In June of 2020, the FORATOM Supply Chain Optimisation Working Group (today the Nucleareurope Supply Chain Taskforce) published a report entitled “Optimising the European Nuclear Supply Chain –Use of High-Quality Industrial Grade Items in European Nuclear Installations”. Based on the observations and recommendations within the report, Nucleareurope , in collaboration with the European Nuclear Installations Safety Standards Initiative (ENISS), embarked on a project to publish a European Guideline on the Use of High-Quality Industrial Grade Items in Nuclear Facilities (European Guideline or Guideline,for short) which is compatible with the well-established commercial-grade dedication(CGD) methodology. The European Guideline Project (EGP) was an industry-led initiative sponsored by a steering group comprised of ten European national nuclear associations, nuclear installation licensees and vendors.
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Nuclear regulatory bodies across Europe have either established requirements or published guidance about quality assurance and quality control which pertains to suppliers of items and services important to safety. Although these measures differ between European countries, sometimes to a large degree, they all aim to ensure that the procured items and services are of a high-quality. A high-quality item or service is one which is very likely to conform to the specified procurement requirements.
Today there are many industries, like the nuclear industry, which leverage well-developed regulation, codes and standards to secure high-quality items and services. There are a number of international (e.g. ISO) and regional (e.g. EN) standards recognized in Europe that could be used in the nuclear industry, after proper assessment and review. In some cases, the measures implemented by suppliers to achieve high-quality items and services when delivering to the nuclear industry are indistinguishable from those established for customers in other industries.
The Guideline describes a methodology, called dedication, for ensuring that items manufactured, or services provided, under non-nuclear-specific quality assurance or quality control arrangements are of a quality commensurate with the same item or service had it been furnished according to local nuclear-specific quality requirements. This approach requires that the dedicating entity (a licensee, for example) take on a more active role in assuring the quality of items or services important to safety. As a part of this approach the existing quality management system capabilities of the supplier can be credited.
The dedication methodology expects the dedicating entity to identify and verify critical characteristics of the procured item which are directly linked to the safety function(s) which the item is expected to perform in service. The conformity of the selected critical characteristics with respect to defined acceptance criteria is accomplished by well-defined quality assurance and control techniques. Dedication relates to control of the procured item or service and does not replace qualification or other design verification activities.
The dedication methodology described in the Guideline is based on the proven commercial-grade dedication methodology currently used by approximately one-third of the world’s nuclear power plant licensees and a number of nuclear fuel cycle facilities. The concept of the dedication first appeared in 1979 in the United States Code of Federal Regulations. Across the world, several regulatory bodies recognize Electric Power Research Institute (EPRI) guidelines and/or local standards on dedication as allowable practice. The Guideline has been written in order to generalize the commercial-grade dedication methodology in such a way that it is readily applicable across the European nuclear regulatory landscape. It is also intended to be largely consistent and compatible with established dedication practices in Europe.
Dedication is a quality assurance methodology related to the procurement of items and services important to safety which were not controlled under the licensee’s nuclear-specific supplier quality expectations. Dedication is an acceptance process which focuses on achieving confidence that an item will fulfill its safety function(s) once installed in a nuclear facility. Dedication is not intended to establish the suitability of the design of an item, rather it furnishes evidence of the quality of the supplied item. Dedication is not qualification.
The concept of ‘dedicating’ items first appeared more than 40 years ago in the United States and has since been rooted in the procurement practices of the nuclear industry in many countries. In Europe, some licensees have been performing dedication activities for decades while others have only recently begun establishing or seeking to establish the process.
Licensees establishing a dedication process are generally doing so in order to create a procurement path for items and services important to safety which ensures a degree quality equivalent to that which results from procurement according to established nuclear-specific rules, but which can be applied to a broader spectrum of suppliers. The methodology helps licensees to maintain or re-establish a supply chain capable of delivering the necessary engineered items and services required throughout the lifetime of their nuclear facility which helps to avoid cases of obsolescence.
Benefits of the dedication methodology include the ability to access items and services from other high-reliability industry supply chains and to accept off-the-shelf items which may include unused items from shut down nuclear facilities. By having the ability to accept items and services through a dedication process, licensees can be part of a growing network of other European licensees, suppliers and third-parties utilizing the same methodology. In other words, licensees can benefit from synergies arising from lessons learned, experience sharing, and the ever-growing range of dedication case studies which enables future dedication activities to be performed more and more accurately and efficiently.
Across the world, several nuclear regulators recognize one or more EPRI guidelines or local standards on the use of dedication as acceptable ways in which to meet expectations related to the quality assurance of items important to nuclear safety. However, until now there has been no generalized description of a dedication methodology which could readily be used as the basis for harmonization across Europe. The objective of the European Guideline project was to develop and publish such a methodology. The benefits of the European Guideline include:
-- A dedication methodology which can be applied across the European continent and which is not tied to one country’s laws, regulations, codes or standards.
-- A robust and proven acceptance process in lieu of no process, many different processes or case-by-case decision-making when the item or supplier is not in compliance with nuclear-specific ways of working.
-- A basis to enable regulatory stability on the subject of high-quality industrial grade item acceptance.
-- The opportunity to integrate a graded, risk-informed approach to the subject of dedication which should serve to both improve the safety and the economics of the process.
A number of industries have established sector-specific quality management requirements, some of which are based on the ISO 9001 standard. The international standard ISO 19443:2018 describes specific requirements for the application of ISO 9001:2015 by organizations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety. An associated standard, ISO/TS 23406:2020, complements existing requirements found in ISO/IEC17021-1 for bodies providing audit and certification of quality management systems against ISO 19443.
ISO 19443:2018 includes the key element of the dedication methodology as a part of the control of externally provided processes, products and services.Organizations working according to the standard are expected to consider critical characteristics of commercial-grade items oractivities1F1F1F[1] when determining verification activities.
When customers, such as licensees, recognize ISO 19443:2018 as an acceptable management system basis for the supply of items or services important to safety, they can expect that the supplier organization may be utilizing commercial-grade items or services in the final product. In doing so, the organization performs acceptance activities to verify critical characteristics of those items or services in accordance with the standard.
Guidance for the application of ISO19443:2018 is provided in ISO/TR 4450:2020. It is recommended that this European Guideline be used as a supplement to ISO/TR 4450:2020 in support of the implementation of ISO 19443:2018 by organizations in the supply chain. The European Guideline provides detailed guidance on topics relevant to organizations working according to ISO 19443:2018, such as the selection of critical characteristics (see Volume 1 Section 9.3), their verification (see Volume 1Section 10), the dedication of services (see Volume 1 Section 12.3) among many other nuances found in Volume 2 of the guideline.
Acceptance Activities
Activities undertaken as a part of dedication in which the dedicating entity verifies item critical characteristics according to acceptance methods documented in a dedication plan.
Acceptance Method
A defined, allowable way of verifying one or more critical characteristics as a part of the dedication process.
Critical characteristics
A subset of design characteristics typically chosen by the dedicating entity, the verification of which establishes confidence that a procured item will perform its intended safety function(s) throughout its anticipated service life, or that a procured service will not negatively impact the safety function(s) of any item.
i Critical characteristics must be identifiable and measurable.
Dedicating entity
An organization which performs dedication.
i When used in the Guideline, dedicating entity usually means the nuclear facility licensee, but a dedicating entity may also be a third party or supplier.
Dedication
A planned series of actions undertaken to establish confidence that a procured item or service will perform its intended safety function(s) throughout its anticipated service life in lieu of the imposition of nuclear-specific quality assurance or quality control arrangements during the design and manufacture of the item.
i Dedication is a quality assurance methodology for procured items (and services) important to safety.
Dedicated item (or service)
An item (or service) whose critical characteristics have been verified and documented as meeting defined acceptance criteria.
i A dedicated item is an item important to safety.
i A dedicated item is a high-quality industrial grade item which has successfully been dedicated.
i A dedicated item is one whose quality is deemed suitable for use in the specified safety-classified application(s) in nuclear facilities.
i A dedicated item is deemed equivalent to an item designed and manufactured under nuclear-specific quality management system arrangements.
i The end-user of a dedicated item has confidence that it will perform its intended safety function(s) throughout its anticipated service life.
Design characteristics
Inherent attributes of an item that encompass both the item’s safety and non-safety functions.
i Physical,performance and dependability characteristics are types of design characteristics.
i Critical characteristics are a subset of design characteristics typically selected by the dedicating entity.
Design suitability
The adequacy of the design of an item with respect to its intended use.
i Design encompasses all characteristics of an item including physical and performance characteristics.
i The process of establishing design suitability for items important to safety may include qualification activities.
End-user
The nuclear facility licensee who will use an item.
High-quality Industrial Grade Item (or Service)
An item designed and manufactured (or service specified and executed) under quality assurance or quality control arrangements other than those typically required by the licensee when procuring items (or services) important to safety.
i High-quality industry grade items are typically designed and manufactured under non-nuclear quality assurance and quality control arrangements, but may also be those furnished by suppliers who comply with foreign nuclear quality expectations.
i High-quality industry grade items include serially manufactured products.
Important to safety
Characteristic of an item or service whose failure could result in undue radiation exposure of people or the environment. (ISO 19443:2018)
i The exact definition of the term important to safety is specific to each country’s regulatory system, it may also be called safety-related.
i In this Guideline important to safety means important to nuclear safety.
Item
Any structure, system, component,part thereof, material or software.
i In this Guideline, item generally refers to a high-quality industrial grade item which undergoes the dedication process in order to be used by a nuclear facility as an item important to safety.
Off-the-shelf item
Fully fabricated, unused item which undergoes no further manufacturing or testing activities prior to sale.Off-the-shelf items include commercial-off-the-shelf-items as well as unused items from warehoused stock at nuclear facilities, for example.
Licensee
The organization holding a license to construct or operate a nuclear facility.
i The licensee is the organization which has overall responsibility for a facility.
Performance-based Supplier Assessment
An acceptance method (Method 2) according to which the dedicating entity assesses the supplier in order to determine if their existing quality controls are sufficient for verifying one or more critical characteristics.
Qualification
Process of determining whether a system or component is suitable for operational use. (IAEA Safety Glossary 2018)
i Qualification is generally performed in the context of a specific set of qualification requirements for the specific facility and class of system and for the specific application. (IAEA Safety Glossary 2018)
i Dedication is not a qualification process.
Quality
Degree to which a set of inherent characteristics in a procured item fulfills specified requirements.
i This definition of quality is sometimes referred to as quality of conformance and is different from the other two quality segments, namely quality of design or quality of performance.
Quality assurance
Part of quality management encompassing all those planned and systematic actions necessary to provide confidence that quality requirements will be fulfilled.
i The function of a management system that provides confidence that specified requirements will be fulfilled. (IAEA Safety Glossary2018)
Quality control
Part of quality management intended to verify that structures, systems and components correspond to predetermined requirements.(IAEA Safety Glossary 2018)
Quality management (system)
Quality management can include establishing quality policies and quality objectives, and processes to achieve these quality objectives through quality planning, quality assurance, quality control, and quality improvement. (ISO9000:2015)
Requirement
Need or expectation that is stated, generally implied or obligatory. (ISO 9000:2015)
Safety function
A specific purpose that must be accomplished for safety for a facility or activity to prevent or to mitigate radiological consequences of normal operation, anticipated operational occurrences and accident conditions. (IAEA Safety Glossary 2018)
Source verification
An acceptance method (Method 3) according to which the dedicating entity witnesses supplier or sub-supplier activities for the purpose of verifying one or more critical characteristics.
Structures, systems and components
A general term encompassing all of the elements of a facility or activity that contribute to protection and safety, except human factors. (IAEA Safety Glossary 2018)
Safety
Safety means nuclear safety and is the achievement of proper operating conditions, prevention of accidents and mitigation of accident consequences, resulting in protection of workers, the public and the environment from undue radiation risks. (IAEA Safety Glossary2018)
Service
Output of a supplier with at least one activity necessarily performed between the supplier and the customer.(adapted from ISO 9000:2015)
Supplier
An organization supplying an item or service according to a contract. Suppliers include designers, vendors,manufacturers, contractors, subcontractors, and carriers who furnish items or services.
