification after correction to demonstrate conformity, where applicable.
When nonconforming product is detected after delivery or use has started, the organization must take appropriate action regarding the consequences of the nonconformity. Typically, organizations will establish processes that provide for a review of the nonconformity by the appropriate individuals. Such processes may have different levels of approval depending on the nature of the action to be taken for the nonconformity. A decision to “use as is,” for example, may require engineering approval because such a decision is effectively a change in design with liability implications. On the other hand, manufacturing management may be permitted to approve a rework or scrap disposition.
When delivered product is subsequently determined to be nonconforming, prudent judgment is needed in addressing such situations. The actions taken must be documented. When it’s required (for example, by contract or by internal procedures) to report a proposed rectification of nonconforming product to the customer, the end-user, a regulatory body, or any other body, processes should be in place to ensure that such reporting occurs. This reporting can be critical to the customer; sometimes a nonconformity that seems trivial to the manufacturer may be very important to the end-user.
This topic is one where significant emphasis is placed on documenting what will be done in the event of nonconformity. You might logically ask, “Why so much emphasis on process documentation to control nonconformity? Wouldn’t we be better off spending time on better product and process planning to prevent nonconformity?” Certainly, we should spend most of our time on prevention activities, but if we have no plans for what to do when things go wrong, we’re likely to do the wrong thing. To avoid complex procedures for controlling nonconformity, here are a few ideas:
• Keep nonconformity processes as simple as possible.
• Don’t allow deviations from simple control procedures.
• Quickly involve all needed parties related to nonconforming product.
• Keep records requirements simple and easy to understand.
• Focus controls on correcting the problem first then on improving or correcting the process that made the problem.
Keeping controls simple but emphasizing that they must be followed can minimize the time spent on nonconformities, providing more time to improve products and processes.