ISO/TR 13881:2000
(Main)Petroleum and natural gas industries — Classification and conformity assessment of products, processes and services
Petroleum and natural gas industries — Classification and conformity assessment of products, processes and services
This Technical Report describes: _ two classification methods (one based on calculated risk, the other on judgement of risk) which may be used to determine the appropriate conformity assessment system for products, processes and services; _ a set of five conformity assessment systems from which the most suitable is chosen when conformity assessment of products, processes and services is required. NOTE Alternative classification models may be used provided their results are consistent with the conformity assessment systems to be applied.
Industries du pétrole et du gaz naturel — Classification et évaluation de la conformité des produits, procédés et services
General Information
Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 13881
First edition
2000-04-15
Petroleum and natural gas industries —
Classification and conformity assessment
of products, processes and services
Industries du pétrole et du gaz naturel — Classification et évaluation
de la conformité des produits, procédés et services
Reference number
©
ISO 2000
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ii © ISO 2000 – All rights reserved
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 References.1
3 Terms and definitions .1
4 Classification principles .2
5 Classification method based on calculation.3
6 Classification method based on judgement .4
7 Limitations.6
8 Conformity assessment systems.6
9 System A.8
10 System B.10
11 System C.12
12 System D.13
13 System E.14
Annex A Classification method based on judgement.15
Annex B Frequently asked questions.18
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from that which is
normally published as an International Standard ("state of the art", for example), it may decide by a simple majority
vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature
and does not have to be reviewed until the data it provides are considered to be no longer valid or useful.
Attention is drawn to the possibility that some of the elements of this Technical Report may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TR 13881 was prepared by Technical Committee ISO/TC 67, Materials, equipment and offshore structures for
petroleum and natural gas industries.
iv © ISO 2000 – All rights reserved
Introduction
When a user/purchaser wishes to procure a product, process or service, the user/purchaser may produce a
functional specification (see ISO 13879). If so, the manufacturer/supplier provides a technical specification (see
ISO 13880) as the basis for manufacturing or execution. The user/purchaser decides on the extent to which it is
necessary to determine, directly or indirectly, that relevant requirements are fulfilled and states this in the contract
with the manufacturer/supplier.
This document describes:
� two methodologies which enable the required degree of assurance to be determined by classification, which in
turn dictates the conformity assessment system;
� a set of five conformity assessment systems which when applied can give an increasing level of confidence
that the product, process or service conforms to stated requirements.
TECHNICAL REPORT ISO/TR 13881:2000(E)
Petroleum and natural gas industries — Classification and
conformity assessment of products, processes and services
1 Scope
This Technical Report describes:
� two classification methods (one based on calculated risk, the other on judgement of risk) which may be used to
determine the appropriate conformity assessment system for products, processes and services;
� a set of five conformity assessment systems from which the most suitable is chosen when conformity
assessment of products, processes and services is required.
NOTE Alternative classification models may be used provided their results are consistent with the conformity assessment
systems to be applied.
2 References
ISO/IEC Guide 2:1996, Standardization and related activities — General vocabulary.
ISO/IEC Guide 22:1996, General criteria for supplier's declaration of conformity.
ISO/IEC Guide 28:1982, General rules for a model third-party certification system for products.
1)
ISO 9001:— , Quality management systems — Requirements.
ISO 9002:1994, Quality systems — Model for quality assurance in production, installation and servicing.
ISO 9003:1994, Quality systems — Model for quality assurance in final inspection and test.
ISO 13879:1999, Petroleum and natural gas industries — Content and drafting of a functional specification.
ISO 13880:1999, Petroleum and natural gas industries — Content and drafting of a technical specification.
3 Terms and definitions
For the purposes of this Technical Report, the terms and definitions of conformity-assessment-related terms given
in ISO/IEC Guide 2 apply, with the exception of the terms defined below.
3.1
class
number assigned to a product, process or service, associated with the risk of its failure during use due to design or
manufacturing, process or service errors, that indicates the appropriate conformity assessment system to be
adopted
1) To be published. (Revision of ISO 9001:1994)
NOTE The classification of a product, process or service does not take into consideration failure due to misuse or incorrect
maintenance of the product, process or service.
3.2
probability of failure
frequency of occurrence of a product, process or service failure happening within one year divided by the total
number of the particular products, processes or services in operation during the same year
3.3
consequence of failure
results of the failure of the product, process or service
NOTE In the petroleum and natural gas industries, the most commonly used measure of consequence is financial cost. This
implies that the intangible aspects of the results following a failure, such as community acceptance, be translated to financial
cost. The cost for failure can comprise cost for restoring the environment (i.e. damage to the environment), deferred or loss of
production, reduction in efficiency, health and safety-related cost, etc.
3.4
risk of failure
probability multiplied by consequence
3.5
design review
formal, documented, comprehensive and systematic examination of a design to evaluate the design requirements
and the capabilities of the design to meet these requirements
NOTE 1 In the context of the document, the acceptance criteria for the design review are defined in the functional and
technical specifications (see ISO 13879 and ISO 13880).
NOTE 2 A service is also designed and can be reviewed in the same manner.
3.6
witness point
point in the chain of activities, defined in the quality or inspection plan agreed upon, to be witnessed by the
conformity assessment body if deemed necessary
3.7
hold point
point, defined in an appropriate document, beyond which an activity should not proceed without the approval of a
designated organization or authority
NOTE The approval to proceed beyond a hold point is usually given in written form, but it may be given by any other agreed
system of authorization.
4 Classification principles
For the purposes of this Technical Report, the following classification principles apply.
� CLASS should be determined taking full account of the total life of the product, process or service, starting with
its functional specification and ending with its decommissioning/demobilization.
� CLASS should take full account of the health, safety and environmental requirements valid for the countries in
which the product, process or service is created, used and/or decommissioned/demobilized.
� CLASS, when established according to clause 5 or clause 6, should be determined using verifiable
parameters.
In this Technical Report, five classes are defined, from 1 to 5, of which CLASS 1 represents the highest risk of
failure and CLASS 5 represents the lowest risk of failure.
The relationship between the classes and the conformity assessment systems is defined in Table 1.
2 © ISO 2000 – All rights reserved
CLASS only has a meaning and/or significance in combination with one of the conformity assessment systems
defined.
Table 1 — Class and conformity assessment system relationship
CLASS 1 System A
CLASS 2 System B
CLASS 3 System C
CLASS 4 System D
CLASS 5 System E
Clause 5 and clause 6 provide two different methods of CLASS determination.
5 Classification method based on calculation
5.1 General
This method can be used when specific data on costs and probabilities are available. Two sub-models are
presented here. When combined, they provide a full model for classification. The sub-models are based on the
assumption that cost can be allocated to the level of certainty that the product, process or service will fulfil its
intended purpose without failure. Other models may be used but are not described within this Technical Report.
NOTE The classification models are used by the user/purchaser of a product, process or service to calculate and thereafter
indicate which CLASS number is required to obtain the appropriate conformity assessment. The CLASS is related to the risk of
failure during use of a product, process and/or service.
5.2 Explanation of the factors used in the sub-models
The sub-models are built on the following premises:
� every activity bears risks which can be translated into cost;
� the models are applicable to the design and manufacture as well as the operational life of the product, process
or service.
The risks are connected with failures whereby the operational cost during the life is determined by in situ
maintenance, periodic inspection, required level of spare parts, etc.
NOTE The risk of failure can be reduced by, for example, more frequent inspections or supervisory actions, a thorough
maintenance process, a better controlled manufacturing/service process, etc.
5.3 Risk-related sub-model
T =(p � c )+(p � c )+(p � c ) [1]
r 0 0 1 1 2 2
where
T is the total risk, in monetary terms;
r
p is the probability of failure of the product, process or service during use, due to design;
c is the consequence of design-related failure;
p is the probability of failure of the product, process or service during use, due to manufacturing of product
or execution of services/processes;
c is the consequence of manufacturing/execution-related failure;
p is the probability of failure of the product, process or service during use, for other reasons such as
absence of proper instructions, etc.;
c is the consequence of failure related to other reasons.
The probability of failure can be obtained from historical data, preferably from a public database. In any case, a
record should be kept of where the probability data was obtained.
Furthermore, for the purposes of this Technical Report, the probability factors have to be correlated to both the
conformity assessment system which was adopted when producing the product or executing the service or
process, and the verification of performance during the life cycle.
5.4 Integrity-related sub-model
T = C + C [2]
v v c
where
T is the total cost for verification;
v
C is the planned cost for verifications during the life of the product, process or service per year;
v
C is the cost of obtaining a product, process or service using the conformity assessment system on the basis
c
of which the probability factors have been derived.
NOTE 1 Increasing the in situ verifications of products, processes or services will reduce the probability of failure because
failures are generally not incidents which happen suddenly but are preceded by a deterioration of the product's performance or
service, process execution.
NOTE 2 These increased verifications will have a risk-limiting effect and therefore act as a compensation for the risk-related
costs.
NOTE 3 The need for costs to be assessed on a yearly basis is related to the fact that the probability of failure is also based
upon annual figures. Furthermore, it should be noted that the cost spent on conformity assessment will also reduce the
probability of failure.
5.5 CLASS calculation
The CLASS calculation is based on the concept that the risk of failure of a product, process or service can be
reduced by increasing the frequency or type of verifications during the various phases of its life cycle until the point
where the risk, in monetary terms, T , is about equal to the total cost for verification, T .
r v
Therefore the CLASS calculation is iterated until the following ratio is achieved:
T /T u 1 [3]
r v
When using this Technical Report in conjunction with conformity assessment, a record of the data used to calculate
the class should be used.
6 Classification method based on judgement
6.1 General
This method can be used when specific data on costs and probabilities of failure are not available.
4 © ISO 2000 – All rights reserved
6.2 Classification process
Classification should be performed by a team of experts, from or under the responsibility of the user/purchaser, in
cooperation with the manufacturer/supplier.
The team should be knowledgeable in the following areas:
� the use of the product, process or service;
� the possible consequences which can result from failure in use of the product, process or service;
� the engineering, design/manufacturing, execution and maturity/complexity of the product, process or service.
When applicable, the manufacturer/supplier should contribute appropriate experts. Input from process and future
operating people may be available later in time, therefore classification may sometimes be the result of a step-
by-step procedure with several iterations.
A meeting is recommended during which experts should address all relevant topics. The following should be
recorded:
� meeting date;
� product, process or service identification;
� those who participated;
� the justification used to reach the final CLASS;
� unresolved issues on which consensus could not be obtained;
� the statement of CLASS.
6.3 Classification checklist
The classification checklist is used to assist the team to determine the CLASS in a structured way. The checklist
gives guidance and assistance to ensure that all aspects are discussed. Although the checklist can be extended to
a greater level of detail, it is not intended to be complete but to assist in the thinking process related to
classification. The following topics should be ranked in terms of the required level of evidence to be collected
regarding:
� intended use and reasonably foreseeable misuse;
� field-proven design;
� past use of the same product, process or service;
� effects on health;
� effects on safety;
� effects on environment;
� reliability/durability;
� effects on operational expenditure (OPEX);
� effects on capital expenditure (CAPEX);
� requirements for special skills during use;
� requirements for special skills during design, manufacturing or execution;
� the use of identical product(s), process(es) or service(s) without failure;
� confidence in manufacturer/supplier.
6.4 Determination of the CLASS
The CLASS should be determined by the user/purchaser based upon the discussion and the result of the checklist.
Annex A gives a possible model for the determination of the CLASS.
7 Limitations
The CLASS can be used to determine the required conformity assessment system if the following requirements are
met:
� CLASS is determined according to the methods stated in the scope of this Technical Report or equivalent
methods;
� the records, quoted in clause 5 or clause 6, can be made available to the conformity assessment body before
the process of conformity assessment takes place;
� the records, quoted in clause 5 and clause 6, are kept for one year after completion of the conformity
assessment.
8 Conformity assessment systems
For conformity assessment purposes, five systems, identified as systems A, B, C, D and E, are considered in this
Technical Report.
These systems, one of which is specified by the user/purchaser, are intended to provide assurance that products,
processes or services are in conformity with the functional, as well as the technical, specification.
It is assumed that the functional specification is a fixed document for the duration of the conformity assessment
activities dealt with in this Technical Report.
These systems provide different levels of confidence that gradually decrease from system A to system E. Table 2
illustrates the main characteristics of the five systems. Design review and/or type tests are an important part of the
conformity assessment systems. Type testing, including examination of a product, process or service design or
testing of prototypes, or witnessing of processes or services, can provide a basis for conformity assessment of
manufactured products or executed processes and services.
Type tests can be omitted and/or replaced by an examination, review or alternative calculation whenever one or
both of the following conditions is relevant:
� the type test is not relevant and/or practical for the product, process or service to be assessed;
� the requirement for type testing is waived in the functional specification. The system to be adopted for each
specific product, processes or service should be defined in the contract.
In addition to the documentation issued by the conformity assessment body in accordance with its conformity
assessment scheme, the manufacturer/supplier should issue a declaration of conformity for the product, process or
service in conjunction with a reference list of verifications that demonstrate conformity.
NOTE ISO/IEC Guide 22 provides general criteria for a supplier's declaration of conformity (SDoC) in cases where it is
desirable, or necessary, that conformity of a product, process or service to normative documents be indicated, irrespective of
the sector involved. The supplier may then declare under its responsibility the conformity to normative documents.
ISO/IEC Guide 22 is intended for application in situations where a third party is not required.
6 © ISO 2000 – All rights reserved
Table 2 — Characteristics of conformity assessment systems relevant for the petroleum
and natural gas industries
Conformity assessment
System A System B System C System D System E
operation
Design review(s) x
2 2 2
Type test(s) x x x
Conformity between functional and
xx x
technical specification
Quality system verification, x x
using: ISO 9001, ISO 9002,
ISO 9002 ISO 9003
Product, process or service
surveillance by:
3 3
— periodic inspection x , and/or — x —
— inspection of samples/trials — x, or — x, or
— 100 % inspection x x — x
Declarations of conformity by
conformity assessment body, by
means of:
— certificate and/or mark of
xx x —
conformity
— certificate of inspection results — — — x
Manufacturer/supplier’s declaration
yy yy y
of conformity inclusive reference
list
NOTE ISO/IEC Guide 28 provides a model third-party certification system of determining conformity with product
specifications through initial testing, assessment of a factory quality management system and its acceptance, followed
by surveillance. This model system is comprehensive and can therefore offer a basis for the development of other
systems.
x Action by assessor.
x Action by assessor. This action is not required if the specific product, process or service does not require
design. In this case the quality system verification should be based on ISO 9002.
x Action by assessor. The type test can be omitted if:
� it is not relevant and/or practical for type of product, process or service;
� the functional specification waives the requirements for type testing.
x Action by assessor. This action is to be performed during the manufacturing or execution during the period of
certificate validity.
y Action by manufacturer/supplier.
9SystemA
9.1 General
This system describes the procedure whereby the conformity assessment body performs examinations, type tests
and surveillance in order to declare that identified products, processes or services fulfil the performance
requirements defined in the functional specification.
It includes the following activities:
� the design review, resulting in the issue of a design review declaration;
� the execution and/or witnessing of type tests as required;
� the verification of the manufacturer/supplier’s quality system in accordance with ISO 9001. In case the specific
product, process or service does not require design, ISO 9002 applies;
� the execution of product, process or service surveillance relating to the requirements of the technical
specification, by both periodic inspection during the manufacturing process or execution of process or service
and 100 % inspection of the product, process or service taking into account the selected characteristics
identified during the design review.
9.2 Design review, type test and verification of conformity of the technical specification
with the functional specification
In case the specific product, process or service does not require design, subclause 10.2 of this Technical Report
applies. The manufacturer/supplier should apply to the conformity assessment body for a design review. The
manufacturer/supplier should provide the necessary information, which enables conformity assessment with the
functional specification. It should include:
� the technical specification, including reference to standards that have been used;
� supporting evidence of conformity with the functional specification, including relevant results of design reviews,
alternative calculations and, if applicable, type tests carried out.
The conformity assessment body should:
� examine the technical documentation;
� in case of a type test, verify that the sample(s) of products, processes or services to undergo the type test
have been manufactured or their execution planned in conformity with the technical documentation;
� agree with the manufacturer/supplier the location at which the inspections should be carried out;
� perform the approp
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