Inspection review and

Procedures and controls shall include the ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. 

Authority to make inspections, review and copy documents, and take samples and collect other evidence Ability to enforce requirements and to remove products found in violation of such requirements from the market Substansive manufacturing requirements Accountability of the regulatory authority Inventory of current products and manufacturers System for maintaining or accessing inspection reports, samples and other analytical data, and other firm/product information Mechanisms in place to assure appropriate professional standards and avoidance of conflicts of interest Administration of the regulatory authority... 

Complete copies of records must be available for inspection, review, and copying by regulatory authorities. 

Use of validated computer systems. All computer systems used to generate, maintain and archive electronic records must be validated to ensure accuracy, reliability, consistent independent performance and the ability to discern invalid or altered records. Secure retention and instant retrieval of the records. Procedures are in place to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Records must be protected to enable their accurate and ready retrieval throughout the records retention period. 

It is able to make available accurate and complete (data, audit trail, and metadata) copies of records in electronic form for inspection, review, and copying. Records are protected so that they are accurate and readily retrievable throughout the required retention period. 

QA methods and tools (how ) - including inspections, reviews and audits. 

Major elements of an occupational safety and health program address recognition, evaluation, and control of hazards. The activities may include risk assessment and charting of probability and severity of potential incidents. The activities may deal with routine functions as well as non-routine functions. Changes in operations and conditions or equipment may also trigger these activities. Inspections, reviews, and other analysis methods will help identify the hazards, the likelihood of occurrence and the potential severity. For example, there should be inspections of repair and maintenance work to ensure that guards and other protections are in place or an area is clear of flammable and combustible materials and sources of heat and fire. Previous chapters offered several methods for hazard recognition and control. 

Details of such inspections are likely to be retained within the fire log book or fire safety manual so that evidence is readily available for future fire safety inspections, reviews and audits. 

Other offices within ODER may become involved in the review process via consults. Eor example, the Office of Epidemiology and Biostatistics analyzes statistical data, the Office of Research Resources provides bioavailabiHty reviews, and the Office of Compliance determines from the results of inspections whether the firms meet EDA s Current Good Manufacturing Practice (cGMP) regulations. Advisory committees composed of independent experts are often asked to meet and further analyze the data. Often they also advise as to what additional data and information may be needed. After PDA s review is completed, PDA issues either a Summary Basis of Approval (SBA) for the dmg or a recommendation against approval. If approved, PDA releases the SBA and a summary of the safety and effectiveness data to the general pubHc. 

Upon completion of tlie inspection process the results were reviewed, and the following requirements were defined for each major component of the hot gas expander and its respective subassemblies ... 

The aforementioned reviews and assessments were assimilated to characterize the effect of dielectric, rotational, and mechanical hazards on motor performance and operational readiness. Functional indicators were identified that can be monitored to assess motor component deterioration caused by aging or other accidental stressors. The study also includes a preliminary discussion of current standards and guides, maintenance programs, and research activities pertaining to nuclear power plant safety-related electric motors. Included are motor manufacturer recommendations, responses from repair facilities to a questionnaire, in-service inspection data, expert knowledge, USNRC-IE audit reports, and standards and guides published by the Institute of Electrical and Electronics Engineers (IEEE). 

This report evaluates recent performance of DGs and all DG vendors with the exception of Transamerica Delaval, Inc. (TDl), because of the emphasis already being given to TDI diesels in other studies. For the period 1980 through 1983 inclusive, BNL reviewed and evaluated DG failure data, DG vendor inspection reports, the TDI lessons learned as they related to the other vendors, and previous pertinent studies. The data sources used for DG failure analysis were LERs, 10 CFR 50.55E, Part 21, NPRDS, and EPRI document files. The DG failures were classified relative to the DG component that failed (e.g., main bearings, starting system). The failures were also categorized and analyzed by mode, manufacturer, and cause. Manufacturers with significant failures are identified in the report. 

QA is an important aspect of any technical study. It is particularly crucial in an LSMBS, because several hundred participants, widely separated geographically, are involved. The analytical laboratories typically have standard provisions for QA inspections and reviews, and the field phase management organization is also likely to have standard provisions for QA inspection and review. Shoppers, however, are typically external to study management and analytical laboratories and, thus, are not directly covered by existing QA systems. The study design must include a means by which the field phase, i.e., sample collection and shipment by the shoppers, is made to comply with QA requirements. 

The QA unit should have written procedures (SOPs) for the conduct of inspections and audits. These procedures should incorporate all considerations for the review of electronic data systems. The QA unit SOPs should address the role and responsibilities of the QA unit in software development, purchase, and validation activities, in-process audit procedures for data collected on line, procedures for on-line review of data (i.e., what will be verified and how much data will be reviewed), and the procedure for auditing reports using on-line data. 

Nevertheless, during inspection of the above-mentioned reviews and many of the works cited therein, many excellent analytical methods which can be applied to other polyene molecules were found. 

Property damage and loss of production must also be considered in loss prevention. These losses can be substantial. Accidents of this type are much more common than fatalities. This is demonstrated in the accident pyramid shown in Figure 1-3. The numbers provided are only approximate. The exact numbers vary by industry, location, and time. No Damage accidents are frequently called near misses and provide a good opportunity for companies to determine that a problem exists and to correct it before a more serious accident occurs. It is frequently said that the cause of an accident is visible the day before it occurs. Inspections, safety reviews and careful evaluation of near misses will identify hazardous conditions that can be corrected before real accidents occur. 

Develop recommendations to improve the management system to prevent the existence of safety hazards, including training, checklists, inspections, safety reviews, and audits,... 

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