Non-conformance

Declare the conformity or non conformity of the particular flaw detector under test, in accordance with the criteria of CEN standards. 

Finite elements that maintain inter-element compatibility of functions are called conforming elements . Finite elements that do not have this property are referred to as the non-conforming elements . Under certain conditions non-conforming elements can lead to accurate solutions and are more advantageous to use. 

Crouzeix, M. and Raviart, P. A., 1973. Conforming and non-conforming finite elements for solving the stationary Navier-Stokes equations. RAIRO, Seric Rouge 3, 33 -76. 

This first example applies to UK industry in general. The turnover for UK manufacturing industry was in the order of 150 billion in 1990 (Smith, 1990). If the total quality cost for a business was likely to be somewhere in the region of 20%, with failure costs at approximately 50% of the total, it is likely that about 15 billion was wasted in defects and failures. A 10% improvement in failure costs would have released an estimated 1.5 billion into the economy. IBM, the computer manufacturer, estimated that they were losing about 5.6 billion in 1986 owing to costs of non-conformance and its failure to meet quality standards set for its products and... 

Measures to minimize safety problems must be initiated at the start of the life cycle of any product, but too often determinations of criticality are left to production or quality control personnel who may have an incomplete knowledge of which items are safety critical (Hammer, 1980). Any potential non-conformity that occurs with a severity sufficient to cause a product or service not to satisfy intended normal or reasonably foreseeable usage requirements is termed a defect (Kutz, 1986). The optimum defect level will vary according to the application, where the more severe the consequences of failure the higher the quality of conformance needs to be. 

The losses that companies can face are influenced by many factors including market sector, sales turnover and product liability history. It is not easy to make a satisfactory estimate of the product liability costs associated with quality of non-conformance, and... 

Tolerance stack analysis - Tolerances on components that are assembled together to achieve an overall design tolerance across an assembly can be individually analysed, their potential variability predicted and their combined effect on the overall conformance determined. The analysis can be used to optimize the design through the explorations of alternative tolerances, processes and materials with the goal of minimizing the costs of non-conformance. This topic is discussed in depth in Chapter 3. 

The CA methodology is useful in this respect. It is comprised of three sections the Component Manufacturing Variability Risks Analysis, the Component Assembly Variability Risks Analysis and the determination of the Effects of Non-conformance through the Conformability Map. 

To improve customer satisfaction and business competitiveness, companies need to reduce the levels of non-conformance and attendant failure costs associated with poor product design and development. Attention needs to be focused on the quality and reliability of the design as early as possible in the product development process. This can be achieved by understanding the potential for variability in design parameters and the likely failure consequences in order to reduce the overall risk. The effective use of tools and techniques for designing for quality and reliability can provide this necessary understanding to reduce failure costs. 

Monitoring and measurement Non-conformance and corrective and preventive action Records... 

G Have measures been taken to reduce the likelihood of non-conformance with established criteria ... 

Data collected on the day-to-day operation of a facility are a more immediate source of information. This requires the recording of all non-conformances, procedure... 

Control of Non-conforming Product (Prevent use or delivery of non-conforming product)... 

Control of non-conforming product - Establish procedures for rework, reject, or release under concession... 

On completion of an audit and before the auditors leave the premises, the management of the site will be briefed as regards the main observations during the audit. Where issues arise, FDA inspectors use Form 483 to present the manufacturer with a list items that may be deemed as non-compliant with the regulations. Should any non-conformances be highlighted at the audit close-out session, management should state their commitment to correcting these and, if possible, indicate what the... 

Waste water rules sometimes require that water conform to the limitations at all times. Under such rules, surges of non-conforming sewage are not permitted. Tests run on composite samples over a 24-hour period, for example, will then not be acceptable. 

Accidents, incidents, non-conformances and corrective and preventative action. 

A reason for such non-conformity on the part of o-substituted benzene, and of aliphatic, derivatives is not far to seek. Thus for the base-catalysed hydrolysis (p. 238) of the esters (3) in Figs 13.2 and... 

Guidelines on Grading of Non-conformities , ILAC G20 2002, International Laboratory Accreditation Cooperation (ILAC), Silverwater, Australia, 2002. 

Table B.l. The currently known chemical elements, showing atomic number (Z), chemical symbol, name, relative atomic mass, ground-state electron configuration, and APH indices (t = turn number l-n = angular number) asterisks (, ) symbolize anomalous (APH non-conforming) ground-state electronic configurations, which are indicative of configurational near-degeneracy...

Once the qualification protocols are complete, a qualification report is written. The qualification report should summarize the results from each of the protocols, explain any deviations or non-conforming data, and declare that the instrument is suitable for use (or unsuitable if the acceptance criteria were not met or the non-conforming data could not be justified). 

In order to reduce the probability of non-conforming work, the laboratoiy shall continuously improve its management system using appropriate pohcies, procedures, corrective actions, preventive actions and management reviews. 

Where the identification of non-conformances or deviations generates doubts on the laboratory s compliance with its own policies and procedures the laboratory shall ensure that the appropriate areas of activity are audited in accordance with 4.14 (slide 37) as soon as possible. 

Non-conformities are corrected and relevant records are collected and analyzed. Such data can provide valuable information for improving the effectiveness and efficiency of the laboratoiy processes. 

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