Classifying nonconformities

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 ... 

When read in conjunction with Annex 1.3 of the Rules, the only reason to classify a nonconformity as major is when making a decision to terminate the audit. 

A nonconformity will only be classified as major in order to determine whether an audit should be terminated prematurely or de-certification effected. 

All these may be in harmony but there may be occasions when there is conflict. To avoid any confusion you should classify all failures to meet these four requirements as nonconformities and then assign classification so as to treat each according to its merits. 

Example 1 A medical device manufacturer is concerned about the nonconforming (defective) and the nonconformity (defect) produced in its recently set-up production line. Twenty batches of this medical device were randomly selected from the production line. Each batch contained 100 units. Each unit is inspected and is classified as either conforming or nonconforming. During the inspection, the number of nonconformities (defects) was also counted. The data collected are shown in Table 3. 

To understand the polishing process, it is necessary to determine the load acting on the contacting surfaces. The geometry of surface contacts may be classified as either conformal or nonconformal (or counterformal). 

The final outpirt from the overall system is a unit of product classified into one of a small number of categories corresponding to different system responses. Thus, a circuit board could be classified as Conforming or Nonconforming (Hou et al. 1993) or into three levels of acceptability, such as Tight, Open 1, or Open 2, for rose grades. 

Step 1 Determine the method to classify the data (e.g., by type of nonconformity, problem, cause). 

The EPCM contractor s quality assurance (QA) department decides whether or not this can be classified as a nonconformity. If the decision is in the affirmative, it is entered in the NCLSR and a serial number is assigned to the NCR. The nonconformity now exists. 

At the end of the audit both parties shall review the completed questionnaire to identify anomalies to be designated as audit findings (AFs), numbered AFl, AF2, and so on. The more significant AFs may, where appropriate, be classified as nonconformities to be entered into the nonconformity management system described in Chapter 8. 

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