Surveillance inspections, areas

The examination of records and reports usually concludes the GLP surveillance inspection of a facility, although there may be extenuating circumstances that will prolong the investigation and require closer review of a given area. 

However, a November 15-23, 1999, preapproval FDA inspection of BioPort s manufacturing renovations, which was more focused in scope and purpose than the 1998 surveillance inspections, resulted in BioPort receiving a FDA form 483 report with observations and possible deviations in some of the following areas validation, failure... 

To resolve these problems, the DARCOM Ammunition Center was tasked to design a Mobile Surveillance Inspection Shop that would provide a suitable work location and contain all of the necessary tools and equipment to accommodate the variety of inspections when conducted at the storage site. This mobile shop was to be transportable and selfsustaining. It would be designed to insure ease of operation, service and storage of the unit, as well as to provide an efficient work area with a maximum consideration for... 

Provision has been made to ensure adequate access and workspace for personnel and equipment. Where hands-on access is permitted, clearance is provided for the head and shoulders of a man within arm s length of the area to be inspected or surveyed. Access routes to locations requiring ISI or surveillance are provided. These routes permit storage of ladders and temporary platforms as required. Insulation and penetration plugs are designed for easy removal and installation. Temporary working platforms will be provided where necessary to facilitate access to areas for inspection and surveillance. 

Criterion 32 - Inspection of reactor coolant pressure boundary. Components which are part of the reactor coolant pressure boundary shall be designed to permit (1) periodic inspection and testing of important areas and features to assess their structural and leaktight integrity, and (2) an appropriate material surveillance program for the reactor pressure vessel. 

Criterion 53 - Provisions for containment testing and inspection. The reactor containment shall be designed to permit (1) appropriate periodic inspection of all important areas, such as penetrations, (2) an appropriate surveillance program, and (3) periodic testing at containment design pressure of the leaktightness of penetrations which have resilient seals and expansion bellows. 

A prioritization may be required to manage effectively safety control programs. Thus a structured industrial area is suitable to experiment a risk based approach in inspection and surveillance program. It could enable safety authorities to concentrate resources on establishments at a higher risk level, thus reducing efforts... 

Fit testing requirements and procedures Inspection, cleaning, maintenance, and storage procedures Provision for medical examinations Process for work area surveillance Acceptable air quality standards Use of approved respirators... 

Puerto Rico Environmental Quality Board Land Pollution Control Area Inspection, Monitoring, and Surveillance PO. Box 11488... 

The RQV Surveillance Program has been providing valuable support to the Reactor Restart Division over the past months by ensuring that safety significant problems are either prevented or detected early and resolved in a timely manner. Additionally, the Safety Oversight Division conducts day-to-day inspections and has so far looked into areas such as ... 

This restart criteria requires demonstration that structural integrity of the CWS is maintained under normal and abnormal load conditions using applicable codes, standards and analysis methods, including those specified in the seismic section of the SER. Components which are part of the CWS shall be subject to (1) periodic inspection and testing of areas important to safety to assess their leak tight integrity, and (-2) periodic evaluation based on surveillance of the condition of the material. 

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