Graded Approach

National Workshop on Overseeing Manufacturing and Construction

IAEA / NPPA, Cairo, Egypt, 19-22 September 2022

Pirjo Knuuttila
Quality Professional
Konsultointi Knuuttila Oy
Tel. + 358 40 759 1841
Email: pirjo.knuuttila@konsultointi-knuuttila.fi
https://www.linkedin.com/in/pirjo-knuuttila-22b25730/
Table of Content

1. Definitions
2. Grading process
 Selecting processes
 Grading activities
 Defining controls
 Grading products
3. Summary

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What is graded approach is?

 Objective is to ensure that requirements and

activities correspond to the safety significance
 The applied controls shall be aligned with risk
level

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Graded approach definition
Source: Use of a graded approach in the application of the management system requirements for facilities and
activities, IAEA-TECDOC-1740

 In practical terms, a graded approach applies to management system

requirements of a product, item, system, structure or component,
service, activity or controls of a process commensurate with its
relative importance, complexity, variability, maturity, potential
impact on safety, health, environmental, security, quality and
economical aspects.
 By the application of a graded approach, the controls, measures,
training, qualification, inspections, detail of procedures, etc. might
be adapted to the level of risk or importance for safety, health,
environmental, security, quality and economical aspects. In evaluating
these aspects the system is to be considered holistically.

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Finnish graded approach related requirements for
Management system Products
 The management system shall be developed and applied  The quality requirements for systems, structures and
with consideration to the safety significance of the components as well as for quality assurance shall be so
operation. The principles of observing risk-based decision- defined that the requirement level is higher in a
making and safety significance shall be described. higher safety class. The requirements shall focus on
matters affecting the reliability of safety functions:
 The assessment of safety significance shall take into verification of the structural integrity of structures and
account, for example, the following: components as well as the operational reliability of
 safety significance and complexity of the organisation and
systems. The requirements shall cover the design,
operation manufacture, construction, installation,
commissioning, inspection and actions during the
 safety significance, exactingness, complexity, uniqueness operation of the classified item
and novelty of the product or function and the resulting lack
of experience
 risks related to the plant or operation, including the Source: YVL B.2 - Classification of systems, structures and
probabilistic risk assessment (PRA).
components of a nuclear facility
 The quality of products and services shall be conformed
with consideration to their safety significance. The
higher their safety significance is, the more extensive and
stricter the quality management procedures of products
and services shall be.

Source: YVL A.3 - Leadership and management for safety

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Why graded approach is needed?

 To ensure safety by allocating resources appropriately

Use of Use of
resources resources

Graded
approach

Risk level Risk level

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Mitigating risks – factors to be considered

For process For product

 Process objective  Safety
 Critical success factor  including nuclear, radiation and conventional
safety and security
 Risks and opportunities
 Availability
 Roles and responsibilities
 Design maturity
 Interfaces
 Complexity
 Costs
 Experiences

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Simplified process for graded approach

Effectively
used
resources

Grading
Defining products
controls
Grading
activities

Selecting
processes

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Activity + Product = Control level

Product Grade
A B C D
Category 1 Full Full Extended Normal

Category 2 Full Extended Extended Normal

Category
Activity

Extended Extended Normal Normal

Control level
Category 3
Category 4 Extended Normal Normal Normal

Category 5 Normal Normal Normal Normal

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Simplified process for graded approach

Grading
Defining products
controls
Grading
activities

Selecting
processes

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Processes for grading

 Define criteria for process grading

 Grade process within a team
 Justify grades
 Document results
 Set the criteria for processes to be graded on activity level

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Example for selecting processes for detailed
grading
• The processes setting requirements for plant and
Category 1 verifying them

Category 2 • The processes ensuring integrity of plant

• The processes ensuring sufficient resources for plant

Category 3 implementation

Category 4 • Processes verifying operations

Category 5 • Administrative processes

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Simplified process for graded approach

Grading
Defining products
controls

Grading
activities

Selecting
processes

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Activity grading
 Grading team
 Process Owner to select team members, chair of the grading team
 Facilitator is an expert on grading, secretary of the grading team
 Team members should be contributing in the process or interfacing with it
 Activities shall not be graded above the process grade
 Consider activity's risk to
 Process objective
 Critical success factor
 Risks and opportunities
 Roles and responsibilities
 Interfaces
 Visual process flowchart is useful

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Detailed grading
– no category should be above the process category

Category 1
Category 2
Category 3
Category 4
Category 5

Ensure applicable controls for

 Steps 1, 2, 3 and 4
 Decision 1

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Simplified process for graded approach

Grading
products
Defining
controls
Grading
activities

Selecting
processes

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Aspects considered when setting controls to
process and activities
 Inputs and outputs
 Human and other resources
 Documented procedures
 Decision making and reporting
 Performance indicators
 Grading team could be utilized for control definition

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Defining control - example

Activity description Category Controls

The final decision to accept or not accept the inspected 1 Full

product Extended
Normal
Control aspect Full Extended Normal Needed process development

Input – Test results Tests verified by Teste verified by Tests verified by None
third party the Owner the manufacturer
Output – Test Signed by third Signed by the Signed by Procedure to be updated
reports party Owner manufacturer
Resources - Inspectors Inspectors Inspectors Qualification certificates to be
Inspectors qualified by third qualified by third qualified by added to HR data base
party party manufacturer

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Grading is part of continuous
improvement of the processes

Process
monitoring

Regular
Process
process
updates
review

Improvement
Grading
needs
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Process grading can be directly used for

 Focusing audits and other assessments

 Performance monitoring
 Process review frequency
 Level of documented procedures and their review and approval
 Nonconformity management
 Communication or reporting level

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Simplified process for graded approach

Grading
Defining products
controls
Grading
activities

Selecting
processes

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Product grading principles
 When grading the product you should consider different factors
 E.g., safety, availability, design maturity, complexity, costs, experiences
 Starting point could also be based on safety classification
 E.g., Finnish classification SC1, SC2, SC3, EYT (non-nuclear safety)
 It is useful to grade plant items in different levels
 Systems and buildings, structures and components
 However, the components and structures can be classified higher or lower than
related system or building
 Product grade can be used for several purposes during construction and
operation phase
 E.g., nonconformity classification, inspections, periodic testing, preventive
maintenance
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Product grading – example for advance
method
 Severity values Xn described to all  Total risk value Z
factors with the same scale e.g. from 0  Z = (X1Y1 + X2Y2 + X3Y3 + ..+ XnYn)
to 4
 X1 = severity value for safety
 Final product grade is based on
 X2 = severity value for availability
 X3 = severity value for design maturity
A B C D
 …
> Z3 Z3 – Z2 Z2 - Z1 < Z1
 Importance highlighted with weighting
value Y running from 1-3
 Y1 = weight value for safety
 Y2 = weight value for availability
 Y3 = weight value for design maturity
 …

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Product grading – example for simple method
Should it also
decrease?
 After safety class other factors can only increase the grade
 Highest grade counts
 Final grade below is B

Grade Safety Availability Design maturity Environmental

class safety
A SC1 Interruption New design nnn

B SC2 Major failure Evaluated design nnn

C SC3 Minor failure Tested design nnn

D EYT Insignificant Proven design nnn

failure
Resulting
C B B B
grade

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Summary -
successfully applied graded approach
Effective
resource
allocation

Applicable
controls
Safe plant
producing
Risks electricity
identified
reliably

Well
defined
processes

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 Thank You!

Questions & Comments

Pirjo Knuuttila
Quality Professional
Konsultointi Knuuttila Oy
Tel. + 358 40 759 1841
Email: pirjo.knuuttila@konsultointi-knuuttila.fi
https://www.linkedin.com/in/pirjo-knuuttila-22b25730/

pirjo.knuuttila@konsultointi-knuuttila.fi Graded Approach 2022-09-20 26