Transcript No Slide Title

QUALITY MANAGEMENT SYSTEM
ISO9001: 2000
SHIP BUILDING AND SHIP REPAIR INDUSTRY
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QUALITY MANAGEMENT SYSTEM
* What is Quality, Quality Management System
*
Product Certification/ System Certification
* What other standards are available, Who made these
standards?
*
Main Changes from 1994 to 2000 Standards
*
Transition Steps
* Appreciation of some clauses as applied to Shipbuilding
and Ship repair Industry
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QUALITY MANAGEMENT SYSTEM
Quality
( ISO9000 )
Degree to which a set of inherent characteristics fulfils
requirements
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QUALITY MANAGEMENT SYSTEM
MAJOR QUALITY PROBLEMS
(RESULTS SURVEY OF ENGINEERING INDUSTRIES IN BRITAIN IN 1970)
* Human Error…………………………….. 12%
* Bad Inspection Method…………………. 10%
* Lack of and/or wrong specification……. 16%
* Lack of Proving (new design, materials, manufacturing
processes) ………………………………. 36%
* Poor Planning……………………………. 14%
* Unforeseeable & other………………….. 12%
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QUALITY MANAGEMENT SYSTEM
Quality Management System
( ISO9000 )
Coordinated activities to direct and control an organization
with regard to quality
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QUALITY MANAGEMENT SYSTEM
* Product Certification Vs Management System Certification
*
-
Management System Certification Schemes
Quality Management ( ISO9000/AS9000/QS9000/TickIT etc)
Environmental Management ( Greenhouse Gas Services/
ISO14000:1996 etc )
Safety Management ( OHSMS/SSC or VCA )
Food Safety ( HACCP/GHP/GMP/BRC)
Information Security Management ( BS7799 )
Social Accountability ( SA8000 )
Integrated Management Systems
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QUALITY MANAGEMENT SYSTEM
What is this ISO…… ?
* ISO is an International Standards Organization having
office at Geneva, Switzerland
* ISO (The International Organisation for Standardisation is a World- wide
Federation of National Standard Bodies (ISO -Member Bodies e.g. IS BIS)
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QUALITY MANAGEMENT SYSTEM
Who Makes Standards?
* International Standards are Prepared through ISO Technical Committees
* Each Member Body interested in a Subject for which a Technical Committee is established has the Right to be Represented on that Committee
* International Organisations, Government and Non-Governmental, in
liaison with ISO, also Take Part in Work
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QUALITY MANAGEMENT SYSTEM
How Standards are made……?
* Draft International Standards adopted by the Technical committee
are circulated to the member bodies for comments/approval before
their acceptance as International Standards by the ISO council.
* They are approved in accordance with ISO procedures requiring at
least 75% approval by the member bodies voting
* ISO 9000 series International standards is the responsibility of ISO
Technical Committee 176, Quality Management & Quality
Assurance.
* ISO/TC 176 adopted in 1990 a strategy for revision of the ISO9000
series originally published in 1987. The present standard was released
in 1994 which is again revised/released now in Dec’2000
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QUALITY MANAGEMENT SYSTEM
ISO 9000 Family of Standards
Revised Structure : four Primary Standards
* ISO 9000 Concept & Vocabulary( rev. of ISO 8402 & 90001:94)
* ISO 9001 QMS Requirements( rev. of ISO 9001/2/3:94)
* ISO 9004 Guidelines( rev. of ISO9004-1,-2,-3,-4:94)
* ISO 19011 Guidelines for Auditing
Note : The Clauses of ISO 9000-1 (Guidelines for selection and
use) that constitutes the ‘road map’ to the ISO 9000 family of
standards, will be published as a separate brochures
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QUALITY MANAGEMENT SYSTEM
ADVANTAGES OF QMS
* A systematic, methodical approach in way business is
done
* A tool for consistent delivery
* Continuous improvement in quality
* System dependent regime instead of person dependent
* Efficiency in sub-processes
* Positive impact on customer satisfaction
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QUALITY MANAGEMENT SYSTEM
ISO9001:1994 Standards
4.1 Management responsibility
4.2 Quality systems
4.3 Contract Review
4.4 Design Control
4.5 Document & Data Control
4.6 Purchasing
4.7 Control of customer supplied product
4.8 Product identification & traceability
4.9 Process Control
4.10 Inspection & testing
4.11 Control of inspection, measuring and
test equipment
4.12 Inspection & test status
4.13 Control of non-conforming
product
4.14 Corrective & preventive
action.
4.15 Handling, storage,
packaging, delivery
4.16 Control of quality records
4.17 Internal quality audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000 Standards
4 Quality Management System ( Documentation/Manual/Records )
5 Management Responsibility ( Commitment/ Customer Focus/
Quality Policy/ Objectives/ Planning/Responsibility/MR/ Internal
Communication/ Reviews )
6 Resource Management ( Human Resources/Infrastructure )
7 Product Realization ( Planning/Customer requirements & review/
Communication/Design & Development/Purchasing/Production
and Service Provision ie Validation of Processes/ Identification &
Traceability/ Care of Customer Property and Preservation/ Control
of Monitoring & Measuring Devices )
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
8 Measurement, Analysis and Improvement
( Customer Satisfaction/Internal Audit/ M&M of Processes and Product/
Control of Non - confirming product/ Analysis/ Continual Improvement/
Corrective & Preventive Actions )
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QUALITY MANAGEMENT SYSTEM
Changes from ISO9001:1994 to ISO9001:2000
*
Another Creation of Trade Barrier ?
* Consultants and Certification Bodies Continue to
Make Money ?
* To Confuse the Organisation Using the Standards ?
* Additional Investments with No Returns ?
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000 Need of Changes ?
“ NOTHING IS CONSTANT IN THE WORLD EXCEPT CHANGES.”
ISO Rules require the review of all standards every 5 year,
 to ensure that they reflect the best practices, and
 take into account the lessons learnt
OUTCOME Standards confirmed, revised or withdrawn ?
In 1990, TC176 adopted a two-phase revision process :
 First Phase completed in 1994 : Minor Changes pertaining to Tidying up, clarified ambiguity
and better use of English
 Second Phase undergone now : Has significant number of changes both in style and content
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000 Need of Changes ?
In 1997, TC176 undertook a global survey of ISO9000
users and the need of significant changes was felt as a
result of analysis of responses :
 Revised standards should have increased compatibility with ISO14000
 Revised standard should have a common structure based on a process model
 Provision should be made for tailoring the requirements to omit elements not applicable
 Requirements should include demonstration of continuous improvement and prevention of non
conformity
 ISO9001 should address effectiveness while ISO9004 should address efficiency and effectiveness
 ISO9004 should help achieve benefits for all interested parties, e.g. Customers, Owners, Employees,
Suppliers & Society
 Revised standard should be simple to use, easy to understand and use clear language and
terminology
 Revised standards should facilitate self - evaluation
 Manufacturing orientation of current standards be removed
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000 Need of Changes ?
In 1997, TC176 issued a document entitled “Quality Management
Principles and Guidelines on their Application” ( ref. ISO/TC176/SC
2/N130 )
This document formed one of the other design inputs to the ISO
Working Group responsible for the development of a consistent pair
of standards
i.e. ISO9001:2000 and ISO9004:2000
A Quality Management Principle(QMP) is defined as:
“ a comprehensive and fundamental rule or belief, for leading and operating an organisation,
aimed at continually improving performance over the long term by focusing on customers
while addressing the needs of all other stakeholders”
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000 What are Changes ?
• Change in Management System Philosophy itself
• Changes reflect an approach which is more complete and consider
management principles that go towards Total Management
Main Changes
* Customer Focus
* Use of Demming’s
Act
Plan
•How to improve
next time?
•What to do?
•How to do it?
( Process Approach )
Check
Do
• Did things happen
according to plan?
•Do what was
planned
PLAN- DO-CHECK-ACT Cycle
Check
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000 Summary of Changes :
• Continual Improvement of the System is Mandatory
• Approach is based on “Input”, “process” and “Out Put”
• Competency of Personnel requirement made more
elaborate
• Quality Objectives - SMART ( specific, measurable, achievable, result oriented and time bound
)
• QM to define the SCOPE of certification
• Product requirements to include specified & intended use
• Proactive customer satisfaction measures
• Requirements for Effective Communication defined
• Internal Audits to confirm compliance to ISO9001
• More complete as a Management System Specification
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QUALITY MANAGEMENT SYSTEM
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Continual Improvement of the
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Resource
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Measurement,
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Product
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Process Based Quality Management system
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QUALITY
MANAGEMENT SYSTEM
ISO9001:2000
THE PRINCIPLES BEHIND MANAGEMENT SYSTEMS
Policy
System
Procedures
Instructions
What we want
How we organize
and control
Who does what
and when
How
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QUALITY MANAGEMENT SYSTEM
Improvements
POLICY
Management review
SYSTEMS
Corrective/preventive
actions
PROCEDURES
WORK INSTRUCTIONS
Nonconformities
Internal Audits
STRUCTURE OF A MANAGEMENT SYSTEM eg. ISO 9000 & its DYNAMICS
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
Basic principles in system development
• Utilise existing documentation and routines
• Limit the System to what is vital
• Limit the documentation
( Documented Procedure needed for SIX activities only : Control of Documents, Control of Records,
Internal Audits, Control of Non conforming Products, Corrective Actions and Preventive Actions )
• Organise the System to get ADEQUATE control
• Avoid overlapping systems/instructions/routines
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
Conditions for success
•
•
•
•
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Management commitment
Information and training
Motivation and involvement of employees
Project organisation and management
A detailed and strict project plan
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
Steps in writing procedures
• Describe the main steps in a flow diagram
•
•
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Analyse the need for more details
Add necessary details
Make references
Benefits:
 Employees can start to contribute at any given time
 No QA knowledge and experience are needed
 Easy control with format and style
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
Certification Process
INQUIRY
QUOTATION
CERTIFICATION AGREEMENT
DOCUMENTATION REVIEW
INITIAL VISIT
INITIAL AUDIT
FOLLOW - UP AUDITS
PERIODIC AUDITS
RENEWAL AUDIT
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
IMPLEMENTATION/ TRANSITION
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
AUDIT
( a systematic and independent verification )
Why quality audits?
• health of unit
• compliance to a standard
• to determine effectiveness of system
• identify and prioritize area of improvement
What auditor looks for?
• Existence of system
• operation of system
• effectiveness
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
( Where these slides do not refer to ISO elements, the standard interpretation is applicable )
Process Description
• Hull Processes
Pre - treatment/ Marking and Cutting/ Bending( cold or hot )/ Block Assembly/ Pre erection and Erection
• Outfitting Production/ Installation Process
Covers all outfitting to be installed on hull e.g. Piping, fittings, equipment and Cable etc
- Manufacturing ( marking, cutting, bending, fit up, welding and painting and galvanizing)
- Installation ( fit up and welding, bolting and bushing )
• Painting Process
Cleaning, pre treatment ( blasting and shop priming ) and coating
• Repair and/or Reconditioning of machinery
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
4.2.3 Control of Documents
* Drawing control is the key area of document control
* Other documents e.g. WPS, Quality Plans, Inspection Procedures
including NDT, DT, Calibration and Qualification records
* External documents to be checked are :
• class rules, legislations, regulations
• industrial standards/ codes e.g. AWS, ASME
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
5.4.2 Quality Planning
Quality Planning should focus on identifying processes needed to meet effectively and efficiently the
organizations quality objectives and requirements
Input : Strategies, Objectives, Need & Expectations, statutory & regulatory
requirements, evaluation of performance data, lessons learnt from previous
experiences, related risk assessments etc
Output: Need for skill, resources, responsibilities, improvement in process/tools,
records etc
A quality plan is normally prepared for a new ship or a series of ships ( ships with
same design ), coverage of the plan may vary depending upon experience
In case of repair units, a quality plan is to be made for each product and/ or process
QUALITY PLAN may be in the form of ITP, traveller’s card , control
plan etc
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
6.2.2 Competence, Awareness and Training
For each position job description and qualification to be defined.
Welding, heat treatment, NDT and painting are special processes
which normally require specific qualification of personnel
7.2.1 Identification of Customer Requirements
Specified :
Ship Building: Contract Documents normally include commercial terms, contract
specifications and the basic drawings
Ship Repairs : is carried out as per Class rules and/or suppliers’ standards based on
the industrial standards
Not specified:
Supplies to EC countries, special requirements for particular flag vessel.
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
7.2.1 Identification of Customer Requirements
The process shall consider:
• extent to which customers have specified requirements
• requirements not specified by the customer
• product and/or service obligations, including regulatory and legal requirements
( e.g.API, ASME, ASTM, IBR, CE etc)
• requirements for availability, delivery and support
The object of this process is to develop a clear picture of what are the customer needs and
expectations, both in terms of the product/ service itself and its delivery .
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
7.3 Design and/or Development
• Ship design function are hull, hull outfitting, machinery, electrical etc
• Design stages can be grouped as basic design, detailed design and production
design. They can be conducted by separate or in the same organization ( depending
upon the size of shipyard )
• Design input shall consider class rules, customer requirements and statutory and/or
regulatory requirements
• Design verification includes design reviews, ship’s model test, drawing review
against design input checklist etc
• Design validation normally includes inclined test and sea trial
Verification: Confirmation by examination and provision of objective evidence that specified requirements
have been fulfilled
Validation: Confirmation by examination and provision of objective evidence that the particular requirements
for a specific intended usage are fulfilled
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
7.4.1 Purchasing Control
•Check if supplier evaluation includes the suppliers capability to get
the supplied product certified by the Class (e.g., DNV), when
required ( steel plates, welding fillers, machinery & spares etc )
•Purchasing documents should be checked at both design &
purchasing functions.
•Purchasing documents shall include requirements of product
certification by the class, and verification requirements of shipyard
and/or ship owner's inspectors at source.
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
7.4.3 Verification of Purchased Product
•Receiving inspection shall include that all applicable class
certificates and/or manufacturer’s certificates have been received.
(When not received with the product, positive recall procedure shall
apply.
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
7.5.1 Operations Control
• In the process of block assembly, pre-erection and erection, fit-up and welding
processes are most important.
• Monitoring and control should include following process.
Material Identification, Dimensions for hull and piping,
during marking, cutting, bending and assembly (fit-up and
welding) process.
- Welding being a special process need following controls:
• Procedure should comply with the reference standards/codes e.g. AWS
codes, ASME codes, Class rules etc.
• Qualification test results should be recorded in PQR
Contd…..
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
7.5.1
Operations Control
• Procedure may be documented in WPS and shall normally include specifications of
welding materials, welding equipment, welding parameters ( voltage, current, speed ) ,
welding environment ( temp, wind speed, pre heat ) and criteria for workmanship ( e.g.
groove angle, root gap etc )
• Externally qualified WPS may also be used, such as customer supplied WPS,
manufacturer’s WPS or WPS in the reference standard/ code.
• Monitoring and/or operating criteria ( this is a special process ) - monitoring as per quality
plan and WPS. Shall cover welding consumable, welding parameters and environment
and criteria for workmanship
• Qualification requirements for welders shall be specified and maintained as quality
records
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
7.5.2 Identification & Traceability
Identification and/or traceability of the structural plates and shapes,
and of pipes are critical, during the process of marking, cutting and
assembly.
•Identification of machinery and components are important, during
storage and installation onboard.
•Check if inspection (including NDT) status is identified when hull
blocks and pipe spools are painted, erected and/or installed.
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
7.5.3 Customer Property
It is normal that ship owners are supplying some equipment to be
installed onboard
•Inventories are partly supplied by the ship owners
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
7.5.4 Preservation of Product
Storage conditions should be suitable to prevent rust, pitting, etc and
prevent grits and dirt's contaminating the inside of piping.
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
7.6 Control of Measuring & Monitoring Devices
Equipment to be calibrated included welding equipment (except
SMAW ( shielded metal arc welding ) equipment), temperature gauges of drying
ovens for welding consumables, temperature gauges and recorders of
heat treatment equipment.
•Equipment used for hull inspection, painting inspection, outfitting
inspection including inclining test, deadweight measurement and sea
trial also requires to be calibrated and cover Non destructive,
mechanical and chemical testing.
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
8.2.3 Measurement and Monitoring of Process
• Welding, heat treatment (sometimes following welding) and
painting are special process.
-They normally require qualification of process and personnel.
• Process monitoring is also required specifically for these activities.
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QUALITY MANAGEMENT SYSTEM
ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
8.2.4 Measurement and Monitoring of Product
•Inspection and test plans are prepared for each (series of) ship(s).
The plans shall cover hull inspection, painting inspection, outfitting
inspection (including inclining test, deadweight measurement and
sea trial) and NDT (non-destructive testing).
•NDT activities should adhere to class rule requirements.
•At the final stage inspections shall include inclining test, deadweight
measurement and sea trial.
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QUALITY MANAGEMENT SYSTEM
HAPPY ISO9000
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