QA Manual English version.PT.ISI

download QA Manual English version.PT.ISI

of 45

Transcript of QA Manual English version.PT.ISI

  • 7/27/2019 QA Manual English version.PT.ISI

    1/45

    1

    Quality Assurance Manual

    PT. INDOMOBIL SUZUKI INTERNATIONAL

  • 7/27/2019 QA Manual English version.PT.ISI

    2/45

    2

    Table of Content

    Introduction 3

    1. Quality Assurance Manager ... 8

    2. Preparation for Production . 10

    3. New Process / Process Change . 12

    4. Process Control standard 155. Inspection Standard 21

    6. Inspection Result Sheet .. 277. Operation Standard . 29

    8. Initial Parts Control 319. Initial Production Control ... 34

    10. Lot Control 3711. Disposition of Quality Problems .. 39

    12. Maintenance of Inspection Machinery and tools .. 4413. Quality Control Audit .. 46

    14. Quality Control Education 48

    15. Vendor Evaluation 49

  • 7/27/2019 QA Manual English version.PT.ISI

    3/45

    3

    Introduction

    This Manual is a summary of the fundamental requirements for Quality Assurance

    activities that PT. Indomobil Suzuki International ( PT. ISI ) expects its vendors tofulfill under the supply / purchase agreement.

    PT. ISI has prepared this manual to assist vendors in reaching a good understanding ofPT. ISIs basic policy and quality assurance activities. Vendors are required to deliver

    parts to PT. ISI in strict accordance with the PT. ISIs quality assurance requirements.

    To use this manual effectively, it is necessary that vendors understand PT. ISIs basic

    policy of Quality Assurance. Hereunder, you will find PT. ISIs basic qualityrequirements and definitions of terms which will help you carry out your quality

    control activities. Follow all items and quality control activities.

    1.

    Basic RequirementsThe parts to be delivered to PT. ISI must meet any of the following :

    1). The drawings, specifications, inspection standards, designated standards

    prepared and lent to vendors by PT. ISI or similar standards and data.

    2). The drawings, specifications or documents and other data prepared by vendors

    and approved by PT. ISI or similar documents and data.

    3). The officially specified standards such as JIS, JASO, and ISO which do not

    belong to the above items (1) and (2).

    2. Definition of Terms :

    1). A Parts .. those parts and components which are essential for the safeoperation of vehicles under normal use, and if defective,

    could result in incidents of personal injury or fatality bycausing loss of vehicle control or fire.

    2). A Items those quality features of A parts that, if defective, couldresult in incidents of personal injury or fatality by causing

    loss of vehicle control or fire.3). Functional Parts those parts and components of the engine and transmission

    that, if defective, could result in a reduction or total loss of

    vehicle motive power and performance.

    4). Functional Items those quality features of functional parts that, if defective,

    could result in a reduction or total loss of vehicle motive

    power and performance.

    5). General Parts . those parts and components not already designated as A

    Parts or Functional Parts.

    3. Quality Control Activities

    Vendors are required to promote Quality control activities in accordance with total

    flow of the Quality Assurance System between Vendors and PT. ISI .

  • 7/27/2019 QA Manual English version.PT.ISI

    4/45

    4

    4. Submission of DataIn order to promote quality control activities between vendors and PT. ISI, vendors

    are required to submit such data as requested in page 5, List of data to be

    submitted to PT. ISI. As to the details of each data, please refer to the text of thismanual.

  • 7/27/2019 QA Manual English version.PT.ISI

    5/45

    5

    List of Documents Required by PT. ISI

    No. Item

    A

    Part

    F

    Part

    G

    Part

    Submission

    Period Submitted to Remarks

    New o o o

    Within one

    month after

    purchase

    agreement

    Procurement

    Dept.

    1 Quality Assurance

    Manager

    Change o o o

    Within one

    month after

    change

    Procurement

    Dept

    New o o -

    Before trial

    mass

    production

    Inspection Div.

    Submit the

    original

    2 Process Control

    Standard Change o o -

    One week

    before delivery

    of parts

    Inspection Div.

    Submit the

    number of

    copiesrequested

    in the

    distribution

    column plus

    one copy

    for vendor.

    New o o o

    Before trial

    mass

    production

    Inspection Div.

    Submit the

    original

    3 Inspection Standard

    Change o o o

    One week

    before delivery

    of parts

    Inspection Div.

    Submit the

    original

    New o - -

    Before trial

    mass

    production

    Procurement

    4

    Application for

    Approval of New A

    Process / Process

    Change Change o - -

    One month

    before the

    desired date of

    change

    Procurement

    Div.

    5 Inspection Result

    sheet of Initial

    Products

    o o o On the delivery

    date designated

    by PT.ISI

    Designated

    delivery Place

    Attach to

    the

    products

    together

    with the

    Initial

    Production

    Part Tag

  • 7/27/2019 QA Manual English version.PT.ISI

    6/45

    6

    No. Item

    A

    Part

    F

    Part

    G

    Part

    Submission

    Period Submitted to Remarks

    6 Inspection Result

    Sheet

    o -

    By 10th

    of the

    following month

    Inspection Div.

    Report on

    the items

    specifie in

    Inspection

    Standard

    7 Investigation Report

    on Process

    Capability

    o o -

    By the date

    designated by

    Inspection Div.

    Inspection Div.

  • 7/27/2019 QA Manual English version.PT.ISI

    7/45

    7

  • 7/27/2019 QA Manual English version.PT.ISI

    8/45

    8

    1. Quality Assurance ManagerVendors should designate a staff that will be responsible for planning, implementing

    and monitoring the Quality Assurance Program as well as coordinating interdepartmental Quality activities.

    The following are the qualifications for the Quality Assurance Manager and his (her)assistant. His ( her ) name should be notified to PT. ISI in accordance with the

    following formalities :

    1. Qualification and Appointment of Quality Assurance Manager.

    1). QA Manager

    QA Manager is assigned responsibility and accountability concerning Quality

    Assurance by President of each vendors.

    2). Assistant to QA Manager

    The QA assistant Manager should be a person who can take the leadership in

    the area of Quality Assurance.

    2. Notification of the Name of QA Manager

    The attached form Notification of Appointment / Change of QA Manager should

    be filled in and submitted to PT. ISI Procurement Dept. within one month after

    signing of supply / purchase agreement. In case of any change in the Notificationdue to an organizational change or any other reasons, the form Notification of

    Appointment / Change of QA Manager shall be filled in and submitted to PT. ISIProcurement Dept.

    The form Notification of Appointment / Change of QA Manager is available fromPT. ISI Procurement Division.

    3. The form Notification of Appointment / Change of QA Manager shall be

    filled in as follows :

    1). Notification : New . Circle Appointment

    Change .. circle Change

    2). Vendor Name : Write the Vendors name, code number, and telephone

    number.

    3). Address : Write the address of vendors

    4). Business : Write the main line of business.

    5). Plant Site : Circle the name PT. ISIs Plant site to where the

    approved parts are delivered.

    6). Date of Appoint- : Write the date when the Quality Assurance Manager

    ment / Change is Appointed / Change.7). QA Manager : Write the title and name of a person who is responsible

    for QA. His signature is needed.8). Assistant : Write the title and name of a person who can assist

    Manager the QA Manager. His signature is needed.

  • 7/27/2019 QA Manual English version.PT.ISI

    9/45

    9

    PT. INDOMOBIL SUZUKI INTERNATIONAL Date : ..

    To : _______________________________

    Notification of Appointment / Change of Quality Assurance Manager

    Control No:

    Vendor Name

    Code :

    TEL :

    Fax :

    Email :

    Address

    Business

    Plant Site Plant TB I (2W), Plant TB II (4W), Plant CK (E/G)

    Date of Appointment / Change

    Title Name

    QA Program Implementation

    Staff ( Senior )

    Signature

    QA Program ImplementationStaff ( Junior )

    Signature

  • 7/27/2019 QA Manual English version.PT.ISI

    10/45

    10

    2. Preparation for ProductionIn order to achieve the required quality of products for mass production, the following

    are the Control points and methods to be carry out by vendors before production.

    1. Specification MeetingWhen the vendors receives an order for new parts from PT. ISI, a specification

    meeting shall be held between vendors and PT. ISI Inspection Div. The purpose of

    the meeting is to understanding the functions and features of such new parts prior to

    the production. The date of meeting shall be fixed between the vendor and PT. ISI

    Inspection Div. It is most important to make a careful study about the issues on the

    agenda prior to the meeting.

    1). Matters to be discussed at the meeting

    (1). Functions and features of the parts ( notes specified in the drawing,

    correlation with other parts, etc)(2). Manufacturing key points (accuracy, manufacturing method, etc )

    (3). Correct understanding of the manufacturing process and control points.

    (4). Indicating method and place of manufacturing Lot No.

    (5). Arrangement concerning Inspection(6). Schedule Adjustment

    2). Documents Required

    (1). Process Control Standard ( the brief outline of the process )(2). Application for Approval of New A Process / Process Change ( if a

    Subcontractor is used for A process ).(3). Proposal for drawings, molds, jigs, and equipments.

    (4). Preparation schedule of drawings, molds, jigs, and equipment.

    (5). Any other documents which are considered useful for the control of

    manufacturing process.

    2. Designing Process

    When a process is designed, attention must be paid to the following points to

    prevent defects from being produced.

    1). The accuracy of each part shall be carefully observed, and Process Capability

    must be secured so that required quality level of the parts can be achieved and

    maintained.

    2). Past records of defects of similar parts must be investigated so that Poka-yoke( fail-Proofing ) may be incorporated into every activity, from design through to

    actual mass Production. This mechanism will prevent defects from being

    produced or passed on to subsequent process operation.

    3). The flow of parts between the processes must be carefully inspected in order to

    prevent any foreign matter from getting mixed in the parts.

  • 7/27/2019 QA Manual English version.PT.ISI

    11/45

  • 7/27/2019 QA Manual English version.PT.ISI

    12/45

    12

    3. New Process / Process Change

    In the events that vendors make a new process / process change, the following

    applications shall be submitted to PT. ISI.

    1. Scope

    If any of following cases should apply to A parts, submit the Application for

    Approval of New A Process / Process Change to PT. ISI Procurement Dept.

    1). If some or all of the manufacturing process of the parts ordered by PT. ISI be

    subcontracted ( as a rule, A items of A parts are not allowed to be

    subcontracted ).

    2). If a subcontractor is changed.

    3). If the Manufacturing Plant is changed.

    4). If the Manufacturing Method is changed.

    Vendors can obtain a form Application for Approval of New A Process / Process

    Change from PT. ISI Procurement Dept.

    2. Time of Submission

    1). In case of New Process, an application shall be submitted to PT. ISI before Trial

    Production.

    2). In case of Process Change, an application shall be submitted to PT. ISI one

    month before the desired date of change.

    3. The form Application for Approval of New A Process / Process Change

    shall be filled in as follows :* Notification : New Process circle New

    Process Change . circle Change

    * Vendor Name : Write the name of vendor and code number* Plant Site : Circle the name of PT. ISIs Plant Site to where

    the approved parts are delivered.* Part Name : Write the Part Name as stated on the purchased order

    * Part No. : Write the Part No. as stated on the purchased order.* Subcontractor Name : ( only in case of New Process or Process Change made

    at the Subcontractor ).- Subcontractor Name : Write the name of subcontractor

    - Address : Write the address of subcontractor

    - Capital : Write the paid-up capital of the subcontractor.

    - No. of employees : Write the number of employees of the subcontractor.

    - Business : Write the main line of business of the subcontractor.

    - QA Manager : Write the name of QA Manager.

    * Process Allocation : Write either new process or process change clearly. If

    the work subcontracted, write the details of process

    allocation to be subcontracted.

    * Reason for New Pro- : Write the detailed reasons for New Process / Process

    cess/Process Change Change.

  • 7/27/2019 QA Manual English version.PT.ISI

    13/45

    13

    * Scheduled date of New : Write the scheduled date of New Process/Process

    Process/Process Change Change.

    4. Procedures to Change the ProcessThe following shows a flow from the submission of Application for Approval of

    New A Process / Process Change to the delivery of parts after the Process Change.

    Submission of Application

    Receipt by PT.ISI

    Revision and Submission of

    Process Control Standard

    Revision and Submission of

    Inspection Standard

    ( in case of revision )

    Approval by PT.ISI

    Inspection of Initial Products

    Delivery to PT.ISI

    * Initial Production Part Tag

    to be attached

    * Initial Product Inspection

    result sheet to be attached

    ( a copy will be returned to vendor

    after judgment )

    ( See No.4 Process Control Standard )

    ( See No.5 Inspection Standard )

    ( See No.8 Initial Product Control )

    ( See No.8 Initial Product Control )

  • 7/27/2019 QA Manual English version.PT.ISI

    14/45

    14

  • 7/27/2019 QA Manual English version.PT.ISI

    15/45

    15

    4. Process Control Standard

    For the purpose of thoroughly understanding the parts manufacturing process and the

    control points, this standard provides that vendors should develop and maintain aProcess Control Standard. In this Standards, control characteristics for each process areto be identified and documented. The Vendors are required to submit copies of the

    Process Control Standard to PT. ISI.

    1. ScopeThe Process Control Standard shall be prepared for all the parts ordered by PT. ISI

    including their components parts. However, among the component parts purchased

    by the vendors and the parts supplied by PT. ISI may be excluded from the Process

    Control Standard.

    2. Issuance and Revision

    To ensure proper issuance and revision of the Process Control Standard, vendorsare required to set up a clear system in the organization..

    3. SubmissionThe Process Control Standard for A Parts and Functional Parts shall be submitted

    to the PT. ISI Inspection Div. The Process Control Standard for General Parts shall

    be also submitted if so instructed by PT. ISI.

    Vendors are required to take the following procedures by the form, Process

    Control Standard Establishment and Revision Procedures .

    1). In case of newly designed parts, submit the original document to PT. ISI by the

    time of pilot run Production.

    2). In case of revision resulting from the design or process change, submit the

    document to PT. ISI in number of copies requested in the distribution columnplus one copy for the vendor by one week before the delivery of parts.

    In case of the Process Change of A Parts, notify PT. ISI in accordance with thesection 4 of A Process New issuance and change Notification.

    3). In case of other revision, submit the number of copies requested in the

    distribution column plus one copy for the vendor with the clear reason for

    revisions. When the Process Control Standard is revised for some reasons, the

    original document shall be submitted to PT. ISI.

    4. Acknowledgement of Receipt

    1). The original document of the Process Control Standard shall be carefully

    examined and signed by PT. ISI Inspection Division and it will be returned to

    the vendor.

  • 7/27/2019 QA Manual English version.PT.ISI

    16/45

    16

    2). In case the vendor submits to PT. ISI a copy of the Process Control Standard, it

    will be carefully examined by the PT. ISI Inspection Div. The vendor will

    receive one copy of this standard bearing the stamp for receipt.

    5. Method of Preparation

    1). Forms

    The Process Control Standard May be prepared in any style at the vendorsoption, subject to the following items being included. The vendor may use the

    Process Control Standard form provided by PT. ISI. Please contact the PT. ISIInspection Div.

    2). How to Fill in the form :

    * Vendor Name : Enter the name of vendor.* Plant site : Enter the name of PT. ISIs plant to where the approved

    parts are supplied.

    * Page : Enter the page number.* Date of issue : Enter the date of issue

    * Applicable model : Enter the name of model for which the parts are used.

    * Part No. : Enter the part No. as stated on PT. ISIs purchased order

    In case of set, assembly or Complete respective

    parts number shall be quoted.

    In case of essential components parts, their parts

    number shall be also quoted.

    In case of A Parts, mark suffix A . If the applicable

    parts are too many to be quoted in the column, a list of

    such applicable parts may be attached.

    * Part name : Enter the Part name as stated on PT. ISIs purchased

    order.* Part classification : Select the appropriate part from among A Part ;

    Functional Part and General Part.

    * Flowchart : To understand the total flow, prepare a flow chart withreference numbers in serial order starting from 1.

    * Process : Enter the name of each manufacturing process in orderand show clearly whether it is in-house manufacture or

    outsourcing. For the operation process applicable to

    item A , mark suffix A . For the operation process

    applicable to the Functional item, mark suffix F .

    * Subcontractor Name: In case of outsourcing, enter the name of subcontractor.

    * Name of facilities : Enter the name of facilities to be used for the process.

    * Control points : Enter the control points that are necessary to maintainthe quality in the process as well as the quality

    characteristic to be controlled.

    * Control standard : Enter the control level and allowable limits for the

    above control points in specific numerical value.

  • 7/27/2019 QA Manual English version.PT.ISI

    17/45

    17

    * Checking Methods : Enter the frequency of check and the time of check for

    control conditions. Also enter the number of samples,

    the frequency of check, and the time of check necessary

    for the check of quality characteristic.* Inspection equipment : Enter machines, inspection apparatuses, inspection

    methods necessary for checking each control item..

    * Data form : Enter the name of form and check sheet to be used forcontrolling each item.

    * Allotting duties : For each item, state rules for allotting duties ofchecking staff.

    * Related materials : Specify the standards and instructions required forcontrolling each process.

    * Reason for revision : Describe the reasons for revision in consecutive orderstarting from page 1 in accordance with the following :

    < Submission due to new preparation >Enter the reasons for submission in the last column

    This standard has been newly prepared by the reason

    of .. In case of design modification, state the

    design modification number, too.

    < Submission due to revision >

    Enter the reasons for revision ( Ex. Due to design

    modification number 000-0000 ) in the column of

    reasons for revision. Also state the date of revision in

    the designated column.

  • 7/27/2019 QA Manual English version.PT.ISI

    18/45

    18

    Issuing and Revising Procedures of Process Control Standard

    Vendor PT .ISI

    5. Inspection Standard

    To ensure conformance to the specified quality requirements by PT. ISI, vendor are

    required to established and maintain an Inspection Standard in which on going

    inspection characteristics, methods, equipments, number, frequency, etc, are designated.

    1. Scope

    The Inspection Standard shall be prepared for all the parts that are ordered by PT.

    ISI.

    2. Issuance and RevisionTo ensure proper issuance and revision of the Process Control Standard, vendors

    are required to set up a clear system in the organization..

    3. SubmissionThe Inspection Standard shall be documented on the form provided by PT. ISI. It is

    not necessary to include standard parts and some special standard parts for generaluse in the Inspection Standard. Submit the Inspection Standard to the PT. ISI

    Inspection Div. as follows :

    As for the procedures, refer to the attached Inspection standard Issuing and

    Revising Procedures.

    1). In case of Newly established parts, submit the original document to PT. ISI by

    the time of pilot run production.

    2). In case of Revisions from design or process change, submit the document to PT.

    ISI in the number of copies requested in the distribution column plus one copy

    for the vendor one week before the delivery of parts.

    3). In case of other revision, submit the number of copies requested in the

    distribution column plus one copy for the vendor with the clear reasons for

    revisions. When the Inspection Standard is revised for some reasons, theoriginal document shall be submit to PT. ISI. The Inspection Standard shall be

    submitted to each and every plant of PT. ISI, as and when necessary.

    4. Acknowledgement of Receipt1). The original document of the Inspection Standard shall be carefully examined

    and signed by PT. ISI Inspection Division and it will be returned to the vendors.

  • 7/27/2019 QA Manual English version.PT.ISI

    19/45

    19

    2). In case the vendor submits to PT. ISI a copy of the Inspection Standard, it will

    be carefully examined by the Inspection Division. The vendor will receive one

    copy of this Standard bearing the stamp for receipt.

    5. Method of Preparation

    1). FormThe Inspection Standard shall be documented on the form provided by PT. ISI.

    When attaching any rough drawing, the size of such drawing shall be A3 (29.7cm x 42.1 cm) at the largest. Both part number and part name shall be stated in

    the Inspection Standard.The specified form is available from PT. ISI Procurement Division.

    2). How to fill in the form :

    * Part classification : Encircle the appropriate part.

    * Vendor name : Enter the vendor name and its code number* Page : Enter the page number

    * Date : Enter the date of issue, revision or renewal

    * Part Name : Enter the part name as stated on PT. ISIs purchased

    order.

    * Part No. : Enter the Part No as stated on the purchased order

    In case of A Part, mark suffix A . If the applicable

    parts are too many to be filled in the column, the

    applicable parts list may be attached.

    * Reference Number : Enter the reference Number for the items of large group

    ( in the left column ) and for the items of small group

    ( in the right column ).

    - Large Group : 1. Appearance2. Dimensions3. Function and performance

    4. Endurance / Strength Test5. other, etc in serial number.

    - Small group : For each inspection item in the large group,

    allocate the serial number. As regards

    dimensions, circle the serial number so that

    cross reference sketch can be made between the

    dimension number and the drawing number.

    * Inspection items : Enter the characteristic or the name of operation which

    is the object of inspection. Each of A item andFunctional item shall be inspected.

    * Judgment criteria : Specify the criterion for inspection items so that right

    adjustment ( Pass or Fail ) may be made.

    * Inspection Method: Enter criteria, conditions, measuring, position, etc,

    necessary for performing the inspection.

  • 7/27/2019 QA Manual English version.PT.ISI

    20/45

    20

    * Inspection Equip. : Enter the meters, inspection apparatuses, etc, to be

    used for each checking item.

    * Delivery Inspection mode : Enter the Inspection frequency and the number

    of samples necessary for assuring the quality level ofparts to supplied to PT. ISI.

    * Inspection : Enter the classification of process to be inspected.

    Classification* Reason for revision : Describe the reasons for revision starting from page 1

    in accordance with the following :

    < Submission due to new preparation >

    Enter the reasons for submission in the column Thisstandard has been newly prepared by the reason of .

    In case of design modification, also state the design

    modification number.

    < Submission due to revision >

    Enter the reasons for revision ( Ex. Due to design

    modification number 000-0000 ) in the reasons for

    revision column. Also state the date of revision in the

    date revised.

  • 7/27/2019 QA Manual English version.PT.ISI

    21/45

    21

    Issuing and Revising Procedures of Vendors Inspection Standard

    Vendor PT .ISI

  • 7/27/2019 QA Manual English version.PT.ISI

    22/45

    22

    ( original )

    ( original )

    Pre aration of the ori inal lan

    Concept

    Examination

    Approval

    Copy

    Copy

    Distributionto Related

    Section

    Distributionto related

    Section

    Filling

    Revision of Original

    Examination

    Copy

    Copy

    Distribution toRelated Section

    Distribution to

    Related Section

    Approval

    Filling

    Approval

    Approval

    ( original )

    ( original )

    ( copy )

    ( original )

    ( copy )

  • 7/27/2019 QA Manual English version.PT.ISI

    23/45

    23

    6. Inspection Result Sheet

  • 7/27/2019 QA Manual English version.PT.ISI

    24/45

    24

    The Inspection result Sheet shall be submitted to PT. ISI periodically during the period

    of mass production, as follows :

    1. Submission of Inspection Result SheetIf the Indomobil Suzuki Inspection Standard ( ISIS P )bears the following rubber

    stamp, vendors shall submit their inspection results as follows :

    Vendors are required to submit some or all of the following data to PT. ISI inaccordance with the requirements specified in ISIS - P.

    1). Items marked A Every inspection record according to ISIS P2). Items marked F One record inspection per month

    3). Items marked X Inspection records and broken parts after the breaking test.

    Vendors are required to keep inspection data for each and every part so that its pastquality levels may be traceable in the method of series comparison.

    2. Time and Place of Submission of the Inspection Result Sheet1). Time : Before the 10th day of each month ).

    2). Place : PT. ISI Inspection Division to where the parts are delivered. If

    the same parts are delivered to more than one Plant, submit the

    Inspection Result to each Plant Inspection Division.

    3. Entry in the Inspection Result Sheet1). Form

    Any form can be used, but the following items must be included.

    2). Items to be included :

    * Vendor Name

    * Classification of Parts ( A Parts, Functional Parts or General Parts )* Inspection items* Judgment Criteria

    * Inspection Method* Inspection Result :

    In case of Total Inspection :Write the number of defects / number of part inspected.

    In case of Sampling Inspection :

    Measured values must be quoted instead of OK or

    NG if quality judgment is made by such values.

    * Judgment Result

    * Date of Inspection* Inspectors signature and QA Managers signature

    * Inspection Lot No.

    4. Filling of Inspection Records

  • 7/27/2019 QA Manual English version.PT.ISI

    25/45

    25

    Vendors are required to keep their inspection results for two years so that they may

    submit these records promptly when they are requested by PT. ISI.

    7. Operation Standard

  • 7/27/2019 QA Manual English version.PT.ISI

    26/45

    26

    In order to ensure the required quality of parts always without depending upon a

    specific skilled operator, vendor should establish an Operation Standard that documents

    process operation condition and inspection methods. The operation Standard should beposted in a conspicuous location so that the operators can verify that their workconforms with the Operation Standard.

    1. Scope

    An Operation Standard shall be prepared for each and every process of production.

    2. Issuance and RevisionsTo ensure proper issuance and revisions of the Operation Standard, vendor are

    required to set up a clear system in the organization. The supervision of each

    manufacturing section shall be responsible for the issuance and revision of the

    Operation Standard.

    3. Designing Method1). Form

    Any form can be used, but the items having an important effect on the quality of

    all process and at least 5 to 6 items of check points for the ease of observation

    by operators should be shown clearly by the picture and others.

    The Operation Standard of A Parts should have the mark A in the title

    column, and the manufacturing process of A items should be clearly framed

    red. The Operation Standard of Functional Parts should have a clear indication

    of Functional Parts in any place such as the upper part of the marginal space

    where it can be easily seen by operators.

    2). Items of the operation Standard

    * Operation Procedures : Write the working conditions, the order of work andworking points having important effects upon quality.

    * Matters to be attended : Write important matters and prohibitive mattersduring the work by showing some examples in the

    past.* Items for Quality : Write items such as quality checking, standard of

    checking judgment, checking frequency, etc.

    * Action for troubles : Write the scope and action for troubles, measures to

    be taken by operators, and the reporting system to

    their supervisors.

    * Record of Past Defects: Write the outline and causes of serious quality

    problems occurred in the manufacturing process. To

    prevent similar troubles in future, it is important for

    operators to refer to the past records.

    4. Important Points for Preparing Operation standard

  • 7/27/2019 QA Manual English version.PT.ISI

    27/45

    27

    The Operation Standard shall be used for making good products and not for

    inspecting the parts manufactured. So, it is important to take preventative measures

    against all kinds of causes creating troubles. These important points should be

    shown by pictures, charts, graphs, etc, instead of sentences so that operators mayunderstand their work clearly.

    5. Periodical CheckFactory supervisors must regularly check whether or not the operation standard is

    observed by operators. If there is any lack of observance on the part of operators, itis necessary to call such negligence to operators attention. At the same time, it is

    necessary to amend the operation standard if there is any unreasonable demandwhich does not suit the actual operation. The standard should not impose a heavy

    burden on operators.

    8. Initial Parts Control

  • 7/27/2019 QA Manual English version.PT.ISI

    28/45

    28

    In order to prevent problems arising from initial parts, this standard explain the special

    quality control procedures which shall be applicable to the initial parts, manufactured at

    the stages of trial production, trial mass production, after engineering changes andprocess modifications.

    1. Definitions of Initial Parts

    The Initial Parts mean any of the following first parts which are supplied to PT. ISI.

    These initial parts shall be subject to special control procedures.

    1). The Parts from the trial production and trial mass production.

    2). The first parts produced after changes in the engineering drawings.

    3). The first parts produced after changes in the manufacturing location and

    processes, such as,

    a). a new part

    b). a different manufacturing

    c). a modified process lay outd). a different condition or method for manufacturing, or

    e). a modified die, machine, jig, or tool

    2. Identification of Initial Production Part Tag and Inspection Result of Initial

    Parts.Initial Parts defined in the above item a) must be very clearly identified including a

    Initial Production Parts Tag and a Inspection result Sheets which are attached

    to each delivery box or container ( or parts themselves ). The Initial Production

    Part Tag is available from PT. ISI Procurements Division to where the parts are

    supplied.

    3. Initial Parts Inspection1). Inspection Items

    The Initial Parts shall be inspected and tested for conformance to qualityrequirements in the following manner :

    a). Certain events that occur in the vendors parts development process requireInitial Parts Inspection that is, parts inspection for all characteristics outlined

    in the drawings, Part Inspection Standard or otherwise identified by PT. ISI.This process is to be carried out at the stages of trial production, trial mass

    production and for new parts.

    b). For changes in Engineering drawings, part inspection standards or the

    manufacturing processes, all initial parts need only be inspected for those

    characteristics affected by the changes.

    c). For the renewal of dies and jigs, the parts shall be inspected for those

    affected by the dies and jigs.

    2). Part Inspection data sheet

  • 7/27/2019 QA Manual English version.PT.ISI

    29/45

    29

    Vendors shall submit their inspection results in any appropriate form which

    should state the following items :

    * Model

    * Part No.* Part Name

    * Category of Initial Parts ( In case of design modification, the design

    modification number should be quoted )* Process ( Temporary process or regular process )

    * Date inspected and name of inspector* Inspection Items

    * Judgment Criteria ( in case of dimension, the measurement criteria should bespecified )

    * Results of measurement* Judgment

    3). Number of samples for InspectionIn principle, the number of sample for inspection shall be five. For breakdown

    test, at least one and for casting parts at least one per die ). If the quantity less

    than five (5), all the samples shall be inspected.

    4). In case of the failure in the initial inspection by PT. ISI :

    If the initial parts fail to pass the initial inspection, PT. ISI Inspection Division

    will issue an Inspection result sheet to be sent to the Vendors showing the

    defects. Such parts rejected by PT. ISI shall be handled as Initial Parts until

    they pass the Inspection. Therefore, all the initial parts must be delivered to PT.

    ISI together with Initial Production Part Tag and Initial Part Inspection Result

    Sheet.

    5). Retention of Inspection RecordsAll the original documents of inspection records shall be kept for two years and

    be ready for prompt submission to PT. ISI upon request.

  • 7/27/2019 QA Manual English version.PT.ISI

    30/45

    30

    9. Initial Production Control

    The initial production control must be carried out at a time of starting Mass Productionas follows :

    1. Definition of Initial Production Control

    The Initial Production control means such special control as required at a time of

    starting mass production to judge the appropriateness of the manufacturing process.

    2. Establishment of Initial Production Control System

    Vendors are required to establish their initial production control system which

    specifies the initial production control items and the control period. The following

    is an example of the initial production control :

    1). Initial Production Control Items

    * Lot Control

    * Investigation of Process Capability ( important checking items ; checking

    method ; and checking frequency to be determined and carried out ).

    * Removal of problems and improvement* Verification of effectiveness of measures against the problems which occurred

    during the trial production.* Inspecting methods during the Initial Production Period ( more strict standard

    than the standard for the process control shall be adopted), etc.

    2). Initial Production PeriodThe period shall be fixed as three (3) month. But this period may be not needed

    depending on the characteristic of design changes or process changes.

    3). Abolition of Initial Production Control

    Upon the expiry of the initial production period, the initial production control

    may be abolished if any of the following conditions is satisfied.

    * The process capability could meet all the standard

    * The measures against the problems during the trial production are considered

    effective.

    * The measures have been taken effectively against the problems during the

    initial production period.

    3. Report of process capability investigation result

    If process capability investigation is requested by the Inspection Division of PT. ISIat the specification meeting, the vendor shall submit a report to PT. ISI as follows :

    1). PT. ISIs instructions :* Quality feature which require investigation of process capability.

  • 7/27/2019 QA Manual English version.PT.ISI

    31/45

    31

    * Sampling method ( number of samples, sampling frequency, etc. )

    * Period, etc.

    2). Investigation of process capabilityProcess capability must be investigated according to PT. ISIs instructions.

    Vendors are required to submit their results in the form provided by PT. ISI,

    Process Capability Investigation Report to the PT. ISI Inspection Division.

  • 7/27/2019 QA Manual English version.PT.ISI

    32/45

    32

    10. Lot Control

    To facilitate trace-ability of parts and components that may be discovered to bedefective at the vendors location, at PT. ISI, or in the market place, vendors are

    required to establish a lot control system. This allow PT. ISI to gain quick access to thehistory of all parts and components. Rapid identification and solution of problems will

    minimize losses and costs related to these defects.

    1. Format of Lot Identification on the Parts

    For A Parts and Functional Parts, as a rule, the date of manufacture ( including lot

    number ) must be recorded on the parts. Such lot identification must be easily

    recognized even after the parts are assembled to the vehicle. The format of lot

    identification system must be approved by PT. ISI Inspection Division or Design

    Department well in advance for production.

    2. Concept of Lot

    A lot means a group of part produced from the first setting of working condition to

    the next setting of work conditions. In case of continuous production, a lot means a

    group of parts produced per day.

    3. Production RecordsThe following items must be recorded for each Lot No.

    * Lot size ( the number of parts produced )* Working conditions

    * Inspection results* Delivery records to PT. ISI

    Those parts without batch no. shall be controlled by the date of delivery to PT. ISI

    and the manufacturing history including the date of manufacture.

    4. First In ; First Out ( FIFO )In order to make the lot identification system meaningful, it is important to

    implement First In ; First Out delivery. Careful attention shall be paid to the

    following points :

    * Be careful not to skip over any process while moving Parts in Process.

    * Defective parts shall be repaired promptly so that they may continue to travel

    through the production and delivery process with the same lot in which there

    where originally produced. It is extremely important not to mix these repairedparts with another lot.

    * Parts from different production lots may not be mixed in the same container orpallet. Each container ( pallet ) shall accommodate the parts of the same

    production lot.

  • 7/27/2019 QA Manual English version.PT.ISI

    33/45

    33

    5. Identification of PartsTo eliminate any unidentified parts throughout the manufacturing process, parts

    shall be identified as follows :

    * Identification of defective partsTo be distinguished from other good parts by red/yellow paint, or red/yellow

    indelible ink or by a tag ( NG ).

    * Identification of Inspection records

    Inspected lots shall be distinguished from Non Inspected lots, andAccepted lots shall be distinguished from rejected lots. Each lot shall be

    identified at a glance.

    * Identification of materials and PartsTo prevent a mixture of similar materials and parts, each container ( pallet ) shall

    show part no; part name; manufacturing date; and delivery date.

  • 7/27/2019 QA Manual English version.PT.ISI

    34/45

    34

    11. Disposition of Quality Problems

    Vendors shall establish a system for resolving problems discovered at the vendorslocation, PT. ISI, or in the marketplace in a prompt and proper manner.

    1. Defective Parts discovered at PT. ISI

    When discovered parts are discovered at PT. ISI, and deemed to be the

    responsibility of the vendor, PT. ISI will request that the vendor resolve the

    problem. Vendor must take appropriate corrective action to prevent recurrence an

    submit the Problems Analysis and Countermeasure Sheet in the form provided

    by PT. ISI inspection division.

    1). Disposition of Products in process ( Temporary Action )In the event that any particular lot should contain some defective products, such

    lot must be promptly identified and isolated from others lot. This may involved

    sorting or rework of the parts, whether or not they have been assembled onto

    vehicle. Vendors are required to try every possible means so that any suspectparts may not be used for vehicles, KD Parts or spare parts.

    In the event that any suspect lot has been shipped to PT. ISI, the vendor is

    requested to notify PT. ISI in order to receive instructions. The vendor shouldtake corrective action in accordance with the instructions from PT. ISI

    inspection division or Quality Assurance division. At the same time, the vendorshould notify the process operators in order to stop producing defective parts at

    once.

    2). Investigation of Causes of Defective Parts

    To discover the causes of the quality problems, Investigation in the following

    areas shall be made at once :

    * Defective Parts

    * Manufacturing processes

    * Standards* Engineering drawings

    * 4 M ( Man, Machine, Methods, Material )

    * Records of defective products or defective lot

    * Prospect of occurrence of quality problems in the marketplace

    3). Basic countermeasures ( Corrective action to prevent recurrence )

    As a result of the above-mentioned investigations, the vendor is requested to

    take countermeasures to prevent similar occurrence of defects in the future.

    When it comes to taking the countermeasures, the following points must be

    taken into consideration :

  • 7/27/2019 QA Manual English version.PT.ISI

    35/45

    35

    * In addition to quality control education / training program, vendors should

    take an appropriate action to improve the control method and to revise the

    relative standards.

    * Every vendor is requested to review its processes and equipment to makecontinuous efforts to develop Poka-yoke ( Fail-Proofing ) as is commonly

    said, to consistently achieve PT. ISI quality requirements.

    * It is necessary to check if there is any fear of similar occurrence of qualityproblems among similar parts in similar processes. Preventative action shall

    be taken to prevent recurrence of problems.

    4). Checking the effect of countermeasuresAfter the implementation of countermeasures, it is necessary to check the effect

    of such countermeasures by the reproduction test of defective parts.

    5). Submission of Problem Analysis and Countermeasure Sheet

    Vendors is requested to submit this document to the PT. ISI Inspection Divisionby the designated date of submission. ( If it cannot be submitted by the

    designated date because of the delay in finding the causes of problems or in

    taking corrective action, vendors has to request PT. ISI to change the date of

    submission ). If the document is not satisfactory to PT. ISI , the vendors may be

    requested to resubmit it to PT. ISI.

  • 7/27/2019 QA Manual English version.PT.ISI

    36/45

    36

    PT. ISI Vendor

    2. Defective Parts Discovered at the Vendors

    When defective parts are discovered at the vendors location, the vendors must take

    prompt action in accordance with the same procedures as describe in the paragraph

    1 ( one ). The following action must be taken by the vendors :

    Receipt of Problem Analysisand Countermeasure Sheet

    Issuance of Problem Analysisand Countermeasure Sheet

    Submission of Problem Analysis

    and Countermeasure Sheet

    Disposition of Products in

    Process (Temporary Action)

    Acceptance of Problem Analysis

    and Countermeasure Sheet

    Investigation of causes of

    occurrence

    Signature of Quality

    Assurance Manager

    Basic Measures (CorrectiveAction to Prevent Recurrence )

    Checking of effect of

    Measures

    Report of Problem Analysis

    and Countermeasure Sheet

  • 7/27/2019 QA Manual English version.PT.ISI

    37/45

    37

    * If suspect parts have been shipped to PT. ISI, the vendor is requested to notify PT.

    ISI inspection division in order to receive instructions.

    * As to the defective parts, the vendors must record in one sheet of form, if possible,

    all the details such as nature of defect, background of occurrence, disposition,causes, corrective measures, etc.

    * The vendors shall establish a system for resolving quality problems.

    * When heat treated parts are heat-treated again, vendors shall submit the part andtheir heat treatment records to PT. ISI inspection division for approval.

    3. Application for Special Limited or Provisional Acceptance

    When a vendor produces a quantity of non-conformance parts that can be usedwithout adversely affecting appearance, performance, durability, assembly, etc., a

    limited quantity of such parts may be accepted. However, these parts will notconsidered for acceptance unless the vendor has submitted the necessary application

    to the PT. ISI procurement division prior to shipment.

    * This case shall be applicable only when shipping schedules are delayed

    considerably by the discovery of defective parts, causing PT. ISI to lose heavily

    by the delay in production. Besides, the provisional acceptance of defective parts

    shall not affect adversely assembly, function, performance, service warranty,

    regulations or standards. The application form ( at the vendors option ) must

    show the nature of defects, the number of defective parts, causes of problems,

    shipment date, etc. The parts must be submitted together with the application.

  • 7/27/2019 QA Manual English version.PT.ISI

    38/45

    38

    12. Maintenance of Inspection Machinery and Tools

    In order to ensure that their products meet all of PT. ISIs quality requirements, vendorhave all the necessary inspection machinery and tools at their disposal. Vendors are

    required to maintain and record the accuracy of all inspection machinery and tools.

    1. Periodic Inspection of Accuracy

    The following instruments must be inspected periodically.

    1). Measuring Instruments :

    Dial gauge, Micrometer, Slide Caliper, Cylinder Gauge, Torque Wrench, etc.

    2). Gauges :

    Snap Gauges, Plug Gauges, Width Gauge, Ring Gauge, etc.

    3). Machine and Instruments :

    Tension / Compression Tester, Roughness gauge, Hardness Tester, SpringTester, etc.

    2. Vendors are expected to identify selected check items for inspection machinery

    and tools that are to be verified on a frequent basis ( daily, prior to use, etc ). This

    is to ensure proper calibration prior to inspection or testing.

    The following table is an example of inspection frequency :

    Inspection instruments When used in themanufacturing section

    When used in theInspection section

    Measuring instruments Once / 6 month Once / 12 month

    Gauge Once / 1 months Once / 6 month

    Machinery Once / 12 months Once / 12 months

    3. Preparation of Inspection Standard

    Vendors are required to prepare acontrol standard in order to specify check items,

    judgment criteria, inspection frequency, etc. This is to ensure proper calibration

    prior to inspection or testing.

    4. Indication of the term of validityAs to inspection instruments that have passed the accuracy testing, it is necessary to

    specify the term of validity by a label or colors.

    5. Accuracy test of Master Instrument

  • 7/27/2019 QA Manual English version.PT.ISI

    39/45

    39

    It is essential that vendor shall check accuracy of each and every master instrument

    at least once a year

    6. Registration of Inspection InstrumentsInspection instrument should be registered in the Machinery Control List quoting

    the name of instrument, model, manufacturer, date of acquisition, place of

    installation, place of use, name of operator , control number, etc.

    7. Annual schedule of Periodic InspectionTo avoid any omission of inspection for products, vendors are required to make an

    annual schedule for periodic inspection.

    8. Retention of Inspection RecordsCalibration procedures are to be well-documented, and the periodic accuracy

    inspection results shall be kept for one year by vendors or independent laboratories.

  • 7/27/2019 QA Manual English version.PT.ISI

    40/45

    40

    13. Quality Control Audit

    In order to maintain and improve the vendors manufacturing facilities and Quality

    Assurance system, the vendor audit shall be conducted periodically by the PT. ISI

    Quality Assurance Division. On the other hand, each vendor shall be responsible for

    conducting the proper implementation of quality audit in their own company and at

    their contractors.

    1. Audit by PT. ISI

    1). Type

    A. Periodic audit* This audit shall be conducted according to an annual schedule on the basis

    of result of vendor ranking.( As for the ranking, refer to 15. Vendor Evaluation )

    B. Temporary audit* This audit shall be conducted as and when necessary at PT. ISIs judgment

    in the following events :

    a. In the event that market claims and defects attributable to vendorsabnormal quality problems are discovered at the marketplace.

    b. In the event that the manufacturing process for parts has beenchanged.

    c. In the event that quality problems are discovered at PT. ISI plant inthe prototype stage ( production prototype or pilot run ).

    d. In the event that PT. ISI has ordered new parts whose mechanisms orthe method of manufacture are different from those of conventional

    parts.

    2). Submission of corrective action program

    In compliance with the instructions resulting from the above audit by PT. ISI,

    vendors are required to submit a corrective action program to PT. ISI Quality

    Assurance Division.

    1. Voluntary Audit

    1). Type

    * Executive Audit : Audit by President or Executive.

    * Plant Manager Audit : Audit by Plant Manager

    * QA General Manager Audit : Audit by Quality Assurance Manager

  • 7/27/2019 QA Manual English version.PT.ISI

    41/45

    41

    * Subcontractor Audit : Each vendor shall be responsible for ensuring

    the proper implementation of quality audit at their

    subcontractors.

    2). Standardization of Quality Audit SystemIn order to implement a quality audit system periodically, it is necessary to

    standardize the audit system specifying the number of audit, frequency, time of

    audit, methods, etc.

    3). Purpose of Audit

    The audit will be performed for the purpose of evaluating and improving, if

    necessary, the vendors manufacturing facilities and quality assurance system,

    with an emphasis on the completeness and effectiveness of :

    * the total quality assurance system

    * In-process quality control performance

    * the part inspection system, and* corrective action plan to prevent recurrence of quality problems

    4). Annual Audit Schedule

    Vendors are required to conduct an audit according to their annual audit

    schedule for each fiscal year.

    5). Retention of Audit Results

    The results of audit shall be retained so that vendors may investigate the process

    which has produced the defects. It is most important for the audit section to

    follow up the problems and to ensure the proper implementation of corrective

    measures.

  • 7/27/2019 QA Manual English version.PT.ISI

    42/45

    42

    14. Quality Control Education

    The success of a quality assurance program depends ultimately on the people involved.

    Vendors must consider the people factors of their quality assurance program and take

    the appropriate action to maximize the effectiveness of their human resources. It is

    essential that vendors develop and implement a training program throughout the

    organization. In order to maintain and improve the quality, vendors must promote

    quality control activities by giving their employees the following education :

    1. Quality Control Education or training Program

    Education and training program must be given regularly to those who are engaged

    in quality control. Their knowledge and skills necessary for the quality controlshall be acquired through the self-development and mutual enlightenment. The

    quality control education should be directed at different functions and levels. Some

    examples are :

    * Education for beginners

    * Education for operators

    * Education for supervisors

    * Education for inspectors

    PT. ISI recommends that these courses be conducted by staff inside the company

    and also taken through independent instruction from outside the company, as

    necessary.

    2. Promotion of Quality Control Education

    It is essential to establish quality control education promotion section in their owncompany. This section must make and implement an annual quality control

    program.

  • 7/27/2019 QA Manual English version.PT.ISI

    43/45

    43

    15. Vendor Evaluation

    PT. ISI will evaluate Vendor Quality performance as follows :

    1. Vendor Evaluation

    PT. ISIs intention is to evaluate vendor quality performance once a year. The

    evaluation will be based on two elements :

    * The frequency and seriousness of quality problems caused by the vendor.

    * An on-site audit of the manufacturing facilities and Quality Assurance Program.

    PT. ISI will assign the vendor a ranking of A through E, with A being the

    highest mark.

    2. Formula of evaluation points

    The evaluation points will be determined by the following formula :

    Evaluation points = 100 ( total of quality problems points for one year) x 0.7 +( average of vendor audit points for one year ) x 0.3

    * Quality problems points Evaluation points will be given to vendor when Problem Analysis and Countermeasure Sheet

    and/or Claim Application Form are issued( including disadvantage points which will be given

    defective parts are discovered at PT. ISI plant ).

    * Vendor Audit points. Evaluation points will be given to vendor when thevendor audit is conducted periodically by PT. ISI

    and also at a time of opening an account.

    N.B If the vendor audit has not yet been completed, the evaluation points shall

    be given as follows :

    Evaluation ranking 90 points

    3. Ranking of VendorsAs a result of the evaluation, Suzuki will assign the vendor a ranking of A through

    E according to the numerical evaluation points as follows :

  • 7/27/2019 QA Manual English version.PT.ISI

    44/45

    44

    Rank Ranking CriteriaA 91 ~ 100

    B 71 ~ 90

    C 51 ~ 70

    D 31 ~ 50

    E < 50

    4. Application of ranking

    As a result of the ranking, PT. ISI will determine the frequency of vendor audits forthe following year. In principle, the vendor audit shall be conducted periodically inaccordance with the following table :

    Rank Vendor who supplies A Parts

    Or Functional Parts

    Vendor who supplies General Parts

    A 1 time / 24 month 1 time / 48 month

    B 1 time / 12 month 1 time / 12 month

    C 1 time / 6 month 1 time / 6 month

    D 1 time / 4 month 1 time / 4 month

    E 1 time / 3 month 1 time / 3 month

  • 7/27/2019 QA Manual English version.PT.ISI

    45/45

    QUALITY ASSURANCE MANUALJune 1999

    PT. INDOMOBIL SUZUKI INTERNATIONAL

    1. Plant Tambun I (2W) Telp. (021) 880 1235, 880 1251 Fax. (021) 880 1297

    2. Plant Tambun II (4W) Telp. (021) 880 1235, 880 1251 Fax. (021) 880 7401, 8828479

    3. Plant Cakung Telp. (021) 460 9214, 460 9215 Fax (021) 4609216

    Establised : Juni 1999

    1st

    Revised : December 2003

    2

    nd

    Revised : February 2004

    PT. INDOMOBIL SUZUKI INTERNATIONAL