DNV技术资格认证：保障安全与责任的全球风险管理指南

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"技术资格认证(DNV-RP-A203)"是DNV（Det Norske Veritas AS）提供的一个推荐实践指南，该公司作为全球风险管理领域的领导者，专注于确保业务安全和负责任地运营。这份文档的重要性在于它定义了技术资格的标准和最佳实践，以帮助企业客户有效地管理风险，提升业务表现，同时符合法律和行业规范。在七月2013年发布的这一版本中，DNV基于当时的知识、技术和信息进行了编写，旨在反映当代最前沿的技术。主要内容包括以下几个方面： 1. **核心竞争力**：DNV的核心能力在于识别、评估和提供风险管理建议。通过在认证、分类、验证和培训方面的领先地位，他们制定并实施标准化流程和最佳实践，帮助客户在其业务中实施安全和负责任的决策。 2. **服务性质**：作为独立组织，DNV在全球100多个国家拥有专门的风险管理专家团队，他们的目标是保护生命财产和环境。用户应自行承担使用本服务文档的风险，因为DNV不承担因使用此文档导致的任何损失或损害的责任。 3. **官方版本与获取反馈**：电子版的DNV-RP-A203文档可通过DNV官方网站获取，它是官方权威版本。用户如有任何意见或建议，可以直接发送电子邮件至rules@dnv.com。 4. **适用范围**：该文档旨在提供当代技术的指导，但用户在使用时应自行判断其适用性，因为DNV对其可能存在的过时或未来变化不承担责任。 5. **前言部分**：强调了在当前商业环境中，安全和负责任的经营行为不仅是企业运营的许可证，也是竞争优势的关键。DNV的服务旨在协助客户在追求业绩提升的同时，充分考虑风险因素，确保业务持续稳定发展。 DNV-RP-A203技术资格认证文档是IT行业中关于风险管理的重要参考资料，适用于各类企业在面临技术选择和升级时，了解如何通过采用DNV认可的技术标准和最佳实践来提升组织的安全性和合规性。在实际应用中，企业需谨慎评估自身需求，理解并遵循其中的指导，以确保在遵循风险管理体系的同时，最大化地实现业务目标。

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Recommended Practice DNV-RP-A203, July 2013

Sec.4 Technology Qualification Programme – Page 14

4 Technology Qualification Programme

The Technology Qualification Program provides a framework for managing qualification progress.

4.1 Technology Development and Qualification Progress

The uncertainties and failure probability generally decrease as a technology evolves through stages of

development and as knowledge and evidence is generated through technology qualification. The Technology

Qualification Process can be run throughout the development of the technology, or be started at any time in the

development. Figure 4-1 illustrates that uncertainty and the probability of failure are reduced as qualification

progresses, until a remaining failure probability is determined. In cases where the technology develops in

parallel with the qualification activities, the uncertainty will often increase when modifications are introduced,

before being reduced by further qualification activities.

Figure 4-1

Illustration of qualification progress for development phases represented by a series of milestones (MS)

The uncertainty is shown in

Figure 4-1 as probability density functions. Qualification is concluded when the

requirements for success, as laid down in the Technology Qualification Basis, have been reached. This process

is visualised in Figure 4-1 by the probability density function of the failure margin (defined in Sec.[2.1.10]),

being negative when failure occurs. Qualification concludes (success occurs) when a defined part of the tail

extends below zero.

In the early stages of development, assessment of the technology depends heavily on expert judgement (often

referred to as qualitative assessment). The main objective is to identify the main uncertainties. Subsequently,

the Technology Qualification Process addresses the most important uncertainties and gradually replaces expert

judgement with empirical evidence (often referred to as quantitative evidence). However, an element of

judgements will always remain, as the reports and statements supporting the Technology Qualification Basis

shall often depend on the interpretation of empirical evidence.

4.2 Contents of the Technology Qualification Programme

A Technology Qualification Program shall be established to support the management of the Technology

Qualification Process. Where applicable, it shall reflect the iterative nature of technology development as

illustrated in the example in Figure 4-2. The program shall also control the qualification activities and comply

with steps laid down in the framework found in Figure 5-1. Elements to be included in the Technology

Qualification Programme comprise:

— qualification strategy

— critical parameters

— decision gates

— the qualification team appointed to carry out the qualification

— resources needed (people, software/hardware, competencies etc.)

— roles (e.g. developer, independent reviewer, subject matter experts providing experience/analogues,

independent expert consulted to enhance confidence in evidence and conclusions, providers of evidence)

— responsibilities (specify requirements, completion of work, verification, make decisions)

— involvement of stakeholders, such as partners, clients, end users, sub-contractors, authorities, third parties

— regulatory requirements

— budget constraints

— schedule and milestones

Technology development phases with qualification milestones

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Recommended Practice DNV-RP-A203, July 2013

Sec.4 Technology Qualification Programme – Page 15

— QA/QC and SHE requirements

— supply chain risks

— interaction with technology and business development processes on-going in parallel with the Technology

Qualification Programme.

The Technology Qualification Programme should incorporate a qualification strategy that shows how the

technology shall be taken from its existing stage of development to its goal. Interim milestones representing

significant achievement should be established. Where possible, decision gates (at which key decisions to accept

or reject a course of development, or equally invest more time and money) should be linked to the achievement/

non-achievement of these milestones.

Figure 4-2

Illustration of Technology Qualification Programme iterating through three phases, each of which includes a cycle

of the basic Technology Qualification Process detailed in Figure 5-1 that requires to be successfully concluded

before going on to the next phase

Guidance note:

This sequence of qualification development may include deployment in controlled conditions that are governed by

strict limitations. Then experience from use/operation in those conditions can be used to further reduce uncertainties

in a subsequent iteration by providing information on operating procedures and limitations.

Such qualification development may be facilitated by taking the technology through defined development stages such

as a prototype stage where the solution is developed, a technical evaluation stage and an operational evaluation stage.

Advantages in defining milestones in the Technology Qualification Programme include the measurement of progress;

the review of technology qualification strategy against timelines and decision gates; and the review of technology

development progress against a business plan.

It is common in the industry to use Technology Readiness Levels (TRLs, see App.

[B.4]) as a means of illustrating

the development stage of a technology. The TRLs (as defined in App. [B.4]) describe what broadly needs to be done

to reach the subsequent level. TRLs can be used to map out the phases of a Technology Qualification Programme,

providing that they include sufficient detail, including the acceptance criteria for each level.

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The relevant approval authority for the intended service should be identified. In addition, the implications of

the applicable regulations/ jurisdiction on the Technology Qualification Basis should be shown.

If the technology is an enhancing technology, where a proven fall-back solution exists, the technology

qualification strategy should incorporate the possibility to revert to the fall-back solution. For enabling

technologies, where no fall-back solution exists and the feasibility of the concept depends on a successful

outcome of the Technology Qualification Programme, the technology must fully satisfy its Technology

Figure 4-2

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Recommended Practice DNV-RP-A203, July 2013

Sec.4 Technology Qualification Programme – Page 16

Qualification Basis, If it does not, a decision shall have to be made whether to adopted it as it is, (with a

commensurate reduction in the Technology Qualification Basis), alter it or reject it.

Guidance note:

Sufficient time, effort and resources should be allocated in the Technology Qualification Plan to uncover any

fundamental flaws or prohibitive obstacles as early as possible in the basic Technology Qualification Programme.

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The Technology Qualification Programme is a living document that should be updated after each qualification

phase to accurately reflect the status of the technology.

4.3 Critical Parameters List

The critical parameters list documents limits that must not be exceeded either for or by the technology. Hence,

when the Technology Qualification Programme has been completed, the boundary limits for the critical

parameters will represent the limits for qualification or operating envelope within which the technology is

considered qualified.

Key parameters such as dimensioning loads, capacities, boundary conditions and functional requirements shall

be summarised in a critical parameters list used in the Technology Qualification Process. This ensures that the

relevant input parameters used for analyses and tests are updated, as changes in design or procedures are made.

The critical parameters for failure mechanisms must be identified. The critical parameters list shall include the

limits/ boundaries of these parameters. Where the qualification covers a range (e.g. sizes of the product or

material grades) these ranges should be defined by their respective critical parameters. For uncertain

parameters, available information about the level of uncertainty should be included.

Guidance note:

The qualification effort can be simplified by narrowing down operational limitations, sizes considered, etc. Such

limitations should then be specified in the critical parameter list. The consequences of these limitations should be

assessed to see if they merit the qualification effort.

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The critical parameters list should be established in the initial phase of the Technology Qualification Process.

It is anticipated that both the parameters and their limits shall be refined or changed as the Technology

Qualification Programme progresses and the understanding of the failure modes and mechanisms develops.

4.4 Qualification Team

The members of the qualification team shall be identified in the Technology Qualification Programme and their

respective expertise documented. All critical areas shall be covered by the qualification team, including

manufacture and end use. The expertise should also cover regulatory requirements for the technology in its

intended use.

Guidance note:

An end user should be included in the qualification team to provide operational experience.

Care should be exercised to ensure that the team includes independent experts capable of challenging team members

with vested interests.

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DET NORSKE VERITAS AS

Recommended Practice DNV-RP-A203, July 2013

Sec.5 The basic Technology Qualification Process – Page 17

5 The basic Technology Qualification Process

The basic Technology Qualification Process comprises the following main steps visualised in

Figure 5-1:

— Technology Qualification Basis: Establish a qualification basis identifying the technology, its functions, its

intended use, as well as the expectations to the technology and the qualification targets.

— Technology Assessment: Assess the technology by categorizing the degree of novelty to focus the effort

where the related uncertainty is most significant and identify the key challenges and uncertainties.

— Threat Assessment: Assess threats and identify failure modes and their risks.

— Technology Qualification Plan: Develop a plan containing the qualification activities necessary to address

the identified risks.

— Execution of the plan: Execute the activities specified in the Technology Qualification Plan. Evidence is

collected through experience, numerical analyses and tests.

Performance Assessment: Assess whether the evidence produced meets the requirements of the Technology

Qualification Basis.

Figure 5-1

Steps in the basic Technology Qualification Process

Each step of the process shall be documented making the conclusions traceable. The required level of detail for

documentation tends to increase as the Technology Qualification Process progresses.

Feedback loops between the steps imply that the process is iterative in nature. Consideration should be given

to design modification to improve safety, performance, longevity, cost and ease of manufacture or operation,

amongst others. Modification of specifications may also take place. Such modification will trigger full or

partial iterations of the basic Technology Qualification Process in order for the Technology Qualification Basis

to be satisfied. The need for and number of iterations will depend on factors such as:

— changes in boundary conditions

— changes to the technology (e.g. concept improvements) motivated by qualification results or external

factors

— any changes needed to account for qualification results e.g. those that lie outside the specified limits

(acceptance criteria)

— changes in reliability and/ or performance expectations of the technology.

Iterations shall be used to incorporate threats as they are identified; new knowledge from other qualification

activities; more detailed knowledge about the technology; and capture when and how the technology has been

modified. All modifications shall be identifiable and traceable and shall be reflected in the updated Technology

Qualification Basis. Their impact shall be assessed against the Technology Qualification Basis. Modification

to the technology shall, when relevant, have a defined purpose e.g.:

Qualification Basis

Set the requirements

Technology Assessment (TA)

Novelty and prohibitive obstacles

Qualification plan (QP)

Select qualification methods

Threat Assessment

Failure modes and risks

Execution of the plan

Collect evidence

Performance assessment

Verify compliance with requirements

Modifications

Requirements

met?

Technology Qualified (TQ)

Yes

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