Intended Purpose

Intended purpose represents the use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer [3]. Hazards that arise from system operation essentially fall into two categories those hazards that occur when the system is being used in the way in which it was intended and those which occur only when it is used outside of that intention. Section 9.4 discusses the practicalities of assessing hazards that arise from system misuse. However, one can only place hazards in this category after the system s intended purpose has been clearly defined. 

The CRM Plan should state or reference the agreed intended purpose and in this way contribute to the boundary setting of the CRM analysis and safety case. As a minimum a HIT system s intended purpose should include  

Over time there is always the opportunity for scope CTeep. The intended purpose may change or grow as the product is developed and healthcare organisations find increasingly innovative ways of harnessing a system s functionality. It is therefore important to monitor the currently defined intended purpose against its live operation and the product roadmap. Where the intended purpose changes, it is likely that the safety case will need to be revisited and the clinical risk reassessed. 

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There have been numerous efforts to inspect specimens by ultrasonic reflectivity (or pulse-echo) measurements. In these inspections ultrasonic reflectivity is often used to observe changes in the acoustical impedance, and from this observation to localize defects in the specimen. However, the term defect is related to any discontinuity within the specimen and, consequently, more information is needed than only ultrasonic reflectivity to define the discontinuity as a defect. This information may be provided by three-dimensional ultrasonic reflection tomography and a priori knowledge about the specimen (e.g., the specimen fabrication process, its design, the intended purpose and the material). A more comprehensive review of defect characterization and related nondestructive evaluation (NDE) methods is provided elsewhere [1]. 

The first step in designing a new compound is to find compounds that have even a slight amount of usefulness for the intended purpose. These are called lead compounds. Once such compounds are identified, the problem becomes one of refinement. Computational techniques are a fairly minor part of finding lead compounds. The use of computer-based techniques for lead compound identification is usually limited to searching databases for compounds similar to known lead compounds or known to treat diseases with similar causes or symptoms. 

Pesticide Runoff Modeling. Obtaining the field data necessary to understand the potential mnoff of pesticides under a variety of conditions and sods would be an expensive and time-consuming process. As a result, a variety of simulation models that vary in their conceptual approach and degree of complexity have been developed. Models are influenced by their intended purpose, the biases of the developer, and the scale at which they are used. 

Because the technical barriers previously outhned increase uncertainty in the data, plant-performance analysts must approach the data analysis with an unprejudiced eye. Significant technical judgment is required to evaluate each measurement and its uncertainty with respec t to the intended purpose, the model development, and the conclusions. If there is any bias on the analysts part, it is likely that this bias will be built into the subsequent model and parameter estimates. Since engineers rely upon the model to extrapolate from current operation, the bias can be amplified and lead to decisions that are inaccurate, unwarranted, and potentially dangerous. 

Once the model parameters have been estimated, analysts should perform a sensitivity analysis to establish the uniqueness of the parameters and the model. Figure 30-9 presents a procedure for performing this sensitivity analysis. If the model will ultimately be used for exploration of other operating conditions, analysts should use the results of the sensitivity analysis to estabhsh the error in extrapolation that will result from database/model interactions, database uncertainties, plant fluctuations, and alternative models. These sensitivity analyses and subsequent extrapolations will assist analysts in determining whether the results of the unit test will lead to results suitable for the intended purpose. 

It is sincerely hoped that the information presented in this document will lead to an even more impressive record for the entire industry however, the American Institute of Chemical Engineers, its consultants, CCPS Subcommittee members, their employers, their employers officers and directors, and Arthur D. Little, Inc., disclaim making or giving any warranties or representations, express or implied, including with respect to fitness, intended purpose, use or merchantability and/or correctness or accuracy of the content of the information presented in this document. As between (1) American Institute of Chemical Engineers, its consultants, CCPS Subcommittee members, their employers, their employers officers and directors, and Arthur D. Little, Inc., and (2) the user of this document, the user accepts any legal liability or responsibility whatsoever for the consequence of its use or misuse. 

Responsibility for maintenance of new equipment Responsibility for determining if the new equipment or technology is suitable for the intended purpose Payment for equipment or R D... 

Seller warrants that Product delivered to [insert company name] will (1) conform to the descriptions and specifications as set forth in this Agreement (2) be of good quality and workmanship and free from defects, latent or patent and (3) be merchantable and fit and sufficient for [insert company name] s intended purpose. Payment, inspection, acceptance or use of Product will not affect Seller s obligation under this warranty. 

The important question, then, is not whether a substance is pure but whether a given sample is sufficiently pure for some intended purpose. That is, are the contaminants likely to interfere in the process or measurement that is to be studied. By suitable manipulation it is often possible to reduce levels of impurities to acceptable limits, but absolute purity is an ideal which, no matter how closely approached, can never be attained. A negative physical or chemical test indicates only that the amount of an impurity in a substance lies below a certain sensitivity level no test can demonstrate that a specified impurity is entirely al ent. 

Several of these IFNs of mouse and human lymphocytes and fibroblasts are available commercially and have been best prepared in quantity by recombinant DNA procedures because they are produced in very small amounts by the cells. The commercial materials do not generally require further purification for their intended purposes. [Pestkas, Interferons and Interferon standards and general abbreviations. Methods Enzymol, Wiley Sons, 119 1986, ISBN 012182019X Lengyel, Biochemistry of interferons and their actions, Ann Bev Biochem 51 251-282 7982 De Maeyer and De Maeyer-Guignard, Interferons in The Cytokine Handbook, 3rd Edn, Thomson et al. Eds, pp. 491-516 7998 Academic Press, San Diego, ISBN 0126896623.]... 

To evaluate a job effectively, you should have some experience and be trained in the intended purpose of the JHA, have an open mind, and have examples of correct methods. Focusing on safety is essential to the job being evaluated. 

Once you have selected the job for analysis, discuss the procedure with the employee who performs the job and explain the intended purpose. Point out that you are studying the job itself and not checking on the employee s job performance. Involve the employee in all phases of the analysis, from reviewing the job steps and procedures to discussing potential hazards and recommended solutions. You should... 

The requirements are specified in terms of the features and characteristics that will make the product or service fit for its intended purpose. A list of typical features and characteristics is given in Part 1 Chapter 1 for both products and services. 

Users should be the prime participants in the preparation process so that the resultant documents reflect their needs and are fit for the intended purpose - hence the requirement that documents be reviewed as well as approved. You will need to be able to demonstrate that your documents have in fact been reviewed prior to issue. The presence of a signature on the front cover is not sufficient evidence. To demonstrate that documents have been reviewed you will need to show that nominated personnel have been issued with drafts for comment and that they have provided comments which have been considered by the approval authorities. A simple method is to employ a standard comment sheet on which reviewers can indicate their comments or signify that they have no comment. During the review process you may undertake several revisions. You may feel it necessary to retain these in case of dispute later, but there is no compulsion for you to do so, providing you have evidence that the review took place. You also need to show that the current issue has been reviewed so your comment sheet needs to indicate document issue status. 

Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose. 

Flame arresters cannot be designed from first principles and can only be proven by tests simnlating the conditions of nse. The riser should ensure that a flame arrester has been properly tested to meet the intended purpose, and should be prepared to stipulate the required performance standard or test protocol to be followed. 

The material in this book vvas prepared in good faith and carefully reviewed and edited. The author and publisher, however, cannot be held liable for errors of any sort in these chapters. Furthermore, because the author has no means of checking the reliability of some of the data presented in the public literature, but can only examine it for suitability for the intended purpose herein, this information cannot be w arranted. Also because the author cannot vouch for the experience or technical capability of the user of the information and the suitability of the information for the user s purpose, the use of the contents must be at the best judgment of the user. 

Not only is it chemically wasteful to synthesize and administer an enantiomer that doesn t serve the intended purpose, many examples are now known where the presence of the "wrong" enantiomer in a racemic mixture ... 

A declaration stating whether or not the device incorporates, as an integral part, a substance or human blood derivative, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device... 

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