Recall of products

The nature of the complaint dictates the appropriate response, which could range from a conciliatory letter ( I am sorry you do not like our product... ) to a full public recall of product and cessation of production until a fault is resolved (for example a major incident of fermentation in a glass bottled product). In all cases the cycle of events must be to understand the problem, to identify the cause, to decide the response and then to take appropriate action. 

Health Canada, the Canadian health regulatory agency, requested a voluntary recall of products containing both natural and chemical ephedra. 

The United States is not the only country concerned about the safety of ephedra. Health Canada, the Canadian health regulatory agency, requested a voluntary recall of products containing both natural and chemical ephedra in 2002, because it received 60 reports of adverse events related to ephedra use. 

The QAP is a proactive tool that can be used to assess the potential impact of information from one system on another. An ineffective or inefficient customer complaint-handling process is not only a reflection of the company from the customer s perspective but quickly becomes a regulatory concern. This could ultimately result in the recall of product from the market and affect the public image of the company. An effective recall prevention program is closely linked to an effective QAP that consistently identifies deficiencies in customer complaint handling and expeditiously corrects them. (Fig.l). 

Failure to comply with current GMP may result in a number of sanctions from the regulatory authorities, up to and including recall of product from the marketplace and withdrawal of manufacturing... 

Increased manufacturing costs for refund/replacement of damaged products and recall of products with potentially compromised sterility or integrity. 

Research by consumer organisations in Europe (and USA) and the results of the market surveillance authorities have shown that a substantial number of products are not safe, notwithstanding the New Approach and the efforts of industry to convince the consumers that industry acts in a responsible way. Currently recalls of products are relatively commonplace. This is partly due to inadequacies in the standards, but in most cases it is caused by failures in the operation of the manufacturing process (Gundlach, 1999). 

The Consumer Product Safety Act of 1972 created an independent 5-member Consumer Product Safety Commission and empowered it to promulgate standards and labeling requirements reasonably necessary to protect consumers from unreasonable risks posed by the products subject to its jurisdiction. The statute contained a novel procedural device, called the offeror process, under which consumer groups or companies could offer to draft standards to address particular product hazards and the agency could then use the draft as the basis for a rulemaking. It further empowered CPSC to ban dangerous products when standards would not adequately protect the public and to order recalls of products that presented a substantial product hazard. ... 

It would be considered prudent to prohibit the premature release of product if you did not have an adequate traceability system in place. If in fact any nonconformities in a component will be detected by the end product tests, it may be worth allowing production to commence without the receipt tests being available, in which case the tests will only be confidence checks and not verification checks. If only one product is received and released prior to verification one would think that, as the requirement applies prior to verification, there is no need to positively identify the product to permit recall because you would know where it was if you found it to be nonconforming. However, the nonconformity may have been reported to you by the supplier after delivery. The standard does not stipulate when and by whom the nonconformity may have been detected. If you lose the means of determining conformity by premature release, don t release the product until you have verified it is acceptable. 

Sometimes we need to know how much product to expect from a reaction, or how much reactant we need to make a desired amount of product. The quantitative aspect of chemical reactions is the part of chemistry called reaction stoichiometry. The key to reaction stoichiometry is the balanced chemical equation. Recall from Section H that a stoichiometric coefficient in a chemical equation tells us the relative amount (number of moles) of a substance that reacts or is produced. Thus, the stoichiometric coefficients in... 

A system must be established to thoroughly investigate all complaints. Ifthe situation so demands, there must be procedures in place to effectively recall a product from the market. This requires the retention of distributor contact details and precise distribution records so that the destination of each shipment can be determined. 

The regulatory authorities must be informed of any planned recall actions (see Chapter 12). Procedures are also required for emergency un-blinding of materials undergoing clinical trial. The responsibility for complaints and the initiation of product recalls should be assigned to designated individuals. 

The urgent variation, suspension or withdrawal of the marketing authorisation or recall of the product from the market. 

Recall that the numerator of Q contains concentrations of products, and the denominator contains concentrations of reactants, all raised to powers equal to their stoichiometric coefficients. Solvents and pure solids and liquids do not appear in the concentration quotient. Thus, only solutes and gases appearing in the cell reaction affect its cell potential. Nevertheless, most cell reactions involve solutes, so a typical cell potential differs from E °. Example... 

On further investigation by an internal FDA task force, the following recall definitions were established in 1973, which seemed to better define the types of product defects that currently are being found. The recalls are now divided into the following three classes. 

Only after QC personnel are satisfied that the product meets these specifications will it be labelled and packed. These operations are highly automated. Labelling, in particular, deserves special atten-tioa Mislabelling of product remains one of the most common reasons for product recall. This can occur relatively easily, particularly if the facility manufactures several different products, or even a single product at several different strengths. Information presented on a label should normally include ... 

Taco Bell and other food companies recalled 300 products (150 brands of corn chips, taco shells, corn dogs, corn bread, breakfast cereals and polenta), but decided to continue selling taco shells obtained from the same supplier. 

Problem definition A colleague from the cookies product development department of your company has come to your office to describe what appears to be a significant business issue. Complaints of an off-flavor in your chocolate chip cookies, sold throughout the country, are being reported. Samples of the product are being shipped from the plant by overnight air. Production has been stopped. A recall of all product is under consideration Identification of the off-flavor and its cause are now your top priority ... 

The Safe Medical Devices Act requires reporting of medical devices that probably caused the death, serious filness, or injury of a patient. Postmarket surveillance on permanently implanted devices required with methods for tracing and locating patients depending on such devices. FDA is authorized to recall device product. 

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