CHAPTER 10

WEIGHING AREA

Ref. 32

WHO

YES

NO

1

Section

11.19.

Is there a physically separated weighing area?

2

Sections11.4;

14.46(c) and

14.49.

Is there a SOP for the cleaning of the weighing area?

3

Section

11.4

Is the weighing area clean?

4

Section

11.5

Are the necessary precautions taken when working with photosensitive raw materials?

5

Sections11.19 and 15.10

Are special systems for the localized dust extraction available?

6

Sections

11.5 and

12.26

Is there a ventilation system with pressure differentials, and the raw materials handled with controlled temperature, humidity, and air filtration, if required?

7

Sections11.1;

12.12 and

13.7

Is there an area for the cleaning and sanitation of the containers with containing rawe divided?

8

Section

15.12(d).

Does it have its own change room, in case the area is not located in the production area?

9

Section 15.6 and 13.15

If orders which are already separated are not transferred to the plant immediately, is there a sector or system that prevents mix-ups?

Ref. 32

WHO

WEIGHING AREA

YES

NO

10

Are the containers containing raw materials to be weighed transferred safely to the weighing and measuring area?

10.1

Section

12.1

Are these containers cleaned before opening?

11

Section

4.1 and

15.12(e)

Is there a SOP for cleaning the tools/utensils used in weighing and/or measuring?

12

Section

4.1.

Are the tools/utensils for weighing and/or measuring clean?

13

Section

1.11

Is there an area for washing the tools/utensils used in weighing and/or measuring?

14

Sections

1.11 and

12.1

Are these tools/utensils kept clean and labeled in a safe place?

15

Section

12.5 and

15.22

Are the scales calibrated periodically?

15.1

Section

12.5 and

15.22

Are the scales checked on a defined scheduled basis?

15.2

Section

12.5 and

15.22

Are records kept?

15.3

Sections

12.5 and

12.22.

Do the capacity and sensitivity of the scales correspond with the quantities that are weighed?

16

Sections

10.21 and

10.23

Is protective equipment used when necessary?

17

Are containers of raw materials already weighed or measured closed well?

Ref. 32

WHO

WEIGHING AREA

YES

NO

18

Section

12.1

Are the containers used to weight or measure raw materials reused?

18.1

Sections

12.1;13.13 and15.11

If so, are they cleaned very well, free from any previous identification marks and newly

labeled?

19

Section

13.13

Are the materials, after being weighed or measured, immediately labeled in order to

prevent mix-ups?

20

On the label, does it state:

20.1

Name or code and batch of the item?

20.2

Name or code of the product to which the item is destined?

20.3

Product Batch number?

20.4

Section

13.14

Quantity that was weighed or measured?

20.5

Section

13.14

Gross weight and tare?

20.6

Section13.14.

Net weight?

20.7

Signature and date of the worker who carried out the operation?

20.8

Signature and date of weight verification?

21

Section

13.15

Are the raw materials of a batch, already weighed or measured, physically separated from those of another batch already weighed?

22

Are the containers that contain a raw material already weighed, transferred safely to the manufacturing area?

23

Section15.2

Is there a SOP that describes all the operations of this sector/area?