Production defects hazards

Scandals concerning hazardous substances or product defects that have been made public in a broader context have learning effects, which go far beyond the company concerned. This means that journalistic interest in the subject of chemicals and comparative testing facilities are important drivers for innovation. 

When a product defect is identified, the evaluation should include a health hazard assessment by a qualified person, usually a physician. The FDA s recall policy regulations contain a suggested rubric for performing a health hazard assessment (see 21 CFR 7.41). 

A product defect will only be reportable imder Section 15 if it could create a substantial product hazard. Thus, inadequate labeling or other product shortcomings will not be reportable unless they result in an increased risk of injury. It should be noted, however, that clear and convincing evidence of a potential hazard is unnecessary the statute requires reporting wherever a product defect could create a substantial risk of iiyury. 

A complaint (or otherwise) reported product defect or adverse event may be lead to the need for a recall. Any action taken to recall a product suspected or known to be defective or hazardous, should be prompt and in accordance with a predetermined plan. The procedures to be followed should be specified in writing and made known to all who may be concerned. 

The Consumer Products Safety Commission (CPSC) requires that manufacturers, importers, distributors, and retailers report product defects that could create a substantial hazard. CPSC must report failure to foUow its standards or bans of products. 

Risk-Based Inspection. Inspection programs developed using risk analysis methods are becoming increasingly popular (15,16) (see Hazard ANALYSIS AND RISK ASSESSMENT). In this approach, the frequency and type of in-service inspection (IS I) is determined by the probabiUstic risk assessment (PRA) of the inspection results. Here, the results might be a false acceptance of a part that will fail as well as the false rejection of a part that will not fail. Whether a plant or a consumer product, false acceptance of a defective part could lead to catastrophic failure and considerable cost. Also, the false rejection of parts may lead to unjustified, and sometimes exorbitant, costs of operation (2). Risk is defined as follows ... 

There are three major categories of filth and extraneous material that constitute contamination potentially hazardous, indicators of insanitation, and aesthetic defects (Zimmerman et al., 2003). Potentially hazardous material includes physical hazards such as hard or sharp objects, chemical hazards such as mites that can cause allergic reactions (Olsen, 1998), or insects that may carry food-borne diseases. Even if insects do not present a health hazard, the presence of insects as foreign matter in food is considered an indication of unsanitary conditions (Zimmerman et al., 2003). The presence of unsanitary conditions can be indicated by the presence of live or dead insects and by intact insects, fragments of insects, or insect products such as... 

The disinfection of drinking water has been rightly hailed as a public health triumph of the twentieth century. Before its widespread use, millions of people died from waterborne diseases. Now, people in developed nations receive quality drinking water every day from their public water systems. However, chemical disinfection has also produced an unintended health hazard the potential for cancer and reproductive and developmental effects (including early-term miscarriages and birth defects) that are associated with chemical disinfection by-products (DBFs) [1-6]. Research is being conducted worldwide to solve these important human health issues. 

Any concern producing a product which may be dangerous to life or property has a legal responsibility to indicate the potential hazard by use of warning labels or other protective methods. The manufacturer must supply safe shipping containers and make certain that any hazards involved in their handling or use are clearly indicated. Legal liability also holds for defective or misrepresented products. 

Paragraph 1 explains the rationale under which traceability is established. It should be noted here that all the stakeholders are expected to benefit from the introduction of the Article public authorities, because of facilitation of control, manufacturers and users of food contact products, who will benefit from recall and easier attribution of responsibility, and finally a stricter regulation of traceability would give additional reassurance to consumers. As stated above, the main reason for traceability procedures having been introduced by food contact materials producers was related to defective product recall, i.e., linked to potential technical failure of them, rather than health hazards (that are extremely unlikely). Therefore such a paragraph can be interpreted as a measure of prevention that is not deemed to bring extra safety factors to the final consumers. 

This product may be hazardous to your health. This product has been determined to cause birth defects in laboratory animals. 

The recall initiated by the National Pharmaceutical Administration as a result of an ADR report or QSP of registered medicinal products is classified either Class 1 or Class 2 recall depending on the potential hazard of the defective product. 

A Class 2 recall is initiated when the problem or defect is likely to cause less serious harm to users. Some examples of defects that will result in a Class 2 recall are failure to meet product specification or pharmacopoeial standards which are likely to cause minimal hazard to users, minor labelling errors, contamination of products with non-toxic substances, etc. The recall would be carried out within 48 hours of notification from the Ministry. 

This category must only be used for a defect which hazards the patient. For example a rogue printed component mixed within a batch of other products misidentifies and misinforms the user of its contents. This is an intolerable defect and a batch cannot be used until after a 100% fail safe sorting operation (if possible). 

Perhaps the most important provision of Section 15 is subsection (b), under which manufacturers, distributors or retailers of products that may present a substantial product hazard are required to submit reports to the Commission. Section 15(b) provides that companies must immediately inform the Commission when they obtain information which reasonably supports the conclusion that a product that they manufacture, distribute or retail either fails to comply with an applicable consumer product safety rule or contains a defect which could create a substantial product hazard. The only exception to this requirement is where the company involved has actual knowledge that the Commission has been adequately informed of such defect or failure to comply. ... 

Nitrate is usually added to the milk for some varieties of cheese. It is reduced to nitrite which inhibits the growth of Clostridium spp. responsible for late gas blowing and flavor defects. Nitrite is rapidly destroyed in cheese so that the finished product contains only trace levels which pose no hazard to consumers. The contribution by cheese to the total intake of nitrite is negligible (Renner, 1987). 

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