Defining requirements

We have defined the various types of enclosures adopted by various manufacturers to suit different locations and environmental conditions in Tables 1.10 and 1.11. Here we briefly discuss methods for testing these enclosures to check their compliance with defined requirements. 

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. 

It is quite normal to provide sufficient resources to produce product. However, when it comes to verifying that you have done what you say you will do, there is a tendency to underestimate or to cut verification resources when costs escalate. These cuts are often seen as a risk worth taking. Another common weakness is defining requirements that are desirable rather than essential and then not verifying that they have been implemented. Being able to demonstrate provision of adequate verification resources is another sign of commitment to quality (see Defining commitment to quality above). 

Generically there are two types of requirements defining requirements and verification requirements. Defining requirements specify the features and characteristics required of a product, process, or service. (Within the standard these are termed specified requirements.) These may be wholly specified by the customer or by the supplier or a mixture of the two. Verification requirements specify the requirements for verifying that the defining requirements have been achieved and again may be wholly specified by the customer or by the supplier or a mixture of the two. With verification requirements, how-... 

What you need to verify to demonstrate that you are meeting all your customer s defining requirements. (You may have a choice as to how you do this, so it is not as onerous as it appears.)... 

These generally defined requirements are met quite comprehensively by microfiber glass fleeces. These are blends of C-glass fibers of various diameter, which are processed in the usual way on a Foudrinier paper machine into a voluminous glass mat. The blending ratio gains special importance since cost aspects have to be balanced against technical properties. The... 

Chaddock (1975) defined design as, the conversion of an ill-defined requirement into a satisfied customer. 

For this, the manufacturer and the importer have to register the chemicals they are placing on the European market. The registration is mandatory for all chemicals that are sold in a volume of more than 1 Mg/a. With the registration the manufacturer and the importer have to provide a special registration dossier. This dossier should cover all necessary information to do the safety check. To be precise, the structure of the dossier has to follow well-defined requirements, which will not be explained in this article. More information is offered here [10, 11]. 

Perhaps the most noteworthy of this brief historical outline is that all the cited dates are from more than a quarter century ago. Of course, this is not to imply that nothing has happened since in terms of theoretical or technological developments, but the message is that EPR in general, and bioEPR in particular, is a mature spectroscopy, whose application readily pays off if you just take the trouble of getting acquainted with its now-well-defined requirements, possibilities, and limitations. 

Write the effect postcondition in a (pre ==> post) style when you wish to ensure that there is no getting out of the contract and that if the precondition is tme, then the postcondition will be met. Then combine them into actions using and. This approach is generally better when you re combining several separately defined requirements—for example, when you re building a component that conforms to the interfaces expected by several different clients. 

Each part defines requirements for piping or pipelines, as applicable, within its scope. The requirements are different for different aspects of components, design, fabrication, installation, assembly, erection, inspection, examination, and testing. It is required that each part be used in conjunction with the General Requirements section but independent of the other parts. The joint connecting piping governed by two different parts shall... 

Another requirement of the PSM Standard is that the employer conduct process hazard analysis, which OSHA defines as an organized and systematic effort to identify and analyze the significance of potential hazards associated with the processing or handling of highly hazardous chemicals. The analysis must identify the hazards of the process and necessary safeguards however, the standard does not explicitly define requirements for addressing reactive hazards. 

What expectations do local management and corporate management have for the investigation team for timing, interim reports, final reports, and defining requirements for startup of units or equipment ... 

Any laboratory processes that are outsowced shall be identified within the QMS and the laboratory shall ensiue control over such processes. Such a control depends on the significance of the outsourced activities to the conformity of the result to defined requirements. The degree and extent of control exerted to outsourced activities is defined and documented to the QMS. 

Customer requirements are explicit and implicit. The laboratory shall review the requirements specified by the customer prior to commitment to undertake the job and ensure that it has the ability to meet the defined requirements. Anything that is discussed and agreed with the customer is confirmed and recorded. If any changes to agreed requirements occur,... 

The laboratory shall define the characteristics of the materials, reagents and instrument to be purchased and evaluate the ability of the eligible suppliers to supply the required materials and/or services. The verification process that is, the process to ensure that the purchased products conform to the defined requirements shall be defined and the necessary resources, including persormel, shall be provided. 

This procedure defines requirements for monitoring of air quality relative to airborne particulates of injection manufacturing and packing area and delineates the responsibilities for assurance of compliance with this procedure. The room number, activity, and location number defined are hypothetical. Individual companies can apply the SOP as a model to develop their own SOPs. 

The guidance for industry Q1A (R2) [7] defines requirements for API stability data package submission with drug applications in the EU, Japan, and the United States. 

The limit of quantification is more relevant than the limit of detection in the analysis of drug residues in foods. In these applications, the limit of quantification can be more practically defined as the lowest drug concentration in food samples that can be measured with a desired level of accuracy and precision. It is usually determined by reducing the analyte concentration until a level is reached where the precision of the assay becomes unacceptable. If the required precision of the method at the limit of quantification has been specified, a number of samples with decreasing amounts of the analyte are analyzed 6 times at minimum, and the calculated RSD% of the precision is plotted against the analyte amount the amount that corresponds to the previously defined required precision is equal to the limit of quantification. 

In performing the validation, defining the quality attributes—that is, gaining a clear understanding of the required quality and intended use—is the most important issue, and should be determined before starting the validation. Without defining required quality attributes we cannot establish validation protocols, which are the basis of all validation studies. 

Good manufacturing practice regulations identify what controls must be in place and adhered to in order to be in compliance, but do not provide instruction on how to implement these controls. The methods used to ensure the product meets its defined requirements are the responsibility of the pharmaceutical manufacturer, who must be prepared to demonstrate GMP compliance with validated systems and formal records. 

Traceability and accountability of information to be maintained throughout validation life-cycle documents (particularly important in relating qualification tests to defined requirements). The mechanism (e.g., matrix) for establishing and maintaining requirements traceability should document where a user-specified requirement is met by more than one system function or covered by multiple tests... 

Similar to installation rules, national standards for explosion protection in the presence of combustible dusts were established long before international standards. In Germany, VDE 0165/1991-092 (and this standard referring in parts to VDE 0170/0171 Teil 13/1986-11) defines requirements for electrical equipment operating in areas hazardous due to combustible dusts. 

In the United States the discrimination between categories ia and ib is necessary only if the IEC-based classification of hazardous areas has been adopted. According to the differentiation into Divisions 1 and 2 (still predominant), one single type of intrinsic safety (IS) has been defined, requiring a two-fault assessment. 

Problems arise in interpreting the results, and therefore defining requirements, when different markers of adequacy respond to different levels of intake. This explains the difference in the tables of reference intakes published by different national and international authorities (see Tables 1.5-1.8). 

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