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CHAPTER 6

 

RETURNED PRODUCTS

 

Ref.

32ยบ WHO

 

 

YES

NO

 

1

Section

11.11 and

11.16

 

Is there an area that is physically separated and has restricted access for the storage of returned products until their fate is determined?

 

 

 

2

Section

13.30.

Are returned products properly identified as such?

 

 

 

3

Section

13.30

 

Is there an operating procedure that defines responsible persons and the criteria for the treatment of returned products?

 

 

 

4

Section

13.30

 

Does the qualified person responsible for the Quality assurance /Quality control

Department decide the treatment of these returned products?

 

 

 

 

5

Section

13.30

 

Are all actions and decision taken recorded?

 

 

 

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