Technology qualification management and verification

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1 SERVICE SPECIFICATION DNVGL-SE-0160 Edition December 2015 Technology qualification management and verification The electronic pdf version of this document found through is the officially binding version. The documents are available free of charge in PDF format.

2 FOREWORD DNV GL service specifications contain procedural requirements for obtaining and retaining certificates and other conformity statements to the objects, personnel, organisations and/or operations in question. December 2015 Any comments may be sent by to This service document has been prepared based on available knowledge, technology and/or information at the time of issuance of this document. The use of this document by others than DNV GL is at the user's sole risk. DNV GL does not accept any liability or responsibility for loss or damages resulting from any use of this document.

3 CHANGES CURRENT General This document supersedes DNV-DSS-401, December This new document has a wider scope, and the scope of the preceding document is now covered in Sec. [3.3]. Text affected by the main changes in this edition is highlighted in red colour. However, if the changes involve a whole chapter, section or sub-section, normally only the title will be in red colour. On 12 September 2013, DNV and GL merged to form DNV GL Group. On 25 November 2013 Det Norske Veritas AS became the 100% shareholder of Germanischer Lloyd SE, the parent company of the GL Group, and on 27 November 2013 Det Norske Veritas AS, company registration number , changed its name to. For further information, see Any reference in this document to Det Norske Veritas AS, Det Norske Veritas, DNV, GL, Germanischer Lloyd SE, GL Group or any other legal entity name or trading name presently owned by the DNV GL Group shall therefore also be considered a reference to. Changes current Main changes August 2015 General The title of document has been changed from Technology qualification management to Technology qualification management and verification to reflect the increased scope. The document has been structured to match the different phases of a project. Sec.1 Introduction New text to introduce to entire scope. Sec.2 Pre-qualification New section has been added. Sec.3 The planning phase [3.1] and [3.2]: Early stage pre-qualification and screening services included. [3.3]: Adjustments and editing of the scope previously described in DNV-DSS-401. [3.4]: New sub-section Design verification and document review. [3.5]: New sub-section Qualification of the manufacturing process. Sec. 4 to 5 New sections Sec.4 Verification of technical functionality and Sec.5 The cessation phase. Appendix A Use of technology readiness levels App.A has been amended compared to the preceding DNV-DSS-401. Editorial corrections In addition to the above stated main changes, editorial corrections may have been made. Service specification DNVGL-SE-0160 Edition December 2015 Page 3

4 Contents CHANGES CURRENT... 3 Sec.1 Introduction General Assuring qualified technical functionality for designated service Value proposition Purpose Definitions Value creation Premisses for qualification of technical functionality Objectives of qualification of technical functionality Building trust and confidence Principles of qualification of technical functionality Qualification of technical functionality in the perspectives of owners, users and suppliers About this document References...13 Sec.2 Pre-qualification Sec.3 The planning phase Screening Introduction DNV GL assistance Concept selection Introduction DNV GL assistance Technology qualification management Introduction Objective The basic technology qualification process Definition of qualification basis Technology assessment Threat assessment Modifications Development of the technology qualification plan Provision of qualification evidence execution of the qualification plan Performance assessment stating the acceptance criteria Technology certification scheme Determination of scope of work Design verification and document review Introduction DNV GL assistance Qualification of the manufacturing process General principles Verification scheme Results...24 Sec.4 Verification of technical functionality Products for delivery Verification scheme for products...25 Contents Service specification DNVGL-SE-0160 Edition December 2015 Page 4

5 4.1.2 DNV GL scope Integration for delivery Verification scheme for integration DNV GL scope Operations Purpose Verification schemes for operations Documentation requirements Scope Main principles Verification deliverables Renewal General Re-verification Introduction Scope...27 Sec.5 Cessation phase Qualification and verification of decommissioning Removal Recycling and disposal...29 App. A Use of technology readiness levels Contents Service specification DNVGL-SE-0160 Edition December 2015 Page 5

6 SECTION 1 INTRODUCTION 1.1 General This service description supersedes the previous DNV-DSS-401 that described services denoted Technology qualification management offered by DNV GL. This new service specification describes: A performance-based end-to-end service offering from early planning through to verification of deliveries, their use in operations and their cessation of use. This includes the technology qualification management services already described in the previous DNV-DSS-401 which is now found in Sec The connection between the services for technology qualification and verification of technical functionality as provided by DNV GL. Involvement required by DNV GL depending on the requested service and the pertinent project phase. Focus of this document is placed on the transactions and hand-overs for which technology qualification and verification of technical functionality is needed: When planning is completed and specifications are handed over to a supplier that takes responsibility for delivery. At delivery when responsibility for the delivery is handed over to the operator or another recipient. When operations cease and responsibility is handed over to an internal or external recipient for discontinuing the operations in a responsible manner. This document is subdivided into sections that address planning, delivery, operation and cessation. The technology qualification services described in the previous DNV-DSS-401 are now mainly described under the Technology qualification management in [3.3]. 1.2 Assuring qualified technical functionality for designated service Value proposition Qualification of technical functionality is for: Manufacturers and service providers seeking market access for their equipment, devices and facilities or associated use. Operators, contractors and others seeking acceptance for their operations When adequate acceptance criteria for a technology do not exist already, then qualification and verification of technical functionality enables the delivery of equipment, devices and facilities that are in demand, as well as the operation of these in the manner that is needed Purpose This document is intended to be used as contractual reference between a supplier and a recipient of a delivery. The recipient can be an end user such as an operator of an oil field, a contractor offering services to operators or a system integrator that integrates the delivery with other products or services This document is also intended as a contractual reference when DNV GL performs qualification services for customers The purpose is to help suppliers getting justified market access and help recipients assuring the adequacy of deliveries and getting justified acceptance for using them in operations. Service specification DNVGL-SE-0160 Edition December 2015 Page 6

7 1.3 Definitions Table 1-1 Definitions of verbal forms Term shall should may Definition verbal form used to indicate requirements strictly to be followed in order to conform to the document verbal form used to indicate that among several possibilities one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required verbal form used to indicate a course of action permissible within the limits of the document Table 1-2 Definitions except for the definitions provided in this table, this document uses the definitions that are provided in DNV-RP-A203 Term adequate argument basic claim certificate conceptually feasible critical parameter customer evidence endorsement of qualification plan fit for designated service function functionality hazard hazid qualification of technical functionality novel technology performance proven qualified technology solution solution qualification Definition determined relevant for the particular case and that with best endeavours has been assured complete (about a set of acceptance criteria) demonstration of how evidence supports a claim in context what the qualification aims to prove true in the context of this Service Specification a verification deliverable issued by DNV GL based on a certification scheme that is already published that the main challenges have been identified and judged to be resolvable by use of sound engineering practices (about a technology at an early stage of development) Although a technology has been stated conceptually feasible, there are still activities necessary to be performed in order to qualify the technology. Consequently, there will be a possibility that in practice it will not be possible to establish relevant and complete acceptance criteria for Solutions, and associated requirements to certification. parameters used to express the difference between function and mal-function or failure quantitatively DNV GL s contractual partner facts used in an argument to support a claim in context statement by DNV GL affirming that, at the time of assessment, the technology can be qualified through the remaining, planned activities capable of providing the required functions with adequate performance on the conditions of proper use and proper condition management what something is intended to do external function departure from the design and operating intention that could cause damage, injury or other form of loss (from Chemical Industries Association HAZOP Guide) structured review with the purpose of identifying all significant hazards associated with the particular task under consideration DNV GL s contribution to the process between a supplier and a recipient to ensure that deliveries can be depended on This includes technology qualification to develop acceptance criteria and associated documentation requirements when needed in an end to end perspective that includes verification of compliance with validated requirements and stating this for production, delivery and implementation to service. technology for which acceptance criteria for the solutions are incomplete This includes the application of previously qualified technology in a different context. A technology that has been qualified by some may be novel to others, who are unfamiliar with adequate acceptance criteria for the solutions. quantitative expression of function demonstrated not to fail in service when adequate acceptance criteria, proper use, proper condition management and requirements to documentation are adhered to The degree to which something is proven depends on the extent of service exposure and the extent to which the actual service has challenged failure margins. A proven technology can be unknown to a particular supplier or user and therefore require qualification if supplied or used by that party. technology for which adequate acceptance criteria for the solutions are available practical application of technology, by way of using equipment, devices or facilities substantiation that a solution conforms with adequate acceptance criteria Service specification DNVGL-SE-0160 Edition December 2015 Page 7

8 Table 1-2 Definitions except for the definitions provided in this table, this document uses the definitions that are provided in DNV-RP-A203 (Continued) Term statement of feasibility system task technology technology qualification verification statement Definition document issued by DNV GL affirming that, at the time of assessment, the technology was considered conceptually feasible and suited for further development and qualification according to the principles of DNV-RP-A203 entity that interacts with other entities, i.e. other systems, including hardware, software, humans, and the physical world with its natural phenomena piece of work to be undertaken (for example to produce natural gas, transport oil, harvest wind energy or distribute power) way to provide function, by combining methods, techniques, skills, equipment, tools, materials, or other, in a given service context process of establishing adequate acceptance criteria for solutions This definition, synonymous with the one stated in DNV-RP-A203, is used here to clarify that the acceptance criteria stemming from the technology qualification constitute the basis for verification of technical functionality of solutions. in the context of this service specification a verification deliverable issued by DNV GL based on a verification scheme that is not conforming to a published certification scheme, e.g. because elements of the verification scheme are stemming from the technology qualification process for the case at hand Such verification scheme is typically based on customer's specification and/or negotiated between DNV GL and customer. 1.4 Value creation Premisses for qualification of technical functionality Wealth in society arises from performing tasks such as producing natural gas, harnessing wind energy or distributing electric power. These tasks are undertaken by putting equipment, devices or facilities to use To perform tasks and thus create value depends on the following premisses: Confidence by the supplier that the product or service will be accepted, or else the supplier will not undertake to develop and offer it to the market. Confidence by the recipient that the solution will work, or else the recipient will not rely on it when committing to undertake a task. Assurance that the task can and will be performed in a responsible manner without undue risks or environmental impact, or else the undertaking of the tasks will not be accepted by society Objectives of qualification of technical functionality The objective of qualification of technical functionality is to assure fulfilment of the above premisses for customers who contribute to the performance of a task: Recipients who consider offerings of prospective suppliers and who integrate them into a system capable of performing the task. The recipient may delegate the role as system integrator to another party. Recipients who employ a network of suppliers, contractors and others to provide equipment, devices or facilities. Recipients who employ a network of suppliers, contractors and others to operate equipment, devices or facilities (these suppliers are typically different from those providing the initial delivery). Suppliers who develop products or services for which they think there will be a future need. Suppliers who offer a delivery to a recipient and want to demonstrate the capabilities (functions and associated performance) that can be expected in use Qualification of technical functionality enables progress by creating confidence in novel solutions that might not be completely covered by acceptance criteria given by existing standards and practices, and by providing assurance for performing tasks in novel ways which those standards and practices might not cover. Service specification DNVGL-SE-0160 Edition December 2015 Page 8

9 Qualification of technical functionality helps make explicit the contribution to value creation of each party in the network of suppliers and recipients, so that critical contributions to task performance can be identified and assured Building trust and confidence Qualification of the technical functionality of equipment, devices or facilities contributes to the trust and confidence in solutions that they are safe and reliable in use by: Identification of relevant acceptance criteria and documentation requirements from existing standards and practices. Filling the gaps for innovative solutions where existing standards and practices lack relevance or completeness by developing tailored acceptance criteria and documentation requirements for the particular case. Substantiation that solutions conform to those criteria. Issuance of verification deliverables to affirm this Verification can cover: That solutions are designed properly and implemented with suitable manufacturing processes. That solutions are integrated properly. That adequate systematics are in place for safe and reliable operations The level of independent involvement in qualification and verification should be differentiated according to risk. For example, if the risk is high, the level of involvement should be high. Conversely, if the risk is substantiated to be low, the level of involvement can be adapted accordingly Principles of qualification of technical functionality Technology qualification delivers adequate acceptance criteria that make equipment, devices or facilities qualified for designated service based on conformance with those criteria. Guidance note: The term qualified technology can be used to say that adequate acceptance criteria and documentation requirements exist for the case at hand. ---e-n-d---of---g-u-i-d-a-n-c-e---n-o-t-e--- A set of acceptance criteria is considered adequate if it is determined to be relevant for the particular case, and if it is substantiated that best endeavours have been made to assure completeness The technology qualification process identifies and adopts relevant requirements and acceptance criteria of existing DNV GL standards and other, validated standards and practices and adds tailored criteria for completeness Qualification of technical functionality delivers the requirements to documentation as described herein. The adequacy of the resulting verification requirements brings trust and confidence to those who rely on the equipment, devices or facilities in service This document describes how the qualified technical functionality of equipment, devices or facilities can be affirmed by DNV GL, following design verification and production survey and follow-up. This document further describes how DNV GL can affirm that the designated service is adhered to when in operation Independent qualification facilitates the processes and transactions between suppliers and recipients by: Creating trust and confidence throughout the network of suppliers and recipients by assuring that validated requirements are developed and available to be followed. Provision of documentation about function and performance as well as potential failures and consequences. Clarification of roles and responsibilities in the network of suppliers and recipients. Service specification DNVGL-SE-0160 Edition December 2015 Page 9

10 The starting point for qualification of technical functionality is the qualification basis. The qualification basis shall contain a clear statement of the basic claim that the qualification processes will aim to prove true. Guidance note: The basic claim could e.g. state that a piece of equipment, device or facility can operate safely, reliably and efficiently in its designated service without undue impact on the environment. The basic claim can evolve as qualification progresses, e.g. for clarification when more precise knowledge is established, or by adjusting the ambition up or down (e.g. targeted reliability level) depending on the qualification efforts needed, or market situation. In a technology qualification process the basic claim will be included in the qualification basis. ---e-n-d---of---g-u-i-d-a-n-c-e---n-o-t-e A solution employed to perform a task might consist of interacting subsystems as illustrated in Figure 1-1. The qualification principles herein can be applied to the higher-order system and to each of the subsystems. The interfaces between sub-systems define the boundary conditions for qualifying each subsystem. System System integrator Subsystem Subsystem Subsystem Subsystem Subsystem Figure 1-1 A system consisting of subsystems; qualification of technical functionality can be used on the total system and on individual sub-systems Individual technical subsystems can be delivered and operated by different parties. To ensure successful task performance, roles and responsibilities in the network of suppliers and recipients must be clear A system integrator takes on that role to assure that the integrated system performs according to the performance description The user is responsible for how the system is operated and for feeding service experience back into development so that further progress can be made The technology qualification process aims to substantiate the basic claim ([ ]) with qualification documentation. The qualification documentation will consist of evidence and argument to show that the resulting acceptance criteria for the solution are adequate Key inputs to technology qualification are: a system description what it is that the qualification addresses a description of owner requirements including performance, service context and intended use On this basis, key elements of independent qualification are to: Establish adequate acceptance criteria for qualification of equipment, devices or facilities assuring that the basic claim is valid throughout the service life. Demonstrate compliance with the acceptance criteria during planning, delivery, operations and cessation of use In support of this aim, DNV GL can issue official statements in accordance with the provisions herein In order that verification deliverables for equipment, devices or facilities can be issued by DNV GL, the basic claim ([ ]) must as a minimum cover the safety and environmental impact as required or implied by government or international regulation. Service specification DNVGL-SE-0160 Edition December 2015 Page 10

11 In cases of inadequate government requirements for safety and environmental impact, DNV GL will require substantiation of best endeavours to assure the safety and the minimal impact on the environment The technical functionality of equipment, devices and facilities can be verified according to this service specification. Details of the case-specific verification scheme that are not published by DNV GL already will be published on exchange.dnv.com with reference to this document Qualification of technical functionality in the perspectives of owners, users and suppliers Figure 1-2 illustrates the handovers that qualification of technical functionality can help assure. Qualification of technical functionality can be applied to support decision-making in all these hand-overs. Guidance note: The task to be performed by an end user in the operations phase could be to produce natural gas or to perform underwater work. The operations of suppliers consists in providing solutions for delivery to recipients. The task to be performed in a supplier s operations is thus to deliver a solution to a recipient. The planning phase is the development and qualification of the technology. The delivery phase is the implementation in the supplier s factory of the means to produce and deliver the solution in compliance with set requirements for the qualified technology. ---e-n-d---of---g-u-i-d-a-n-c-e---n-o-t-e--- Qualification of technical functionality Technology qualification Prequalification (Ch. 2) Planning (Ch. 3) Delivery (Ch. 4) Operation (Ch. 5) Cessation (Ch. 6) Feasible Ready for delivery Designated service Operation ceased Figure 1-2 Major hand-overs that qualification of technical functionality can help to assure illustrated by phases (referencing chapters of this document) When a recipient contemplates delivery from a supplier, both parties to this transaction want the solution to be qualified for its designated service. This gives rise to different perspectives on qualification: The supplier perspective considers delivery to a user with a performance description that defines what the delivery is capable of doing and the boundary conditions that were assumed (the red circle in Figure 1-3). The owner and user perspectives consider the service of the solution in task performance. In addition to the delivery, this perspective includes the users of the system, the task that is performed and interfaces to other sub-systems needed for task performance The user perspective changes when entering the operation phase: The planning and delivery phases focus on the planning, procurement, manufacture and integration of all the subsystems (from the left in Figure 1-3). The operations phase focuses on the use of the system to perform tasks (from the right in Figure 1-3). The network of suppliers and recipients differ in these phases, as do the main concerns and interests of the involved parties Qualification of technical functionality supports all these perspectives. The handover to operations is a critical milestone towards successful task performance that qualification of technical functionality helps to assure. Service specification DNVGL-SE-0160 Edition December 2015 Page 11

12 People Supplier Tasks Recipient Figure 1-3 A transaction in the network of suppliers and recipients: supplier perspective (inside out) and recipient perspectives in the delivery phase (from the left) and the operations phase (from the right) About this document This document describes how DNV GL can assist the network of suppliers and recipients to substantiate that deliverables can be depended on. Guidance note: A complete list of service documents that are applied in connection with technology qualification, verification, certification and classification can be found at ---e-n-d---of---g-u-i-d-a-n-c-e---n-o-t-e This document explains DNV GLs application of the intention and principles of DNV-RP-A203 for technology qualification, as the core of qualification of technical functionality and as the basis for verification of the finished solutions This document applies to qualification of technical functionality within all industries To provide for introducing solutions that are based on technologies which are not covered (completely) by relevant, pre-existing acceptance criteria, this document describes the provisions for issuance in such cases of statement of feasibility, endorsement of qualification plan, technology certificate as well as verification deliverables for equipment, devices and facilities and the appropriate use and condition management during operations For solutions covered completely by relevant, pre-existing acceptance criteria and verification requirements, those pre-existing acceptance criteria and verification requirements apply This document consists of five sections, this introductory section followed by a section covering an introductory pre-qualification phase, and one section covering each phase of a generic development project: Sec.1 (this section) describes the value proposition for qualification of technical functionality, introduces the premisses and principles, and provides definitions and references. Sec.2 describes general services offered by DNV GL in order to support choice of general concepts and other high-level, pre-development activities. Sec.3 describes services offered by DNV GL in the planning phase of projects, covering both the supplier and recipient perspectives. This includes services based on DNV GL s general technology qualification process which is further detailed in DNV-RP-A203. Service specification DNVGL-SE-0160 Edition December 2015 Page 12

13 Sec.4 to Sec.5 describes services offered by DNV GL in the delivery, operations and cessation phases, respectively. 1.5 References DNV-RP-A203 Technology Qualification DNV GL rules for classification: Offshore units DNV-OSS-300 Risk Based Verification Reference is also made to the other documents listed at Service specification DNVGL-SE-0160 Edition December 2015 Page 13

14 SECTION 2 PRE-QUALIFICATION Products and services can be prequalified for a designated service type, with the aim of enhancing subsequent concept selection and conceptual design for a particular project. DNV GL can assist establishing suitable prequalification requirements for a type of designated service. DNV GL can verify compliance of candidate product or service offerings with stated prequalification requirements. Service specification DNVGL-SE-0160 Edition December 2015 Page 14

15 SECTION 3 THE PLANNING PHASE 3.1 Screening Introduction Prior to concept selection, products and service offerings can be screened for fulfilment of goals and higher-level acceptance criteria DNV GL assistance DNV GL can assist establishing screening criteria addressing: opportunities (performance gains, cost saving opportunities and efficiency gains) obstacles (qualification effort remaining, lead time etc.) risks (hazards and failures) DNV GL can assist with assessing fulfilment of stated screening criteria and report the results DNV GL can provide advice on the further handling of screened solutions, e.g. regarding follow-up and whether technology qualification would be needed. 3.2 Concept selection Introduction Concepts can be matured to provide the functionality required for successful task performance by choosing among existing products and services, by developing new solutions or by combining them DNV GL assistance DNV GL can assist choosing candidates for evaluation, evaluate the candidates and report the results of the evaluation including recommendations and limitations To provide a solid basis for concept selection, DNV GL can assist with analysis of opportunities, obstacles and risks of candidates using methods such as function assessment, value analysis, hazard identification and risk assessment DNV GL will not perform the actual concept selection. DNV GL will not in any way assume responsibility for or ownership to the selected solutions. 3.3 Technology qualification management Introduction If a solution exceeds the scopes of established rules, standards or practices or available, relevant operational experience, it cannot be taken as fully covered by adequate acceptance criteria. For such solution to be qualified, adequate acceptance criteria for qualification of the solution shall first be established using technology qualification principles. Guidance note: This section is equivalent to the preceding service specification DNV-DSS-401 Technology Qualification Management. ---e-n-d---of---g-u-i-d-a-n-c-e---n-o-t-e Adequate acceptance criteria for solutions can be developed by a systematic technology qualification process in accordance with DNV-RP-A DNV GL offers technology qualification services in an independent capacity where the technology is challenged and assessed and acceptance criteria for safety, performance, and other relevant Service specification DNVGL-SE-0160 Edition December 2015 Page 15

16 characteristics are developed. This makes solutions ready for verification and certification, which require these acceptance criteria for completeness This section describes the following services: Facilitation of the basic technology qualification process. Performance of independent qualification activities such as independent tests and analyses Objective The objective of this section is to describe how DNV GL can assist technology developers and users with independent and professional technology qualification in accordance with the recommendations of DNV-RP-A The basic technology qualification process Technology qualification is a systematic, stepwise and iterative process described in DNV-RP-A203 with the following steps: 1) definition of qualification basis 2) technology assessment 3) threat assessment 4) development of the qualification plan 5) execution of the qualification plan (collect evidence, perform analyses and testing) 6) performance assessment. Qualification Basis Set the performance targets Modifications Tailor targets, plan or the technology Technology Assessment Analyse how to assure the functions Threat Assessment Identify the failure modes and risks Qualification Plan Plan the provision of evidence When no prohibitive obstacles When technically executable Statement of Feasibility Endorsement of Qualification Plan Qualification Execution Provision of the evidence Performance Assessment Compare with the performance targets 3. No Targets met? Yes Technology Qualified When requirements met Technology Certificate Figure 3-1 Steps in the basic technology qualification process (from DNV-RP-A203) showing also issuance of the statements and certificates described in Sec.3 C1100. Service specification DNVGL-SE-0160 Edition December 2015 Page 16

17 The technology qualification process is iterative. Iterations are triggered by modifications to the technology or to the requirements Figure 3-2 illustrates the technology qualification strategy for defined solutions and where the designated service is evolved by successive technology qualification processes. Alternatively a technology qualification strategy can be performed for a given designated service and use successive technology qualification process iterations to help develop the solution. 1 st stage: Very limited service with frequent inspection and testing in parallel 2 nd stage: Limited service based on some experience and improved test results Final stage: Full service based on field experience and completed tests Qualification stage TQ1: Qualification stage TQ2: Final qualification stage: Qualification Basis Set the requirements Technology Assessment (TA) Novelty and prohibitive obstacles Threat Assessment Failure modes and risks Qualification Plan (QP) Select qualification methods Execution of the plan Collect evidence Performance assessment Verify compliance with requirements Qualification Basis Set the requirements Technology Assessment (TA) Novelty and prohibitive obstacles Threat Assessment Failure modes and risks Qualification Plan (QP) Select qualification methods Execution of the plan Collect evidence Performance assessment Verify compliance with requirements Qualification Basis Set the requirements Technology Assessment (TA) Novelty and prohibitive obstacles Threat Assessment Failure modes and risks Qualification Plan (QP) Select qualification methods Execution of the plan Collect evidence Performance assessment Verify compliance with requirements Requirements met? No Requirements met? No Requirements met? No Yes Yes Yes Technology Qualified (TQ1) Technology Qualified (TQ2) Technology Qualified (TQ) Figure 3-2 Technology qualification stages in a sequential programme for entering to service of technology that is not qualified for its intended, final use immediately Definition of qualification basis The qualification basis provides a technology description, a performance description and a manufacturing description including installation with basis in DNV-RP-A203 Sec.6 and states the basic claim that the qualification aims to prove true The purpose of the qualification basis is to provide a common set of requirements against which all qualification activities and decisions will be assessed. Through further qualification processes these requirements are demonstrated to be fulfilled The qualification basis can either be compiled by DNV GL using inputs provided by the customer or written by the customer and verified by DNV GL DNV GL can provide information which the customer can use as basis for choosing solutions. DNV GL can also evaluate solutions and report the results of the evaluation, including recommendations or limitations DNV GL will not perform the actual selection of solutions. DNV GL will not in any way assume responsibility for or ownership to the solutions described in the qualification basis. Service specification DNVGL-SE-0160 Edition December 2015 Page 17

18 3.3.5 Technology assessment The purpose of the technology assessment is to determine which elements are not completely covered by existing relevant acceptance criteria, and identify their key challenges and uncertainties. Guidance note: Elements that are not completely covered by existing relevant acceptance criteria are called novel elements The technology assessment includes: ---e-n-d---of---g-u-i-d-a-n-c-e---n-o-t-e--- Description of the functions and performance of the system needed for it to perform its specified types of tasks. Identification of parameters that quantify the performance expectations to those functions. Analysis of the structure of the technology (i.e. the composition and interaction between elements). Categorisation of the technology elements distinguishing those that require technology qualification from those where adequate acceptance criteria exist; and for the latter provide traceable references to those acceptance criteria. Identification of the main challenges and uncertainties to be addressed by the technology qualification For complex systems the main challenges and uncertainties should be identified by carrying out a high level hazid (hazard identification). Guidance note: A high level hazid is a means of obtaining a better understanding of a system at an early stage, and to identify which parts of the system that need to be further developed or documented in more detail, prior to the threat assessment. ---e-n-d---of---g-u-i-d-a-n-c-e---n-o-t-e The technology assessment may be carried out by DNV GL with participation by the customer and other stakeholders, or can be carried out by the customer and verified by DNV GL with basis in Sec.7 of DNV-RP-A Threat assessment The objective of the threat assessment is to identify relevant failure modes with underlying causes and failure mechanisms for the technology, and to assess the associated risks The threat assessment is performed using methods described in Sec.8 of DNV-RP-A203 and is used as the basis for defining and prioritising the activities in the technology qualification plan The failure mode identification and risk assessment involves: General preparations including selection of threat assessment methods to be employed. Determination of probability and consequence classes and defining the risk matrix when used. Failure mode assessment involving relevant expertise Conservative estimates can be used in lack of evidence to support more accurate estimates of failure probabilities or failure margins. The degree of conservatism reflects the level of uncertainty and hence tends to increase with degree of novelty. The conservatism of assumptions shall be substantiated. High consequence risks are not considered low risk, regardless of probability class, to ensure that highconsequence and low-probability risks are addressed by the qualification activities and not dismissed based on low probability For complex systems or boundary conditions the threat assessment process can be carried out as workshops, involving experts covering the necessary fields of competence and experience The report from the threat assessment contains a register of all identified risks and it identifies those to be addressed by the continued technology qualification. For each risk determined not to be addressed by the technology qualification, it also provides either reference to acceptance criteria from referenced standards or practices that are considered adequate for that risk, or reference to evidence substantiating that the risk has been adequately accounted for. Service specification DNVGL-SE-0160 Edition December 2015 Page 18

19 The failure mode identification will be planned, chaired and reported by DNV GL. In cases where DNV GL possesses sufficient knowledge and experience with similar technologies, the threat assessment may be performed as a back-office exercise by DNV GL. A threat assessment executed without DNV GL involvement may be accepted by DNV GL after careful review Modifications Feedback loops between the steps imply that the technology qualification process is iterative in nature. Consideration is given to design modification to improve safety, performance, longevity, cost and ease of manufacture or operation, amongst others. User requirements may also be modified Modification shall be incorporated in the qualification basis DNV GL can provide inputs to the choice of modifications, evaluate their effects and report the results of the evaluation including recommendations or limitations DNV GL will not perform the actual selection of modifications. DNV GL will not in any way assume responsibility for or ownership to modifications adopted or solutions described in the qualification basis Such modifications trigger full or partial iterations of the basic technology qualification process in order for the requirements in the technology qualification basis to be fulfilled Development of the technology qualification plan The purpose of technology qualification planning is to describe how qualification evidence will be provided The pieces of evidence to be provided in support of the basic claim ([ ], [ ]) are identified. The qualification argument addresses both assurance of specified functionality and performance ([ ], 1 st bullet) and mitigation of the failure modes in the risk register ([ ]) Suitable qualification methods are identified that can provide those pieces of evidence The qualification plan shall provide the information necessary to serve as a basis for: iterating through specified qualification states later development of detailed descriptions of qualification activities The qualification plan explains the reasoning justifying the selected qualification activities by: Identifying the pieces of evidence they are intended to produce. Tracing this evidence back to claims made of functionality and performance and the failure modes they intend to mitigate and the required failure margins. Entailing an unambiguous description of the acceptance criteria to determine if the qualification activities were successful in providing the required evidence Preparation of the qualification plan can be done by the customer or the customer s subcontractor and reviewed by DNV GL or subcontracted to DNV GL Detailed descriptions of the qualification activities are subsequently developed at a procedural level as required to carry out the activities and obtain satisfactory results: These detailed descriptions can be prepared by the customer or the customer s subcontractor or subcontracted to DNV GL. When prepared by the customer or the customer s subcontractor they are verified by DNV GL to ensure they are suitable for providing the evidence described in the qualification plan Provision of qualification evidence execution of the qualification plan The Technology qualification plan is executed in order to provide qualification evidence. Service specification DNVGL-SE-0160 Edition December 2015 Page 19

20 The activities in the qualification plan can be performed by the customer or the customer s subcontractor or they can be subcontracted to DNV GL. This can include: providing technical expertise in failure mode identification and risk ranking formulation of assurance arguments technical analyses and studies laboratory testing or computer analyses development of models for failure mechanisms development of plans and specifications for analyses and testing to be carried out by DNV GL or others risk and reliability analyses For the purpose of issuing a technology certificate, DNV GL must be sufficiently involved in the qualification activities in order to determine whether: the activities have been performed according to the technology qualification plan and as detailed in procedural descriptions the results are derived and reported correctly. For activities not performed by DNV GL this can include surveys, witnessing and independent analyses and tests Performance assessment stating the acceptance criteria The performance assessment reviews the available qualification documentation against the technology qualification basis and the acceptance criteria in the qualification plan A successful performance assessment implies that the technology qualification has been successfully completed and hence that the basic claim is proven true for the cases covered by the qualification For the purpose of issuing DNV GL technology certificate, DNV GL will review evidence and arguments to assess whether the claims made have been adequately substantiated and whether the critical failure modes identified in the threat assessment have been accounted for. Furthermore DNV GL will review the evidence to confirm that it has been established and documented in accordance with the provisions of DNV-RP-A Following a successful performance assessment, acceptance criteria are stated in terms of critical parameters that, when complied with, imply that the qualification conclusion is valid. In case the qualification addresses a particular instance, with clearly specified design and designated service, the acceptance criteria would state the values of the critical parameters that were covered by the qualification. This could be e.g. dimensions, geometry, material properties and service conditions. In case a range of instances are covered by the technology qualification, such as a range of dimensions or performance ranges, the acceptance criteria would specify what combinations of the critical parameters that are covered by the qualification so that the basic claim has been substantiated. Such acceptance criteria can be formulated e.g. as mathematical equations, tables or design curves in terms of critical parameters Technology certification scheme DNV GL can deliver reports and statements associated with the progress of the basic technology qualification process described in DNV-RP-A The main steps in the basic qualification process are: TA - Finalisation of the technology assessment. QP - The technology qualification plan has been defined. TQ - Completion of technology qualification. Service specification DNVGL-SE-0160 Edition December 2015 Page 20

21 When several basic qualification processes are performed successively as phases in a technology qualification program, then the final step of each phase is designated attainment of qualification state (QS). Guidance note: The qualification state (milestone) that concludes each phase should be defined by the qualification plan for that phase. The phases can be seen in relation to typical phases in offshore field development projects, where information from the technology qualification progress is needed as basis for decisions (Figure 3-2). ---e-n-d---of---g-u-i-d-a-n-c-e---n-o-t-e The qualification states can refer to service conditions that are more restrictive than for the end goal conditions (when the full qualification program has been completed). This approach can be useful to enable putting a solution to restricted service so that field experience can be captured and used as qualification evidence for subsequent technology qualification states. Reference is made to Figure When successive qualification states are defined by technology readiness levels (TRLs) as associated with decision gates, the provisions of App.A should be observed The following DNV GL technology qualification statements can be issued to affirm a positive conclusion of these reports (Figure 3-1): At TA - Statement of feasibility At QP - Endorsement of qualification plan At TQ - Technology certificate. The basis for issuance of technology qualification statements will be provided by DNV GL in separate reports A statement of feasibility can be issued to affirm that DNV GL considers the technology qualification to be technically feasible on the following conditions (numbered according to Figure 3-1): 1) Following a technology assessment that has concluded that the main challenges have been identified and determined to be resolvable by use of sound engineering practice. 2) Or else after completion of a threat assessment concluding that potential failure causes and mechanisms have been identified and determined to be resolvable by use of sound engineering practice. 3) Or else after completion of qualification activities substantiating that those potential failures can be resolved by use of sound engineering practice. Guidance note: There is an established practice by classification societies, in particular within the maritime industry, to issue approval in principle. A DNV GL technology assessment report or Statement of feasibility may serve as input to an approval in principle. ---e-n-d---of---g-u-i-d-a-n-c-e---n-o-t-e At the QP stage, an endorsement of qualification plan can be issued to affirm that DNV GL considers that sufficient overview of remaining activities has been gained and that the technology can be successfully qualified on basis of the plan. Detailed procedures for testing etc. can be used to justify the overview. Detailing of test procedures can otherwise be activities in the technology qualification plan, in which case review of critical procedures would become activities in that plan. The endorsement identifies the qualification state targeted by the plan. After partial completion of the qualification plan, a revised endorsement can be issued with reference to a remaining qualification scope considered adequate to reach the targeted qualification state. In the next phase, such an endorsement can be issued for the next qualification state At the TQ stage, a technology certificate can be issued to affirm that the technology qualification was successful, and performed as set forth in this document. The technology certificate is issued to state that the technology has been qualified according to the principles of DNV-RP-A203 based on the requirements in the qualification basis. The technology certificate refers to acceptance criteria arising from the qualification process and acceptance criteria from reference standards and practices that particular solutions will have to comply with in order that the qualification conclusion is valid. The scope of technology qualification is to develop the basis for product certification. To prevent misunderstanding, the technology certificate will therefore state clearly that it is not a product certificate. Service specification DNVGL-SE-0160 Edition December 2015 Page 21

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