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Risk Analysis - Stretchbander
Risk Analysis - Stretchbander
Version: 1.0
Machine type
Machine number
Customer
S 3015 - Stretchbander
1100117
Bosnalijek d.d., Bosnia-Herzegovina
Uhlmann Pac-Systeme
GmbH & Co. KG
Uhlmannstrae 14-18
88471 Laupheim, Germany
Phone +49 (0)7392 702-0
Fax +49 (0)7392 702-18972
validierung@uhlmann.de
www.uhlmann.de
Position
Date
Signature
Date
Signature
Prepared
Reviewed
Approved
Name
Position
Approved
Approved
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Contents List
1.
Preface .................................................................................................................................... 3
2.
Introduction ............................................................................................................................ 4
3.
4.
Handling of Document........................................................................................................... 5
5.
Listing of Functions............................................................................................................... 6
6.
References.............................................................................................................................. 6
7.
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1. Preface
Dear customer
The Risk Analysis is a highly complex procedure and represents the starting point for all qualification activities.
This document has been prepared using the assembly descriptions and the Hardware and Software Design Specifications relevant for this particular type of machine.
This document for risk analysis has been prepared by a team of people in order to cover all aspects and all possible risks.
The team consisted of the following members:
Electrical engineers
Mechanical engineers
Validation manager
Members of the after-sales service
The present document is copyrighted. In compliance with the provisions of the copyright law, the
present printout is not permitted to be copied or transferred onto another medium in whole or in
part without the prior written consent of Uhlmann Pac-Systeme Germany.
Authorized copies must bear the same copyright and property notices as the original. In line with
the interpretation of the law, translations will be considered as copies.
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2. Introduction
The Risk Analysis is an integral part of the documented production safety in the pharmaceutical
industry today.
The intention of the FDA and cGMP guidelines is to enhance drug safety by strictly observing the
basic principle stipulated by the WHO of ensuring the proper manufacture and quality of drugs.
3. Definition of terms
Within the present document, the following terms will be used:
Risk Analysis is the systematic examination of all functions being part of a process, the analysis
of possible failures and their effects as well as the consequences ensuing thereof.
Installation Qualification (IQ) is the formal and systematic evidence that the major features of
system installation (hardware and software) are in conformity with agreed specifications and that
the instructions and recommendations made by suppliers have been observed.
Operation Qualification (OQ) is the formal and systematic evidence that the equipment or system functions faultlessly and operates as expected throughout the range of applications.
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4. Handling of Document
Example for assessing machine functions:
Critical:
Not critical:
Document set-up:
No.:
Consecutive number
Assembly:
Failure/Function:
Failure effect:
Detected by machine:
Risk assessment:
Comments:
IQ test:
OQ test:
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5. Listing of Functions
No.
Assembly
Error/function
Failure effect
Det. by
mach.
Risk
Assessment
Comments
IQ Test
OQ Test
Yes
/ No
No.
Yes
/ No
No.
General
items
No
Critical
Equipment of the machine with the item stipulated in the order confirmation is ensured only if
the machine numbers on
the rating plate and on
the order confirmation
are indentical.
Yes
IQ_GENE
RAL
ITEMS
1.0
No
General
items
Correct installation
of main components
No
Critical
A flawless operation of
the machine is ensured
only if the main components have been correctly delivered and installed.
Yes
IQ_GENE
RAL
ITEMS
1.1
No
General
items
Complete technical
documentation
No
Critical
Yes
IQ_GENE
RAL
ITEMS
1.3
No
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No.
Assembly
Error/function
Failure effect
Det. by
mach.
Risk
Assessment
Comments
IQ Test
OQ Test
Yes
/ No
No.
Yes
/ No
No.
General
items
Complete validation
documentation
No
Critical
Yes
IQ_GENE
RAL
ITEMS
1.4
No
General
items
No
Critical
Yes
IQ_GENE
RAL
ITEMS 1.5
No
General
items
Compressed air
supply
No
Critical
Yes
IQ_GENE
RAL
ITEMS 1.6
No
General
items
Consistency of item
designations
No
Critical
Yes
IQ_GENE
RAL
ITEMS
1.7
No
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No.
Assembly
Error/function
Failure effect
Det. by
mach.
Risk
Assessment
Comments
IQ Test
OQ Test
Yes
/ No
No.
Yes
/ No
No.
Supply of
services
Compressed air
monitoring
Machine will
stop or machine start is
disable
Yes
Critical
IQ sensors
& actuators
01.01.01
Safety
guards
Warning safety
guard 1 open
Production is
not possible if
guard is open
Yes
Critical
IQ_GENE
RAL
ITEMS 1.8
01.02.01
10
Safety
guards
Warning safety
guard 2 open
Production is
not possible if
guard is open
Yes
Critical
IQ_GENE
RAL
ITEMS 1.8
01.02.02
11
Safety
guards
Warning safety
guard 3 open
Production is
not possible if
guard is open
Yes
Critical
IQ_GENE
RAL
ITEMS 1.8
01.02.03
12
Safety
guards
Warning safety
guard 4 open
Production is
not possible if
guard is open
Yes
Critical
IQ_GENE
RAL
ITEMS 1.8
01.02.04
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No.
Assembly
Error/function
Failure effect
Det. by
mach.
Risk
Assessment
Comments
IQ Test
OQ Test
Yes
/ No
No.
Yes
/ No
No.
IQ sensors
& actuators
01.03.02
01.04.01
13
Control
cabinet
Machine
stops, the
temperature
in the control
cabinet has
risen above
the limit
Yes
Critical
14
Machine
operation
Emergency stop
active
(TouchPanel)
Machine
stops in undefined position
Yes
Critical
15
Machine
operation
A warning
window appears on the
screen
Yes
Not
Critical
01.04.13
16
Machine
operation
Reference drive
(TouchPanel)
Yes
Not
Critical
01.04.14
01.04.15
17
Line operation
Machine
stops, product
transfer to
downstream
machine is
impossible
Yes
Critical
01.06.01
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& actuators
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No.
Assembly
Error/function
Failure effect
Det. by
mach.
Risk
Assessment
Comments
IQ Test
OQ Test
Yes
/ No
No.
Yes
/ No
No.
18
Line operation
Machine
stops
Yes
Critical
IQ sensors
& actuators
01.06.02
19
Control
cabinet
Yes
Critical
IQ sensors
& actuators
02.01.01
20
Infeed
Jam at infeed
A cycle stop
will be triggered if fault
product inquiry infeed.
Yes
Critical
IQ sensors
& actuators
02.01.02
21
Control
cabinet
Yes
Critical
IQ sensors
& actuators
02.01.03
22
Infeed
pusher
Yes
Critical
IQ sensors
& actuators
02.01.04
23
Infeed
pusher
Yes
Critical
IQ sensors
& actuators
02.01.05
24
Stacker
Yes
Critical
IQ sensors
& actuators
02.02.02
25
Stacker
Yes
Critical
IQ sensors
02.02.03
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No.
Assembly
Error/function
Failure effect
per position
Det. by
mach.
Risk
Assessment
Comments
IQ Test
OQ Test
Yes
/ No
Yes
/ No
No.
No.
& actuators
26
Sealing
bar
Film sealing
Yes
Critical
IQ sensors
& actuators
02.03.02
27
Sealing
bar
Temperature of film
sealing
Irregular film
sealing
Yes
Critical
02.03.03
02.03.04
28
Sealing
bar
Machine
stops, sealing
is impossible
Critical
02.03.05
29
Sealing
bar
Yes
Critical
IQ sensors
& actuators
02.03.06
30
Sealing
bar
Yes
Critical
IQ sensors
& actuators
02.03.07
31
Sealing
bar
Tear control
Machine
stops
Yes
Critical
02.04.01
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No.
Assembly
Error/function
Failure effect
Det. by
mach.
Risk
Assessment
Comments
IQ Test
OQ Test
Yes
/ No
No.
Yes
/ No
No.
32
Control
cabinet
Upper film
drive not running
Yes
Critical
IQ sensors
& actuators
02.04.02
33
Control
cabinet
Lower film
drive not running
Yes
Critical
IQ sensors
& actuators
02.04.03
34
Filmdrive
top
Yes
Critical
IQ sensors
& actuators
02.04.04
35
Filmdrive
bottom
Yes
Critical
IQ sensors
& actuators
02.04.05
36
Film drive
An acustic
signal and a
warning window appears
Yes
Not
Critical
Replenish film.
IQ sensors
& actuators
02.04.06
02.04.07
37
Outward
transfer
Yes
Critical
IQ sensors
& actuators
02.06.03
38
Quality
control
Products in carton
or carton itself is
damaged
Damaged
carton or
product will be
produced
No
Critical
06.01.01
06.01.02
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6. References
For preparation of the present document, the following guidelines and technical documents have
been used as reference:
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Date
Chapter
Reason
Name
1.0
25.05.2009
First release
A. Arbeiter
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