Form-
385
Issue date:
Vendor Audit Questionnaire
(Ref. SOP
QMS
-
045
; QMS-
080
)
All information contained within this documen
t will be treated as
confidential
between the Supplier and
Buyer
.
File Location: Date Printed:
Page
8
of
9
Investigation of reject
ed material
Yes
No
N/A
Product complaints
Yes
No
N/A
Handling out of specification results
Yes
No
N/A
Are manual calculations checked by a second person?
Yes
No
N/A
Are data transcriptions checked by a second person?
Yes
No
N/A
Is all raw
-
data ret
ained?
Yes
No
N/A
Are all standards traceable to their preparation and the reagents used?
Yes
No
N/A
Are analytical methods validated?
Yes
No
N/A
Do you perform stability testing on materials and/or products?
Yes
No
N/A
If so, what shelf life / retest
dates are available for the referenced product(s)?
Do you perform annual product reviews or campaign reviews on
products?
Yes
No
N/A
Material Release
Is the decision to release/reject product made by a person or function
independent from productio
n?
Yes
No
N/A
Is the final status recorded?
Yes
No
N/A
Are certificates issued for each batch?
Yes
No
N/A
Are certificates signed by QA/QC?
Yes
No
N/A
If not, who signs certificates?
Is shelf life or retest dates or expiry date provided on the ³C of A ³ OR
³C of C¶s´
Yes
No
N/A
Is there a documented recall procedure?
Yes
No
N/A
Transport
Is a list of approved hauliers in use?
Yes
No
N/A
Is temperature controlled transports used?
Yes
No
N/A
If ³Yes´, are temperature records reviewed and retained
?
Yes
No
N/A
If bulk tankers are used, is a cleaning certificate required?
Yes
No
N/A
If bulk tankers are used, are they dedicated?
Yes
No
N/A
If not, what other substances could be transported in the tankers?