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www.tuv.at © TÜV AUSTRIA SERVICES GMBH / 2010
Risk Based
Approaches in
Conformity
Assessment
Process Safety,
Pressure Equipment,
Machinery & Inspection
Dr. Reinhard Preiss
www.tuv.at © TÜV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010 page 2
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
Industrial fields of application of risk
based approaches to achieve
technical safety
APPLICATION
To show compliance with the
requirements of Directives and Codes /
Standards
CONFORMITY ASSESSMENT
www.tuv.at © TÜV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010 page 3
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;
www.tuv.at © TÜV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010 page 4
Process Safety
IEC 61511 / ISA-84.00.01
Informal annexes for possible determination of required risk
reduction by safety instrumented functions (SIL), e.g.
www.tuv.at © TÜV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010 page 5
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
www.tuv.at © TÜV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010 page 6
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.
www.tuv.at © TÜV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010 page 7
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.
www.tuv.at © TÜV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010 page 8
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.
www.tuv.at © TÜV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010 page 9
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.
www.tuv.at © TÜV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010 page 10
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.
www.tuv.at © TÜV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010 page 11
Risk Bases Inspection
>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
Consequence
Pro
ba
bilit
y
A B C D E
1
2
3
4
5
Very High
High
Medium
Low
Very Low
R I S K
www.tuv.at © TÜV AUSTRIA SERVICES GMBH / Dr. R. Preiss / 2010 page 12
Risk Bases Inspection
Codes & Standards
>RIMAP application workbooks according to the European R&D
Project GIRD-CT-2001-03008:
>CEN Workshop Agreement CWA 15740:2008
>API RP 580, 1st Edition, 2002-05
>API RP 581, 2nd 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!