Monday, June 17, 2013

What are critical, major and minor defects of a product ?



1.What are critical, major and minor defects of a product ?

Critical defect : Critical defect are those defect which can be life-threating & which require the company to take immediate action by all responsible means as soon as the defect becomes apart whether in or out of business hours.
Example : 1. Products labeled with incorrect name.
                 2. Counterfeit or deliberately tampered with product/
                 3. Microbiological contamination of a sterile product

Major defect : Major defect are those defects which may put the patient at some risk but. Which are not life-threating
Example : 1. Any labeling/leaflet misinformation which represents a significant hazard to the patient
                 2. Microbial contamination of non-sterile product with some risks.

Minor defect: Minor defect are those defects which present only a minor risk to the patient. Any batch recall or product withdrawal would normally be initiated a few days.
Example: 1. Readily visible isolated packing faults
                2. Contamination which may cause spoilage or dirt & where there is minimal risk to the patient

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