Quality control certification

A final component of a quality control program is the certification of an analyst s competence to perform the analysis for which he or she is responsible. Before an analyst is allowed to perform a new analytical method, he or she may be required to successfully analyze an independent check sample with acceptable accuracy and precision. The check sample should be similar in composition to samples that the analyst will routinely encounter, with a concentration that is 5 to 50 times that of the method s detection limit. 

Ceitification and records for components and materials. The examiner shall be assured, by examination of certification, records, or other evidence, that the materials and components are of the specified grades and that they have received reqiiired heat treatment, examination, and testing. The examiner shall provide the inspec tor with a certification that all quality-control requirements of the code and of the engineering design have been met. 

Prior to the publication of ISO 9000, several nations had developed national quality system standards, with many used only in the procurement of military equipment. With the emergence of the NATO Quality Control System standards in 1973, the Quality Panel of the UK Society of Motor Manufacturers set out to develop an equivalent standard for non-military applications. The result was BS 4891, which was published in 1972. In 1974 this was followed by BS 5179 with the title Operation and Evaluation of Quality Assurance Systems. However, BS 5179 was intended only as a guide and it was not until 1979, with the publication of BS 5750, that major purchasers in the UK had a standard that could be invoked in contracts. A certification scheme was eventually established in 1983, following the UK government s white paper on competitiveness ... 

Benoliel MJ. Quevauviller P, Rodrigues E, Andrade ME, Cavaco MA, Cortez L (1997) Certification of reference materials for quality control of major element determinations in ground-water Part i Feasibility study, fresenius J Anal Chem 358 574-580. 

Quevauviller Ph, Herzig R. and Muntau H (1996b) Certified reference material of lichen (CRM 482) for the quality control of trace element biomonitoring. Sci Total Environ 187 143-152 Quevauviller Ph, Lachica M., Barahona E, Rauret G, Ure A, Gomez A, and Muntau H (1997) The certification of the EDTA-extractable contents (mass fractions) of Cd, Cr, Ni, Pb, and Zn and of the DTPA-extractable contents (mass fractions) of Cd and Ni in calcareous soil by the extraction procedures given CRM 600. EUR Report 17555 Quevauviller Ph. Maier EA, and Griepink B, eds. (1995) Quality Assurance for Environmental Analysis. Elsevier. Amsterdam. 

Particularly for direct microanalytical techniques using <10 mg of sample for analysis, it is highly desirable to obtain quantitative information on element- and compound-specific homogeneity in the certificates for validation and quality control of measurements. As the mean concentration in a CRM is clearly material-related, the standard deviation of this mean value should represent the element s distribution in this matrix rather than differences in the analytical procedures used. 

Quality assurance includes all the quality controls, the generation of expectations (acceptance limits) from the quality controls, plus a great number of other activities, such as (1) analyst training and certification (2) data review and evaluation (3) preparation of final reports of analysis (4) information given to clients about tests that are needed to fulfill regulatory requirements (5) use of the... 

Why should a laboratory participate in PT schemes First there is the possibility to uncover errors that couldn t be found with other quality control measures and second a successful participation can be used as a certificate of competence for clients, authorities and accreditation bodies. 

The standard of any steps of manufacture and quality control conducted outside Australia must also be shown to be acceptable for the Inclusion of therapeutic goods on the ARTG. The TGA document Standard of Overseas Manufacturers specifies what is regarded as acceptable evidence of GMP standards, and Is available on the TGA website. The TGA will accept GMP certification only from coimtrles where It Is satisfied that the standard of GMP inspection is equivalent to GMP Inspections In Australia. 

The luminescence of diamonds is related to various defects in its structure. Almost always, luminescence centers in diamonds are related to N atoms. It is logical, because the atomic radii of C and N are nearly equal (approximately 0.77 A). Luminescence spectroscopy has proven to be the most widely used method in studies of diamonds even in comparison with optical absorption, ESR, IR and Raman spectroscopies. Himdreds of spectra have been obtained, fluorescence characteristics enter into diamond quality gemological certificates, a wide range of electronic and laser applications are based on diamond optical properties in excited states nitrogen center aggregation is controlled by the residence time of diamond in the mantle, distinction between natural... 

Licensing or certification of laboratories was considered impractical for toxicology laboratories because of the great diversity and range of testing capabilities and the complex quality control procedures used in toxicology testing. 

After vendor approval, quality control or quality assurance will reduce the number of tests and inspections of incoming goods as agreed in the certification report, e.g., one out of ten batches. 

Components are received and are quarantined in ABC Pharmaceutical Industries stores until all testing and certificate of analysis requirements are reviewed and have met the acceptance criteria set forth in manufacturing site standard operating procedures. When all acceptance criteria have been met, the components are released by Quality Control and are ready to be issued for production using the procedures specified in manufacturing site standard operating procedures. 

Maier, E A., Quevauviller, Ph, and Griepink, (1993), Interlaboratory studies as a tool for many purposes proficiency testing, learning exercises, quality control and certification of matrix materials. Analytica Chimica Acta, 283 (1), 590-99. 

The EMSL-Cincinnati conducts other PE studies under the USEPA Mandatory Quality Control Program for drinking water analysis certification and general water analysis. 

Table 2-5 lists tolerances for micropipets from one manufacturer. As internal parts wear out, both precision and accuracy can decline by an order of magnitude. In a study17 of 54 micropipets in use at a biomedical lab, 12 were accurate and precise to <1%. Five of 54 had errors >10%. When 54 quality control technicians at four pharmaceutical companies used a properly functioning micropipet, 10 people were accurate and precise to <1%. Six were inaccurate by >10%. Micropipets require periodic calibration and maintenance (cleaning, seal replacement, and lubrication) and operators require certification.18... 

Although phospholipids are natural components of nearly all food products, the analysis of the phospholipid composition is of importance mainly in the certification and quality control of lecithins. According to the European Analytical Subgroup of the International Lecithin and Phospholipid Society (ILPS), there is an urgent need for a standard method for the determination of the PL composition, for this would allow a better characterization of lecithin and PL products (15,16). Besides, the nonavailability of good calibration standards is a major problem when comparing analytical results between companies. In order to try to solve the latter problem, the ILPS proposes a calibration standard whose composition is certified by 31P-NMR as an absolute tech-... 

Requires a commitment on the part of the purchaser to an external audit for GMP and/or ISO 9000 compliance Requires more internal quality control on the part of the purchaser beyond certificate of analysis acceptance... 

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