Deviation report

Appendix III of this report provides a detailed description of the reliability data used in event tree and fault tree quantification. Because of its extensive operating experience and the uniqueness of the BRP design, BRP plant-specific data was used whenever possible. Plant-specific data sources included plant maintenance orders, control room log books, surveillance tests, LERs, event reports, deviation reports, plant review committee meeting minutes, and USNRC correspondence. The plant-specific data used spanned the period from 1970 to 1979. Data before 1970 did not include maintenance orders or surveillance tests and therefore were excluded. The plant-specific data collected for BRP is presented in detail in Appendix XIII. Table III-4 summarizes 30 plant-specific component failure rates and Table 11-06 contains plant-specific maintenance unavailabilities for 20 components. These tables are a summary of the BRP component failure and maintenance outages. 

Protocol deviations in the processing phase of the study must be reported to the Study Director without delay. The Study Director will determine any potential impact upon the study that would result from the protocol deviation and will advise the PPI how to proceed with the study. Regardless of the form of communication by which the Study Director is notified of the protocol deviation, a formal description of the protocol deviation must be written by the PPI and submitted to the Smdy Director for an assessment of impact on the study. The assessment of impact by the Study Director should address any scientific and GLP compliance issues. A signed copy of the deviation report is included with the raw data notebook. 

The deviation reported for chloral hydrate as a catalyst disappears if wo use a more recent value of p C (Bell and Onwood, 1962). 

Table 1. Study differences detectable given a fixed sample size. Values represent minimum detectable differences between trial arms given the standard deviation reported for the row in the table, and a fixed sample size for each arm of the trial...

The requirement to assure that deviations reported by the QAU are communicated to the study director and that corrective actions are taken and documented does not mean that management itself must communicate the findings and take appropriate corrective action. An efficient QAU will document deviations and the fact that corrective action has already occurred in reports that are distributed to both management and the study director. The need for additional management follow-up will then be necessary only in those few instances in which corrective action was not adequately negotiated between the QAU and the scientific staff before the issuance of the QAU report. When corrective action is un-... 

Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products... 

Installation Review purchase orders, design Need to write deviation reports,... 

Information requests/project holds Deviation reporting Corrective action Audits (internal and external)... 

Responsibilities and data collection procedures Test procedures, specific acceptance criteria Documentation procedures Summary and deviation report... 

Measure ionized magnesium using selected controls on three instruments. Calculate standard deviation. Report the results as a mean value of four measurements and the results of our measurements are given in Table 1.3. 

In the event that the CIP procedure does not proceed in accordance with the validated procedure, a deviation report and investigation would need to occur. Unfortunately, documentation associated with deviations, pharmaceutical exceptions, and failures is often not handled with the extent of detail and urgency required by regulatory agencies. 

Quality assurance coordination of completion of formal deviation report in a timely manner. 

A common error is to limit the types of deviations reported to and evaluated by the APR system to just deviations from finished-product specifications. All deviations should be evaluated, including deviations from manufacturing procedures, in-process specifications, deviations from raw material specifications, and other expected results. Each of these occurrences could indicate changes are necessary to prevent recurrence. For example, the cause of deviations from manufacturing procedures is frequently evaluated as a lack of training. If there are several of these occurrences by different individuals, however, it is also likely that there maybe another root cause, such as unclear or insufficient batch record instructions or inadequately designed or unclear batch record data forms. 

What is the significance of la, 2a, and 3a deviations reported with a numerical value For the beta-particle standard solution counted repeatedly, what percentage of the values is in the range of +la to -la ... 

Memos, master production and control records, SOPs, deviation reports, validation protocols, manual batch documentation, and many more. 

Deviation Reports should be prepared to describe the nonconformance, analyze the nature of the deviation, and define how the deviation is being addressed. The criticahty of the deviation will determine appropriate controls ... 

Software used out of the box without deviation report or investigation into configuration error. [FDA 483, 2002]... 

Priority lists for applications Change control logs Deviation reports on failures... 

Back-up scheduling, logging, recorded data verification, problem detection, deviation reporting Media labeling and storage (on-site, off-site)... 

From the standard deviations reported in tables i and 2, we notice that the energetic interactions are sensitive to both the adsorbent and the organic specie. Indeed, energy deviations observed for a same compound on different carbon materials are in the same order of magnitude as that measured with different VOCs on one type of GAC. 

Table 3.5 Standard deviations reported by Orazem et al. for their impedance data obtained for the reduction of ferricyanide on a Pt rotating disk electrode. The methods of Agarwal et a 56,86 yjgjj tQ fjitgr p jnor lack of replicacy from 26 repeated impedance experiments.

It is possible also to derive from D an apparent plate number, N = Lu/ 2Da). These data are shown in Figure 14.8. From these results as well as from those of Zhu et al. [19,20] discussed above, we conclude that there is a good agreement between the predictions of the shock layer theory and the experimental measurements of the shock layer thickness, but that it seems that the less valid one of the several assumptions made in the derivation of the shock layer theory is the assumption that kf is independent of the concentration. A significant variation of kf with the component concentration would explain most of the deviations reported. These results are in agreement with the conclusions of the comparisons... 

Procedure 1. Prepare a checklist of all components and parts, including spare parts according to the purchase order and manufacturer s specifications. 2. Record the information for each actual part, component, item of auxiliary equipment, supporting facilities, and compare with the manufacturer s specifications. 3. Record any deviations to the system/equipment. 4. Prepare a deviation report including justification of acceptance and impact on the function. 5. Prepare an IQ report. 6. Submit the report to QA for review and approval. 

As a minimum, the iQ report shouid inciude the date of initiation of the study, date compieted, observations made, probiems encountered, compieteness of information coiiected, summary of deviation report, resuits of any tests, sampie data (if appropriate), iocation of originai data, other information reievant to the study, and the conciusion on the vaiidity of the instaiiation. 

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