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TV SD South Asia Slide No 1

TV SD South AsiaTV SD South Asia


TV SD South AsiaTV SD South AsiaWelcomes You to the One Day Awareness ProgramWelcomes You to the One Day Awareness Program

OnOnISO/TS16949:2009ISO/TS16949:2009

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Chapter 1Chapter 1Introduction to QMSIntroduction to QMS

8September 2011


QMS Objectives

1. To Prevent Defect

2. To Eliminate Waste in the entire Supply Chain3. To Reduce Variation

4. To Continually Improve Effectiveness of Quality Management System

QMS Principles1. Customer Focus Meeting Current and future requirements of customer2. Leadership Direct and Control3. Involvement of People All functions, all levels and all employees4. Process Approach Requirements (Input ), Results (output), Resources (control)5. Systems Approach to Management Plan-Do-check-Act6. Continual Improvement Enhance probability of customer satisfaction

7. Factual Approach to Decision Making Personally verified facts for decision making8. Mutually Beneficial Supplier Relationships - Win win relationship

QMS Objectives / Principles

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Customer

/Other

Interested

Parties

Management

Responsibility

Resource

Management

Measurement,

Analysis and

Improvement

Product

Realization

5

Requirements

Customer

/Other

Interested

Parties

Satisfaction

86

7

ProductInput Output

Continual Improvement of

The Quality Management System

Value Adding Activity Information Flow

Process Approach


Marketing

DesignandDevelopment

Planning

Production

QualityAssuranceandQC

LogisticsP

urchase

Store

Lab

Customer

Requirements

Customer

Satisfaction

Product

MOP

SOP

COP

COP :

Customer Oriented Process

SOP :

Support Oriented Process

MOP:

Management Oriented Process

Classification of processes

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Requirement

Desired Results

Conformity

ProcessInput Output

Man :From self :

Knowledge,

Skill,

Competency

From Organisation :Roles,

Responsibility

Authority

Material :Infrastructure (6.3)Physical resources like Land, building,

Plant, Machinery, Hardwares, Offices,

etc.

Work Environment (6.4)Heat, Noise, Light, Hygiene, Humidity,

Cleanliness, Pollution, Vibration, Air

Flow, etc.

Measurement

Effectiveness :

Extent to which the planned activities are

realized and planned results are achieved.Effectiveness = Results / Requirements

Efficiency :

Relationship between result achieved and

resources used.

Efficiency = Results / Resources

MethodGeneric Methods

1. Control of Documents

2. Control of Records

3. Training4. Internal Audit

5. Control of Non Conforming

Products

6. Corrective Actions

7. Preventive Actions

Function Specific Methods

Undesired Results

Non-Conformity

Process Approach

Process Approach


Chapter 2Chapter 2Quality Management SystemQuality Management System

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1.1 Scope : Purpose of organizations business, Design-Manufacture-Service

1.2 Application Exclusions with Justifications Only in Clause 7.3 (Productdesign related clauses only)

2 Normative Reference Standards referred.

3 Terms and Definitions

4 Quality Management Systems

4.1 General Requirements4.1.1 Outsourced Processes

4.2 Documentation Requirements

4.2.1 General4.2.2 Quality Manual

4.2.3 Control of Documents

4.2.3.1 Engineering Specifications4.2.4 Control of Records

4.2.4.1 Record retention

Clause 4 : Quality Management Systems


4.1 General requirements

Establish, Document, Implement, maintain and continually improve

effectiveness of QMSa. Identify Processes and its applications

b. Determine its sequence and interactionsc. Determine criteria and methods for operation and control of the

processes

d. Ensure Availability of resources and information for effective monitoringand operation.

e. Monitor, measure and analyze the performance(effectiveness/efficiency) of the process.

f. Implement actions necessary to achieve planned resultsg. Continually improve effectiveness of QMS

For outsourced processes, determine and implement type and extent ofcontrol over suppliers.

4.1.1 Though Outsourced, responsibility of conformity to product requirements

remains with Organization.


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4.2.1 General Requirements Documented statements of Quality policy, Documented statement of Quality Objectives

Corporate, Functional, Individual Quality Objectives Quality Manual Documented procedures

Control of Documents Control of records Internal Audit Control of Non conforming product Corrective Action Preventive Action

Work Procedures and Product Process related documents Records

4.2.2 Quality Manual Scope and Exclusions References to documented procedures Interaction between various processes



4.2.3.1 Engineering Specifications Process of timely review, distribution and implementation of engineering

specs. And Changes Review of Changes within 2 weeks Date of implementation of each change shall be recorded.

Implementation shall include updated documents Updated PPAP, updated control plan, updated FMEA and related

documents, etc.

4.2.3 Control of Documents Approval prior to issue Review , update and re-approve Identification of changes and current versions Availability of relevant versions at point of use Legible and readily identifiable Control over external origin documents Control over unintended use of obsolete documents


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4.2.4 Control of records Identification Storage Protection, Retrieval, Retention Disposition Legible, readily identifiable and retrievable


4.2.4.1 Records Retention Records shall be retained and controlled as per statutory, regulatory and

customer requirements.


Chapter 3Chapter 3Management Respons ibilityManagement Respons ibility

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5.1 Management Commitment

5.1.1 Process Efficiency5.2 Customer Focus

5.3 Quality Policy

5.4 Planning5.4.1 Quality objectives

5.4.1.1 Quality Objectives Business Plan5.4.2 QMS Planning

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and authority5.5.1.1 Responsibility for Quality

5.5.2 Management Representative5.5.2.1 Customer Representative

5.5.3 Internal Communication5.6 Management Review

5.6.1 General5.6.1.1 QMS Performance

5.6.2 Review Input

5.6.2.1 Analysis of Field Failures5.6.3 Review output

Clause 5 : Management Responsibility

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5.2 Customer Focus Determination and meeting of Current as well as future requirements

5.1 Management Commitment Communicate importance of meeting customer, statutory andregulatory requirements [5.2 ]

Establish Quality Policy [5.3 ] Establish Quality Objectives [ 5.4.1] Assign Responsibilities and Authorities [5.5.1] Conduct Management Reviews [5.6] Ensure Availability of resources [6]

5.3 Quality Policy Appropriate to Purpose of Organisation Include commitment to meet requirements and improving effectiveness of

QMS Provides framework to review of quality objectives Communicated and understood Reviewed for continued suitability


5.1.1 Process Efficiency Effectiveness and Efficiency of product realization and Support processes

shall be reviewed.

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5.4 Planning

5.4.1 Quality Objectives Established at relevant functions and levels of organisation

Corporate Functional Individual

Measureable and consistent with quality policy SMART

Specific Measurable Ambitious Realistic Time Bound

Effectiveness and Efficiency, Both are defined

5.4.1.1 Quality Objectives Business plan linkage Business plan shall include Quality objectives and measurements

based on customer expectations and should be achievable in

defined time period.



5.4.2 Planning of Quality Management Systems Quality planning Quality Assurance Quality Control Quality improvement


5.5 Responsibility, Authority and Communication5.5.1 Responsibility and Authority

Defined and communicated

5.5.1.1 Responsibility for Quality Rapid feedback about product / process nonconformity to

Managers having responsibility and authority to take corrective

actions

Authority to stop production with personnel responsible for productconformity.

Adequate staff for responsibility for quality across all shifts.

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5.5.2 Management Representative Establish, implement and maintain processes needed for QMS Report organizations QMS performance to Top management Promote awareness of Customer Requirements throughout the

organisation.

5.5.3 Internal Communication

Means and Methods of Communication shall be defined.


5.5.2.1 Customer Representative Address customer requirements like

Selection of special characteristics Setting of quality objectives and related training Product design and development Corrective and preventive actions


5.6 Management Review5.6.1 General

Review of QMS to ensure Continued suitability Adequacy and Effectiveness

Planned intervals


5.6.1.1 QMS Performance Review of

All performance trends Cost of Poor Quality Quality Objectives mentioned in business plan Customer satisfaction

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5.6.2 Review Inputs

Results of Audit Customer Feedback Product Conformity Process Performance Status of Corrective and Preventive Actions Last Reviews Changes affecting QMS (Modification, addition and Deletion) Recommendations for Improvement

5.6.3 Review Output Decisions and actions related to improvement in QMS and Product Resource Needs


5.6.2.1 Review Inputs Supplemental Analysis of actual and potential field failures and their impact on

safety, quality and environment, shall be considered as input toManagement Review


Chapter 4Chapter 4Resource ManagementResource Management

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6.1 Provision of Resources6.2 Human Resource

6.2.1 General

6.2.2 Competency, awareness and training6.2.2.1 Product design skills

6.2.2.2 Training

6.2.2.3 Training on the job6.2.2.4 Employee motivation and empowerment

6.3 Infrastructure6.3.1 Plant, facility and equipment planning

6.3.2 Contingency plans

6.4 Work Environment6.4.1 Personnel safety

6.4.2 Cleanliness of premises

Clause 6 : Resource Management

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6.1 Provision of Resources6.2 Human Resources6.2.1 General

Personnel responsible for product conformity shall have necessarycompetence on the basis of education, skills, experience and

training.

6.2.2 Competency, awareness and training Determine Competence (based on education, skills, training and

experience) necessary to ensure conformity to product

requirements Give training or other necessary actions to achieve competence. Evaluate effectiveness of actions taken Awareness about relevance and importance of their activities and

their contribution in achieving quality objectives. Records of education, training, skills and experience


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6.2.2.1 Product Design Skills Product design competency to achieve design requirements Skills in applicable design tools and techniques, as identified by the

organization

6.2.2.2 Training Documented procedure for identification of training needs and

development of necessary competence. Personnel having specific assigned tasks shall be qualified based

on customer requirements.

6.2.2.3 Training on the job On the job training for new or modified job for company

personnel as well as contract or agency personnel. Awareness about effect of defect (consequences of product non-

conformities) on customer.



6.2.2.4 Employee Motivation and empowerment Process of Motivation

To achieve quality objective To do continual improvement To create an environment to promote innovation

Process of motivation shall include quality and technological

awareness throughout the organisation Measurement of extent to which quality objectives are achieved

and relevance and importance of activities are understood.

6.3 Infrastructure Land, Building, workspace and associated utilities Process Equipment (Hardware and Software) Supporting systems (Transport, Communication, information Systems)


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6.3.1 Plant, Facility and Equipment Planning Multidisciplinary approach Plant layouts shall

Optimize material travel, handling and value-added use offloor space

Facilitate use of synchronous material flow. Use of Lean Manufacturing Principles

Methods for evaluation of effectiveness of existing operations.(Value Stream Mapping)


6.3.2 Contingency Plans Contingency plans in the situations like

Labor Shortage Key equipment failure

Field failures Utility interruptions


6.4 Work Environment Manage Work Environment (Noise, humidity, temperature, vibration, air flow,

lighting, weather and other physical conditions)


6.4.1 Personnel Safety Product safety and personnel safety risks and means to eliminate that shall be

addressed during product design and development and in manufacturing

activities.

6.4.2 Cleanliness of premises Workplace in the state of order, Cleanliness and repair as needed for product

realization process.

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Chapter 4Chapter 4Product Realization (7.1Product Realization (7.1--7.3)7.3)

8September 2011


7.1 Planning Of Product Realization7.1.1 Quality plan

7.1.2 Acceptance Criteria

7.1.3 Confidentiality

7.1.4 Change control

7.2 Customer Related Process7.2.1 Determination of Requirements

7.2.1.1. Customer designated special characteristics

7.2.2 Review of Requirements

7.2.2.1 Customer Authorization to waivers

7.2.2.2.Organization Manufacturing Feasibility

7.2.3 Customer Communication

7.2.3.1 Customer specified language and format

7.3 Design and Development7.3.1 Design and Development Planning

7.3.1.1 Multidisciplinary approach

7.3.2 Design and Development Inputs

7.3.2.1 Product design Inputs

7.3.2.2 Manufacturing Process Design Inputs

7.3.2.3 Special Characteristics

7.3.3 Design and Development Outputs

7.3.3.1 Product design outputs

7.3.3.2 Manufacturing Process Design Output

Clause 7 : Product Realization

7.3 Design and Development7.3.4 Design and Development Review

7.3.4.1 Project Monitoring

7.3.5 Design and Development verification

7.3.6 Design and development Validation

7.3.6.1 Programme timing

7.3.6.2 Prototype programme

7.3.6.3 Product approval process

7.3.7 Design and development Changes

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7.1 Planning Of Product Realization Determine Quality Objectives and Requirements of Product Determination of processes and documents needed Determine need to provide resources necessary for product (Machine,

Tools, Fixtures, Gauges, Instruments and others) Determine required verification, validation, monitor, measurement,

inspection and test activities Determine records needed to show evidence that the requirements are

met.

7.1.1 Quality Plan Quality plan shall include customer requirements and technical

specifications


7.1.2 Acceptance Criteria

Acceptance criteria shall be defined and as applicable, approved bycustomer. For attribute sampling, C=0 should be acceptance criteria.


7.2 Customer Related Processes7.2.1 Determination of Product Requirements

Fit, form, function, finish, material, process, packaging, labeling Cost, Volume, Project and QMS

Statutory and regulatory (All government, safety and environmental requirementsrelated to acquisition, storage, handling, recycling or disposal of materials)

Delivery and post delivery requirements


7.1.3 Confidentiality Products and projects alongwith product information shall be kept

confidential.

7.1.3 Change Control Process for controlling and reacting to changes, impacting product

realization. Evaluation of effects of changes Verification and Validation activities before change implementation. For proprietary designs , impact on fit, form, function, performance,

durability shall be reviewed with customer.

7.2.1.1 Customer Designated Special Characteristics Requirements related to designation, documentation and control of special

Characteristics

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7.2 Customer Related Processes

7.2.2 Review of Product Requirements Evaluate ability to meet requirements Determine Risks like quality risk, capacity risk, profitability risk, systems risk Devise Risk Mitigation Plan Make Contracts and agreements with customer. In case of amendments, necessary documents shall be changed.


7.2.2.1 Customer Authorization for waiver Waiver to formal review shall be authorized by customer .

7.2.2.2 Organization Manufacturing Feasibility Investigation, confirmation and documentation of manufacturing feasibility

including risk analysis.

7.2.3 Customer Communication Ensure arrangements for communication with customer in relation to -

Customer feedback including Customer Complaints

Enquires, contracts, orders and its amendments Product information

7.2.3.1 Customer Specified language and format Organization shall have means to communicate in customer specified language,

versions, formats (e.g. CAD data, web portals, Electronic data exchange, etc.


7.3 Design and Development7.3.1 Design and Development planning Define stages of design and development Define responsibilities and authorities of personnel (CFT) Define review, verification and validation arrangements at each stage. CFT design and development, marketing, manufacturing, quality

assurance, suppliers, etc.

7.3.1.1 Multidisciplinary approach Use CFT (cross functional teams) for -

Development /finalization and monitoring of special characteristics Development and review of FMEAs and actions arising from the

same. Development and review of control plan


7.3.2 Design and Development Inputs Get Inputs like Functional and performance requirements Statutory and regulatory requirements Similar designs, CFTs previous experience Other requirements.

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7.3.2.1 Product Design Inputs

Identify, document and review of product design input requirementsincluding

Requirements related to special characteristics, identification ,

traceability and packaging A process to deploy information from

Previous design projects Competitor analysis Supplier feedback Internal output Field data Information from various sources regarding current and future

projects of similar nature Targets for

Quality (product requirements)

Durability Maintainability Reliability Cost Project timing



7.3.2.2 Manufacturing Process Design Inputs Identify, document and review of manufacturing process design inputrequirements including

Product design output data (drawings/specs/standards) Targets for

Productivity (speed of production) Process Capability Cost

Customer requirements related to manufacturing processes Experience from previous designs.

7.3.2.3 Special characteristics Identify special characteristics (product and/or process, as applicable) Include the same on control plan

Comply with customer specified definitions and symbols Special Characteristics symbols shall be shown on Drawings, FMEAs,

Control Plans, Operator instructions

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7.3 Design and Development

7.3.3 Design and Development Outputs Output shall

Meet input requirements Provide information for purchasing, production and service

provision Contain product acceptance criteria Specify characteristics of product for its safety and use.

7.3.3.1 Product Design Output Product design output shall be verified and validated against input

requirements. Outputs shall include

Design FMEA, Reliability results Product special characteristics and specifications

Product error proofing Drawings and mathematical data Product design review results Diagnostic guidelines



7.3.3.2 Manufacturing Process Design Outputs Manufacturing process design output shall be verified and validated

against input requirements. Output shall include

Specifications of processes and drawings of processes (tools,fixtures, moulds, gauges, templates, checking fixtures, etc)

Manufacturing process flow chart / layout Manufacturing process FMEAs Control plans Work instructions Process approval acceptance criteria Data for quality, reliability, maintainability and measurability Results of error-proofing Methods of rapid detection and feedback of product/manufacturing

process nonconformities


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7.3.4 Design and Development Review At suitable stages of design and development, systematic reviews shall

happen to Evaluate ability to meet requirements Identify any problems and Propose necessary actions


7.3.5 Design and Development Verification Verification shall happen to see whether input requirements are met by

output results

7.3.4.1 Monitoring Measurements shall be done at specified stages, analyzed and reported with

summary results to top management as an input to management review. The monitoring shall include

Quality risk, Lead time Cost Critical path


7.3.6 Design and Development validation Validations shall happen to see whether product meets specified

application or use. Validations shall be completed prior to use.


7.3.6.1 Programme timing D & D validations shall be as per customer requirements, including

programme timing

7.3.6.2 Prototype Programme Prototype programme and control plan Same suppliers, tooling and manufacturing processes as that of production are

preferred. Timely completion, conformity to requirements Where outsourced, its organization's responsibility, including technical

leadership.

7.3.6.2 Product approval process Product and Process approval procedure shall be recognized by customer Applicable to suppliers, too.

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7.3.7 Design and Development Changes Changes shall be reviewed, verified, validated and approved before

implementation. Effect on constituent part or product already delivered shall also be

evaluated during review of changes.



Chapter 5Chapter 5Product Realization (7.4Product Realization (7.4--7.6)7.6)

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7.4 Purchasing7.4.1 Purchasing Process

7.4.1.1 Statutory and regulatory conformity

7.4.1.2 Supplier QMS development

7.4.1.3 Customer approved sources

7.4.2 Purchasing Information7.4.3 Verification of Purchased Product

7.4.3.1 Incoming product quality

7.4.3.2 Supplier Monitoring

7.5 Production and Service provision7.5.1 Control of production and service provision

7.5.1.1 Control plan

7.5.1.2 Work instructions

7.5.1.3 Verification of job set ups

7.5.1.4 Preventive and predictive maintenance

7.5.1.5 Management of production tooling

7.5.1.6 Production Scheduling

7.5.1.7 Feedback of information from service

7.5.1.8 Service agreement With Customer

7.5.2 Validation of processes for production and service provision7.5.2.1 All processes validation

7.5.3 Identification and Traceability7.5.3.1 No exclusions to traceability

7.5.4 Customer Property7.5.4.1 Customer-owned Production tooling

7.5.5 Preservation of product7.5.5.1 Storage and Inventory


7.6 Control of Monitoring and Measurement Equipment7.6.1 Measurement system Analysis

7.6.2 Calibration / verification records

7.6.3 Laboratory requirements

7.6.3.1 Internal Laboratory

7.6.3.2 External laboratory

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7.4 Purchasing7.4.1 Purchasing Process

Supplier Evaluation Supplier Selection Supplier Re-evaluation Actions based on evaluation Type and extent of control over suppliers


7.4.1.1 Statutory and regulatory requirements All purchased products shall confirm to applicable statutory and

regulatory requirements

7.4.1.2 Supplier QMS development Goal Certification to ISO/TS16949:2009 First Step Certification to ISO9001:2008

Priority for QMS development depends upon suppliers qualityperformance and importance of product supplied.

7.4.1.3 Customer Approved Sources Where specified, organisation shall use approved sources and be

responsible for conformity to requirements in all cases.

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7.4.2 Purchasing Information Requirements for approval of product, process, procedure andequipment

Requirement for approval of personnel QMS requirements All requirements shall be adequate.

7.4.3 Verification of Purchased Product Receiving inspections or audits Receiving quality plans (sampling, 100% inspection) Arrangements for inspections or audits


7.4.3.1 Incoming product conformity to requirements Purchased product shall be verified using one or more methods given below

Sampling inspection Evaluation of Statistical data (Ongoing Process capability study, etc)

Second or third party audits Evaluation by laboratory Any other method agreed with customer



7.4.3.2 Supplier Monitoring Supplier Performance shall be monitored using following indicators -

Delivered product quality performance Delivery schedule compliance Incidences of premium freight Line stoppages / field failures

Organisation shall promote supplier monitoring of performance of their

manufacturing processes

7.5 Production and Service provision7.5.1 Control of Production and service provision

Controlled Conditions shall include Availability of information related to characteristics of product Availability of work Instructions

Availability of suitable equipment Availability and use of monitoring and measurement equipment Implementation of monitoring and measurement Implementation of product release, delivery and post-delivery

activities

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7.5.1.1 Control Plan Develop Control plan at all levels (System, subsystem, component,

material, bulk material. Develop control plant at prelaunch and production stage considering

outputs of design FMEA and Manufacturing process FMEA. Control plan shall

List all manufacturing process controls Include methods of monitoring of control exercised over special

characteristics Include customer related information Initiate specific reaction plan when process becomes unstable or

incapable. Control plan shall be reviewed when any changes occur in product,

process, measurement, controls, logistic, supply sources or FMEA Customer Approval may be required after review and update of an

control plan.



7.5.1.2 Work Instructions Documented work instructions shall be prepared for all the personnel

whose work can impact conformity to product requirements. These shall be accessible for use at the work station. These work instructions shall be derived from quality plan, control plan

and product realization process.

7.5.1.3 Verifications of Job set-ups Job set-ups shall be verified when performed such as initial run of job,

change of material or job change. Set-up instructions shall be available. Statistical methods of verification can be used. Last off inspections are recommended

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7.5.1.4 Preventive and predictive maintenance Identification of key process equipment Develop methods of machine/equipment maintenance Develop a total preventive maintenance system, which, as a minimum,

shall include Planned maintenance activities Packaging and preservation of equipment, tooling and gauging Spare parts availability for key manufacturing equipment Documenting, evaluating and improving maintenance objectives

Predictive maintenance (condition based maintenance) shall be used tocontinually improve effectiveness and efficiency of maintenance

system.



7.5.1.5 Management of production tooling Resource provision for tooling and gauge design, fabrication andverification activities.

System for Production tooling management shall include Maintenance and repair facilities and personnel, Storage and recovery Tool-change programmes for perishable tools Tool design modification documentation, including engineering

change level Tool modification and revision to documentation Tool identification, defining status such as production, repair,

disposal When outsourced, a system for monitoring these activities shall be

implemented.

This requirement is also applicable to tools used for vehicle serviceparts.

7.5.1.6 Production scheduling Order driven, access to information at key stages of operation Just in time supply to customer

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7.5.1.6 Feedback of information from service

A process of communication of information from service concerns tomanufacturing, engineering and service activities shall be established

and maintained.

7.5.1.6 Service agreement with customer In case of a service agreement, the organization shall verify the

effectiveness of Service centers Measurement equipment or special purpose tools Training of service personnel



7.5.2 Validation of Processes for production and service provision Processes whose results can not be verified by subsequent

measurement or monitoring, and as a result, deficiencies are detected

only when product is delivered. Validation shall demonstrate ability of these processes to meet

requirements. Arrangements for validation shall include

Defined criteria for approval of process Approval of equipment and personnel Use of specific methods and procedures Requirements of records Re-validation

7.5.2.1 Validation of Processes

All manufacturing processes needs to be validated.

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7.5.3 Identification and Traceability Identification of product status by suitable means at various stages ofproduct realization

For traceability, unique identification of product shall be controlled and

records maintained.7.5.3.1 Supplemental

Identification and traceability requirement is applicable to all products.

7.5.4 Customer Property Identification, verification, protection and safeguarding of customer

property Any loss, damage or unsuitability for use shall be informed to customer

and records maintained.


7.5.4.1 Customer-owned production tooling Permanent marking on customer-owned production tooling,

manufacturing, test , inspection tooling and equipment shall be provided

for easy visibility and determination of ownership


7.5.5 Preservation of Product Preservation shall induce identification, storage, handling, packaging

and protection of product during manufacturing, delivery of product.


7.5.5.1 Storage and inventory In order t detect deterioration, stock shall be assessed for quality at

appropriate intervals First in first out method for stock rotation Optimization of inventory turns Obsolete products to be treated as non-conforming product and suitably

controlled.

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7.6 Control of Monitoring and Measurement Equipment Determine monitoring and measurement to be undertaken and

equipment to be used. Establish processes for monitoring and measurement. Monitoring and Measuring equipment shall be

Calibrated or verified, at specified interval, or prior to use. Adjusted to re-adjusted Identified to determine calibration status Safeguarded from adjustments that invalidate measurement results Protected from damage and deterioration during handling,

maintenance and storage In case of previous invalid results, appropriate action on equipment and

product affected shall be taken



7.6.1 Measurement System analysis Statistical studies to be used for analysis of variation available in any

measurement system and test equipment system. Applicable to measurement systems referred in control plan. Analytical methods and acceptance criteria shall be as per customer

reference manuals


7.6.2 Calibration / Verification records Calibration / verification records shall include

Equipment identification, including the measurement standardagainst which equipment is calibrated.

Revisions following engineering changes Out of specification readings received for calibration/verification Assessment of impact of out-of-specification condition

Statement of conformity after calibration / verification Notification to customer is suspect product is shipped.

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7.6.3 Laboratory requirements

7.6.3.1 Internal laboratory Defined scope for laboratory (to be included in QMS documentation) Capability to perform defined inspection, test or calibration services The laboratory shall specify and implement , as a minimum, technical

requirements for Adequacy of laboratory procedures Competency of laboratory personnel Testing of product Capability to perform services correctly, traceable to process

standard specified. Review of related records

Conformity to ISO/IEC 17025 recommended but not mandatory.


7.6.3.2 External Laboratory

Defined scope for laboratory (to be included in QMS documentation) Capability to perform defined inspection, test or calibration services Either, the external lab should be acceptable to customer or shall be

accredited to ISO/IEC 17025 or national equivalent.


Chapter 6Chapter 6Measurement, Analysis and Improvement (8)Measurement, Analysis and Improvement (8)

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8.1 General8.1.1 Identification of statistical tools8.1.2 knowledge of basic statistical concepts

8.2 Monitoring and Measurement8.2.1 Customer Satisfaction

8.2.1.1 Customer Satisfaction

Supplemental

8.2.2 Internal Audit8.2.2.1 QMS audit

8.2.2.2 Manufacturing product audit

8.2.2.3 Product audit

8.2.2.4 Internal audit plans

8.2.2.5 internal auditor qualification8.2.3 Monitoring and Measurement of

Processes8.2.3.1 Monitoring and measurement of

manufacturing processes

8.2.4 Monitoring and Measurement of product8.2.4.1 Layout inspection and functional

testing

8.2.4.2 Appearance items

Clause 8 : Measurement, Analysis and Improvement

8.3 Control of Non conforming Product8.3.1 Control on non conforming product

supplemental

8.3.2 Control of reworked product

8.3.3 Customer information

8.3.4 Customer waiver8.4 Analysis of data

8.4.1 Analysis and use of data

8.5 Improvement8.5.1 Continual Improvement

8.5.1.1 Continual improvement of organization

8.5.1.2 Manufacturing process improvement8.5.2 Corrective action

8.5.2.1 Problem Solving

8.5.2.2 Error proofing

8.5.2.3 Corrective action impact

8.5.2.4 Rejected part test/analysis8.5.3 Preventive action


8.1 General Plan and implement monitor, measurement, analysis and improvement

processes in order to Ensure conformity to product requirements Ensure conformity to QMS Continually improve effectiveness of QMS and its processes


8.1.1 Identification of Statistical tools Appropriate statistical tools shall be identified during APQP and shall be

mentioned in control plan

8.1.2 Knowledge of basic statistical concepts Concepts variation, control (Stability), process capability and over

adjustment Understanding and utilization throughout the organization.

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8.2 Monitoring and measurement

8.2.1 Customer Satisfaction Determine customer perception about product and services provided

using Customer satisfaction surveys Vendor ratings given by customer based on delivery, quality, cost

and response User opinion surveys Lost order analysis Compliments Dealer reports Warranty claims


8.2.1.1 Customer Satisfaction Supplemental Performance indicators related to customer satisfaction, may include

Delivered product quality Delivery schedule compliance Incidences of premium freight Incidences of line stoppages and field failures


8.2 Monitoring and measurement8.2.2 Internal Audit

Conduct audits at specified intervals to determine whether QMS conforms to ISO9001:2008 requirements and to

organizations requirements It is effectively implemented and maintained.

Audit Programme Annual , to cover all functions and should be based

on status, importance of processes and results of previous audits. Audit Schedule Micro plan indicating time, auditor, auditee and focus

of audit. Audit procedure to indicate criteria, frequency, scope and methods of

audit Auditors Selection criteria, qualification based on certain

competencies, managerial and behavioral skills.

Audit Report Findings and Non conformity reports NCR closures through corrections, corrective actions and effectiveness

verifications, without undue delay.


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8.2.2.1 QMS audit Verification of compliance with ISO/TS16949:2009 requirements and

any other QMS requirements laid down by the organization.


8.2.2.2 Manufacturing Process Audit Each manufacturing process shall be audited to determine its

effectiveness.

8.2.2.3 Product Audit Products shall be audited , at a defined frequency, at appropriate stages of

production and delivery to verify compliance to all specified requirements such

as dimensions, functional testing, packaging and labeling.

8.2.2.4 Internal audit plans Internal audits shall cover all QMS processes, activities and shifts and shall be

scheduled according to an annual plan.

When internal/external non conformities or customer complaints occur, auditfrequency shall be appropriately increased.

8.2.2.5 Internal auditor qualification Internal auditors shall be qualified to audit as per ISO/TS16949:2009 std.


8.2.3 Monitoring and Measurement of processes Methods of monitoring and measurement of processes shall be decided based on Impact on product conformity

Impact on effectiveness of QMS

Monitoring and measurement shall happen to determine the extent to which the planned

results are achieved.

Where results are not achieved, corrections and corrective actions are to be taken and

effectiveness to be ensured.


8.2.3 Monitoring and Measurement of manufacturing processes For new manufacturing process (including assembling and sequencing)

Process capability to be determined and additional inputs for process control shall be

given.

Results of process studies shall be documented with specifications for developing

production, measurement , test and maintenance instructions

Objectives for manufacturing process capability, reliability, maintainability and

availability, as well as acceptance criteria shall be part these documents.

For production processes, Maintain process capability or performance specified by customer PPAP requirements

Implementation of process flow diagram and control plan including adherence to

Measurement techniques , Sampling plans

Acceptance criteria, Reaction plans when not accepted.

Significant process events such as tool change, machine repair shall be recorded.

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8.2.4 Monitoring and Measurement of product

Verification of product characteristics at appropriate stages of productrealization with against acceptance criteria

Involves inspection and testing at stages like raw material, semi-finished,

finished, etc. Implementation of activities like approval and release by designated

authorities.


8.2.4.1 Layout inspection and functional testing Complete measurement of all dimensions on the design record. Material testing as per material standards Functional testing as per performance standards Records shall be available for customer review.

8.2.4.2 Appearance items Organizations supplying appearance items shall provide

Appropriate resources for evaluation, including lighting Masters for colors, grain, gloss, metallic brilliance, distinctness of image (DOI),

as applicable Maintenance and control of masters and evaluation equipment Qualification and competency of personnel making appearance evaluation


8.3 Control of non conforming products Identification and control of non conforming product to prevent itsunintended use.

Methods to prevent unintended use Scrap, Rework , Repair , Regrade, Concession or Deviation permit

Re-verification after correction


8.3.1 Control of non conforming products supplemental Product with unidentified or suspect status shall be classified as non conforming product.

8.3.2 Control of reworked product Rework and re-inspection instructions , shall be available and utilized.

8.3.3 Customer Information In case of shipment of non conforming parts, customer shall be promptly informed.

8.3.4 Customer waiver

Concession or deviation permit prior to manufacture of deviated product or process Record of expiration date or quantity authorized.

Achievement of original specs before authorization expires

Identification on each container carrying deviated and authorized material.

Applicable to all purchased products, also.

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8.4 Analysis of Data

Analysis to evaluate continuing suitability and effectiveness of QMS andto identify areas for continually improving the same.

Data can be related to Customer satisfaction Product conformity Trends and characteristics of processes and products Opportunities for preventive actions Suppliers performance


8.4.1 Analysis and use of Data Data like trends in quality and operational performance shall be compared with

objectives set and lead to action to support the following Development of priorities for prompt solutions to customer related problems Determination of key customer related trends and correlation for status review,

decision making and longer term planning An information system for timely reporting of product information arising from

usage.


8.5 Improvement8.5.1 Continual Improvement Improve effectiveness of QMS thro use of

Quality Policy, Quality Objectives Analysis of data Corrective and preventive actions Management review


8.5.1.1 Continual Improvement of the organization Organization shall define process for continual improvement. (refer next slide)

8.5.1.2 Manufacturing Process Improvement Continual focus on control (stability) and reduction in variation of product

characteristics and manufacturing process parameters.

Continual Improvement is implemented once manufacturing processes arecapable and stable, or product characteristics are predictable and meetcustomer requirement.

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8.5 Improvement8.5.2 Corrective Action Action taken to eliminate root cause of detected non conformity to avoid

its recurrence Organisation shall

Review nonconformities, including customer complaints Determine causes of nonconformities Evaluate need for taking corrective actions Determine and implement actions Record the results of action taken Review effectiveness of corrective actions taken.

Organisation shall use various problem solving tools like 7 QC tools,8D, 7 step problem solving method for this.


8.5.2.1 Problem Solving Use of process of problem solving for root cause identification and

elimination. Customer specific formats, if specified, are to be used. Organisation shall use various problem solving tools like 7 QC tools,

8D, 7 step problem solving method for this.


8.5.3 Preventive Action Action taken to eliminate root cause of potential non conformity to avoid

its occurrence. Organisation shall

Review potential nonconformities and its possible causes

Evaluate need for taking preventive actions Determine and implement actions Record the results of action taken Review effectiveness of preventive actions taken.

Organisation shall use tools like Failure Mode Effect Analysis, etc to

determine preventive actions.


8.5.2.2 Error Proofing Use of error proofing methods in corrective action process8.5.2.3 Corrective Action Impact

Corrective actions and controls to be applied to similar products and

similar processes.

8.5.2.4 Rejected part test / analysis Analysis of parts rejected by customer, engineering facilities and dealers. Minimize cycle time for this analysis. Keep records of analysis and make it available for review.

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Chapter 7Chapter 7Core ToolsCore Tools APQP & PPAPAPQP & PPAP

8September 2011


APQP Phases and Generic Timing Plan

Planning

Product Design & Development

Process Design & Development

Product & Process Validation

Feedback Assessment and Corrective Action

Production

Planning

LaunchPilotPrototype

Program

Approval

Concept

Initiation/

Approval

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PPAP Documentation

1. Design Records2. Engineering Change Records, if any.3. Customer Engineering approvals, If required.4. Design FMEA5. Process Flow Diagram6. Process FMEA7. Production Control Plan8. Dimensional Results9. Material test results10. Performance test results11. Measurement System Analysis12. Initial Process Capability Studies13. Appearance Approval Report14. Qualified Laboratory Documentation15. Checking Aids16. Master Sample17. Records of compliance with Customer Specific Requirements

18. Sample Product19. Part Submission Warrant

1-7 Before PPAP(Preparation)

8-13 During PPAP(PPAP Run Results)

14-16 During PPAP(QualityDocumentation)

17-19 After PPAP

(Administrative)

PPAP DocumentationRetention

Part Active Time + One Calendar Year


Chapter 8Chapter 8Core ToolsCore Tools FMEA & Control PlanFMEA & Control Plan

8September 2011

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Mechanism ofProcess FMEA

Function Requirement Failure Modes

Cause 1 Cause 2 Cause 3

Effect 1 Effect 2 Effect 3

Current

Preventive

Controls

Current

Detection

Controls

New

Preventive

Controls

New

Detection

Controls

Current

Preventive

Controls

Current

Detection

Controls

New

Preventive

Controls

New

Detection

Controls

Current

Preventive

Controls

Current

Detection

Controls

New

Preventive

Controls

New

Detection

Controls


Elements of Control Plan1. Prototype, Prelaunch, Production

2. Control Plan number

3. Part Number / Latest Change level

4. Part Name / Description

5. Organization / Plant

6. Organization Code / Vendor Code

7. Key Contact / Phone and other Contact

information

8. Core Team

9. Organization / Plant Approval / Date

10. Date (Original)

11. Date (Revised)

12. Customer Engineering Approval / Date

13. Customer quality approval /date

14. Other Approval / Date

14. Part / Process Number

15. Process Name / Operation Description

16. Machine, Device , Jig, Tools for

manufacturing

17. Characteristic Number

18. Product Characteristics

19. Process Characteristics

20. Special Characteristics Classification

21. Product / Process Specification /

Tolerance

22. Evaluation / Measurement Technique

23. Sample Size / frequency

24. Control Method

25. Reaction Plan

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Chapter 9Chapter 9Core ToolsCore Tools SPC & MSASPC & MSA

8September 2011


Determine

Characteristic

To Be Charted

What is the

type of

data?

Are we tracking

proportion

or % defective

Are they homogeneous

in natur e e.g. chemical

bath, paint batch, etc.

Is Sample

Size Constant?

Is Sample

Size Constant ?

Subgroup

Size 9

or more ?

Can s be easily

computed ?

Use Charts f or

Individuals:

X -MR

np Or P Chart

C or U Chart

P Chart

U Chart

Variable

YE S

YE S

YE S

YE S

NO

NO

NOYE S

NO

NO

NOAttribute

We are tracking

no. of defects

or D.P.U.

chartsX

chartRX

YE S

chartsX

Selection of Control Charts

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TV SD South Asia Slide No 79 8September 2011

For any Query Please write at [email protected]