Quality requirements

The controversy over the shape of the dose-response curve in risk assessment is an example that shows the influential, yet somewhat sporadic and unpredictable, role of the courts in risk assessment policy issues. In the regulatory context, agencies such as the U.S. EPAhave traditionally applied a linear, no-threshold dose-response 

A few court decisions, however, have been more skeptical of the linear model. Eor example, the U.S. EPA s use of the linear, no-threshold model in its risk assessment for drinking water chlorinated byproducts was rejected by the court because it was contrary to evidence suggesting a nonlinear model that had been accepted by both the U.S. EPA and its Science Advisory Board (CCC 2000). On the other hand, the U.S. OSHA s departure from the linear, no-threshold model in its formaldehyde risk assessment was likewise rejected by the court (lU 1989). The court held that the U.S. OSHAhad improperly used the maximum likelihood estimate (MLE) rather than the upper confidence limit (UCL) to calculate risk, and the UCL but not the MLE model was consistent with a linear dose-response assumption. The court held that the U.S. OSHA had failed to justify its departure from its traditional linear, no-threshold dose-response assumption. 

Judicial decisions in nonregulatory contexts such as toxic tort and product liability suits are likewise inconsistent in their consideration of the linear, no threshold model. As in the regulatory context, most cases find no problem with an expert s reliance on a risk assessment using the linear model. In a handful of cases, however, the court rejects reliance on a linear dose-response assumption. Eor example, one court in addressing the cancer risks from a low concentration of benzene in Perrier held that there is no scientific evidence that the linear no-safe threshold analysis is an acceptable scientific technique used by experts in determining causation in an individual instance (Sutera 1997). Another court decision concluded that [t]he linear non-threshold model cannot be falsified, nor can it be validated. To the extent that it has been subjected to peer review and publication, it has been rejected by the overwhelming majority of the scientific community. It has no known or potential rate of error. It is merely an hypothesis (Whiting 1995). The inconsistency and unpredictability of judicial review of risk assessments adds an additional element of uncertainty into the risk assessment process. 

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Tertiary treatment. Tertiary or polishing treatment prepares the aqueous waste for final discharge. The final quality of the effluent depends on the nature and flow of the receiving water. Table 11.3 gives an indication of the final quality required. ... 

Specifications and test methods for jet fuel. The specifications of jet fuels are set at the international level and are written into the Aviation Fuel Quality Requirements for Jointly Operated Systems". 

Products of the described type have very high quality requirements as the consumers are typically families with children or restaurants catering to same, where even the smallest bones are unacceptable. Previously, sample tests were conducted on selected blocks. The blocks were thawed and sieved. This was a very slow way of inspection where the production line had to wait for the raw material. 

Table 4. General Water Quality Requirements for Trout and Warmwater Aquatic Animals in Fresh Water ...

Specifications, Standards, Quality Control, and Health and Safety Factors. The hardboard industry is represented by the American Hardboard Association (AHA). Specifications and standards are contained in several ANSI standards (8—11). These standards define the various hardboard product categories as well as specific product qualities required for each group. 

Horizontal filter surfaces also allow a high degree of control over cake formation. Allowances can be made for changed feeds and/or different cake quality requirements. This is particularly tme of the horizontal belt vacuum filters. With these units the relative proportions of the belt allocated to filtration, washing, drying, etc, as well as the belt speed and vacuum quality, can be easily altered to suit process changes. 

In recent years, production of liquid resins of higher purity, ie, higher monomer content and fewer side-reactions, has been accompHshed. This is in response to more stringent product quality requirements. 

Plant Strategies At the plant level, a number of things can be done to minimize the impact of environmental quality requirements. These include ... 

If yes, additional review of good manufacturing practice and product quality requirements may be necessary. 

Is there a purchasing policy that includes quality requirements ... 

Is there a formal written contract between your company and the client, covering all commercial, compliance, safety, operational and quality requirements ... 

The achievement of more effective levels of quality requires systematic planning and budgeting. There should be evidence of ongoing effort to identify variability in the quality of service and plans for improvement in areas that will have major benefits to the client. 

Sometimes a compromise in the quality of the inputs (perhaps due to non-availability of a particular component to the required specification) may be necessory to avoid a production delay. Similar constraints in the design or process may also make it necessary to have a deviation in design, without undermining the quality requirements. The ISO emphasizes that, for such deviations, written authorization from a competent authority, and preferably also the written consent of the customer, is essential before implementing sueh a change. This will be for a specific period and for a specific number of items. 

To fulfil the quality requirements, the material inputs going into the making of a bus system must be properly checked as soon as they are received. 

Qualifying the supplier s eapability to meet quality requirements on produetion lots. 

Define a produet and programme quality requirements Evaluate alternative suppliers Seleet suppliers... 

ISO 1940/1, Mechanical Vibration—Balance Quality Requirements of Rigid Rotors—Part 1 Determination of Permissible Residual I nbal-ance, First Edition, International Organization for Standardization, Geneva, Switzerland, 1986. 

Other speeial requirements sueh as medieal examinations, safety proeedures and equipment, training, quality requirement programs, or other preeautions... 

In the ideal case the target level procedure for industrial ventilation can be compared with materials selection. Somebody who wants steel AISl 316, for instance, just selects and buys it by specifying this standard. The person will obtain steel with the desired properties, because the steel is made according to the producer s quality requirements and the producer guarantees its quality. 

As an example of special rooms, air quality requirements in electronics work rooms according to standard lEC 72I-,3-.3 were used. 

Most industrial companies would like to set air quality requirements regarding health hazard at a lower concentration level compared to values found in regulations. For example, when a TWA concentration is given as x kg per nC of air for a certain contaminant, the required concentration level for design of general ventilation in an industrial enclosure could be chosen as one-third of that value. This value can be considered the target value for the first design. 

Air quality requirements may be set as content of particles and as content of chemical substances. Other requirements for temperature, humidity, and air speed could be set. One example is the spray painting process, which is very dependent on a minimum relative humidity (RH) level to... 

These are the characteristics which need to be specified and their achievement controlled, assured, improved, managed, and demonstrated. These are the characteristics which form the subject matter of the specified requirements referred to in ISO 9000. When the value of these characteristics is quantified or qualified they are termed quality requirements or requirements for quality. ISO 8402 1994 defines requirements for quality as an expression of the needs or their translation into a set of quantitatively or qualitatively stated requirements for the characteristics of an entity to enable its realization and examination. While rather verbose, this definition removes the confusion over quality requirements and technical requirements. (An additional definition is provided in Appendix A.) Technical requirements for a product or service are quality requirements. The requirements of ISO 9000 are quality system requirements. 

The quality system developed to meet the requirements of ISO/TS 16949 is likely to be a generic system, not specific to any particular product, project, or contract other than the range of products and services which your organization supplies. By implementing the policies and procedures of the documented quality system, product, project, or contract specific plans, procedures, specifications, etc. are generated. ISO 9001 contains a series of quality system requirements, not product quality requirements. For a given product, project, or contract there will be specific product, project, or contract requirements and it is these requirements to which this clause of the standard refers. 

Quality requirements are not the requirements contained in ISO/TS 16949. These are quality system requirements they apply to quality systems, not to products and services. A product cannot conform with ISO/TS 16949 as it contains no product requirements (see also Part 1 Chapter 2). 

The strategic quality audit to verify that the strategic plans of the organization address specified legal, environmental, safety, and market quality requirements. 

Plans produced to define how specified quality requirements will be achieved, controlled, assured, and managed for specific contracts or projects. 

Objective evidence of the achieved features and characteristics of a product or service and the processes applied to its development, design, production, installation, maintenance, and disposal as well as records of assessments, audits, and other examinations of an organization to determine its capability to achieve given quality requirements. 

The procedure is issued without proper approval and has few quality requirements included. 

Product verification requires inspection and testing programs to confirm that product meets the quality requirements. In PSM and ESH terms, the product is the management of environmental, health and safety issues and may be difficult to separate from measurement (Chapter 7) and Audit. 

From Section 2.1 it has become very clear that the synthesis of an ionic liquid is in general quite simple organic chemistry, while the preparation of an ionic liquid of a certain quality requires some know-how and experience. Since neither distillation nor crystallization can be used to purify ionic liquids after their synthesis (due to their nonvolatility and low melting points), maximum care has to be taken before and during the ionic liquid synthesis to obtain the desired quality. 

In addition to varying in costs, the chemical composition of the water provided from the mains supply also varies between the water companies, as may that between independent supplies within each company s area. The current criterion on potable water quality requires it to be wholesome i.e. it should not create a health hazard, with relatively wide limits on particular constituents. The cost of removing these constituents (e.g. calcium, magnesium, chlorides, iron and silica) increases with concentration and variability. This imposes a cost burden on, for example, the semiconductor and electronic component industries and on the operation of high-pressure boilers. Therefore both the potential cost of metered water supply and the chemical composition of the supply waters may influence future decisions on the water company s area in which an industry may wish to locate. 

Aluminum has many of the characteristics and qualities required for fluid power lines. Is has high resistance to corrosion and is easily drawn or bent. In addition, it has the outstanding characteristic of lightweight. Since weight elimination is a vital factor in the design of aircraft, aluminum alloy tubing is used in the majority of aircraft fluid power systems. 

Planning for quality requires attention to detail. The goal of quality planning is to assure that the outputs of the project will perform - that it will do what it is supposed to do. The quality plan also establishes the criteria of performance by which the project output will be measured when it is completed. 

The water supply for boilers is usually treated. Treatment depends on the quality of the water supply, the pressure of the boiler, the heat flux through the tube walls and the steam quality required. Most waters require de-alkalization. The water produced in this process is nonscaling and potentially corrosive (see above). 

Most simple inorganic salt solutions cause virtually no attack on aluminium-base alloys, unless they possess the qualities required for pitting corrosion, which have been considered previously, or hydrolyse in solution to give acid or alkaline reactions, as do, for example, aluminium, ferric and zinc chlorides. With salts of heavy metals —notably copper, silver, and gold —the heavy metal deposits on to the aluminium, where it subsequently causes serious bimetallic corrosion. 

Table 10.8 outlines the quality requirements of the basis, or primary, metal for the three generic types of anode. These are the qualities required even when sequestering is also adopted. It will be seen that two grades are listed in the case of aluminium. This is because certain patented formulations permit the lower (99- 8%) grade material providing that the iron and silicon are within the limit given. 

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