Nonconforming products

The Taylor system, successful in the United States until the end of World War II, resulted in a dramatic increase in productivity. The transfer of responsibihty for product quahty from production to the QC laboratory allowed production to emphasize productivity, relying on quahty control to keep nonconforming products from reaching the customer. In the years following World War II, quahty became secondary to productivity (6). 

Requirement for the customer to be promptly informed in the event that nonconforming product is shipped... 

Requirement for obsolete product to be controlled in a similar manner to nonconforming product... 

Are documented procedures employed to prevent the inadvertent use or installation of nonconforming products ... 

Notifying customers of nonconforming product shipment (clause 4.13.1.3)... 

Personnel who control further processing, delivery, or installation of nonconforming product (4.1.2.1.1e)... 

The requirement in clause 4.13.1 of ISO 9001 requires the supplier s nonconforming product controls to provide for notifying the functions concerned. This supplementary... 

As stated previously, traceability is fundamental to establishing and eliminating the root cause of nonconforming product and therefore it should be mandatory in view of the requirements for Corrective Action. Providing traceability can be an onerous task. Some applications require products to be traced back to the original ingot from which they were produced. In situations of safety or national security it is necessary to identify product in such a manner because if a product is used in a critical application and subsequently found defective, it may be necessary to track down all other products of the same batch and eliminate them before there is a disaster. It happens in product recall situations. It is also very important in the automobile and food industries in fact, any industry where human life may be at risk due to a defective product being in circulation. 

As is stated in the standard, all characteristics are important and need to be controlled. However, some need special attention as excessive variation may affect product safety, compliance with government regulations, fit, form, function, appearance, or the quality of subsequent operations. Designating such characteristics with special symbols alerts planners and operators to take particular care. It also alerts those responsible for dispo-sitioning nonconforming product to exercise due care when reaching their decisions. 

The standard requires the procedures for control of nonconforming product to apply to any product which fails to pass any inspection and/or test. 

The standard emphasizes that a nonconforming product is one which has failed a planned inspection and/or test. Up to that stage the product is neither conforming nor nonconforming - it is merely in-process. Hence the requirements of section 4.13 only apply after product or service has been inspected or tested and are clearly not intended to be applied at any other stage. 

Establish means of dealing with nonconforming product. 

Provide a quarantine area to place nonconforming product pending disposition. 

Don t release nonconforming product until remedial action has been authorized and carried out. 

Inspection and test status is either reject or accept . There are no gray areas. If not fully conforming the product should be rejected and identified as such. If conforming the product should be accepted and identified as such. If a nonconforming product is later deemed acceptable, the identification should be changed but this can lead to problems. 

Not all product intended for delivery may in fact have passed the required inspections and tests as the customer may have waived some of the requirements for that particular delivery. Hence the reference to release under an authorized concession. Identifying product correctly will help preclude any unidentified or nonconforming product from being delivered, used, or installed. However, the only way to make certain is to remove them from areas where they may be inadvertently dispatched, used, or installed. 

The definition of nonconformity in ISO 8402 states that it is the nonfulfillment of specified requirements therefore a nonconforming product is one that does not conform to the specified requirements. Specified requirements are either requirements prescribed by the customer and agreed by the supplier in a contract for products or services, or are requirements prescribed by the supplier which are perceived as satisfying a market need. This limits the term nonconformity to situations where you have failed to meet customer requirements. However, ISO 8402 1987 suggests that nonconformity also applies to the absence of one or more quality system elements, but clearly the requirements of clause 4.13 cannot be applied to nonconformity with quality s /stem requirements. Both ISO 9001 and ISO 9004 only address nonconformity in the context of products, processes, and services and when addressing quality system elements the term deficiencies is used. Some auditors use the term nonconformity to describe a departure from the requirements of ISO 9001 but it would be preferable if they chose the term noncompliance to avoid any confusion. The requirements of clause 4.13 therefore only apply to products, processes, and services and not to activities, quality system elements, or procedures. 

Suspect product should be treated in the same manner as nonconforming product and quarantined until dispositioned. However, until a nonconformity can be proven, the documentation of the nonconformity merely reveals the reason for the product being suspect. 

Figure 13.1 Clause relationships with the control of nonconforming product element...

The only sure way of preventing inadvertent use of nonconforming product is to destroy it, but that may be a little drastic in some cases. It may be possible to eliminate the nonconformity by repair, completion of processing, or rework. A more practical way of preventing the inadvertent use or installation of nonconforming or unserviceable products is to identify the product as nonconforming or unserviceable and place in an area where access to it is controlled. These two aspects are covered further below. 

The standard requires the supplier to provide for the identification of nonconforming product and that this identification be visual. 

---