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TV SD South Asia

TV SD South Asia

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TV SD South Asia Welcomes You to the One Day Awareness Program On ISO/TS16949:2009

TV SD South Asia

Slide No 2

8 September 2011

Chapter 1 Introduction to QMS

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Slide No 3

8 September 2011

QMS Objectives / Principles

QMS Objectives
1. 2. 3. 4. To Prevent Defect To Eliminate Waste in the entire Supply Chain To Reduce Variation To Continually Improve Effectiveness of Quality Management System

QMS Principles
1. 2. 3. 4. 5. 6. 7. 8. Customer Focus Meeting Current and future requirements of customer Leadership Direct and Control Involvement of People All functions, all levels and all employees Process Approach Requirements (Input ), Results (output), Resources (control) Systems Approach to Management Plan-Do-check-Act Continual Improvement Enhance probability of customer satisfaction Factual Approach to Decision Making Personally verified facts for decision making Mutually Beneficial Supplier Relationships - Win win relationship

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Slide No 4

Process Approach Continual Improvement of The Quality Management System Customer /Other Interested Parties
6 Resource Management 7 Input
Requirements

5 Management Responsibility 8 Measurement, Analysis and Improvement Output

Customer /Other Interested Parties

Satisfaction

Product Realization

Product

Value Adding Activity


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Slide No 5

Information Flow

Classification of processes

Purchase

Store

Quality Assurance and QC

Design and Development

Customer Requirements

Planning

MOP

COP
COP :

SOP

Lab

Customer Oriented Process

SOP :
Support Oriented Process

MOP :
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Slide No 6

Management Oriented Process

Customer Satisfaction

Marketing

Production

Product

Logistics

Process Approach
Material :
Infrastructure (6.3)
Physical resources like Land, building, Plant, Machinery, Hardwares, Offices, etc.

Man :
From self :
Knowledge, Skill, Competency

Process Approach

Work Environment (6.4)


Heat, Noise, Light, Hygiene, Humidity, Cleanliness, Pollution, Vibration, Air Flow, etc.

From Organisation :
Roles, Responsibility Authority

Desired Results Conformity

Input
Requirement

Output

Process
Undesired Results Non-Conformity

Method
Generic Methods
1. 2. 3. 4. 5. Control of Documents Control of Records Training Internal Audit Control of Non Conforming Products 6. Corrective Actions 7. Preventive Actions

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
Slide No 7

Function Specific Methods


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Chapter 2 Quality Management System

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Slide No 8

8 September 2011

Clause 4 : Quality Management Systems


1.1 Scope : Purpose of organizations business, Design-Manufacture-Service 1.2 Application Exclusions with Justifications Only in Clause 7.3 (Product design related clauses only) 2 Normative Reference Standards referred. 3 Terms and Definitions 4 Quality Management Systems 4.1 General Requirements 4.1.1 Outsourced Processes 4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual 4.2.3 Control of Documents 4.2.3.1 Engineering Specifications 4.2.4 Control of Records 4.2.4.1 Record retention

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Slide No 9

Clause 4 : Quality Management Systems


4.1 General requirements Establish, Document, Implement, maintain and continually improve effectiveness of QMS a. Identify Processes and its applications b. Determine its sequence and interactions c. Determine criteria and methods for operation and control of the processes d. Ensure Availability of resources and information for effective monitoring and operation. e. Monitor, measure and analyze the performance (effectiveness/efficiency) of the process. f. Implement actions necessary to achieve planned results g. Continually improve effectiveness of QMS For outsourced processes, determine and implement type and extent of control over suppliers. 4.1.1 Though Outsourced, responsibility of conformity to product requirements remains with Organization.
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Slide No 10

Clause 4 : Quality Management Systems


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 Quality Manual Scope and Exclusions References to documented procedures Interaction between various processes
Slide No 11

4.2.2

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Clause 4 : Quality Management Systems


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 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.

4.2.3.1

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Clause 4 : Quality Management Systems


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.

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Slide No 13

Chapter 3 Management Responsibility

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Slide No 14

8 September 2011

Clause 5 : Management Responsibility


5.1 Management Commitment 5.1.1 Process Efficiency 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.4.1 Quality objectives 5.4.1.1 Quality Objectives Business Plan 5.4.2 QMS Planning 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and authority 5.5.1.1 Responsibility for Quality 5.5.2 Management Representative 5.5.2.1 Customer Representative 5.5.3 Internal Communication 5.6 Management Review 5.6.1 General 5.6.1.1 QMS Performance 5.6.2 Review Input 5.6.2.1 Analysis of Field Failures 5.6.3 Review output
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Slide No 15

Clause 5 : Management Responsibility


5.1 Management Commitment Communicate importance of meeting customer, statutory and regulatory 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]

5.1.1 Process Efficiency Effectiveness and Efficiency of product realization and Support processes shall be reviewed. 5.2 Customer Focus Determination and meeting of Current as well as future requirements 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
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Slide No 16

Clause 5 : Management Responsibility


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.

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Slide No 17

Clause 5 : Management Responsibility


5.4.2 Planning of Quality Management Systems Quality planning Quality Assurance Quality Control Quality improvement 5.5 Responsibility, Authority and Communication 5.5.1 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 product conformity. Adequate staff for responsibility for quality across all shifts.

TV SD South Asia

Slide No 18

Clause 5 : Management Responsibility


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. 5.5.2.1 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

5.5.3 Internal Communication Means and Methods of Communication shall be defined.

TV SD South Asia

Slide No 19

Clause 5 : Management Responsibility


5.6 Management Review 5.6.1 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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Clause 5 : Management Responsibility


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 5.6.2.1 Review Inputs Supplemental Analysis of actual and potential field failures and their impact on safety, quality and environment, shall be considered as input to Management Review 5.6.3 Review Output Decisions and actions related to improvement in QMS and Product Resource Needs

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Slide No 21

Chapter 4 Resource Management

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Slide No 22

8 September 2011

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Clause 6 : Resource Management


6.1 Provision of Resources 6.2 Human Resource 6.2.1 General 6.2.2 Competency, awareness and training 6.2.2.1 Product design skills 6.2.2.2 Training 6.2.2.3 Training on the job 6.2.2.4 Employee motivation and empowerment 6.3 Infrastructure 6.3.1 Plant, facility and equipment planning 6.3.2 Contingency plans 6.4 Work Environment 6.4.1 Personnel safety 6.4.2 Cleanliness of premises

TV SD South Asia

Slide No 23

Clause 6 : Resource Management


6.1 Provision of Resources 6.2 Human Resources 6.2.1 General Personnel responsible for product conformity shall have necessary competence 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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Clause 6 : Resource Management


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 nonconformities) on customer.

TV SD South Asia

Slide No 25

Clause 6 : Resource Management


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)

TV SD South Asia

Slide No 26

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Clause 6 : Resource Management


6.3.1 Plant, Facility and Equipment Planning Multidisciplinary approach Plant layouts shall Optimize material travel, handling and value-added use of floor space Facilitate use of synchronous material flow. Use of Lean Manufacturing Principles Methods for evaluation of effectiveness of existing operations. (Value Stream Mapping) Contingency Plans Contingency plans in the situations like Labor Shortage Key equipment failure Field failures Utility interruptions

6.3.2

TV SD South Asia

Slide No 27

Clause 6 : Resource Management


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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Slide No 28

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Chapter 4 Product Realization (7.1(7.1-7.3)

TV SD South Asia

Slide No 29

8 September 2011

Clause 7 : Product Realization


7.1 Planning Of Product Realization 7.1.1 Quality plan 7.1.2 Acceptance Criteria 7.1.3 Confidentiality 7.1.4 Change control 7.3 Design and Development 7.3.4 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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7.2 Customer Related Process 7.2.1 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 Development 7.3.1 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

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Slide No 30

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Clause 7 : Product Realization


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 by customer. For attribute sampling, C=0 should be acceptance criteria.

TV SD South Asia

Slide No 31

Clause 7 : Product Realization


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 Customer Related Processes 7.2.1 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 requirements related to acquisition, storage, handling, recycling or disposal of materials) Delivery and post delivery requirements 7.2.1.1 Customer Designated Special Characteristics Requirements related to designation, documentation and control of special Characteristics
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Clause 7 : Product Realization


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.
TV SD South Asia
Slide No 33

Clause 7 : Product Realization


7.3 Design and Development 7.3.1 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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Clause 7 : Product Realization


7.3.2.1 Product Design Inputs Identify, document and review of product design input requirements including 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
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Slide No 35

Clause 7 : Product Realization


7.3.2.2 Manufacturing Process Design Inputs Identify, document and review of manufacturing process design input requirements 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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Clause 7 : Product Realization


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
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Slide No 37

Clause 7 : Product Realization


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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Clause 7 : Product Realization


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 7.3.4.1 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 7.3.5 Design and Development Verification Verification shall happen to see whether input requirements are met by output results
TV SD South Asia
Slide No 39

Clause 7 : Product Realization


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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Clause 7 : Product Realization


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.

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Slide No 41

Chapter 5 Product Realization (7.4(7.4-7.6)

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Slide No 42

8 September 2011

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Clause 7 : Product Realization


7.4 Purchasing 7.4.1 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 Information 7.4.3 Verification of Purchased Product 7.4.3.1 Incoming product quality 7.4.3.2 Supplier Monitoring

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7.6 Control of Monitoring and Measurement Equipment 7.6.1 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

7.5 Production and Service provision 7.5.1 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 provision 7.5.2.1 All processes validation 7.5.3 Identification and Traceability 7.5.3.1 No exclusions to traceability 7.5.4 Customer Property 7.5.4.1 Customer-owned Production tooling 7.5.5 Preservation of product 7.5.5.1 Storage and Inventory
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Slide No 43

Clause 7 : Product Realization


7.4 Purchasing 7.4.1 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 quality performance 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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Clause 7 : Product Realization


7.4.2 Purchasing Information Requirements for approval of product, process, procedure and equipment 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

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Slide No 45

Clause 7 : Product Realization


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 provision 7.5.1 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
TV SD South Asia
Slide No 46

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Clause 7 : Product Realization


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.

TV SD South Asia

Slide No 47

Clause 7 : Product Realization


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

TV SD South Asia

Slide No 48

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Clause 7 : Product Realization


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 to continually improve effectiveness and efficiency of maintenance system.

TV SD South Asia

Slide No 49

Clause 7 : Product Realization


7.5.1.5 Management of production tooling Resource provision for tooling and gauge design, fabrication and verification 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 service parts. 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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Slide No 50

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Clause 7 : Product Realization


7.5.1.6 Feedback of information from service A process of communication of information from service concerns to manufacturing, 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

TV SD South Asia

Slide No 51

Clause 7 : Product Realization


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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Clause 7 : Product Realization


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

TV SD South Asia

Slide No 53

Clause 7 : Product Realization


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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Slide No 54

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Clause 7 : Product Realization


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

TV SD South Asia

Slide No 55

Clause 7 : Product Realization


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 standard against 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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Clause 7 : Product Realization


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.
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Slide No 57

Chapter 6 Measurement, Analysis and Improvement (8)

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Slide No 58

8 September 2011

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Clause 8 : Measurement, Analysis and Improvement


8.1 General 8.1.1 Identification of statistical tools 8.1.2 knowledge of basic statistical concepts 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction 8.2.1.1 Customer Satisfaction Supplemental 8.2.2 Internal Audit 8.2.2.1 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 qualification 8.2.3 Monitoring and Measurement of Processes 8.2.3.1 Monitoring and measurement of manufacturing processes 8.2.4 Monitoring and Measurement of product 8.2.4.1 Layout inspection and functional testing 8.2.4.2 Appearance items

8.3 Control of Non conforming Product 8.3.1 Control on non conforming product supplemental 8.3.2 Control of reworked product 8.3.3 Customer information 8.3.4 Customer waiver 8.4 Analysis of data 8.4.1 Analysis and use of data 8.5 Improvement 8.5.1 Continual Improvement 8.5.1.1 Continual improvement of organization 8.5.1.2 Manufacturing process improvement 8.5.2 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/analysis 8.5.3 Preventive action

TV SD South Asia

Slide No 59

Clause 8 : Measurement, Analysis and Improvement


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.

TV SD South Asia

Slide No 60

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Clause 8 : Measurement, Analysis and Improvement


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
Slide No 61

TV SD South Asia

Clause 8 : Measurement, Analysis and Improvement


8.2 Monitoring and measurement 8.2.2 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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Clause 8 : Measurement, Analysis and Improvement


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, audit frequency shall be appropriately increased. 8.2.2.5 Internal auditor qualification Internal auditors shall be qualified to audit as per ISO/TS16949:2009 std.
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Clause 8 : Measurement, Analysis and Improvement


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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Clause 8 : Measurement, Analysis and Improvement


8.2.4 Monitoring and Measurement of product Verification of product characteristics at appropriate stages of product realization 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
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TV SD South Asia

Clause 8 : Measurement, Analysis and Improvement


8.3 Control of non conforming products Identification and control of non conforming product to prevent its unintended 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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Clause 8 : Measurement, Analysis and Improvement


8.4 Analysis of Data Analysis to evaluate continuing suitability and effectiveness of QMS and to 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.

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Clause 8 : Measurement, Analysis and Improvement


8.5 Improvement 8.5.1 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 are capable and stable, or product characteristics are predictable and meet customer requirement.

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Clause 8 : Measurement, Analysis and Improvement


8.5 Improvement 8.5.2 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.
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Clause 8 : Measurement, Analysis and Improvement


8.5.2.2 Error Proofing Use of error proofing methods in corrective action process 8.5.2.3 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. 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.
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Chapter 7 Core Tools APQP & PPAP

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8 September 2011

APQP Phases and Generic Timing Plan


Concept Initiation/ Approval

Program Approval

Prototype

Pilot

Launch

Planning Product Design & Development Process Design & Development Product & Process Validation

Planning

Production Feedback Assessment and Corrective Action

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PPAP Documentation
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. Design Records Engineering Change Records, if any. Customer Engineering approvals, If required. Design FMEA Process Flow Diagram Process FMEA Production Control Plan Dimensional Results Material test results Performance test results Measurement System Analysis Initial Process Capability Studies Appearance Approval Report Qualified Laboratory Documentation Checking Aids Master Sample Records of compliance with Customer Specific Requirements Sample Product Part Submission Warrant

1-7 Before PPAP (Preparation)

8-13 During PPAP (PPAP Run Results) 14-16 During PPAP (Quality Documentation) 17-19 After PPAP (Administrative)

PPAP Documentation Retention


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Part Active Time + One Calendar Year

Slide No 73

Chapter 8 Core Tools FMEA & Control Plan

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Mechanism of Process FMEA

Effect 1

Effect 2

Effect 3

Function

Requirement

Failure Modes

Cause 1

Cause 2 Current Preventive Controls Current Detection Controls

Cause 3

Current Preventive Controls

Current Detection Controls

Current Preventive Controls New Preventive Controls

Current Detection Controls New Detection Controls

New Preventive Controls

New Detection Controls

New Preventive Controls

New Detection Controls

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Slide No 75

Elements of Control Plan


1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Prototype, Prelaunch, Production Control Plan number Part Number / Latest Change level Part Name / Description Organization / Plant Organization Code / Vendor Code Key Contact / Phone and other Contact information Core Team Organization / Plant Approval / Date Date (Original) Date (Revised) Customer Engineering Approval / Date Customer quality approval /date 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 9 Core Tools SPC & MSA

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Slide No 77

8 September 2011

Selection of Control Charts


Determine Characteristic To Be Charted What is the type of data?

Attribute

Are we tracking proportion or % defective

NO

We are tracking no. of defects or D.P.U.

Variable

YES

Is Sample Size Constant?


YES

NO

Is Sample Size Constant?


YES

NO

U Chart

C or U Chart P Chart

np Or P Chart

Are they homogeneous in nature e.g. chemical bath, paint batch, etc.

NO

Subgroup Size 9 or more ?


NO

YES

X s chart

YES

Can s be easily computed ?


YES

NO

X R chart

Use Charts for Individuals: X - MR

X s chart
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For any Query Please write at academy@tuv-sud.in

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Slide No 79

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