Probationary Phase Rules: Section Vi
Probationary Phase Rules: Section Vi
Probationary Phase Rules: Section Vi
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SECTION VI
Design and Construction Rules for Mechanical
Components of PWR Nuclear Islands
Z I SUBSECTIONS A - GENERAL RULES
SECTION VI
PROBATIONARY PHASE RULES (RPP)
Pages
n° 137-2012 RPP / 1
RCC-M - 2012 Edition Tome VI - RPP
RPP / 2 n° 137-2012
RCC-M - 2012 Edition Section VI- RPP No. 0
RPP*
PROBATIONARY PHASE RULES (RPP)
GENERAL INFORMATION
Probationary Phase Rules have been introduced to allow innovative developments to be included by
the replacement of or addition to Code chapters or parts thereof as specified in each RPP.
The implementation of Probationary Phase Rules and related measures are the responsibility of the
user, who shall verify the soundness of the solutions adopted and their relevance to result sought.
Subject to prior approval from the Operator, the user may propose compensatory measures should
the content of a Probationary Phase Rule proves difficult to implement.
The continued inclusion of a Probationary Phase Rule shall be subject to periodic review in the light
of available feedback.
* RPP : stands for "PROBATIONARY PHASE RULES" even if PPR should be the right abbreviation
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RPP No. 1
Its application is the responsibility of the user who wishes to comply with the scope of chapter
A 5000 of the Code, as an alternative to the detailed requirements in subchapter A 5100. It
demonstrates how chapter A 5000 is applied by giving answers accepted under the Code.
Users of this RPP shall be conscious of the innovative nature of this rule and the need to make
choices as to how it should be applied based on their own best knowledge of industrial practice.
They are urged to submit suggested improvements or modifications to the authors of the Code.
This document incorporates information and criteria from GS-R-3 (1) of 2006 in literally (shown in
bold, with a reference in quotation marks to the source paragraph of the GS-R-3), so that it is self-
contained from a user perspective.
Its structure follows that of IAEA Safety Requirements document No. GS-R-3 and uses the same
terminology.
1
IAEA Safety Requirements No. GS-R-3: 2006. See also application guides GS-G-3.1 and GS-G-3.5.
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The management system integrates all elements of an organization into one coherent system to
enable all of the organization’s objectives to be achieved. These elements include the structure,
resources and processes. Personnel, equipment and organizational culture as well as the
documented policies and processes are parts of the management system. The organization’s
processes have to address the totality of the requirements on the organization as established
in, for example, IAEA safety standards and other international codes and standards.
A quality management system which complies with the requirements of ISO 9001-20082 is a
prerequisite to the provision of any activity specified by this body of rules.
Any supplier in charge of such an activity shall implement a management system which fulfils the
requirements of this chapter.
[2.2.] Safety shall be paramount within the management system, overriding all other
demands.
The safety requirements or safety level shall be specified in the purchase order. The
management system supplied in fulfilment of the order shall demonstrate how it prioritizes
safety over other aspects.
2
Standard NF EN ISO 9001 Ed. 11/2008 +AC 07/2009 "Quality Management Systems - Requirements"; certification
by a third party organization in relation to this standard is not required.
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[2.3.modified] The management system shall incorporate the requirements of this chapter:
- Provisions ensuring compliance with the statutory and regulatory requirements of
the State to which the equipment is being delivered;
- Provisions ensuring compliance with any requirements formally agreed with
interested parties;
- Provisions ensuring compliance with any requirements contained in other codes and
standards adopted by the organization relating to its use;
Identification of the provisions referred to in [2.3] and their application shall be contractually
defined between purchaser and supplier.
[2.4.] The organization shall be able to demonstrate the effective fulfilment of its
management system requirements.
The promotion and support of the safety culture shall, as a minimum, be founded on:
- identification of activities which are important for safety within the organization,
- planning and provision of resources as required to perform the tasks in question,
- an awareness program for all concerned people of the organization.
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[2.7.] Grading of the application of management system requirements shall be applied to the
products and activities of each process.
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[3.2.] Senior management shall develop individual values, institutional values and
behavioural expectations for the organization to support the implementation of the
management system and shall act as role models in the promulgation of these values
and expectations.
[3.3.] Management at all levels shall communicate to individuals the need to adopt these
individual values, institutional values and behavioural expectations as well as to comply
with the requirements of the management system.
[3.4.] Management at all levels shall foster the involvement of all individuals in the
implementation and continual improvement of the management system.
[3.5.] Senior management shall ensure that it is clear when, how and by whom decisions are
to be made within the management system.
The organization shall put the resources in place so that it can be notified immediately of any
problem with the performance of a product or activity which might impact compliance with
critical characteristics (having repercussions for safety choices), and can additionally be in a
position to communicate this in a timely manner to the customer (see paragraph RPP-1/ 550)
and other interested parties.
3
CEO: Chief Executive Officer or Chairman
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[3.9.] Senior management shall develop the goals, strategies, plans and objectives of the
organization in an integrated manner so that their collective impact on safety is
understood and managed.
[3.10.] Senior management shall ensure that measurable objectives for implementing the
goals, strategies and plans are established through appropriate processes at various
levels in the organization.
[3.11.] Senior management shall ensure that the implementation of the plans is regularly
reviewed against these objectives and that actions are taken to address deviations from
the plans where necessary.
[3.13.] An individual reporting directly to senior management shall have specific responsibility
and authority for:
- Coordinating the development and implementation of the management system, and
its assessment and continual improvement;
- Reporting on the performance of the management system, including its influence on
safety and safety culture, and any need for improvement;
- Resolving any potential conflicts between requirements and within the processes of
the management system.
[3.14.] The organization shall retain overall responsibility for the management system when
an external organization is involved in the work of developing all or part of the
management system.
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[4.2.] The information and knowledge of the organization shall be managed as a resource.
Criterion 4.2 implies perpetuating the company’s skills in respect of safety-related activities,
the lack of which might impact conformance of off-the-shelf equipment to qualified
equipment, or even the capability to produce the said equipment.
[4.4.] Senior management shall ensure that individuals are competent to perform their
assigned work and that they understand the consequences for safety of their activities.
Individuals shall have received appropriate education and training, and shall have
acquired suitable skills, knowledge and experience to ensure their competence.
Training shall ensure that individuals are aware of the relevance and importance of
their activities and of how their activities contribute to safety in the achievement of the
organization’s objectives.
Comment: Criterion 4.4 is a direct consequence of the instilment of the safety culture within
the supply chain.
4
‘Resources’ includes individuals, infrastructure, the working environment, information and knowledge, and suppliers,
as well as material and financial resources.
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[5.3.] The methods necessary to ensure the effectiveness of both the implementation and the
control of the processes shall be determined and implemented.
[5.4.] The development of each process shall ensure that the following are achieved:
- Process requirements, such as applicable regulatory, statutory, legal, safety, health,
environmental, security, quality and economic requirements, are specified and addressed.
- Hazards and risks are identified, together with any necessary mitigatory actions.
- Interactions with interfacing processes are identified.
- Process inputs are identified.
- The process flow is described.
- Process outputs (products) are identified.
- Process measurement criteria are established.
[5.5.] The activities of and interfaces between different individuals or groups involved in a
single process shall be planned, controlled and managed in a manner that ensures
effective communication and the clear assignment of responsibilities.
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[5.7.] For each process, any activities for inspection, testing, verification and validation, their
acceptance criteria and the responsibilities for carrying out these activities shall be
specified. For each process, it shall be specified if and when these activities are to be
performed by designated individuals or groups other than those who originally
performed the work.
In implementing the two aforementioned criteria [5.6] and [5.7], the requirements to be met
by the test laboratories shall be specified. For activities defined by standard
NF EN ISO/CEI 17025: 2005, the laboratory’s documented process may satisfy the
requirements of the standard.
[5.9.] The work performed in each process shall be carried out under controlled conditions,
by using approved current procedures, instructions, drawings or other appropriate
means that are periodically reviewed to ensure their adequacy and effectiveness.
Results shall be compared with expected values.
[5.10.] The control of processes contracted to external organizations shall be identified within
the management system. The organization shall retain overall responsibility when
contracting any processes.
5
Documents may include: policies; procedures; instructions; specifications and drawings (or representations in other
media); training materials; and any other texts that describe processes, specify requirements or establish product
specifications.
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The documents shall be checked by different individuals from those who drew them up.
[5.13.] Changes to documents shall be reviewed and recorded and shall be subject to the same
level of approval as the documents themselves.
[5.15.] Activities for inspection, testing, verification and validation shall be completed before
the acceptance, implementation or operational use of products.
These activities shall be performed by persons other than those who made the product.
Instruments and equipment used for these activities shall be of the appropriate
measurement range, type, accuracy and precision.
[5.16.] The organization shall confirm that products meet the specified requirements and shall
ensure that products perform satisfactorily in service when contractually required.
[5.17.] Products shall be provided in such a form that it can be verified that they satisfy the
requirements.
Criteria 5.17 and 5.18 may apply via lead product qualification.
[5.18.] Controls shall be used to ensure that products do not bypass the required verification
activities.
[5.19.] Products shall be identified to ensure their proper use. Where traceability is a
requirement, the organization shall control and record the unique identification of the
product.
[5.20.] Products shall be handled, transported, stored, maintained and operated as specified,
to prevent their damage, loss, deterioration or inadvertent use.
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[5.22.] Retention times of records and associated test materials and specimens shall be
established to be consistent with the statutory requirements and knowledge
management obligations of the organization. The media used for records shall be such
as to ensure that the records are readable for the duration of the retention times
specified for each record.
The duration of archiving shall be defined by the purchaser.
It is the responsibility of the supplier to demonstrate his ability to retrieve records during the
specified period.
[5.23.] Suppliers of products shall be selected on the basis of specified criteria and their
performance shall be evaluated.
[5.25.] Requirements for the reporting and resolution of non-conformances shall be specified
in procurement documents.
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Note: INSAG 18 (International Nuclear Safety Advisory Group “Managing change in the Nuclear Industry: the effect
on Safety”, 2003) outlines this requirement in greater detail.
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[6.4.] An organizational unit shall be established with the responsibility for conducting
independent assessments6. This unit shall have sufficient authority to discharge its
responsibilities.
The roles and authority of the assessors shall be clearly defined and documented.
[6.5.] Individuals conducting independent assessments shall not assess their own work.
[6.6.] Senior management shall evaluate the results of the independent assessments, shall take
any necessary actions, and shall record and communicate their decisions and the
reasons for them.
The type of decision and actions to be undertaken as a result of the findings of the
assessments shall be defined in advance. (Consistency, legitimacy of implementation, etc.).
Note: this point includes the following actions, in particular: inspections of activities, audits (internal and external),
technical audits of processes and activities
[6.8.] The review shall cover but shall not be limited to:
- Outputs from all forms of assessment;
- Results delivered and objectives achieved by the organization and its processes;
- Non-conformances and corrective and preventive actions;
- Lessons learned from other organizations;
- Opportunities for improvement.
[6.9.] Weaknesses and obstacles shall be identified, evaluated and remedied in a timely
manner.
[6.10.] The review shall identify whether there is a need to make changes to or improvements
in policies, goals, strategies, plans, objectives and processes.
In addition to the knowledge gained by the supplier from his experience of other
organizations as indicated under criterion 6.8, the customer’s order shall prescribe the
requirements based on his own knowledge gained from experience.
6
The size of the assessment unit differs from organization to organization. In some organizations, the assessment
function may even be a responsibility assigned to a single individual or to an external organization.
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[6.12.] Products and processes that do not conform to the specified requirements shall be
identified, segregated, controlled, recorded and reported to an appropriate level of
management within the organization. The impact of nonconformances shall be
evaluated and non-conforming products or processes shall be either:
- Accepted;
- Reworked or corrected within a specified time period; or
- Rejected and discarded or destroyed to prevent their inadvertent use.
Authorisation levels shall be defined and documented and take into account the impact of
nonconformance. Waivers shall be authorized by the organization which issued the
requirements.
[6.15.] The status and effectiveness of all corrective and preventive actions shall be monitored
and reported to management at an appropriate level in the organization.
[6.16.] Potential non-conformances that could detract from the organization’s performance
shall be identified. This shall be done: by using feedback from other organizations, both
internal and external; through the use of technical advances and research; through the
sharing of knowledge and experience; and through the use of techniques that identify
best practices.
[6.18.] Improvement plans shall include plans for the provision of adequate resources. Actions
for improvement shall be monitored through to their completion and the effectiveness
of the improvement shall be checked.
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