The document discusses quality management systems and ISO 9001. It covers key aspects of a quality management system including continual improvement, management involvement, monitoring customer satisfaction, controlling outsourced processes, identifying non-conformities, corrective and preventive actions, and implementing a quality management system. Diagrams show flows and relationships between various quality management activities and requirements.

2. Customer Satisfaction + Continual
Improvement

3. Контроль
состояния
оборудования
Проверка
Статистика закупленного
продукта
Контроль
Система оборудования
Контроль
несоответствий
менеджмента для
качества мониторинга и
измерений
Контроль
Закупки
документации
Контроль
поставщиков и
подрядных
организаций
Перед началом использования В ходе выполнения работ

4. QUALITY SYSTEM = VEHICLE
QUALITY MANAGEMENT = DRIVER
QUALITY POLICY = ROAD MAP
4

5. ISO 9001 Revision 2000 been developed by TC 176, after a great
deal of research on Eight Quality Management Principles
Eight Quality Management Principles
• Customer - focused organization
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier
relationship
5

6. The ISO 9001:2000 standard has new more clearly defined
requirements relating to :
Continual improvement;
Increased emphasis on the role of top
management;
Consideration of legal and regulatory
requirements;
Establishment of measurable objectives at
relevant functions and levels;
Monitoring of information of customer
satisfaction as a measure of system
performance;
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7. The ISO 9001:2000 standard has new more clearly defined
requirements relating to:
Increased attention to resource
availability;
Determination of training effectiveness;
Measurements extended to systems, process and product;
Analysis of collected data on the performance of
the QMS;
Control of outsourced processes .
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8. 2 main aspect of managing quality
• Identify and correct defects
• Identify opportunities for processes
improvements.

9. DESIGN
PURCHASING
ЦЕЛЬ
PRODUCTION
DELIVERY
Company activities
without system
Company activities
based on the system
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10. Training Monitoring
of all of
Company Processes
Personnel
Audit Feedback
System System
Implemen Implemen
tation tation
10

11. Customer Customer
Requirements Satisfaction
11

13. Objectives & Targets Plans & Procedures

15. The QC Plan define:
The activity (WHAT)
The responsibilities (WHO) The involment to the
 documents or references to project of:
be used for the execution of Personnel
the project (HOW) Client Personnel ???
The records to be produced Sub-contractors
to assure that the activity is Which are the Quality
performed and controlled. Records and the frequency to
(FORMS)
be used for the project

16. Activity under
Pos Inspection or QC activity References Quality Record Involvement
S C V
control
GE-SQ Technical Query/Concession OBGN-AA-Q-
Request 0003
GE-SQ.01 Verify that all Client Change 1c 4 -
Requests are documented by the
issuing of formal Change Orders
detailing any additional (or Involvement
reductive) work
(Organization,
GE-SQ.02 Verify that any Saipem Change SPDC Form 1b/4L 4 -
proposal is documented by the Type of
Reference issuing of a formal Saipem Performance,
Technical Query or Concession 1b/4L
Document Request. 6 -
Responsibility
Verify, as applicable, the formal )
Client approval/rejection of the 1b
above documents. 6 -
SQ.02B
Record all relevant information
on appropriate log.
GE- SQ.03 Check that any additional work, SPDC Form 1c 6 -
generated by a Client Change
Order or by an Approved by the
Client Technical Query or
Inspection Concession Request, is covered
by the relevant Saipem
Report Additional Work Report.
Frequency

17. Material Certificates Traceability
CATALOGCOMPUTER DATA BASE
CERTIFICATEMANUAL
EQUIPMENTMATERIAL

18. Training
Implementation

19. Measuring of Processes Key Performance
Indicators

20. Key Performances Indicator
Measurement of performances in term of: Operations, Safety,
Technical Integrity, Quality, Financial, Procurement and
Resources
Result of
daily monitoring and measurements
of processes performances
Definition of
Measuring & new targets
Reporting of Data
Analysis of Data Trend Analysis

21. Monitoring
Planned Inspection
Analysis of Performances
Activities
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22. QMS Audit
Corrective Action (CA) Action
to eliminate the cause of
Audit Planning nonconformity in order to
prevent recurrence.
Corrective action shall be
appropriate to the effects of non
conformities encountered.
Preventive Action (PA): Action
to eliminate the causes of
potential non conformities in
order to prevent their
occurrence. Preventive actions
shall be appropriate to the
PERFORM AUDIT effects of the potential
problems.

23. Suppliers AUDIT Flow
PLAN & SCHEDULE AUDIT & FINDINGS FOLLOW-UP REPORT & CLOSE
Audit Preparation Record Findings Address
Plan Audit Follow-Up
Self-Assessment Assign CAR
Pre-Audit Review if applicable
Route
• Define Team Conduct Audit asking No for Closure
all mandatory Follow Up?
• Notification
questions as a
• Audit Agenda minimum
• Audit Objectives
Yes
Approved?
No
Yes
Set Audit Assign
schedule with Findings? Follow-Up
Supplier No Yes Task
Close &
Upload Report
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24. Improvement of
Performances
Analysis & Definition
New Targets

25. Feedback System
Customer Complain Non Conformances
Analysis Review
Management
Review
Corrective & Preventive Identification of Improvement
Actions Review Tools & New Targets

26. Non Conformances
Non conformity: non fulfilment of a requirements
Requirements: Need or expectation that is stated,
generally implied or obligatory

27. CAUSES OF NCR
Post Commissioning Period Enviromental Conditions Inacurancy / Inefficiency
0% 4% Human Error 7% Design Control
7%
Innacurate Installation 2% Lack of training
4% 2%
Lack of Planning
Lack of Contract Review
1%
0%
Lack of PPM
1% Lack of Subcontractors /
Vendors
Equipment Failure 6%
14% Lack of Information
1%
Lack of Inspection
Lack of Maintenance 3%
1%
Inaccurate Control
of Document / Drawings
2%
Procedure Inapplicable
/ Missing / Supersede
Equipment Wear Out 1%
16%
Procedure not followed u
Lack of Suitable Lack of Certification 3%
Equipment / Material / Spare 5%
Lack of Spare Parts / Material
Parts
5%
7% Lack of Calibration
Equipment / Material Arrived
4%
damaged
3%
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28. QMS Implementation Schedule
• Make assessment of current documents
• Prepare QMS Implementation Plan
• Review and write procedures
• Prepare Quality Assurance Plan (???)
• Prepare Quality Control Plan
• Training of Personal

29. Assessment of documents
• Unapproved documents are in use
• Procedures don’t match practices
• “Unofficial” changes are on procedures
• Obsolete documentation is in use
• Documents are not located where they’re
supposed to be

30. QMS Implementation Goal
• Use as many existing procedures as possible
• Consolidate duplicative procedures

31. Assessment of people
• Not trained
• Not aware of requirements
• Don’t have access to procedures
• Not complying with procedures
• Organization and responsibilities not as
described in quality manual