Products becoming suspect

CE Marking Directive 93/68/EEC states that the choice of conformity assessment procedures must not lead to a lowering of safety standards of electrical equip-ment/products, which have already been established throughout the Community. Alternatives to European standards are possible in the case where no European harmonized standard exists. Conformity to International standards (i.e., lEC) or European national standards (i.e., DIN, BS, NF) is sometimes an acceptable alternative, but in this case the manufacturer must be able to demonstrate conformity with the ERs of the directives and at the same time not fall below the minimum acceptable criteria. The General Product Safety Directive 92/59/EEC allows the use of EU national standards when no European harmonized standards exist. This alternative may be needed as a transitional measure until a European standard is published (see General Product Safety in Chapter 2). This approach is not recommended when European harmonized standards exist, especially if a product becomes suspect, since... 

Producers beware Placing the CE marking on a product informs users, competitors, and authorities that the producer is aware of the laws, standards, and consequences when a product becomes suspect. 

When a product becomes suspect the national enforcement authority will typically use the EN or equivalent national standards (usually with the help of a notified body) to evaluate the product s conformity or lack thereof. Taking any route other than the harmonized standards approach may work against diose who do not conform with the recognized standards, since compliance with these standards is universally recognized and expected by the enforcement authorities, notified bodies, and customers. 

European notified bodies (safety) and competent bodies (EMC) are accredited at the national level by the member states, such as in Germany at the European level accreditation occurs when notified to the Commission and listed in the Official Journal of the European Communities. These accredited bodies are sanctioned by the European Commission and the member states to interpret directives and standards, and issue test reports and certificates on conformity. When a product becomes suspect or an incident occurs, the national enforcement authority may consider a test report or certificate issued by a European body. Having the notified body mark, certificate, and test report usually shifts the onus of proof in the manufacturer s favor, since the product was evaluated and certified by European recognized experts. 

The objective is to manufacture and sell safe products and not waste time arguing with customers who challenge a product s conformity. Designing and certifying products to meet the EU regulations may be more profitable than the oftentimes endless discussions and meetings within a company about the possible benefits. In the end, it s the customer s safety concerns that wilt determine whether the product is a success. Also remember that when a product becomes suspect, enforcement authorities will most likely refer the product to a notified body for testing and assessment. 

If a product becomes suspect, enforcement authorities will most likely refer the product to a notified body for testing and assessment. 

Technical file. The manufacturer s technical documentation file supports the CE marking. The contents of a technical file generally include the declaration of conformity, name and address of manufacturer, product description and identification, list of standards and directives applied, design and schematic drawings, calculations, test reports, parts lists, manuals, and so on. Technical files must be readily available and may be requested by enforcement authorities for inspection purposes should a product become suspect or an incident occur. 

It is often the distributor, importer, or authorized representative who is first called to task if an incident occurs or a product s conformity becomes suspect ... 

Several antimicrobials have been banned or severely restricted by the EPA based on documented or suspected toxicity or environmental problems. Others have been discontinued in the face of testing costs required by the EPA reregistration program mandated by the Pederal Insecticide, Pungicide, and Rodenticide Act (PIPRA) of 1988 (10). Some of the significant products that have become obsolete are 2,4,5-trichlorophenol/P3 -5 3 -47, sodium... 

In informing your customer when nonconforming product has been shipped you obviously need to do this immediately you are certain that there is a nonconformity. If you are investigating a suspect nonconformity it only becomes a matter for reporting to your customer when the nonconformity remains suspect after you have concluded your investigations. Alerting your customer every time you think there is a problem will destroy confidence in your organization. Customers appreciate zeal but not paranoid personnel ... 

The limitation noted above, whereby reactions that are more than slightly endothermic do not occur owing to ion loss (hereafter referred to as the tool of no endothermic reactions ), can be used as an important mechanistic tool in the gas phase. If a reaction that is expected to be endothermic is observed to yield a product ion, then the structure of that product ion may not be as expected. An alternative use of this tool involves the employment of a series of structurally similar reactants for a given reaction. The structure of these can be varied in such a way as to make a given step in a suspected mechanism pass from exothermic to endothermic. If the observed product ion ceases to be produced for a situation where that step is expected to become endothermic, then this can be taken as evidence supporting the occurrence of the proposed mechanism. 

Because the objective of this process is the preservation of the lyophilized material, the presence of collapsed material is suspect. Collapse may simply be considered a cosmetic defect. When the collapsed material exhibits an increased reconstitution time or poor solubility, the presence of collapse becomes more than just a cosmetic defect. If, however, the collapsed material retains a higher amount of residual water, where this water becomes involved in degradation of the product through hydrolysis, then there is a more serious concern. The presence of a significant amount of residual water may promote degradation of the product, such that the assay falls outside of the compendial limits. There would also be a concern for the toxicity or an influence on the therapeutic effectiveness of the product. Both potential results should be considered during product development. 

The ability to monitor compounds related to the Chemical Weapons Convention has become an increasingly important issue in recent years. Sensitive analytical techniques are required for identifying chemical weapons at suspected attack sites and for monitoring alleged production facilities. Most chemical warfare (CW) agents degrade after... 

Concerns about deception and trust are at the heart of deliberations over what is considered ecologically clean when products are sold in commercial markets. Russian consumers who suspect that industrially produced and commercially marketed foods and beverages are tainted put their trust in nature instead. As one man in his late fifties commented, Here there is no kind of guarantee. Here no one is certain if foods have additives, if they are healthy or poisonous. And then it becomes clear, it turns out that at all the firms there is no one responsible. A married couple put it more simply in their comments that natural products were superior to anything industrially produced because it is impossible to deceive nature You cannot fool [or cheat] nature [prirodu ne obmanesh ] ... 

Penicillins should be avoided in any patient who gives a history of a skin reaction or anaphylaxis to any penicillin derivative. To prevent mild skin reactions becoming severe when they occur, it is advisable to withdraw the culprit antibiotic not only when a type I reaction is suspected but in aU kinds of common rashes, in view of a possible epider-moljdic process. A diet free of dairy products was curative in 30 of 70 patients with positive tests (170). 

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