Criteria acceptance

A clear definition of what criteria mnst be met for acceptance of the computer system must be defined. Reference to a Validation Report alone is not sufficient. The criteria to be used by the Validation Report in measuring the compnter system for acceptability as validated must be stated, together with the maimer in which compliance failures logged during the project are resolved. 

The validation process is used to support acceptance criteria used for study sample analysis. The targeted acceptance criteria to be used for sample analysis will be dictated by the analytical requirement, sponsor, or regulatory guidelines but ultimately, the final criteria that will be used for 

For study sample analysis the calibration curve and QC samples are evaluated separately, and run acceptance is based upon criteria estabhshed for both curves and QCs. For validation runs, however, only the standard curve and other factors such as carryover are considered for run acceptance and aU of the results for the various types of validation QCs, e.g., precision and accuracy, stability, etc., are reported and used for statistical analysis. It is important at this time to emphasize the distinction between a failed and rejected validation run. Runs may be rejected for specific assignable cause such as documented evidence that the method was run incorrectly or hardware failure (Section 10.5.2c). Data from failed runs on the other hand, such as those where an excessive number of calibrators are considered to be outhers or QCs used to assess precision and accuracy do not meet the 

Reporting requirements for validation runs are addressed in Section 10.3.4. For runs that fail due to an excessive number of calibrator outliers, a reference to the failed run should be provided in the report along with a description of underlying cause for the failure. For validation QCs, accuracy and precision calculations should include all data although additional tables with outhers excluded can be provided also. Poor precision and accuracy for a particular experiment e.g. stability, may indicate the need to repeat that study in a subsequent validation run. If poor results are observed for the QCs used for intra-day and inter-day precision and accuracy, it may be necessary to repeat the entire vahdation run. In these instances, a reference to the failed run must be included in the final vahdation report. 

Background information that should be fully documented for vahdation sample analysis includes dates of extraction and analysis, identification of instruments and operators, identify of calibrators, QCs and samples. With respect to the analytical instrument itself (GC/MS, LC-MS/MS etc.), in addition to the maintenance and calibration records, the chromatography conditions, mass spectrometer and interface operating parameters, injection sequence and quantitation parameters are often documented automatically in the electronic raw data file that is associated with each injection, but critical parameters that are not captured elec-tronicaUy must be recorded manuahy alternatively, all of 

If both the operating organization and the regulatory body develop acceptance criteria to reflect the respective philosophies, the set of acceptance criteria agreed upon by both organizations must be satisfactory to the regulatory body. 

Acceptance criteria should be stated for both the operational states of the reactor and the accident conditions considered in the design of the facility. Such criteria will vary among Member States they may include considerations such as those listed below. 

INFORMATION REQUIREMENTS DURING THE STAGES OF THE LICENSING PROCESS 

The operating organization shall provide to the regulatory body all relevant information on the basic safety approach for the facility. The manner in which this information is requested, prepared and submitted for assessment differs among 

Residue/contamination limits can be determined in various ways although this can be the most challenging part of the validation. As outlined in PDA Technical Report No. 29, Points to Consider for Cleaning Validation,some commonly used approaches are to base the maximum allowable carryover (MAC) on 

The reasoning for selection of the approach and calculation of the MAC should be logical and based on sound scientific rationale. Once determined, the MAC should be distributed among the different pieces of equipment used in the manufacture of the product, such as a compounding tank, a surge tank, or filling nozzles. 

A typical pharmacological potency-based formula used to evaluate the total MAC for all equipment used in the production process is (TD) (BS) (SF) 

A limit based on the toxicity of the residue can be evaluated by the ADI/NOET equation 

000 to 1/10,000 of a normal daily dose Injections, ophthalmic products 

Exceeding the safe operating hmit by some parameter (if such a hmit is set for this parameter) may lead to an accident, i.e. to failure of the barrier(s) preventing the release of radioactivity. 

A safety analysis for an RBMK nuclear power plant should assess the integrity of the foUowing barriers against release of radioactivity  

Should any barrier fail, thus opening the pathway for the release of radioactivity beyond the plant boundaries, the amount of radioactivity and the population exposure need to be assessed. 

For RBMKs designed and licensed before the main safety criteria and requirements came into force in 1993, the radiation criterion is absolute in the sense that the consequences of a DBA (in terms of radioactive releases and discharges to the environment) should never result in such a population exposure as to require emergency protective actions in the early phase of an accident (i.e. for about ten days after the accident). 

As far as the conditions of barrier integrity are concerned, exceeding a given threshold value will only mean that the integrity of the barrier in question is not guaranteed and that an additional, more comprehensive, analysis should be performed to assess the actual state of this barrier. 

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This study has been launched in order to provide quantified data about the compared performances of liquid penetrant product family and, finally, to introduce an acceptance criteria on performance of liquid penetrant range of products in RCC-M code which had no requirement on that point. 

The table given in fig (I) gives the list of parameters concerned by the periodical verification, with acceptance criteria, if applicable. 

The verifications can be performed by the user himself, with electronic measurement equipment described in this project. The consequences of the application of future European standard are very important since is established a mandatory verification of each particular flaw detector, at least once a year. Their verification is to be performed according to a well defined procedure of measurement, including acceptance criteria for each parameter. 

When converted into decibel, the sensitivity of elements should rather stand in the range of +/-3 dB. The time of flight should show very smooth variations corresponding to a mispositioning of the probe or of the active surface, if any. Acceptance criteria depends on the shape of the probe let us just say that for plane probes expected variations should be below... 

After many decades of application, industry has completely accepted standard NDT as an inevitable but invaluable part of production and maintenance of components. Its application has been well-regulated, acceptance criteria for weld defects exist, good schemes for personnel qualification are in place and equipment has evolved to a standard of nearperfection. NDT has become a commodity. Pioneering years are over. 

Examples will cover maintenance inspection such as corrosion detection in piping and tanks, but also routine weld inspection. The need for acceptance criteria for weld defects adapted for modern NDT techniques will be highlighted, because these form (in many cases) the key to benefit. 

NDT has a very important formal status. Requirements for performanee of NDT, acceptance criteria and requirements for personnel qualification are implemented in codes and standards. The NDT procedure is part of the contract. During the many years that NDT methods have been used in industry a well-established situation has evolved, enabling the use of NDT for the evaluation of welds against Good Workmanship Criteria on a routine basis, thus maintaining workmanship standards and minimising the risks of component failure. 

It seems almost perfect. Established methods, established acceptance criteria, established procedures and personnel qualification schemes. Almost perfect. Because the reason of this presentation is, to show that things could be improved. 

It may therefore be argued that the merit of conventional NDT using existing acceptance criteria is limited to the aspect of evaluating the welder s performance because this has always been the best we could. 

But there is a price to be paid. Good Workmanship acceptance criteria for conventional techniques must, to a certain extent, be conservative, in order to compensate for the inherent "limitations" of conventional NDT. And, what is worse, the degree of conservatism is more or less unknown. Therefore the question can be asked "if the historic background of present NDT practice would not exist, what would we like to know today about a weld to be able to accept or reject it "... 

For many years, the technical capabilities of standard NDT methods did not allow for this approach. If NDT would have produced quantitative data on defect size from the beginning, it is highly probable that current acceptance criteria for weld defects would have used this information. Acceptance criteria would have been completely different from what they are... 

Unfortunately, now that such methods have become available, such as the Time Of Flight Diffraction (TOFD) technique, this revolution does not happen. What we see instead is a much slower process towards quantitative NDT, in combination with adapted acceptance criteria for weld defects. 

For NDT of new construction this implies that, the more one knows about the material properties and operational conditions, the better the acceptance criteria for weld defects can be based on the required weld integrity and fine-tuned to a specific application. In pipeline industry, this is already going to happen. 

F.H. Dijkstra, J.A. de Raad and T. Bouma, TOFD Acceptance Criteria a Perfect Team. 14" World Conference on Non-Destructive Testing, New Delhi, India, December 1996... 

The Development of Acceptance Criteria for the TOFD Inspection Technique. Draft final report of a Dutch KINT project (draft, document number T098-54, Rev. 0, January 1998)... 

F.H. Dijkstra, J.A. de Raad, H hy Develop Acceptance Criteria for Pipeline Girth Weld Defects European-American Workshop Determination of Reliability and Validation Methods of NDE, Berlin 18-20 June 1997... 

O. Farli, R.M. Denys, S. Crutzen, Development of Acceptance Criteria for Pipeline Girth Weld Defects. European Conference on Non-Destructive Testing, Copenhagen, 26 - 29 May 1998... 

Based on a preliminary set of acceptance criteria s developed by LM Glasfiber a standard data-set has been developed for each of the above mentioned set-ups, in order to minimize the scanning time. During the performance demonstration at LM Glasfiber the effective scanning time for a complete 21m wind turbine rotor blade based on the preliminary acceptance criteria s, was found to be less than hour. 

Decide whether to accept the new configuration. There is an acceptance criteria based on the old and new energies, which will ensure that the re-... 

The remaining step in the hazard identification and risk assessment procedure shown in Figure 1 is to decide on risk acceptance. For this step, few resources are available and analysts are left basically by themselves. Some companies have formal risk acceptance criteria. Most companies, however, use the results on a relative basis. That is, the results are compared to another process or processes where hazards and risks are weU-characterized. 

A thorough sampling plan should describe when the sample is to be taken and how many samples are required. It also specifies from what location within the equipment, such as the manway or discharge valve, to take the sample. The plan should also indicate what sampling equipment and sample container should be used, as well as the type of tests to be performed and the acceptance criteria. 

Any tests and associated acceptance criteria which are part of the welding-procedure qualification for filler materials and heat-affected zone need not he repeated. 

According to Phannacopoeia, methods of dmg quality control must be validated. But now there no justified acceptability criteria and standai dized validation procedures. It presents problems for analysts during method development. 

For criteria development we used systematical application of an insignificancy principle (IP). Uncertainty is insignificant in comparison with on the level of 95% if their pooled uncertainty is at most 5% exceeds A. It results in an inequality A < 0.32-A that is the main instiximent in development of acceptability criteria of validation characteristics. 

Application of IP and NCS in conjunction with specification tolerance limits enables to substantiate acceptance criteria for linear regression metrological characteristics (residual standard deviation, correlation coefficient, y-intercept), accuracy and repeatability. Acceptance criteria for impurity influence (in spectrophotometric assay), solution stability and intermediate precision are substantiated as well. 

This approach enables also to substantiate acceptance criteria for detection and qualification limits in impurity control method validation. 

After acceptable design tolerances have been agreed to by all parties, then these become the basis for system design and unit acceptance criteria. 

If the previously agreed-on test acceptance criteria are not met, then additional testing will be required. 

The API mechanical standards for the rotary and centrifugal compressor have a test specified for proof of rotor insensitivity. This would normally be the test invoked at this point to ultimately prove the rotor. The fifth edition of API 617 expanded on this test and changed the acceptance criteria from those based on amplification factor to an acceptance level based on internal seal clearances. 

After the completion of the balanced acceleration and deceleration runs, the unbalance weight must be placed at the predetermined location and the acceleration and deceleration test repeated using the same recording instrumentation. The results should be compared to the appropriate computer predictions and the API acceptance criteria applied. Acceptance criteria were added in the API 617 sixth edition. 

Material and welding quality inspections, based on industry standards, are desirable. Again, API gives some guidance. Beyond this, the inspection method and acceptance criteria must be clearly stated. In preparing his bid, the vendor must understand exactly what is desired. 

The purpose of a scoping analysis is to determine, under worst case assumptions, if there is a risk that can cause injury, death or financial impact to the public, workers, company, or environment. The PSA begins by identifying the hazards, their physical and chemical properties, the confinement, conditions and distance for transport to a target, estimating the effects on the target, and comparing these effects with accepted criteria. 

Completion of the PSA to higher levels depends on the sale of a CANDU-9. The plant is expected to meet the following PSA acceptance criteria. 

Compare the results to existing international acceptability criteria ... 

Miller, B. and R. E. Hall, Index of Risk Exposure and Risk Acceptance Criteria, February... 

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