Nonconformity

Maday, Y., Mavripilis, C. and Petera, A. T., 1980. Nonconforming mortar element methods application to. spectral discretizations. In Chan, T. F, Glowinski, R., Perianx, J. and Widlund, O. B. (eds). Domain Decomposition Methods, SIAM, Philadelphia, pp. 392- 418. 

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). 

Prior to JIT, defective parts could be discarded and a replacement taken from inventory. Under JIT there is insufficient inventory to replace defective parts, often lea ding to a shutdown of the assembly process. The Japanese use this impact to heighten the awareness of nonconforming material... 

Sample test data are either manually entered into the system or captured from analytical instmments coimected to the LIMS. The system performs any necessary calculations and compares the result to the appropriate specification stored in the database. If the comparison indicates the material is in conformance, the system can automatically provide an approval. Otherwise, the LIMS can alert lab supervision to the nonconforming sample analysis. 

Quality Audit. Another important responsibiUty of quahty assurance is the audit function. Using the quahty audit as a tool, QA can monitor the operation of the manufacturing faciUty a toU, ie, contract, manufacturer or raw material suppHer to assure that written procedures are in place and that there is documentation to indicate the procedures are being followed. Properly executed audits allow QA to spot potential weakness in the quahty system that could allow errors to occur. Once identified, these weaknesses can then be corrected before they result in nonconformance. 

Customer Complaints. A failure in a company s quaUty system often shows up in the form of a customer complaint. These reports of nonconformances, whether for product or service deficiencies, are typically received by the sales or customer service organization and then channeled to QA. Quahty assurance often tracks the progress and coordinates the complaint investigation. Once completed, it is QA that reviews the report of the investigation and corrective action for thoroughness and efficacy. QuaUty assurance then either passes the information along to the sales or customer service organization or contacts the customer direcdy. 

Are nonconformance summaries sent to facility manager at least quarterly ... 

Is there a written procedure for handling nonconformance with quality of service ... 

Making staff aware of the impact of nonconformities on customers... 

We have only to look at the introductory clauses of ISO 9001 to find that the aim of the requirements is to achieve customer satisfaction by prevention of nonconformities. Hence quality management is a means for planning, organizing, and controlling the prevention of failure. All the tools and techniques that are used in quality management serve to improve our ability to succeed in our pursuit of excellence. 

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... 

Requirement for personnel affecting quality to be informed about the consequences for the customer of nonconformities with quality standards... 

Quality systems shall not be registered to ISO/TS 16949 if open minor or major nonconformities to ISO/TS 16949 exist. 

After certification, when a nonconformity is identified by the certification body, then the de-certification process shall be initiated. 

Such identification (of nonconformities) can occur as a result of a customer complaint. 

Auditors cannot clear minor nonconformities on the first surveillance visit following the initial audit - hence additional visits may be necessary before the first surveillance audit. 

The auditor needs to assess all customer complaints and determine if they arose from a system nonconformity and if so initiate the de-certification process. 

This implies that the customer provides third parties with evidence of nonconformity. 

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. 

However, if a nonconformity could not be closed within the 90-day period, it becomes a major nonconformity, implying that the auditor has to resolve the classification with the QMR prior to the Closing Meeting. 

A major nonconformity is the absence or total breakdown of a system to meet an ISO/TS 16949 requirement. 

A major nonconformity is a noncompliance that judgement and experience indicate is likely either to result in the failure of the quality system or to materially reduce its ability to assure controlled processes and products. 

The implication is that a failure to meet one shall statement is a major nonconformity. 

It also implies that not all major nonconformities are indicative of a failure of the quality system to prevent shipment of defective product. 

Any nonconformity that arises from an audit of such areas is invalid. 

The auditor should verify that all elements have been subject to internal audit during the initial audit and, if not, a nonconformity is warranted. 

Repeated failure to meet specified targets, especially customer-specified targets, would constitute a nonconformity. 

Nonconformities are not OFIs - hence an OFI is an area where the supplier is compliant but performance is below industry norm. 

You will not receive any certificate until you have resolved all nonconformities. 

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

You will be subject to de-certification if nonconformities are detected after initial certification. 

Customer complaints can warrant de-certification action by the certification body if the complaint was as a result of a system nonconformity. 

If the nonconformity is not resolved within 90 days of its detection, de-certification will be enacted. 

You will be required to perform a root cause analysis on each detected nonconformity. 

Certificates cannot be issued if there are any outstanding nonconformities. 

Is product identified in a way that indicates its conformance or nonconformance with regard to inspections and tests performed ... 

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

Are customer complaints and reports of product nonconformities handled in accordance with documented procedures ... 

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