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New version quality procedure release

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 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.

Dimensional failures

Color different from approved sample

Bent connector pin on Holster

Missing accessories

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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