Defect manufacturing

A considerable assumption in the exponential distribution is the assumption of a constant failure rate. Real devices demonstrate a failure rate curve more like that shown in Eigure 9. Eor a new device, the failure rate is initially high owing to manufacturing defects, material defects, etc. This period is called infant mortaUty. EoUowing this is a period of relatively constant failure rate. This is the period during which the exponential distribution is most apphcable. EinaHy, as the device ages, the failure rate eventually increases. 

Grading, Measuring, and Shipping. Prior to shipment each hide, side, or skin is inspected and sorted. The grading is done on the basis of hide defects, shape of the skin, manufacturing defects, or any other factors of importance to the specifications of the sale. 

Defect. A plaintiff must estabUsh that the product which iajured him was defective. A product can be defective ia three ways it may be defectively manufactured, defectively designed, or sold with iaadequate warnings. 

In June 1992, the American Law Institute undertook the task of drafting the Restatement (Third) of Torts "Products LiabiUty." Tentative Draft No. 2 takes the position that different HabiUty rules must apply for manufacturing defects and defects based on inadequate design or failure to warn ... 

In general, manufacturing defects can exist in any component. However, defects resulting from fabrication or installation activities tend to occur in specific locations, such as ... 

This study reveals the need for separate investigative tools for quantitatively characterizing the influence of manufacturing defects and chemical characteristics on the hygrothermal fatigue response and morphology of epoxy thermosets. 

Field Alert Reports of manufacturing defects must be made to the local district office vdthin 3 days of discovery of a problem with a distributed product. 

Catastrophic rupture of a tank. It may be the result of a manufacturing defect, abusive handling or stress fracture, puncture by a sharp object, or external fire combined with failure of pressure relief device to open. 

Air bubbles vials should be free from any glass air bubbles (glass vials manufacturing defect). 

For each specific application of a rubber compound as an insulating material, there is a minimum value of resistivity below which it does not function satisfactorily. In addition, insulating compounds are required to withstand the effect of water, moist atmosphere, or heat without their resistivity values falling below a satisfactory level. Insulation resistance measurements frequently serve as useful control tests to detect impurities and manufacturing defects in rubber products. 

Even if failure to prevent the above errors has not caused a leak outright, prolonged misuse eventually causes wear on a joint or stopcock, which can then cause permanent damage. Not all defects caused by wear can be distinguished from manufacturing defects by appearance alone. However, if a new item leaks from structural defects, it probably is a manufacturing imperfection. 

This discussion is about drugs that have been properly mcmufactured and meet proper standards, e.g. of purity, stability, as laid down by regulatory bodies or pharmacopoeias. A manufacturing defect would be dealt with in a way no different from manufacturing errors in other products. 

When the product in question is intended only for use in clinical trials, the fundamental purpose of the regulation, protection of patients from defective products, must still be of primary concern. However, the quantity of product at risk, and its limited distribution will impact the process of complaint investigation. For example, the generally smaller amount of product involved may make it difficult to identify low-level occurrences of manufacturing defects. The limited and more tightly controlled system of distribution of clinical trial supplies, however, will likely facilitate and limit the recall process should that be deemed necessary. 

Complaints of adverse reactions to clinical supplies are typically seen as reportable events that impact the safety or efficacy of the test article. Companies should give consideration to the possibility that an increase in the frequency or severity of adverse reactions may be linked to a manufacturing defect. For example, a product that has been formulated such that it is super-potent in its final form can be expected to produce adverse reactions of greater severity or frequency than if it was properly formulated. Labeling mix-ups can have devastating impact on patients, or, at minimum, may seriously affect the validity of a clinical trial. Therefore, the following elements should be included in the complaint assessment system ... 

Regarding strict liability for manufacturing defects (e.g., decomposed mouse in a bottle of soda, or excessive amounts of arsenic in a cattle dip), 2A of the... 

It is important to note that each bag in a set may have a different life as a result of fabric quality, bag manufacturing tolerances, location in the collector, and variation in the bag cleaning mechanism. Any one or a combination of these factors can cause bags to fail. This means that a baghouse will experience a series of intermittent bag failures until the failure rate requires total bag replacement. Typically, a few bags will fail initially or after a short period of operation due to installation damage or manufacturing defects. The failure rate should then remain very low until the... 

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