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SPC DOZA Scientific Production Company "Doza", Ltd

APPROVED
General Director
SPC Doza, Ltd.
_______________ A.K. Nurlybaev
May 12, 2022

Regulation
"Nonconformity management
in performance of activities of development and manufacture of
equipment for Akkuyu NPP

Regulation 1998/1
(revision 2)

Moscow, 2022
Contents
1 Purpose and field of application..................................................................................................4
2 Regulatory references..................................................................................................................5
3 Terms and definitions..................................................................................................................5
4 General provisions.......................................................................................................................6

4.1 Purpose of nonconformity management..................................................................6


4.2 Basic principles of nonconformity management.......................................................6
4.3 Nonconformity classification.....................................................................................6
4.4 Distribution of roles in nonconformity management................................................7
4.5 Team composition.....................................................................................................7
4.6 Team interaction........................................................................................................8
4.7 Ways of nonconformity elimination..........................................................................8
4.8 Determination of nonconformity significance and scope of work of nonconformity
management................................................................................................................................8
4.9 Classification of types of root causes of nonconformities.........................................9
4.10 Requirements for documents of registration of nonconformities and taken
decisions......................................................................................................................................9
4.11 System analysis of identified nonconformities........................................................9

5 Nonconformity detection procedure........................................................................................10

5.1 Employee of SPC Doza identified the nonconformity:............................................10


5.2 Person responsible for quality in the organization that identified the
nonconformity (RQI):.................................................................................................................11
5.3 Person responsible for quality in the organization that committed the
nonconformity (RQC):................................................................................................................11
5.4 Team leader:............................................................................................................11
5.5 Team:.......................................................................................................................12
5.6 Persons responsible for implementation of correction and ICA activity:...............13
5.7 Persons responsible for implementation of activity of CA and PA:.........................13
5.8 Storage of documented information.......................................................................13

6 Responsibility.............................................................................................................................13
7 Requirements for sub-suppliers................................................................................................14
8 Making amendments.................................................................................................................15

2
Appendix A (mandatory) Distribution of roles in UIS-Quality according to positions in SPC Doza
16
Appendix B.....................................................................................................................................17
Appendix C.....................................................................................................................................19
Appendix D (recommended) Nonconformity Notice form...........................................................22
Appendix E Correction Plan and ICA form.....................................................................................24
Appendix F Corrective Action Plan form.......................................................................................26
Appendix G Preventive Action Plan form......................................................................................28
Appendix H Nonconformity Elimination Act form.........................................................................30
Appendix I Final or Interim Nonconformity Report form..............................................................32
Revision sheet................................................................................................................................37

3
1 Purpose and field of application

1.1 This Regulation regulates the activities of SPC Doza in the field of nonconformity management
within the frame of Contract No. FT-04-22-64 of 18.02.2022.
1.2 Regulation applies to:
1.2.1 Product nonconformities identified by the personnel of manufacturing enterprise and/or
specialists of organizations involved in conformity assessment during performance (reporting documentation
audit on performance results) of inspection and process operations as follows:
a) incoming inspection of basic and welding (filler) materials, semi-finished products and
components at the manufacturing enterprise and its sub-suppliers;
b) process and/or inspection operations of product manufacturing at the manufacturing
enterprise and its sub-suppliers;
c) preliminary, integrated and/or off-line, acceptance, qualification, acceptance and delivery, type,
periodic and other tests of products at the manufacturing enterprise and its sub-suppliers.
1.2.2 Product nonconformities identified during performance of incoming inspection at the NPP.
1.3 Requirements of SPC Doza for nonconformity management are formed with due regard to
QUA-II-RG-CQ-14-192-2021, the Unified Industry Procedure for Nonconformity Management and on the basis
of principles as follows:
a) graded approach in decision making on nonconformities from the position of responsibility
distribution between organizations, depending on the degree of influence of nonconformity on the
operational properties and safety of products;
b) fulfillment by all organizations-participants of product manufacturing, delivery and incoming
inspection of the requirements of: legislation of the Republic of Turkey (RT) and the Russian Federation (RF),
Regulatory Documentation (RD) of the RT and the RF, regulatory legal acts, standards and guidelines included
in the License base of the project;
c) unification of procedures and forms of information submission in nonconformity accounting,
registration, identification and elimination;
d) interaction among all participants of decision-making on nonconformities in accordance with
the requirements of this Regulation;
e) documenting and timely reporting of identified nonconformities;
f) making coordinated decisions on implementation and execution control of actions to eliminate
the identified nonconformities;
g) documenting the results of correction, Interim Containment Actions (ICA), corrective and
preventive actions (if performed);
h) periodic control and inspections by Company of timeliness and completeness of fulfillment by
all organizations-participants of product manufacturing, delivery and incoming inspection of the requirements
of this Regulation.
1.4 Regulation provides for application of a graded approach to work of nonconformity management,
including application of appropriate resources and inspection means necessary for effective and efficient
implementation of the process of Nonconformity Management. The graded approach at work with
nonconformities is based on a nonconformity classification depending on nonconformity significance. Through
application of this graded approach an amount of work performed to manage nonconformities, inspection
means, activity, qualifications, decision-making level, etc. are adapted to the risk level or importance of the
above aspects.
1.5 Activities of product nonconformity management are conducted in the unified industry
information system of the State Atomic Energy Corporation Rosatom, hereinafter referred to as "Rosatom",
UIS-Quality and in accordance with the requirements of this Regulation.

2 Regulatory references

This Regulation uses regulatory references as follows:


NP-001-97 General Provisions on Ensuring Safety of Nuclear Power Plants;
QUA-II-RG-CQ-14-192-2021 Regulation. Management of Nonconformity Detected during
Manufacturing and Incoming Inspection of Products for Akkuyu NPP;
GD.AKU.8.7-0630-0023-2020 Guideline. Nonconformity Management. General Requirements;
EMS-II-RG-CE-15-042-2021 Regulation. Incoming Inspection of Equipment for Akkuyu NPP;
QUA-II-RG-CQ-14-194 Regulation. Acceptance Inspection of Products for Akkuyu NPP;
IMS-AKU-P-094-01-21 Provision on Management of Nonconformity in Manufacturing and Incoming
Inspection of Products for Akkuyu NPP;
QUA-II-RG-CQ-14-190 Regulations. Conformity Assessment in Form of Acceptance and Tests of
Products for Akkuyu NPP;
Order of State Corporation Rosatom of 12.03.2018 No. 1/257-P Unified Industry Methodical Guidelines
for Calculation of Costs Caused by Nonconformity of Products with Established Requirements;
Unified Industry Procedure for Nonconformity Management approved by order of State Corporation
Rosatom No. 1/433-P of 18.05.2017, as amended by order of State Corporation Rosatom No. 1/1084-P of
27.08.2021.

3 Terms and definitions

This Regulation uses terms and their definitions in accordance with QUA-II-RG-CQ-14-192-2021, QUA-
II-RG-CQ-14-190, Unified Industry Procedure for Nonconformity Management approved by order of State
Corporation Rosatom as well as:
Company – AKKUYU NÜKLEER ANONIM ŞIRKETI;
Document of registration of nonconformities and taken decisions – Decision or Nonconformity Report
executed in accordance with requirements of this Regulation;
Nonconformity – Noncompliance with one or several requirements established by ITD, ToR/TS/TR,
WEDD, Engineering and Manufacturing Documentation (EMD) or Working Documentation (WD), regulatory
legal acts of the RT and the RF, Federal regulations and rules in the field of use of nuclear energy, and other
RD specified in ITD, ToR/TS/TR, WEDD or WD;
Remarks – Deviations from established requirements:
- errors in accompanying documentation (except for nonconformity of technical characteristics,
amount and methods of inspection of base metal, welded joints, fillers with the relevant requirements of
Initial Technical Documentation (ITD), Terms of Reference (ToR), Technical Specifications (TS), Working
Equipment Design Documentation (WEDD), RD and the passport form (certificate of manufacture) of the
products, with the form specified in the Federal regulations and rules in the field of use of nuclear energy);
- deviations of incompleteness of accompanying documentation (except for absence of: quality
document of the products (quality certificate/ form/ passport/ data sheet/ certificate of manufacture), User
Manual, Installation Guidelines (in the absence of this section in User Manual), Quality Plan, Decision on Use
and Certificate of Conformity, Type Approval Certificate of Measuring Instrument);
- deviations from requirements of ITD/ToR in the presence of WEDD approved by Company;
- deviations not affecting the installation of equipment (according to Company's decision).
This Regulation uses the following abbreviations:
CA – Corrective Actions;
ClbD – Calibration Department;
EAS – Electronic Assembly Shop;
DED – Design and Engineering Department;
DO – Design Office;
ICA – Interim Containment Actions;
LCMG – Licence and Certificate Management Group;
MAS – Machine Assembly Shop;
NPP – Nuclear Power Plant;
PA – Preventive Actions;
PD – Purchasing Department;
PMD – Project Management Department;
QAD – Quality Assurance Department;
RD – Regulatory Documentation;
RQC – person responsible for quality in the organization that committed the nonconformity;
RQI – person responsible for quality in the organization that identified the nonconformity;
SRD – Service Repair Department;
TCD – Technical Control Department;
ToR – Terms of Reference;
TR – Technical Requirements;
TS – Technical Specifications;
UIPNM – Unified Industry Procedure for Nonconformity Management approved by order of State
Corporation Rosatom;
UIS-Quality – Unified Industry Quality Management System of State Corporation Rosatom;
WEDD – Working Equipment Design Documentation.

4 General provisions

1.1 Purpose of nonconformity management


Purposes of nonconformity management are:
 continuous enhancement of management system;
 improvement of customer’s satisfaction;
 provision of compliance of processes and products with established requirements;
 prevention of use of inappropriate results of process and products;
 avoidance of increasing time, cost of process and products;
 minimization of actual or potential negative effects on processes and products due to timely
identification of processes, products that do not comply with the established requirements.

1.2 Basic principles of nonconformity management


4.2.1 Nonconformity management in SPC Doza is performed in accordance with UIPNM of State
Corporation Rosatom using the method 8D by means of fulfillment of tasks as follows:
1) nonconformity notice;
2) formation of a team;
3) clarification and/or addition of nonconformity description;
4) planning and implementation of correction and ICA;
5) determination of root causes of nonconformity;
6) development and implementation of CA;
7) development and implementation of PA;
8) formalization of conclusions.

1.3 Nonconformity classification


1.3.1 Nonconformities specified in i.1.2 of QUA-II-RG-CQ-14-192-2021 are divided into 2 (two) classes:

Class A: - deviations from the requirements of regulatory and legal acts and safety
guidelines of the Republic of Turkey;
- deviations from the requirements of Federal regulations and rules in the field of
use of nuclear energy and safety guidelines of the Russian Federation.

Class B - deviations that are not deviations of Class A;


- deviations identified in the accompanying documentation and the products;
- deviations identified in the technological processes of product manufacturing
from RD requirements to this process.
1.3.2 Nonconformities of Class B are classified according to types corresponding to the nonconformity types
of UIS-Quality:

Type 1 - a nonconformity whose elimination requires rework / alteration / repair / additional testing /
inspection of products, possibility of which is provided by applicable RD and standard procedures for
these products. After the nonconformity is eliminated, the products shall comply with requirements
established in ToR/TS/TR, WEDD, EMD and other RD stated in ToR/TS/TR, WEDD, EMD and/or
requirements (technical, quality) of contract (agreement) of manufacture and/or supply;

Type 2 - a nonconformity whose elimination requires rework / alteration / repair / additional testing /
inspection of products, possibility of which is provided by applicable RD for these products, but
requires development of additional elimination procedures by the manufacturing enterprise. After the
nonconformity is eliminated, the products shall comply with requirements established in ToR/TS/TR,
WEDD, EMD and other RD stated in ToR/TS/TR, WEDD, EMD and/or requirements (technical, quality)
of contract (agreement) of manufacture and/or supply;

Type 3 - a nonconformity with which the products can be used for intended purpose without their
rework / alteration / repair / additional testing / inspection. In this case, possibility of using the
products shall be justified by the developer-enterprise of WEDD of the products or holder-enterprise
of Industry Standard/TS of the products (in its absence, by General Designer of NPP). This justification
shall be given in the document of registration of nonconformities and taken decisions with reference
to the relevant RD and EMD or executed by separate documents attached to it (calculations, drawings,
etc.);

Type 4 - a nonconformity in which the requirements cannot be achieved, and the products and/or
process shall be replaced.

1.4 Distribution of roles in nonconformity management


Roles in nonconformity management are distributed at SPC Doza in accordance with Table:

Roles Connected to
Position
Team RQI RQC CA/PA Correction/ICA UIS-Quality

Engineer of QAD R – – R P Yes


Quality Assurance
C C C P – Yes
Director
Heads of departments
R – – C P Yes
involved
Employees of
P – – P C Yes
departments involved
R – person responsible; C – person in charge; P - participates if necessary

1.5 Team composition


4.5.1 Representatives of the following structural divisions and heads of business directions connected
to UIS-Quality system have roles in accordance with Appendix A of this Regulation: Quality Assurance Director,
Head of Production, Deputy Head of SRD, Head of DED, Head of DO, Engineer of QAD, Head of TCD, Head of
MAS, Head of EAS, Head of ClbD, Chief Metrologist, Head and Engineer of LCMG, Head of PD, Head of PMD
and Project Manager.
4.5.2 Other employees of the enterprise may be included in the team at the discretion of the leader.
Their notification and coordination with them take place via email.
4.5.3 The employees involved in implementation of nonconformity management process shall have
the knowledge and skills to use the methodology 8D when detecting nonconformities of products, work,
services and processes.
4.5.4 Employees assigned to perform the roles of RQI, RQC and functions of Leader shall confirm their
knowledge and skills with documents that certify their studying at a training course, full- or part-time, on
application of the methodology 8D when detecting nonconformities of products, work, services and processes
in the nuclear industry and their knowledge testing with a positive result.
4.5.5 When using UIS-Quality, employees authorized in accordance with the procedure established in
the organization to perform actions in UIS-Quality shall undergo external/internal full- or part-time (distance)
training on working in UIS-Quality.

1.6 Team interaction


Internal interaction of the team occurs by means of email and meetings. After that, notices in UIS-
Quality are formed for external approval of documentation.

1.7 Ways of nonconformity elimination


Rework – actions to eliminate nonconformities by the use of current procedures that ensure
compliance of products and/or processes with existing requirements established in technical specifications,
terms of reference, working documentation, process documentation, regulatory documents and other
applicable documents and/or requirements (both technical and quality) of contract/ agreement of
manufacture of products.
Repair – actions to eliminate nonconformities, which are aimed at restoring the functional capability of
products, that require additional tests/ inspection not provided for by current procedures, and development
of additional procedures to eliminate nonconformity is required. After the nonconformity is eliminated, the
products and/or process shall comply with the requirements established in the technical specifications, terms
of reference, working documentation, process documentation, regulatory documentation and other
applicable documents and/or requirements (both technical and quality) of contract/ agreement of
manufacture of products.
Concession (Use-as-is) – actions to eliminate nonconformities with which the products and/or process
can be used for intended purpose without rework/ repair. In this case, permissibility of use is justified by the
developer-enterprise of WEDD of the products, holder-enterprise of Industry Standard/TS of the products,
General Designer of NPP or the owner of process. This justification is specified in the document containing
decisions on nonconformities with reference to the relevant applicable documents, process documentation or
executed by separate documents (calculations, drawings, etc.).
Replace – actions aimed at replacing products and/or processes because of the presence of defects
that are irremediable, and the transfer of products to the consumer is not allowed because of their presence.

1.8 Determination of nonconformity significance and scope of work of nonconformity management


4.8.1 Nonconformity significance is determined in accordance with Appendix B of this Regulation.
4.8.2 Influence on the product delivery schedule of the contractor under the contract / agreement is
determined as the influence of planned period of nonconformity elimination on compliance with the product
delivery deadlines established in the said schedule.
4.8.3 In case of nonconformity identified after customer’s acceptance of the products under the
contract/ agreement, the meaning "Affects" is set.
4.8.4 Scope of work on nonconformity management is determined according to Table:

Nonconformity significance
Point of detection
Insignificant Significant Critical
At the customer Correction + ICA + CA Correction + ICA + CA + Correction + ICA + CA
(D6) PA (D8) + PA (D8)
In production/operational Correction + ICA + CA Correction + ICA + CA
Correction + ICA (D3)
process (D6) + PA (D8)
1.9 Classification of types of root causes of nonconformities
4.9.1 Classification of types of root causes of nonconformities is determined according to Appendix 3
of UIPNM:
1. Design products, construction/engineering documentation – factors related to placement/transfer,
execution, encoding, links to documents, spelling/vocabulary, translation, making amendments incorrectly,
information nonconformity between paper and electronic versions, technical/estimated parts of
documentation, incorrect application of established requirements.
2. Machines – factors related to the characteristics and condition of equipment used in the production
processes, including accompanying documentation.
3. Man – factors related to violation of technology/ procedure of work performance by personnel,
including the procedure of inspection operations.
4. Management – factors related to the general organization of process /work, planning, human
resource management / training, organizational changes.
5. Methods/technology – factors related to errors in process documentation, production technology,
inspection methods used or their absence.
6. Material, raw materials, components – factors related to properties of raw materials, materials or
components used for product manufacture.
7. Environment ‒ factors related to negative environmental effect on the production process.
4.9.2 On the basis of specifics of the enterprise's activities, additional detailing of causes is allowed for
each of the above types of root causes.

1.10 Requirements for documents of registration of nonconformities and taken decisions


4.10.1 Document of registration of nonconformities and taken decisions for nonconformities of Class A
is a Decision. The Decision is executed according to a form specified in Appendix C.
4.10.2 Procedure of Decisions’ approval, agreement, registration and storage of the products intended
for use as part of elements, or as an element, assigned to safety classes 1, 2, 3, 4 according to NP-001, to
which quality assurance categories QA1, QA2, QA3, QNC/QA4 are assigned, is given in Appendix 3 of
Regulation QUA-II-RG-CQ-14-192-2021.
4.10.3 Decisions concerning deviations from requirements of regulatory legal acts and safety
guidelines of the Republic of Turkey shall be approved by the Nuclear Regulatory Agency of the Republic of
Turkey.
4.10.4 Decision shall be sent for approval within 5 (five) working days from the date of nonconformity
detection at the manufacturing enterprise or receipt by the enterprise that committed the nonconformity of a
nonconformity notice in UIS-Quality or Act of incoming inspection of products containing nonconformity. The
period of consideration of Decision shall be not more than 10 (ten) working days from the date of receipt of
the document subject to provision of a full set of justifying documents.
4.10.5 The company reserves the right to extend the period of consideration of Decision, but not more
than to 5 (five) working days.
4.10.6 Document of registration of nonconformities and taken decisions for nonconformities B-1, B-2,
B-3, B-4 is a Nonconformity Report or Final Nonconformity Report, which is generated automatically on the
basis of results of entering information about nonconformity into UIS-Quality and consists of several modules
of unified forms given in Appendix D-I of this Regulation.
4.10.7 Documents of registration of nonconformities and taken decisions are not executed if the
deviation is classified as a Remark in accordance with i.3 of this Regulation.

1.11 System analysis of identified nonconformities


4.11.1 Quality Assurance Director arranges a meeting to review commited nonconformities (if any).
The team members listed in Appendix A, as well as other employees of the enterprise, if necessary, are invited
to the meeting. System analysis periodicity shall be determined as every three months or often (on request of
the customer of the contract) in accordance with Provision of IMS-AKU-P-094-01-21.
4.11.2 At the meeting an information review is performed about the following:
- statistics of identified nonconformities (classification, frequency and point of detection);
- causes of nonconformities;
- trends in the causes and nature of violations of the established requirements;
- effectiveness of methods and ways of nonconformity elimination;
- effectiveness of undertaken CA and PA.
4.11.3 Result of system analysis of nonconformities is a determination of root causes of identified
nonconformities and performance of repeated corrective actions (if taken corrective actions were ineffective),
development and performance of preventive actions aimed at preventing the occurrence of repeated
nonconformities.

4.12 Counterfeit, falsified and doubtful product/-s, if identified, are recognized as nonconforming
product/-s. In relation to such nonconforming product/-s, measures to prevent their use are applied, including
identification and separation, until a decision on their use is taken. After identifying doubtful product/-s and
product/-s with proven falsification/ contrafactness, it is necessary to notify the customer in a timely manner
(within the period up to 5 days). The management of nonconformities identified in counterfeit, falsified and
doubtful product/-s is performed in accordance with the requirements of this Regulation.

4.13 Management of claim and plaint work related to the identified nonconformities is performed by
the legal department in accordance with the requirements of contract of product supply.

4.14 Nonconformity cancellation in UIS-Quality is possible after approval by RQI and subject to absence
of violations on implementation of activity/ actions on time. Nonconformity with overdue actions shall be
canceled upon mandatory approval by the head of business direction of the organization that identified the
nonconformity. Subject to absence of connection of the head of business direction of the organization to UIS-
Quality, a scanned copy of nonconformity cancellation approval signed by the head of business direction of
the organization shall be attached.

4.15 Within the frame of Contract No. FT-04-22-64 of 18.02.2022 by an official letter to Customer’s
address, SPC Doza shall send copies of the following administrative documents:
- on appointment of officials responsible for work with nonconformities, with mandatory indication of
roles and information about connection to UIS-Quality;
- on appointment of person responsible for submission of system analysis.
Copies of administrative documents shall be sent within 10 working days from the date of:
- signing the supply contract,
- making amendments to the administrative documents on appointment of responsible employees for
nonconformity management related to personnel changes /changes of contracts of work performance and
service rendering.

5 Procedure subject to nonconformity detected

1.12 Employee of SPC Doza who identified the nonconformity:


5.1.1 sends a nonconformity notice to Quality Assurance Director via UIS-Quality, if connected, or e-
mail, or in hard copy (recommended form is given in Appendix D), as a person responsible for quality in the
organization who identified and/or committed the nonconformity, during one working day after
nonconformity detection;
5.1.2 identifies nonconforming products by marking them, isolates them from products complying with
the established requirements to prevent their unintentional use.

1.13 Person responsible for quality in the organization that identified the nonconformity (RQI):
1.13.1 sends a nonconformity notice through UIS-Quality to RQC during one working day after
nonconformity identification; specifies in the notice a period of consideration, but not less than two working
days; subject to RQC be not connected to UIS-Quality, RQI sends an official letter of notice by e-mail
(recommended form is in Appendix D);
1.13.2 reviews the correction plan and ICA during one working day after the plan has been sent for
signing by the team leader through the system UIS-Quality; signs it with a qualified Electronic Digital Signature
(EDS) or rejects it, specifying reasons in comments;
1.13.3 reviews the act of completed corrections and ICA during one working day after the act has been
sent for signing by the team leader through the system UIS-Quality; signs it with a qualified EDS or rejects it,
specifying reasons in comments;
1.13.4 reviews the plan of CA/PA during one working day after the plan has been sent for signing by
the team leader through the system UIS-Quality; signs it with a qualified EDS or rejects it, specifying reasons in
comments;
1.13.5 reviews the final nonconformity report during one working day after the report has been sent
for signing by the team leader through the system UIS-Quality; signs it with a qualified EDS or rejects it,
specifying reasons in comments.

1.14 Person responsible for quality in the organization that committed the nonconformity (RQC):
1.1.1 examines and reviews the nonconformity notice during the time set by RQI; takes a decision on
acceptance it for work or reject it with comments (request for information clarification, justification of
nonconformity absence fact or absence of responsibility for nonconformity occurrence); if necessary, attracts
specialists from the divisions responsible for work with nonconformity;
1.1.2 if the nonconformity has been accepted, appoints a team leader from the heads of the
departments involved and forms together with him a team composition during two working days after
acceptance of nonconformity notice; connects and notifies the team members in UIS-Quality and duplicates
information by email, if necessary.
If the nonconformity is rejected, RQC sends a notice for further consideration to RQI via UIS-Quality
and in the field "comments" indicates a reason of nonconformity rejection;
1.1.3 reviews the correction plan and ICA during one working day after the plan has been sent for
signing by the team leader through the system UIS-Quality; signs it with a qualified EDS or rejects it, specifying
reasons in comments;
1.1.4 reviews the act of completed corrections and ICA during one working day after the act has been
sent for signing by the team leader through the system UIS-Quality; signs it with a qualified EDS or rejects it,
specifying reasons in comments;
1.1.5 reviews the plan of CA/PA during one working day after the plan has been sent for signing by the
team leader through the system UIS-Quality; signs it with a qualified EDS or rejects it, specifying reasons in
comments;
1.1.6 reviews the final nonconformity report during one working day after the report has been sent for
signing by the team leader through the system UIS-Quality; signs it with a qualified EDS or rejects it, specifying
reasons in comments.

1.15 Team leader:


1.1.7 after receiving a notice in UIS-Quality that he has been appointed a team leader, he/she
participates in formation of team to work with nonconformities; organizes meetings at all subsequent stages
of team's work, if necessary;
1.1.8 as part of the team during two working days immediately after the team’s formation, participates
in clarification and/or addition of the nonconformity description, attracts the suppliers/contractors who have
committed the nonconformity, if necessary;
1.1.9 as part of the team during five working days, unless otherwise agreed with the customer,
performs planning of correction and ICA immediately after the clarification stage; adds a class of
nonconformity to the nonconformity description taking into account the requirements of i.4.6; appoints
people responsible for implementation of the correction plan and ICA from among employees subordinated to
the team members;
1.1.10 determines a nonconformity significance and scope of work of nonconformity management
during one working day immediately after receiving the correction plan and ICA in accordance with i.4.7 of
this Regulation;
1.1.11 executes a correction plan and ICA in UIS-Quality (in accordance with Appendix E of this
Regulation) during the time allocated to determine the nonconformity significance, and sends it for approval
to RQC, RQI, team members, as well as other participants of the procedure, if provided by the supply contract;
1.1.12 as part of the team during two working days immediately after approval of the correction action
plan and ICA, participates in clarification of root causes of the nonconformity, unless otherwise agreed with
the customer;
1.1.13 as part of the team within five working days immediately after the stage of identifying root
causes of nonconformity, unless otherwise agreed by the customer, participates in development of the plan of
CA/PA on the basis of information received when identifying root causes of nonconformity; analyzes the
ineffectiveness of CA if the nonconformity is repeated and occurred for a cause previously identified; appoints
persons responsible for implementation of the plan CA/PA from among employees subordinated to the team
members;
1.1.14 executes the plan CA/PA in UIS-Quality in accordance with Appendices F and G, respectively,
during the time allocated for the development and planning of CA, and sends it for approval to RQC, RQI,
team members, as well as other participants of the procedure, if provided by the supply contract;
1.1.15 monitors the implementation of correction and ICA activity; ensures compliance with the
deadlines for corrections and ICA according to the plan, allocates resources if necessary; after all planned
activities are completed, confirms in UIS-Quality the implementation of the correction plan and ICA;
1.1.16 as part of the team during two working days after implementation of correction and ICA activity,
determines an amount of costs incurred by the organizations as a result of nonconformity elimination;
clarifies the nonconformity significance and scope of work of nonconformity management in accordance with
i.4.6, 4.7 of this Regulation;
1.1.17 during one working day after the clarification stage of nonconformity significance, executes an
act of nonconformity elimination in UIS-Quality in accordance with Appendix H and sends it for approval to
RQC, RQI, team members, as well as other participants of the procedure, if provided by the supply contract;
1.1.18 monitors the implementation of CA/PA activity; ensures compliance with the deadlines of
CA/PA according to the plan, allocates resources if necessary; after all the planned activities are completed,
confirms in UIS-Quality the implementation of the plan of CA/PA;
1.1.19 executes a final nonconformity report in UIS-Quality in accordance with Appendix I during two
working days immediately after the completion of all activity of CA/PA, if any, or after completion of
corrections and ICA; sends it for approval to RQC, RQI, team members, as well as other participants of the
procedure, if provided by the supply contract.

1.16 Team:
1.1.20 analyzes a received nonconformity notice during two working days immediately after the team’s
formation; if necessary, requests clarification and/or additional information on the nonconformity;
1.1.21 plans correction and ICA activity during five working days, unless otherwise agreed with the
customer, immediately after the clarification stage; appoints persons responsible for implementation of the
correction plan and ICA from among employees subordinated to the team members; sends out the correction
and ICA activity plan to the employees responsible for its implementation;
1.1.22 determines a nonconformity significance during one working day immediately after execution of
the correction plan and ICA in accordance with i.4.7 of this Regulation;
1.1.23 analyzes the correction plan and ICA during one working day after the plan has been sent for
approval by the team leader through the system UIS-Quality; approves it or rejects it, specifying reasons in
comments;
1.1.24 determines root causes of the nonconformity during two working days, unless otherwise agreed
with the customer, immediately after approval of the correction plan and ICA;
1.1.25 develops a plan of CA/PA during five working days immediately after the stage of identifying
root causes of the nonconformity, unless otherwise agreed with the customer, on the basis of information
received when identifying root causes of the nonconformity; finds out causes for ineffectiveness of the
previous CA, if the nonconformity is repeated and occurs for the previously identified cause; appoints persons
responsible for implementation of the plan of CA/PA from among employees subordinated to team members;
1.1.26 analyzes the plan of CA/PA during one working day after the plan has been sent for approval by
the team leader through the system UIS-Quality; approves it or rejects it, specifying reasons in comments;
1.1.27 determines a cost, time and resources spent to implement the correction and ICA activity during
two working days immediately after all activity is completed; transmits this data to the team leader via UIS-
Quality or, if necessary, by e-mail;
1.1.28 analyzes an act of completed corrections and ICA during one working day after the act has been
sent for approval by the team leader through the system UIS-Quality; approves it or rejects it, specifying
reasons in comments;
1.1.29 analyzes a final nonconformity report during one working day after the report has been sent for
approval by the team leader through the system UIS-Quality; approves it or rejects it, specifying reasons in
comments.

1.17 Persons responsible for implementation of correction and ICA activity:


1.1.30 implement correction and ICA activity within the scheduled terms; notify a representative of
their department in the team on work completion via e-mail or in hard copy;
1.1.31 transmit data on cost, time and resources spent to implement the correction and ICA activity to
team members (representatives of their divisions registered in UIS-Quality) by e-mail or in hard copy during
two working days immediately after all activity is completed.

1.18 Persons responsible for implementation of activity of CA and PA:


1.1.32 implement activity of CA and PA within the scheduled terms; notify a representative of their
department in the team on work completion of work via e-mail or in hard copy.

1.19 Storage of documented information


Execution of documented information about nonconformity in electronic form is allowed. The
documented information about nonconformity is stored on the enterprise’s server, as well as in UIS-Quality.

6 Responsibility

SPC Doza, Ltd. is responsible for:


a) compliance with the requirements of this Regulation during product manufacturing, testing and
incoming inspection;
b) development/updating (taking into account the requirements of QUA-II-RG-CQ-14-192-2021)
and implementation of procedures for nonconformity management;
c) assignment of nonconformity classification and development of appropriate corrections, ICA,
corrective and preventive actions;
d) development of documents of nonconformity registration and decisions made on
nonconformities;
e) submission for consideration for the purpose of approval of documents of nonconformity
registration and decisions made according to the procedure established by this Regulation;
f) provision of Company/General Contractor with materials and information related to
management of nonconformities identified during manufacture and/or testing and/or incoming inspection;
g) isolation of nonconforming products, their marking and storage;
h) elimination of identified nonconformities/comments according to decisions made and
registration of nonconformities identified during conformity assessment in form of acceptance and testing
within due time limits in UIS-Quality, sending a nonconformity notice to the organization committed the
nonconformity;
i)ensuring the fact that the General Contractor’s or Company’s product requirements, which are
specified in the supply contracts (agreements) concluded with them, are included in the contracts
(agreements) with sub-suppliers.

7 Requirements for sub-suppliers

7.1 Manufacturing enterprises/sub-suppliers are responsible for:


a) compliance with the requirements of this Regulation during product manufacturing, testing and
incoming inspection;
b) development/updating (taking into account the requirements of QUA-II-RG-CQ-14-192-2021)
and implementation of procedures for nonconformity management;
c) assignment of nonconformity classification and development of appropriate corrections, ICA,
corrective and preventive actions;
d) development of documents of nonconformity registration and decisions made on
nonconformities;
e) submission for consideration for the purpose of approval of documents of nonconformity
registration and decisions made according to the procedure established by this Regulation;
f) provision of Company/General Contractor with materials and information related to
management of nonconformities identified during manufacture and/or testing and/or incoming inspection;
g) isolation of nonconforming products, their marking and storage;
h) elimination of identified nonconformities/comments according to decisions made and
registration of nonconformities identified during conformity assessment in form of acceptance and testing
within due time limits in UIS-Quality, sending a nonconformity notice to the organization committed the
nonconformity.
7.2 Procedures for nonconformity management developed by the product manufacturing enterprise
/sub-suppliers shall take into account the requirements of QUA-II-RG-CQ-14-192-2021 and establish as
follows:
a) procedure of interaction among parties (officials, divisions, organizations) involved in
nonconformity management, with distribution of obligations and responsibilities, including responsibility for
agreement of correction and ICA activity, corrective and preventive actions, organization and control of their
implementation, with indication of target terms of work completion, as well as procedure of nonconformity
document approval with the customer under the contract (agreement) and/or Company and/or the
supervisory authority;
b) procedure of identification of products non-conforming to the established requirements by
means of their marking, labeling, isolating from the products conforming to the established requirements,
their storage or otherwise to prevent their unintended use;
c) procedure of data receipt on the amount of costs incurred by the Company / General
Contractor / Supplier/ Manufacturing enterprise as a result of nonconformity elimination, which are
calculated in accordance with requirements of the Unified Industry Methodical Guidelines for Calculation of
Costs Caused by Nonconformity of Products with Established Requirements;
d) procedure of determination of nonconformity significance taking into account the
requirements of QUA-II-RG-CQ-14-192-2021;
e) procedure of determination of scope of work performed for nonconformity management
depending on nonconformity significance taking into account the requirements of QUA-II-RG-CQ-14-192-
2021;
f) procedure of development and implementation of correction actions, ICA, corrective actions
and actions aimed to prevent similar nonconformities and their effectiveness assessment/review;
g) classifier of types of root causes of nonconformities that taking into account the requirements
of QUA-II-RG-CQ-14-192-2021;
h) classification of nonconformities in accordance with the requirements of QUA-II-RG-CQ-14-192-
2021;
i) requirements for the need to perform the periodic system analysis of nonconformities;
j) unified forms of nonconformity documents taking into account the requirements of QUA-II-RG-
CQ-14-192-2021, which depending on the possible subjects of nonconformities shall contain a detailed list of
information, procedure of their storage and distribution, if necessary;
k) procedure of accounting and registration of identified nonconformities before the use of UIS-
Quality, if necessary.
7.3 In the organization committed the nonconformity, it is to be established:
a) procedure of Leader appointment and determination of his authorities;
b) procedure of team formation, determination of its members’ authorities and responsibilities;
c) storage time of documented information on nonconformities.
The team as a whole shall have skills and competencies necessary to develop correction and ICA activity,
identify the causes of nonconformities, develop corrective and preventive actions, perform assessment of
nonconformity significance.
A composition and number of active Teams is determined by RQC on the basis of specifics of their
activities, variety of products etc. The composition of Team is determined on the basis of specifics of
nonconformity and can be changed at subsequent stages of work on nonconformity. If necessary,
representatives of other organizations are involved in Team work.

2 Making amendments

Checking the relevance of this Regulation, making amendments, storage and archiving or disposal are
performed in accordance with a documentation management standard of the enterprise.
Quality Assurance Director is responsible for maintenance of this Regulation in an up-to-date state and
making amendments.
Each employee of the enterprise may make a proposal to amend and/or supplement this Regulation
and submit it to Quality Assurance Director.
Roles in UIS-Quality
Conformity Assessment
Nonconformity Management subsystem Inspection Operations subsystem
subsystem
No Position Person
Applicant for
Participant responsible for Participant Head of
Data viewing RQI RQC Conformity Data viewing Controller Data viewing
of procedure quality in of procedure Controller
Assessment
organization
Quality Assurance
1 Yes Yes Yes Yes Yes Yes – Yes – Yes Yes
Director
2 Head of Production Yes – – – – – – – – – –
3 Deputy Head of SRD Yes – – – Yes – – – – – –
4 Head of DED Yes – – – – – – – – – –
5 Head of DO Yes – – – – – – – – – –
6 Engineer of QAD Yes Yes – – – – – Yes – – Yes
7 Head of TCD Yes – – – Yes – – Yes Yes – Yes
8 Head of MAS Yes – – – – – – – – – –
9 Head of EAS Yes – – – – – – – – – –
10 Head of ClbD Yes – – – – – – – – – –
11 Chief Metrologist Yes – – – – – – – – – –
12 Head of LCMG Yes – – – – Yes Yes – – – –
13 Engineer of LCMG Yes – – – – Yes Yes – – – –
14 Head of PD Yes – – – – – – – – – –
15 Head of PMD Yes Yes – – – – – – – – –
16 Project Manager Yes Yes – – – – – – – – –
Appendix A
(mandatory)
Distribution of roles in UIS-Quality according to positions in SPC Doza
Appendix B
Determination of nonconformity significance

Influence on the product


Nonconformity identified Influence of uncorrected nonconformity Influence on the cost of
delivery schedule of the Nonconformity
Repeatability in equipment of safety on functional capability/ operation of products under the
contractor under the contract/ significance
class 3 products contract/ agreement
agreement

Affects
Affects
No influence
Affects
Affects Critical
No influence
No influence
Yes
Affects
Affects
No influence
No influence Significant
Affects
No influence
No influence Insignificant
Repeated
Affects
Affects
No influence Critical
Affects
Affects
No influence
No influence Significant
No
Affects Critical
Affects
No influence
No influence Significant
Affects
No influence
No influence Insignificant

Single Yes Affects Affects Affects Critical


No influence

Affects
No influence
No influence

Affects
Affects Significant
No influence
No influence
Affects
No influence
No influence Insignificant

Affects Critical
Affects
No influence
Affects Significant
Affects
No influence
No influence Insignificant
No
Affects
Affects
No influence Significant
No influence
Affects
No influence
No influence Insignificant
Appendix C

Form of Decision on Nonconformity of Class A


APPROVE
First Deputy General Director –
Director of
Nuclear Power Plant under construction
AKKUYU NÜKLEER ANONIM SIRKETI
_____________ ________________
(signature) (initials, surname)
__________________________ 20 ____

Decision No ______________________________ of ____________________


(registration number of decision) (date of registration)

(name of decision)

Product name:
Serial number:
Classification designation according to NP-001:
Equipment group according to PNAE G-7-008:
Seismic resistance category according to NP-031:
KKS code:
ToR/TS/TR (or other RD, according to which products manufactured):
Quality plan1*:
Manufacturing enterprise:
Products will be used in the manufacture of equipment2:
Equipment name2*:
Classification designation according to NP-0012*:
Group of equipment according to PNAE G-7-0082*:
Seismic resistance category according to NP-0312*:
KKS code2*:
ToR/TS/TR2*:
Quality plan2*:
Manufacturing enterprise2*:
Nonconformity description:
(detailed information about nonconformity with attached drawings, test results, etc., if necessary)
Brief justification of the need to perform work:
Preliminary assessment results of influence of planned activity on nuclear and radiation
safety:
List and results of corrective and preventive actions:
IT IS HEREBY DECIDED:
Subject of decision:
Activity with indication of responsible persons and deadlines:
Appendices:
1. 3*
2. 3*
n. Copies of letters of agreement and approval of Decision 3*

DEVELOPED by:
Manufacturing enterprise of products ________
_______________________________________ ____________________
(name of organization and position of person developed this Decision) (signature) (surname, initials)
____________________
20_______

APPROVED by:
Manufacturing enterprise of products ________
_______________________________________ ____________________
(name of organization and position of person entitled to approve this (signature) (surname, initials)
Decision) ____________________
20_______

Developer of engineering documentation of


products ________
_______________________________________ ____________________
(name of organization and position of person signed this Decision) (signature) (surname, initials)
____________________
20_______

Developer of engineering documentation of


equipment2* ________
_______________________________________ ____________________
(name of organization and position of person signed this Decision) (signature) (surname, initials)
____________________
20_______

Head materials science organization4* ________


_______________________________________ ____________________
(name of organization and position of person entitled to approve this (signature) (surname, initials)
Decision) ____________________
20_______

Authorized organization ________


_______________________________________ ____________________
(name of organization and position of person entitled to approve this (signature) (surname, initials)
Decision) ____________________
20_______

General Designer of Akkuyu NPP ________


_______________________________________ ____________________
(name of organization and position of person entitled to approve this (signature) (surname, initials)
Decision) ____________________
20_______

Chief Designer of Reactor Unit5* ________


_______________________________________ ____________________
(name of organization and position of person entitled to approve this (signature) (surname, initials)
Decision) ____________________
20_______

Equipment supplier ________


_______________________________________ ____________________
(name of organization and position of person entitled to approve this (signature) (surname, initials)
Decision) ____________________
20_______

General Contractor6* ________


_______________________________________ ____________________
(name of organization and position of person entitled to approve this (signature) (surname, initials)
Decision) ____________________
20_______

Design Director of AKKUYU NÜKLEER A.Ş. ________


____________________
(signature) (surname, initials)
____________________
20_______

Deputy Director of NPP under construction – ________


Technical Director of AKKUYU NÜKLEER A.Ş. ____________________
(signature) (surname, initials)
____________________
20_______

________
Quality Director of AKKUYU NÜKLEER A.Ş. ____________________
(signature) (surname, initials)
____________________
20_______

1* To be filled if the products is manufactured according to Quality Plan.


2* To be filled if the products is used the manufacture of equipment.
3* Mandatory Appendices to Decision.
4* Approval by the Head materials science organization is mandatory for
products/equipment that are subject to the Federal regulations and rules PNAE G-7-008.
5* Approval by the Chief Designer of Reactor Unit is mandatory for the products/
equipment included in the reactor unit.
6* Approval by the General Contractor is mandatory if there is no direct agreement
(contract) between the Supplier and Company.

Instead of approving signatures, referencing to the number and date of approval letter is
allowed, at the same time an entry "agreed by letter of __________ No __________" is made
opposite the organization.
Appendix D
(recommended)
Nonconformity Notice form

Identified Nonconformity notice1


No _______________________________ of ___________
Subject of nonconformity :
Project: details and name of contract and, if applicable, project name
during which implementation the nonconformity of the products
has been identified; for the construction projects of Facilities of
Nuclear Energy Use (OIAE) a name of OIAE is indicated
Site/ Facility: place of nonconformity identification (geographically), for
example, address of site of OIAE under construction, number of
the power unit (applicable for NPP), address and name of
manufacturing enterprise, etc.
Identification information
Organization that identified: name of organization that identified the nonconformities
stage/ sub-stage of product life cycle at which its
nonconformity was indentified, for example, construction and
Identification stage
installation work, commissioning, etc.; if the products are intended
for OIAE, then stage of life cycle of OIAE is additionally indicated
name of inspection activity, as a result of which the
Inspection activity
nonconformity was identified
Organization that name of organization that committed the nonconformity
committed the (indicated on the basis of information received in specific
nonconformity circumstances related to a specific nonconformity)
details of document in which the nonconformity was initially
Primary registration
documented (if any), for example, an entry in the general work log,
document etc.
date of identification is indicated in accordance with the
Date of initial registration
primary registration document of nonconformity
Description of subject of nonconformity
(see i. 5 of this Appendix)
Description of nonconformity
prior to carring into effect of the Industry classifier of
Type of nonconformity nonconformities, it is indicated in accordance with the local classifier
of types of nonconformities of the organization
detailed description of nonconformity is provided, as well as
other information that is missing in the other fields of the form and
is necessary for analyzing the nonconformity and making a decision
regarding it, suggestions for ICA and correction, if any, are indicated;
Description of
description of nonconformity shall not allow for different
nonconformity interpretations;
stating in appendix of a detailed description of all identified
deviations from the established requirements within the framework
of one identified nonconformity subject is allowed.
Requirements violated details and name of the document which requirements were
violated, number of section/ item / page in which the violated

1
Comments to fill in the form fields are shown in italics
requirements have been established are indicated
information about the need for arrival and date of arrival of
Calling for contractor the supplier/contractor's representative at the place of identification
the nonconformity is indicated
Signature,
Division Position Name
date
Nonconformity was
registered by:
Approval of notice
Organization Division Position Name Signature, date

Appendices
Number of
No Name
sheets
Appendix E Correction Plan and ICA form

Correction Plan and ICA1


No of
Subject of nonconformity:
name of project during which implementation the nonconformity of
the products has been identified, if applicable; for construction
Project:
projects of Facilities of Nuclear Energy Use (OIAE) a name of OIAE is
indicated
place of nonconformity identification (geographically), for example,
address of site of OIAE under construction, number of the power unit
Site/ Facility:
(applicable for NPP), address and name of manufacturing enterprise,
etc.
Nonconformity notice
Number and date of details of document in which the nonconformity was initially
registration of documented, if any, as well as number and date of nonconformity
nonconformity notice notice
Organization, division that identified name of organization and division that identified the
nonconformity
position and full name of employee who identified the
Person who identified
nonconformity according to the notice
Stage of stage/sub-stage of product life cycle at which its nonconformity is
nonconformity identified, for example, construction and installation work,
identification commissioning work, etc.
name of inspection activity as a result of which the nonconformity
Inspection activity
is identified
2
Team

Organization/
Role3 Position Name
division

Organizations which notices have been sent to 4


Responsible for quality in
organization committed
Organization Contract/ agreement
the nonconformity

1
Comments to fill in fields of the form are shown in italics.
2
Persons included in the members of Team are indicated.
3
Employee’s role in the nonconformity management process: RQI, RQC, Leader, Team member, approving person.
4
Organization committed the nonconformity and their RQC, as well as names of its suppliers that committed the
nonconformity and are in contractual relations with the specified organization and their RQC, if applicable, are indicated.

Description
Description of subject of nonconformity

Description of nonconformity
indicated in accordance with the classifier of types of nonconformities
Type of nonconformity
(Appendix J)
detailed description of nonconformity is provided, as well as other
information that is missing in the other fields of the form and is
necessary for analyzing the nonconformity and making a decision
regarding it; suggestions for correction and ICA, if any, are indicated;
description of nonconformity shall not allow for different
interpretations;
Description of nonconformity information is supplemented/ clarified, if necessary, in comparison
with one indicated in the nonconformity notice (identified party
shall participate in approval of the Correction Plan and ICA).

details and name of document whose requirements have


Requirements violated been violated, number of section / item / page in which the
violated requirements have been established are indicated

Analysis of nonconformity significance


Influence
Troubleshooting Influence on Scope of
on Safety class9 Significance10
method5 operability/ operation7 Repeatability8 work11
schedule6

Correction and Interim Containment Actions


Correction12/ Target
No Action Organization Responsible
ICA term

"correction" is indicated for employee


nonconformity elimination action description organization responsible for
and meaning "ICA" for actions of action responsible for implementation of
according to ICA implementation action

12
Approval of Correction Plan and ICA
Signature,
Organization Division Name Position date

Appendices
Number of
No Name sheets

5
Method of nonconformity elimination is indicated.
6
Indicated in accordance with item 4.7 of this Regulation.
7
Determined and filled in automatically depending on the method of elimination.
8
When the nonconformity is determined as repeated, registration numbers of the nonconformities for which
repeatability was determined are indicated.
9
Nonconformity identified in the equipment /product assigned to safety class 1 - 3 (according to NP-001-15). It is
indicated in accordance with Appendix B hereto.
10
Indicated in accordance with i.4.8 of this Regulation.
11
Act of nonconformity elimination is formed after completion of correction actions.
12
Persons who approve information in Correction Plan and ICA are indicated.
Appendix F Corrective Action Plan form

Corrective Action Plan1


No of
Subject of nonconformity:
details and name of contract and, if applicable, name of
project during implementation of which the nonconformity
Project: of products is identified; for construction projects of
Facilities of Nuclear Energy Use (OIAE) a name of OIAE is
indicated
Site/ Facility: place of nonconformity identification (geographically), for
example, address of site of OIAE under construction,
number of the power unit (applicable for NPP), address and
name of manufacturing enterprise, etc.

Nonconformity notice
Number and date of details of document in which the nonconformity was initially
nonconformity notice documented, if any, as well as number and date of
registration nonconformity notice

Organization, division that name of organization and division that identified the
identified nonconformity

position and full name of employee who identified


Person who identified
the nonconformity in accordance with the notice
Stage of stage/sub-stage of product life cycle at which its
nonconformity nonconformity is identified, for example, construction and
installation work, commissioning work, etc.
identification
name of inspection activity as a result of which the
Inspection activity
nonconformity is identified
2
Team
Organization/
Role3 division Position Name

Organizations which notices have been sent to 4

Responsible for quality in


organization committed
Organization Contract/ agreement
nonconformity

Description
Description of subject of
nonconformity

Description of nonconformity
indicated in accordance with the classifier of types of
Type of nonconformity nonconformities (Appendix J)
description in accordance with the Correction Plan and ICA
Description of nonconformity
is indicated
details and name of document whose requirements have
Requirements violated been violated, number of section/ item / page in which
the violated requirements have been established are
indicated
Analysis of nonconformity causes
Reason why the nonconformity
was not identified at the previous indicated if the nonconformity could have been identified
stages of product manufacture at the previous stages of product manufacture

Root causes of occurrence:


Type of cause Description
in accordance with
i. 4.8 of this
Regulation
Development of corrective actions
Root Organization, Target
No cause Actions division Responsible term

Approval of Corrective Action Plan


Organization,
No division Position Name Signature, date

Appendices
Number of
No Name
sheets

1
Comments to fill in fields of the form are shown in italics in brackets.
2
Persons included in the members of Team are indicated. Composition of Team can be expanded/ changed at
subsequent stages of process implementation.
3
Employee’s role in the nonconformity management process: RQI, RQC, Leader, Team member, approving person.
4
Organization committed the nonconformity and their RQC, as well as names of its suppliers that committed the
nonconformity and are in contractual relations with the specified organization and their RQC, if applicable, are indicated.
Appendix G Preventive Action Plan form

Preventive Action Plan1


No of
Subject of nonconformity: details and name of contract and, if applicable, name of project during
Project: implementation of which the nonconformity of products is identified;
for construction projects of Facilities of Nuclear Energy Use (OIAE) a
name of OIAE is indicated
Site/ Facility:
place of nonconformity identification (geographically), for example,
address of site of OIAE under construction, number of the power unit
(applicable for NPP), address and name of manufacturing enterprise,
etc.
Nonconformity notice
Number and date of details of document in which the nonconformity
nonconformity notice was initially documented, if any, as well as
registration number and date of nonconformity notice

Organization, division that name of organization and division that identified the
identified nonconformity
position and full name of employee who identified
Person who identified the nonconformity according to the notice
Stage of stage/sub-stage of product life cycle at which its
nonconformity nonconformity is identified, for example, construction and
identification installation work, commissioning work, etc.

name of inspection activity as a result of which the


Inspection activity nonconformity is identified
2
Team

Organization/
Role3 Division Position Name

4
Organizations which notices have been sent to
Responsible for
quality in
Organization Contract/ agreement
organization
committed the
nonconformity

1
Comments to fill in fields of the form are shown in italics.
2
Persons included in the members of Team are indicated. Composition of Team can be expanded/ changed at
the subsequent stages of process implementation.
3
Employee’s role in the nonconformity management process: RQI, RQC, Leader, Team member, approving person.
4
Organization committed the nonconformity and their RQC, as well as names of its suppliers that committed the
nonconformity and are in contractual relations with the specified organization and their RQC, if applicable, are indicated.
Description
Description of subject of nonconformity

Description of nonconformity
indicated in accordance with the classifier of types of
Type of nonconformity nonconformities (Appendix J)
description in accordance with the Correction Plan and ICA
Description of nonconformity is indicated
details and name of document whose requirements have
Requirements violated been violated, number of section/ item / page in which the
violated requirements have been established are indicated
Analysis of nonconformity causes
Reason why the nonconformity
was not identified at the previous indicated if the nonconformity could have been identified
stages of product manufacture at the previous stages of product manufacture

Root causes of occurrence:


Type of cause Description
in accordance with i. 4.8 of this
Regulation
Development and implementation of preventive
actions Development of preventive actions
Organization, Target
No Actions Responsible
division date

Approval of Preventive Action Plan


Organization,
No division Name Position Signature, date

Appendices
Number of
No Name sheets
Appendix H Nonconformity Elimination Act form

Nonconformity Elimination (Correction) Act1


No of
Subject of nonconformity:
name of project during implementation of which the
nonconformity of products is identified; for construction
Project: projects of Facilities of Nuclear Energy Use (OIAE) a name of
OIAE is indicated

place of nonconformity identification (geographically), for


example, address of site of OIAE under construction, number
Site/ Facility:
of the power unit (applicable for NPP), address and name of
manufacturing enterprise, etc.
Date of elimination: date of completion of all correction actions is indicated
Description of nonconformity
Description of subject of
nonconformity

Description of nonconformity
indicated in accordance with the classifier of types of
Type of nonconformity
nonconformities (Appendix J)
Description of nonconformity indicated in accordance with the Correction Plan

details and name of document whose requirements have


Requirements violated been violated, number of section/ item / page in which the
violated requirements have been established are indicated
Corrective actions (nonconformity elimination)
Target
No Action Organization Responsible term
(organization (responsible
(action description) responsible for from the
implementation) organization)
2
Approval of Corrective Action Plan

Organization Division Name Position

Report on implementation of corrective actions


Actual
No Actions Report term
brief description of completed
actions and taken decisions,
comments
Clarification of nonconformity significance
Influence on cost of the
products under contract/ Significance Scope of work4
agreement3

5
Approval of clarified significance

Division Name Position Signature, date


Agreement and approval of correction report
NONCONFORMITY HAS BEEN ELIMINATED

Organization, Signature,
Position Name
division date

Appendices
Number of
No Name sheets

1
Comments to fill in fields of the form are shown in italics.
2
Persons agreed with the information in Correction Plan and ICA are indicated.
3
The amount and influence are indicated in accordance with Appendix B hereto.
4
Indicated in accordance with Appendix B hereto.
5
Approval is performed within the organization committed the nonconformity in accordance with the procedure
established in the organization.
Appendix I Final or Interim Nonconformity Report form

Final 1 Nonconformity report 2


No of
Subject of nonconformity:
Project: details and name of contract and, if applicable, name of
project during implementation of which the nonconformity of
products is identified; for construction projects of Facilities of
Nuclear Energy Use (OIAE) a name of OIAE is indicated
Site/ Facility: place of nonconformity identification (geographically), for
example, address of site of OIAE under construction, number
of the power unit (applicable for NPP), address and name of
manufacturing enterprise, etc.
Nonconformity notice
Number and date of details of document in which the nonconformity was initially
nonconformity notice documented, if any, as well as number and date of
registration nonconformity notice
Organization, division that name of organization and division that identified the
identified nonconformity
position and full name of employee who identified
Person who identified the nonconformity according to the notice
Stage of stage/sub-stage of product life cycle at which its
nonconformity nonconformity is identified, for example, construction and
identification installation work, commissioning work, etc.

name of inspection activity as a result of which the


Inspection activity nonconformity is identified
3
Team

Organization/
Role 4 division Position Name

5
Organizations which notices have been sent to

Organization Contract/ agreement Responsible for quality

1
For an interim report a word "Interim" is used instead of "Final". If a creation of document confirming
the implementation of actions is necessary, the interim report is filled in by stages, depending on availability of
correction actions ICA, CA, PA.
2
Comments to fill in fields of the form are shown in italics.
3
Persons included in the members of Team are indicated.
4
Employee’s role in the nonconformity management process: RQI, RQC, Leader, Team member, approving
person.
5
Organization committed the nonconformity and their RQC, as well as names of its suppliers that
committed the nonconformity and are in contractual relations with the specified organization and their RQC, if
applicable, are indicated.

Description
Description of subject of nonconformity

Description of nonconformity
indicated in accordance with the classifier of types of
Type of nonconformity
nonconformities (Appendix J)
description in accordance with the Correction Plan and ICA
Description of nonconformity
is indicated
details and name of document whose requirements have
Requirements violated been violated, number of section/ item / page in which the
violated requirements have been established are indicated
Analysis of nonconformity significance
Impact on Safety Significance
Influence amount of 9
class Repeatability10
Troubleshooting Influence on work under Scope of
on
method6 operability/operation contract/ work12
schedule7
agreement8

Correction and Interim Containment Actions


Responsible Target
No Correction13/ ICA Action Organization
term

"correction" is indicated for


(organization
elimination action and (responsible
responsible for
meaning "ICA" for actions (description of from
implementation)
according to ICA actions) organization)

13
Approval of nonconformity description, correction action plan and ICA

Organization Division Name Position

Report on implementation of correction actions


Actual term
No Activity Report
brief description of completed
actions, comments
Agreement and approval of Correction Report
Organization Division Position Name

6
Method of nonconformity elimination is indicated.
7
Indicated in accordance with Appendix B of this Regulation.
8
Amount and influence are indicated in accordance with Appendix B of this Regulation.
9
Nonconformity found in the equipment/product assigned to safety class 1-3 (according to NP-001-15).
10
When the nonconformity is determined as repeated, registration numbers of the nonconformities for
which repeatability was determined are indicated
11
Indicated in accordance with Appendix B hereto.
12
Act of nonconformity elimination is formed after completion of correction actions.
13
Persons who approve information in Correction Plan and ICA are indicated.
Report on implementation of actions according to ICA
Actual
No Actions Report term

Analysis of nonconformity causes


Reason why the
nonconformity was not
identified at the indicated if the nonconformity could have been identified at
previous stages of the previous stages of product manufacture
product manufacture

Root causes of occurrence:


Type of cause Description
(in accordance with
i. 4.8 of this Regulation)
Development of corrective actions
Root Organization, Target
No Actions Responsible
cause division term

Agreement on nonconformity causes and corrective actions


Organization,
No division Position Name

Implementation of corrective actions


Report on implementation of corrective actions
Actual
No Actions Report term

Development and implementation of preventive actions


Organization, Target
No Actions Responsible
division date

Approval of preventive actions


Organization,
No division Name Position

Report on implementation of preventive actions


Actual
No Actions Report term

Approval of reports on implementation of ICA, corrective and preventive actions


NONCONFORMITY REPORT IS CLOSED

Organization, Signature,
No division Position Name date

Appendices
Number of
No Name sheets

Content of information specified in section "Description of subject of nonconformity" of the unified


forms:
I.1 Subject of nonconformity – Equipment
Content of information on subject of nonconformity entered in Nonconformity Report
designation and name according to the coding system
Building / facility
adopted for project
Place of identification (address) place of nonconformity identification is indicated
designation and name of working documentation according
Designation and name of to which the equipment is manufactured/ purchased/
working documentation mounted/ installed

audit of working documentation according to which the


Audit of working
equipment is manufactured/ purchased/ mounted/
documentation
mounted
designation and name of process system which the
Designation and name of
equipment belongs to, in accordance with the coding system
process system adopted for project
Manufacturer's name manufacturer's name
Designation and name of
equipment serial designation and equipment name
Classifier of material and
technical resources and designation and name of MTR&E
equipment (MTR&E)
designation and name of equipment according to the coding
KKS of equipment system adopted for project (KKS, etc.)
Serial number, date of serial number of equipment, as well as part number of
manufacture equipment, if any
Drawing number, TS, ToR,
Industry Standard, GOST indicated for equipment/material

Safety class safety class of equipment/part of equipment is indicated


Class (group), classification
classification designation is indicated according to
designation according to the
Federal Regulations and Rules NP-001-15
(FRR)
designation of quality assurance category adopted by
Quality assurance category
for project, if any
Number and item of violated item number and number of violated federal regulations and
FRR rules
number of Quality Plan, as well as number of milestone of
Quality Plan number Quality Plan, if nonconformity is identified at milestone of
Quality Plan
Certificate details of certificate of conformity, if any
Organization issued
certificate name of organization that issued the certificate

I.2 Subject of nonconformity – Material


Content of information on subject of nonconformity entered in Nonconformity Report
designation and name according to the coding system adopted
Building / facility for project
Place of identification (address) place of nonconformity identification is indicated
designation and name of working documentation, according to
Designation and name of which the equipment is manufactured/purchased/ mounted/
working documentation installed
audit of working documentation according to which the
Audit of working
equipment is manufactured/ purchased/ mounted/
documentation
mounted
designation and name of process system which the
Designation and name of
equipment belongs to, in accordance with the coding
process system
system adopted for project
Manufacturer's name manufacturer's name
Designation and name of
equipment serial designation and equipment name
Classifier of MTR&E designation and name of MTR&E
KKS of equipment designation and name of equipment according to the coding
system adopted for project (KKS, etc.)
Serial number, date of serial number of equipment, as well as part number of
manufacture equipment, if any
Drawing number, TS, ToR,
Industry Standard, GOST indicated for equipment/material

Safety class safety class of equipment/part of equipment is indicated

Class (group), classification classification designation is indicated according to


designation according to FRR NP-001-15
designation of quality assurance category adopted by
Quality assurance category
for project, if any
Number and point of violated item number and number of violated federal regulations and
FRR rules
number of Quality Plan, as well as number of milestone of
Quality Plan number Quality Plan, if nonconformity is identified at milestone of
Quality Plan
Certificate details of certificate of conformity, if any
Organization issued
certificate name of organization that issued the certificate
Revision sheet

No Date Revision Amendment made Amended by


1 12.05.2022 2 1. Amended item 1.2; G.G. Ageeva
2. Amended item 1.3;
3. Updated section 2;
4. Amended item 4.3.1;
5. Amended item 4.11.1;
6. Amended section 6;
7. Added section 7;
8. Added section 8.

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