management system requirements · rwe technology · jan 2012 page 1 management system requirements...
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PAGE 1 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
PAGE 2 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)
PAGE 3 RWE Technology · January 2012
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.
PAGE 4 RWE Technology · January 2012
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, ...)
PAGE 5 RWE Technology · January 2012
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
PAGE 6 RWE Technology · January 2012
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
PAGE 7 RWE Technology · January 2012
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
PAGE 8 RWE Technology · January 2012
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
PAGE 9 RWE Technology · January 2012
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
PAGE 10 RWE Technology · January 2012
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
PAGE 11 RWE Technology · January 2012
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
Fabrication / Execution
QA/QC/ENG Welding supervision A1 A2 A3 A3 A4 A4
Fabrication / Execution
QA/QC/ENG Batch Test Plan for Weld Material/Welding Consumables D1 D2 D2 D2 D3 D4
Fabrication / Execution
QA/QC/ ENG Welding Procedure Qualification Records D1 D1 D1 D2 D2 D4
Fabrication / Execution
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
PAGE 12 RWE Technology · January 2012
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
PAGE 13 RWE Technology · January 2012
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
PAGE 14 RWE Technology · January 2012
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
PAGE 16 RWE Technology · January 2012
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. √
PAGE 17 RWE Technology · January 2012
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
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