management system requirements · rwe technology · jan 2012 page 1 management system requirements...

RWE Technology · Jan 2012

Management System Requirements

IAEA Technical Meeting „Grading of the Application of Management System Requirements Vienna, 23 – 27 January 2012 RWE Technology GmbH Dr. Thomas Schöße

Identification, Recognition, Application

RWE Technology · January 2012

Preamble (1) > Presentation describes views of a Project company based on the

experience of an Operator. RWE Power ... Operator of several units at different stages RWE Technology ... Project consultant for conventional and

nuclear power plant projects

> Issues are based on experience within the German regulatory environment, however can be generalised and extended to an international one.

> Experiences during preliminary phases in Nuclear New Build projects outside of Germany (UK, Romania, Bulgaria)


Preamble (2) > The overriding interest of all involved parties in the design,

construction, operation and decommissioning of Nuclear installation is Nuclear Safety ... however other interests are to cover as well: Nuclear Regulator ... Nuclear Safety Other regulator and organisations ... Specific issues (Environment, Industrial

Safety, local development ... ) Licensee / Vendor / Contractor ... Nuclear Safety, Industrial Safety, Env. ...

Commercial Success (Profit).

> No differences of successful Management Systems for conventional and nuclear activities ... General Management Standards provide appropriate guidance. Specifics are added adequately and consistent.


Definition of Scope In General: > Management System describes the sum of all coordinated tasks and

activities including the determination of values, structures and processes, rules and tools to make a best possible contribution in attaining the company's objectives.

> The nature of an applied Management System are defined by legal and regulatory requirements (external) and corporate framework condition (internal). For example: Legal and regulatory requirements (prescriptive / non-prescriptive) Applied code and standards (ASME, RCCM, EN, KTA) Roles and responsibilities of involved parties (Licensee, Vendor,

Regulator, Independent Third Party Agency, ...)


Management system Limits

Normative Management

Strategic Management

Steering operational processes

■ Definition of corporate governance ■ Definition and communication of:

• corporate policy • corporate culture and values • corporate visions and goals

Board of Management

■ Set up and steering of management systems ■ Definition of organisational structures ■ Definition of processes and projects ■ Fostering of problem-solving and learning

abilities

Line Managers (HL)/ Process Owners

■ Implementation of management systems ■ Definition and steering of processes and tasks ■ Steering of projects and orders ■ Fostering of personal performance and

cooperation

Line Managers (LL) or Project Manager/ Process Owners

Fulfilling and Execution of processes and tasks Process Executors (employees / external staff)

M A N A G E M E N T S Y S T E M

Responsibilities and task regarding the management system


One company ... One integrated approach.

Integrated Management System ... ... brings together the different perspectives.

Policy Objectives Rules & Regulations

Processes & respon-sibilities

Org. Structures,

Roles

Continuous Improvement (PDCA)

L1

RWE T

L1

L1

L1

Tools & Templates

PDCA

Project Management

Quality Management

Environment Management

Risk & Crisis Management

…

H&S


Experience driven Success factors System View > Strong leadership and commitment by TOP management > Appropriate number and qualification of staff with regard to the

activities ( or project stages) > Defined and documented targets based and updated on the

identified requirements > Integrated, consistent and central controlled approach for

Management System arrangements, documented in e.g. Organisational roles and responsibilities Management Manual and system description down to an appropriate

level of detail Processes documentation

> Adequate document control system > Strong review, assessment and improvement process > For new build projects: Consideration of management system

requirements from Day 1


Grading of Management System Requirements Example: QA /QC activities in Nuclear New Build Projects

Highlights > Identification and definition of the framework Roles and responsibilities of the actively involved parties and their

interactions applicable requirements (e.g. legal requirements, Code & Standards)

> Determination of the quality arrangements in all project phases

> Consideration on Licensee-Vendor/Contractor Relation with regard to QA/QC arrangements (definition and contracting of expectations)

> Systematic approach for allocation of QA /QC activities

> Based on the experience in present conventional (all project phases) and nuclear project (here phase before construction)

> Flexible but systematic approach is required to reflect individual conditions of the projects


Framework for the QA/QC activities

Definition of the project scope Determination of involved parties What actions should be done by the

Lincensee? What activities must be

done by the ITPIA? What actions are necessary by the

vendor? What are the expectations of the

Regulator regarding Licensee? Sub-Contractors/ Suppliers

Qualifications? Code Requirements? What deliverables are needed? Which criteria have to be fulfilled

and how?

Licensee

ITPIA

Regulator

NOBO

Vendor/Main

Contractor

AuthorizedNuclear

Inspector / ANI

Vendor

Third Party AgencyA

Supplierall Tiers

Supplierall Tiers

ASME Section IIIRCC M Sect. 1 – BKTA / IAEA/ NQA

HSE RequirementsLaw and Directives

Contract

Report

Report

Contract

EC DirectivesEN/ ISO Standards

13480; 13445 AD 2000Natianal Law

Rules and RegulationsIEC / ISO

ASME Sect. I - Pow er BoilersASME Sect. VIII - Pressure Vessel

ASME B 31.1 -Pow er Piping

Reference CodeASME Sect. II - Material

ASME Sect. V - NDEASME Sect. IX - Welding

Auth. Inspector

AIReport

Contract

ASME Section III NCASub Section NB/NC/ND forNuclear Components Cl.1-3


Basic Design

Extended Basic Design

RFP/ Supplier

Supplier Selection

GDA Process

Request Information

RFP/Vendor Selection

FEED Phases

Delivery Contract

Extended Stand.Design

Supplier Qualification

Procure- ment

Supplier Engineering

Shop Fabrication

Packing & Transportation

Site Preparation

Civil Works

Pre-fab Mech. E

Erection/ Assembly

Cold Commissioning

Electrical Completion

Nuclear Fuel Supply

COD

Trial Run

Hot Commissioning

Quality arrangements in project phases for the NNB Supply Chain

Pre Contract Phase

Design Phase

Fabrication Phase

Commissioning Phase

Construction Phase

Operation Quality Assurance Activities Quality Control Activities

> Based on the experience in present conventional and nuclear project

Rem

ark:

Pro

ject

ste

ps o

nly

for i

llust

artio

n


Determination of the Licensee-Vendor relation Idendify and agree on Licensee Oversight activities

Level 1 Level 2 Topic Level 3 SC1 SC2 SC3 QL A QL B QL C

Document or ActivityFabrication / Execution

QA/QC/ENG Welders qualification certificate D1 D1 D1 D1 D2 D4

Fabrication / Execution

QA/QC/ENG Welding supervision procedureD1 D2 D3 D2 D4 D4


QA/QC/ENG Welding supervision A1 A2 A3 A3 A4 A4


QA/QC/ENG Batch Test Plan for Weld Material/Welding Consumables D1 D2 D2 D2 D3 D4


QA/QC/ ENG Welding Procedure Qualification Records D1 D1 D1 D2 D2 D4


QA/QC/ ENG Accompanying Material Tests and Specimen Plan D1 D2 D2 D2 D4 D4

Inspections QA/QC/ ENG Test specifications D1 D2 D2 D2 D4 D4

Inspection QA/QC/ ENG Inspection program schedule D1 D2 D2 D2 D2 D4

Inspection QA/QC/ ENG Inspection announcement form D1 D2 D3 D3 D4 D4

Inspection QA/QC/ ENG Intermediate inspections A1 A2 A3 A2 A4 A4

Inspection QA/QC/ ENG Final inspections - Single equipment audits

A1 A2 A3 A2 A4 A4

Inspection QA/QC/ ENG Inspection reports D1 D2 D3 D2 D4 D4

Expediting activities QA/QC/SC Expediting Kick-off MeetingA1 A2 A3 A2 A4 A4

Expediting activities QA/QC/SC Document ExpeditingD1 D2 D3 D2 D3 D3

Expediting activities QA/QC/SC Shop ExpeditingA1 A2 A3 A2 A4 A4

Expediting activities QA/QC/SC Expediting Status ReportD1 D2 D3 D2 D4 D4

Factory acceptance test (FAT)

QA/QC/ ENG Quality Assurance Records/Test Reports/Welding Records D1 D2 D3 D2 D4 D4

QA/QC/ ENG Tightness test proceduresD1 D2 D3 D3 D4 D4

Fabr

icat

ion

Nuclear Island (NI)Convent.Island (CI)Bal. of Plant (BOP)Code Extract of Definitions

A1 …..Licensee has the right to attend on listed activities and also the right to additional attendance….

A2 ….Licensee has the right and option to attend on activities and to extend the level of involvement, mainly …

A3 …Licensee has the right of sporadic attendance ….

A4 …Licensee has the right of attendance where sub standard execution may induce a major risk ….

D1 …Licensee must receive certain documents prior …

D2 …Licensee may require receipt of certain documents prior…

D3

…Licensee will indicate the requirement to access selected documents on a sample basis "FOR INFORMATION/ FOR REVIEW" prior…

D4

Licensee reserve the right of document review and approval where sub standard execution may induce a major risk on the project regarding quality, cost and time.

Licensee Oversight Plan


How to identify specific QA/QC activities? Graded approach > has to consider various conditions integrated approach

> considers the activities of independent inspection agencies/code requirements appropriate use of resources

> has to be flexible and easy to handle

Grade A

Grade B

Grade C

Grade D

Grade E

Grade F

8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 CR 4 24 CR 3 25 CR 2 26 CR 1 27

Low risk

Medium risk

Medium high krisk

High risk

> Utilize a risk matrix • Level of complexity of equipment • Influencing factor reflecting the integrated

approach > Identified Risk Level lead to allocation of predefined

QA and QC activities.

Complexity Grading

Influ

ence

Fac

tor


Grade

Allocation

System

Structure/ Machinery

Single

Equipment

Material

A

Major Engineered Commodity

Primary circuit Steam Generator Safety Valve Diverse

B

Major Electrical Commodity

HV System Machine-

transformer Bus Ducts,

Power Cables Diverse

C

Main Static Commodity

Feed Water

System Pressure

Piping PED-Cat III Elbow, Tubes

Support Diverse

D

Rotating Commodity

Condensate

System Main Condensate

Pump

Pump, Motor

Diverse

E

Static Commodity

Diverse Secondary Steel

structure Coloumns,

Beams, Plattforms

Diverse

F

Standard / Cataloque Commodity

Diverse Standard Pumps Motors, Gears,

Actuators, Diverse

Allocation of SSC (in general equipment) Complexity Grade Allocation by Engineering Department

considering the safety classification and engineering complexity


Influencing factor

Competence to be involved Process Engineering Mechanical Engineering Electrical Engineering Procurement process Scheduling Quality Assurance & Control Health, Safety & Environment Plant Operations Maintainance

Influencing factors Risk / Consequence Score

Safety to Personnel/ Equipment: • Low • Moderate • High

1 2 3

Environment Impact:

• No significant impact • Moderate Impact • High Impact

1 2 3

Operational / Process significance:

• Faillure coverd by stand by Unit or without difficulty

• Some Loss of production but no loss of integrity

• Major Loss of production or jeopardise plant integrity

1 2 3

Design Maturity: • Proven • Frequently Used • New Design

1 2 3

Fabrication Complexity: (incl.Replacement time and repairability)

• Single known process • One complex process • More than one complex process

1 2 3

Design Data Requirement:

• Not significant in overall design • Partly essential to design • Essential to overall design

1 2 3

Cost, Size:

• Low cost, small item • Moderate cost, moderate item • Large and expensive item

1 2 3

Assembly and schedule impact: • Not critical • Significant important • Vital important

1 2 3

Supplier Qualif./Capability:

• Main Qualified Supplier Status, • Frequent Supplier Status • Has to be qualified,

no relevant experience

1 2 3

Summary

> covers various aspects (standardised to ensure structured approach) > evaluated by experienced and competent persons

Approach of Allocation of Risk Levels

Increase of QA/QC Requirements

Decrease in QC activities (inspection )

Grade A

Grade B

Grade C

Grade D

Grade E

Grade F

8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 CR 4 24 CR 3 25 CR 2 26 CR 1 27

Low risk

Medium risk

Medium high krisk

High risk

CR 3

Complexity Grading

Influ

ence

Fac

tor

Allocation defines on required QA and QC activities


Level of required Quality Assurance activities

Note:

Vendor: Contracted by the Licensee

Sub-Contractor:. Employed by the Vendor

Sub-Vendor: Employed by the Sub-Contractor

Commodity:

All Systems, Structures / Machinery, Equipment and material.

Level of required QA Activities Risk Level 1 2 3 4

Licensee to employ Independent Third Party Inspection (TPI) to monitor Vendor, Sub-Contractor and any Sub-Vendor and to issue Certificate of Compliance.

√

Scope of Licensee’s Quality Surveillance to be agreed and all Hold and Witness Points included in Vendor and Sub-Contractor Quality Control Plans.

√ √ √

Vendor shall review Sub-Contractor QA competence, prior to enquiry. √ √ √ Sub-Contractor shall submit with the bid an overview of their QA system (Quality Manual).

√ √ √

Sub-Contractor shall submit with the bid a typical Quality Plan for a similar commodity.

√ √ √

Sub-Contractor shall submit with the bid a List of qualified Sub-Vendor √ √ √ √ Sub-Contractor shall submit with the bid an proposal of Document Submission Schedule (DSS), confirming scope of document requirements and delivery times.

√ √ √

Sub-Contractor shall submit after order a Document Submission Schedule( DSS) √ √ √ √ Licensee shall review and approve Vendors List of qualified Sub-Contractor √ √ √ √ Vendor shall approve any Sub-Vendors employed by the Sub-Contractor. √ √ √ √ Vendor shall agree scope of Sub-Contractor’s and their Sub-Vendor’s QA/QC. √ √ Sub-Contractor’s shall include in the status report, the Sub-Vendor’s performance.

√ √ √ √

Vendor shall hold a pre-production meeting with the Sub-Contractor. √ √ √ Vendor shall audit the Sub-Contractor’s Quality Plan during execution of the order.

√ √ √

Vendor shall review the Sub-Contractor’s corrective actions taken to rectify non-conformance.

√ √ √ √

Vendor shall perform document review and random quality surveillance. √


Minimum of Inspections related to Risk Level

Involvement of Inspection parties Risk Level 1 = Inspection Class 1 Inspection by Vendor and ITPIA nominated by Licensee., ITPIA reports directly to Licensee. Risk Level 2 = Inspection Class 2 Inspection by Vendor or his nominated Third Party Agency (TPA). Monitoring of TPA execution by Vendor required. Risk Level 3 = Inspection Class 3 Inspection by Vendor or Sub-Contractor with the nominated Third Party Agency (TPA). Risk Level 4 = Inspection Class 4 Review of Sub-Contractors / Sub-Vendor documentation/attestation by Vendors QA/QC and Issue of Release Note by QA/QC.

MINIMUM QUALITY INSPECTION ACTIVITIES INSPECTION CLASS

1 2 3 4 Attend Pre-inspection/Manufacturing Meeting.

X X X

Inspect prefabrication layout, cutting, forming, machining and other preparations.

X X

Inspect raw material and review related documentation including certification.

X X

Inspect fit up, alignment, and assembly.

X X

Witness/verify welding and other special processes (PWHT).

X X

Witness/verify NDE and related processes.

X X

Inspect internal cleaning.

X X

Perform in-process and final dimensional checks for size, location, orientation and configuration.

X

Perform final dimensional checks for size, location, orientation and configuration.

X X X

Witness acceptance testing (hydro, performance, NPSH, etc) and sign off testing sheets

X X X

Witness Factory Acceptance Test.

X X

Vendor’s specialist engineer shall witness Factory Acceptance Test.

X X X

Witness Site Acceptance Test.

X X

Vendor’s specialist engineer shall witness Site Acceptance Test.

X X X

Review acceptance testing package/documentation

X X

Perform final visual inspection and final completeness check

X X X

Examine paint/coating/lining preparation and final surface condition.

X X X

Inspect painting, tagging and preparation for shipment.

X X X

Review documentation package - including concession requests.

X X X X

No Inspection Review test reports and Data required by Purchase Order.

X

Issue Release Note erspectively Interim Certificate or Final Inspection Report

X X X X


… for closure.

The game is always the same. It will be decided by … … the best strategy, … its application and … the flexibility to act on changes.

Assumption: You know the game.

management system requirements · rwe technology · jan 2012 page 1 management system requirements...

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