Nonconformity: definition

Many suppliers will already have methods in place that cover many of the requirements of ISO/TS 16949. What they may not have done, however, is to integrate these methods into a system that will cause conformity and prevent nonconformity. The ISO 8402 definition of a quality system makes it clear that a quality system is not just a set of procedures. It is the organization structure, processes, and resources to manage the achievement, control, and improvement of quality. 

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. 

Although the standard does not recognize any classification of nonconformities, the practical application of nonconformity controls requires controls to be balanced with the severity of the nonconformity. It is not necessary to seek concessions from a customer against requirements that have not been specified, or seek design authority approval for workmanship imperfections. The definition of the term defect in ISO 8402, and the fact that there are many requirements other than those specified in a contract or needed to satisfy market needs, demands that it is sensible to classify nonconformities into three categories ... 

Returning to the standard, this clause also only addresses the correction and prevention of nonconformities, i.e. departures from the specified requirements. It does not address the correction of defects, of inconsistencies, of errors, or in fact any deviations from your internal specifications or requirements. As explained in Part 2 Chapter 13, if we apply the definition of nonconformity literally, a departure from a requirement that is not included in the Specified Requirements is not a nonconformity and hence the standard is not requiring corrective action for such deviations. Clearly this was not the intention of the requirement because preventing the recurrence of any problem is a sensible course of action to take, providing it is economical. Economics is, however, the crux of the matter. If you include every requirement in the Specified Requirements , you not only overcomplicate the nonconformity controls but the corrective and preventive action controls as well. 

The corrective action requirements fail to stipulate when corrective action should be taken except to say that they shall be to a degree appropriate to the risks encountered. There is no compulsion for the supplier to correct nonconformities before repeat production or shipment of subsequent product. However, immediate correction is not always practical. You should base the timing of your corrective action on the severity of the nonconformities. All nonconformities are costly to the business, but correction also adds to the cost and should be matched to the benefits it will accrue (see later under Risks). Any action taken to eliminate a nonconformity before the customer receives the product or service could be considered a preventive action. By this definition, final inspection is a preventive action because it should prevent the supply of nonconforming product to the customer. However, an error becomes a nonconformity when detected at any acceptance stage in the process, as indicated in clause 4.12 of the standard. Therefore an action taken to eliminate a potential nonconformity prior to an acceptance stage is a preventive action. This rules out any inspection stages as being preventive action measures - they are detection measures only. 

When steady-state conduction occurs within and outside solids, or between two contacting solids, it is frequently handled by means of conduction shape factors and thermal contact conductances (or contact resistances), respectively. This chapter covers the basic equations, definitions, and relationships that define shape factors and the thermal contact, gap, and joint conductances for conforming, rough surfaces, and nonconforming, smooth surfaces. 

Nonconformities are defined as the nonfulfilment of specified requirements in the ISO 9000 standards for quality management systems (see ISO, 1994). To avoid confusion with this definition, we will here use the term deviation instead. It covers those aspects of the accident sequence that represent a mismatch between our norms for a faultless production process and what actually happened. Nonconformities are one type of deviations, where the norm has been defined and documented. 

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