Flotsum Pharmaceutics Ltd. manufactures a variety of prescription drugs. By government…

Flotsum Pharmaceutics Ltd. manufactures a variety of prescription drugs. By government regulation, each batch of manufactured product is subjected to laboratory testing before it can be sold. This is done at the Flotsum quality assurance lab. The lab has recently been reorganized in an effort to make its operation more efficient. Previously, lab technicians would withdraw bulk chemicals from inventory at the time of testing. Using the bulk chemicals, they would prepare reagents for the tests and use the reagents and other chemicals to test a sample of the product brought to the lab from production. Under the new system, “testing kits” are prepared in advance of testing by chemists and stored in cabinets in the lab. Each testing kit contains all the reagents and chemicals necessary for completely performing a specific laboratory test. This eliminates the withdrawal and mixing of bulk chemicals at the time of testing.
Management wants to design a database to support the operation of this lab. It will manage the use of the kits, the testing procedures, and the work of the quality assurance technicians. Develop an E-R diagram based on the following description of the business rules governing the lab.

(a) Reagents are made up of more than one chemical. A chemical may be used in more than one reagent. Some chemicals are not used in reagents.

(b) A “kit specification” is a description of reagents and chemicals that are in each kit. Each chemical and reagent may be specified for more than one kit, and a kit can require more than one reagent or chemical.

(c) “Chemical lots” are the physical realizations of the material classification “Chemical.” A chemical may have zero, one, or many chemical lots associated with it. Each chemical lot is associated with only one chemical.

(d) Reagent lots are made from more than one chemical lot. A chemical lot may be used in zero, one, or many reagent lots. Some chemical lots are not used in reagent lots.

(e) A “test kit” is the physical realization of a kit specification. Each kit specification may have zero, one, or more test kits associated with it, but each test kit is based on only one kit specification.

(f) Test kits are composed of reagent lots and chemical lots. Reagent lots and chemical lots may be used in one or more test kits, and each test kit may contain more than one reagent lot or chemical lot number.

(g) A “laboratory procedure specification” describes a quality control test. A “kit specification” is associated with one or more laboratory procedure specifications. However, a laboratory procedure specification notes the use of one and only one kit specification.

(h) A laboratory procedure specification involves more than one “procedure steps,” which are the sequential steps used to carry out the procedure. Each procedure step is noted in one and only one laboratory procedure specification.

(i) “Test kits” are stored in laboratory cabinets. A laboratory cabinet will store more than one test kit. A specific Test Kit ID is stored in one and only one cabinet.

(j) When a technician uses a “laboratory procedure specification” to perform a test, it is called a “QA_Test” and is given a unique ID each time it is performed. In other words, the QA_ Test is the actualization, or use, of the specification. A QA_Test uses one and only one laboratory procedure, but the same laboratory procedure can be used in more than one QA_Test.

(k) When test kits are withdrawn from a cabinet to be used in a QA_Test, or replaced back into a cabinet after the test, a “usage transaction” is recorded. This keeps track of test kit usage. A test kit will be involved in more than one usage transaction, but each usage transaction involves only one test kit. A QA_Test will normally be involved in two usage transactions: (1) the withdrawal and (2) the replacement. Each usage transaction involves only one QA_Test.

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