Defects of Product

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