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Training programme

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Title: Training programme


1
Training programme
"ISO 90012008"
2
INTRODUCTION TO ISO 9000 2008
  • Every top management always maintains that their
    business organization mission is to provide top
    quality products/service to meet the needs of
    their customer. The reality is that the
    organization has many other goals also to
    peruses, such as maximizing customers, profits,
    declaring more benefits to the dependents,
    enhancing employees job satisfaction and
    ultimately serving the community and society at
    large.

3
INTRODUCTION TO ISO 9000 2008
  • The ultimate goal of a company is to make
    profit. This can be fulfilled only if we have
    such cross-functional goals as quality, cost and
    delivery. Without achieving these goals, the
    company will be left behind by the competition.
    Out of these goals, which need to be fulfilled by
    the company, quality is the most important as
    inferior quality will lead to its profits eroded
    by higher costs and it will be enable to deliver
    the product in time for the customer.

4
INTRODUCTION TO ISO 9000 2008
  • If these cross-functional goals are realized,
    profit will fallow. Therefore we should regard
    all other management functions as existing to
    serve the super ordinate goal of quality . To
    survive in a competitive market, it is imperative
    for the organization not only to maintain the
    high levels of quality but keep on enhancing
    these levels continuously to keep pace with the
    ever increasing expectations of the customer. To
    achieve this the organization need to have a
    world class Quality Management Systems (QMS) One
    model of such a QMS, described in ISO
    90002008series of standard, has been designed by
    top experts and specialists of the world in the
    field of quality after a great deal of
    deliberation and discussions in the ISO Technical
    Committee TC 176

5
The first steps
  • 1950s and 1960s
  • Dominance of Military based Quality Programs
    (MIL-Q-9858, AQAP, Def Std etc.)
  • 1970s
  • QA Standards
  • BS 5750 first published (1979)

6
The birth of ISO 9000
  • ISO 9000 series developed by ISO/TC 176 (early
    80s) and published (1987)
  • ISO 9000 Concepts, selection and use
  • ISO 9001/2/3 Certification
  • ISO 9004 Guidelines
  • Internationally developed, but not truly accepted
    worldwide.

7
Growth of QMS Standards
  • 1990s
  • Widespread acceptance of ISO 9000 around the
    world (now over 9,00,000 cert. issued)
  • Revision work done on ISO 9000 from 1997-2000
    worldwide participation and strong consensus.
  • Aim to simplify, consolidate and improve.

8
Key Elements of ISO 90012008
  • Process approach and PDCA
  • Comparison (may be a little unfair on ISO
    90011994!)
  • ISO 90011998 Documented procedures evidenced by
    records
  • ISO 90012008Defined and managed processes
    evidenced by results.

9
Deming's Formula
  • PLAN
  • DO
  • CHECK
  • ACT

10
Deming's Formula
  • Plan
  • What do we want to achieve?
  • Vision, Mission, Objectives
  • How can we achieve it?
  • Business plan, Strategies,Resources
  • Dr. Deming Its pointless to establish an
    objective without defining a method to achieve it

11
Deming's Formula
  • Do
  • Get everyone involved, committed and motivated
    (Leadership!)
  • Carry out the plan
  • Deploy throughout the organization
  • Break down the objectives to the appropriate
    functions and levels.

12
Deming's Formula
  • Check
  • Is this want we expected?
  • Are the results OK?
  • Look for trends

13
Deming's Formula
  • Act Correct what went wrong (Correction) Plan to
    do it right next time (Corrective action)
  • Learn to make things error-proof (Preventive
    action)
  • Think how can we do this..
  • Faster?,
  • Cheaper?
  • Better?
  • Safer?

14
WHAT IS ISO 9000 CERTIFICATION ALL ABOUT?
  • CONFIDENCE
  • Providing CONFIDENCE to the customer that
    requirements for the product will be met.
  • ISO 9001 2008 Philosophy
  • ISO 9000 lays down what requirements your quality
    management system must meet.
  • But it does not dictate how they should be met.
  • Allows great flexibility for implementation in
    different business sectors and business cultures.

15
Do we need Certification?
  • Some options
  • Internal audits
  • I want to use ISO 90012008 as a management tool,
    but my customers dont require me to be
    certified.
  • 2nd party audits
  • I provide my products to a very limited number of
    customers, and they audit me to ISO 90012008as
    part of their supplier evaluation programme.
  • 3rd Party Certification
  • I want to be able to demonstrate to a number of
    customers that my QMS meets ISO 90012008
    requirements.
  • Avoid multiple audits by the organizations
    clients or reduce the frequency or duration of
    client audits.

16
QUALITY
  • Confirmation to specification
  • Fitness for purpose
  • Meeting the agreed requirements

17
Customers expect quality because
  • They want product or service that is reliable
  • They want it to meet their requirements
  • They want value for their money

18
QUALITY MATTERS TO YOU
  • You want job satisfaction
  • You want to be respected
  • You want to enjoy work
  • You want to do a good job
  • You want to secure job
  • You want to be proud to work for your
    organization.

19
CUSTOMER DISSATISFACTION
  • Failure to meet delivery
  • Failure to meet specification
  • Not fit for the purpose
  • Failure in service
  • Results for which is
  • They complain
  • They change the supplier
  • They inspect

20
WE SHOULD ALWAYS REMEMBER
  • Our customers are the only judge of whether we
    are a Quality Organization
  • Never assume you know what your customer wants

21
Customer Assurance (Confidence)
  • Quality will be achieved
  • Quality will be maintained
  • Problems will be minimized
  • Confidence can be obtained by effective quality
    management.

22
QUALITY MEASUREMENT AND IMPROVEMENTS
  • Identify product characteristics
  • Define levels of achievement
  • Adopt statistics
  • Measure achievement
  • Innovate to improve
  • Publicize improvement

23
6 aspects of ISO 9000 (Cuboid)
  • 1. Commitment
  • 2. People
  • 3. Processes
  • 4. Procedures
  • 5. Implement
  • 6. Maintain

24
BENEFITS OF ISO
  • Customer confidence
  • International recognition
  • Acceptance in Global Markets
  • Identification of specified implied needs of
    quality
  • Consistency in quality
  • Understanding customers requirement throughout
    the organization
  • Reduction in product liability
  • Better Management of safety, Risk and Hazard
  • Reduction in waste and rework
  • Employee participation in company activity
  • Improvement in profits
  • Doing right work at the first time
  • Increase in the prestige or level of the
    organization

25
A Customer is the most important visitor on
our premises. He is not dependent on us. We are
dependent on him. He is not an interruption on
our work. He is the purpose of it. He is not an
outsider on our business. He is a part of it. We
are not doing him a favour by serving him. He is
doing us a favour by giving us an opportunity to
do so.

- Mahatma Gandhi
26
A Customer is the most important visitor on
our premises. He is not dependent on us. We are
dependent on him. He is not an interruption on
our work. He is the purpose of it. He is not an
outsider on our business. He is a part of it. We
are not doing him a favour by serving him. He is
doing us a favour by giving us an opportunity to
do so.

- Mahatma Gandhi
27
  • 4.0 Quality Management System
  • 5.0 Management Responsibility
  • 6.0 Resource Management
  • 7.0 Product realization
  • 8.0 Measurement, Analysis and Improvement

28
1.0 SCOPE
  • This International Standard specifies
    requirements for a quality management system
    where an organization
  • needs to demonstrate its ability to consistency
    provide product that meets customer and
    applicable regulatory requirements, and
  • Aims to enhance customer satisfaction through the
    effective application of the system, including
    processes for continual improvement of the system
    and the assurance of conformity to customer and
    applicable regulatory requirements.

29
2.0 APPLICATION
  • All requirements of this International Standard
    are generic and are intended to be applicable to
    all organizations, regardless of type, size and
    product provided.
  • Where any requirements (s) of this International
    Standard cannot be applied due to the nature of
    an organization and its product, this can be
    considered for exclusion.
  • Where exclusion are made, claims of conformity to
    this International Standard are not applicable
    unless these exclusions are limited to
    requirements within clause 7, and such exclusions
    do not affect the organizations ability, or
    responsibility, to provide product that meets
    customer and applicable regulatory requirements.

30
4. Quality Management system
  • 4.1 General Requirement
  • The organization shall establish, document,
    implement, maintain and continually improve the
    QMS effectiveness in accordance with the
    requirements of this International Standard.
  • The organization shall
  • Identify the process needed for the QMS and its
    application thru out the organization (see 1.2
    Application)
  • Determine the sequence and interaction of these
    processes
  • Determine criteria and methods needed to ensure
    the effectiveness of processes operations and
    control
  • Ensure the resources and information necessary
    are available to support the process operation
    and monitoring
  • Measure, monitor and analyze these processes and
  • Implement necessary actions to achieve planned
    results and continual improvement of these
    processes
  • Define outsourced process if any and its control
    (2008)

31
4.2.1 The quality management system
documentation shall include
  • Documented Quality Policy and Objectives
  • Quality Manual
  • Documented procedures required by the Standard.
  • Documents required by the organization to ensure
    the effective planning, operation and control of
    its processes.
  • Records required by the Standard
  • The extent of documentation is dependent on the
    organization size, type of activities, processes
    complexity, their interactions as well as
    personnel competence. Procedures required by the
    standard can be individual or combined. A single
    document can address one or more procedures.
    Documentation can be any form, type of medium.
    (2008)

32
Discussion
  • Define documentation including records to support
    an effective and efficient operation of the
    organization of processes.
  • Extent of documentation to consider contractual
    requirements, regulatory requirements and
    interested parties and organization competency,
  • Evaluation of documentation from functionality,
    user friendliness, resources needed, policy and
    objectives, current and future requirements,
    benchmarking and interface with interested
    parties.

33
4.2.2 Quality Manual
  • The Quality Manual shall include
  • The Scope of the QMS, including any exclusion
    details Justification.
  • Documented procedures established for the QMS, or
    make reference to them.
  • A description of the QMS processes interaction
  • Discussion
  • What should be covered in Quality Manual?

34
4.2.3 Control of Documents
  • A documented procedure shall be established. The
    controls needed are
  • Approval for adequacy prior to issue
  • Review and update and re-approve
  • Ensure identification of document changes and
    current revision status
  • At points of uses, relevant versions of
    applicable documents are available
  • Ensure documents are readily identifiable and
    remain legible
  • To identify and control distribution of
    externally originated documents relevant to QMS
    (2008)
  • To prevent unintended use of obsolete documents
    and suitably identify them if they are retained
    for any purpose.

35
4.2.4 Control of Records
  • Quality records provide evidence of conformity
    and of the effective operation of the QMS. These
    shall remain legible, readily identifiable and
    retrievable.
  • A documented procedure shall be established to
    define the controls for identification,
    legibility, storage, protection, retrieval,
    retention time and disposition.

36
5.Management Responsibility
  • 5.1 Management Commitment
  • Top management shall provide evidence of its
    commitment to the development and implementation
    of the QMS and continually improve its
    effectiveness by
  • Communication to the organization the importance
    of meeting customer as well as statutory
    regulatory requirements
  • Establishing the quality policy
  • Ensuring that the Quality Objectives are
    established
  • Conducting management reviews
  • Ensuring resources are available

37
Discussion
  • Involvement of top management is essential for
    developing and maintaining an effective and
    efficient quality management system by
  • Establishing vision, policies and strategic
    objectives
  • Leading by example
  • Improvement projects
  • Identifying product realization process
  • Creating an environment that influences
    development and involvement of people.
  • To determine achievement of set objectives
  • Defining method for measurement of organizational
    performance.

38
5.2 Customer focus
  • Top management shall ensure that customer
    requirements are determined, and met with the aim
    of customer satisfaction enhancement.
  • Discussion
  • Understanding and meet the needs and
    expectations of interested parties by
  • Identifying interested parties needs
    expectations
  • Translate needs into requirements
  • Communicate the requirement throughout the
    organization
  • Focus on process improvement to ensure value for
    the identified interested parties.

39
End user needs and expectations may include
  • Conformity
  • Dependability
  • Availability
  • Delivery
  • Post realization activities
  • Price and life cycle cost
  • Safety
  • Liability
  • Environmental impact

40
5.3Quality policy
  • Top management shall ensure that the quality
    policy
  • Is appropriate to the purpose of the
    organization
  • Includes a commitment to meeting requirements and
    continual improvement of the QMS effectiveness
  • Provides a framework for establishing and
    reviewing quality objectives
  • Is communicated and understood in the
    organization
  • Is reviewed for continuing suitability

41
5.4 Planning
  • 5.4.1 Quality Objectives
  • Top management ensures that quality objectives
    are established at relevant functions and levels
    within the organization, including those needed
    to meet requirements of product.
  • Objectives shall be consistent with the quality
    policy shall be measurable.

42
Discussion
  • Quality Policy provides a framework for the
    setting of quality objective, leading to improved
    performance.
  • Communication of objectives to enable people to
    contribute.

43
5.4.2 Quality Management System Planning
  • Top management shall ensure that
  • QMS planning is carried out in order to meet
    requirements in 4.1 and quality objectives.
  • Plans implementation of changes to QMS shall
    not affect the integrity of the QMS.

44
Discussion
  • Responsibility of management for quality planning
    of the organization.
  • Focusing on defining the processes needed to meet
    effectively and efficiently organization quality
    objectives and requirements consistently.

45
5.5. Responsibility, Authority Communication
  • 5.5.1 Responsibility and authority
  • Top management ensures responsibilities and
    authorities are defined communicated.
  • Discussion
  • Responsibility and authority of personnel
    throughout the organization defined to enable
    them to achieve the quality objectives and to
    enable their involvement, motivation and
    commitment.

46
5.5.2 Management representative
  • Top management shall appoint a member of the
    organisations management (2008) as MR.
  • Irrespective of other responsibilities, MR is
    responsible and has authority to
  • Ensure establishment, implementation
    maintenance of the processes needed for the QMS
  • Reporting to top management on the QMS
    performance and any improvement need
  • Ensure awareness of customer requirements
    throughout the organization is promoted.

47
Discussion
  • Reporting to top management and communicate with
    customers and other interrelated parties on
    matters pertaining to the quality management.

48
5.5.3 Internal communication
  • Top management shall ensure that appropriate
    processes for communication within the
    organization are established.
  • Top management shall ensure that communication
    regarding the effectiveness of the QMS takes
    place.

49
Discussion
  • Effective and efficient processes for
    communicating the quality policy, requirements,
    objectives and accomplishments.
  • Encouragement for providing feedback and
    communication from people reflecting their
    involvements including
  • Employee survey and suggestion scheme
  • Team briefing and other meetings

50
5.6 Management review
  • 5.6.1 General
  • Top management shall review QMS at planned
    intervals to ensure suitability, adequacy and
    effectiveness.
  • Include assessing improvement opportunities and
    the need for QMS, quality policy quality
    objectives changes.
  • Maintain records of review.

51
Discussion
  • Value addition to the organization from the
    management review.
  • Control of performance of realization and support
    processes by systematic review based on quality
    management principles.
  • Review of input and output that extends beyond
    the effectiveness and efficiency of the quality
    management systems.

52
5.6.2 Review Input
  • Reviews inputs shall include the following
    information
  • Audit results,
  • Process performance and conformity of product
  • Feedback from customer
  • Status of corrective and preventive actions
  • Changes that could affect the QMS
  • Improvement opportunities

53
Discussion
  • Inputs to consider the requirement of customer
    and other interested parties.

54
5.6.3 Review Output
  • Review output includes actions and decisions
    related to
  • Improving the QMS effectiveness and its processes
  • Improving the product related to customer
    requirements
  • Resource needs

55
Discussion
  • Use of output as inputs to improvement processes.
  • Communication of selected output to the people in
    the organization of how review process leads to
    new objectives for the benefit of the
    organization.

56
6 Resource Management
  • 6.1 Provision of resources
  • Organization shall determine and provide the
    necessary resources to
  • Implement, maintain and continually improving the
    QMS
  • Enhance customer satisfaction

57
Discussion
  • Ensuring resources essential to the
    implementation of strategy and the achievement of
    the organizations objectives.

58
6.2 Human Resources
  • 6.2.1 General
  • Personnel whose work affects conformity to
    product requirement (2008) shall be competent in
    terms of appropriate education, training, skills
    and experience.
  • Discussion
  • Involvement of people

59
6.2.2 Competence, Awareness Training
  • Organization shall determine competence for
    personnel performing work that affect conformity
    to product requirements (2008)
  • Provide training or initiate other actions to
    meet these needs
  • Evaluate effectiveness of these actions
  • Ensure personnel are aware of their importance
    relevance and their contribution to achieving
    quality objectives.
  • Records of education, experience, training and
    skills shall be kept.

60
Discussion
  • Planning for education, training and development
    of people
  • Ensuring necessary competence for effective and
    efficient operation of the organization

61
6.3 Infrastructure
  • Organization to identify, provide and maintain
    infrastructure to achieve product requirements
    conformity, where applicable
  • Workspace, buildings and associated utilities.
  • Equipment for processes (hardware and software)
  • Supporting services (transportation,
    communication or information systems ). (2008)

62
Discussion
  • Definition of infrastructure.
  • Include provision, maintenance, evaluation and
    environmental aspects of infrastructure.
  • Impact of nature phenomena on the infrastructure

63
6.4 Work Environment
  • Organization shall identify and manage the work
    environment to achieve conformity of product
    requirements.
  • Work Environment relates to those conditions
    under which work is performed including physical,
    environmental and other factors (such as noise,
    temperature, humidity, lighting or weather )
    (2008)
  • Discussion
  • Factors to consider when creating a suitable work
    environment.

64
7.0 Product Realization
  • 7.1 Planning of product realization
  • Process shall be planned and developed for
    product realization
  • Planning to be consistent with other QMS
    processes requirements
  • As appropriate, the following shall be
    determined
  • Product requirements and quality objectives
  • The need to establish product specific processes,
    documentation and provision of resources
  • Product-specific verification, validation,
    monitoring, inspection and test activities and
    acceptance criteria
  • Records to show evidence of realization processes
    and product conformity
  • Planning output shall be in a form deemed
    suitable for the organization's operational
    methods.

65
7.2 Customer-related processes
  • 7.2.1 Determination of requirements related to
    the product
  • Organization shall determine
  • Customer specified requirements, including
    delivery post-delivery requirements
  • Requirements that are not stated by customers,
    but are necessary for the specified or intended
    use, where known
  • Regulatory statutory requirements related to
    the product
  • Additional requirements determined by the
    organization

66
Discussion
  • Post delivery activities include , actions under
    warranty provisions, contractual obligations such
    as maintenance services, and supplementary
    services such as recycling or final disposal
    (2008)
  • Importance of meeting customers as well as
    interested parties needs.
  • Examples of relevant processes information.

67
7.2.2 Review of requirements related to the
product
  • Review shall be conducted prior to commitment to
    ensure
  • Requirements of product are defined
  • Order or contract requirements that differ from
    the previously expressed are resolved
  • Has the ability to meet the defined requirements
  • Shall maintain records of results of, and actions
    arising from, the reviews
  • If customer does not provide documented statement
    of requirement, organization shall confirm these
    requirements prior to acceptance
  • If product requirements are changed, relevant
    documents shall be amended and relevant personnel
    are made aware of the changes.

68
7.2.3 Customer communication
  • Organization shall determine and implement
    effective communication arrangements related to
  • Product Information
  • Contract, Enquires or order handling (including
    amendments)
  • Customer feedback's and complaints
  • Discussion
  • Methods of communication

69
7.3 Design and development
  • 7.3.1Design and development planning
  • Organization shall plan and control design and
    development of product.
  • During planning, organization determines
  • Design and development stages
  • Review, verify validate appropriate at each
    stage
  • Responsibilities and authorities for design and
    development
  • Shall manage interfaces between various groups
    and ensure communication clear assignment of
    responsibility
  • As appropriate, planning output must be updated.

70
Discussion
  • All factors to consider include
  • Life cycle
  • Safety and health
  • Testability
  • Usability
  • User-friendliness
  • Ergonomics
  • Environment
  • Identified risks
  • Tools for risk assessment for design
    development
  • Design review, verification and validation can be
    recorded separately or in combination as suitable
    (2008)

71
7.3.2 Design and development inputs
  • Inputs relating to product requirements shall
    include
  • Performance functional requirements
  • Applicable regulation and statutory requirements
  • Inputs from previous designs, where applicable
  • Other essential requirements
  • Shall maintain records
  • Inputs shall be reviewed for adequacy,
    completeness, non-ambiguity absence of
    conflicting requirements

72
Discussion
  • Examples of external internal design inputs.
  • Importance of product-related inputs based on
    appreciation of the needs and expectation of
    users and customers.

73
7.3.3Design and development outputs
  • Outputs must be documented in a form that
    enables verification against design and
    development inputs
  • Before release, outputs shall be approved.
  • These outputs shall
  • Satisfy input requirements
  • Provide appropriate information for purchasing,
    production and service provision.
  • Reference product acceptance criteria.
  • Define the characteristics of the product for
    safe proper use.

74
Discussion
  • Examples of outputs include product, process,
    material and testing specifications and data
    demonstrating the comparison of process inputs
    process outputs.
  • Output includes information needed for production
    and service provision includes preservation of
    product. (2008)

75
7.3.4 Design and development review
  • Organization shall review design at suitable as
    per planned arrangements (clause 7.1)
  • Evaluate ability to meet requirements
  • Identify problems and propose necessary actions
  • Representatives concerned with the design shall
    participate in the reviews.
  • Record of results of reviews and any necessary
    actions shall be maintained

76
Discussion Design Review
  1. Involves all functions (internal or external)
  2. Timing of design review is influenced by the cost
    of the product and Complexity
  3. Satisfying all specified requirements for the
    product
  4. Safety considerations
  5. Compatibility of process capability with product
    design
  6. Meeting functional and operational requirements
  7. Use of appropriate materials and facilities
  8. Adequate compatibility of materials, components,
    service elements.
  9. Standardization
  10. Provision of tolerance, and/or configuration
  11. Validation of software used in design
  12. Requirement of Prototype testing

77
7.3.5 Design and development verification
  • Organization shall verify outputs (as per 7.3.1)
    to ensure ability to meet design or input
    requirements
  • Shall record results of verification necessary
    actions

78
7.3.6 Design and development validation
  • Design and development validation shall be
    performed according to planned arrangements to
    confirm that the resulting product conforms to
    the specified requirements or intended
    use/application, where known.
  • Wherever practicable, validation shall be
    completed prior to the delivery or implementation
    of the product.
  • The results of the validation and necessary
    actions shall be recorded.

79
7.3.7 Control of design and development changes
  • Organization shall identify and record design and
    development changes.
  • Review shall include evaluation of the effect of
    the changes on constituent parts and products
    already delivered.
  • Changes shall be reviewed, verified and
    validated, as appropriate, and approved before
    implementation.
  • The results of the review of changes and any
    necessary actions shall be recorded.

80
Discussion Design changes
  • Procedure for review of changes
  • Communication to all concerned function
  • Design changes are approved
  • Undergoes same cycle of review / rectification

81
7.4 Purchasing
  • 7.4.1 Purchasing control
  • The organization shall ensure product purchased
    conforms to specified purchase requirements
  • Type extent of applicable control depends on
    the effect of the purchased product on the final
    product or subsequent product realization
  • Suppliers shall be selected and evaluated on
    their ability to meet organization's requirements
  • Criteria for selection, evaluation and
    re-evaluation shall be defined.
  • The results of evaluations and necessary actions
    shall be recorded.

82
7.4.2 Purchasing information
  • Purchasing information shall contain description
    about product to be purchased.
  • Where appropriate, information includes
  • Approval of product, procedures, processes
    equipment requirements
  • Qualification of personnel
  • QMS requirements
  • Shall ensure adequacy of specified purchase
    requirements prior to communication with supplier.

83
Discussion
  • Ensure that purchased products are adequate to
    satisfy the input requirements of the
    organization processes.

84
7.4.3 Verification of purchased product
  • Shall establish implement inspection or other
    necessary activities to ensure purchased product
    conformity.
  • For customer's verification at the supplier's
    premises, the intended verification arrangements
    and product release method shall be stated in the
    purchasing information.

85
7.5 Production and service operations
  • 7.5.1 Control of production service provision
  • Organization shall plan carry out production
    services provision under controlled conditions,
  • As applicable
  • Available information that describes the product
    characteristics
  • Available work instructions, as necessary
  • Using of suitable equipment
  • Available use of measuring and monitoring
    devices
  • The implementation of measuring monitoring
    activities
  • The implementation of release, delivery and
    post-delivery activities

86
7.5.2 Validation of processes for production
service provision
  • Validation of any processes for providing
    production and service where the resulting output
    cannot be verified by subsequent measurement or
    monitoring.
  • Includes any processes where deficiencies become
    apparent only after the product is in use or the
    service has been delivered.
  • Ability to achieve planned results shall be
    demonstrated by the validation
  • Where Applicable
  • Define criteria for review approval of
    processes
  • Personnel qualification equipment approval
  • Use of specific methods procedures
  • Record keeping
  • Re-validation

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7.5.2 Identification and Traceability
  • The organization shall identify the product by
    suitable means throughout the product
    realization, where appropriate.
  • Identification of the product status with respect
    to measurement and monitoring requirements.
  • The organization shall control and record the
    unique identification of the product, where
    traceability is a requirement.

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Discussion
  • Where appropriate, define the means for
    identification e.g. marking, tagging, location,
    color, batch nos.
  • Service identification may be achieved by
    documentation that accompanies the service
  • Traceability involves the ability to trace the
    history, application or location of an item or
    activity
  • - Traceability required when there is a need to
    track a Nonconformity back to the source
  • In case of service functions, recording of
    identification evidenced through signature or
    serially numbered documents in invoicing and
    banking operation
  • Cases wherein identification and traceability is
    necessary. Example relevant statutory
    regulatory requirements mitigation of risks.

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7.5.4 Customer property
  • The organization shall exercise care with
    customer property while it is under the
    organization's control or being used by
    organization.
  • Identification, verification, protection and
    safeguard of customer property shall be
    performed.
  • Loss, damages or suitability for use shall be
    reported to customer records shall be
    maintained.
  • Can include intellectual property and personal
    data (2008)

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7.5.5 Preservation of product
  • The organization shall define implement product
    handling, packaging, storage, preservation and
    delivery processes.
  • Prevent deterioration, damage misuse to ensure
    product conformity during internal processing and
    delivery to the intended destination
  • Applicable also to constituent parts of a product

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7.6 Control of Monitoring and Measuring Equipment
(2008)
  • Determine measurement monitoring to be
    undertaken
  • Determine devices required to provide evidence of
    product conformity
  • Ensure MMD calibrations are carried out and in a
    manner consistent with requirements
  • Measuring equipment shall be
  • Calibrated or verified prior to use or at
    specified intervals against standards traceable
    to national or international standards, or record
    basis used if no such standard exist.
  • Adjusted re-adjusted
  • Calibration status be identified
  • Safeguarded against adjustments
  • Protected against damage deterioration during
    handling, maintenance storage.
  • When devices are found to be out of calibration,
    previous results shall be assessed for validity
    recorded. Appropriate action be taken on devices
    and any affected product.
  • Confirm ability of software used for measurement
    monitoring prior to initial use reconfirmed
    if necessary.
  • Ability of the computer software to satisfy the
    intended application would include its
    verification and configuration management to
    maintain its suitability for use (2008)

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8.1 General
  • Shall plan implement the monitoring,
    measurement, analysis improvement processes in
    order to
  • Demonstrate product conformity
  • Ensure QMS conformity
  • Continually improve QMS effectiveness
  • Determine applicable methods, including
    statistical techniques.
  • Discussion
  • How to measure process performance.
  • Issues to be considered to consider in
    measurement, analysis improvement.

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8.2 Measurement and monitoring
  • 8.2.1 Customer Satisfaction
  • Determine methods to obtain use information
    relating to customer perception.
  • Monitor this information as a means to measure
    QMS performance.
  • Monitoring customer perception can include
    obtaining inputs from sources such as customer
    satisfaction surveys, customer data on delivered
    product quality, user opinion surveys, lost
    business analysis, complaints, warranty claims
    and dealer reports. (2008)
  • Discussion
  • - Understand customer complaint relationship with
    customer satisfaction.

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8.2.2 Internal audit
  • Shall perform at planned interval
  • Objectives are to determine whether
  • QMS conforms to planned arrangements ISO
    requirements
  • QMS effectively implemented maintained.
  • Plan audit taking into consideration importance
    status of the processes areas and the results
    of previous audits.
  • Define audit criteria, scope, frequency and
    methods.
  • Auditors shall not audit their own work and
    shall ensure objectivity impartiality of the
    audit process
  • Documented procedure to define responsibilities
    requirements for planning, conducting
    reporting audits maintaining records.
  • Responsible management shall take actions to
    eliminate NC and their causes without undue
    delay.
  • Verification of the actions taken reporting
    results of such verification shall be performed.

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8.2.3Measurement and monitoring of processes
  • Apply suitable methods for monitoring, where
    applicable, measurement of QMS processes to
    demonstrate ability to achieve planned results
  • Corrective preventive action shall be taken
    when planned results are not obtained.
  • Type and extent of monitoring or measurement
    appropriate to each of the process depends upon
    their impact on the conformity to product
    requirements and on the effectiveness on QMS
    (2008)

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8.2.4Measurement and monitoring of product
  • Measurement and monitoring of product to verify
    product requirements are satisfied, at
    appropriate stages as per 7.1
  • Evidence to conformity with acceptance criteria
    is to be maintained.
  • Release of product with identification of
    personnel authorizing the release shall be
    recorded.
  • Shall not release product delivery service
    until planned arrangements have been
    satisfactorily completed, unless approved by
    relevant authority customer where applicable).

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Discussion
  • How are measurement and monitoring of product
    requirement implemented?

98
8.2.4 Measurement and monitoring of product
  • Measurement and monitoring of product to verify
    product requirements are satisfied, at
    appropriate stages as per 7.1
  • Evidence to conformity with acceptance criteria
    is to be maintained.
  • Release of product with identification of
    personnel authorizing the release shall be
    recorded.
  • Shall not release product delivery service
    until planned arrangements have been
    satisfactorily completed, unless approved by
    relevant authority customer (where applicable).
  • Discussion
  • - How are measurement and monitoring of product
    requirement implemented?

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8.3 Control of nonconforming product
  • Documented procedure to define responsibilities
    authorities to control nonconforming product.
  • Shall ensure that NC products are identified and
    prevent against unintended use or delivery.
  • One or more of the following ways
  • Eliminating detected nonconformity
  • Relevant authority authorize use, release or
    acceptance under concession where applicable,
    by customer.
  • Preclude original application or intended use.

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  • Maintain records of nonconformity's nature
    subsequent actions taken, including any
    concessions obtained
  • Re-verify corrected product for conformance
  • Act appropriately, depending on the effects or
    potential effects, when nonconforming product is
    detected after delivery or use.

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8.4 Analysis of data
  • Shall determine, gather analyze data to
    demonstrate QMS effectiveness suitability and
    to evaluate continual improvement of QMS
    effectiveness.
  • Data shall include results of measurement and
    monitoring and other relevant information
    relating to
  • Customer satisfaction
  • Product conformance
  • Characteristic trends of processes products
    and preventive action opportunities
  • Suppliers
  • Discussion
  • - Can statistical tools be used?

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8.5 Improvement
  • 8.5.1Continual improvement
  • Organization shall use the quality policy,
    quality objectives, and result of audits, data
    analysis, corrective preventive actions and
    management reviews for the QMS continual
    improvement.
  • Discussion
  • Should be pro-active instead of waiting for a
    problem to reveal opportunities for improvement
  • Small-step improvement Vs breakthrough

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8.5.2 Corrective action
  • Documented procedure to define requirements for
  • Nonconformity's reviews
  • Causes of nonconformity's investigation
  • Evaluation for action to prevent recurrence of
    nonconformity's
  • Determine implement action needed
  • Recording results of action taken
  • Reviewing corrective action
  • Corrective actions shall be appropriate to the
    effects of nonconformity's encountered, to
    prevent recurrence

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8.5.3 Preventive action
  • Documented procedure for
  • Determining potential nonconformity's and their
    causes
  • Evaluate the need for action to prevent
    occurrence
  • Determine implementation required
  • Recording results of action taken
  • Reviewing preventive action

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internal auditing
Auditing Techniques
Auditing is a process for obtaining audit
evidence and evaluating objectively. Audit
evidence is obtained by auditor. Auditor is a
person with competence to conduct the audit by
auditing the auditee. Auditee is the person /
organization being audited. For obtaining audit
evidence, auditors have to communicate with the
auditee. Effective communication is essential to
support auditors deliverable, which is the
audit report based on facts.
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Communication Effective communications
comprise Speaking
  • Speak at the level of the auditee
  • Frame the messages in the language vocabulary
    of the target
  • audience to get a clear answers
  • Structure your questioning
  • Ensure the brain is in gear before operating mouth

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Likely problems of speaking
  • What is spoken, may not be heard
  • Due to
  • physical barriers
  • noise
  • disinterest
  • lack of concentration
  • tiredness
  • undeclared deafness
  • Boredom
  • What is heard, may not be understood
  • Due to
  • Lack of technical knowledge
  • Industry related vocabulary used
  • language / accent
  • basic education

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Listening
  • Active listening is very important for an
    auditor.
  • Active listening is a way of listening and
    responding to auditee to improve mutual
    understanding.
  • Half listening
  • Half thinking about something else
  • Do not listen with a conflict in mind as you will
    be busy formulating a response to what is being
    said and focus on how to win the argument.
  • Active listening is a structured way of listening
    and responding that focuses the attention on the
    auditee.

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An auditor should balance speaking and listening
feature as
Speaking Listening
20
80
110
Questioning Technique
  • Open ended questions
  • Questions which has descriptive answers detailed
  • information
  • on the subject matter
  • overall picture
  • huge amount of information
  • puts people at ease
  • to be used during
  • Interrogation
  • in beginning of the audit interview
  • to get more information on a certain subject

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  • Closed questions
  • Questions which has yes or no answers on the
    subject matter
  • Zoom-in
  • Clear answer (yes no dont know)
  • To be used
  • To check understanding
  • To get a clear answer
  • To stop communications hogs or evasive answers

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Observing
  • Auditor shall observe all details around during
    the audit.
  • Requires attention to detail combined with
    analytical skills
  • Body language
  • Mannerism
  • Deduction
  • Do not report these conclusions based on above
    observation unless substantiated by objective
    evidence.
  • But
  • Use them to reach objective evidence of
    compliance and / or non-compliance.

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Reporting
  • Audit report is the only deliverable of an
    auditor and audit report provide data to the top
    management for review and identify opportunities
    for improvement.
  • Make it as good combination of listening and
    writing.
  • Avoid giving an impression that you are more
    worried about writing than understanding and
    appreciating the implementation
  • Writing information based on facts is an
    important parameter of auditing technology.
  • Note all supporting information based on facts
  • Be concise but provide complete information. Do
    not sacrifice correctness, completeness or
    clarity for the sake of brevity.
  • Be right accurate information based on
    objective Evidence

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  • Functional responsibility
  • Audit investigation is planned based on each
    function and all the applicable processes for
    each function is audited
  • Advantages
  • shows overall understanding of the quality
    management system by department
  • covers several processes in one location
  • verifies system implementation
  • Disadvantages
  • requires experienced auditors
  • requires good notes

115
PLANING
  • Audit Planning
  • Description of the activities and arrangement for
    an audit,
  • PLANNING STAGES
  • Scope
  • The scope define the objective of the audit
  • The depth of the audit
  • E.g.
  • Audit of a company for design, manufacture and
    installation of boilers.
  • Audit of the activities of the QA/QC department
    against the applicable procedures that are part
    of the ISO 9000 quality management systems

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  • Requirements
  • Defines the audit criteria
  • Based on the scope of the audit
  • External Requirements
  • ISO- standard
  • Other standards
  • Laws and Regulations
  • Contract
  • Customer supplied documents / drawings
  • Product / Business sector code of conduct
  • Internal Requirements
  • Quality Manual (policy objectives)
  • Procedures
  • Work instructions (where appropriate)
  • Projects
  • Processes
  • Product

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  • Collect Department / Functional information
  • Organizational units
  • Different sites
  • Locations
  • Process complexity and importance of the process
  • Previous audit results and status
  • Audit duration No. of days for the audit.
  • Audit duration is based on
  • Size of the function
  • Complexity of the processes
  • Multiple locations
  • IAF Guidance ISO/IEC 17021

118
  • Document review
  • Review of QMS Documents for adequacy to the
    requirements and is the preliminary and important
    stage in the Audit Process.
  • A Typical review of documents include
  • Quality Manual
  • Documented Procedures
  • Policies and Objectives
  • Process definitions and interfaces
  • Resource provision
  • Compliance to ISO 90012008 standard with
    emphasis on allowable exclusions in section 7.0.
  • Document review maybe an off site audit and does
    not refer to the depth implementation.

119
A Typical documentation structure may include
120
  • QUALITY MANAGEMENT SYSTEM FORMAT
  • Documents may be in a
  • Hard copy / Soft copy
  • multi layer / single layer
  • corporate and departmental manuals / just one
    manual
  • The quality system is in the first place
    developed to suit the needs of the auditee.
  • The auditors should be more practical to adapt
    to various type of documentation.

121
QUALITY MANUAL
  • Generally includes
  • Quality policy
  • Quality objectives
  • Information on the organization
  • Information on the structure of the quality
    system
  • Scope of Quality Management System, including
    details of and justification for any exclusions
  • A description of the interaction between the
    processes of the quality management systems.
  • Address all requirements of the ISO 90012008.
  • CAN INCLUDE PROCEDURES OR MAKE REFERENCE TO
    PROCEDURES

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PROCEDURES
  • ISO REQUIRES DOCUMENTED PROCEDURES TO BE
    ESTABLISHED TO DEFINE CONTROLS FOR THE FOLLOWING
  • control of documents (4.2.3)
  • control of records (4.2.4)
  • internal audit (8.2.2)
  • control of non conforming product (8.3)
  • corrective action (8.5.2)
  • preventive action (8.5.3)
  • Auditors shall investigate the strategy and
    methods adopted in planning arrangements to
    achieve the Quality Objectives of product/
    project/contract and identify other documents
    within the QMS.

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Title Table of Contents Section A Page 1 of 1
Revision Nr. 0 Date of Effective Date of Effective
Approved by the General Manager Signature Signature
Section No. Section Title Revision No. Date of Effective
A Table of Contents 0 01.01.01
B Revision Record Sheet 0 01.01.01
C Introduction 0 01.01.01
D Quality Policy 0 01.01.01
E Quality Objectives 0 01.01.01
G Abbreviations 0 01.01.01
H Control of Documents 0 20.02.01
I Control of Records 0 20.02.01
J Internal Quality Audits 0 20.02.01
K Control of Nonconforming Product 0 20.02.01
L Corrective action 0 20.02.01
M Preventive Action 0 20.02.01
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Audit Programme
  • Agenda specifying Time, Auditor, Function that
    will be audited
  • Based on
  • Duration of the audit
  • Team size
  • Technical skills of the auditors
  • Results of the document review (desk top results)
  • previous audit plans
  • type of audit investigation (see chapter 8)
  • the status and importance of the activity being
    audited
  • Concurrence of the Auditee
  • More time for the larger more complex processes
  • Keep the audit programme realistic flexible
    (time for the unexpected)
  • Within company hours

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Team Selection
  • Audit team shall be competent to audit the
    product sector under consideration.
  • BASED ON
  • Department Size / extent of activities and
    locations of work
  • Product and services provided (technical audit
    skills needed)
  • Independence (nobody can audit their own
    department / activities / work
  • It may be kept in mind that the total duration
    of the audit may not exceed 5 days.

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  • Audit Notification
  • Formal Notification
  • Issued to the responsible manager
  • Notification should include
  • Scope and criteria of audit
  • Name(s) of auditor(s)
  • Schedule / agenda
  • Date and time of opening meeting
  • Support requirements (Site, accommodation,
    transportation etc.)
  • Any logistical information
  • Matrix of requirement
  • Audit Plan

127
Typical example of Audit Plan Matrix
  • Example 1

Day Dept. Ref. ISO Elements Lead Auditor Auditor Auditor
09.00 AM Opening meeting - ? ? ?
09.30 AM Plant Visit - ? ? ?
10.00 AM Management ? ? ?
11.00 AM Marketing ?
11.00 AM Purchasing ?
11.00 AM Quality Control ?
03.00 PM Training ?
03.00 PM Design ?
03.00 PM MR ?
128
Workshop 5 MATRIX OF REQUIREMENT
129
  • AUDIT MATRIX
  • You have been assigned to plan and lead an
    internal audit for the plant described below
    which has implemented a quality management system
    based on the ISO 9001-2008 standard.
  • You will be conducting a complete quality system
    audit to ensure that an ISO 9001-2008 quality
    system has been developed, implemented and
    maintained.
  • The plant has four major product lines, each
    involving fabrication and assembly of various
    components. It has a three-shift operation and
    500 employees total.
  • Two other trained internal auditors will
    participate in the audit with you.
  • Plan the audit matrix.

130
Checklist preparation
  • Purpose
  • Provides consistency and uniformity
  • Assures full coverage of the clauses to be
    audited
  • Reminds auditor of areas where nonconformities
    have been found during the previous audit
  • Supplements the auditors memory
  • Provides a basis to reconstruct the audit when
    stuck
  • Improves the auditors efficiency (timing)
  • Useful for training new auditors
  • Useful attachment to the audit report
  • Sources for the check list
  • Quality Management System documents like
  • Quality manual
  • documented procedures and defined processes
  • work instructions
  • Applicable contractual standards
  • contractual requirements
  • process/product regulations

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  • Type of Check List
  • list with key words
  • list with questions
  • Check List is
  • An integral part of audit report
  • Filled in by the auditor
  • Check List should be Flexible
  • Caution
  • Do not let the checklist take over you.
  • Check list should not restrict your questions.

132
  • Sample Check List 1
  • Key Words
  • evaluation of suppliers
  • record of validation of processes
  • purchasing information
  • validation of design
  • review of purchase information
  • report on damage / loss of customer property
  • procedure for internal audit
  • SAMPLE Check List 2
  • Are the subcontractor evaluated?
  • What are the criteria for subcontractors
    evaluation?
  • What type of control exercised over
    subcontractors?
  • Are the records of evaluation of subcontractors
    maintained?
  • Is there any verification arrangements at
    subcontractor works defined?

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AUDIT
  • Conducting the Audit
  • Phase Pre-Audit meeting
  • Participants Lead Auditors and auditors
  • Purpose
  • Initial understanding of the quality management
    systems and processes
  • Organization of audit team
  • Deciding on frequency of team reviews
  • Preparation of Check List
  • Contents
  • Audit scope
  • Overview of document review
  • Logistical arrangement
  • Explain audit plan
  • Define tasks of lead auditor auditors (for more
    then one member audit)
  • Review audit notification for scope and criteria
    for audit.

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  • Phase Opening Meeting
  • Participants Lead auditor / auditors, Auditee,
    Guides
  • Purpose
  • Explain the objective of the audit to the auditee
    management
  • Contents
  • Introduction
  • Audit scope
  • Explain auditing method including sampling
  • Define everybodys role
  • Audit schedule
  • Define type of Nonconformities
  • Basis of evaluating effectiveness of
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