The purpose of this procedure is to define and document the methodologies for material inspection and acceptance activities for IR laser illuminator in Tyson. General inspection level II, tightened inspection tables are used for the incoming inspection process and the out of box audit unless otherwise stated in the relevant PQPs or this document, refer to below Table A for details.
| General Description / Classification | Examples |
Critical Defect Not Allowed A defect, which could result in hazardous or unsafe conditions for individuals using or maintaining the product as well as defects contravening legal regulations. (i) Safety risk to the end user (ii) Cause a product recall | Product mix up issue |
Functional Major Defects A defect, which if undetected will result in a failure of the product to function when operated per the User Instruction Manual These defects could result in a functional problem with product | Electronic failures resulting in error messages. Electrical part test failure Missing components from IR laser illuminator Faulty lead connections. |
| Non-functional Major Defects A defect, which if undetected will result in a failure of the product to function when operated per the User | Dimensional failures Color different from approved sample Bent connector pin on Holster Missing accessories |
Instruction Manual These defects could result in a (i) A problem with identification and or traceability. (ii) A visual defect if detected by the customer will result in a loss in customer satisfaction but may not impact on the correct functioning of the device. | Missing literature Incorrect product labelling or literature Missing and or incorrect label or label position. Incorrect part numbers and revision details on literature and packaging Illegible labels or literature. Torn labels Ripped or torn Gel Packs Cosmetic failures that would be clearly visible to the customer when the product is in use i.e. marks and scratches on stains, fraying |
Minor Defects 2.5 AQL A defect that is unlikely to be detected by the user and has no impact on the functionality of the product | Damaged packaging. Cosmetic and visual failures which would not be clearly visible to the customer when the product is in use. |
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