Verification During Development

During the development of the product ISO 26262 asks frequently for verifications. Most likely always, if a development activity relies on the input of a former development step. In the descending branch of the V-model verifications are always required at interfaces of horizontal abstractions. 

In this context, the verification is seen as the completion of a higher level activity and the lower level activities usually begins with a requirement analysis. ISO 26262 considers also tests especially in the lower horizontal abstraction levels, particularly during component design as verifications. However, methodical, the method for the correct derivation from a higher level would need to be a validation. What is important though is that this verification regarding correctness, completeness and 

Does the verification really only happen during the development of the requirements Is the development of requirements completed before the realization Obviously not When the result is validated and all requirements are correctly implemented at the product, there are always new aspects that can occur in the usage phase, which haven t been sufficiently considered. 

Also in this case, constant iteration loops occur and because of today s short iimovation cycle, products are often only mature after years of their usage and each change also becomes a risk for other characteristics. This of course is not acceptable when it comes to the safety characteristics of a product. It is tme that an inexperienced development team often doesn t know the influence factors, but an experienced team can also make incorrect assumption. Unfortunately, there are certain amounts of risk even in the approach itself. If requirements are systematically developed and properly derived according processes, the known influence factors will also be incorporated. If experienced people perform these analyses, some aspects will also be included in the analysis, which go beyond the requirements and the experience of the designer. At the verification certain levels of experience can 

Besides the safety analyses and tests, more and more verifications are necessary for the determinations of the safety maturity for the product under development. At each organizational interfaces and all horizontal interfaces as well as the in between elements, all characteristics should be verified at the end of the development. In general verification could show the fulfillment of requirements, from a methodology point of view you only get answer if the targets or goals are fulfilled could be only shown by validation. The activity to validate the correctness of requirements, by evaluating higher level requirements or constraints to their correct derivation to lower level requirements called ISO 26262 verification . 

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The following considerations, when applied during method development, are likely to produce more robust, reliable, and transferable methods (a) the concerns of the customer (user) are considered in advance, (b) key process input variables are identified, (c) criticaTto-quality factors are determined, (d) several method verification tests are installed, (e) proactive evaluation of method performance during development is performed, (f) continuous customer involvement and focus are institutionalized, and (g) method capability assessment (suitability to be applied for release testing against specification limits) is established. 

This case study does not cover verification activities during development at the vendor s site. This is described elsewhere. ... 

The HCF has not previously experienced any major accidents or hazardous situations (e.g., fires, explosions . Minor contamination events of personnel and equipment have occurred in Zone 2 that were satisfactorilv resolved bv removal of the contamination. Some spills in the shielded hot cell laboratory steel confinement boxes during isotope production process verification and development tests did not result in large releases and were mitigated using established spill control and cleanup equipment and procedures. ... 

This article catalogs and describes the different aspects of a method that must be studied to ensure that it is, indeed, a valid method. The relationship between systematic measurements made during development and validation, the so-called development-validation cycle will be discussed. When using a previously validated method, there is still a necessity to assert that the method performs as expected in the user s laboratory. This is known as verification. 

Verifications during conception and product development arc rcquircd as a mayor input for aU confirmation measures. In ISO 26262, Part 2, annex D some proposals for planning and execution of verifications and other confirmation measures are shown. 

If activities, which are supported by the tools, can emphasize safety relevant product influences verifications should lead to inconsistencies. Simply consider-ing s, principals and many methods are based on process verifications even Process- and System-FMEAs are very similar. Considering a System-FMEA in a way that systematic failure can influence the function of a product, measures have to be taken against it. Possible malfunction (which are mainly systematic errors) in the Process-EMEA are controlled by measures during the production process, which is mainly the aim of a Control Plan. Analogical to that, the System-FMEA evaluates systematic errors during development process and determines adequate implemented safely mechanism. 

SRCA is applicable to analysis of all types of systems, facilities, and software where hazards and safety requirements are involved during development. SRCA is particularly useful when used in an SwSEThe SRCA technique, when applied to a given system by experienced safety personnel, is very thorough in providing an accurate traceability of safety design requirement verification and safety test requirement validation. 

As illustrated in Figure 1.6, there are two primary activities, valida-hon and verification, during a typical software code development and in... 

Taking into account that it is necessary to make vary the flaw detector settings during the main part of the verifications, the total number of verifications is rather important. So, Technical Center for Mechanical Industries (CETIM) began the development of an electronic system enabling to benefit of the current possibilities of generation of synthesised radio frequency signals and help of personal computer for operator assistance and calculation. 

The standard provides a choice as to whether you define the inspections and tests required in a quality plan or in documented procedures. You may of course need to do both. As the quality system is often designed to accommodate all products and services you supply, it may not specify inspections and tests which are needed for particular products. This is one of the roles of the quality plan. Within such a plan you should identify the verification stages during product development, production, installation, and servicing as applicable. These stages will vary depending on the product, so your quality plan will be product, contract, or project specific (see Part 2 Chapter 2). There may... 

Devices that you use for product verification at all stages in the quality loop need to be controlled and this includes devices used for inspection and test on receipt of product, in-process, and final acceptance before release to the customer. It also includes devices used during design and development for determining product characteristics and for design verification. Some characteristics cannot be determined by calculation and need to be derived by experiment. In such cases the accuracy of devices you use must be con-... 

GLP regulations require QA personnel to inspect/audit each study conducted, but the extent to which QA personnel are involved in software development and the val-idation/verification process varies from company to company. In some companies, there is little or no QA involvement in these processes, whereas in others QA personnel are involved. QA personnel can provide assistance in the area of vendor audits for purchased software or can conduct inspections of in-house software development to ensure that internal procedures are being followed. QA personnel, who conduct in-process inspections and review the resulting data and validation report for accuracy, could provide inspection support during the validation and verification process. During system development and validation, properly trained QA personnel can provide the regulatory advice needed to ensure that the system will meet government standards. QA personnel become more familiar with the system(s) that will be used when they are involved early in the validation process. 

Fulleiene derivatives appear to act both in vitro and in vivo by effectively blocking apoptotic cell death in the presence of known chemical, biological and physical toxins, and it would be interesting to evaluate if these derivatives can also block apoptosis occurring during embryonic development. For verification zebiafish embryos were exposed to 1,1-tris, 6 and 7 for 5 days post-fertilization and after staining with acridine orange apoptotic cells were detected. As depicted in Fig. 3.9,1 and 7 showed... 

The lack of standardization during method verification is a long-standing problem in vitamin analyses. This makes it difficult, if not impossible, to assess the validity of individual methods and to compare different assays without extensive bench work. Although standard or certified reference materials are available for the minerals in foods, development of similar materials for the vitamins is being hampered by the lability of the vitamins as well as by inconsistent results from the various analyses for the same vitamin or, in certain cases, the interlaboratory variability for the same method. 

The transition from a successful pilot-scale process or research scale to a full-scale process requires careful planning and implementation. Although a large amount of information has been gathered during the development of the process (i.e., process characterization and process verification studies), it does not necessarily follow that the full-scale process can be completely predicted. 

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