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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|
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
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
Color different from approved sample
Bent connector pin on Holster
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.
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.
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
Cosmetic and visual failures which would not be
clearly visible to the customer when the product is in use.