QUALITY MANAGEMENT SYSTEM

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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 ( ISO9000 ) Degree to which a set of
inherent characteristics fulfils requirements
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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/ ISO140001996 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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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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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
Dec2000








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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
9000- 194) ISO 9001 QMS Requirements(
rev. of ISO 9001/2/394) ISO 9004 Guidelines(
rev. of ISO9004-1,-2,-3,-494) 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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• ISO90011994 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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ISO90012000 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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ISO90012000 8 Measurement, Analysis and
Improvement ( Customer Satisfaction/Internal
Audit/ MM of Processes and Product/ Control of
Non - confirming product/ Analysis/ Continual
Improvement/ Corrective Preventive Actions )









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Changes from ISO90011994 to ISO90012000
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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ISO90012000 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

ISO90012000 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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ISO90012000 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.
ISO90012000 and ISO90042000 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

• ISO90012000 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 Demmings
• ( Process Approach )
• PLAN- DO-CHECK-ACT Cycle

Check
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QUALITY MANAGEMENT SYSTEM

• ISO90012000 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

Continual Improvement of the Quality Management
System

?

C u s t o m e r


C u s t o m e r

S a t i s f a c t i o n
Management Responsibility
?

?
R e q u i r m e n t s
Resource Management
Measurement, analysis, improvement



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?

Product realization

Product
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Process Based Quality Management system
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QUALITY MANAGEMENT SYSTEM


I
ISO90012000
THE PRINCIPLES BEHIND MANAGEMENT SYSTEMS


What we want


Policy


How we organize and control

System
Who does what and when







Procedures


How
Instructions
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DYNAMICELEMENTS
Improvements




POLICY
Management review


SYSTEMS
Corrective/preventive actions

PROCEDURES
Nonconformities






Internal Audits
WORK INSTRUCTIONS



STRUCTURE OF A MANAGEMENT SYSTEM eg. ISO 9000
its DYNAMICS
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ISO90012000

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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ISO90012000

Conditions for success

• Management commitment
• Information and training
• Motivation and involvement of employees
• Project organisation and management
• A detailed and strict project plan

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ISO90012000

Steps in writing procedures

• Describe the main steps in a flow diagram
• 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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ISO90012000 Certification Process


INQUIRY QUOTATION CERTIFICATION
AGREEMENT DOCUMENTATION REVIEW INITIAL
VISIT INITIAL AUDIT FOLLOW - UP
AUDITS PERIODIC AUDITS RENEWAL AUDIT







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ISO90012000 IMPLEMENTATION/ TRANSITION









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ISO90012000

• 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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• ISO90012000
• 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

• ISO90012000
• 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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ISO90012000 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,
travellers card , control plan etc









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ISO90012000 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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• ISO90012000
• 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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• ISO90012000
• 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,
  ships 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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• ISO90012000
• 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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• ISO90012000
• SHIPBUILDING and SHIP REPAIR Industry
• 7.4.3 Verification of Purchased Product
• Receiving inspection shall include that all
  applicable class certificates and/or
  manufacturers certificates have been received.
  (When not received with the product, positive
  recall procedure shall apply.

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• ISO90012000
• 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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• ISO90012000
• 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,
• manufacturers 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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• ISO90012000
• 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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• ISO90012000
• 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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ISO90012000 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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• ISO90012000
• 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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• ISO90012000
• 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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• ISO90012000
• 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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HAPPY ISO9000
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