SHYAM JI TRIVEDI

Need for Revisions to Standards

ISO Protocol requires 5 yearsCurrent 20 element model oriented towards manufacturing sector.Need for driving process oriented managementEvolving customer/consumer/end-user needsExpectation from the standard to help move beyond certification towards performance improvement.Compatibility between ISO 9001 and ISO 9004.Difficulties experienced by small business, especially in terms of documentationProliferation of guideline standardsConfusing supply chain terminology

Year 2000 QMS Standards

Earlier versions of ISO 8402 and ISO 9000 replaced by ISO 9000:2000

Earlier version of ISO 9001, ISO 9002 and ISO 9003 replaced by ISO 9001:2000 Earlier version of ISO 9004 replaced by ISO 9004:2000

Goal of this Technical Specification

The goal of this technical specification is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain .

The technical specification, coupled with applicable customer-specific requirement, defines the fundamental quality management system requirements for those subscribing to this document.

This technical specification is intended to avoid multiple certification audits and provide a common approach to a quality management system for automotive production, and relevant service part organization.

TS 16949 : 2006

FORMATION OF TASK FORCE IN 1995 BY THE AUTOMOTIVE MANUFACTURERS OF USA, FRANCE, GERMANY AND ITLY TO HARMONISE QUALITY SYSTEM REQUIREMENTS.

ISO/ TS 16949:2002 WAS PREPARED BY IATF (INTERNATIONAL AUTOMOTIVE TASK FORCE, JAPAN AUTOMOBILE MANUFACTURES ASSOCIATION (JAMA) AND REPRESENTATIVES FROM ISO/TC176, QUALITY MANAGEMENT AND QUALITY ASSURANCE, AND ITS SUBCOMMITTEES.

RELEASE OF TS 16949 AS A STANDARD IN THE YEAR 1999 ISO/TS 16949:2006 has been released subsequently

EVALUATION OF ISO/TS 16949

VDA 6.1 (Germany)QS 9000 (USA)AVSQ94 (ITALY)

EAQF94 (FRANCE)

ISO/TS 16949

IATFINTERNATIONAL AUTOMATIVE TASK FORCE

INCLUDES

OEMS BMW, DIAMLER CHRYSLER, FIAT, FORD, GENERAL MOTORS, PEUGEOT, VOLKSWAGEN.TRADE ASSOCIATIONSANFIA- ITALY (Association National Far /industries Automobilist)AIAG-USA. (Automotive Industry Action Group)CCFA-FRANCE (Comate des constructers Franois d Automobile)FIEV- FRANCE (Federation des Industries des Equipments pour Vehicles)SMMT LTD. UK (Society of motor manufactures and traders Ltd.)VDA-GERMANY ( Verb and deer Automobilindustrie)

BENEFITS OF GETTING ISO/TS 16949 CERTIFICATION

Improved Product and Process quality.Provide additional confidence for global sourcing.Freeing up supplier resources for other quality activities.Common quality system approach in the supply chain.

BENEFITS OF GETTING ISO/TS 16949

Reduction of variation and increased efficiency.Reduction in 2nd part system auditsReduction in multiple 3rd party registrationsCommon language to improve understanding of quality requirements

Process Approach TS 16949 : 2002 promotes the adoption of a process approach when developing , implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the Process Approach

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of :-

Understanding and meeting requirements,

The need to consider processes in terms of added value

Obtaining results of process performance and effectiveness,and

Continual improvement of processes based on objective measurement.

PROCESS APPROACH

The model of a process-based quality management system shown below, illustrates the process linkages presented in clause 4 to 8 of this international standard. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customers satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown below covers all the requirements of this international Standard, but does not show processes at a detailed level.

Continual Improvement of the Quality Management SystemCustomersRequirementsCustomersSatisfactionManagementResponsibilityResource Management

Measurement, Analysis andimprovement

ProductRealizationProductKey Value-adding activitiesInformation flowModel of a process-based quality management systemInputOutput

WHAT IS A PROCESS

PROCESS : Any activity or group of activities that takes an input, adds value to it, and provides an output to an Internal or External Customer. Processes use an Organizations Resources to provide Definitive Results.

WHAT IS PROCESS ?

PROCESS : 1. Is a chain of value added activities. 2. Delivering a product or a service to a customer (Internal or External) of the process

A Process has a start and end defined by two limits

INPUT OUTPUTCustomer who has a need Customer who has a

WHAT IS PROCESS ?

And a chain of activities between these two limitsINPUTSTEP1STEP2STEP3STEPnOUTPUT

PROCESS ANALYSIS

CUSTOMER ORIENTED PROCESS : (COP)

Any process that comes into physical contact with the hardware or software that will be delivered to a customer, up to the point the product is Packaged.

CUSTOMER ORIENTED PROCESS(COP) :

Key QuestionHow does an organization develop effective and efficient COP s ?

Answer:Support Processes

ANALYSIS OF A COP :

ODEPARTMENT A

ACTIVITY 1ACTIVITY 2ACTIVITY 3ACTIVITY 4

SUPPORT PROCESSESI

WHAT IS A PROCESS ?

12 SUPPORT PROCESS (SOP) :All service Processes and Processes that support customer Oriented Processes. A Support process consists of a group of Logicallyrelated tasks that use the Resources of the Organization to provide Defined Results in support of the organization's Objectives.EXAMPLES???

WHAT IS PROCESS ?

MANAGEMENT PROCESS (MP) :

All such processes which establish the policy, objectives and goals, provide necessary and adequate resources and actions to achieve the sameEXAMPLES???

List of typical business processes in a COMPANY

Market Survey,Product Launch,Product & Process Design Purchasing ManufacturingCalibrationInspectionDispatchPlant &Equipment ControlRecruitment & TrainingOperation Review, Sales Review, Quality, Review, Supplier Review.

PROCESS APPROACH

SYSTEMATIC IDENTIFICATION AND MANAGEMENT OF THE VARIOUS PROCESSES EMPLOYED WITHIN AN ORGANIZATION,

AND PARTICULARLY

THE INTERACTIONS BETWEEN SUCH PROCESSES, IS REFERRED TO, AS THE PROCESS APPROACH TO MANAGEMENT

PROCESS APROACH

All well defined and well-managed processes have common characteristics:

A well-defined team with a leader is held accountable for how well the process performs (the process owner) Well defined boundaries (the process scope) Well defined interfaces and responsibilities Well documented procedures, work instructions and training. Well defined measurement and feedback controls Customer related measurements and targets Well known cycle times.

ESTABLISHQUALITY POLICYSET QUALITY TARGETM.S. PLANNINGAPPOINT M.R.CONTROL OF MANAGEMENT RESOURCESREVIEW & UPDATE M/SREPORT MS RESULTIMPLEMENT MSConti..MANAGEMENTPROCESS

MARKET SURVEYACCEPT ORDERREPORTPRODUCTION PLANXYZ, R&D, JAPANPURCHASINGRECEIVE PRODUCT DRG.SPECIFICATION, TOOLINGMANUFACTURINGINSPECTIONPKG/STOREDESPATCHCUSTOMER ORIENTEDPROCESSConti..E.G. FOR

PROCESS TO PROCESS INTERRELATION

CONTROL OF MEASURING & MONITORING DEVICEEDUCATION / TRAININGCONTROL OF DOCUMENTS/RECORDSCUSTOMER SATISFACTIONSURVEYINTERNAL QUALITY AUDITCORRECTIVE ACTION / PREVENTIVE ACTIONNONCONFORMITY/ MARKET CLAIM PROCESSSUPPORTING PROCESS

Compatibility with other management systems

This international standard has been aligned with ISO 14001:1996 in order to enhance the capability of the two standards for the benefit of the user community This international standard does not include requirements specific to other management systems such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this international standard enable an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this international standard.

TERMS AND DEFINITIONS USED IN ISO / TS 16949 : 2002

Control PlanDocumented description of the systems and processes required for controlling product

Design Responsible OrganizationOrganization with authority to establish a new, or change an existing, product specification

NOTE : This responsibility includes testing and verification of design performance within the customers specified application.

Error ProofingProduct and manufacturing process design and development to prevent manufacture of nonconforming products.

LaboratoryFacility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical or reliability testing.

Laboratory ScopeControlled document containing Specific tests, evaluations and calibrations that a laboratory is qualified to perform. List of equipment which it uses to perform the above, and List of methods and standards to which it performs the above

ManufacturingProcess of making or fabricating Production Material Production of Service Parts Assemblies, or Heat treating, Welding, Painting, Plating or other finishing services

Predictive MaintenanceActivities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes.

Preventive MaintenancePlanned action to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design.

Premium FreightExtra costs or charge incurred additional to contracted deliveryNOTE : This can be caused by method, quantity, unscheduled or late deliveries, etc.

Remote LocationLocation that supports site and at which non-production processes occur.

SiteLocation at which value-added manufacturing processes occur.

Special CharacteristicsProduct characteristics or manufacturing process parameters which can affect safety or compliance with regulations, fit function, performance or subsequent processing of product.Active PartAn active part is one currently being supplied to the customer for original equipment or service applications. The part remains active until tolling scrap authorization is or service applications. The part remains active until tooling scrap authorization is given by the appropriate customer activity. For parts with no customer-owned tooling or situations where multiple parts are made from the same tool. Written confirmation from Ford Engineering and the Buyer is required to deactivate a part.

Aftermarket PartsReplacement parts not produced or released by Ford Motor Company for service part applications which may or may not be produced to original equipment specifications

Capacity VerificationA verification methodology to demonstrate that an organization can meet the capacity planning volume requirements as defined in the purchasing request for Quote (RFQ)

CustomerFor the purpose of ISO/TS 16949:2002, References to Customer in this document shall be interpreted as the entity, e.g. Ford Motor Company, Which is both purchasing and receiving product from the organization complying with ISO/TS 16949:2002ErgonomicsErgonomics is the evaluation of the design of a product or process to assure compatibility with the capabilities of human beings. Analysis of motion refers to capabilities of people with respect to tasks (e.g. lifting, twisting, reaching) to prevent or relieve problems of strain, stress, excessive fatigue, etc. Factors involved include anatomical dimensions of the worker, placement to be worked upon, placement of buttons/Switches, Physical loads imposed on the worker, and environmental effects such as noise, vibration, lighting and space.

Initial Process StudyInitial process studies are conducted to obtain early information on the performance of new or revised processes relative to internal or customer requirements. In many cases, Initial Process studies should be conducted at several points in the evolution of new processes (e.g. at the equipment for tooling subcontractors plant, and after installation at the organizations plant). These studies should be based on variables data evaluated using statistically valid methods.

NOTE : The following terms used in this standards to describe the supply chain Supplier Organization CustomerThe terms organization replaces the terms supplier used in QS- 9000:1998, and refers to the unit to which this international standard applies. Also the terms supplier now replace the terms subcontractors

OrganizationFacility adding manufacturing value to production materials; providers of production or service parts, or heat treating, plating, painting or other finishing services, directly to Ford Motor Company.

NOTE 1 : For the purpose of registration under ISO/TS 16949:2002 the Organization is the entity normally referred to by Ford as the supplier supplier . Ford Motor Company will continue to use that term when negotiating with the organization.

NOTE 2 : To avoid additional confusion although the terms supplier is used by ISO/TS 16949:2002 to indicate subcontractor, Ford Motor Company will continue to use the term subcontractor in its normal usage.

NOTE 3 : Full service supplier also provide engineering services. Program specific Engineering Statement of work defines engineering responsibilities.

NOTE 4 : Sequencing warehouses and other facilities not adding manufacturing value to the product are not eligible for stand-alone registration to ISO/TS 16949:2002.

PPMPPM (parts per million) is a method or stating the performance of a process in terms of actual nonconforming material. PPM data can be used to prioritize corrective actions. Definition of defective units varies with customer (e.g. All sorted, only those found to be wrong, all in box).

QUALITY MANAGEMENT PRINCIPLES & PDCA

Principles of Quality Management

To lead and operate an organization successfully, it is necessary to direct and control it in a systematic and transparent manner.Managing an organization encompasses quality management amongst other management disciplines.Eight Quality management principles have been identified and they from the basis ISO 9001:2000 / TS 16949 : 2002 standard.

Principles 1

Customer-Focused Organization

Organization depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations

Principles 2 Leadership

leader establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become full involved in achieving the organizations objectives

Principles 3

Involvement of people

people at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit

Principles 4

Process approach

A desired results in achieved more efficiently when related resources and activities are managed

Principles 5

Systems approach to management Identifying understanding and managing a system of interrelated processes for a given objective improves the organizations effectiveness and efficiency

Principles 6

Continual Improvement

Continual improvement should be a permanent objective of the organization

Principles 7

Factual approach to decision making Effective decisions are based on the analysis of data and information

Principles 8

Mutually beneficial supplier relationship

An organization and its suppliers are interdependent, and a mutually beneficial relationship enhance the ability of both to create value

SUMMARY OF CHANGES ISO9001:2000 BASED

1. PROCESS APPROACH INTRODUCED:

FOCUS BUSSINESS PROCESSES

ESTABLISH INPUTS TO & OUTPUT FROM

GENERATE DIRECTIONS (SEQUENCE) OF FLOW

ESTABLISH INTERRELATION

MEASURE PROCESS CAPABILITYFOR EFFECTIVE& TARGETDIVISION MANAGEMENTMOSTIMPORTANT!!!

SUMMARY OF CHANGES ISO9001:2000 BASED

2. QUALITY OBJECTIVES

S.M.A.R.T.

TO IMOLEMENT IMPROVEMENT INITIATIVESSTRATEGICMEASURABLEACHEIVABLERELEVANTTARGETEDKPI!

SUMMARY OF CHANGES ISO9001:2000 BASED

COMMUNICATION

INTERNAL

WITH CUSTOMER

SYSTEM EFFECTIVENESS PRODUCT INFORMATION ORDER MANAGEMENTInfo Tech/EDP ProcessesIn QM Scope

SUMMARY OF CHANGES ISO9001:2000 BASED

CUSTOMER SATISFACTION

PROACTIVE APPROACH FOR TAKING PREVENTIVE ACTIONVOC!!

ISO/TS16949 : 2006ELEMENT LISTININGISO/TS 16949:2006

ISO/TS 16949:2000concepts

Action elements for ISO9000:2000 is basedOn 5 key ElementsElement 4 to 8

ISO/TS 16949:2000concepts

5 key element can be divided intoSystem based :Elements4,5 and 6

Operational(Product Centered)Element 7 and 8

ISO/TS 16949 :2002

ISO/TS SPECIFIC REQUIREMENTS

ISO/TS 16949 :2002

4.1.1 General Requirements- SupplementalThe organization shall be responsible for the conformity to all customer requirements in case of outsourced processesProcess not to be confused with manufacturing process????E.g. Calibration/Maintenance

ISO/TS 16949 :2002

4.2.3.1 Engineering Specifications

Timely review (shall not exceed two working weeks) of all customer engineering standards and changes.Maintain record of Implementation date in productionUpdate all appropriate documents. (E.g PPAP documents viz Control plan FMEAs etc

E.g PPAP document viz Control Plan, FMEAs etc

ISO/TS 16949 :2002

4.2.4.1 Record Retention Shall satisfy regulatory and customer requirements.

Homologation

ISO/TS 16949 :2002

5.1.1 process Efficiency Top management shall review. Product Realization Process (Element 7.0) Support Processes??? Assuring Effectiveness and Efficiency.

MIS?KPIs does it reflect onlyEfficiency???? Or Effectiveness????Or Both????Not to be Confused With productRealization/APQPIn 1999 version

ISO/TS 16949 :2002

5.4.1.1 Quality Objectives - Supplemental Top management shall : Shall define the goals and the measurable Shall be referenced in the business Shall be referenced in the business.

Quality objectives should link to customer expectations and achievable within a defined time period

ISO/TS 16949 :2002

5.4.1.1 Quality Objectives - Supplemental Management with responsibility and authority for corrective action shall be Promptly informed or products and processes which do not conform to requirements

Quality responsibility personnel needs to be identified. He shall have authority to stop production to correct quality problems.

Shift resources especially concerning the production shall be staffed with personnel in charge of quality.

Who is responsible for quality????

ISO/TS 16949 :2002

5.5.2.1 customer Representative Management with responsibility and authority for corrective action shall be Promptly informed or products and processes which do not conform to requirements

Quality responsibility personnel needs to be identified. He shall have authority to stop production to correct quality problems.

Shift resources especially concerning the production shall be staffed with personnel in charge of quality.

Who is responsible for quality????

ISO/TS 16949 :2002

5.5.2.1 customer Representative Customer Representative shall be identified to represent the needs of the customer Needs to include: Selection of special Characteristics Setting quality Objectives Related Training Corrective action and preventive actions Product design and development

ISO/TS 16949 :2002

5.6.1.1 QMS Performance Review performance trends and link to continual improvement process. Review shall include all requirements of the quality systems Part of Management review shall be the monitoring of quality objectives and evaluation of the cost of poor quality. Evidence of achievement pertaining to Objectives specified in the business plan Customer satisfaction with product supplied

ISO/TS 16949 :2002

5.6.2.1 Review Input - Supplemental Shall include : Analysis of actual and potential field failures. Impact on Quality, safety and environment

FMEAs???

ISO/TS 16949 :2002

6.6.2.1 Product Design Skills Applicable tools and techniques shall be identified by the organization Personnel in product design are competent?? And have requires skills in the applicable tools and techniques

Will experience be enough?? Or should include Qualification/Certifications for the skill

ISO/TS 16949 :2002

6.6.2.2 Training Establish and maintain documented procedure for. Identify Training Needs Achieving competence of all personnel performing activities affecting product quality Personnel performing specific assigned task shall be qualified with particular attention to the satisfaction of customer requirements.

Applies to all employees having effect on qualityE.g. of customer specific req. is the application of digitized mathematically based data

ISO/TS 16949 :2002

6.6.2.3 Training on the job On job training for personnel in new or modified job affecting quality.

Consequences incurred by customer in case of non conformities.

Personnel affecting quality needs to be informed of the consequences.

Include contract or agency personnel.

Process Operators???

ISO/TS 16949 :2002

6.2.2.4Employee motivation and empowerment Shall have a process for motivation of employee. To achieve quality objectives To make continuous improvements To create an environment to promote innovation Shall include promotion of Quality and Technological Awareness on all levels Shall have a process to measure the extent to which its personnel Are aware of the relevance and importance of their activities Aware of how they contribute to the achievement of the quality objective

NEW

ISO/TS 16949 :2002

6.3.1 Plant, Facility and Equipment Planning Use multidisciplinary approach. Plant layout to optimize material travel and handling. Synchronous Material Flow Maximize Value Added Use of Floor Space

Methods to evaluate and monitor the effectiveness of existing operations and processes shall be developed and implemented.These requirements should focus on lean manufacturing principles and the link to effectiveness of the QMS Red underlined is new

ISO/TS 16949 :2002

6.3.2 Contingency Plans To safety customer requirements in the event of emergency

Emergency Includes utility interruptions, labour shortages, key equipment failure and field returns.

May involve visit to Dealers/Service to replace a defective part????

ISO/TS 16949 :2002

6.4.1 Personnel Safety to achieve product Quality Due care regarding product safety

Means to minimize potential risk to employees shall be addresses especially in design control and progress control

ISO/TS 16949 :2002

6.4.2 Cleanliness of premises Maintain its premises in a state of order, cleanliness and repair

Shall be consistent with the product and manufacturing process needs.Dust free???? Temperature and humidity control?????

ISO/TS 16949 :2002

7.1.1 Cleanliness of premises Needs to reference customer requirements and from as a component of the quality plan

ISO/TS 16949 :2002

7.1.2 Acceptance criteria Accurate criteria shall be defined by the Organization and approved by the customer.

For attribute data sampling, the acceptance level shall be zero defects.

ISO/TS 16949 :2002

7.1.3 Confidentiality Shall ensure the confidentially of customer related products and projects under developments.

Includes related product information.

ISO/TS 16949 :2002

7.1.4 Change Control Shall have a process to control and react to change that impact product realization. Shall be linked to verification/validation to ensure compliance with customer requirements.Shall include changes caused by supplier. Synchronous Material Flow Maximize Value Added Use of Floor SpaceShall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.

ISO/TS 16949 :2002

7.2.1.1 Customer-designated special characteristics Shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.

ISO/TS 16949 :2002

7.2.2.1 Review of requirements related to the product-Supplemental Waiving the requirements stated in contract review (e.g. internet salves where formal review is impractical) shall require customer authorization.

ISO/TS 16949 :2002

7.2.2.2 Organization manufacturing feasibility Shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process.Shall include risk analysis.Statutory/regulatory violations??? Manufacturing environment????

ISO/TS 16949 :2002

7.2.3.1 Customer Communication-Supplemental Shall communicate necessary information, including data in a customer specified language and format

ISO/TS 16949 :2002

7.3 Design and Development This covers both product and manufacturing process design

Focus on error prevention rather than detection

ISO/TS 16949 :2002

7.3.1.1 Multidisciplinary approach Use of MFT during the product realization stages especially related toDevelopment/Finalization and monitoring of special characteristics,Development and review of FMEa including actions to reduce potential riskDevelopment and review of control planFocus on error prevention rather than detectionMFT includes design, manufacturing,engineering, quality, production and appropriate personnel

ISO/TS 16949 :2002

7.3.2.1 Product Design Input Design inputs needs to reference targets for product quality, life, reliability, durability and maintainability, timing and cost

Needs to have a information systems to review the previous design projects and competitor analysis, supplier feedback, internal input, field data for current and future projects of similar nature.

Customer requirements E.g. special characteristics, identification and traceability and packaging.

ISO/TS 16949 :2002

7.3.2.2 Manufacturing process design input Process design input requirements to be documents to be documented, reviewed and include.

Product design output data

Targets for productivity, process capability and costCustomers requirementsExperience from previous developmentsShall include product characteristics and process parameters

ISO/TS 16949 :2002

7.3.3.2 Manufacturing process Design output Specifications and drawings. Manufacturing process flow chart/layout Process FMEAs Control plans/job instructions Process Approval acceptance criteria- Data for quality, reliability, maintainability and measurabilityResults of mistake-proofing activities Methods of rapid detection and feedback of product/process non conformities

ISO/TS 16949 :2002

7.3.4.1 Monitoring Should be defined at appropriate stages, analyzed and reported as an input to the management review.Includes Quality risks, costs, lead-times, critical paths

ISO/TS 16949 :2002

7.3.6.1 Design and Development Validation- Supplemental Shall be as per Customer requirements including programme timing

ISO/TS 16949 :2002

7.3.6.2 Prototype Programme Prototype programme when required by the customerUse of same supplies, tooling and processes as will be used in productionMonitoring of testing activities for timely completion and conformance to requirementsServices may be outsourced.

ISO/TS 16949 :2002

7.3.6.3 Product approval process Use product and manufacturing process approval procedure recognized by the customer Shall also be applied to suppliersProduct approval should be subsequent to the verification of the manufacturing process

ISO/TS 16949 :2002

7.4.1.1 Regulatory conformity All purchased products or material used in product shall conform to applicable regulatory requirementsIncludes consumables Grease/Oil??? Raw material

ISO/TS 16949 :2002

7.4.1.2 Supplier Quality Management System Development Quality system development with the goal of compliance to TS or an existing customer Quality System manual.Conformity with ISO 9001:2000 is the first step in achieving this goal.The prioritization of suppliers for development depends upon supplier performance and importance of the product suppliedThird party audit to ISO9001:2000 if not specified by the customer

ISO/TS 16949 :2002

7.4.1.3 Customer Approved Sources If specified in the contract (including drawing/specifications.) the organization shall purchase products, material or services from approved sources

ISO/TS 16949 :2002

7.4.3.1 Incoming product quality Receipt and evaluation of statistical data Receiving inspection and /or testing Second or third party assessments or audits of supplier sites, when coupled with records of acceptable delivered product quality Part evaluation by accredited labs Another method agreed with the customer

ISO/TS 16949 :2002

7.4.3.2 Supplier Monitoring Following indicators shall be used Delivered product quality Customer disruptions including field returns Delivery schedule performance (including incidents of premium freight) Special status customer notifications related to quality or delivery issues.Shall promote supplier monitoring of the performance of their manufacturing processes

ISO/TS 16949 :2002

7.5.1.1 Control Plan At system, subsystem, component, material level for the product suppliedShall Cover Pre-launch and production PhasesShall link to design FMEA and manufacturing process FMEA output

ISO/TS 16949 :2002

7.5.1.1 Control Plan Shall list the controls used for manufacturing process controlInclude for monitoring related to special characteristics.Include the customer required informationInitiate the specified reaction plan when the process becomes unstable or not statistically capable.Shall be reviewed when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources or FMEA

Customer approval may be required after review or updated of the control plan

ISO/TS 16949 :2002

7.5.1.2 Work Instructions Work instructions for all employees having responsibilities for the operation of processes that impact product.Shall be accessible for use at the work stationShall be linked to Quality plan, the control plan and the product realization process.

Quality plan and control plan??? Any differences????

ISO/TS 16949 :2002

7.5.1.3 Verification of job set-ups Verify whenever a set up is done (initial run, material changeover, job change, significant time period, etc..)Job instruction for set up personnelUse of statistical methods of verification

Last off part comparisons are recommended

ISO/TS 16949 :2002

7.5.1.4 Preventive and Predictive maintenance Identify key process equipmentDevelop an effective planned total preventive maintenance and shall includePlanned maintenance activities.Packaging and preservation of equipment, tooling and gaugingAvailability to replacement parts for key manufacturing equipmentDocumenting, evaluating and improving maintenance objectivesUse predictive maintenance methods (Noise level of brg. Vibration, contamination level of fluids, etc.,) to improve effectiveness and efficiency of production equipment.

ISO/TS 16949 :2002

7.5.1.5 Management of Production Tooling Provide resources for tool and gauge design, fabrication and verification activities.Tool design, manufacturing and modifications, if any including documentationPlanned preventive maintenance and repair facilitiesStorage and RecoverySet upTool change programs for perishable toolsTool identification, defining the status such as production, repair or disposalTrack & follow up in case of outsourcing

ISO/TS 16949 :2002

7.5.1.6 Production Scheduling

Shall meet customer requirements.

Information system that permits access to production information at key stages of the process and is order driven

ISO/TS 16949 :2002

7.5.1.7 Feedback of information from service

Communication On service concerns internally to manufacturing, engineering and design activities shall be established and maintainedThis is to certify that the organization is aware of nonconformities that occur external to its organization

ISO/TS 16949 :2002

7.5.1.8 Service agreement with customer

Verify the effectiveness of

Any organization service centers

Special purpose tools

Training of servicing personnel

ISO/TS 16949 :2002

7.5.4.1 Customer- owned production tooling

Customer owned tools, manufacturing test, inspection tooling and equipment shall be permanently marked.Note added to 7.5.4 Customer property Includes customer owned returnable packaging

ISO/TS 16949 :2002

7.6.1 Measurement system analysis

Applies to measurement system referred in control plan.

Appropriate statistical studies E.G. Bias, Linearity, Stability, Repeatability and reproducibility etc.

The analytical methods and acceptance criteria used shall conform to customer reference manuals on MSA

ISO/TS 16949 :2002

7.6.2 Calibration/Verification records

Shall cover employee and customer owned equipmentRecords of calibration/Verification activity shall includeEquipment identification including the mastersRevision following engineering changesOut of specifications readings and an assessment of the impactStatements of conformity to specification after calibration/VerificationNotification to customer in case of shipment of suspect product/material

ISO/TS 16949 :2002

7.6.3.1 Measurement system analysis

The laboratory shall specify and implement Laboratory proceduresCompetency of the laboratory personnel Testing of productsCapability to perform these services correctly and review of the relatedAccreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house laboratory conformity but is not mandatory

ISO/TS 16949 :2002

7.6.3.2 External Laboratory Covers External, commercial and independent laboratory.Shall have a defined lab.Scope and includes the capability to perform testing/calibration and other:Evidence that the external laboratory is acceptable to the customerThe laboratory shall be accredited to ISO/IEC 17025 or national equipmentCustomer assessment or customer approved second party assessment may be used.In case qualified lab is not available then such services can be performed by an equipment manufacturer provided internal lab. Requirements are satisfied

ISO/TS 16949 :2002

8.1.1 Identification of Statistical tools Identify appropriate statistical toolsLink through Advance quality planning and included in control plan

ISO/TS 16949 :2002

8.1.2 Knowledge of basic statistical concepts Understanding of basic statistical concepts E.g. verification, control, process capability

ISO/TS 16949 :2002

8.2.1.1 Customer satisfaction-supplemental Customer satisfaction needs to monitored through performance indicators:Delivered part quality performanceCustomer disruptions including field returnsDelivery schedule performance (including incidents of premium freight)Customer notifications related to quality or delivery issuesMonitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiencySupported by Objective information

ISO/TS 16949 :2002

8.2.2.1 Quality Management System audit Audit for compliance to TS standard.

Audit for any other additional QMS requirements.

What could this mean???

ISO/TS 16949 :2002

8.2.2.2 Manufacturing process unit Audit each manufacturing process to determine its effectiveness.

ISO/TS 16949 :2002

8.2.2.3 Product Unit Audit at a defined frequency the products at appropriate stages of production and deliveryVerify the specified requirements/product dimensions/functionality/packaging and labeling

ISO/TS 16949 :2002

8.2.2.4 Internal audit Plans Schedule as per annual plan

Cover all quality management related processes, activities and shifts.

ISO/TS 16949 :2002

8.2.2.5 Internal auditor qualification Auditors to be qualified to audit the requirement of TS

IATC objective

ISO/TS 16949 :2002

8.2.3.1 Monitoring and measurement of manufacturing processes Perform process studies on all new manufacturing processes to verify the process capabilityThese results shall be documented along with objectives for manufacturing process capability, reliability, maintainability and availability as well as acceptance criteria.Shall maintain manufacturing process capabilityControl plan and process flow diagram are implemented

ISO/TS 16949 :2002

8.2.3.1 Monitoring and measurement of manufacturing processes Significant process events (tool change, machine repair, etc.,) shall be recordedFor characteristics listed in control plan, If it is unstable or non-capable100% inspectionsCorrective action plan to achieve stability and capability Customer approval, if requiredMaintain records of process change effective dates

ISO/TS 16949 :2002

8.2.4.1 Layout inspection and functional testing Shall be performed for each product as specified in the control plans.Results shall be available for customer review

Layout inspection is the complete measurement of all product dimensions shown on the design records

ISO/TS 16949 :2002

8.2.4.2 Appearance Appropriate lighting for evaluation areas.Master for color, grain, gloss, metallic, brilliance, texture, distinctness of image.Maintenance and control of appearance masters and evaluation equipment.Verification by qualified and competent personnel.

ISO/TS 16949 :2002

8.3.1 Control of nonconforming product-Supplemental Product with unidentified or suspect status shall be classified as non conforming product

ISO/TS 16949 :2002

8.3.2 Control of reworked project Instruction for rework, including re-inspection requirements, shall be accessible to any utilized by the appropriate personnel.

ISO/TS 16949 :2002

8.3.3 Customer information Customer shall be informed promptly in the event that nonconforming product has been shipped

ISO/TS 16949 :2002

8.3.4 Customer waiver The organization shall obtain a customer concession or deviation permit prior to further processingThe organization shall maintain a record of the expiration date or quality authorizedMaterial shipped on an authorization shall be properly identified on each shipping containerThis applies equally to purchase product. The organization shall agree with any request from suppliers before submission to the customer

ISO/TS 16949 :2002

8.4.1 Analysis and use of data Development of priorities for prompt solution to customer related problemDetermination of key customer-related trends and correlation for status review, decision-making and longer term planning.An information system for the timely reporting of product information arising from usage.

Data should be compared with those of competitors and/or appropriate benchmarks

ISO/TS 16949 :2002

8.5.1.1 Continual improvement of the organization The organization shall define a process for continual improvement.

ISO/TS 16949 :2002

8.5.1.2 Manufacturing process improvement Manufacturing process improvement shall continually focus upon control and reduction of variation in product characteristics process parameters Continual improvement is implemented once manufacturing process are capable and stable, or product characteristics are predictable and meet customer requirements

ISO/TS 16949 :2002

8.5.2.1 Problem Solving The organization shall have a defined process for problem solving leading to root cause identification and elimination.

ISO/TS 16949 :2002

8.5.2.2 Corrective action impact The organization shall apply to other similar processes and product the corrective action, and controls implemented, to eliminate the cause of nonconformity.

ISO/TS 16949 :2002

8.5.2.4 Rejected product test/analysis The organizational shall analysis part rejected by the customers manufacturing plants engineerings plants, engineerings facilities and dealership.The organization shall minimize the cycle time of this process.Records of these analysis shall be kept and made available upon request.The organization shall perform analysis and initiate corrective action to prevent recurrence

Cycle time related to reject product analysis should be consistent with the determination of roots cause, corrective action and monitoring the effective of implementation