Case study solutions
Functional Equivalence for Equipment Replacements The second in a series of eight case study solutions studies from the Product Quality Research Institute focuses on functional equivalence for equipment.
Pharmaceutical manufacturers have an obligation to ensure that their manufacturing equipment is properly designed, installed, tested, operated, and maintained throughout their service lifetimes. During these service lifetimes, manufacturing equipment will likely require both preventive and corrective maintenance activities that may involve the replacement of parts within the systems. Proper roles and responsibilities of the functional areas involved in the process of determining whether original and replacement parts are functionally equivalent. The outputs of the risk-management approach used by the firm included a generic, robust, and repeatable process for performing functional-equivalence assessments as well as defining organizational roles and responsibilities supporting the process. The risk question developed for the subject case study was: What process and associated functional area roles and responsibilities are required in order to assess whether replacement parts are functionally equivalent with original parts in order to ensure proper manufacturing-equipment change control while also preventing unnecessary revalidation activities? Identify new or improved activities that would lead to robust, efficient, and consistent functional-equivalence assessments moving forward.
To support selection of a risk-assessment method, the team examined the above risk question and identified the core activities supporting the historical functional-equivalence assessment process. Core activities examined included the equipment change-control process and the maintenance-systems inventory process-control flow. Visit our Teacher Benefits page to learn more. The printing of data from this product is authorized for individual use only. Distribution or publication of printouts in the absence of specific authorization from Cengage Learning is expressly forbidden. Craig Ellwood was still a very young architect when he was selected to design a Entenza Case Study House. This is the first in the series of three villas he designed for the Case Study House Program.
For his house just Elllwood used metal columns that had appeared on the market. Indeed, due to the decline of the railway, many found themselves unused rails produced. The use of square columns instead of columns H can save a lot of money, they are lighter and can simplify a number of details such as those bindings woodwork. The beams used are I to 6 inches and 36 feet long. Translucent panels 10 feet in height are treated as extended walls of the house. The interior walls of the house are also treated as screens. They are of the same material as the exterior walls to express continuity between interior and exterior spaces spaces.
These panels are by exposing the structure which is painted black. They are off the ground, and are separated from the ceiling by a transom window. The villa consists of a grid of 8 feet. The house is divided into two areas occupied by the circulations, one inner and one outer longitudinally extending in the direction of the project. The boundary with the street is freely drawn by a solid line turn opaque or translucent tower. The indoor and outdoor spaces are organized around the two perpendicular axes carry the project.
The partition between social spaces and individual spaces is along a North-South axis passing at the entrance. It amazing how close the villa whose area is in a simple rectangle, which is built with a completely systematic metal structure does not prevent to achieve a wide variety of spaces and uses. This remark is particularly sensitive to the game of indoor and outdoor spaces. This is illustrated for example in the input sequence: the porch is divided into two parts, creating a covered walkway for pedestrian access. Basically, the villa allows a double entry: service entrance that allows access to the court and the kitchen but also main entrance angles. The patio at the entrance allows movement of the light at the output while creating a case study solutions. Each room is extended by outdoor spaces in direct continuity with the interior space.
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Similarly, the living areas have a triple orientation with three types of large spaces. Open to the outside distant and providing a wide view to the south: the view terrace as baptized Craig Ellwood. Open to foreign direct space and close to the garden: the living-terrace is protected under large pergolas. It comes in direct extension of the dining room. Much more protected, the child-play may have lived both as a space service and much more closed and intimate space. The position and status of the service areas is much less clear.
These spaces are scattered and fragmented in the plan of a house. This house was designed in collaboration with Charles Eames and Eero Saarinen. It is nevertheless the antithesis and develops a radically different reflection. This villa was built for J. Entenza wanted to focus on the reception areas. The aim was to enclose the maximum possible space in shape and structure as simple as possible.
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