0343Conformity assessment
by: ing. H. Verschuren
Lloyd’s Register Netherlands
0343Content
• Questions and Guidelines
• Hazard Analysis
• Essential Safety Requirements
• Instructions for use
• Hazard analysis, example
• Proposed changes to new approach
0343Guidelines
Approved by:
CABF
WPG
WGP
0343Guidelines
1. Scope and Exclusions
2. Classification and Categories
3. Assemblies
4. Evaluation Assessment
5. ESRs on Design
1/3 1/47
2/8 2/29
3/11
4/10
5/6
0343Guidelines
6. ESRs on Manufacturing
7. ESRs on Material
8. Other ESRs
9. Miscellaneous
10. Horizontal Issues 10/2
9/22
8/16
7/6
6/7
0343Content
• Questions and Guidelines
• Hazard Analysis
• Essential Safety Requirements
• Instructions for use
• Hazard analysis, example
• Proposed changes to new approach
0343Manufacturer
Responsibilities
• ensure design and manufacturing to ESR’s
• ensure conformity assessment with ESR’s
0343Manufacturer
• Hazard Analysis. Consider all applicable hazards. Known and foreseeable, use and foreseeable misuse.
• Take into account all ESR’s if applicable.
• Instructions for use, containing all safety information.
0343Hazard Analysis
MethodEN 1050
• elimination
• reduction
• warning
0343
Essential Safety Requirements
• From cat I to IV obliged
• manufacturer has to provide a description of solutions adopted to meet the ESR’s. If non-harmonised standards are used.
0343Instructions for use
Pressure equipment should be accompanied by instructions for use.
Contain information relating to:
• mounting / assembling
• putting into service
• use
• maintenance
0343Instructions for use
Content
• All info as mentioned in ann I §3.3 “Marking and labelling”
• All other relevant safety info
• All hazards not prevented by design or protective measures
0343Hazard Analysis example
• Evaluation of all appl hazards
• Description of solutions adopted to meet ESR’s (harm standards not used)
• Determining content for instructions for use
0343
Hazard Analysis example
• Type of hazard
2.2 design for adequate strength2.2.1 Internal pressure
0343
No Type of hazard Rele-vantY / N
Risk estimation by
Description of hazard
1 Internal pressure-normal operating conditions-regeneration conditions-thermal liquid expansion-exothermal reactions/run away
YNNN
MMMM
2 External pressure-vacuum-normal operating conditions-regeneration conditions-condensing steam/vapour due to cooling down
0343
Description of hazard Risk No.
ActionRequired
Y / N
Inlet from V1504, heating from steam jacket
0343
Determining the risk number Rn
Probability
Effect Frequenty
low(unlikely)
moderate (likely)
high (very likely)
Light(First aid)
seldom(1 < year)
1 6 10 14 18 22regularly
(daily / weekly
)11 16 20 24 28 32
serious
(hospital
treatment)
seldom(1 < year)
21 26 30 34 38 42regularly
(daily / weekly
)31 36 40 44 48 52
Severe
(death)
seldom(1 < year)
41 46 50 54 58 62regularly
(daily / weekly
)51 56 60 64 68 72
possible(almost)
impossible
possible(almost)
impossible
possible(almost)
impossible
Possibility of avoidance
0343
Description of hazard Risk No.
ActionRequired
Y / N
Inlet from V1504, heating from steam jacket
72
0343
Interpretation Risk number
risk no descriptionrecommended
precaution
1 - 14 very low not necessary
15 - 26 lowsimple
precaution
27 - 36 moderate recommended
37 - 51 highstrongly
recommended
52 - 72 unacceptable obliged
0343
Description of hazard Risk No.
ActionRequired
Y / N
Inlet from V1504, heating from steam jacket
72 Y
0343
If applicable: risk reduction by
Design Use3)
Construction Reduction Additional precautions
Warning
EN 13445-3 NA NA Y
0343
4)Explications Action number
1Design
2Warning
03431)Type of action
Description
1D Design for internal pressure of 12 bar according to EN13445-3
2W Max allowable pressure 12 bar.
0343Content
• Questions and Guidelines
• Hazard Analysis
• Essential Safety Requirements
• Instructions for use
• Hazard analysis, example
• Proposed changes to new approach
0343New module system
• ISO 9001:2000
• Option 1– One standard, One QA system, one
module– H, B+H, B1+H, B2+H
0343
Conformity asssessment procedures
AG H
D F
Nobo/UI
Nobo
Nobo
Nobo/UI
Nobo/ UI
Man
ufD
esig
n
= QA System Certifications
Fin
al a
sses
E1
Nobo
A A1
Nobo/
UI
Nobo/
UI
E
Nobo/UI
NoboNobo
Nobo
D1 H1I II II II IIIIV IV
III
Typeond.
B1 Ontwp Ond.
IVIIIIII
IV
Nobo Nobo
III
Nobo/UI
C1
B
+
+
Nobo
Nobo
Nobo
NoboNobo Nobo
+
0343
Conformity asssessment procedures
G H
F
Nobo/UI
Nobo/ UI
Man
ufD
esig
n
= QA System Certifications
Fin
al a
sses
Nobo/
UINobo/
UI
Nobo/UI
Nobo
Type
B1
Nobo Nobo
Nobo/UI
C
B
Nobo
Nobo
B2
Nobo
A DesignTech doc
0343New module system
• ISO 9001:2000
• Option 2– One standard, three QA systems, three
modules– D, E, H
0343New module system
• Category of equipment
• Clarity of QA system (cat of equipment)– B+E (3) B+D(4) both B+H
0343
Lloyds Register Netherlands
0343