DEFECTS undesirable characteristic of a product; failure to conform to specifications (Cascabel, 2017) : Variable Defect Attribute Defect
Can be measured directly by instruments Cannot be measured directly by instruments
Critical Defect
May endanger life, property and may render the product non functional Example: absence of warning in a label f or a potent drug Renders the product useless Example: crack in a syrup bottle Does not endanger life, property nor will it affect the function, but nevertheless remains a defect, since it is outside the prescribed limits Example: slight deviation of the color of the label from the color standards
Major Defect Minor Defect
Ocular Defect Internal Defect Performance Defect
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Visible defects Example: foreign particulate contamination Not seen, although present Example: subpotent drug product Defect in function Example: suppository that does not melt at body temperature
Sources of Variation Source of Variation Materials
Machines
Methods
Men
Prepared by Manuzon
Examples Between suppliers of same substance Between batches from same supplier Variation within a batch Variation of equipment for the same process Difference in adjustment of equipment Aging and improper care Inexact procedures Inadequate procedures Negligence by chance Improper working conditions Inadequate training and understanding Dishonesty, fatigue and carelessness
