Verification requirements

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-... 

Verification requirements are not limited to product/service features and characteristics. One may need to consider who carries out the verification, where and when it is carried out, and under what conditions and on what quantity (sample or 100%) and standard of product (prototype or production models). 

You may find that the only way you can put your product on the market is by having it tested by an independent test authority. You may need a license to manufacture it or to supply it to certain countries and this may only be granted after independent certification. Some verification requirements only apply to the type of product/service, others to the process or each batch of product, and others to each product or service delivery. Some requirements can only be verified under actual conditions of use. Others can be verified by analysis or similarity with other products that have been thoroughly tested (see Part 2 Chapter 4). The range is so widespread it is not possible in this book to explore all examples, but as you can see, this small and innocuous requirement contains... 

There are a number of ways of documenting verification requirements ... 

How do you identify verification requirements and plan their implementation at the appropriate stages ... 

Acceptance criteria are the requirements which, if met, will deem the product acceptable. Every requirement should be stated in such a way that it can be verified. Characteristics should be specified in measurable terms with tolerances or min/max limits. These limits should be such that will ensure that all production versions will perform to the product specification and that such limits are well within the limits to which the design has been tested (see also Part 2 Chapter 2 under Identifying verification requirements). Where there are common standards for certain features, these may be contained in a standards manual. Where this method is used it is still necessary to reference the standards in the particular specifications to ensure that the producers are always given full instructions. Some organizations omit common standards from their specifications. This makes it difficult to specify different standards or to subcontract the manufacture of the product without handing over proprietary information. 

How are your subcontractor verification requirements and methods of product release conveyed to subcontractors ... 

You are only required to indicate whether product conforms to the inspections and tests performed. This is not the same as indicating whether the product conforms to the customer requirements. It may well pass the prescribed inspections and tests but these inspections and tests may not be sufficiently comprehensive to verify conformance to all the customer s requirements. However, the only indication you can give is the product s conformance or nonconformance with some verification requirement. It follows therefore that you should not go around putting reject labels on products, or acceptance labels for that matter, if you have not performed a specific inspection to determine conformance. There are only three conditions uninspected , inspected and found conforming , and inspected and found nonconforming . If you have a policy of only applying labels after inspection, anything without a label is therefore deemed uninspected, unless it has been installed and the label removed. 

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. 

Table 44.6 is a vibration troubleshooting chart that identifies some of the common failure modes. This table provides general guidelines for interpreting the most common abnormal vibration profiles. These guidelines, however, do not provide positive verification or identification of machine-train problems. Verification requires an understanding of the failure mode and how it appears in the vibration signature. 

Describe individual items of equipment and how they are connected in sufficient detail to enable unambiguous set-up. List minimum performance requirements and verification requirements, cross-referenced to the calibration section and any relevant instrument manuals. Number for later reference. For glassware, include grade where applicable (bear in mind that use of a particular grade may require justification and that proof of compliance may be required). Include environmental requirements (fume cupboards, etc.). 

TABLE 5 Validation and Verification Requirements for HPLC Assay of Final Dosage Forms... 

Table 5 summarizes the comparison of the vahdation requirements with the verification requirements of the HPLC assay of an example final dosage form. ICH requires the validation of accuracy, precision, specificity, linearity, and range. Generally, verification will only require a minimal of precision and specificity validation. The accuracy requirements will be dependent on the specific situation of the final dosage form. 

Calibration or performance verification requirements, acceptance criteria, frequency of testing, and the actions required if the instrument, does not meet the performance verification requirements. 

The verification requirements and reports on the material for release and shipment... 

Verification requires sniffing an authentic standard to verify that the component and the standard have the same retention index and odor quality. Table G 1.8.1 shows the result obtained when sniffing the sample used in Figure Gl.8.4. 

Verification requires sniffing an authentic standard to ensure that the component and the standard have the same retention index and odor quality. 

Critical parameters and related means of controls Responsibilities of each of the groups participating Cleaning validation/verification requirements Master batch components (percentage by weight)... 

Article IV (Verification) and the Protocol establish the verification regime. Such a regime—consisting of IMS, IDC, consultation and clarification, on-site inspections and confidence-building measures— shall be capable of meeting the verification requirements of the Treaty at its entry into force. 

Jakob and Chabal reasoned that the silicon atoms, such as those at the steps and kink sites, that are most physically accessible are preferentially attacked. The reactants and the dissolved complex have certain physical dimension and orientation so that certain pathways may be forbidden due to steric constraints. While this argument is intuitively sound, its verification requires information on the solvation structure of the involved species and their interaction with the surface atomic structures. 

For all study subjects, source data verification requires a review of the following items ... 

The problems relating to the size threshold are two-fold. First, and most evident in this first allocation cycle, data requirements are installation-specific. Therefore, much of the data problem discussed above was created by the small size threshold. Second, the reporting and verification requirements will impose costs on small installations that are disproportionate to their emissions or the abatement that could be expected from them. 

Establishment of Criticality. By using the methodology just outlined, the criticality inherent in eq 1, as predicted by theory, could be verified, as far as we know, for the first time. In view of the molecular weight dependence of t (discussed later) this verification required ideally mono-disperse material, which amongst readily available polymers is best approximated by anionically polymerized polystyrene, a material used in much that is to follow. 

Current trends in macroeconomics, defense systems, and advanced communications seem to suggest that large, complex, multinational enterprises like the ISS will become increasingly important over the decades to come. Here I have outlined a variety of unique systems engineering challenges associated with the development of the ISS, including the protracted development cycle, test and verification requirements, and infrastructure considerations. 

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