Independent assessors

ISO has two important functions in analytical chemistry. The first is to publish descriptions of accepted methods. These are effectively industry standard methods for particular protocols. The second is in laboratory accreditation. For a laboratory to be ISO accredited, compliance with international QA standards must be confirmed by an initial assessment and subsequently from repeated audits by an independent assessor. Since ISO has no legal or regulatory powers, the standards are voluntary. It is unlikely, however, that a forensic analysis which did not conform to an ISO standard would be upheld in court, for example. Most commercial laboratories need to be accredited to remain competitive and to deal with regulatory authorities. Most university labs are not accredited, mainly due to the time and costs involved, and also to the nonroutine nature of much university research. However, university accreditation may become a requirement in the near future, especially for publicly funded research in the UK. The details of laboratory accreditation are discussed by Christie et al. (1999) and Dobb (2004). 

Where the feedstock has an intrinsic value c.g. it can be used as a fuel in other processes (and, thus, there is some competition between procurers), the independent assessors of the project will require to see evidence of its long term, reliable, delivery in sufficient quantity to satisfy the needs of the project Some measure of price stability will be necessary, for example by linking fiiel purchase price to recognized and appropriate cost indices. 

With reference to Section 6.2.2.1, the independent assessor might wish to capture the result of this analysis in coliunn 3 of Table 6.2. 

There are several methods and tools that evaluate the performance of HS, E or Q. Some of these are developed to assess the performance of supplying companies while another have been developed to assess the principal companies performance. Kjellen (2000) lists three different data collection methods self-evaluation by a company rating team, rating by an independent assessor (third-party evaluations) and questionnaire to the workforce. 

Independent assessors need to think out of the box to identify errors of omission, as well as simply checking for errors of commission such as calculation errors. The failme of Lloyd s Register to discover design mistakes undermines the confidence that is placed in Independent Assessors in engineering activities aU over the world. 

The safety case, particularly for computer based systems, traditionally contains diverse arguments that support its claims. These arguments are sometimes called the legs of the safety case and are based on different evidence. Just as there is defence in depth in employing diversity at system architecture level, so we see an analogous approach within the safety case itself Another important feature of the safety case process is independent assessment. The objective of independent assessment is to ensure that more than one person or team sees the evidence so as to overcome possible conflicts of interest and blinkered views that may arise from a single assessment. The existence of an independent assessor can also motivate the... 

In Germany, safety critical applications must be certified by independent assessors before they are licensed by the authorities. The certification, which is conducted according to state of the art principles, is performed almost exclusively by the TUV s. 

During the assessment process, there is a documented interactive dialogue between each assessor and the applicant to clarify points that are complex or ambiguous or to enable the applicant to provide additional raw data, statistical appendices and detailed protocols to facilitate the assessment process. However, none of the various parts of the dossier is self-standing or independent of others. There are areas within each, which are intricately linked to the others. In preparing a comprehensive and integrated regulatory assessment report, it is important that these areas of common interest are appropriately addressed. 

The influence of the sensitivity of the assessors on AEDA has been studied [11], with the result that the differences in the FD factors determined by a group of six panellists amount to not more than two dilution steps (e.g. 64 and 256), implying that the key odorants in a given extract will undoubtedly be detected. However, to avoid falsification of the result by anosmia, AEDA of a sample should be independently performed by at least two assessors. As detailed in [6], odour threshold values of odorants can be determined by AEDA using a sensory internal standard, e.g. ( )-2-decenal. However, as shown in Table 16.6 these odour threshold values may vary by several orders of magnitude [8] owing to different properties of the stationary phases. Consequently, such effects will also influence the results of dilution experiments. Indeed, different FD factors were determined for 2-methyl-3-furanthiol on the stationary phases SE-54 and FFAP 2 and 2 , respectively. In contrast, 5-ethyl-3-hydroxy-4-methyl-2(5H)-furanone showed higher FD factors on FFAP than on SE-54 2 and 2, respectively. Consequently, FD factors should be determined on suitable GC capillaries [8]. However, the best method to overcome the limitations of GC-O and the dilution experiment is a sensory study of aroma models (Sect. 16.6.3). 

There is an industry trend toward dedicating specific personnel to the function of internal audits and quality assessments. This approach allows the assessor or auditor to focus on the compliance of the company and its vendors and contractors as well as maintain an independent role allowing for impartial assessment of all areas, including the QA unit. Those companies whose assessors and auditors also perform QA responsibilities might seriously consider the regular use of an independent assessment group, such as corporate auditors or an independent consultant. A fresh pair of eyes, coupled with extensive exposure to multiple worldwide operations, makes using external auditors, preferably with some former FDA experience a tremendous asset to any company. 

A lead assessor (and/or assessment manager) w ill perform the assessment supported by independent technical assessors with the expertise to look at the specific areas of the laboratory s work that are being accredited. 

There would be a regular and independent assessment of the technical performance of the laboratory - by assessors appointed by the accreditation agency and the first assessment would take place before accreditation is granted. 

Applications for licensing are considered by assessors at the MHRA. In arriving at a decision, the assessors may take independent advice on matters such as safety, quality and efficacy from medicine advisory bodies... 

Independent outcome assessors may mitigate these problems to some degree. 

The U.S. EPA approach to risk assessments for toxic chemicals follows the format described by the NRC. Because Hazard Identification and Dose-Response Assessment for an agent do not depend upon specific local situations, EPA assumes that risk assessors evaluating specific sites will not conduct independent analyses in these areas but will instead rely on the results of peer-reviewed evaluations by qualified authorities in toxicology. EPA is assembling an agency-wide database of such authoritative assessments, the Integrated Risk Information System (IRIS). 

Instead of using the generic approach in assessing sites, many risk assessors prefer to generate their own site specific data. In such cases, calculations are carried out to develop independent assessments. 

JECEA is an independent expert committee established (and jointly administered) by the FAO and the WHO in 1956 to evaluate the safety of food additives. Uie work has since expanded to include the evaluation of the safety of contaminants, naturally occurring toxicants and residues of veterinary drugs in food. JECFA serves as the risk assessor for the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF), establishing an acceptable daily intake (ADI) for a veterinary drug when sufficient information is available, recommending maximum residue limits (MRLs) for consideration by... 

Chemical reaction hazards should be assessed by technically-qualified personnel who have some experience of hazards evaluation and a good knowledge of the chemistry of the process. They should also be familiar with the plant to be used. Ideally the hazard assessors should be part of an independent team, to avoid conflict of interest between production and safety. 

In Fig. 4.3, independence is indicated via an AND gate and the assessor then has some options on how to flow the DAL down ... 

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