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?
|
|
|