Preparing for Inspections

Conduct education and training sessions about how to conduct inspections. Periodic inspections provide opportunities for hazard control personnel, line supervisors, and top managers to listen to the concerns of those doing the work. Inspections should accurately assess all environments. 

Note Review all contracts to ensure inclusion of safety-related considerations. 

Understand that hazard analysis deals with the science of and standards relating to 

Evaluate hazard information using a practical approach Investigate accidents and near-miss events to discover causes Conduct root cause analysis to uncover contributing causes Determine woiker perceptions about safety in the workplace Deal with perceptions (it cannot be avoided) 

Remember that effective hazard analysis leads to effective hazard control or correction Identify employees at risk of exposure and evaluate control measures Establish a baseline to be used throughout a continuous or ongoing process Use inspections to identify and assess hazards in each work environment Determine potential hazard severity and possible effects on workers Evaluate PPE effectiveness 

Biological hazards include bacteria, viruses, infectious waste, and blood-borne pathogens. 

Chemical hazards can pose a variety of risks due to their physical, chemical, and toxic properties. 

Ergonomic and environmental hazards include repetitive motion, standing, lifting, trips, and falls. 

Physical hazards include things such as radiation-, noise-, and machine-generated hazards. Psychosocial hazards include substance abuse, work-related stress, and workplace violence. 

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The system has recently been used with success for inspection of 11 inclined nozzle welds during the R1 SPRINT project at Vattenfall Ringhals, Sweden during the summer 1997. At the moment a full system and personal qualification is prepared for inspection of the pressurizer spray nozzle weld at Vattenfall Ringhals, block 2 at May, 1998. 

After preparation, a checklist may be used by less expert engineers than the preparers for inspecting the process areas to compare the process equipment and operations with the checklist oidrcr on hardcopy or laptop computer. The analyst fills in the checklist according to observations from their inspection, process documentation, and interviews with operators and their perceptions. 

The preparation for inspections shonld inclnde a risk assessment based on the drug product being processed, the production process involved, and the technology mix including the use of computer systems and a review of the company s internal audit and regulatory inspection history. 

As the manufacturer will be inspected as part of the prequalification process for specific products to the procurement agency, inspectors should prepare for inspections by studying the product information submitted by the manufacturer. Appendix 10 contains an example of an SOP for preparing for an inspection. 

The examination of documentation by regulatory inspectors may in some cases take place in part off the site, for example at headquarters, and can contribute towards their preparation for inspection of the facility. 

In this chapter City Guilds asks us once again to look at a safe isolation procedure as a preparation for inspecting and testing an electrical installation. 

The interior of the cylinder is prepared for inspection by the removal of internal scale, dirt, or other condition as necessary to permit the inspection of the internal surface. Cylinders with interior coating must be examined for defects in the coating. If the coating is defective, it must be removed. 

Once testing and final inspection are complete, the unit is prepared for shipment. The specification should have detailed the type of storage anticipated and expected time. It should have specified indoor, warehouse, outside storage, or whatever is planned. An anticipated time point should also have been stated. The contract should have stated the mode of shipment and destination instructions. Upon notice of shipment, the traffic department (if there is one) may wish to monitor the shipment. 

Prepare procedures for inspecting customer supplied product and notifying the customer of any problems. 

Prepare procedures for inspecting and testing incoming goods. 

Preparing a boiler for inspection requires the operator to first follow a sequence of specific boiler shutdown procedures, including cooling the boiler slowly to prevent undue stress to the metal and refractory. The primary purpose of the inspection process is to ensure continued boiler safety, and therefore a thorough inspection of all appurtenances is mandatory. 

Before initiating a clinical investigation, the manufacturer (or his/her authorised representative) must prepare a statement containing the information outlined in Figure 10.2, and notify the relevant Competent Authorities of the proposed study. The manufacturer must also keep available for inspection by the Competent Authorities the information outlined in Figure 10.3. Unlike for clinical trials, a standard application form has not been developed. Instead, appropriate application forms are... 

M. D. Hynes, Preparing for FDA Preapproval Inspections. New York Marcel Dekker, Inc., 1998. 

Preparing for FDA Pre-Approval Inspections, edited by Martin D. Hynes III... 

There is an EU scheme for classification and labelling of dangerous preparations (i.e., formulations of substances) the Dangerous Preparations Directive (DPD) (a. 7). The EU supplier has to keep a record of the evaluation for inspection by the regulatory authorities. There is no obligation to conduct new studies, but the available information has to be used and interpreted according to the DSD and DPD. 

The morphology of mesoporous structures can be investigated by TEM, as shown in Fig. 7.2 b and d. However, sample preparation for TEM is time-consuming. Fortunately the mesoporous regime can also be studied by today s most advanced SEMs. For SEM inspection no sample preparation is required, and even sputtering of the sample is dispensable, as shown by the SEM micrographs displayed in this and the next section. 

The equipment shall be prepared for shipment after all testing and inspection has been eompleted and the equipment has been released by the purehaser. The preparation shall include that specified in 4.4.3.1 through 4.4.3.11. 

In an effort to assess the reliability and consistency of visual inspection by medicinal chemists, the following process was implemented. The approximately 22 000 compounds that did not pass the NR filters were broken up into 11 lists of approximately 2000 compounds each. Two chemists were assigned to each of the lists, and each chemist reviewed two lists. A list of the acceptable compounds was compiled from the reviews. A detailed analysis of the study is being prepared for publication [18]. 

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