Inspection process

On a daily base the fiinetioning and the sensitivity of the system is tested to ensure the quality of the inspection process. 

If improvements should be achieved by an automation of the inspection process this requires a control of the process parameters of the whole equipment by an integrated "intelligent" system and not by displays still being controlled by the human inspector. This integrated control-system ensures that the inspection conditions are at the highest reproduction level. 

As already said before the QAP for LPI systems has been developped on a modular basis and can vary with the composition of the LPl system given by the specific inspection process. 

Visual Inspection. Visual inspection should always be regarded as the first defense against failure (1). Without scientific proof, it is estimated that 80% of defects are found by visual inspection. A pilot walking around an aircraft, or a mechanic observing a machine in operation often finds defects very quickly. The cost of this inspection is minimal. Human factor considerations are particularly important for the visual inspection process. Although the visual inspection is perhaps the most inexpensive and finds the most defects, the 20% of the defects remaining after the visual inspection must also be found thus the more costly and technically elaborate NDE methods are needed. 

The inspection process involved considerable work, due to the amount of damage experienced. The following steps were involved in the inspection process they can be considered typical of recommended procedures ... 

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 ... 

If our inspection process has pointed out areas in need of housekeeping, and these same areas continually show up on our inspection, an adjustment would appear to be in order. One possible solution would be to spend more time and effort on housekeeping issues. However, no matter how much time and effort we spend on housekeeping, we can usually find places lacking in housekeeping. Possibly there is no money, time, equipment, or other resources available to perform housekeeping activities at this time. 

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. 

Inspection tolerance can be divided into two major components the accuracy variability of the instruction and the repeatability of the measuring method. The calibration and accuracy of the instrument are documented and certified by its manufacturer, and it is periodically checked. Understanding the overall inspection process is extremely useful in selecting the proper method for measuring a specific dimension. When all the inspection methods available provide an acceptable level of accuracy, the most economical method should be used. 

In almost all countries today, safety codes and regulations exist for the construction, operation, and inspection of all boilers and associated pressure vessels and boiler systems. Both HW and steam-raising plants are provided with several vital boiler appurtenances (appliances or fittings) and various subsystems containing auxiliaries (accessories) that must be maintained, monitored, and controlled. However, for small HW and LP steam boiler plants the inspection process may be rather cursory with regard to the pressure vessel internals and tends to concentrate primarily on ensuring the proper operation of the various appurtenances that provide for boiler safety. 

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. 

In the following sections, the informal inspection process is discussed, rather than the more exhaustive and time-consuming regulatory or plant inspection processes. 

The inspection process is the precursor to determining when a boiler needs cleaning. Visual inspections cutting out tubes and the use of chipping hammers, fiberscopes, Turner gauges, and other aids are employed, together with a full and representative deposit analysis to assess the requirement for cleaning. 

Examining the inspectors workloads will also help to establish reasons for the success or failure of the inspection process. EHiring their inspection of pharmaceutical establishments, inspectors may learn of the presence of unregistered products, counterfeit products, etc. Quantitative information on these and other issues is valuable as an outcome measure. 

For health professionals in consultations with patients complaining of diarrhea, it is pertinent to ask "Is it oily " and "Have you consumed fish " If answers are confirmative, the case should be reported to food inspection agencies. To follow up on the alert, food inspection agencies should collect the expelled oil sample, a residual sample of the cooked fish (if available), and any uncooked fish from the same source to check for wax esters. If wax esters are detected, DNA analysis should be applied, if possible, to identify the source species. Concurrently during the inspection process, food safety agencies should trace back to the supply source of the fish to see if proper labels were in place. If not,... 

As noted previously, QAU review of adherence to protocol requirements and SOP are part and parcel of the inspection process. 

When a random sampling approach to the inspection process is used, it may be desirable to indicate the date(s) of inspection(s) of similar studies during a period that includes the time of conduct of the study for which the QAU statement is being prepared. Any such additional inspections should be clearly labeled as such. 

Having discussed the inspection processes of FDA as far as GLP regulations are concerned, the question may then be asked What are the recent and historic results of the FDA s toxicology laboratory monitoring program ... 

The BLA was established pursuant to the Food and Drug Administration Modernization Act of 1997, consolidating a prior requirement for two applications a Product License Application and an Establishment License Application. The final implementing rule reduced the amount of information a manufacturer is required to file in its BLA application and shifted responsibility to the plant inspection process to ensure that manufacturers complied with cGMP standards. 

Document the results of the visual inspection process of ampoules in attachment no. 1700.110(A). 

Product and/or process defects and/or limitation of inspectional processes... 

Section 305 Proceedings Due to the nature of the inspection process, a company that the FDA deems is in violation of the cGMPs should not be surprised when a warning letter or more elevated enforcement techniques are implemented. Even so, the FDA sometimes issues a formal form of notice that criminal charges will be brought by what is called a Section 305 notice. 

In fairness it has to be admitted that visits from inspectors are often highly professional. However, there have been suspicions that inspectors from certain local offices have slightly different agenda that are usually unfavorable to the industry. It is not a pleasant experience to hear an inspector openly taking credit for effectively putting a company out of business this should not be the purpose of the inspection process. 

Procedures are in place to ensure that the measurement and inspection processes are in a state of control, and that the uncertainties associated with the measurement are suitably small, so as to have a negligible effect on decisions or actions based on inspection results or measurements. 

The Resource Recovery Unit staff also provides direct technical assistance to industry, when requested, and can perform plant inspections, process reviews or just meet with plant inspections, process reviews or just meet with plant representatives to discuss regulatory or technological issues. 

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