Safety during inspections

During inspections, FDA places a great deal of emphasis on the following systems they feel most directly will impact the safety and efficacy of sterile products manufactured, namely ... 

The objective of the assessment process is to verify that the required information regarding safety, efficacy and quality of the product is documented and submitted in the required format. Where possible during inspections, and as a part of the verification process, the data and results should be verified to ensure that correct, accurate and reliable data have been submitted to the procurement agency. 

During inspection, some parts of a product are more important than others in terms of allowable defects. Each company defines its own product zones and includes these in their specifications as there is no industry standard. The highest priority zone (could be identified as Zone 1, Zone A, or Zone 1) is usually identified as the area that will most likely been seen during a face-to-face conversation, whereas the inside of a garment is not as critical in terms of acceptable defects. Companies will also define what they deem as critical, major, and minor defects. A critical defect results in a flaw that produces an unsafe or hazardous situation like a hole in a latex glove that would compromise the safety of the wearer. A major defect is a flaw that often contributes to product failure or lack of usability for a product. Examples of a major defect could be a broken zipper, broken stitches, or tears in the fabric. A minor defect is a flaw that does not reduce the usability of a product, but still deviates from standards... 

Management must make sure drivers and maintenance personnel are trained and knowledgeable to make a determination during inspections as to whether or not a vehicle is safe or should be taken out of service. Neither set of employees (drivers or maintenance personnel) should perceive that management wants them to circumvent good vehicle safety practices. 

Mark Wilhelm, S., Avoiding Exposure to Mercury During Inspection and Maintenance Operation in Oil and Gas Processing, Process Safety Progress, Fall (1999)... 

A risk assessment will be conducted as part of inspection and activity planning in order to rninirnise health and safety risks. This assessment shall include, inter alia, an evaluation of environmental, structural, physical and chemical hazards as weU as radiation, endemic diseases and appropriate ways of managing them. Where this evaluation implies undue knowledge of issues protected by confidentiality restrictions, the relevant components of the risk assessment in terms of level and measures to be adopted shall be provided by the inspected State Party. Risk assessments will be updated during inspections as appropriate. Risk assessment procedures wdl be standardised throughout the OPCW. 

To ensure the health and safety of inspection team members and of the inspected site without impairing confidentiality during all inspections, particularly challenge inspections, and subject to the provisions of the Convention, the following procedures shall apply whenever the inspected State Party deems appropriate ... 

Is Enviromnental, Safety and Health Department persoimel present on-site during inspection unless otherwise instmcted before inspector is allowed access to groundwater or vadose zone monitoring wells ------------... 

An occupational safety audit or safety audit comprises the experiences of managers and experts in the field of occupational health and safety during the examination of a business, inspection and control of workplaces and technical devices, and during training and seminars. 

When a motor carrier or driver feels a roadside inspection was not conducted in accordance with the Out-of-Service Criteria, or an officer acted inappropriately or misinterpreted the Out-of-Service Criteria during a roadside inspection, they can contact the Commercial Vehicle Safety Alliance (CVSA) to lodge a formal complaint. In addition, if a motor carrier feels the Out-of-Service Criteria — referenced by enforcement personnel during inspections — is incorrect, they may also contact CVSA and challenge the document. 

Violations are recorded during inspections and entered into the MCMIS database. Serious violations result in driver or vehicle Out-of-Service (OOS) orders. These OOS violations must be corrected before the affected driver or vehicle is allowed to return to service. (Note If a driver is cited and convicted of a violation related to Unsafe Driving or the safety regulations, but it does not appear on the roadside inspection report, it will not be entered into MCMIS. It will appear on the driver s motor vehicle report... 

Ammonia is extensively transported by rail car. The type of tank cars used in the U.S. for transportation of anhydrous ammonia as well as their safety aspects, inspections and safety record are discussed in [28]. Here also two accidents involving ammonia tank cars are dealt with. The detailed description of the accident which occurred in 1976 at Glen Ellyn, Illinois, is described in [29,49]. This accident was due to a derailment as two trains passed each other. The tank head of an ammonia car was punctured by a coupler of an adjacent car. One of the conclusions of the analysis is that if the tank car had been provided with head shields, the tank head would not have been punctured during the derailment. Another accident in which a railroad tank car carrying anhydrous ammonia suffered a puncture is described in [30]. This tank car contained about 75 t of anhydrous ammonia at a pressure of 4 to 5 atm. The handling of the railroad derailments involving anhydrous ammonia and other hazardous materials is discussed in [31]. Computer-aided ammonia rail car loading is described in [32]. 

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