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level: Level 2

Questions and Answers List

Question	Answer
An undesirable characteristics of a product and therefore its failure to conform to specifications	DEFECTS
DEFECTS can be classified as	1 According to MEASURABILITY 2 According to SERIOUSNESS OR GRAVITY 3 According to NATURE MSN
Defect according to measurability	1 Variable defect 2 Attribute defect
can be measured directly by instruments (length, weight, height, thickness, concentration, pH, etc.)	Variable defect
cannot be measured directly by instruments (odor, color, clarity, cleanliness, taste, etc.)	Attribute defect
Defect according to seriousness or gravity	1 Critical defect 2 Major defect 3 Minor defect
Endanger life or property and may render product nonfunctional	Critical defect
Affect the function of objects and may render product useless	Major defect
Does not endanger life nor will it affect the function	Minor defect
Defect according to nature	1 Ocular defect 2 Internal defect 3 Performance defect
Visible; ex. Foreign particulate contamination	Ocular defect
Not seen but present; ex. Subpotent drug product	Internal defect
Defect in function; Ex. Suppository that does not melt at body temp.	Performance defect