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