AA_REQ_000131 - QUALITY REQUIREMENTS THIRD PARTY DESIGN VERIFICATION

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AA REQ 131 QUALITY REQUIREMENTS THIRD PARTY DESIGN VERIFICATION

ISSUE 0 20 October 2011

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QUALITY REQUIREMENTS THIRD PARTY DESIGN VERIFICATION

1 Scope and Definitions 31.1 Scope 31.2 Definitions 3

2 General 42.1 Tenders 42.2 Sub-Contracting of Inspection Work 42.3 Risk Management 42.4 Schedule 52.5 Independence of Inspectors 5

3 Quality Management System 53.1 ISO/IEC 17020 5

4 Design Assurance 64.1 General 64.2 Design Assurance Plan 64.3 Design control planning 64.4 Design assurance activities 74.5 Exceptions (Problems) 74.6 Reports 8



ISSUE 0 20 October 2011 COPYRIGHT

4.7 Business Intelligence 8Appendix A: Referenced documents 9Appendix B: Record of Amendments 9Appendix C: Quotation for third party design verification 10Example: Monthly Report 11




1 SCOPE AND DEFINITIONS

1.1 Scope

Certain equipment is very important to the user. It is categorised as Critical or Major by the Company Representative and AA REQ 100 is included in related enquiries and contracts.

Independent third party inspection is required on manufacturing activities and AA REQ 130 is included in enquiries and contracts for third party inspection work.

Independent third party checking of critical aspects of design is also required and this document AA REQ 131 is included in enquiries and contracts for design quality assurance

1.2 Definitions

The following terms are defined in the contract: Approved, Company, Engineer.

Assess : Evaluate the suitability of the requirements

Company Representative

: Person responsible for technical aspects of the contract

Design Assurance Plan : Document defining controls and procedures to be applied to the assurance of design work.

Design Assurance Representative

: Company responsible for independent 3rd party design assurance activities

Design Audit : Repeat a piece of work and compare with the original.

Design Control Plan : Document listing design activities, showing the relevant standards to be applied and marked up to identify intervention points by other bodies.

Design Review : Examine the initialisation of a design activity and confirm that the basis of design is suitable

Equipment : Goods and services required to be supplied in terms of the contract

Items : Those components and assemblies that comprise the equipment. May include software

RACI : Diagram listing deliverables against organisations showing who are Responsible, Accountable, Consulted and Informed.




Review : Examine a piece of work and determine if it has been done correctly

System Audit : Check procedures and systems comply with the Design Assurance Plan

Supply Contract : Contract including design work

Verification : The process of ensuring the completeness and consistency of the design against the specification requirements.

2 GENERAL

2.1 Tenders

2.1.1 The minimum content of Tenders for Design Assurance services is shown in APPENDIX C unless otherwise specified in the enquiry document. The Design Assurance Representative shall propose alternate staff where nominated staff is not acceptable or available.

2.1.2 On request, the Design Assurance Representative shall attend a design assurance pre-award meeting to establish clarity on the technical requirements.

2.1.3 On request, the Design Assurance Representative shall attend a design assurance kick-off meeting subsequent to the award of the Contract to initiate the contract requirements

2.2 Sub-Contracting of Inspection Work

2.2.1 The Design Assurance Representative shall obtain approval from the Company prior to any services being subcontracted. This shall normally be proposed in the Tender for design assurance work.

2.2.2 The Design Assurance Representative shall invoke AA REQ 131 and relevant technical requirements in all levels of sub-contracts including overseas affiliates.

2.3 Risk Management

2.3.1 The Design Assurance Representative has a duty to ensure that his work is performed without risk to health and safety. Where relevant they shall comply with all site specific requirements.

2.3.2 The Design Assurance Representative shall review the proposed design activities with the designer and review any risk assessments conducted by the Company relating to the design.

2.3.3 On request, the QAR shall provide expert input to any risk assessment exercises conducted by the Company relating to the Equipment.




2.4 Schedule

2.4.1 The Design Assurance Representative shall review the approved version of the schedule for the supply contract and ensure that milestones related to design and design assurance is included.

2.5 Independence of Design Assurance

2.5.1 The Design Assurance Representative shall meet the independence criteria for a type A inspection body as defined in ISO/IEC 17020.

2.5.2 The Design Assurance Representative shall advise the Company within 1 working day of any potential Conflict of Interest relating to the contract, supplier and or sub-suppliers.

2.5.3 On request, the Design Assurance Representative shall sign a confidentiality agreement with the owner of the intellectual property.

2.5.4 On request, the Design Assurance Representative shall sign undergo a Technical Assessment by the Company of his ability to comply with the requirements of this standard.

2.5.5 On request, the Design Assurance Representative shall sign a confidentiality agreement with the Company.

3 QUALITY MANAGEMENT SYSTEM

3.1 ISO 9001

3.1.1 The Design Assurance Representative shall comply with ISO 9001 Quality Management Systems.

3.2 ISO/IEC 17020

3.2.1 Competency requirements will be in equivalent to those in ISO / IEC 17020 for inspection bodies

3.2.2 The Design Assurance Representative shall obtain approval from the Company for any period greater than 5 working days for which any nominated staff are not available, stating who is standing in for the period.




4 DESIGN ASSURANCE

4.1 General

4.2 Design Assurance Plan

4.2.1 A draft Design Assurance Plan shall be produced in conjunction with the Design Authority and submitted by the Design Assurance Representative to the Company with each tender for work.

4.2.2 The Design Assurance Representative shall submit a final Design Assurance Plan to the Company within 14 days of contract award or on a mutually agreed date between the parties.

The Design Assurance Plan shall include as a minimum:

a) Relevant project information (e.g. Title, EPCM, Contract Number, end users, etc.)

b) Scope

c) RACI

d) Referenced documents

e) Organogram

f) Reporting formats and protocol (e.g. exceptions, monthly reports / supplier visits)

g) Document routing / control (e.g. Drawings / calculations / reports / decision log )

h) Exclusions

4.3 Design control planning

The Design Assurance Representative shall:

4.3.1 Hold meetings with the designers as early as possible to identify and resolve design issues.

4.3.2 Review the Designers item list for the equipment and confirm the list of key items in terms of design criticality.

4.3.3 Review the Designers risk assessment to ensure that all issues have been identified, assessed and documented. The adequacy and effectiveness of controls shall be taken into account. Any decisions by the Company to omit available controls from the design have been clearly shown as exclusions on the Designers risk assessment.

4.3.4 Monitor the Designers register of Design Control Plans required for the contract showing approval status, date received and date approved.




4.3.5 Review Design Control Plans to ensure that:

a) All design activities which should be performed as risk controls have been identified on the Designers baseline risk assessment which includes representation from the Operation and incorporated into the Design Control Plans.

b) Contractual technical requirements are included as activities and acceptance standards.

c) All relevant activities are shown.

d) Records required for the data books are shown.

4.3.6 Mark-up Design Control Plans with appropriate levels of intervention by the Design Assurance Representative and the Company.

4.4 Design assurance activities

The Design Assurance Representative shall:

4.4.1 Ensure that personnel performing design assurance activities are competent.

4.4.2 Review the functional specification for completeness including any assumptions made.

4.4.3 Log technical queries to track closure.

4.5 Exceptions (Technical Queries)

4.5.1 Technical queries shall be identified on the activity reports and discussed with the Suppliers representative before issuing the equipment report.

4.5.2 Significant technical queries shall be reported immediately by e-mail (and telephone in cases of urgency) to the Company.

4.5.3 All technical queries shall be logged in the monthly reports.

4.5.4 Potential back charges and / or cost implications and potential delays shall be clearly identified on the report.




4.6 Reports

4.6.1 Reports shall be produced covering each activity shown on the Design Control plans.

4.6.2 Reports shall cover each piece of equipment reviewed summarising the conclusions reached and any issues that need to be resolved.

4.6.3 Where applicable, a report shall be produced on the integrity of the system design.

4.6.4 Monthly reports shall be submitted with invoices to the Company for each calendar month the design assurance contract is active (see attached example)

4.6.5 The Design Assurance Representative shall retain a copy of records produced for the contract for at least three years after the completion of the contract. An electronic copy of all of the records in pdf format shall be supplied to the company with the final invoice.

4.7 Business Intelligence

4.7.1 During the course of activities, the Design Assurance Representative shall take cognisance of signs indicating potential problems at suppliers which could affect delivery or quality or costs. Potential risks shall be highlighted to Company in confidence.




APPENDIX A: REFERENCED DOCUMENTS AA REQ 131; Quality Requirements for Third party Design Verification

AA REQ 100 : Quality Requirements for Critical and Major Equipment

ISO/IEC 17020 : General criteria for the operation of various types of bodies performing inspection

ISO 9001 : Quality Management Systems

APPENDIX B: RECORD OF AMENDMENTS

Issue 0 : New document (J Orkney, G Dryden, K Xu, S Xin, A Aphane, Y Naidoo April 2011)




APPENDIX C: QUOTATION FOR THIRD PARTY DESIGN VERIFICATION

AA REQ 131 shall apply to this contract

CONTRACT NO.

EQUIPMENT DESCRIPTION

MAIN SUPPLIER

PLANNED START

ESTIMATED DURATION

NOMINATED STAFF (WITH SHORT CVS)

COSTS

COSTS BASED on time and rates for the following as appropriate.

CONTRACT MANAGEMENT

SYSTEM AUDITS/ASSESSMENTS

DESIGN

DESIGN PLAN REVIEW

DESIGN CONTROL PLAN REVIEW

RISK ASSESSMENT

REVIEW MEETINGS

DESIGN ACTIVITIES

TRAVEL

SUNDRY OTHER COSTS

TOTAL




EXAMPLE: MONTHLY REPORT

Summary Work is almost complete and the ABC response to Technical Query 019 is overdue. This will be followed up during the next planned visit on 20TH August.

Cumulative Technical Query Log

TECHNICAL QUERY NO. AND DATE

SUPPLIER SUMMARY STATUS

P001 19 JUN ABC Design calculations for drawing 001 need to be re-submitted for revision D ACTION ABC

P002 21 JUN DEF Drawing 003 rev B has not been updated in line with the actions agreed on 1 May CLOSED Report 123

Cost Summary

Date Description Credit Debit Balance

8 Jan Contract confirmed 20 000 20 000

4 Feb Invoice 1234 3 000 17 000

13 Mar Invoice 2345 1 000 16 000

7 May Invoice 3456 7 000 9 000

14 Jun Invoice 4567 4 000 5 000

21 Jul Contract Amendment 1 5 000 10 000

23 Jul Invoice 5678 3 000 7 000

15 Aug Invoice 6789 4 000 3 000

Totals 22 000 3 000

Forecast total expenditure R25 000

Forecast completion date September

Reports

Copies of reports for activities during (MONTH) are attached

Documents

AA_REQ_000131 - QUALITY REQUIREMENTS THIRD PARTY DESIGN VERIFICATION