The organization conforming to ISO 9001 certification shall ensure that nonconforming outputs in its processes, its products or services are controlled. The nonconformity may arise because of not meeting customer requirements, regulatory or statutory requirements or your organizations own requirements. The organization should have an effective Quality Control system for early detection of nonconformities. Raw material Inspection, In Process Inspection and final inspection should be carried out for outputs.
Nonconformities can occur in material or product supplied by subcontractors or in outsourced work. The organization should have to appropriate controls so that nonconforming products or services are prevented from unintended use or delivery. You should prevent further processing of affected part or product. You should keep records about the nature and details of nonconformity.
You should take appropriate action based on the nature of nonconformity and its impact on conformity of products and services. Appropriate personnel and customer where appropriate shall be notified of the nonconformity. Then evaluation of options shall be done for disposition. Even if deliver of product or service has been made and delivered then also the same steps are to be taken. This can be one of the following:
If the situation permits, the organization can undertake corrective action to remove the defect and also remove the cause of nonconformity.
- Segregation, containment or suspension of product and services
Nonconforming products are separated and segregated from the rest of the products. They can be physically contained to a specific location or the provision of products or services can be suspended depending on the severity of the situation.
- Informing the customer
The organization can choose to inform the customer about the problem and get his opinion and direction about disposition.
- Obtaining authorization for acceptance under concession
The organization can offer the nonconforming product to the customer under a concession at a lower price.
Concession authorization allows the organization to provide nonconforming products or services under controlled conditions and environment. Deviation authorization lets the organization to produce product under different conditions and specifications. You should get the authorization in writing in these situations.
It can also establish Indicators to measure effectiveness of control of nonconforming products, services or process outputs. The organization shall determine the policies for further processing or shipment to the customer.
If the process output, product or service has been corrected then the organization shall take steps to verify it.
The organization shall treat product with no identification or quality status as nonconforming and shall be controlled.
The organization shall also meet the reporting requirements of regulatory authorities for nonconforming outputs.
Improving Performance Indicators
Some performance indicators that you can use and improve in order to control nonconforming outputs can be reducing the time to evaluate and dispose of nonconforming outputs, reduction in errors to prevent unintended use or delivery and improved alternate uses of nonconforming products and cost recovery methods.
It is a requirement of ISO 9001:2015 that the organization shall retain documented information in the form of quality or production records that
- Describes the nonconformity
- Describes the actions taken
- Describes any concessions obtained
- Identifies the authority deciding the action in respect of the nonconformity
Your ISO 9001 Consultants will guide you in developing appropriate procedures and documentation as required by ISO 9001 and as detailed above for control of nonconforming outputs.