Labeling errors

Labeling Errors Cause Accidents, Safety Note No. DOE/EH-0328, U.S. Dept, of Energy, Washington, D.C., July 1993. 

This table can also be examined to identifr possible outliers. If, for example, sample 1 was labeled as an A. but all of its closest neighbors w-ere from class B. a labeling error is suspected. In Table 4.8 there are misclassifications of samples in the C and D classes, but the large number of errors is more an indication of overlap than outliers. It is possible that there multiple outliers, but outliers cease to be outliers when they are the majorin . 

Failed USP dissolution test requirements Microbial contamination of non-sterile products Lack of efficacy Impurities/degradation products Lack of assurance of sterility Lack of product stability Labeling Label error on declared strength Misbranded Promotional literature with unapproved therapeutic claims... 

This subpart covers one of the aspects of pharmaceutical production that has received much attention because of recalls, including an increase in recalls related to labeling errors or product mix-ups associated with the packaging and labeling operation. Specific requirements identified in this section recently include the following. 

A Class 1 recall is initiated when the problem or defect poses a life-threatening situation to users. Some examples of defects that might result in a Class 1 recall are injections which are tested to be nonsterile, contamination with toxic substances, major labelling errors, adulteration of products, etc. The recall would be carried out and completed within 24 hours of notification from the Ministry. 

To prevent packaging and labelling errors a known number of labelling and packaging units should be issued and, if required, coded. Such issuance should be made against a written, signed request that indicated the quantity and types required. 

Special attentions shall be directed at all stages to prevent packaging and labelling errors. 

The labelling of semi-packed products must be completed without delay after filling. Where this is impossible, a detailed procedures must be implemented in order to prevent mix-ups and. labeling errors. 

Measures which will help to avoid labeling errors include (a) Training staff in the special care needed in the handling... 

The next day, the Chief of Pathology called the trainee to enquire about the case. The specimen he received was labelled right hemivulvectomy and did not reveal any evidence of cancer. The pre-operative biopsies the pathologist had reviewed had been positive, however they were labelled left vulvar biopsy . He wondered if there had been a labelling error. 

Hollnagel (1993) labeled errors as erroneous actions and defined an error as an action which fails to produce the expected result and which therefore leads to an unwanted consequence. Probably the most widely recognized definition of human error was offered by Reason (1990, p. 9), who formally defined human error as a generic term to encompass all those occasions in which a planned sequence of mental or physical activities fails to achieve its intended outcome, and when these failures cannot be attributed to the intervention of some chance agency. ... 

To view design warnings, click on the tab labeled Errors/ Warnings located at the bottom left of the screen. If any projected performance parameters violate the Toray Design guidelines (based on the raw water type selected earlier), a warning will appear and corrective action is warranted. 

Packaging and labeling errors (wrong drug, wrong gas)... 

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