Risk Based Approaches in Conformity Assessment: Process Safety, Pressure Equipment, Machinery & Inspection

Risk Based
Approaches in
Conformity
Assessment
Process Safety,
Pressure Equipment,
Machinery & Inspection
Dr. Reinhard Preiss

TV AUSTRIA SERVICES GMBH / 2010
www.tuv.at
Overview
1. Process Safety risk analysis & functional

safety
2. Pressure Equipment safety concept of

assemblies
3. Machinery risk analysis & functional safety
4. Risk Based Inspection of pressure equipment
APPLICATION
CONFORMITY ASSESSMENT
Industrial fields of application of risk

based approaches to achieve
technical safety
To show compliance with the

requirements of Directives and Codes /
Standards
TV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010
page 2
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Process Safety
IEC 61511 / ISA-84.00.01
Safety instrumented systems for the process industry sector
Clause 8: Hazard and Risk Assessment
The objectives of the requirements of this clause are:
> to determine the hazards and hazardous events of the process and
associated equipment;
> to determine the process risks associated with the hazardous event;
> to determine any requirements for
risk reduction;
> to determine the safety functions
required to achieve the necessary

risk reduction;
page 3
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Process Safety
IEC 61511 / ISA-84.00.01
Informal annexes for possible determination of required risk
reduction by safety instrumented functions (SIL), e.g.
page 4
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Process Safety
IEC 61511 / ISA-84.00.01
but no indication of safety target levels in general, e.g.
..the plant internal safety target level for release of material to the
environment of 10-4 per year is not met
responsibility of the user
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Pressure Equipment
Pressure Equipment Directive 97/23/EC
Assembly
Several pieces of pressure equipment assembled by a manufacturer to
constitute an integrated and functional whole.
Annex I, ESR
Where, under reasonably foreseeable conditions,
the allowable limits could be exceeded, the
pressure equipment must be fitted with suitable
protective devices, unless the equipment is
intended to be protected by other protective
devices within an assembly.
page 6
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Pressure Equipment
Pressure Equipment Directive 97/23/EC
Thus, examination of the safety of an assembly, i.e.
conformity assessment with regard to the ESR of the
Directive, requires consideration of deviations from
the intended operation.
But, there are nor further statements on what is
reasonably foreseeable and on required risk
reduction (no safeguard is perfect) in the Directive.
in practice, a risk based approach, e.g. as
given in IEC 61511 is used.
page 7
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Machinery
Machinery Directive 2006/42/EC
> The manufacturer of machinery must ensure that a risk assessment is
carried out in order to determine the health and safety requirements which
apply to the machinery. The machinery must then be designed and
constructed taking into account the results of the risk assessment.
> It is required to estimate the risks, taking into account the severity of the
possible injury or damage to health and the probability of its occurrence.
page 8
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Machinery
EN ISO 14121-1: Safety of machinery - Risk assessment - Part 1:
Principles
In practice:
Risk reduction measures according to standards (harmonized product safety
standards), or according to state-of-the-art, or according to company
internal requirements.
page 9
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Risk Bases Inspection

RBI Principle:
> Adjust inspection periods and inspection methodology according to
probability of failure and consequence of failure of the equipment,

i.e. adjustment according to the risk.
> In some countries inspection periods are
given due to legal requirements but
exclusions based on RBI are possible, in

others RBI can be used regularly.
> Inspection bodies can play an important
role in that context.
page 10
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> Systematic evaluation of damage mechanisms and estimation of

the probability of failure (PoF)
> Determination of possible consequences (harm to people,
environment and asset losses) in case of equipment failure (CoF)
> Equipment is ranked in a risk matrix

> Based on the ranking inspection activities
are determined
RISK
Very High
Probability
High
3
Medium
Low
Very Low
1
A
Consequence
page 11
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Codes & Standards
>RIMAP application workbooks according to the European R&D
Project GIRD-CT-2001-03008:
>CEN Workshop Agreement CWA 15740:2008
st
>API RP 580, 1 Edition, 2002-05

>API RP 581, 2
nd
Edition, 2008-09
>HSE Safety implications of European risk based inspection and
maintenance methodology; Research report 304/2005
An EN/ISO standard on RBI principles and application

is of high importance!
page 12
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Risk Based Approaches in Conformity Assessment: Process Safety, Pressure Equipment, Machinery & Inspection

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Risk Based

Dr. Reinhard Preiss

1. Process Safety risk analysis & functional

2. Pressure Equipment safety concept of

Industrial fields of application of risk

To show compliance with the

TV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010

> to determine any requirements for

required to achieve the necessary

TV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010

TV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010

given in IEC 61511 is used.

TV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010

TV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010

TV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010

Risk Bases Inspection

probability of failure and consequence of failure of the equipment,

exclusions based on RBI are possible, in

role in that context.

TV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010

Risk Bases Inspection

> Systematic evaluation of damage mechanisms and estimation of

> Equipment is ranked in a risk matrix

Risk Bases Inspection

>API RP 580, 1 Edition, 2002-05

>HSE Safety implications of European risk based inspection and

maintenance methodology; Research report 304/2005

An EN/ISO standard on RBI principles and application

TV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010

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