Verification requirements - meaning

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

ID Requirement Target specification Minimum specification Verification/validation means... 

Regarding the validation of the design space, there is no universally recommended procedure for verification of a model, and there is limited literature or regulatory guidance that addresses the extent of verification required to justify a design space (Hallow et al. 2010). In the present work, eight additional runs were performed inside the design space and confronted with the predictions of the optimization model. A 3 DoE was centered in the optimized operation point (see Fig. 8.30). The results obtained showed very small errors (the root mean squared error was 0.06 p,m for particle size and 0.003 g/ml for BD). 

It is calculated as the difference between the minimum guaranteed income threshold (established by law) and the monthly net income of poor households. Diflerentiated minimum income thresholds have been established in accordance with the number of people per household. The program uses a two-tier testing system an administrative testing of personal Income based on applicants declarations of their incomes (including imputed income from assets such as land and animals) and a verification of means procedure based on inquiries at the claimant s domicile. Provisions include work requirements for those able to work. Beneficiaries are also entitled to health insurance and heating subsidies. 

To the best of our knowledge, existing research has assessed both problems by means of testing and error injections, e. g., [20] for arithmetic encoding or [7] for replication, arithmetic encoding and assertion-based techniques. However, testing as well as error injection are far from providing the completeness of verification required for safety- and mission-critical systems. 

Another potential problem is due to rotor instability caused by gas dynamic forces. The frequency of this occurrence is non-synchronous. This has been described as aerodynamic forces set up within an impeller when the rotational axis is not coincident with the geometric axis. The verification of a compressor train requires a test at full pressure and speed. Aerodynamic cross-coupling, the interaction of the rotor mechanically with the gas flow in the compressor, can be predicted. A caution flag should be raised at this point because the full-pressure full-speed tests as normally conducted are not Class IASME performance tests. This means the staging probably is mismatched and can lead to other problems [22], It might also be appropriate to caution the reader this test is expensive. 

By producing defining specifications that prescribe requirements for products or services and also the means by which these requirements are to be verified in-house in terms of the inspections, tests, analyses, audits, reviews, evaluations, and other means of verification... 

It should also not be assumed that these requirements are only intended for implementation by a department with the title Inspection or Test. Whenever a product is supplied, produced, or repaired, rebuilt, modified, or otherwise changed, it should be subject to verification that it conforms with the prescribed requirements and any deficiencies corrected before being released for use. That is what control means. Control is not just the inspection part of the process and hence quality control , which for years was the name given to inspection departments, was misunderstood. Inspection and test don t control quality. Inspection and test merely measure the quality achieved and pass the results to the producer for remedial action. 

It would be considered prudent to prohibit the premature release of product if you did not have an adequate traceability system in place. If in fact any nonconformities in a component will be detected by the end product tests, it may be worth allowing production to commence without the receipt tests being available, in which case the tests will only be confidence checks and not verification checks. If only one product is received and released prior to verification one would think that, as the requirement applies prior to verification, there is no need to positively identify the product to permit recall because you would know where it was if you found it to be nonconforming. However, the nonconformity may have been reported to you by the supplier after delivery. The standard does not stipulate when and by whom the nonconformity may have been detected. If you lose the means of determining conformity by premature release, don t release the product until you have verified it is acceptable. 

To accomplish this, you need to specify either in the quality plan or the documented procedures, the inspections and tests you intend to carry out to verify that the product meets specified requirements. In Part 2 Chapter 4 there is a description of a Design Verification Plan and this includes a specification of the tests and inspections to be performed on each production item as a means of ensuring that the qualified design standard is being maintained. This requires that you produce something like an Acceptance Test Plan which contains, as appropriate, some or all of the following ... 

However, these requirements go further than merely controlling the devices used for measurement. They address the measurements themselves, the selection of the devices for measurement and also apply to devices which create product features, if they are used for product verification purposes. If you rely on jigs, tools, fixtures, templates, patterns, etc. to form shapes or other characteristics and have no other means of verifying the shape achieved, these devices become a means of verification. If you use software to control equipment, simulate the environment or operational conditions, or carry out tests and you rely on that software doing what it is supposed to do, without any separate means of checking the result, the quality of such software becomes critical to product verification. In fact the requirements apply to metrology as a whole rather than being limited to the equipment that is used to obtain the measurement and therefore a more appropriate title of the section would be Control of measurements . 

Should you not use measuring devices in your organization, these requirements will not apply. If your means of verification are limited to visual inspection or professional judgement, as is the case with organizations that deal only with documentation, you will have no devices to control. However, you may use tools or computer software to assist you to determine conformance and these will need to be proven capable of producing a reliable result. 

The standard does not require you to use statistical techniques but identify the need for them. Within your procedures you will therefore need a means of determining when statistical techniques will be needed to determine product characteristics and process capability. One way of doing this is to use checklists when preparing customer specifications, design specifications, and verification specifications and procedures. These checklists need to prompt the user to state whether the product characteristics or process capability will be determined using statistical techniques and if so which techniques are to be used. 

Verification means confirmation by examination or direct measurement that specified requirements are met. 

It is important to realize that though the formulas for RME explicitly do not depend on reaction scale, x, since this variable cancels out in the computation, RME does in fact implicitly depend on reaction scale because reaction yields are scale dependent and RME in turn depends on reaction yield. Reaction yields are parameters whose magnitude cannot be predicted theoretically but must be verified experimentally. It does not always follow that a reported yield for a given reaction at a given scale will be the same at another scale. This requires experimental verification. Moreover, the direction of change as the scale is changed is also not predictable. AH of this means that when the same synthesis plan is run at a different scale, different reaction yields will be determined and hence different material efficiency performance values of RME, Em and mass of waste will be obtained. However, the... 

To assure consistency and speed in multidisciplinary structure analysis of low-MW compounds involving various techniques (IR, NMR, MS, etc.) most industrial laboratories use a Standard Operating Procedure (SOP). In such schemes IR analysis is frequently used as a cheap filter for a quick starting control and as a means for verification. As IR detects only structural units identification of an unknown compound on the basis of IR is difficult. Mass spectrometry is used as the prime identification tool and is especially important in the determination of the exact mass and gross formulae. While structural prognostication on the basis of MS is difficult for the non-expert, a posteriori interpretation is quite feasible. H NMR is both easy and cheap, however requires greater sample quantities than either... 

The process of specification should always be subjected to verification to ensure accuracy and meaning in the data provided. Even without recourse to full-scale calculation of the solution, internal consistency of the geometry can be checked, as can closure of curves or overlap of distinct components, whereas physical properties can be matched, say, with tables of established values representing material properties, or compared against experience accrued by modellers. In Figure 15.1 each operational component is connected multiply and reversibly with other components, illustrating the practical side of modeling, where one is often required to repeat steps to correct, clarify, or modify actions taken previously. 

Ab initio calculations show [83JA(105) 1760] that the D6/l structure of hexazine corresponds to a very shallow minimum on the PES. Hexazine has been detected experimentally by means of the low-temperature matrix isolation (80AG745) but, according to [83JMS(105)351], this result still requires verification. 

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