Walk-through inspections

FD-483 Citation 4 During the walk-through inspection on—it was observed that—product in the fluid bed dryer basket was not protected to prevent contamination as a cursory room cleaning was on going. The cleaning was not recorded in the batch records and was not part of the manufacturing procedure. 

Is conducted by walk-through inspections and in sit-down team sessions... 

Manual techniques such as reviews, walk-throughs, inspections or audits should be applied to the verification of all life cycle phases and they may be the only applicable technique for verification of those phases which precede source code generation. Since these are manual methods it is important that the means by which the results of such reviews are to be recorded is considered. Use can be made of checklists. However, care should be taken in the construction of checklists to optimize their usefulness (for example, the required response to a checklist item should be clear and not open to interpretation). The means by which the verifiers are to record the results of their reviews should be stated in the verification plan together with a justification of the chosen method. 

NOTE 1 Methods for verification include review, walk-through, inspection, model-checking, simulation, engineering analyses, demonstration, and testing. Typically verification applies a combination of these and other methods... 

An essential part of the on-site visit is the physical inspection of the toller facility—the walk-through. It offers the opportunity to confirm interview responses, observe work practices, interview employees, and note general housekeeping, soil contamination and safety issues. 

The HASP should describe how potential health and safety hazards at the work site are located, identified, and measured. A written schedule including inspections and walk-throughs conducted by designated individuals should be specified. 

Walk-through survey An examination or inspection of a workplace involving a review of hazardous materials present and/or used, observation of work practices, and consversations with individuals to identify all of the actual or potential chemical, physical, biological, and ergonomic hazards. 

It should be possible when walking through a machine shop, for example, to identify which products are awaiting inspection, which have been inspected and found conforming, and which have been rejected. If, by chance, some product were to become separated from its parent batch, it should still be possible to return the product to the location from whence it came. A machine shop is where this type of identification is essential - it is where mix-ups can occur. In other places, where mix-ups are unlikely, inspection and test identification does not need to be so explicit. 

Before beginning the actual detailed examination that is the thrust of the walk-through survey, it is necessary to prepare yourself for what you are about to do. You can t just walk in and start looking at various activities. If you are not already familiar with every aspect of plant activity, you should familiarize yourself with the nature of the operation, including the organizational and demographic background, the processes, the tasks, the flow of activities, the equipment, and so on. Before you start any inspection you should ask yourself some specific questions such as those listed in Table 14-1. 

Firefighter Muhammed is at an elementary school with his lieutenant, doing an inspection of the school. While walking through the halls, he is approached by a six-year-old boy who asks why he should bother to learn fire safety rules. Firefighter Muhammed should tell him that... 

Structural testing takes into account the internal mechanism (structure) of a system or component. It is sometimes referred to as white box testing. Structural testing should show that the software creator followed contemporary quality standards (e.g., consensus standards from national and international standards development organizations. This testing usually includes inspection (or walk-through) of the program code and development documents. 

These include static analyses such as document and code inspections, walk-through, and technical reviews. 

Numerous inspection steps undertaken throughout the system development and operational life support that a computer system is validated. These include static analyses such as document and code inspections, walk-through, and technical reviews. These activities and their outcomes help to reduce the amount of system level functional testing needed at the operational environment to confirm that software meets requirements and intended uses. 

The input/output driver is also used for the (retro)synthetic tree inspection. The user can walk through the tree generated, inspect the selected nodes, edit them, and submit them for further processing by the SPS generator, thus creating new branches and levels of the (retro)synthetic tree. Each node of the (retrosynthetic trees stores not only the two-dimensional structure of the chemical compound, but also the distance from its father (i.e starting structure) measured by the reaction as well as chemical distances, and also its fragmentation level, measured by its order. 

Perform a quick walk-through of key computer systems and user workstations in the facility at their point of use. Consider conducting a mock inspection. Pull the records from archives (can information be retrieved in a timely manner ). Review documentation for obvious errors — a fresh pair of eyes Identify potential problem areas and have answers prepared. Final computer validation reports should be available in English for the FDA. 

Provide knowledge of how computer systems are used Support inspection of validation documentation from retrieval of appropriate documents to walking through validation conducted Keeps minutes of inspector s comments and observations Keeps a record of documents requested and provides to inspector Accompanies the inspector during the inspection at all times Brings and removes documents requested by the inspector... 

Project activities, e.g., design reviews, code walk-throughs (or for larger software teams, formal software inspection— both forms of structural testing, desaibed below)... 

Walk-Through- A final inspection of a home before "Closing" to look for and document problems that need to be corrected. 

The lifters should not be used too close to the burner flame (1) because flame contact with the granules may be harmful and (2) because the hfe of the shelves would be shortened. Lifter flights have been as wide as 10% of drum inside diameter, but the greater widths require sturdier eonstruction to carry a deeper pile, which obstructs gas flow. Many short, closely spaced flights make it difficult for maintenance persons to walk through the cold drum to inspect it. Parts 4 and 5 of figure 4.4 show the use of suspended chains to heat up when hanging across the hot gas stream, and then heat the load in the bottom of the dram by conduction (contact). 

Safety walk A formal safety inspection process. An individual or group of individuals, using a safety check sheet, walks through a department or facility with an eye for safety. Any noncompliance issues or situations are noted on the inspection form. 

As opposed to testing, which attempts to uncover errors in a product by running the product, analytic techniques try to uncover errors by analyzing arepresentation of the product such as its software code. Program proof techniques fall in this category. A more common approach involves reviews of a work product by peer engineers. Two such techniques are code walk-throughs and inspections. 

Another organized activity devoted to analyzing code is called code inspection. The organizational aspects of code inspection are similar to those of code walk-throughs (i.e., the number of participants, duration of the meeting, psychological attitudes of the participants, etc., should be about the same), but there is a difference in goals. 

There is some evidence that walk-throughs and inspections are cost-effective and many software engineering organizations are adopting them as standard procedures in the life cycle. 

Compatible with SAV Architecture Results of a combination of analysis techniques and reviews/inspections, including modelling and simulation of the properties of the S/W architecture including the executive and scheduler, resource allocation, timing constraints and so on design analysis of dependencies between the function and the S/W architectural properties structured walk-throughs and inspections. 

Consistent Results of a combination of analysis techniques and reviews/ inspections, including safety analysis, S/W safety analysis, modelling and simulation, formal method proofs that show internal consistency and completeness, structured design walk-throughs and inspections. 

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