New supplier

Given a series of tests with the new material, the average yield x would be compared with Po. If x < Po, the new supplier would be dismissed. If X > Po, the question would be Is it sufficiently greater in the light of its corresponding reliability, i.e., beyond a reasonable doubt If the confidence intei v for p included Po, the answer would be no, but if it did not include Po, the answer would be yes. In this simple apphcation, the formal test of hypothesis would result in the same conclusion as that derived from the confidence intei val. However, the utility of tests of hypothesis lies in their generality, whereas confidence intei vals are restricted to a few special cases. 

Application. In the past, the yield for a chemical process has heen established at 89.6 percent with a standard deviation of 3.4 percent. A new supplier of raw materials will he used and tested for 7 days. 

The variability or spread of the data does not always take the form of the true Normal distribution of course. There can be skewness in the shape of the distribution curve, this means the distribution is not symmetrical, leading to the distribution appearing lopsided . However, the approach is adequate for distributions which are fairly symmetrical about the tolerance limits. But what about when the distribution mean is not symmetrical about the tolerance limits A second index, Cp, is used to accommodate this shift or drift in the process. It has been estimated that over a very large number of lots produced, the mean could expect to drift about 1.5cr (standard deviations) from the target value or the centre of the tolerance limits and is caused by some problem in the process, for example tooling settings have been altered or a new supplier for the material being processed. 

Potassium nitrate in cloth sacks stowed next to baled peat moss became involved in a ship fire and caused rapid flame spread and explosions [1]. Heat transfer salt from a new supplier was added to a pilot plant reactor salt bath. Some 12 h after start of heating to melt the bath contents a muffled explosion occurred, attributed to presence of organic impurities in the new salt [2],... 

Suppose that a company has been using a certain supplier of raw materials in one of its chemical processes. A new supplier approaches the company and states that its material, at the same cost, will increase the process yield. If the new supplier has a good reputation, the company might be willing to run a limited test. On the basis of the test results it would then make a decision to change suppliers or not. Good management would dictate that an improvement must be demonstrated... 

Problem definition Ever since a production plant started using a new supplier of a carbon decolorizing agent, consistently acceptable polymer has not been obtained. The plant s technical director recently read an article about the power of new mass spectrometric techniques, so she sends you an urgent e-mail and sends a sample of the offending carbon and a retained sample of the previous supply. The technical director asks you to find the impurity in the new, ineffective decolorizing carbon. 

TABLE I Impurity Results from Three Validation Batches Using the New Suppliers Drug Substance. Specifications Are <0.1%... 

Silica is an expensive filler compared to carbon black and day. With the entrance of four or five new suppliers the capacity is more than adequate for the foreseeable future. Much devdopment work is being done by Degussa and PPG to devdop products equivalent to the Rhcjme Poulenc HDS silica. Huber reportedly has the ability to produce the high structure already. 

Case example 1 How company A was able to reduce its purchase prices by developing a deep understanding of suppliers economics and leveraging new suppliers (Fig. 15.5). 

Where a new supplier is being selected a number of factors need to be considered and a detailed supplier selection process may be undertaken. Evaluation may consist of gathering information from various sources such as the suppliers themselves, companies who already have a system installed, and trial demonstrations. Where possible a fixed-duration trial (pilot) should be set up on site for the project team and user representatives to run through some scenarios of how the system may be used. 

The permanent switching costs - such as the risk presented by a new supplier, or the additional transaction cost... 

Despite this and other measures, it was not possible after the milk market organization took effect to prevent an imbalance between butter production and consumption. Even the U.K. s accession to the EC in 1973 did not bring about a turn in the overall development. Although imports from New Zealand into the new member country were cut from nearly 165,000 to 55,000 tons and although the U.K. turned mainly to France, the Netherlands, and Germany as new supplier countries, the rise of butter prices caused restricted consumption on the English market. In the course of a few years, per capita consumption dropped from 8.8 kg in 1970 to 3.3 kg in 1991 (143). 

Excipients can be crucial determinants of product performance and quality. Thus, they should be sourced directly from a reputable vendor who has quality systems in place to ensure consistent manufacture and control. Procurement from brokers is to be discouraged. Auditing such providers for the presence of quality systems and controls should be the norm, particularly if they are new suppliers to the pharmaceutical industry. A validation program should be put in place to establish reliability of the supply source. This program should take the following into account ... 

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