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ISO/TS 16949: 2009 Awareness

to Awareness Training ISO/TS 16949:2009 The Automotive standard

ISO/TS 16949: 2009 Awareness

TS 16949 Evolution

Goal of the standard Common system problems Examples of system Eight Quality Management Principles Process Approach Permissible Exclusions ISO/TS 16949 standard requirements Advanced Product Quality Planning Production Part Approval Process Failure Mode & Effect Analysis Statistical Process Control Measurement System Analysis Internal Audit

ISO/TS 16949: 2009 Awareness TS 16949 Evolution

QS 9000 not acceptable by Europeans (German, Italy, etc). Hence it requires multiple certification against VDA 6.1, EAQF94 To avoid multiple certification and to create the global standard for automobile suppliers.

Hence IATF is formed, which includes representatives from BIG-3,

VDA, ANFIA, CCFA & ISO/TC176. They released in the form of technical specification in 1999 which requires only approval of 2/3 of the members vote the first edition was in line with ISO 9000:1994 second edition released during March 2002 in line with ISO 9001:2000 16949:2009 inline with ISO 9001:2008 and Third Edition ISO/TS

ISO/TS 16949: 2009 Awareness

Goal of the standard

Continual Improvement Defect Prevention Reduction of Variation And Waste In Supply Chain

Common System Problems

No system No communication Not suitable Not effective

ISO/TS 16949: 2009 Awareness Examples of systems

Inspection System Corrective Action System Management Review System Training System Document Control System Quality Records System Recruitment System Measurement Analysis System Auditing System Etc.

ISO/TS 16949: 2009 Awareness Key Quality Management Principles

The eight Key Principles of ISO 9001:2008 which are embedded as requirements 1. Customer Focus 2. Leadership 3. Involvement of People 4. Process Approach 5. System Approach to Management 6. Continual Improvement 7. Factual Approach to Decision - Making. 8. Mutually Beneficial Supplier Relationship

ISO/TS 16949: 2009 Awareness Process Approach

Standards Requirement towards Process approach Determine the process Determine the Sequence of the Processes & Determine the Interaction between the Processes Determine the criteria and methods needed to control the processes Ensure the availability of resources and information necessary to carryout these processes Monitor, measure where applicable and analyze these processes Implement actions necessary to achieve results and Improve the processes

ISO/TS 16949: 2009 Awareness What is a Process?

Set of interrelated or interacting activities

Input Monitoring and Measuring opportunities

(Before, During & After the Process)

(Specified way to carryout an activity or a process-may be documented or not) Effectiveness of process (Ability to achieve desired results)



Efficiency of process (Results achieved v/s. Resources used)

ISO/TS 16949: 2009 Awareness

Continual Improvement of Quality Management System

Requirement s

Resource Management

Management Responsibility

Process Model ISO 9001:2008

Product Realization

Measurement, Analysis and Improvement Product Satisfaction Customer

ISO/TS 16949: 2009 Awareness Total 8 Clauses In The Standard:

1. Scope (Including Application & Justification For Exclusion)
2. Normative Reference 3. Terms And Definitions 4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis & Improvement
Permissible Exclusions Exclusions to this standard are limited to requirements within clause 7.3 related to Product Design & Development (Not Included Manufacturing Process Design)

ISO/TS 16949: 2009 Awareness ISO/TS 16949 standard requirements

Quality Management System (QMS) 4.1 General Requirements Quality management system is to be Established, Documented, implemented, maintained and continually improved for its effectiveness. Note :- Clarity On Outsourcing Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory & regulatory requirements. The type of control & extent of control to be applied to the outsourced processes.

ISO/TS 16949: 2009 Awareness

4.2 Documentation Requirements 4.2.1 QMS documentation shall include Statement of Quality Policy & Objectives, Quality Manual Procedures & records required by the standard Documents, including records determined by the organization to be necessary to ensure effective planning, operation and control of its processes 4.2.2 Quality Manual The scope of QMS, including justification for exclusions Documented Procedures established, or reference to them Description of interaction between the processes of QMS like Management Responsibility, Resources, Product Realization, Measurements

ISO/TS 16949: 2009 Awareness

4.2.3 Control of Documents Procedure to define the controls needed to approve documents for adequacy prior to issue Review & update as necessary and re-approve To identify current revision status of documents Availability of latest versions of applicable documents at points of use Legibility & identification To ensure that documents of external origin determined by the organization to be necessary for the planning & operation of the QMS are identified & their distribution control Identification of obsolete documents Engineering Specifications Customer Engineering Changes - Timely review, distribution and implementation. Maintain record of date on which change is implemented (Timely review shall not exceed two working weeks)

ISO/TS 16949: 2009 Awareness

4.2.4 Control Of Records Records shall remain legible, readily identifiable and retrievable as per a procedure defining controls for Identification, Storage, Protection, Retrieval, Retention & Disposition Records Retention Identify minimum statutory & regulatory and customer requirements and establish retention period as per requirement Note: Disposition Includes disposal & customer specified records

ISO/TS 16949: 2009 Awareness

5 Management Responsibility 5.1 Management Commitment Top managements commitment for the development of the QMS and for the continual improvement of its effectiveness by: Communicating the importance of meeting customer as well as statutory& regulatory requirements Establishing quality policy & objectives Conducting management reviews Ensuring the availability of resources

ISO/TS 16949: 2009 Awareness Process Efficiency Top management to monitor the product realization and support process to assure their effectiveness and efficiency 5.2 Customer Focus

Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction

ISO/TS 16949: 2009 Awareness

5.3 Quality Policy To be appropriate to the purpose of the organization Should include commitment to comply with requirements and continually improve the effectiveness of QMS Is a framework for establishing & reviewing Quality Objectives To be communicated and understood within the Organization To be reviewed for continued suitability

ISO/TS 16949: 2009 Awareness

5.4 Planning 5.4.1 Quality Objectives Established at relevant functions & levels Should be measurable Consistent with the quality policy Quality Objectives Supplemental To define quality objectives and measurements in the business plan to deploy the quality policy

5.4.2 Quality Management System Planning QMS Process Planning Quality objectives Integrity to be maintained during QMS changes

ISO/TS 16949: 2009 Awareness

5.5 Responsibility ,Authority and communication 5.5.1 Responsibility & authority Responsibility and authority is to be defined and communicated Responsibility for Quality

Management with responsibility and authority for corrective action shall be promptly informed of products or processes which do not comply with requirements Authority to stop the production to correct quality problems All shifts to have staff to assure conformity to product requirements

ISO/TS 16949: 2009 Awareness

5.5.2 Management Representative Top management shall appoint a member of the organizations management who irrespective of other responsibilities , shall have responsibility & authority that includes Establish, implement and maintain the processes needed for QMS Report to top management on the performance of the QMS, including need for improvement Promote awareness of customer requirements throughout the organization Customer Representative To designate individuals who will represent the needs of the customer like Selection of special characteristics Setting quality objectives and related training Corrective and preventive action Product design and development 5.5.3 Internal Communication Establish communication channels within the Organization and ensure communication regarding the effectiveness of QMS.

ISO/TS 16949: 2009 Awareness

5.6 Management Review Meeting 5.6.1 General

QMS Review at planned intervals

Review to assess opportunities for improvement Need for changes to QMS, Quality Policy & objectives Quality Management System performance Includes all elements of Quality System and its performance as an essential part of the continual improvement process Monitoring of quality objectives Reporting and evaluation of the cost of poor quality Minimum evidence for the achievement of objectives specified in the quality policy Objectives specified in the business plan Customer satisfaction with product supplied

ISO/TS 16949: 2009 Awareness

5.6.2 Review Input Results of audits Customer feedback Process performance and product conformance Status of preventive and corrective actions Follow-up actions from previous management reviews Changes that could affect the QMS Recommendations for improvement 5.6.2 Review Input - Supplemental Includes Analysis of actual and potential field failures and their impact on Quality, Safety or the Environment 5.6.3 Review Output Improvement of the effectiveness of QMS and its Processes Improvement of product related to customer requirements Resource needs Result of management review to be recorded.

ISO/TS 16949: 2009 Awareness

6 Resource Management

6.1 Provision of resources

To implement and maintain the QMS and continually improve its effectiveness To enhance customer satisfaction
6.2 Human Resources 6.2.1 General Qualification on the basis of appropriate education, training, skills and experience

Note:- Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the QMS

ISO/TS 16949: 2009 Awareness

6.2.2 Competence , training & awareness
Assignment of competent personnel Where applicable ,Provide training or take other actions Evaluate the effectiveness of the training Ensure personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives Maintain records of education, training, skills and experience Product design skills

Product design personnel to be qualified to achieve design requirements and skilled Applicable tools and techniques to be identified

ISO/TS 16949: 2009 Awareness Training
Documented procedures for identifying training needs and achieving competence Specific assigned tasks Qualifications Training Records to be maintained Special attention to satisfy customer specific requirements Training on the job

For personnel in any new or modified job Include contract or agency personnel Inform about the consequence to customer due to non-conformance

ISO/TS 16949: 2009 Awareness Employee Motivation and empowerment

Process for employee motivation to achieve Quality Objectives and make improvements Promotion of quality and technological awareness at all levels Process for measurement to the extent to which the personnel are aware of the relevance and importance of their activities and contribution towards the achievement of Quality Objectives

6.3 Infrastructure
Identify, provide and maintain the infrastructure (workspace and associated facilities, equipment, hardware and software, supporting services such as transport , communication or information systems ) to achieve product conformity.

ISO/TS 16949: 2009 Awareness

6.3.1 Plant ,facility and equipment planning
Use Multidisciplinary Approach to optimize material travel, handling and synchronous flow Methods to evaluate and monitor effectiveness of existing operations

6.3.2 Contingency Plans

Prepare contingency plans to satisfy the customer specified requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns

ISO/TS 16949: 2009 Awareness

6.4 Work Environment
Determine and manage the work environment needed to achieve conformity of product Note :- The term work environment relates to those conditions under which work is performed including physical , environmental and other factors such as noise, temp.,humidity , lighting or weather .

6.4.1 Personnel safety to achieve conformity to product requirements

Address due care regarding product safety and means to minimize potential risks to employees

6.4.2 Cleanliness of premises

Maintain the premises in a state of order, cleanliness and repair

ISO/TS 16949: 2009 Awareness

7 Product Realization 7.1 Planning of product realization
Product realization planning to determine the following: Quality objectives Required process documents and resources Verification, validation, monitoring ,measurement, inspection and criteria for product acceptance Records to provide evidence The output of planning is to be documented.

7.1.1 Planning of product realization supplemental

Develop quality plan, which includes customer requirements and references to technical specifications

ISO/TS 16949: 2009 Awareness

7.1.2 Acceptance Criteria To be defined by the organization, when required approved by the customer. For attribute data sampling, the criteria shall be zero. 7.1.3 Confidentiality Ensure confidentiality of customer-contracted products and projects under development and related product information.

7.1.4 Change Control

Have a process to control and react to changes that impact product realization Assess the effect of changes and define verification and validation activities Validate the changes before implementation For proprietary designs , impact on form, fit and function to be reviewed with the customer If required by the customer , additional verification / identification requirements to be met.

ISO/TS 16949: 2009 Awareness

7.2 Customer Related Processes 7.2.1 Determination of requirements related to the products Requirements determined by the organization , availability , delivery and support Requirements for specified and intended use Statutory and regulatory requirements applicable to the product Any additional requirements considered necessary by the organization

Note : Post delivery activities include, for example , actions under warranty provisions , contractual obligation such as maintenance services , and supplementary services such as recycling or final disposal. Customer designated special characteristics Demonstrate conformity to customer requirements documentation and control of special characteristics for designation,

ISO/TS 16949: 2009 Awareness

7.2.2 Review of requirements related to the products

Review during tenders, orders and amendments to ensure the following Product requirements are defined Differences resolved Ability to meet the defined requirements confirm verbal requirements before acceptance and communicate changes to relevant personnel Review of requirements related to the product supplemental

Waiver for a formal review shall require customer authorization Organization manufacturing feasibility

Investigate, confirm and document the manufacturing feasibility of the proposed products in contract review process including risk analysis
7.2.3 Customer Communication

Identify and implement arrangements for communicating to customers regarding : Product information Enquiries, contracts or order handling including amendments Customer feedback, including customer complaints

ISO/TS 16949: 2009 Awareness CUSTOMER COMMUNICATION SUPPLEMENTAL Have the ability to communicate in a customer specified language and format 7.3 Design & development Includes product and manufacturing process design and development 7.3.1 Design and development planning

Design and development chart (APQP timing plan/chart) which includes Stages of design and development process Review, verification and validation activities Responsibility and authority for design and development activities Interfaces between different groups Planning output shall be updated, as the design and development progresses Multidisciplinary approach
Form a MDT Team or APQP team for product realization process, review of FMEAs, identification of special characteristics, review of control plan, etc.

ISO/TS 16949: 2009 Awareness

7.3.1 Design development inputs
Inputs shall include Functional and performance requirements, Applicable regulatory and statutory requirements, where Applicable information derived from previous similar design, Other requirements essential for design & development, Input shall be reviewed for adequacy Product design input

Identify, document and review the product design input requirements including, Customer requirements, Use of information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data and other relevant sources, for current and future projects of a similar nature, Targets for conformity to product requirements, life, reliability, maintainability, timing, cost.

ISO/TS 16949: 2009 Awareness Manufacturing process design input
Identify, document and review the process design input requirements including Product design output data, Targets for productivity, process capability and cost, Customer requirements, if any & Experience from previous developments Special Characteristics

Special characteristics customer identified and internal identified. Characteristics which affects fit, function, safety and government regulations. Identify & include in FMEA, Control Plan, work instructions.

ISO/TS 16949: 2009 Awareness

7.3.3 Design and developments outputs Product design outputs Supplemental :
Design FMEA, reliability studies Product special characteristics, specifications Product mistake proofing Product definition including drawings Product design reviews results Diagnostic guidelines, where applicable

ISO/TS 16949: 2009 Awareness Manufacturing process design output
Manufacturing Process design output includes Specifications and drawings Manufacturing process flow chart/ layout Manufacturing process FMEAs Control plan Work instructions Process approval acceptance criteria Data for quality, reliability, maintainability and measurability Results of error-proofing activities Methods of rapid detection and feedback of product/ mfg. process nonconformities

ISO/TS 16949: 2009 Awareness

7.3.4 Design and development review
To evaluate the ability to fulfill requirements To identify problems and propose necessary actions To include representatives of functions concerned Records shall be maintained. Monitoring
Define measurements at specified stages of design and development, analyze and report as an input for management review. Measurements include quality risk, cost, lead-time, critical paths as appropriate
7.3.5 & 7.3.6 Design and development verification & validation
Verification to be performed to ensure the output meets the input requirements and records shall be maintained. Validation to be performed to confirm that resulting product is capable of meeting the requirements for the intended use in accordance with planned arrangements and records shall be maintained.

ISO/TS 16949: 2009 Awareness Product approval process

Comply with a product and process approval procedure recognized by the customer. Applies to suppliers also (Product and Manufacturing Process approval)

7.3.7 Control of design and development changes

Changes shall be identified and records maintained. Changes shall be reviewed, verified and validated as appropriate and approve before implementation. Records shall be maintained.

ISO/TS 16949: 2009 Awareness

7.4 Purchasing 7.4.1/ Purchasing process & statutory and regulatory compliance
Methods & criteria for selection, evaluation ,re-evaluation of suppliers and records of actions maintained and Satisfy current applicable statutory & regulatory requirements for the purchased products or materials Supplier quality management system development

Perform supplier quality management system development with the goal of compliance to ISO/TS 16949. Conformity with ISO 9001:2008 as a first step in achieving this goal, unless, otherwise specified by the Customer, suppliers shall be third-party registered to ISO 9001:2008 by an accredited third-party Certification body

ISO/TS 16949: 2009 Awareness Customer approved sources
Purchase products, materials or services from customer approved sources, if required by contract.

7.4.2 Purchasing information

Requirements for approval or qualification of product, procedures, processes, equipment, personnel. Ensure adequacy of specified requirements in purchasing documents.

7.4.3 Verification of purchased product

Organization verification to ensure purchased products meet specified purchase requirements and customer verification

ISO/TS 16949: 2009 Awareness Incoming product conformity to requirements
Process to assure the quality of purchased products by utilizing one or more of the following methods: Receipt and evaluation of statistical data Receiving inspection/ testing Second or third party assessment Part evaluation by designated laboratory Any other method agreed with the customer. Supplier monitoring

Monitoring through the following indicators: Delivered part quality performance Customer disruptions including field returns Delivery schedule performance (incidents of premium freight) Special status customer notification related to quality or delivery issues. Promote supplier monitoring of the performance of manufacturing process

ISO/TS 16949: 2009 Awareness

7.5 Production and service provision 7.5.1 Control of production and service provision
Plan and carry out production and service provision under controlled condition which include the following as appropriate: The availability of information that specifies the characteristics of the Product, where necessary, the availability of work instructions The use of suitable equipment & measuring and monitoring equipments Implementation of measuring & monitoring activities Implementation of product release, delivery and post-delivery activities

ISO/TS 16949: 2009 Awareness Control Plan
Control plan should be developed system, subsystem, component and or material level. While preparing, use multi disciplinary approach. Review and update the control plan when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources or FMEA. Work instructions

Documented work instructions for the operation of the processes, accessible for use at work station, derive from sources such as quality plan, control plan and product realization process Verification of job set -ups

Verify job set-ups, job instructions to be available for set-up personnel, use statistical methods of verification, where applicable

ISO/TS 16949: 2009 Awareness Preventive and predictive maintenance
Preventive maintenance activities across the organization. Identify key manufacturing equipments and apply predictive maintenance methods applicable to your industry set up such as oil viscosity, fluid analysis, sound, noise, vibration, etc.

Packaging and preservation of equipment, tooling and gauging, Availability of replacement parts for key manufacturing equipment, Documenting, evaluating and improving maintenance objectives

ISO/TS 16949: 2009 Awareness Management of production tooling
Provide resources for tool and gauge design, fabrication and verification activities. Establish and implement a system for tooling management including: Maintenance and repair facilities and personnel Storage and recovery, Set-up Tool change programs for perishable tools Tool design modification documentation Tool modification and revision to documentation Tooling identification defining the status such as production, repair or disposal Implement a system to track and follow-up on these activities, if outsourced.

ISO/TS 16949: 2009 Awareness Production scheduling To be scheduled in order to meet customer requirements such as just in time and is order driven & Feedback of information from service

& service agreement with

Establish and maintain a procedure for communication of information on service concerns . Verify the effectiveness of Service centers Special purpose tools or measuring equipment Training of servicing personnel
7.5.2 Validation of processes for production and service provision

Validate the production and service processes where the resulting output cannot be verified by subsequent measurement or monitoring and demonstrate the ability of the processes to achieve planned results. System to consider: Criteria for review and approval of process Approval of equipment and qualification of personnel Use of specific methods and procedures Requirements for records Re-validation Above requirements apply to all processes for production and service provision

ISO/TS 16949: 2009 Awareness

7.5.3 Identification and traceability
Identification at all stages, Identify the product status with respect to monitoring and measurement requirement. Control and record the unique identifications of the product, where traceability is a requirement.

7.5.4 Customer property

Identification, Verification, Protection, Maintenance, reporting to customer in case of loss, damage or otherwise unsuitable for use and maintain records

ISO/TS 16949: 2009 Awareness Customer owned production tooling
Customer-owned tools, manufacturing, equipment to be permanently marked test, inspection tooling and

7.5.5 Preservation of product

Preserve conformity of product during internal processing and delivery. Preservation to include identification, handling, packaging, storage and protection. Storage and inventory

Condition of product in stock to be assessed at planned intervals. Use an inventory management system such as first-in-first-out (FIFO) Obsolete product to be controlled in a manner to similar to nonconforming product

ISO/TS 16949: 2009 Awareness

7.6 Control of monitoring & measuring equipment
Calibration activities identification of instruments, gauges including test software. Calibration against national/ international standards, Status identification, Safeguard and protection. Assess, record validity of measurement when equipment is out of calibration & records of calibration

7.6.1 Measurement system analysis

Conduct statistical studies to analyze variation present in the results of each type of measurement and test equipment system, referred in the control plan. Refer customer reference manuals for analytical methods and acceptance criteria

ISO/TS 16949: 2009 Awareness

7.6.2 Calibration / verification records
Records to include Revisions following engineering changes Any out of specification readings as received for calibration/ verification An assessment of the impact of out-of-specification condition Statements of conformance to specification after calibration/ verification Notification to the customer, if the suspect product or material has been shipped

ISO/TS 16949: 2009 Awareness

7.6.3 Laboratory requirements Internal Laboratory

Preferably a Laboratory manual consisting of defined lab scope, qualified personnel list, environmental conditions, procedures/instructions for testing/calibration, capability to perform tests correctly, traceable to relevant standards. External Laboratory

To have a defined laboratory scope, Laboratory to be accredited to ISO/IEC 17025 or national equivalent, or Evidence that the external laboratory is acceptable to the customer.

ISO/TS 16949: 2009 Awareness

8 Measurement , analysis and improvement

8.1.1 Identification of statistical tools

Determine during advance quality planning and include in control plan

8.1.2 Knowledge of basic statistical concepts

Basic concepts to be understood throughout the organization (variation, control, process capability and over-adjustment)

ISO/TS 16949: 2009 Awareness

8.2 Monitoring and measurement 8.2.1 / Customer satisfaction
Monitor the customer satisfaction and/ or dissatisfaction. Methodologies shall be determined Performance indicators shall be based on objective data and include Delivered part quality performance Customer disruptions including field returns Delivery schedule performance (including incidents of premium freight) Customer notifications related to quality or delivery issues Monitor performance of the manufacturing process to demonstrate compliance with customer requirements for product quality and efficiency of the process

ISO/TS 16949: 2009 Awareness

8.2.2 Internal Audit

Conduct periodical internal audits to determine effective implementation of QMS conform to the requirements of TS. Plan the audit program taking into consideration the status and importance of the activities, areas to be audited as well as the results of previous audits Define the audit scope, criteria ,frequency and methodologies Auditor shall not audit their own work Record audit results Ensure actions without undue delay Follow-up actions to verify the implementation of corrective action and to report the verification results

ISO/TS 16949: 2009 Awareness Quality Management system audit
Audit the quality management system to verify compliance with this technical specification and any additional quality management system requirements. Manufacturing process audit

Audit the manufacturing process to determine the effectiveness Product Audit

Audit products at appropriate stages of production and delivery to verify conformance to product dimensions, functionality, packaging & labeling at a defined frequency

ISO/TS 16949: 2009 Awareness Internal Audit plans

To cover all quality management system related processes, activities and shifts and to be scheduled according to an annual plan Internal Auditor Qualification

Internal auditors to be qualified to audit the requirements of this technical specification

ISO/TS 16949: 2009 Awareness

8.2.3 Monitoring & measurement of processes
Suitable methods for measurement and monitoring (Process measurable identified for each processes) Monitoring & measurement of manufacturing processes

Perform process studies on all new manufacturing processes To implement Statistical Process Control activities in manufacturing process for any special/critical characteristics. Maintain records of effective dates of process changes

8.2.4 Monitoring and measurement of product

Monitor and measure the product characteristics at appropriate stages. Record shall indicate the authority responsible for release of product.

ISO/TS 16949: 2009 Awareness Layout Inspection and functional testing

Perform to applicable customer engineering material and performance standards for all products at frequency specified in the control plan. Results shall be available for customer review . Appearance items

For appearance items, provide appropriate lighting for evaluation areas. Masters for color, grain, gloss, metallic brilliance, texture, distinctness of image. Maintenance and control of appearance masters and equipment. Ensure personnel are qualified for evaluations.

ISO/TS 16949: 2009 Awareness

8.3 /8.3.1 Control of Non Conforming product
Documented procedure to define the following identification and control. Documentation & correction. Re-verification after correction. Record of Nonconformance and subsequent actions including concessions. Product with unidentified or suspected status to be classified as nonconforming product

8.3.2 Control of reworked product

Rework instructions to be accessible and utilized by the appropriate personnel

8.3.3 Customer information

To be informed promptly to the customer in the event, nonconforming product is shipped.

ISO/TS 16949: 2009 Awareness

8.3.4 Customer waiver
Obtain customer authorization prior to changing Customer approved product or processes & Maintain records of expiration date or quantity Authorized. Revert to original or superseding specifications when the authorization expires. Properly identify on each shipping container

8.4 / 8.4.1 Analysis of data

Collect and analyze data to determine the suitability and effectiveness of the QMS and identify improvements Analyze the data to provide information on customer satisfaction Conformance to product requirements characteristics, trends of processes, product and opportunities for preventive action and suppliers. Compare trends with progress towards quality objectives and take action.

ISO/TS 16949: 2009 Awareness

8.5 Improvement 8.5.1 Continual Improvement

Continually improve the effectiveness of the QMS through the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive action and management review. Continual improvement of the organization

The organization shall define a process for continual improvement. Manufacturing process improvement

Focus upon control and reduction of variation in products characteristics and manufacturing process parameters

ISO/TS 16949: 2009 Awareness

8.5.2 Corrective Action
Action taken to eliminate the causes of nonconformities in order to prevent recurrence. Documented procedure as per requirement. Records of results of action taken & reviewing effectiveness of corrective action taken. Problem solving

Have a defined process for problem solving leading to root cause identification and elimination and use customer prescribed format, if any. Error proofing

Use error-proofing methods in the corrective action process.

ISO/TS 16949: 2009 Awareness Corrective action impact

Extend corrective action to other similar processes and products Rejected product test / analysis

Analyze parts rejected by the customers manufacturing plants, engineering facilities and dealerships. Minimize the cycle time of this process, maintain records of this analysis, Initiate corrective action to prevent recurrence

ISO/TS 16949: 2009 Awareness

8.5.3 Preventive Action
Action taken to eliminate the causes of potential nonconformities in order to prevent their occurrence. Documented procedure to define Identifying potential nonconformities and their causes evaluating the need for actions to prevent occurrence of nonconformities. Determining and implementing the preventive action needed. Records of results of action taken Reviewing the effectiveness of preventive action taken

ISO/TS 16949: 2009 Awareness