Safety assessment purpose

Information on the potential of chemicals to cause acute skin irritation becomes important. This assumes great significance to establishing procedures and alternative methods for the safe handling, packing, and transportation of chemicals as well as for general safety-assessment purposes.14-17... 

Information acquired from the above items is not adaptable to any kind of numerical ranking for quantitative safety assessment purposes. However, the information can reveal the owner or user s apparent attention to good practice, careful operation, regular maintenance, and adherence to the recommendations and guidelines developed for susceptible applications. If the assessment indicates cracking and other serious damage problems, it is important that the inspector obtain qualified technical advice and opinion. After all, safety and health are of primary concern regarding pressure vessels. 

Both detenninistic and probabilistic analysis techniques may be used for safety assessment purposes. These methodologies are not mutuaUy exclusive, and in practice a comparative analysis with both techniques is likely. 

When conducting an FMEA for safety assessment purposes, precision should not be forced where data is unreliable and scarce. Hence, to ask an analyst or an expert to assign scores ranging from 1 to 10 (as done in the RPN method) for the different factors considered could produce a false and unrealistic impression. The use of linguistic terms allows for the experts to assign a more meaningful value for the factors considered. 

Although prediction of ADME/PK in man may be the primary purpose for the pre-clinical studies, it is also important that potential new drugs have acceptable properties in toxicology species. Without these it can be very difficult to generate adequate safety margins to allow studies in man to start. It is also likely that the development safety assessment program will be difficult and hence slow. 

The 1981 Council Decision (OECD 1981) sets the policy context agreed by aU OECD Member countries which estabhshed that safety data developed in one Member country will be accepted for use by the relevant registration authorities in assessing the chemical or product in another OECD country, i.e., the data do not have to be generated a second time for the purposes of safety assessment. 

Attention is drawn to the Guidelines for Company Sponsored Safety Assessment of Marketed Medicines (SAMM) which have been produced jointly by the ABPI, the British Medical Association, the Committee on Safety of Medicines, the Medicines and Healthcare products Regulatory Agency and the Royal College of General Practitioners. These state that SAMM studies should not be undertaken for the purposes of promotion. 

In its recommendations, IAEA emphasizes that waste classification, even if it focuses on waste disposal, does not provide an adequate substitute for site-specific safety assessments of particular disposal systems to ensure the acceptability of waste disposal. IAEA also recognizes the role of national authorities in implementing waste classification systems and ensuring the safety of waste disposal, and that different countries may choose to classify waste in different ways depending on their particular situations. However, IAEA believes that, if for no other reason than to facilitate communication, it would be desirable to achieve some level of uniformity of waste classification systems in different countries. IAEA recommends that it is particularly important to obtain an international consensus on the boundary for determining unconditionally exempt material that may be transferred from one country to another, especially for purposes of recycle/reuse. 

Dose loads on the staff from ionizing radiation impacts are one of the basic factors, determining the level of the storage radiation safety. The purpose of studies was to assess the efficiency of the built-in structure in the underground module of the storage... 

However, because of constraint of resources, sometimes toxicogenomics is not necessary if the sole purpose is to run a study in preclinical safety assessment it is more likely to piggyback on other toxicology conducts. At other times, a microarray study happens to run because of leftover of interested frozen tissues, a mere afterthought rather than a planned experiment. Such practice might confound the data interpretation and limit the future reference value of the study. As discussed earlier, the incremental value of toxicogenomics lies in the ever-expanding reference data of quality. 

Substances not included in the final inventory are defined as new and must be notified to the Federal Ministry of the Environment, Youth and the Family befcse they are manufactured or imported, unless notified mere than 10 years neviously. The authorities will publish an annual list of those substances which were notified 10 years earlier. New substances supplied exclusively for testing purposes are exempt from notification. Also exempt are those exported to specified countries where there are equivalent regulations for the notification or safety assessment of new substances, although the Austrian authorities must be notified in writing of the substance s identity and the expected production and expmt quantities, as well as the classification, labelling and proposed uses of hazardous substances. Finally, polymers are not notifiable, unless they contain >2% (by weight) in chemically-bound form of a new substance monomer. 

Managing reference data can be particularly troublesome when two or more systems are merged for example when two local systems are being replaced by a single alternative and there is a need to preserve historical cliifical data. Each system is likely to have its own reference data and, particularly over time, it is common for these datasets to have similar purposes but with different content. For example, a Patient Administration System may have five different options for Admission type whilst the Electronic Health Record may have seven different options for that same field. Whilst it might be possible to live with this discrepancy on a day-to-day basis, the situation suddenly becomes very complex when it is necessary to merge the two datasets. Any proposed solutions need a careful safety assessment. 

A systematic approach to evaluation should be taken to establish which maintenance tasks are to be performed, on which SSCs, and at what intervals, in order to optimize the use of resources allocated for maintenance and to ensure the availability of the plant. This approach can be used in establishing a preventive maintenance programme and for optimization of the ongoing maintenance programme. The aim of optimization is to use condition monitoring to determine where unnecessary maintenance work and failures induced by errors in maintenance can be avoided. If a probabilistic safety assessment has been performed, its results may be used for this purpose. 

For the purposes of the Preliminary System Safety Assessment (PSS A), the FHA considers functional failure modes only (i.e. not their probability of occurrence). Failure conditions identified at this level are not dependent on the way the functions are implemented or the system architecture. 

Note A piece-part FMEA is often only effectively conducted by the design authority of the part being considered. For the purposes of supporting a 2X.1309 System Safety Assessment, the piece-part FMEA is thus seldom applied above System Level 3 and is only conducted(ARP4761 para G.3.2.2) when necessary (eg, when the more conservative results of a functional FMEA will not meet the ETA probability of failure budget). 

The scope of this chapter is limited to considering flight crew errors/mistakes only for the purposes of completing a typical CS25.1309 Safety Assessment. 

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