SIST EN 16991:2018

SLOVENSKI STANDARD
oSIST prEN 16991:2016
01-julij-2016
2EPRþMHQDG]RUDQDSRGODJLRFHQHWYHJDQMD
Risk based inspection framework (RBIF)
Risikobasierte Inspektion (RBIF)
Cadre d’inspection basée sur les risques (RBIF)
Ta slovenski standard je istoveten z: prEN 16991
ICS:
03.100.01 Organizacija in vodenje Company organization and
podjetja na splošno management in general
oSIST prEN 16991:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 16991:2016


DRAFT
EUROPEAN STANDARD
prEN 16991
NORME EUROPÉENNE

EUROPÄISCHE NORM

April 2016
ICS 03.100.01
English Version

Risk based inspection framework (RBIF)
Cadre d'inspection basée sur les risques (RBIF) Risikobasierte Inspektion (RBIF)
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 319.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 16991:2016 E
worldwide for CEN national Members.

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Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Abbreviated terms . 8
5 RBI framework . 9
5.1 RBIF principles . 9
5.2 RBIF requirements . 9
5.2.1 General requirements . 9
5.2.2 Plant and process documentation . 11
5.2.3 Personnel requirements . 12
5.2.4 Requirements for performing PoF analysis . 12
5.2.5 Requirements for performing CoF analysis . 14
5.2.6 Requirements for risk assessment . 15
5.3 RBIF within the overall management system . 16
5.4 Compatibility with other known approaches . 17
6 RBIF procedure . 17
6.1 General . 17
6.2 Initial analysis and planning . 19
6.2.1 General description and scope . 19
6.2.2 Requirements . 22
6.2.3 Inputs . 22
6.2.4 Procedure . 22
6.2.5 Output . 23
6.2.6 Warnings and applicability limits . 23
6.3 Data collection and validation . 23
6.3.1 General description and scope . 23
6.3.2 Requirements . 24
6.3.3 Input . 24
6.3.4 Procedure . 26
6.3.5 Output . 26
6.3.6 Warnings and applicability limits . 27
6.4 Multilevel risk analysis (ranging from screening to detailed) . 27
6.4.1 General description and scope . 27
6.4.2 Risk analysis - screening level . 28
6.4.3 Risk analysis - detailed assessment . 30
6.5 Decision making / action plan . 35
6.5.1 General description and scope . 35
6.5.2 Requirements . 35
6.5.3 Inputs . 35
6.5.4 Procedure . 36
6.5.5 Output . 38
6.5.6 Warnings and applicability limits . 39
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6.6 Execution and reporting . 39
6.6.1 General. 39
6.6.2 Input . 40
6.6.3 Procedure . 40
6.6.4 Output . 43
6.6.5 Warning/application limits . 43
6.7 Evergreen phase / Performance review . 43
6.7.1 General description and scope . 43
6.7.2 Requirements . 44
6.7.3 Inputs . 44
6.7.4 Procedure . 45
Annex A (informative) Assements . 47
A.1 Example of a multilevel risk analysis in power industry . 47
A.2 Example of screening and detailed risk assessment . 50
A.3 Risk assessment during the screening phase . 54
A.4 Example of assessment of damage susceptibility . 55
A.5 Example of probability and consequence factors for qualitative analysis . 57
A.6 Example of various types of in-service damage and their specifications . 59
A.7 Example of various types of damage and their specifications in relation to hierarchical
structure of the plant . 60
A.8 Example of classification of type of damage vs. prioritized methods of inspection . 61
A.9 Example for determination of PoF . 64
A.10 Example for determination of CoF . 65
A.11 Example of formulation and degradation of components, structures and systems . 74
Bibliography . 76

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European foreword
This document (prEN 16991:2016) has been prepared by Technical Committee CEN/TC 319
“Maintenance”, the secretariat of which is held by UNI.
This document is currently submitted to the CEN Enquiry.
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Introduction
Since the late 1990s, the inspection and maintenance approaches in industry have been globally moving
from prescriptive, time-based towards risk-based ones. This trend has been clearly driven by the wish to
increase the on-stream production time, to reduce unscheduled downtime due to corrective maintenance
and/or reduce equipment condition which could ultimately cause a shut down or have an undesirable
impact on process safety.
This European Standard provides the essential elements of risk-based assessment of industrial assets
according to the approach which has been developed and demonstrated in and by the European pre-
standardization document CWA 15740:2008 (validity prolonged in 2011) and the corresponding RIMAP
Network: “Risk-Based Inspection and Maintenance Procedures for European Industry”[2], [3]. One of the
main goals of the project, as well as of this standard, has been to make inspection and maintenance
programs in the industrial plants more cost-efficient while, at the same time, safety, health, and
environmental performance is maintained or improved.
The document is intended for the managers and engineers establishing the RBIM (Risk-based Inspection
and Maintenance) policies in the companies in power, process, steel and other relevant industries. It is
supposed to be used in conjunction with relevant internationally accepted practices, national regulations
and/or company policies. The document is supposed to provide a common reference for formulating the
above policies and developing the corresponding inspection and maintenance programs within different
industrial sectors.
In the context of other “framework” like documents (e.g. API 580 [4]), this document differs in two main
aspects:
— the scope (other, non-process plant, types of equipment are included); and
— the compatibility with the EU regulations and leading ISO standards (9000, 14000, 31000, 55000).
The positive impact and transfer of industry practices resulting from the use of this document and from the
approach promoted are expected to be of benefit for the European industry and strengthening of its
competitiveness through better inspection and maintenance practices. The background of the RBIM
methodology described here is explained more in detailed in the project RIMAP (Risk-based Inspection and
Maintenance Procedures for European Industry), [5]. In the project, the industry independent
methodology, has been validated for chemical, petrochemical, power and steel industries based on the
Application Workbooks [6], [7], [8].
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1 Scope
The objective of this European Standard is to provide the RBI Framework (RBIF) and basic guideline for
Risk-Based Inspection and Maintenance (RBIM) in hydrocarbon and chemical process industries, power
generation and other industries.
Although RBIF encompasses both inspection and maintenance, this document focuses primarily on RBI and
its applicability within the context of RBIM. The RBIF thereby supports optimization of operations and
maintenance as well as asset integrity management.
The main goal of this European Standard is to facilitate the establishment of risk based inspection and
maintenance programs in the industrial plants in a documented and efficient way, while, at the same time,
legal regulations are complied with and safety, health, and environmental performance is maintained or
improved.
The RBIF addresses primarily the static containment equipment (e.g. tanks, piping), dynamic/rotating
containment equipment (e.g. pumps, turbines, valves) and pressure relief devices, but can be extended to
other types of equipment if appropriate. It addresses primary the equipment and/or systems in the in-
service phase of the operation, but can be applied also in the, e.g. design-phase for analysis and
determination of maintenance/inspection strategies or life extension phases.
The RBIF approach can also be used to ensure that targets pertinent to health, safety and environment are
achieved, providing that legislative requirements are implemented and the required actions are taken.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
Not applicable.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
risk
1,2
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO/IEC Guide 51:2014]
3.2
risk management
3
coordinated activities to direct and control an organization with regard to risk
[SOURCE: ISO Guide 73:2009, ISO 31000:2009]

1
The probability of occurrence includes the exposure to a hazardous situation, the occurrence of a hazardous event,
and the possibility to limit the harm.
2
Other definitions, e.g. the one from ISO 31000 are recognized, but not used practically in the document.
3
Systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating and
controlling risk
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3.3
inspection
part of maintenance that can be followed by an active maintenance task in order to restore or to retain the
availability of an item
3.4
maintenance
combination of all technical, administrative and managerial actions during the life cycle of an item intended
4
to retain it in, or restore it to, a state in which it can perform the required function
[SOURCE: EN 13306:2010]
3.5
preventive maintenance
maintenance carried out at predetermined intervals or according to prescribed criteria and intended to
5
reduce the probability of failure or the degradation of the functioning of an item
[SOURCE: EN 13306:2010]
3.6
corrective maintenance
maintenance carried out after fault recognition and intended to put an item into a state in which it can
perform required function
[SOURCE: EN 13306:2010]
3.7
risk based inspection
RBI
risk assessment and management process to plan, implement and evaluate inspections in a structured and
documented way
3.9
reliability centred maintenance
method to identify and select failure management policies to efficiently and effectively achieve the required
safety, availability and economy operation [9]
3.10
probability of failure
extent to which an event is likely to occur within the time frame under consideration [10]
3.11
consequence of failure
outcome of a failure that may be expressed, for example, in terms of safety to personnel, economic loss, and
damage to the environment [11]

4
Maintenance of an asset before the degradation reaches a point that leads to asset failure. It might be divided into
time based (a certain interval of time) or condition based (according to the state of the object). Both types of
preventive maintenance might be based on prescriptive, legislative or risk based requirements.
5
Used to mitigate an unwanted condition e.g. leak or coating break down. For low consequence equipment run-to-
failure followed by repair might be an acceptable corrective maintenance strategy.
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3.12
evergreening
dynamic process of keeping records and analysis updated and relevant for the current situation
4 Abbreviated terms
Table 1 — Abbreviations
Acronym Definition
ALARP As Low As Reasonably Practicable
API American Petroleum Institute
ASME American Society of Mechanical Engineers
CAD Computer Aided Design
CAM Computer Aided Manufacturing
CMMS Computerized Maintenance Management System
CML Condition Monitoring Location
CoF Consequence of Failure
CUI Corrosion Under Insulation
FME(C)A Failure Mode, Effects (Criticality) and Analysis
HAZOP HAZard and OPerability (study/analysis)
HCF / LCF High Cycle Fatigue / Low Cycle Fatigue
HFF / LFF High Fluid Flow / Low Fluid Flow
HS(S)E Health, Safety (Security) and Environment
HSE Health, Safety and Environment
H&S Health and Safety
HT High Temperature
IOW Integrity Operating Window
IPF Instrument Protective Function
KKS Kraftwerk-Kennzeichensystem, Power Plant Classification System
KPI Key Performance Indicators
LoF Likelihood of Failure
NOTE: also referred to Probability of Failure (PoF) in some cases
LoPC Loss of Primary Containment
MEI Maintenance Execution Inspection
MOC Management Of Change
MTBF Mean Time Between Failure
NCR Non Conformity Report
NDT Non-Destructive Testing/inspection
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Acronym Definition
NII Non-Intrusive Inspection
P&ID Process and Instrumentation Diagram
PHA Process Hazard Analysis
POD Probability Of Detection
PoF Probability of Failure.
NOTE: also referred to Likelihood of Failure (LoF) in some cases
PRV Pressure Relief Valve
QA Quality Assurance
QRA Quantitative Risk Assessment
RBI Risk Based Inspection
RBIF Risk Based Inspection Framework
RBIM Risk Based Inspection and Maintenance
RBM, RBLM Risk-Based Maintenance, Risk-Based Life Management
RBWS Risk Based Work Selection
RC(F)A Root Cause (Failure) Analysis
RCM Reliability Centered Maintenance
RIMAP Risk based Inspection and Maintenance Procedures
VIB Vibration
5 RBI framework
5.1 RBIF principles
The risk-based approach shall apply a multi-discipline engineering analysis to ensure that targets related to
health, safety, business and environment are met. These targets shall be met by implementing optimized
inspection, monitoring and maintenance programs based on an appropriate risk-based methodology
covering the following items:
— Planning of the primary work products of RBI assessments and management approach in such a way
that risks at system and/or equipment level are managed, considering risks from both
health/safety/environment (HSE) perspective and/or from the economic/business standpoints;
— Defining the RBI methodology in a framework which meets requirements of good engineering
practices and industrial reference standards in handling hazardous materials and containment;
— Defining the minimum requirements in order to comply with legal or normative regulations and
guidelines.
5.2 RBIF requirements
5.2.1 General requirements
The general requirements of RBIF are:
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— the objectives and risk criteria shall be clearly defined;
— the assessment and the applied procedure shall comply with the locally applicable legal and regulatory
requirements;
— the adequate level of input information shall be available for the assessment;
— the assessment shall be performed by a multidisciplinary team including personnel with the
appropriate required competence and qualifications;
— the integrity and safety assessment and the applied procedures shall provide results, which are:
a) conservative; and
b) representable in a risk matrix, auditable and consistent with both the objectives and applied risk
criteria supporting RBI planning and decision making on the target system or component;
— the assessment shall reflect the real conditions in the plant and be kept “evergreen”;
— change management shall be made according to an accepted and recognized standard - such as
ISO 9000; and
— in the case that the computer models are used, these models shall be validated.
The RBI process is divided into a main level and an inspection and maintenance strategy level. The main
level is shown in Figure 1 and takes into account the following factors:
— the opportunity to eliminate failure causes;
— the risk to personnel during execution of inspection and maintenance; and
— the risk of introducing new failure causes while trying to eliminate existing ones.
In cases where substituting the inspection and maintenance strategy is not possible, technical (e.g.
robotics) or organizational (e.g. training) measures may be introduced to reduce risk and to avoid
introducing new failures.
The decision-logic serves to three important purposes:
— to ensure a systematic evaluation of the need for inspective maintenance activities;
— to ensure consistency of the evaluation between different units, plant systems and similar units in
different locations; and
— to simplify the documenting of the conclusions reached.
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Figure 1 — The main level of the decision making framework
When the inspection and maintenance strategy has been determined, the method, intervals, and extent of
inspection shall be determined so that risks remain acceptable and costs are optimized (ALARP). This is
achieved by establishing risk reduction measures for the items that exceed the acceptance limits, and,
where possible by mitigating measures like inspections and maintenance for items that remain below these
limits for the period of assessment. The risk reduction effect of alternative measures as well as the costs of
these measures shall be determined.
The approaches and methodologies used in RBIF should be compatible with the generic requirement
resulting from basic ISO Standards such as ISO 9000-series, ISO 14000-series, ISO 55000 and, in particular,
ISO 31000-series (IEC/ISO 31010, ISO/IEC Guide 51, ISO Guide 72, ISO Guide 73). Other standards with
which RBIF should be also compatible are EN 13306, OHSAS 18001, ISO 22301 and ISO/IEC 17020.
5.2.2 Plant and process documentation
The assignment of a risk-based inspection plan for pressure equipment item shall follow a well-defined,
rigorous, and logical process to ensure that all pertinent information has been considered. Otherwise,
critical factors may be overlooked.
The RBI process shall be clearly documented in a written procedure. This document procedure shall be
referenced and controlled. The procedure shall define each step to be taken during the risk assessment
process. The procedure shall explain in detail how hazards are defined for each system or item, how PoF
and CoF are established, and how this is used to determine risk level and inspection plans.
It is essential that all RBI assessment shall be clearly documented with all factors contributing to the final
risk assessment defined. A minimum documentation shall include:
— team members performing the assessment and their competence,
— re-assessment interval;
— factors used to determine risk;
— assumptions made during the assessment;
— risk assessment results (unmitigated risk levels);
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— actions required to move to new mitigation risk levels; and
— optionally: risk assessment results (mitigated risks levels).
This documentation will allow risk assessments to be reviewed on a regular basis and to be revised based
on changes to process, updated inspection information, and other new information.
5.2.3 Personnel requirements
RBIF requires competent personnel at all levels as well as appropriate routines for the execution of the
assessment. The RBI program shall define the personnel who will participate during each stage of the risk
assessment, including their required qualifications, training, plant specific knowledge and experience. Key
RBI team membe
...