Demonstrate capability

As a set of minimum standards, ISO 9000 addresses the business community. It was intended for purchasers as a means for them to obtain products and services of consistent quality from their suppliers. In place of purchaser-specified general quality management requirements, ISO 9000 became the common requirement and hence eliminated the need for such requirements. As a consequence, it provides suppliers that meet its requirements with a demonstrable capability that others may not possess and hence such capability becomes a persuasive marketing tool that will increase market share. ISO 9000 was also intended for application to all types of industry and therefore did not contain requirements for any specific industry sector or type of products or services. Partially due to the scope of misinterpretation and the degree to which particular industries have common supplier requirements, certain industry sectors perceived the need for harmonizing such requirements in a form that added to those requirements in ISO 9000. 

Any site may elect to pursue third party certification to ISO/TS 16949 however, such sites shall have demonstrated capability to conform to all ISO/TS 16949 requirements. The auditor has to confirm that the site has a capability to meet all ISO/TS 16949 requirements and, if not, the other sites providing the missing capability have to be included in the certification audit. 

Class C ISO 9000 certified and no demonstrated capabilify. This is the class of those certified subcontractors with which you have done no business. This may appear a contradiction, as ISO 9000 certification is obtained on the basis of demonstrated capability, but you have not established their capability to meet your requirements. 

Class F No demonstrated capability. This is the class of those subcontractors you have not used before and therefore have no historical data. 

The standard requires suppliers to define the type and extent of control exercised bp the supplier over subcontractors and goes on to require that these controls be dependent upon the type of product, the impact of the product on the quality of the final product, and, where applicable, on the quality audit reports and/or quality records of the previ-ousty demonstrated capability and performance of subcontractors. 

Certification through interlaboratory testing. In this case, the reference/certified value is obtained by pooling results from several laboratories that have demonstrated capability in analyzing the analyte(s) of interest. The various laboratory means are manipulated statistically to determine the best or truest estimate of the value of interest. 

Regulators and customers require assurance in consistency of pharmaceutical and biopharmaceutical manufacturing operations. Today s manufacturing supply chains require multiple sites in varying locations to produce a product. Quality systems must be perceived as an integral part of the value chain. This requires that all sites be compliant in their operations and systems. Strong areas in one location do not make up for weak or absent systems in another location. Fines are levied and business is made or lost based on the individual site or weakest link in the supply chain. Management must have a mechanism to measure its processes, and a comprehensive QMS is the mechanism to demonstrate capability. 

If necessary analysis of test material near the LOD to demonstrate capability of detection at that level... 

Measurement uncertainty is a critical parameter for nearly every kind of analytical system. Parameters in the second column of table 8.3 are not unimportant and must be established, but they are not likely to become limiting factors in the development of the method. In table 8.3, where selectivity is in parentheses, this is not to say that the method should not be demonstrably capable of analyzing the target analyte, but that it should be clear very quickly whether or not the method is doing its job. 

MS/MS. The capability of trapping ions for long periods of time is one of the most interesting features of FTMS, and it is this capability that has made FTMS (and its precursor, ion cyclotron resonance) the method of choice for ion-molecule reaction studies. It is this capability that has also lead to the development of MS/MS techniques for FTMS [11]. FTMS has demonstrated capabilities for high resolution daughter ion detection [42-44], and consecutive MS/MS reactions [45], that have shown it to be an intriguing alternative to the use of the instruments with multiple analysis stages. Initial concerns about limited resolution for parent ion selection have been allayed by the development of a stored waveform, inverse Fourier transform method of excitation by Marshall and coworkers [9,10] which allows the operator to tailor the excitation waveform to the desired experiment. 

Calibration using simple solutions of well-characterised pure substance standards or matrix matched standard solutions. Calibration solutions are prepared from materials whose identity and purity have been established to an appropriate level of uncertainty and where the effects of any impurities have been evaluated. Where appropriate and where available, standards provided by metrology institutes with demonstrated capability are used. In other cases, materials from other reputable suppliers or prepared in-house are used after appropriate characterisation. Where necessary, professional judgement is used to estimate the uncertainty associated with chemical standards. The target uncertainty of the identity is for practical purposes zero and for purity less than one-fifth of the desired overall uncertainty. 

Heat evolution during immersion processes involving surface rehydration has been found to occur over a 20- to 40-minute interval, so that high precision methods are required if immersion heats include a contribution due to rehydration. The immersion heat determinations were carried out in a microcalorimeter having a temperature sensitivity of 5 X 10 6° C., rapid thermal response, and carefully determined heat transfer characteristics. The calorimetric system has a demonstrated capability of handling heat input rates as low as 0.005 joule per second (15). Samples for immersion were contained in very thin-walled bulbs holding... 

S-I loop is being constructed jointly by Commissariat a I Energie Atomique (CEA Section I), Sandia National Laboratory (SNL Section 11) and General Atomics (GA Section III). The three sections will be integrated for a bench-scale demonstration capable of delivering 200 to 1,000 1/h of H2 in 2008. °... 

The demonstrated capability of the theory to provide reasonably accurate anticipation of experimental results with the various examples presented attests to its value. Anticipation of ion-exchange processes with the thin layer and cone models shows their value also. The formation of the sharp boundary B/A in the case of strongly favorable isotherms of invading B counterion in the bead and in the cone model (Figs. 7, 8, 10,... 

There are three mid-sized mechanical contractors, qualified to do industrial piping and equipment erection, with demonstrated capability of handling projects requiring more than seventy workers. Two of them also have piping fabrication shops and asked to be considered for the prefabricated piping purchase. All of them asked to bid for the structural steel erection. 

An important method using fungi is Daniels test for phototoxicity, which utilizes the yeast Candida albicans as the test organism. A 1988 study compared favorably the results of this test with the results of photo-patch testing in volunteers for samples from six furocoumarin-containing plants. Many test materials which produce an erythemic response in the photoirritant test are not analyzed as positive in this test. A new test method, Solatex-pi, has demonstrated capability to predict the potential for photoirritation of materials in this class as well as that of other well-known photoirritants. Solatex-pi utilizes the two compartment physicochemical model of Skintex to predict the interactive effects of specific chemicals and UV radiation. Solatex-pi is being validated by Frame and the BGA (Zebet) as an in vitro test to predict photoirritants. 

Assure persistence, demonstrating capabilities to continue for a long period of time... 

Inductively Coupled Plasma Mass Spectrometry (ICP/MS) is a powerful technique for elemental and isotope analysis which has undergone extensive development over the last decade by a number of research groups (1,2,3). These research efforts have led to the recent development of commercially available ICP-MS systems which, by virtue of their novelty, are now just beginning to demonstrate capabilities well suited to the characterization of materials used in the semiconductor industry. This paper will outline the principles of ICP-MS and provide some examples of the instrumentation s analytical capabilities. 

Infrared. The use of infrared for oil fingerprinting is well documented (32,33,34,35). The technique has a well-demonstrated capability and is one of the four primary Coast Guard methods (18) that is in operational use by COIL. In addition, it has been tested in the field for over a year in Philadelphia and will shortly begin testing in San Francisco, California, and New York, using relatively inexpensive dual-beam grating instruments. 

In this paper we demonstrate capabilities of double-pulse laser ablation (DPLA) in liquid environment for fabrication of metallic nanoparticles with a narrow size-distribution. We examined optical properties of the silver colloidal solutions prepared by DPLA in order to reveal the role of the second laser pulse in a size change of the particles produced in the ablation plume. 

While ICP-MS has a demonstrated capability for being able to provide accurate and precise selenium measurements at these levels, there still remained the problem of the identification of the selenium species present in the samples. Research efforts defined here focused on developing a quick and reliable separation technique to separate the selenium species present in the various SSW and wastewater samples prior to quantification by ICP-MS. 

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