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AIDE MEMOIRE

1 = Yes ; 2 = No
AIDE N CHECK THE LIST OBSERVATION COMMENTARY
MEMOIRE O 1 2
How to recording and
1.
receiving products

2.
Whether the product
quality assurance
procedures are in place
properly
3.
How is the application of
product quality
assurance standards

4. How to evaluate the


adequacy of quality
assurance standards

5. How to design a sample


of quality procedures

Whether the quality


6.
review review is in line
with the planning

7. Is the quality efficiency


and inspection system as
planned

What is the monitoring


8.
of testing materials and
products to ensure the
quality of the finished
product

9. What is the execution of


the inspection of
materials and products
to ensure the quality of
the finished product
10. What is the activity of
documenting the internal
audit
AIDE N CHECK THE LIST OBSERVATION COMMENTRAY
MEMOIRE O 1 2
11. How to document other
quality assurance
activities
12.
How to investigate
customer complaints

13. How to investigate the


product mismatch
problem

14. Have statistical quality


data collected

15. Is the statistical quality


data set up correctly?

16. Is the protap,


specification and method
of analysis reviewed and
revised correctly

17. Is the handling of HULS


done according to the
protap and how the
documentation
18.
Whether qualified for
new equipment or
significant changes

19. Do all packaging


materials have
specifications

20. How to develop new


product formulations
AIDE N CHECK THE LIST OBSERVATION COMMENTRAY
MEMOIRE O 1 2
How to research new
21.
product formulations

22.
How to supervise the
production of raw
material product
development
23. How to control the
production section of
product development in
the warehouse

24. How to control product


quality by testing the
final product
25.
How to list the records
during the supervision
process

26. How to document


complaints from
consumers if there is a
procedural error

27. How to list the records in


an effort to maintain the
quality of raw materials

28. Does QA have conducted


quality control properly

Does QA have done


29. quality control according
to protab

How to supervise QA on
30.
the part of research and
development
AIDE N CHECK THE LIST OBSERVATION COMMENTRAY
MEMOIRE O 1 2
How to document
31.
monitoring of corrective
action and prevention

32. How QA works in the


management of risk
management activities
33. What is the QA
responsibility for the
document management
system

34.
How to establish quality
and industry regulatory
requirements documents

35. Is there any training for


QA employee acceptance

Do QA employees have
36.
auditor quality

Is there any employee


37.
training especially
regarding the CPOB and
protab

38. Is there any employee


training especially
regarding CPOB and
Protap

39. Is there a Job description


for all employees in this
area

40. Is there a training record


for all employees
AIDE N CHECK THE LIST OBSERVATION COMMENTRAY
MEMOIRE O 1 2
41.
Is there an annual
training program

42. Do employees look neat,


and clean

43. How knowledge


Employees about the
SOP there is Protap

44. Is there any protap where


necessary?

45.
Is Protap reviewed and
revised regularly

46. Is there any protap


receipt of starting
materials and packing
materials

47. Is there coffee from the


Approved Supplier List

48. Is there a system to


prevent acceptance of
material from
unapproved suppliers

49. Is there a checklist


Receipt of materials

50. Is filled according to the


examination and recorded
all discrepancies