Oq Faw1005

OQ_IV_01
FAW 1005, 52554

Table of Contents
1.
Table of Contents
Bausch + Strbel Installation and Operational Qualification
Volume 3 Operational Qualification

1.
Table of Contents
2.
Alarm Tests
2.1 Test Procedure for Alarm Tests
2.2 Alarm Tests
3.
2.2.1
Protocol Overview for Alarm Tests
2.2.2
Protocols for Alarm Tests
Functional Tests
3.1 Test Procedure for Functional Tests
3.2 Functional Tests
4.
3.2.1
Protocol Overview for Functional Tests
3.2.2
Protocols for Functional Tests
Functional Tests of the Operating Panel

4.1 Test Procedure
4.2 Operating Panel Tests
4.2.1
Operating Panel Test (German Version)
4.2.2
Operating Panel Test (English Version)
OQ_AT_01
FAW 1005, 52554
Alarm Tests
2.
Alarm Tests
2.1
Test Procedure for Alarmtests
Protocol for alarm tests

Alarm tests (e.g. 1010 Schutzschalter ausgelst / Protection switch triggered) establish whether
or not the machine displays the corresponding fault message on the operating panel and makes the
corresponding predetermined reaction.
Alarm tests must be performed as follows:
a) All conditions under the point Prerequisites must be fulfilled or established.
b) Carry out the tasks described under the point Action.
c) When the action described has been performed, the machine must fulfill all the
points listed under the point Acceptance Criteria (Acceptance criterion No.1).
d) All the operations described under b) are now reversed with the help of the procedures described under the point Action, in order to return to the original condition
of the machine again.
e) With the help of the procedure described under the point Acknowledgment try to
clear the fault message now that the cause of the fault has been corrected.
f) After attempting to clear the fault the machine must exhibit all the reactions listed
under the point Acceptance Criteria (if fault is corrected) (Acceptance criterion
No. 2). The machine should now be ready to run or running.
g) The results of a positive test are recorded and signed by the tester to confirm that
the test has been carried out and that all the acceptance criteria have been met.
h) If a negative test result is recorded and signed by the tester, it confirms that the test
has been carried out, but that certain acceptance criteria were not met. A change
log must be added describing further action to be taken. A reference to the change
log should be made in the section Remarks.
Page 1 of 46
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FAW 1005, 52554
Alarm Tests
2.2
Alarm Tests
2.2.1
Protocol Overview for Alarm Tests
Page
Alarm Message
1010 Schutzschalter ausgelst /

Protection switch triggered (43Q5)

Protection switch triggered (3F2)


10

11

12

13

14
1110 berlast Hauptantrieb /

Overload main drive
15
1130 berlast Verkleidung /

Overload machine guard
16
1465 Strung Hauptantrieb /

Fault: main drive
17
3000 NOT-AUS bettigt /

Emergency stop button pressed
18
3050 berlast Ausschieber (Drehbewegung) /

Overload discharge pusher
19
3050 berlast Ausschieber (Schubbewegung) /

Overload discharge pusher
20
3060 berlast Einschieber /

Overload infeed pusher
21
3300 Verkleidung offen /

Guard open (14S3)
22
3601 Positionierzeit abgelaufen /

Positioning time exceeded
Page 2 of 46
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Alarm Tests
Page
Alarm Message
23
3670 Schaltgetriebe entriegelt /

Gear shift unlocked
24
3671 Stellung Schaltgetriebe prfen /

Check gear setting
25
3730 Objekte nicht ausgewaschen /

Containers not rinsed
26
3731 Objekte nicht ausgeblasen /

Containers not blow-cleaned
27
3821 Einlaufschnecke ausgerastet /

Infeed scroll disengaged
28
4851 Wassermangel UST /

Water shortage in UST
29
4870 Druck Medium 1 Druckluft zu niedrig /

Pressure medium 1 compressed air
30
4871 Druck Medium 2 UST-Wasser zu niedrig /

Pressure medium 2 UST water
31
4875 Druck Medium 6 Steuerluft /

Pressure medium 6 control air
32
4882 Druck M 4 Desti-Wasser zu niedrig /

Pressure medium 4 WFI water
33
4900 Maschinenleistung zu hoch /

Machine speed too high
34
5207 berwachung Objekt zhlen /

Error: counter
35
5284 berw. Druckerf. M4 DESTI-Wasser /

Error: press. sens. M4 dist.wat
36
5285 berw. Druckerfassung M1 Druckluft /

Error: press. sen. M1 compressed air
37
5286 berw. Druckerfassung M2 UST-Wasser /

Error: press. sens. M2 UST water
38
5324 Strung PROFIBUS (Bedienterminal) /

Fault PROFIBUS (slave 4)
39
5324 Strung PROFIBUS (Shaft Encoder) /

40
5324 Strung PROFIBUS (Frequency converter) /

41
5413 Str. Kommunik. nachgesch. Masch. /

Communication fault machine downstream
42
7500 Objektmangel Einlauf /

Too few containers at infeed
Page 3 of 46
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Alarm Tests
Page
Alarm Message
43
7650 Objektstau Tunnel /

Too many containers at tunnel
44
7721 Nachgeschaltete Maschine nicht bereit /

Machine downstr. not ready
45
9000 Steuerspannung aus (Not-Aus bettigen) /

Control voltage off
46
9122 Systemfehler /
System fault
Page 4 of 46
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Alarm Tests
2.2.2
Protocols for Alarm Tests
The Alarm Test protocols are completely described and done according to Bausch+Strbel
Qualification standard.
The alarm tests were performed with program version (PLC program)
P52554
The alarm tests were performed with program version (operating panel)
B52554
Page 5 of 46
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Alarm Tests
1010
Schutzschalter ausgelst /
Protection switch triggered
References:
Internal Order
Prerequisites:
1) Machine in operation
Action:
Activate protection switch 43Q5
Y
e
s
j j
Acceptance Criteria: 1) Message appears
j j
2) Machine stops
j j
3) Machine can not be started (after acknowledgement)
j j
Action:
Switch on protection switch 43Q5 again
Acknowledgement:
Clear fault in set-up mode
Acceptance Criteria: 1) Message disappears
j j
2) Machine ready for operation
j j
Test result was successfully achieved:
Examiner: Michael Hopf

Remarks:
N
o
Date:
( YES / NO *)
Signature:
* If test result NO then see Deviation sheet No.:

(Volume 1, Chapter 5)
Page 6 of 46
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Alarm Tests
1010
References:
Internal Order
Prerequisites:
Action:
Activate protection switch 3F2
Y
e
s
j j
j j
2) Machine stops
j j
j j
Action:
Switch on protection switch 3F2 again
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 7 of 46
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Alarm Tests
1010
References:
Internal Order
Prerequisites:
Action:
Y
e
s
j j
j j
2) Machine stops
j j
j j
Action:
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 8 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
1010
References:
Internal Order
Prerequisites:
Action:
Y
e
s
j j
j j
2) Machine stops
j j
j j
Action:
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 9 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
1010
References:
Internal Order
Prerequisites:
Action:
Y
e
s
j j
j j
2) Machine stops
j j
j j
Action:
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 10 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
1010
References:
Internal Order
Prerequisites:
Action:
Y
e
s
j j
j j
2) Machine stops
j j
j j
Action:
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 11 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
1010
References:
Internal Order
Prerequisites:
Action:
Y
e
s
j j
j j
2) Machine stops
j j
j j
Action:
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 12 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
1010
References:
Internal Order
Prerequisites:
Action:
Y
e
s
j j
j j
2) Machine stops
j j
j j
Action:
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 13 of 46
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Alarm Tests
1110
berlast Hauptantrieb /
Overload main drive
References:
Internal Order
Prerequisites:
Action:
Block main drive 19M1
Y
e
s
j j
j j
2) Machine stops
j j
3) Machine can be started (after acknowledgement)
j j
Action:
Dont block main drive any longer
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 14 of 46
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Alarm Tests
1130
berlast Verkleidung /
Overload machine guard
References:
Internal Order
Prerequisites:
Action:
Open machine guard

Block drive 22M3 for the machine guard
Y
e
s
j j
j j
2) Drive for the machine guard stops
j j
3) Drive for the machine can be started (after acknowledgement)
j j
Action:
Dont block drive any longer
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 15 of 46
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Alarm Tests
1465
Strung Hauptantrieb /
Fault: main drive
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Press Stop button at converter 19U1
j j
j j
2) Machine stops
j j
j j
Action:
Press Start button at the converter
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 16 of 46
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Alarm Tests
3000
NOT-AUS bettigt /
Emergency stop button pressed
References:
Internal Order
Prerequisites:
Action:
Press emergency stop button 12S7
Y
e
s
j j
j j
2) Machine stops
j j
j j
Action:
Unlatch emergency stop
Acknowledgement:
Switch on control voltage
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

y<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<yyyyyyyyyy<<qqa<aaaa
Page 17 of 46
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Alarm Tests
3050
berlast Ausschieber (Drehbewegung) /

Overload discharge pusher (rotary movement)
References:
Internal Order
Prerequisites:
Action:
Disconnect plug at sensor 36B3
N
o
j j
j j
2) Machine stops
j j
j j
Action:
Reconnect sensor again
Acknowledgement:
Clear fault
j j
j j

Remarks:
Y
e
s
Date:
( YES / NO *)
Signature:

Page 18 of 46
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Alarm Tests
3050
berlast Ausschieber (Schubbewegung) /

Overload discharge pusher (pushing movement)
References:
Internal Order
Prerequisites:
Action:
N
o
j j
j j
2) Machine stops
j j
j j
Action:
Acknowledgement:
Clear fault
j j
j j

Remarks:
Y
e
s
Date:
( YES / NO *)
Signature:

Page 19 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
3060
berlast Einschieber /
Overload infeed pusher
References:
Internal Order
Prerequisites:
Action:
Y
e
s
j j
j j
2) Machine stops
j j
3) Machine can not be started
j j
Action:
Acknowledgement:
Clear fault
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 20 of 46
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Alarm Tests
3300
Verkleidung offen /
Guard open
References:
Internal Order
Prerequisites:
Action:
Open guard 14S3
Y
e
s
j j
j j
Action:
Close guard
Acknowledgement:
j j
Remarks:
Date:
( YES / NO *)
Signature:

Page 21 of 46
j j
j j
N
o
OQ_AT_01
FAW 1005, 52554
Alarm Tests
3601
Positionierzeit abgelaufen /
Positioning time exceeded
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Disconnect plug (at terminal U, V, W) from frequency converter

19U1
Start machine
Stop machine again
j j
Acceptance Criteria: 1) Message appears after 20 sec.
j j

Action:
Switch off machine

Reconnect plug (at terminal U, V, W) from frequency converter
19U1 again
Switch on main switch
Acknowledgement:
Clear fault
j j
Remarks:
Date:
( YES / NO *)
Signature:

Page 22 of 46
j j
j j
N
o
OQ_AT_01
FAW 1005, 52554
Alarm Tests
3670
Schaltgetriebe entriegelt /
Gear shift unlocked
References:
Internal Order
Prerequisites:
Action:
Disconnect sensor 25B2
Y
e
s
j j
j j
2) Machine stops
j j
j j
Action:
Reconnect sensorr 25B2 again
Acknowledgement:
Automatically
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 23 of 46
OQ_AT_01
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Alarm Tests
3671
Stellung Schaltgetriebe prfen /

Check gear setting
References:
Internal Order
Prerequisites:
1) Machine ready operation
Action:
Chang the size datas at the operating panel
Y
e
s
j j
j j
Action:
Compare the size datas at the operating panel with the size datas at the machine. Both size datas must be the same.
Acknowledgement:
Clear fault
j j
Remarks:
Date:
( YES / NO *)
Signature:

Page 24 of 46
j j
j j
N
o
OQ_AT_01
FAW 1005, 52554
Alarm Tests
3730
Objekte nicht ausgewaschen /

Containers not rinsed
Y
e
s
N
o
References:
Internal Order
Prerequisites:
j j
2) Switch status Wash/Blow clean containers ON (M050)
j j
Action:
Press emergency stop button, when the cleaning needles are in

low position
Rotate main drive manually with the hand wheel, till the fault
message appears
j j
Action:
Unlatch emergency stop button
Acknowledgement:
Clear fault
j j
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 25 of 46
j j
OQ_AT_01
FAW 1005, 52554
Alarm Tests
3731
Objekte nicht ausgeblasen /

Containers not blow-cleaned
Y
e
s
N
o
References:
Internal Order
Prerequisites:
j j
2) Switch status Wash/Blow clean containers ON (M050)
j j
Action:
Press emergency stop button, when the cleaning needles are in

low position
Rotate main drive manually with the hand wheel, till the fault
message appears
j j
Action:
Unlatch emergency stop button
Acknowledgement:
Clear fault
j j
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 26 of 46
j j
OQ_AT_01
FAW 1005, 52554
Alarm Tests
3821
Einlaufschnecke ausgerastet /
Infeed scroll disengaged
Y
e
s
N
o
References:
Internal Order
Prerequisites:
j j
2) Set machine speed to 10 %
j j
Action:
Pull disengagement lever, so that the scroll disengaged
j j
2) Machine stops
j j
j j
Action:
Release disengagement lever, so that the scroll engages
Acknowledgement:
Clear fault
j j
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 27 of 46
OQ_AT_01
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Alarm Tests
4851
Min. Niveau UST unterschritten /

Water shortage in UST
Y
e
s
N
o
References:
Internal Order
Prerequisites:
j j
2) The button for refilling UST is switched on
j j
Action:
Empty UST
Or move float switch 42S2 UST or lowest end stop (attention
hot water !)
Action:
j j
2) Machine stops
j j
3) UST is filled with water
j j
j j
Fill UST
Or release float switch
Acknowledgement:
Clear fault
j j
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 28 of 46
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Alarm Tests
4870
Druck Medium 1 Druckluft zu niedrig /

Pressure medium 1 compressed air
References:
Internal Order
Prerequisites:
Action:
Stop the pressure supply for M1 compressed air

Start machine
N
o
j j
j j
2) Machine stops
j j
j j
Action:
Dont stop the pressure supply for M1 compressed air any longer
Acknowledgement:
Clear fault
j j
j j

Remarks:
Y
e
s
Date:
( YES / NO *)
Signature:

Page 29 of 46
OQ_AT_01
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Alarm Tests
4871
Druck Medium 2 USTWasser zu niedrig /

Pressure medium 2 UST water
References:
Internal Order
Prerequisites:
Action:
Set the lower limit pressure medium 2 to 5 bar (window M043)

Start machine
N
o
j j
j j
2) Machine stops
j j
j j
Action:
Set lower limit pressure medium 2 to initial value
Acknowledgement:
Clear fault
j j
j j

Remarks:
Y
e
s
Date:
( YES / NO *)
Signature:

Page 30 of 46
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Alarm Tests
4875
Druck Medium 6 Steuerluft zu niedrig /

Pressure medium 6 control air
References:
Internal Order
Prerequisites:
Action:
Turn off compressed air slowly until the pressure, displayed on

the pressure reducer, reaches approx. 5,2 bar
N
o
j j
j j
2) Machine stops
j j
j j
Action:
Turn on compressed air again
Acknowledgement:
Clear fault
j j
j j

Remarks:
Y
e
s
Date:
( YES / NO *)
Signature:

Page 31 of 46
OQ_AT_01
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Alarm Tests
4882
Druck Medium 4 DESTIWasser zu niedrig /

Pressure medium 4 DESTI water
References:
Internal Order
Prerequisites:
Action:
Set the lower limit pressure medium 4 to 5 bar (window M043)

Start machine
N
o
j j
j j
2) Machine stops
j j
j j
Action:
Set lower limit pressure medium 4 to initial value
Acknowledgement:
Clear fault
j j
j j

Remarks:
Y
e
s
Date:
( YES / NO *)
Signature:

Page 32 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
4900
Maschinenleistung zu hoch /
Machine speed too high
Y
e
s
N
o
References:
Internal Order
Prerequisites:
j j
2) Set machine speed to 100%
j j
Action:
Set in M 042 the size value Container/cycle to 6

Start machine
j j
2) Machine stops
j j
j j
Action:
Set the size value Container/cycle to initial value
Acknowledgement:
Clear fault
j j
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 33 of 46
OQ_AT_01
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Alarm Tests
5207
berwachung Objekte zhlen /

Error: counter
References:
Internal Order
Prerequisites:
Action:
Cover sensor 36B2

Start machine
Y
e
s
j j
j j
2) Machine stops
j j
j j
Action:
Remove cover
Acknowledgement:
Clear fault
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 34 of 46
OQ_AT_01
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Alarm Tests
5284
berw. Druckerfassung M4 DESTI-Wasser /

Error pressure sens. M4 dist.-water
References:
Internal Order
Prerequisites:
Action:
Disconnect plug at pressure transducer 33B7
N
o
j j
j j
2) Machine stops
j j
j j
Action:
Reconnect plug at pressure transducer 33B7
Acknowledgement:
Clear fault
j j
j j

Remarks:
Y
e
s
Date:
( YES / NO *)
Signature:

Page 35 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
5285
berw. Druckerfassung M1 Druckluft /

Error: press. sens. M1 compressed air
References:
Internal Order
Prerequisites:
Action:
N
o
j j
j j
2) Machine stops
j j
j j
Action:
Acknowledgement:
Clear fault
j j
j j

Remarks:
Y
e
s
Date:
( YES / NO *)
Signature:

Page 36 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
5286
berw. Druckerfassung M2 USTWasser /

Error: press. sens. M2 UST water
References:
Internal Order
Prerequisites:
Action:
N
o
j j
j j
2) Machine stops
j j
j j
Action:
Acknowledgement:
Clear fault
j j
j j

Remarks:
Y
e
s
Date:
( YES / NO *)
Signature:

Page 37 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
5324
Strung PROFIBUS /
Fault PROFIBUS
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Disconnect plug X1 for the voltage supply at operating panel

12A1
Reconnect plug again after approx. 10 sec.
j j
Acceptance Criteria: 1) Message appears after reconnecting from plug X1

(in window M883 the faulty slave is shown,
here: 00000 00000 00000 01000 )
j j
2) Machine stops
j j
j j
Action:
None
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 38 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
5324
Strung PROFIBUS /
Fault PROFIBUS
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Disconnect PROFIBUS connection from cam controller 11B3
N
o
j j
Acceptance Criteria: 1) Message appears (in window M883 the faulty slave is shown, j j
here: 00000 00000 00000 10000 )
2) Machine stops
j j
j j
Action:
Reconnect PROFIBUS connection again
Acknowledgement:
j j
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 39 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
5324
Strung PROFIBUS /
Fault PROFIBUS
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Disconnect PROFIBUS connector at frequency converter 19U1
N
o
j j
Acceptance Criteria: 1) Message appears (in window M883 the faulty slave is shown, j j
here: 00000 00000 00001 00000 )
2) Machine stops
j j
j j
Action:
Reconnect plug again
Acknowledgement:
j j
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 40 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
5413
Str. Kommunikation nachfolgende Maschine /

Communication fault machine downstream
References:
Internal Order
Prerequisites:
Action:
Disconnect plug 6X4.2 at PLC-CPU 6A4
N
o
j j
j j
2) Machine stops
j j
j j
Action:
Reconnect plug again

Clear fault at tunnel
Acknowledgement:
Clear fault
j j
j j

Remarks:
Y
e
s
Date:
( YES / NO *)
Signature:

Page 41 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
7500
Objektmangel Einlauf /
Too few containers at infeed
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Activate sensor 23B2 with the pusher (no containers at infeed)
j j
j j
2) Machine stops
j j
Action:
Allow containers into the infeed (pull pusher back)
Acknowledgement:
Automatically
j j
2) Machine starts automatically
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 42 of 46
N
o
OQ_AT_01
FAW 1005, 52554
Alarm Tests
7650
Stau Tunnel /
Too many containers at tunnel
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Activate accumulation switch 39B2 at the FVF infeed
j j
j j
2) Machine stops
j j
Action:
Dont activate the accumulation switch any longer
Acknowledgement:
Automatically
j j
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 43 of 46
N
o
OQ_AT_01
FAW 1005, 52554
Alarm Tests
7721
Nachg. Maschine nicht bereit /

Machine downstr. not ready
Y
e
s
N
o
References:
Internal Order
Prerequisites:
j j
2) DHT in operation
j j
Action:
Switch off tunnel conveyor belt
j j
2) Machine stops
Action:
Switch on tunnel conveyor belt
Acknowledgement:
Clear fault
j j
j j
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 44 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
9000
Steuerspannung aus /
Control voltage off
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Press emergency stop button 12S7
j j
j j
2) Machine stops
j j
j j
Action:
Unlatch emergency stop
Acknowledgement:
j j
j j

Remarks:
N
o
Date:
( YES / NO *)
Signature:

Page 45 of 46
OQ_AT_01
FAW 1005, 52554
Alarm Tests
9122
Systemfehler /
System fault
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Connect programming unit to the PLC

Set the symbol bte.fe_nr (DB8.DBW440) with the value 9999
under observe and change variable
j j
j j
Action:
Disconnect programming unit
Acknowledgement:
Push Change button approx. 10 sec. in window M882 in set-up

mode
j j
Remarks:
Date:
( YES / NO *)
Signature:

11
Page 46 of 46
j j
j j
N
o
OQ_FT_01
FAW 1005, 52554
Functional Tests
3.
Functional Tests
3.1
Test Procedure for Functional Tests
Protocol for function tests

Functional tests (e.g. Inspection of label fixing) test the operation of the machine i.e. whether the
machine fulfills the criteria specified by the test.
Functional tests must be performed as follows:
a) All conditions under the point Prerequisites must be fulfilled or established.
b) Carry out the tasks described under the point Action.
c) When the action described has been performed, the machine must fulfill all the criteria specified under the point Acceptance Criteria .
d) The results of a positive test are recorded and signed by the tester to confirm that
the test has been carried out and that all the acceptance criteria have been met.
e) If a negative test result is recorded and signed by the tester, it confirms that the test
has been carried out, but that certain acceptance criteria were not met. A change
log must be added describing further action to be taken. A reference to the change
log should be made in the section Remarks.
Page 1 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests
3.2
Functional Tests
3.2.1
Protocol Overview for Functional Tests
Page
Test Description
Acceptance Criteria
Loss of power
After restart the machine must go into

normal production without any problems
Transport system with container no.1
All containers must be processed during a

test run without any troubles (no fallen,
jammed or scratched containers, and not
too few containers at infeed or too many
containers at discharge caused by defects )
(2R vial 16x35 mm)
Without any trouble there can be reached

an output about min. 7200 pcs/h

(10R vial 24x45 mm)


(50H vial 42,5x73 mm)

Main Drive
The main drive can be started and stopped at the operating panel and can be
adjusted between 10% 100%
Infeed Belt
The infeed belt can be started and stopped at the operating panel and can be
adjusted between 10% 100%
10
Drive for machine guard
The machine guard can be opened and

closed at the operating panel
11
Level control UST
The float switch at the UST controls the

filling level in the UST correctly
Counter check for vials
The shown value of the counters must be

correct
12+
13
Page 2 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests
3.2.2
Protocols for Functional Tests
The Functional Test protocols are completely described and done according to
Bausch+Strbel Qualification standard.
The functional tests were performed with program version (PLC program)
P52554
The functional tests were performed with program version (operating panel)
B52554
Page 3 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests
Loss of power
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Switch off main switch

Switch on main switch after approx. 5 sec. again
Carry out all statements which were displayed at the operating
panel + written in the operating manual
N
o
j j
Acceptance Criteria: After switching on the main switch:

1) The PLC must run-up to normal status (operation mode)
j j
2) All status which were switch on before loss of power must be

the same status
j j
3) The counters must show the correct values
j j
4) The size values must show the correct values
j j
5) It is possible to start with production again
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 4 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests

References:
Internal Order
Prerequisites:
Action:
During a test run with container no. 1 (2R vials 16x35 mm) all
containers must be processed without any troubles:
Y
e
s
N
o
j j
1) No fallen containers
2) No broken glass
3) No jammed or scratched containers
4) Not too few containers at infeed or too many containers at
discharge caused by defects
Acceptance Criteria: All containers must be processed during a test run without any
troubles (no fallen containers, no broken glass, and no jammed
or scratched containers, not too few containers at infeed or too
many containers at discharge caused by defects)
5) from the transport belt into the transport grippers
j j
6) the containers will be positioned correctly over the cleaning

needles
j j
7) from the transport grippers into the discharge
j j
8) during a test run without any trouble there can be reached an j j

output from min. 7200 pcs/h
Examiner: Andreas Plank

Remarks:
Date:
( YES / NO *)
Signature:

Page 5 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests

References:
Internal Order
Prerequisites:
Action:
During a test run with container no. 2 (10R vials 24x45 mm) all
containers must be processed without any troubles:
Y
e
s
N
o
j j
2) No broken glass
j j

needles
j j
j j


Remarks:
Date:
( YES / NO *)
Signature:

Page 6 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests

References:
Internal Order
Prerequisites:
Action:
During a test run with container no. 3 (50H vials 42,5x73 mm)
all containers must be processed without any troubles:
Y
e
s
N
o
j j
2) No broken glass
j j

needles
j j
j j


Remarks:
Date:
( YES / NO *)
Signature:

Page 7 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests
Main drive
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Start the main drive through pushing the start button at the operating panel
Change the speed for the main drive at the operating panel between 10% and 100%
Stop the main drive through pushing the stop button at the operating panel
N
o
j j
Acceptance Criteria: The main drive:

1) starts, if there is no failure outstanding, after pushing the start j j
button
2) can be adjusted in 1% steps between the limits 10% 100%
j j
3) stops in position after pushing the stop button
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 8 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests
Infeed belt
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Start the infeed belt through pushing the start button at the operating panel
Change the speed for the infeed belt at the operating panel between 10% and 100%
Stop the infeed belt through pushing the stop button at the operating panel
N
o
j j
Acceptance Criteria: The infeed belt:

1) starts, if there is no failure outstanding, after pushing the start j j
button
2) can be adjusted in 1% steps between the limits 10% 100%
j j
3) stops after pushing the stop button
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 9 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests
Drive for machine guard
Y
e
s
References:
Internal Order
Prerequisites:
Action:
Open and close the machine guard at the operating panel
N
o
j j
Acceptance Criteria: The machine guard can be opened and closed at the operating
panel:
1) The machine guard is opening while activating the select
switch at the operating panel (turn right side)
j j
2) The machine guard is height up and stops after reaching the

top limit
j j
3) The message 3300 Guard open will shown at the operating panel
j j
4) The machine guard is closing while activating the select

switch at the operating panel (turn left side)
j j
5) The machine guard goes lower and stops after reaching the
bottom limit
j j
6) The message 3300 Guard open can be cleared at the op- j j

erating panel

Remarks:
Date:
( YES / NO *)
Signature:

Page 10 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests
Level control UST
Y
e
s
References:
Internal Order
Prerequisites:
Action:
The functions, which were assigned to the switching points of the

float switch in the UST, must be executed
N
o
j j
Acceptance Criteria: Following functions, which were assigned to the switching points
of the float switch in the UST, are executed:
1) When the level falls under the lowest end of the float switch,
the pump is switched off and the media valve V4.3 must be
opened and WFI water is filled into the UST
j j
2) The main drive stops
j j
3) The message 4851 Water shortage in UST is shown at

the operating panel
j j
4) When the middle level is reached, the media valve V4.3 is

opened and WFI water is filled into the UST
j j
5) The message 4851 Water shortage in UST can be

cleared at the operating panel
j j
6) When the highest end of the float switch is reached, the media valve V4.3 is closed
j j

Remarks:
Date:
( YES / NO *)
Signature:

Page 11 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests
Counter check for Vials
Y
e
s
N
o
References:
Internal Order
Prerequisites:
j j
2) Set machine speed to 100%
j j
3) Reset all resettable counters
j j
Action:
Note the actual value of the total container counter:

Process _________ Vials
Note the new value of the total container counter:
Total amount of processed Vials:
Calculation for the non resettable total counter
Value from each counter:
Second value from total counter (after test run):
First value from total counter (before test run):
Total containers (difference from counter):
Concludes on next page
Page 12 of 13
OQ_FT_01
FAW 1005, 52554
Functional Tests
Counter check for Vials
Y
e
s
Acceptance Criteria: 1) The calculated sum and the shown value at the resettable
counter must be equal with the total amount of processed
Vials
2) The difference of the two counter values (from the non resettable counter) must be equal with the total amount of processed vials

Remarks:
Date:
( YES / NO *)
Signature:

12
Page 13 of 13
N
o
j j
j j
OQ_BT_01
FAW 1005, 52554
4.
4.1
Test Procedure
Aims:
This test ensures that the operating panel functions as described in chapter 4 of
the instruction manual. The contents and functions of all the windows are also
checked to ensure that they are conform.
Procedure:
The functional testing of the operating panel is carried out according to chapter 4
of the instruction manual for the FAW 1005, serial no. 52554.
Tests which have been carried out and have passed are signed by the tester.
Each point signed by the tester confirms that the test was carried out and that the
function complies with the description in the instruction manual.
In the event of a failed test, the testers will fill out the corresponding deviation
sheet(s) and place the deviation sheet(s) in Volume 1, Chapter 5: Deviation
sheets. Before repeating the test, the functions on which it is based are checked
and any necessary corrections are made to the instruction manual.
Function keys: Every function key is activated. It is verified that the action is as the
operating panel test declared specification. For function keys which are security
controlled, access is tried for every security group. It is verified that access is possible as specified in the operating panel test.
Screens: Every screen is compared with the screens specified in the operating
panel test. The screens must be corresponded in all elements.
Entry fields: For every numeric entry field a number equalling 0, 50 and 100% of
the full scale is entered. A value below respectively above allowed range is entered
and it is verified, that the appropriated value does not change. For entry fields
which are security controlled, access is tried for every security group. It is verified
that access is possible as specified in the operating panel test.
Page 1 of 6
OQ_BT_01
FAW 1005, 52554
4.2
Operating Panel Tests
Page 2 of 6
OQ_BT_01
FAW 1005, 52554
4.2.1
Operating Panel Test (German Version)
Page 3 of 6
OQ_BT_01
FAW 1005, 52554
Operating panel Test (German Version)

References:
Internal Order
Prerequisites:
1. Machine ready for operation
Y
e
s
N
o
j j
2. The test document developed out of the chapter 4 of the ger- j j

man instruction manual is available
Action:
Document the actual program version of the operating panel:
B52554D______
Check:
all function keys,

all entry fields and
all screens
as descriped in the procedure (Chapter 4.1) and attached test
document
Check each page of the test document. When a section is
tested, the according Checked by box must be signed with initial
Acceptance Criteria: 1. The following action of all function keys are as the test document declared specification
j j
2. All limits of the entry fields are as the test document declared
specification
j j
3. All screens are as the test document declared specification
j j
4. All Checked by boxes are signed with initial
j j
5. The test document is attached to this protocol
j j
Examiner: Elisabeth Heynold

Remarks:
( YES / NO *)
Date:
Signature:

Page 4 of 6
OQ_BT_01
FAW 1005, 52554
4.2.2
Operating Panel Test (English Version)
Page 5 of 6
OQ_BT_01
FAW 1005, 52554
Operating panel Test (English Version)
Y
e
s
N
o
References:
Internal Order
Prerequisites:
1. Machine ready for operation
j j
2. The test document developed out of the chapter 4 of the english instruction manual is available
j j
Action:
Document the actual program version of the operating panel:
B52554E______
Check:
all function keys,

all entry fields and
all screens
as descriped in the procedure (Chapter 4.1) and attached test
document
Check each page of the test document. When a section is
tested, the according Checked by box must be signed with initial
Acceptance Criteria: 1. The following action of all function keys are as the test document declared specification
j j
2. All limits of the entry fields are as the test document declared
specification
j j
3. All screens are as the test document declared specification
j j
4. All Checked by boxes are signed with initial
j j
5. The test document is attached to this protocol
j j

Remarks:
( YES / NO *)
Date:
Signature:

13
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OQ_IV_01

FAW 1005, 52554

Volume 3 Operational Qualification

Protocol Overview for Alarm Tests

Protocols for Alarm Tests

Protocol Overview for Functional Tests

Protocols for Functional Tests

Functional Tests of the Operating Panel

Operating Panel Test (German Version)

Operating Panel Test (English Version)

Test Procedure for Alarmtests

Protocol for alarm tests

Protocol Overview for Alarm Tests

1010 Schutzschalter ausgelst /

1010 Schutzschalter ausgelst /

1010 Schutzschalter ausgelst /

1010 Schutzschalter ausgelst /

1010 Schutzschalter ausgelst /

1010 Schutzschalter ausgelst /

1010 Schutzschalter ausgelst /

1010 Schutzschalter ausgelst /

1110 berlast Hauptantrieb /

1130 berlast Verkleidung /

1465 Strung Hauptantrieb /

3000 NOT-AUS bettigt /

3050 berlast Ausschieber (Drehbewegung) /

3050 berlast Ausschieber (Schubbewegung) /

3060 berlast Einschieber /

3300 Verkleidung offen /

3601 Positionierzeit abgelaufen /

3670 Schaltgetriebe entriegelt /

3671 Stellung Schaltgetriebe prfen /

3730 Objekte nicht ausgewaschen /

3731 Objekte nicht ausgeblasen /

3821 Einlaufschnecke ausgerastet /

4851 Wassermangel UST /

4870 Druck Medium 1 Druckluft zu niedrig /

4871 Druck Medium 2 UST-Wasser zu niedrig /

4875 Druck Medium 6 Steuerluft /

4882 Druck M 4 Desti-Wasser zu niedrig /

4900 Maschinenleistung zu hoch /

5207 berwachung Objekt zhlen /

5284 berw. Druckerf. M4 DESTI-Wasser /

5285 berw. Druckerfassung M1 Druckluft /

5286 berw. Druckerfassung M2 UST-Wasser /

5324 Strung PROFIBUS (Bedienterminal) /

5324 Strung PROFIBUS (Shaft Encoder) /

5324 Strung PROFIBUS (Frequency converter) /

5413 Str. Kommunik. nachgesch. Masch. /

7500 Objektmangel Einlauf /

7650 Objektstau Tunnel /

7721 Nachgeschaltete Maschine nicht bereit /

9000 Steuerspannung aus (Not-Aus bettigen) /

Protocols for Alarm Tests

Activate protection switch 43Q5

Acceptance Criteria: 1) Message appears

3) Machine can not be started (after acknowledgement)

Switch on protection switch 43Q5 again