Certification examples

The selective determination of F83 ((2,3 J,8-T4CDF), free from interferences, requires an extremely good chromatographic resolution. Thus, all chromatographic records were screened and only those data showing sufficient separation were accepted for certification. Examples of good separation are given in the certification report [19]. 

Internal methods of quality assessment should always be viewed with some level of skepticism because of the potential for bias in their execution and interpretation. For this reason, external methods of quality assessment also play an important role in quality assurance programs. One external method of quality assessment is the certification of a laboratory by a sponsoring agency. Certification is based on the successful analysis of a set of proficiency standards prepared by the sponsoring agency. For example, laboratories involved in environmental analyses may be required to analyze standard samples prepared by the Environmental Protection... 

You may find that the only way you can put your product on the market is by having it tested by an independent test authority. You may need a license to manufacture it or to supply it to certain countries and this may only be granted after independent certification. Some verification requirements only apply to the type of product/service, others to the process or each batch of product, and others to each product or service delivery. Some requirements can only be verified under actual conditions of use. Others can be verified by analysis or similarity with other products that have been thoroughly tested (see Part 2 Chapter 4). The range is so widespread it is not possible in this book to explore all examples, but as you can see, this small and innocuous requirement contains... 

Snhseqnent chapters cover installation considerations (Chapter 6), inspection and maintenance practices (Chapter 7), regnlations, standards, and codes, inclnding certification test protocols (Chapter 8), and some illnstrative examples (Chapter 9). Chapter 10 provides a snmmary of the present state-of-the-art and what other information and research is needed, followed hy appendixes, a glossary, and snggested additional reading. 

Each column is shipped with a PSS column quality certificate, a column connector, and the test kit, which was used at the PSS quality inspection laboratory to test the column resolution. This allows the user to reproduce the column tests without problems. It should be noted, however, that column test results not only depend on the performance of the column alone, but also on the instrument employed for the test. Figure 9.8 shows an example of a PSS column quality certificate. 

Examples of tasks that will require the issuing of the Permission to Work on Electrical Systems Certificate are indicated in Method Statements for Work on Electrical Systems. 

An example of this certificate as well as a Hot Work Permit is given below. 

A large number of considerations and factors must be entertained for the conception, development, preparation, assessment, characterization, and certification of RMs, including (a) end use requirements, (b) selection of materials, (c) preparation, (d) physical characterization, (e) chemical characterization, (f) certification, (g) documentation, and (h) distribution. Most of these have an overwhelming impact on the finally developed RM and on its credibility. This section deals with the steps, collectively denoted as collection and preparation, occurring early in the scheme of RM development. It treats general collection and preparation principles, and provides specific examples of preparative procedures. 

Examples of approaches followed by a small selection of the major RM developers are provided below and summarized in Table 3.2. It must be emphasized that these assignments are based on the author s interpretation of approaches described in the literature that placing into one of the approaches defined in this paper is not always feasible due to cross-over between different modes, fusion of ideas from one and another, elimination of steps, selective choices of parameters, modification of parameters, and streamlining of the overall procedure. Variations on a theme are unavoidable. In assigning certification approaches, the numbers refer to the approaches defined above multiple numbers indicate a blending of two or more modes with a asterisk indicating the author s assignment of the dominant mode of certification. 

This section contains further two typical certification applications and a table presenting selected examples for environmental and biological RMs from major producers. This is followed by a more detailed treatment of the use of neutron activation analysis methods. 

As an example of the capabilities of a combination of INAA and RNAA using a two group separation scheme for the simultaneous determination of As, Cd, Cu, Mo, Sb, Hg, and Se (Kucera and Soukal 1993), and a single separation procedure for vanadium determination (Byrne and Kucera 1991), Table 3.8 shows results for NIST-SRM-i573a Tomato Leaves that were obtained prior to certification of this material (Kucera 1995), and later on taken into consideration for deriving the NIST certified and information values (Becker 1995, personal communication). 

There are many similarities in the certification approaches used by NIST and BCR as well as major differences. Both the NIST and BCR approaches are based on results from multiple independent methods. For the NIST SRMs the measurements are generally all performed at NIST with emphasis on the independence of the methods, whereas the BCR relies on results from a large number of laboratories that may use different methods. The certification approaches used by NIST and BCR are described below using as an example the measurement of PAHs in an environmental matrix. 

Evolution of analytical techniques can cause data, once considered to be state of the arf to be shown to be unreliable. A good example is provided by the work of Houba et al. (1995), who demonstrated that a number of older methods for the determination of trace levels of boron in plant materials were subject to the interference by high levels of copper. This and other evidence suggest that older data, even when presented on a certificate, have to be viewed critically see also Section 3.2. The analyst must stay aware of developments and be ready to disregard certified values if the date of certification of the CRM predates the release of new developments and the certification authority concerned cannot confirm that the certified value is good in the light of the new knowledge. 

For example trace elements in milk powder are not consumed as milk, and moisture in transformer oil is not used in transformers, yet matrix reference materials based on milk are imported as food and are subject to health certification requirements and sometimes import quotas. Likewise a matrix based on oil is identified as fuel or lubricating oil and is both classified as a hazardous material and subject to mineral oil tax. These problems arise because RMs are frequently incorrectly classified by specific title of their matrix (as Reference Material of Trace Elements in Rice is classified as rice) and not as reference material which is the intended use. 

Health, Environmental, Quarantine and Other Regulations Many countries have strict regulations designed to protect the ecosystem and agrochemical business. For example any matrix material derived from pork, beef, sheep or horse tissue has to be accompanied with a Veterinary Certificate confirming that the matrix material is free of certain specified diseases before it can be imported into the EU. The Australian import restrictions are even tougher and require the importer to obtain prior permission to import plant and animal materials and products derived from biological materials. To get an import license it is necessary to complete an application, which includes information from the producer about the actual production process used to prepare the matrix ... 

The test substance may be acquired in a number of ways. One common method is to purchase the product from a chemical dealer. This method of acquiring the test substance for a worker exposure or re-entry study allows one to proceed rapidly with the execution of the field portion of the study without the serious delays encountered while waiting for a test substance to be manufactured, assayed, and shipped to the site. Although having a test substance formulation which has been assayed under GLP standards and for which a certificate of analysis has been shipped to the test site is desirable, there are several instances when this is not practical. For example, one may encounter a worker exposure study where the pesticide to be evaluated is sold only in mini-bulk or even large bulk quantities holding as much as 2000 gal. In this case, duplicate 5-10-g or 5-10-mL retainer samples should be taken from the bulk or mini-bulk tanks for assay after the worker exposure study is in progress. 

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