TS interpretation as per HSR1

8/7/2019 TS interpretation as per HSR1

1/134

1.01.0 -- ScopeScope

Organisation shall establish the scope as per theOrganisation shall establish the scope as per theorganizational requirements and Processes involvedorganizational requirements and Processes involved


2/134

2.02.0 Normative ReferenceNormative Reference

For ISO/TS 16949:2009,the reference standard usedFor ISO/TS 16949:2009,the reference standard usedISO 9000:2005, QMS Fundamentals andISO 9000:2005, QMS Fundamentals andVocabularyVocabulary


3/134

3.03.0 Terms and Defination,Terms and Defination,3.13.1--Terms and Defination related to Automotive IndustryTerms and Defination related to Automotive Industry


4/134

4.04.0 Quality Management SystemQuality Management System4.14.1-- QMS requirementsQMS requirements --GeneralGeneral

Determine and Establish process needed for QMS.Determine and Establish process needed for QMS.

Determine the interaction between these process.Determine the interaction between these process.

Establish the control methods required for these process.Establish the control methods required for these process.

Monitor the established controls are efficient and EffectiveMonitor the established controls are efficient and Effective

Take necessary actions if the planned results are not achieved.Take necessary actions if the planned results are not achieved.

Any outsourced processes shall be included in the perview of organizational QMSAny outsourced processes shall be included in the perview of organizational QMS


5/134

4.1.14.1.1-- QMS requirementsQMS requirements --SupplementalSupplemental

Organisation shall own the consequences arising out of outsourcing process.Organisation shall own the consequences arising out of outsourcing process.(i.e. shall not obselve from the responsibility related to outsourced process)(i.e. shall not obselve from the responsibility related to outsourced process)


6/134

4.24.2-- Documentation requirementsDocumentation requirements4.2.14.2.1 Documentation requirementsDocumentation requirements -- GeneralGeneral

Establish Documented statements of Quality Policy and Objectives.Establish Documented statements of Quality Policy and Objectives.

Establish a Quality Manual.Establish a Quality Manual.

Establish Documented procedures needed by this International Standards.Establish Documented procedures needed by this International Standards.

( I,e for Control of documents, Control of records , Internal Audits , CA ,( I,e for Control of documents, Control of records , Internal Audits , CA ,PA , Control of NC product and Training )PA , Control of NC product and Training )

Establish the Documents and records needed by the organization for theEstablish the Documents and records needed by the organization for theeffective planning, operations and control of its processes.effective planning, operations and control of its processes.


7/134

4.2.24.2.2 Quality ManualQuality Manual

a)a) Quality Manual Shall includeQuality Manual Shall include

a) Scope, including the justification for any exclusions.a) Scope, including the justification for any exclusions.

b) Documented procedures established for QMS or references tob) Documented procedures established for QMS or references tothemthem

c) Sequence and interaction of the process established orc) Sequence and interaction of the process established orreferences to them.references to them.


8/134

4.2.34.2.3 Control of DocumentsControl of Documents

The requirements of this clause are,The requirements of this clause are,

Establish a documented procedure for control of documents.Establish a documented procedure for control of documents.This shall includeThis shall include

1.Review,Approval and re1.Review,Approval and re--approval of documentsapproval of documents

2.Latest Version of Documents are available at the work area.2.Latest Version of Documents are available at the work area.

3.Identify and the externally originated documents.3.Identify and the externally originated documents.

4.Control the distribution of these documents.4.Control the distribution of these documents.

5.Obselete the old documents and keep the latest revisions at the5.Obselete the old documents and keep the latest revisions at thepoint of use.point of use.


9/134

4.2.3.14.2.3.1 Engineering SpecificationsEngineering SpecificationsThe requirements of this clause are,The requirements of this clause are,

Contents in the updated Customer drawings /specificationsContents in the updated Customer drawings /specificationsreceived from the customer, shall be reviewed, Distributed withinreceived from the customer, shall be reviewed, Distributed withintwo working weeks.two working weeks.

Relevant personnel involved in control of customer property shallRelevant personnel involved in control of customer property shall

be made aware of the changes .be made aware of the changes .

The date of change implementation in production shall beThe date of change implementation in production shall berecorded.recorded.


10/134

4.2.44.2.4 Control of RecordsControl of Records

The requirements of this clause areThe requirements of this clause are

The organization shall establish a documented procedure forThe organization shall establish a documented procedure forcontrol of records.control of records.

Records shall be Legible, Readily available, identifiable, properlyRecords shall be Legible, Readily available, identifiable, properlystored, Retention period inline with customer specific requirements.stored, Retention period inline with customer specific requirements.


11/134

4.2.4.14.2.4.1 Records retentionRecords retention


Records retention shall be in line with Statutory and regulatoryRecords retention shall be in line with Statutory and regulatory

requirements and Customer Specific requirements.requirements and Customer Specific requirements.


12/134

5.0 Management Responsibility5.0 Management Responsibility5.1 Management Commitment5.1 Management Commitment


Top Management shall be commitment towardsTop Management shall be commitment towards

To establish the Quality Policy .To establish the Quality Policy .

Quality Objectives are established at relevant levels and functionsQuality Objectives are established at relevant levels and functionsand reviewed on periodical basis.and reviewed on periodical basis.

Conducting Management reviews at periodical intervals.Conducting Management reviews at periodical intervals.

Committed towards satisfying the applicable statutory ,regulatoryCommitted towards satisfying the applicable statutory ,regulatoryand customer specific requirements to enhance customerand customer specific requirements to enhance customersatisfaction.satisfaction.


13/134

5.1.15.1.1 Process EfficiencyProcess Efficiency

The requirements of this clause are ,The requirements of this clause are ,

Top Management shall review the organization's ManufacturingTop Management shall review the organization's Manufacturingand other process to check its effectiveness and Efficiency.and other process to check its effectiveness and Efficiency.


14/134

5.25.2 Customer FocusCustomer Focus


Top Management shall ensure that customer specific requirementsTop Management shall ensure that customer specific requirementsare determined and identified with an aim of enhancing theare determined and identified with an aim of enhancing the

customer requirementscustomer requirements..


15/134

5.35.3 Quality PolicyQuality PolicyManagement shall establish a documented quality policy which shouldManagement shall establish a documented quality policy which should

include the following.include the following.

Shall be inline with processes and activities carried out by theShall be inline with processes and activities carried out by theorganizationorganization

Commitment towards continual improvement.Commitment towards continual improvement.

Commitment towards improving the effectiveness of QMS.Commitment towards improving the effectiveness of QMS.

Shall provide a framework for establishing and reviewing theShall provide a framework for establishing and reviewing the

quality objectives .quality objectives .

Shall be understood and communicated within the organization.Shall be understood and communicated within the organization.


16/134

5.45.4 PlanningPlanning5.4.15.4.1-- Quality ObjectivesQuality Objectives


Top Management shall establish quality objectives in line withTop Management shall establish quality objectives in line withestablished quality policy , at relevant levels /Functions in theestablished quality policy , at relevant levels /Functions in the

organization to meet the product requirements as well asorganization to meet the product requirements as well asrequirements as per the planned arrangements.requirements as per the planned arrangements.

Quality objectives shall be SMART.Quality objectives shall be SMART.


17/134

5.45.4 PlanningPlanning5.4.1.15.4.1.1-- Quality ObjectivesQuality Objectives --SupplementalSupplemental

Quality Objectives shall be included an essential part of Business Plan.Quality Objectives shall be included an essential part of Business Plan.


18/134

5.55.5 Responsibility, Authority and CommunicationResponsibility, Authority and Communication5.5.15.5.1-- Responsibility and AuthorityResponsibility and Authority


Responsibility and Authority matrix to be established for eachResponsibility and Authority matrix to be established for eachpersonnel in the organization and shall be communicatedpersonnel in the organization and shall be communicated

adequately.adequately.


19/134


20/134

5.5.25.5.2 Management RepresentativeManagement Representative

Organization shall appoint a member from the management group asOrganization shall appoint a member from the management group asMR.MR.His primary responsibilities as a MR shall include other than hisHis primary responsibilities as a MR shall include other than hisregular workregular work

To ensure that all processes required for QMS are established.To ensure that all processes required for QMS are established.

Reporting to the top management on effective performance of QMSReporting to the top management on effective performance of QMSand recommends need for any changes to QMS.and recommends need for any changes to QMS.

Shall create an awareness regarding Customer specific requirementsShall create an awareness regarding Customer specific requirementsto enhance customer satisfaction.to enhance customer satisfaction.

Also a part of MRs responsibility shall be liaison with externalAlso a part of MRs responsibility shall be liaison with externalparties like ( certifying body) related to QMS .parties like ( certifying body) related to QMS .


21/134

5.5.2.15.5.2.1 Customer RepresentativeCustomer Representative

Organization shall appoint/designate a personnel from theOrganization shall appoint/designate a personnel from themanagement group as CR.management group as CR.His primary responsibilities as a CR shall include other than hisHis primary responsibilities as a CR shall include other than hisregular workregular worka) Identification of Special characteristics at the time of NPD.a) Identification of Special characteristics at the time of NPD.

b) Establishing the Quality Objectives at the time of NPDb) Establishing the Quality Objectives at the time of NPD

c) Shall be a part of MDA,for initiating Corrective and preventivec) Shall be a part of MDA,for initiating Corrective and preventive

actions .actions .


22/134

5.5.35.5.3 Internal CommunicationInternal Communication

Organisation shall establish a communication process in orderOrganisation shall establish a communication process in orderimprove the effectiveness of QMSimprove the effectiveness of QMS

Communication methods shall includeCommunication methods shall include

EmailEmail

Notice BoardsNotice Boards

Communication CornersCommunication Corners

Review MeetingsReview Meetings

Traininings etcTraininings etc


23/134

5.6 Management Review5.6 Management Review5.6.15.6.1-- Review GeneralReview General

Organization shall conduct Management reviews at plannedOrganization shall conduct Management reviews at plannedintervals to ensure whether QMS is adequate, effective ,intervals to ensure whether QMS is adequate, effective ,continuity,continuity,This MRM shall also includes assessment for Opportunities forThis MRM shall also includes assessment for Opportunities forimprovement , Any changes to QMS integrity.improvement , Any changes to QMS integrity.


24/134

5.6.1.15.6.1.1--QMS PerformanceQMS Performance

a)a) These MRMs shall also includesThese MRMs shall also includes

a) Evaluation of Cost of Poor Quality.a) Evaluation of Cost of Poor Quality.

b) Assessment of Quality Objectives.b) Assessment of Quality Objectives.

c) All requirements of QMS requirements.c) All requirements of QMS requirements.


25/134

5.6.25.6.2-- Review InputReview Input

a)a) These MRMs Agenda shall includeThese MRMs Agenda shall include

Results of Internal Audits.Results of Internal Audits.

Customer satisfaction feedback.Customer satisfaction feedback.

Status of Preventive and Corrective actions.Status of Preventive and Corrective actions.

Action points pending from Previous MRM.Action points pending from Previous MRM.

Changes that could affect the integrity of QMS.Changes that could affect the integrity of QMS.

Resource requirements.Resource requirements.

Conformity to Product and Process PerformanceConformity to Product and Process Performance


26/134

5.6.2.15.6.2.1-- Review InputReview Input-- SupplementalSupplemental

a)a) These MRM agenda shall also includeThese MRM agenda shall also include

a) Customer Notifications, if anya) Customer Notifications, if any

b) Potential field failures which could have an impact on safety,b) Potential field failures which could have an impact on safety,Quality and Environment.Quality and Environment.


27/134

5.6.35.6.3-- Review OutputReview Output

Review Output shall includeReview Output shall include

Any actions / decisions which improve the effectiveness of QMSAny actions / decisions which improve the effectiveness of QMSperformance.performance.

Any Resource requirements.Any Resource requirements.


28/134

6.0 Resource Management6.0 Resource Management6.1 Provision of Resources6.1 Provision of Resources

Organisation Shall provide resources to improve effectiveness andOrganisation Shall provide resources to improve effectiveness andEfficiency of the QMS.Efficiency of the QMS.


29/134

6.2.1 Human Resources6.2.1 Human Resources

Organization Shall provide competent Human resource whichOrganization Shall provide competent Human resource which

affects the conformity to product requirements.affects the conformity to product requirements.

This competence shall be based on Experience, Skill, EducationThis competence shall be based on Experience, Skill, Educationand Qualification,and Qualification,


30/134

6.2.2. Competence, Training and Awareness.6.2.2. Competence, Training and Awareness.

a.a. Organisation ShallOrganisation Shalla) Determine competence which affects the conformity to producta) Determine competence which affects the conformity to productrequirementsrequirements

b) Carry out the Gap Analysis.b) Carry out the Gap Analysis.

c) Where applicable, Provide training or other things to bridge thec) Where applicable, Provide training or other things to bridge theCompetence Gap.Competence Gap.

d) Determine the effectiveness of the actions initiated .d) Determine the effectiveness of the actions initiated .

e) Ensure that the personnel are aware of their work and ensuree) Ensure that the personnel are aware of their work and ensurethat how they will contribute in achieving established Qualitythat how they will contribute in achieving established QualityObjectives.Objectives.


31/134

6.2.2.1 Product Design Skills6.2.2.1 Product Design Skills


a) Personnel Performing Product Design related activities shall bea) Personnel Performing Product Design related activities shall becompetent / Versatile in the respective Tools like Procompetent / Versatile in the respective Tools like Pro--e, catia,e, catia,

Drawing Interpretations etc.Drawing Interpretations etc.

b) Persons Performing Audits shall be qualified to do the Audits.b) Persons Performing Audits shall be qualified to do the Audits.Persons involving in Delivery management shall be aware of SAP,Persons involving in Delivery management shall be aware of SAP,

BarBar--coding ,ASN etccoding ,ASN etc


32/134

6.2.2.2 Training6.2.2.2 Training


Organization shall establish a documented procedure forOrganization shall establish a documented procedure foridentifying the training needs for the personnel performing workidentifying the training needs for the personnel performing work

which affects the conformity to product requirements.which affects the conformity to product requirements.How to achieve the required competency.How to achieve the required competency.

Personnel performing some assigned jobs shall be qualified to doPersonnel performing some assigned jobs shall be qualified to doso.so.


33/134

6.2.2.3 On the Job Training6.2.2.3 On the Job Training


The Organisation shall provide on the job training for any new orThe Organisation shall provide on the job training for any new ormodified job, which results in customer dissatisfaction.( shall alsomodified job, which results in customer dissatisfaction.( shall also

be include contract agency personnel )be include contract agency personnel )

The Organisation shall made aware of these personnel ,how theirThe Organisation shall made aware of these personnel ,how theirwork affects customer dissatisfaction.work affects customer dissatisfaction.


34/134

6.2.2.4 Employee Motivation and Empowerment6.2.2.4 Employee Motivation and Empowerment


The Organisation shall identify methods for employeeThe Organisation shall identify methods for employeemotivation which results inmotivation which results in

a) To achieve the established Quality objectives .a) To achieve the established Quality objectives .

b) To make continual improvements ( Kaizens / Suggestionb) To make continual improvements ( Kaizens / Suggestionscheme).scheme).c) To create innovative Environment.c) To create innovative Environment.

This employee Motivation and Empowerment shall be doneThis employee Motivation and Empowerment shall be done

with an aim of promotion of technological and qualitywith an aim of promotion of technological and qualityawareness.awareness.

The organization shall also identify monitoring andThe organization shall also identify monitoring andmeasurement methods to know how they contribute inmeasurement methods to know how they contribute in

achieving the established quality goals.achieving the established quality goals.


35/134

6.3 Infrastructure6.3 Infrastructure


The Organisation shall identify & provide resources.The Organisation shall identify & provide resources.

This shall includeThis shall includea) Building, workspace and Utilitiesa) Building, workspace and Utilities

b) Process equipments (Both software and Hardware).b) Process equipments (Both software and Hardware).

c) Supporting Services (Information systems, Communication andc) Supporting Services (Information systems, Communication andTransportation).Transportation).


36/134

6. 3.1 Plant facility and Equipment Planning6. 3.1 Plant facility and Equipment Planning


a) Organization shall use MDA while plant, Facility and Equipmenta) Organization shall use MDA while plant, Facility and Equipment

Planning.Planning.

b) Shall ensure Optimal material travel ,Synchronous materialb) Shall ensure Optimal material travel ,Synchronous materialflow, Value added use of floor space.flow, Value added use of floor space.

c) Methods to establish the effective operations ( OEE)c) Methods to establish the effective operations ( OEE)Shall use Lean Techniques.Shall use Lean Techniques.


37/134

6.3 Infrastructure6.3 Infrastructure6.3.26.3.2-- Contingency PlansContingency Plans


Shall establish contingency plans in case ofShall establish contingency plans in case of

a) Labour shortagea) Labour shortage

b) Utilities Interruptionsb) Utilities Interruptions

c) Key equipment failures andc) Key equipment failures and

d) Customer field returns.d) Customer field returns.


38/134

6.46.4 Work EnvironmentWork Environment

6.4.16.4.1-- Personnel safety affecting conformity to product requirements.Personnel safety affecting conformity to product requirements.

Organization shall identify methods with aim to avoid potentialOrganization shall identify methods with aim to avoid potentialinjuries for a personnel affecting conformity to productinjuries for a personnel affecting conformity to product

requirements.requirements.

Personnel safety shall be taken care especially whilePersonnel safety shall be taken care especially while

a) Product Design and development , anda) Product Design and development , and

b) Manufacturing process activities.b) Manufacturing process activities.


39/134

6.4.26.4.2-- Cleanliness of the premisesCleanliness of the premises

Organization shall identify methods to keep the work place tidyOrganization shall identify methods to keep the work place tidyand in a state of order. Like 5S.and in a state of order. Like 5S.


40/134

7.0 Product Realization7.0 Product Realization7.1 Planning of Product Realization7.1 Planning of Product Realization

The requirements of this clause are,

The Organisation shall plan and develop process/methods forproduct realisation.This shall include

a) Required Process establishment and necessary documentation.

b) Quality Objectives and requirements.

c) Necessary resources required product specific.

d) Required Verification,Validation,monitoring, Measurement,inspection and Testing with respect a product.

e) The required acceptance criteria.

f) The records resulting in the planning of product realization shallbe maintained. Timing plan, Control plan, PFC, Gauge List etc)


41/134

7.1.1 Planning of the product realization7.1.1 Planning of the product realization --SupplementalSupplemental

Customer Specific requirements shall be referenced / included whileCustomer Specific requirements shall be referenced / included whilemaking Quality planmaking Quality plan


42/134

7.1.2 Acceptance Criteria7.1.2 Acceptance Criteria

Acceptance Criteria shall be established to approve the product,Acceptance Criteria shall be established to approve the product,where required, acceptance criteria shall be approved by thewhere required, acceptance criteria shall be approved by thecustomer.customer.

For attribute samplings, the acceptance criteria shall be zero.For attribute samplings, the acceptance criteria shall be zero.


43/134

7.1.4 Change Control7.1.4 Change Control


Organization shall ensure adequate controls are established inOrganization shall ensure adequate controls are established incase material change, Supplier source change, Change incase material change, Supplier source change, Change inspecificationsspecifications

Respective Personnel shall be made aware of the changes.Respective Personnel shall be made aware of the changes.

Proprieties' items shall be confirmed with customer.Proprieties' items shall be confirmed with customer.


44/134

7.1.3 Confidentiality7.1.3 Confidentiality

Agreement shall be established to ensure the confidentiality. ThisAgreement shall be established to ensure the confidentiality. Thisincludes Customer Drawings / Intellectual Property.includes Customer Drawings / Intellectual Property.


45/134

7.2 Customer Related Process7.2 Customer Related Process7.2.1 Determination of Requirements related to the product7.2.1 Determination of Requirements related to the product


The organization shall determine requirements related to theThe organization shall determine requirements related to theproduct which includesproduct which includes

a) Functional and Performance requirements.a) Functional and Performance requirements.

b) Applicable statutory and regulatory requirements wrt product.b) Applicable statutory and regulatory requirements wrt product.

c) Requirements not stated, but required for an intendedc) Requirements not stated, but required for an intendeduse/applicationuse/application--where known.where known.

d) Any other requirements stated by the customer.d) Any other requirements stated by the customer.


46/134

7.2.1.1 Determination of Requirements related7.2.1.1 Determination of Requirements related to the productto the product --

SupplementalSupplemental

The organization shall use the same symbols for the designatedThe organization shall use the same symbols for the designatedspecial characteristics which are used in the customer designspecial characteristics which are used in the customer designrecords.records.


47/134

7.2.2 Review of Requirements related to the product7.2.2 Review of Requirements related to the product( Contract Review )( Contract Review )


The organization shall review the requirements related to theThe organization shall review the requirements related to the

product.product.

This shall be done prior to the organization's commitment toThis shall be done prior to the organization's commitment tosupply the product / Service.supply the product / Service.

The organization shall ensure that any earlier issues are resolved.The organization shall ensure that any earlier issues are resolved.

If the customer requirements are not given by the customer ,It isIf the customer requirements are not given by the customer ,It isthe organization's responsibility to take the concurrence beforethe organization's responsibility to take the concurrence beforeacceptance.acceptance.


48/134

7.2.2.1 Review of Requirements related to the product7.2.2.1 Review of Requirements related to the product--SupplementalSupplemental

The organization shall ensure that any earlier issues If theThe organization shall ensure that any earlier issues If thecustomer requirements are not given by the customer ,It is thecustomer requirements are not given by the customer ,It is theorganization's responsibility to take the concurrence beforeorganization's responsibility to take the concurrence beforeacceptance.acceptance.


49/134

7.2.2.2 Organizational Manufacturing Feasibility7.2.2.2 Organizational Manufacturing Feasibility


The organization shall ensure its manufacturing capability beforeThe organization shall ensure its manufacturing capability beforeacceptance.acceptance.

This shall include investigation ,Capacity Verification, Risk Analysis,This shall include investigation ,Capacity Verification, Risk Analysis,Manufacturing Feasibility in contract review etc.Manufacturing Feasibility in contract review etc.


50/134

7.2.3 Customer Communication7.2.3 Customer Communication

The organization shall establish methods for customer communication.The organization shall establish methods for customer communication.


51/134

7.2.37.2.3-- Customer communicationCustomer communication-- SupplementalSupplemental

The organization shall ensure the communication shall beThe organization shall ensure the communication shall beconsistent with customer requirements.consistent with customer requirements.


52/134

7.37.3-- Design and DevelopmentDesign and DevelopmentDesign and developmentDesign and development--PlanningPlanning

The organization shall plan and determineThe organization shall plan and determine

Required design and Developmental stages.Required design and Developmental stages.

Required reviews at each stage.Required reviews at each stage.

Required Verification and Validation at each stage.Required Verification and Validation at each stage.

The organization shall maintain records of planning output.The organization shall maintain records of planning output.


53/134

7.3.1.17.3.1.1--Multi Disciplinary Approach.Multi Disciplinary Approach.

The organization shall use multi disciplinary approach (I,e CFT approach)The organization shall use multi disciplinary approach (I,e CFT approach)whilewhilea) Establishing and reviewing FMEA and Control plan.a) Establishing and reviewing FMEA and Control plan.

b) While recommending actions for reducing the RPN .b) While recommending actions for reducing the RPN .

c) Identification , Finalization and Monitoring of Special characteristics.c) Identification , Finalization and Monitoring of Special characteristics.


54/134


55/134

7.3.2.27.3.2.2-- Manufacturing Process DesignManufacturing Process Design --InputsInputs

The organization shall determine the inputs for Manufacturing processThe organization shall determine the inputs for Manufacturing process

design and development. This shall includesdesign and development. This shall includes

Product Design output detailsProduct Design output details

Targets for productivity, capability and costTargets for productivity, capability and cost

Experience gained from previous development.Experience gained from previous development.

Customer specific requirementsCustomer specific requirements


56/134

7.3.2.37.3.2.3-- Special CharacteristicsSpecial Characteristics

The organization shall identify, determine and include the specialThe organization shall identify, determine and include the special

characteristics incharacteristics in

a) PFC,PFMEA and Control plan.a) PFC,PFMEA and Control plan.

b) Shall comply with customer designated symbols.b) Shall comply with customer designated symbols.

c) Customer specific requirementsc) Customer specific requirements..


57/134

7.3.37.3.3-- Design and DevelopmentDesign and Development --OutputsOutputs

The organization shall identify, determine design and development ,whichThe organization shall identify, determine design and development ,whichincludesincludes

Meet the design and development inputs.Meet the design and development inputs.

Provide appropriate information to purchasing and manufacturing.Provide appropriate information to purchasing and manufacturing.

Contain or reference product acceptance criteriaContain or reference product acceptance criteria

Specify the characteristics that affects the safety and proper use.Specify the characteristics that affects the safety and proper use.


58/134

7.3.3.1 Product Design Outputs7.3.3.1 Product Design Outputs --SupplementalSupplemental

The organization shall express product design and development data thatThe organization shall express product design and development data thatcan expressed and verifiable against product design inputs. This shallcan expressed and verifiable against product design inputs. This shallincludeinclude

DFMEA, Reliability resultsDFMEA, Reliability results

Product Special characteristics and specificationsProduct Special characteristics and specifications

Product error proofing, as appropriate.Product error proofing, as appropriate.

Diagnostic guidelines ,where applicableDiagnostic guidelines ,where applicable

Product definition including math data.Product definition including math data.

Product design review results.Product design review results.


59/134

7.3.3.2 Manufacturing process design output7.3.3.2 Manufacturing process design output

The organization shall express manufacturing process design andThe organization shall express manufacturing process design and

development data that can expressed and verifiable against processdevelopment data that can expressed and verifiable against processdesign inputs. This shall includedesign inputs. This shall include

PFC.PFC.

Floor plan LayoutFloor plan Layout

PFMEAPFMEA

Control planControl plan

Work instructionsWork instructions

Data for quality (quality Targets) , reliability, maintainability (I.e. UsersData for quality (quality Targets) , reliability, maintainability (I.e. Usersmanual ),and measurability (gauges, equipments ,measuring methodsmanual ),and measurability (gauges, equipments ,measuring methodsetc)etc)

Results of error proofing activities, as appropriate.Results of error proofing activities, as appropriate.


60/134

7.3.4 Design and Development7.3.4 Design and Development --ReviewReview

The organization shall review the design and development as per theThe organization shall review the design and development as per theplanned arrangements. This shall includeplanned arrangements. This shall include

1. Evaluate the ability to meet the requirements.1. Evaluate the ability to meet the requirements.2. Review plan vs. actual2. Review plan vs. actual

Appropriate actions in case of any problems /delayAppropriate actions in case of any problems /delay

Review shall be conducted in CFT which includes all depts.Review shall be conducted in CFT which includes all depts.


61/134

7.3.4.1 Monitoring7.3.4.1 Monitoring

Measurements at specified stages shall be defined ,analyzed and reportedMeasurements at specified stages shall be defined ,analyzed and reported

with summary results as an input to management review.with summary results as an input to management review.


62/134

7.3.57.3.5 Verification of Design and Development.Verification of Design and Development.

Verification shall be carried out in accordance with the plannedVerification shall be carried out in accordance with the plannedarrangements to ensure that the design and development outputs havearrangements to ensure that the design and development outputs have

met the input requirements.met the input requirements.(I,e Verify for dimensional results, fit /function , regulatory conformance(I,e Verify for dimensional results, fit /function , regulatory conformanceagainst drawing.)against drawing.)

Records shall be maintained.Records shall be maintained.


63/134


64/134

7.3.6.17.3.6.1 Validation of Design and Development.Validation of Design and Development.--SupplementalSupplemental

Design and Development validation shall be performed inDesign and Development validation shall be performed inaccordance with customer requirements , including programaccordance with customer requirements , including programtimimg.timimg.


65/134

7.3.6.37.3.6.3 Product Approval Process.Product Approval Process.

The organization shall conform to a product and manufacturingThe organization shall conform to a product and manufacturingprocess approval process recognized by the customer .process approval process recognized by the customer .

(I.e. PPAP submission Level 1 to 5 as described in PPAP(I.e. PPAP submission Level 1 to 5 as described in PPAP

reference manual of 04reference manual of 04thth

Edition.)Edition.)

Note : Product Approval process should be subsequent toNote : Product Approval process should be subsequent toverification of manufacturing process.verification of manufacturing process.

This PPAP process shall also be applicable to organization'sThis PPAP process shall also be applicable to organization'ssuppliers in a similar manner.suppliers in a similar manner.


66/134


67/134

7.4 Purchasing Process.7.4 Purchasing Process.

The requirements of this clause.The requirements of this clause.

Select the supplier based on the ability of the supplier to meet theSelect the supplier based on the ability of the supplier to meet the

organizational requirements consistently.organizational requirements consistently.

Criticality of the supplied product on the subsequent operations.Criticality of the supplied product on the subsequent operations.

Selection process shall include evaluation of suppliers (I,e conductSelection process shall include evaluation of suppliers (I,e conductsupplier QMS audit / Process audit )supplier QMS audit / Process audit )

ReRe-- evaluation to be done based on the performanceevaluation to be done based on the performance


68/134

7.4.1.1 Statutory and regulatory conformity.7.4.1.1 Statutory and regulatory conformity.


Purchased material shall confirm to either statutory or regulatoryPurchased material shall confirm to either statutory or regulatoryrequirements / Customer specifications.( Like traceable to IS / ASTM /requirements / Customer specifications.( Like traceable to IS / ASTM /DIN )DIN )


69/134

7.4.1.2 Supplier QMS development.7.4.1.2 Supplier QMS development.


The selected supplier shall be certified to ISO /TS 16949 or 9001:2008The selected supplier shall be certified to ISO /TS 16949 or 9001:2008

by third party accredited CB.by third party accredited CB.

The organization shall carry out supplier up gradation program ( in termsThe organization shall carry out supplier up gradation program ( in termsof training, conducting audits to identify the gaps to improve theof training, conducting audits to identify the gaps to improve theperformance, sharing information etc )performance, sharing information etc )


70/134

7.4.1.3 Customer approved sources.7.4.1.3 Customer approved sources.


The organization shall procure the materials from the customer approvedThe organization shall procure the materials from the customer approved/ Designated sources only./ Designated sources only.

Also it does not absolve/ relieve the organizations from theAlso it does not absolve/ relieve the organizations from theresponsibilities ,by procuring from the customer designated sources.responsibilities ,by procuring from the customer designated sources.

This requirement also applicable to the suppliers like Tool / gauge ,This requirement also applicable to the suppliers like Tool / gauge ,

equipment manufacturer.equipment manufacturer.


71/134

7.4.2 Purchasing Information.7.4.2 Purchasing Information.


The organization shallThe organization shallclearly define the purchasing material requirements ( likeclearly define the purchasing material requirements ( likeTechnical names , mutually accepted /agreed codes , TraceableTechnical names , mutually accepted /agreed codes , Traceablestandards , Customer designated names /codes.standards , Customer designated names /codes.

Required acceptance criteria for the purchased material.Required acceptance criteria for the purchased material.

The type of qualification required for a personnel if it is related toThe type of qualification required for a personnel if it is related toa service or operating , installation and commission.a service or operating , installation and commission.

Types of quality records required for acceptance / approval.Types of quality records required for acceptance / approval.

Terms & conditions Delivery, Cost , transportation, Method ofTerms & conditions Delivery, Cost , transportation, Method ofpackingpacking


72/134

7.4.2 Purchasing Information.7.4.2 Purchasing Information.

The requirements of this clause.The requirements of this clause.The organization shallThe organization shall

a) clearly define the purchasing material requirements ( likea) clearly define the purchasing material requirements ( likeTechnical names , mutually accepted /agreed codes , TraceableTechnical names , mutually accepted /agreed codes , Traceablestandards , Customer designated names /codes.standards , Customer designated names /codes.

b) Required acceptance criteria for the purchased material.b) Required acceptance criteria for the purchased material.

c) The type of qualification required for a personnel if it is relatedc) The type of qualification required for a personnel if it is relatedto a service or operating , installation and commission.to a service or operating , installation and commission.

d) Types of quality records required for acceptance / approval ford) Types of quality records required for acceptance / approval forpurchased product.purchased product.

e) Terms & conditions wrt Delivery, Cost , transportation, Methode) Terms & conditions wrt Delivery, Cost , transportation, Methodof packing .of packing .

f) Quality Management System requirements ( like COC , materialf) Quality Management System requirements ( like COC , material

Test reports , performance test results where applicable etc )Test reports , performance test results where applicable etc )


73/134

7 4 3 1 I i d t f it t i t7 4 3 1 I i d t f it t i t


74/134

7.4.3.1 Incoming product conformity to requirements.7.4.3.1 Incoming product conformity to requirements.


The organization shall utilize one or more following methods toThe organization shall utilize one or more following methods toensure the part quality against the established acceptance criteriaensure the part quality against the established acceptance criteria

/ purchasing requirements./ purchasing requirements.

a) Introducing receiving inspection on sampling basis.a) Introducing receiving inspection on sampling basis.

b) Inspection carried out by Second / Third party.b) Inspection carried out by Second / Third party.

c) Inspection / Verification carried out by designated laboratory.c) Inspection / Verification carried out by designated laboratory.

d) By receipt of , evaluation of stastical data from the supplier (d) By receipt of , evaluation of stastical data from the supplier (Self certificates, SPC data , etc)Self certificates, SPC data , etc)

7 4 3 2 S lie Monito ing7 4 3 2 S lie Monito ing


75/134

7.4.3.2 Supplier Monitoring.7.4.3.2 Supplier Monitoring.


The organization shall monitor the supplier performance based onThe organization shall monitor the supplier performance based on

a) Delivery rating.a) Delivery rating.

b) Quality rating.b) Quality rating.

c) Customer line stoppages / Field returns.c) Customer line stoppages / Field returns.

d) Customer notifications related to quality / Delivery.d) Customer notifications related to quality / Delivery.

7.5.1 Control of Production and Service Provision7.5.1 Control of Production and Service Provision


76/134

The requirements of this clause.The requirements of this clause.The organization shall establish and ensure the followingThe organization shall establish and ensure the following

a) information which describes the characteristics of product (a) information which describes the characteristics of product (Quality Check Sheet , Drawings, Control Plan , etc)Quality Check Sheet , Drawings, Control Plan , etc)

b) SOPs/ Work Instructions for carryout an activity in a correctb) SOPs/ Work Instructions for carryout an activity in a correctway.way.

c) Dos and Donts related to handling, preservation , doing anc) Dos and Donts related to handling, preservation , doing anactivity in a controlled atmosphere.activity in a controlled atmosphere.

d) Capable machine and equipment to produce the part and howd) Capable machine and equipment to produce the part and howto use the machine /equipment.to use the machine /equipment.

e) Correct instruments and gauges to monitor and measure.e) Correct instruments and gauges to monitor and measure.

f) Qualified / Competent personnel.f) Qualified / Competent personnel.

g) Acceptance criteria for product either through CPs Quality Plansg) Acceptance criteria for product either through CPs Quality Plans

, Quality Check sheets. etc, Quality Check sheets. etc

7 5 1 1 Control Plan7 5 1 1 Control Plan


77/134

7.5.1.1 Control Plan7.5.1.1 Control Plan


a) Establish Control plan at system level, Subsystem level / parta) Establish Control plan at system level, Subsystem level / partspecific level / Raw Material specific level for all the processspecific level / Raw Material specific level for all the process

which produces the parts including for bulk material producingwhich produces the parts including for bulk material producingprocess.process.

b) Establish Control plans for prototype level( if required only ) /b) Establish Control plans for prototype level( if required only ) /Pre launch level (Before mass production stage , if required) /Pre launch level (Before mass production stage , if required) /

Production level by taking inputs from DFMEA / PFMEAProduction level by taking inputs from DFMEA / PFMEA

7 5 1 1 Control Plan Continued7 5 1 1 Control Plan Continued


78/134

7.5.1.1 Control Plan Continued .7.5.1.1 Control Plan Continued .


a) Include all special characteristics which are identified ina) Include all special characteristics which are identified inCustomer design record( I,e Drawing).Customer design record( I,e Drawing).

b) Include all Special characteristics which are identified internallyb) Include all Special characteristics which are identified internally

by the organization based on process criticality.by the organization based on process criticality.

c) Establish and include the relevant Control methods like SPC /c) Establish and include the relevant Control methods like SPC /Control charts / PM / Calibration / MSA etc to control the specialControl charts / PM / Calibration / MSA etc to control the specialcharacteristics.characteristics.

d) Shall include all Manufacturing process controls to produce thed) Shall include all Manufacturing process controls to produce thedefect free product.defect free product.

e) Shall include reaction plan / Corrective action in case of anye) Shall include reaction plan / Corrective action in case of anydeviations / Non Conformities.deviations / Non Conformities.

7 5 1 2 Work Instructions7 5 1 2 Work Instructions


79/134

7.5.1.2 Work Instructions7.5.1.2 Work Instructions


a) Shall prepare the documented work instructions for all thea) Shall prepare the documented work instructions for all theemployees having the responsibilities for the operation ofemployees having the responsibilities for the operation ofprocesses that impact conformity to product requirements.processes that impact conformity to product requirements.

b) These work instructions shall be made available at the point ofb) These work instructions shall be made available at the point ofuse for effective operations.use for effective operations.

c) These work instructions shall be derived from Quality plan orc) These work instructions shall be derived from Quality plan orControl plan , FMEA, and customer specific requirements.Control plan , FMEA, and customer specific requirements.


80/134


81/134


82/134

7 5 1 6 Production Scheduling7 5 1 6 Production Scheduling


83/134

7.5.1.6 Production Scheduling7.5.1.6 Production Scheduling


a) Organizational Production planning shall be in such a way thata) Organizational Production planning shall be in such a way thatit meets the customer requirements are met consistently .it meets the customer requirements are met consistently .

b) Scheduling shall be towards Just in Time methods in order tob) Scheduling shall be towards Just in Time methods in order toreduce the inventory.reduce the inventory.

c) Shall establish an information system that shall be accessible atc) Shall establish an information system that shall be accessible atall stage of production in order to meet the customerall stage of production in order to meet the customerrequirements.( I,e stock available at each production stage).requirements.( I,e stock available at each production stage).


84/134


85/134

7 5 2 Validation of Process for production and service provision7 5 2 Validation of Process for production and service provision


86/134

7.5.2 Validation of Process for production and service provision7.5.2 Validation of Process for production and service provision


Shall validate( means establish standard process parameters and theirShall validate( means establish standard process parameters and theirspecifications with the help of DOE /or by experience /or by manufacturersspecifications with the help of DOE /or by experience /or by manufacturersrecommendations ) such that these established process parameters should be ablerecommendations ) such that these established process parameters should be ableto demonstrate the ability of meeting the required results.to demonstrate the ability of meeting the required results.

This validation shall be carried out for production process ( like welding processThis validation shall be carried out for production process ( like welding process,electroplating ,painting etc ) and service provision processes ( like surface,electroplating ,painting etc ) and service provision processes ( like surface

treatment process ) where verification for acceptance can not be able to dotreatment process ) where verification for acceptance can not be able to doimmediately / after the process is over (I.e. defects / problems will appear onlyimmediately / after the process is over (I.e. defects / problems will appear onlyafter some time , or when processing next operation / when it is in use etc )after some time , or when processing next operation / when it is in use etc )

Validation data shall be typically includesValidation data shall be typically includes

a) Records of acceptable PPM levels, acceptable % of rejection , Productivity,a) Records of acceptable PPM levels, acceptable % of rejection , Productivity,

b) Records of equipment approval,b) Records of equipment approval,c) Qualification records of competent personnel,c) Qualification records of competent personnel,d) Use of Some specific methods and procedures ( SOPs /WI /Guidelines etc)d) Use of Some specific methods and procedures ( SOPs /WI /Guidelines etc)e) Revalidation frequencye) Revalidation frequency

7.5.2 .1 Validation of Process for production and service provision7.5.2 .1 Validation of Process for production and service provision --supplementalsupplemental


87/134

p pp p pppp


Process validation shall cover not only for special process but also forProcess validation shall cover not only for special process but also forall manufacturing process.all manufacturing process.


88/134

7.5.3 Identification and Traceability7.5.3 Identification and Traceability


89/134

7.5.3 Identification and Traceability7.5.3 Identification and Traceability


Identification and Traceability is mandatory at all stages of product realization.Identification and Traceability is mandatory at all stages of product realization.

7.5.4 Customer Property7.5.4 Customer Property


90/134

7.5.4 Customer Property7.5.4 Customer Property


Shall exercise care of customer property when it is under organizationalShall exercise care of customer property when it is under organizationalcontrol.control.

Shall identify, verify, protect and safeguard the customer property whenShall identify, verify, protect and safeguard the customer property whenit is under organizational control.it is under organizational control.

Shall notify to the customer when the customer property is lost, damagedShall notify to the customer when the customer property is lost, damagedor found unusable condition .or found unusable condition .

Shall maintain records of the same.Shall maintain records of the same.

Note : Customer Property may include but not limitedNote : Customer Property may include but not limited

a) Packaging materials like trolleys, bins, material handling equipmentsa) Packaging materials like trolleys, bins, material handling equipmentsb) Tools , Fixtures, Measuring and test equipments and Gaugesb) Tools , Fixtures, Measuring and test equipments and Gaugesc) parts or constituents of parts which are used for an producing parts.c) parts or constituents of parts which are used for an producing parts.

7.5.4 Customer Owned production Tooling7.5.4 Customer Owned production Tooling


91/134

p gp g


Shall identify permanently the customer owned tools,Shall identify permanently the customer owned tools,manufacturing ,test ,inspection tooling and equipment so thatmanufacturing ,test ,inspection tooling and equipment so thatownership is visible clearly.ownership is visible clearly.

Establish master list of customer property.Establish master list of customer property.

7.5.5 Preservation of the product7.5.5 Preservation of the product


92/134

pp


Shall preserve the product during internal processing and till delivery to theShall preserve the product during internal processing and till delivery to the

intended destination in order to maintain the conformity to requirements.intended destination in order to maintain the conformity to requirements.

Preservation shall typically includes identification , Handling, Packaging , storagePreservation shall typically includes identification , Handling, Packaging , storageand protection.and protection.

This requirement shall also applicable to the constituents of the product.This requirement shall also applicable to the constituents of the product.

7.5.5.1 Storage and Inventory.7.5.5.1 Storage and Inventory.


93/134

g yg y


Shall include the condition verification at planned interval in order toShall include the condition verification at planned interval in order to

detect the deterioration.( I.e. Shelf life Verification at planned intervals).detect the deterioration.( I.e. Shelf life Verification at planned intervals).

Shall establish FIFO with primary intention of stock rotation.Shall establish FIFO with primary intention of stock rotation.

Shall use Inventory Management techniques to optimize the ITR.Shall use Inventory Management techniques to optimize the ITR.

Any obsolete product shall be handled similar to NC parts handling.Any obsolete product shall be handled similar to NC parts handling.

7.6 Control of monitoring and measuring equipments.7.6 Control of monitoring and measuring equipments.


94/134

g g q pg g q p


Establish Master list of Equipments , Gauges, Instruments and test equipments.Establish Master list of Equipments , Gauges, Instruments and test equipments.

Each instrument / test equipment shall have unique identification number.Each instrument / test equipment shall have unique identification number.Establish the calibration / Verification frequency based on the usage.Establish the calibration / Verification frequency based on the usage.

Establish the acceptance criteria based on international standards or criticality ofEstablish the acceptance criteria based on international standards or criticality ofusage.usage.

Carry out the calibration / verification as per the established frequency andCarry out the calibration / verification as per the established frequency andmaintain the records of the same.maintain the records of the same.Calibration and verification status to clearly identified on the instrument.Calibration and verification status to clearly identified on the instrument.

Each instrument / test equipment shall be safe guarded from adjustmentsEach instrument / test equipment shall be safe guarded from adjustmentsthat will lead to invalid results.that will lead to invalid results.

Each instrument /test equipment shall be protected from external damages ,Each instrument /test equipment shall be protected from external damages ,deterioration during handling,maintenanace and storage.deterioration during handling,maintenanace and storage.

If any software being used for calibration/verification , the softwares ability to giveIf any software being used for calibration/verification , the softwares ability to giveconsistent results shall be conformed before / prior to itsconsistent results shall be conformed before / prior to its use.use.

7.6.1 Measurement System Analysis7.6.1 Measurement System Analysis


95/134

y yy y


Analyze the variation present in the results of each type/category of measuringAnalyze the variation present in the results of each type/category of measuringand test equipment.and test equipment.

Measurement System analysis to be carried for the instruments/ test equipmentsMeasurement System analysis to be carried for the instruments/ test equipmentswhich are referenced in quality plan / Control Plan .which are referenced in quality plan / Control Plan .

The acceptance criteria and Analytical methods shall be in line with CustomerThe acceptance criteria and Analytical methods shall be in line with Customerreference MSA Manual or follow AIAG MSA manual of3reference MSA Manual or follow AIAG MSA manual of3rdrd Edition.Edition.

Other analytical methods shall be be carried out in concurrence with Customer.Other analytical methods shall be be carried out in concurrence with Customer.


96/134

7.6.3.1 Internal Lab requirements7.6.3.1 Internal Lab requirements


97/134

The requirements of this clause.The requirements of this clause.If an organization having internal laboratory facility, thenIf an organization having internal laboratory facility, then

a. It should have defined LAB Scope.a. It should have defined LAB Scope.

b. This defined Lab scope shall include the laboratorys capability to perform theb. This defined Lab scope shall include the laboratorys capability to perform therequired inspection , test or calibration services.required inspection , test or calibration services.

c.This Lab scope shall be included in organization's QMS documentation.c.This Lab scope shall be included in organization's QMS documentation.

d.The lab shall specify and implement as a minimum ,technical requirements ford.The lab shall specify and implement as a minimum ,technical requirements for

adequacy of the lab procedures.adequacy of the lab procedures.

Competency of the lab personnel.Competency of the lab personnel.

Testing of the product.Testing of the product.

Capability to perform these services correctly,traceble to the relevant processCapability to perform these services correctly,traceble to the relevant processstandards ( such as ASTM ,EN etc )standards ( such as ASTM ,EN etc )

7.6.3.2 External Lab requirements7.6.3.2 External Lab requirements


98/134


If an organization getting services like inspection, test or calibration from anIf an organization getting services like inspection, test or calibration from anexternal organization , thenexternal organization , then

the organization shall procure the lab scope that includes the capability to performthe organization shall procure the lab scope that includes the capability to performthe required inspection, test or calibration.the required inspection, test or calibration.

The external lab shall be approved / acceptable to customer ORThe external lab shall be approved / acceptable to customer OR

The external lab shall be accredited to ISO/IEC 17025 or national equivalent ( I.e.The external lab shall be accredited to ISO/IEC 17025 or national equivalent ( I.e.NABL )NABL )

8.0 Measurement , Analysis and Improvement.8.0 Measurement , Analysis and Improvement.8 G l8 G l


99/134

8.1 General8.1 General


The organization shall plan and implement processes for monitoring ,The organization shall plan and implement processes for monitoring ,measurement , analysis and improvement in order to determinemeasurement , analysis and improvement in order to determine

a. Conformity to the product requirements.a. Conformity to the product requirements.

b. Conformity to the QMS requirements.b. Conformity to the QMS requirements.

c. to improve the effectiveness of Quality Management Systemc. to improve the effectiveness of Quality Management Systemrequirements.requirements.


100/134

8.1.2. Knowledge about basic stastical concepts.8.1.2. Knowledge about basic stastical concepts.


101/134


The stastical concepts like variation , control, stability, over adjustmentThe stastical concepts like variation , control, stability, over adjustment

shall be understood and implement through the product realization.shall be understood and implement through the product realization.

8.2 Monitoring and measurement.8.2 Monitoring and measurement.i f ii f i


102/134

8.2.1 Customer Satisfaction8.2.1 Customer Satisfaction


The organizational monitor the customer satisfaction as one of theThe organizational monitor the customer satisfaction as one of theperformance indicator for measuring the effectiveness of Qualityperformance indicator for measuring the effectiveness of QualityManagement System .Management System .This Customer satisfaction will indicate how exactly the organizationThis Customer satisfaction will indicate how exactly the organizationhas understood and met the customer specific requirements.has understood and met the customer specific requirements.

The methods used for determination of customer satisfaction shall beThe methods used for determination of customer satisfaction shall bedefined .defined .

Typically customer sattisfaction includesTypically customer sattisfaction includes

a) Customer data wrt to quality product delivered.a) Customer data wrt to quality product delivered.

b) Customer satisfaction surveys.b) Customer satisfaction surveys.C) Competitor Analysis.C) Competitor Analysis.d) Bench marking .d) Bench marking .e) Lost Business analysis.e) Lost Business analysis.f) End user perception.f) End user perception.

The data used for determining the customer satisfaction shall be basedThe data used for determining the customer satisfaction shall be based

on objective data.on objective data.

8.2.1.1 Customer Satisfaction8.2.1.1 Customer Satisfaction --SupplementalSupplemental


103/134


The data used for determining the customer satisfaction shall be basedThe data used for determining the customer satisfaction shall be basedon objective data.on objective data.

The data used for calculating customer satisfaction shall be based onThe data used for calculating customer satisfaction shall be based onfollowing factors , but not limited to those points only.following factors , but not limited to those points only.

A) Delivery RatingA) Delivery Rating

B) Quality RatingB) Quality Rating

C) Any premium freight include the customer line disruptions.C) Any premium freight include the customer line disruptions.

D) Customer Notifications if any , from the supplied product.D) Customer Notifications if any , from the supplied product.

8.2.2 Internal Audits8.2.2 Internal Audits


104/134

The requirements of this clause.The requirements of this clause.Documented procedure shall be established for carrying out internalDocumented procedure shall be established for carrying out internal

audits which should contain responsibilities and requirements foraudits which should contain responsibilities and requirements forplanning and conducting audits ,establishing records and reportingplanning and conducting audits ,establishing records and reportingresults.results.

Internal Audits shall be conducted on planned intervals in order toInternal Audits shall be conducted on planned intervals in order todetermine effectiveness ofdetermine effectiveness of

a) Planned arrangements specified according to 7.1a) Planned arrangements specified according to 7.1

b) requirements of this international standard.b) requirements of this international standard.

c) QMS requirements established by the organization.c) QMS requirements established by the organization.

Internal Audits shall be planned , based on the importance of the area toInternal Audits shall be planned , based on the importance of the area to

be audited and corrective actions status from the previous internalbe audited and corrective actions status from the previous internalAudits.Audits.

Audit scope, criteria , frequency, and methods of audit shall beAudit scope, criteria , frequency, and methods of audit shall beestablished.established.

Auditors shall not audit their own area.Auditors shall not audit their own area.

8.2.2 Internal Audits8.2.2 Internal Audits continued .continued .


105/134


The management ( I,e Manager or HOD responsible for a process ) to beThe management ( I,e Manager or HOD responsible for a process ) to beauditted.auditted.

Necessary corrections / Corrective actions are taken without undueNecessary corrections / Corrective actions are taken without undue

delay .delay .

Follow up activities shall be carryout in order to verify the effectivenessFollow up activities shall be carryout in order to verify the effectivenessof the actions taken .of the actions taken .

8.2.2.1 QMS Audit8.2.2.1 QMS Audit


106/134


The organization shall audit its QMS to verify compliance to thisThe organization shall audit its QMS to verify compliance to this

Technical specification and any additional QMS requirements.Technical specification and any additional QMS requirements.

8.2.2.2 Manufacturing Process Audit.8.2.2.2 Manufacturing Process Audit.


107/134


List the various manufacturing processes carried out in the organization .List the various manufacturing processes carried out in the organization .

Prepare Unique process Audit checklist for each process.Prepare Unique process Audit checklist for each process.

Establish the list of qualified process Auditors based on theirEstablish the list of qualified process Auditors based on theircompetence ( I,e Based on Education , Training , skill & Experience).competence ( I,e Based on Education , Training , skill & Experience).

Prepare a plan to cover all manufacturing process .Prepare a plan to cover all manufacturing process .

Carryout the manufacturing process audit to know the effectivenessCarryout the manufacturing process audit to know the effectiveness( I.e. established controls yielding the required results ).( I.e. established controls yielding the required results ).

Raise Process audit Non conformities in case of any mismatch .Raise Process audit Non conformities in case of any mismatch .

Initiate Corrections and corrective actions without any undue delay.Initiate Corrections and corrective actions without any undue delay.

Note : Planning of process audits shall be based on customer complaintsNote : Planning of process audits shall be based on customer complaintstrends , internal rejection status , status of O & Ts achievement .trends , internal rejection status , status of O & Ts achievement .


108/134


109/134

8.2.2.5 Internal Audit Qualification .8.2.2.5 Internal Audit Qualification .


110/134


Establish the competence of internal audits ( I,e Based on Education ,Establish the competence of internal audits ( I,e Based on Education ,

Training , skill & Experience) to carry out internal audits as per theTraining , skill & Experience) to carry out internal audits as per therequirements of this Technical Specification ISO/TS 16949: 2009.requirements of this Technical Specification ISO/TS 16949: 2009.

Note 1Note 1 -- Training : The Personnel shall undergone a two days of IAT wrtTraining : The Personnel shall undergone a two days of IAT wrtthis Technical Specification according to ISO 19011:2002 guidelines.this Technical Specification according to ISO 19011:2002 guidelines.

Note 2Note 2 Skill and ExperienceSkill and Experience The personnel shall aware of customerThe personnel shall aware of customer

specific requirements of their customers.specific requirements of their customers.

8.2.3 Monitoring and Measurement of process.8.2.3 Monitoring and Measurement of process.


111/134


The organization shall identify suitable methods for monitoring andThe organization shall identify suitable methods for monitoring and

measuring the effectiveness or Efficiency of the QMS Processes.measuring the effectiveness or Efficiency of the QMS Processes.

These identified methods shall demonstrate ability of these processes toThese identified methods shall demonstrate ability of these processes toachieve the planned results.achieve the planned results.

When planned results are not achieved, adequate corrections /When planned results are not achieved, adequate corrections /Corrective actions shall be initiated.Corrective actions shall be initiated.

8.2.3.1 Monitoring and Measurement of Manufacturing process.8.2.3.1 Monitoring and Measurement of Manufacturing process.


112/134


The organization shall carryout process studies on all newThe organization shall carryout process studies on all newmanufacturing processes to verify their capability.manufacturing processes to verify their capability.

This capability information shall be used as additional process control atThis capability information shall be used as additional process control atthe time mass production stage.the time mass production stage.

These capability information shall be documented with specificationsThese capability information shall be documented with specificationsand shall be used for process improvements, measurement and testing ,and shall be used for process improvements, measurement and testing ,for improving efficiency maintenance activities.for improving efficiency maintenance activities.

These capability studies shall have objectives for manufacturing processThese capability studies shall have objectives for manufacturing processcapability, reliability , maintainability , and availability . ( I.e. for whatcapability, reliability , maintainability , and availability . ( I.e. for what

purpose we are conducting these studies ).purpose we are conducting these studies ).

The acceptance criteria for the capability index shall be established. ( I,eThe acceptance criteria for the capability index shall be established. ( I,eCpk or Ppk index > 1.67 or what ?)Cpk or Ppk index > 1.67 or what ?)

8.2.3.1 Monitoring and Measurement of Manufacturing process. Continued.8.2.3.1 Monitoring and Measurement of Manufacturing process. Continued.


113/134


The organization shall maintain the Cp / Cpk or Pp /Ppk studies for all specialThe organization shall maintain the Cp / Cpk or Pp /Ppk studies for all specialcharacteristics which are mentioned in customer approved PPAP documents .characteristics which are mentioned in customer approved PPAP documents .

The organization shall ensure that controls established in control plan/PFDThe organization shall ensure that controls established in control plan/PFDare 100% implemented or adhered.are 100% implemented or adhered.

The organization shall also ensure compliance to the following, as documentedThe organization shall also ensure compliance to the following, as documented

in the control plan.in the control plan.

a) measurement techniquesa) measurement techniques

b) Sampling plansb) Sampling plans

c)acceptance criteriac)acceptance criteria

d) reaction plan when acceptance criteria are not met.d) reaction plan when acceptance criteria are not met.

Significant process events such as tool change , machine repair , NewSignificant process events such as tool change , machine repair , Newoperator, etc shall be captured / recorded for future references.operator, etc shall be captured / recorded for future references.


114/134


115/134

8.2.4.1 Layout inspection and Functional Testing8.2.4.1 Layout inspection and Functional Testing


116/134


A layout inspection ( complete measurement of all product dimensions asA layout inspection ( complete measurement of all product dimensions asshown in the design records)shown in the design records)

andand

Functional verification to applicable customer Engineering materialFunctional verification to applicable customer Engineering material

andandPerformance standards shall be performed for each product as specified inPerformance standards shall be performed for each product as specified inthe control plan.the control plan.

The records of layout inspection & functional testing shall be available forThe records of layout inspection & functional testing shall be available forcustomer review.customer review.

8.2.4.2 Appearance items8.2.4.2 Appearance items


117/134


The organisations which manufacture the parts , which are designated asThe organisations which manufacture the parts , which are designated asAppearance items in the design records, the organization shall provideAppearance items in the design records, the organization shall provide

a. Appropriate resources , including lighting , for evaluation.a. Appropriate resources , including lighting , for evaluation.

b. Masters for color, grain, Gloss ,texture, DOI, metallic brilliance.b. Masters for color, grain, Gloss ,texture, DOI, metallic brilliance.

c. Qualify and evaluate the personnel who perform the appearancec. Qualify and evaluate the personnel who perform the appearanceevaluations.evaluations.

d. maintenance and control of appearance masters and evaluation ofd. maintenance and control of appearance masters and evaluation ofequipment.equipment.


118/134

8.3 Control of Non conforming Product. Continued8.3 Control of Non conforming Product. Continued


119/134

The requirements of this clause continued The requirements of this clause continued When NC product is corrected , it shall be subject to reWhen NC product is corrected , it shall be subject to re--verification toverification to

demonstrate conformity to the requirements.demonstrate conformity to the requirements.

Records of the nature of NCs and any subsequent actions taken includingRecords of the nature of NCs and any subsequent actions taken includingconcessions obtained , shall be maintained.concessions obtained , shall be maintained.


120/134


121/134


122/134


123/134

8.4 Analysis of Data8.4 Analysis of Data


124/134

The requirements of this clauseThe requirements of this clause

The organization shall determine ,collect and analyze appropriate data toThe organization shall determine ,collect and analyze appropriate data to

a) demonstrate suitability and effectiveness of QMSa) demonstrate suitability and effectiveness of QMS

b) evaluate the continual improvement in the effectiveness of QMS.b) evaluate the continual improvement in the effectiveness of QMS.

This data shall generated as a means of monitoring and measurement ofThis data shall generated as a means of monitoring and measurement of

processes and product.processes and product.

This analyzed data shall provide information related toThis analyzed data shall provide information related to

a) customer satisfactiona) customer satisfaction

b) Conformity to product requirements.b) Conformity to product requirements.

c) Characteristics and trends of processes and productsc) Characteristics and trends of processes and products(shall include OIs for PA).(shall include OIs for PA).

d) Suppliers.d) Suppliers.

8.4.1 Analysis and use of Data8.4.1 Analysis and use of Data


125/134


Trends related to quality and operational performance shall be comparedTrends related to quality and operational performance shall be comparedwith established objectives and targets.with established objectives and targets.

These comparison trends shall lead to actions to supportThese comparison trends shall lead to actions to support

a) development of priorities for prompt solutions to customer relateda) development of priorities for prompt solutions to customer relatedproblems.problems.

b) determination of key customer related trends and correlation for statusb) determination of key customer related trends and correlation for statusreview , decision making and long term planning.review , decision making and long term planning.

c) an information system for the timely reporting of product informationc) an information system for the timely reporting of product informationarising from usage.arising from usage.


126/134


127/134


128/134

8.5.2 Corrective Action8.5.2 Corrective Action


129/134


The organization shall establish a documented process for initiating aThe organization shall establish a documented process for initiating acorrective action.( I.e. action taken to eliminate cause(s) of a detected noncorrective action.( I.e. action taken to eliminate cause(s) of a detected nonconformity to prevent its recurrence.conformity to prevent its recurrence.

This documented procedure shall includeThis documented procedure shall include

a) mechanism for reviewing of non conformities including customera) mechanism for reviewing of non conformities including customercomplaints.complaints.

b) the methods to determine the causes for non conformities.b) the methods to determine the causes for non conformit

TS interpretation as per HSR1

Documents

Transcript of TS interpretation as per HSR1