ISO-TS Presentation

ISO/TS 16949 :2002
Quality Management System Awareness Programme

Presentation by:
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INTRODUCTION OF ISO 9001:2000
Standards & Importance of ISO
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Standards - A history of development

NATO Standards AQAPs 21, 24, 29 BS 5179:1974
BS 5750:1979
ISO 9000:1987 ISO 9001:1994
ISO 9001:2000 (Dec 2000)
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The new family of standards

ISO 9000 Fundamentals ISO 9001 The requirements ISO 9004 Guidance ISO 19011 Auditing Quality & Environmental systems
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ISO 9000:2000 family of standards
Reasons for Revision

ISO Protocols require review of Standards every five years to either Confirm or
Revise or
Withdraw Changed Customer / User needs based on experiences of 1994 version and global survey conducted in 1997.
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ISO 9000:2000 family of standards
Reasons for Revision

Need to improve performance continuously by focussing on major processes in the organisation.
Need to monitor Customer Satisfaction.
Promoting use of Quality Management Principles

Need for consistency between QMS requirement and guidelines
Need to restructure the Standards.
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Major Changes in ISO 9001:2000

Quality Management instead of Quality Assurance
ISO 9001, 9002 & 9003 combined into one Standard

New Process oriented structure Increased emphasis on the role of Top Management Significant reduction in mandatory documentation Terminology Changed and Improved to make it user friendly Increased compatibility with ISO 14000 family of Standards
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Establishment of Measurable Objectives at Relevant Levels and Functions
Input to Output from Management Review Meetings has been defined
Additional role of Management Representative (MR) to promote awareness of Customer Requirements throughout the Organisation.
Increased attention to Resource Management and its availability Restructuring of ISO 9000 family Standards.
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32 Clauses of ISO 9001 : 2000 are divided into five main clauses as given below:
Quality Management System Management Responsibility Resource Management Product Realisation Measurement, Analysis and Improvement ISO 9001 & ISO 9004 now a consistent pair of Standards
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Clause 4 Clause 5 Clause 6 Clause 7 Clause 8
New Requirements in ISO 9001 : 2000

Focus on Customer Satisfaction
Stress on Continual Improvement Concept of Permissible Exclusions Consideration of Regulatory Requirement (Legal and Statutory) Specific reference to Quality Management Principles
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New Requirements in ISO 9001 : 2000

Internal Communication Customer Communication Measurement and Monitoring extended to Process Analysis of Data
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Management Principles ISO 9001:2000

Customer focus Leadership Involvement of people Continual Improvements Factual approach to decision making Mutually beneficial supplier relationships Process approach
System approach to management
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Customer focus

You DEPEND on the customer Need to understand current & future needs Meet customer requirements Strive to exceed customer expectations
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Leadership
Leaders establish the vision and direction Create the environment for people to become fully involved in achieving goals & objectives
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Involvement of people
People at ALL levels are the company Their involvement will enable their skills & abilities to be used for companys maximise benefits
the
TEAM
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Continual Improvements
A permanent objective to continually improve
PDCA - Plan - Do - Check - Action
Plan Do Check
Can we do it better ??
Action
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Factual approach to decision making

Effective decisions are based on the logical or intuitive analysis of data & information
Collect data Pareto 80/20 rule
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Process Approach
Results are achieved more efficiently when resources & activities are managed as a process
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A Process
INPUTS
People Equipment Material Methods
The Process diagram

MONITOR
OUTPUTS
Product
PROCESS
Service Information Records
Environment
Managing the inputs - Prevention
Checking - Detection
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Process Control System

Detection v Prevention
Detection
after the event - tolerates waste
Prevention
before the event - avoids waste
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Prevention
Are we capable of doing the job correctly
We need to know and understand the Process
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Identifying, understanding & managing a system of interrelated processes for a given objective contributes to the effectiveness & efficiency of the company
Quality
Management System
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System approach to management The Systematic Approach

What steps to take Measure what we do (Quality) So that we can Manage more effectively (Quality) What system can we use?
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Quality Management Systems

ISO/TS 16949 :2002 Quality Management System Standard
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1.1 Scope
To demonstrate the ability to provide consistent products & meet regulatory requirements To address Customer satisfaction by effective application of the system Process for continual Improvement Prevention of nonconformities
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1.2 Permissible exclusions

Limited to clause 7 Product Realisation
Inputs The Process Activities
NEW
Outputs
Exclusions cannot affect the ability to produce acceptable product that meets: Customer requirements Applicable regulatory requirements
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Continuous Improvement
4. Quality Management System
5. Management Responsibilities
6 Resource management
INPUTS
7 Product realisation
8. Measurement, analysis & improvements
OUTPUTS
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4 Quality management system
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4.1 General requirements

The organisation shall
establish, document, implement, maintain and continually improve in accordance with the International Standard.
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To implement the organisation shall:
identify the processes needed; determine the sequence and interaction of these processes; determine criteria and methods required to ensure the effective operation and control of these processes;
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availability of information to support the operation and monitoring of these processes; measure, monitor and analyse these processes, and implement action necessary to achieve planned results and continual improvement. The organisation shall manage these processes in accordance with the requirements of this International Standard.
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4.2 General documentation requirements

The quality management system documentation shall include:
documented procedures required in this International Standard. documents required by the organisation to ensure the effective operation and control of its processes.
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4.2 General documentation requirements

The extent of the quality management system documentation shall be dependent on the following:
size and type of the organisation; complexity and interaction of the processes; competence of personnel. In any format!
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4.2.2 Quality Manual

A quality manual shall be established and maintained that includes the following: the scope of the quality management system, including details of,
and justification for, any exclusions (see 1.2); documented procedures or reference to them; a description of the sequence and interaction of the processes included in the quality management system.
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4.2.3 Control of documents

Documents required for the quality management system shall be controlled. A documented procedure shall be established: to approve documents for adequacy prior to issue;
to review, update as necessary and re-approve documents; to identify the current revision status of documents; to ensure that relevant versions of applicable documents are available at points of use;
changes and revision status are identified
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4.2.3 Control of documents

to ensure that documents remain legible, readily identifiable and retrievable; to ensure that documents of external origin are identified and their distribution controlled; to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
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4.2.4 Control of records

Records required for the quality management system shall be controlled. Such records shall be maintained to provide evidence of conformance to requirements and of effective operation of the quality management system. A documented procedure shall be established for the identification, storage, retrieval, protection, retention time and disposition of quality records.
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5 Management responsibility
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5.1 Management commitment

Top management shall provide evidence of its commitment to the development and improvement of the quality management system by: communicating to the organisation the importance of meeting customer as well as regulatory and legal requirements; establishing the quality policy and quality objectives; conducting management reviews;
ensuring the availability of necessary resources.
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5.2 Customer focus

Top management shall ensure that customer requirements are determined, converted into requirements and fulfilled with the aim of achieving customer satisfaction. NOTE When determining customer requirements, it is important to consider obligations related to product, including regulatory and legal requirements (see 7.2.1).
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5.3 Quality policy

Top management shall ensure that the quality policy: is appropriate to the purpose of the organisation; includes a commitment to meeting requirements and to continual improvement; provides a framework for establishing and reviewing quality objectives; is communicated and understood at appropriate levels in the organisation; is reviewed for continuing suitability.
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5.4
Planning
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5.4.1 Quality objectives

Top management shall ensure that quality objectives are established at relevant functions and levels within the organisation.
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The quality objectives shall be measurable, and consistent with the quality policy including the commitment to continual improvement.
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Quality objectives shall include those needed to meet requirements for product (see 7. 1a).
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5.4.2 Quality Planning

Top management shall ensure that the resources needed to achieve the quality objectives are identified and planned.
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5.4.2 Quality planning

Quality planning shall ensure that: the planning of the management system is carried out to meet the requirements in clause 4.1 change is conducted in a controlled manner and that the integrity of the quality management system is maintained during this change.
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5.5 Responsibility, authority, and

communication
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5.5.1 Responsibility and

Authority
Top management shall ensure that responsibilities and authorities are defined and communicated within the organisation.
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5.5.2 Management representative

Top management shall appoint a member of the management team who, irrespective of other responsibilities, shall have responsibility and authority that includes: ensuring that processes of the quality management system are established and maintained; reporting to top management on the performance of the quality management system, including needs for improvement; ensuring the promotion of customer requirements
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5.5.3 Internal communication

The organisation shall ensure communication between its various levels and functions regarding the processes of the quality management system and their effectiveness.
Department A
Department B
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5.6 Management review

5.6.1 General
Top management shall review the quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The review shall evaluate the need for changes to the organisation's quality management system, including quality policy and quality objectives. Records shall be maintained
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5.6.2 Review input

Inputs to management review shall include information on: results of audits; customer feedback; process performance and product conformance; status of preventive and corrective actions; follow-up actions from earlier management reviews; changes that could affect the quality management system. Recommendations for improvement
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5.6.3 Review output

The output from the management review shall include decisions and actions related to: improvement of the management system and its processes; improvement of product related to customer requirements; resource needs.
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6 Resource management
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6.1 Provision of resources

The organisation shall determine and provide the resources needed:
to implement and improve the processes of the quality management system, and to enhance customer satisfaction by meeting customer requirements.
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6.2 Human resources
6.2.1 Assignment of personnel

Personnel performing work affecting product quality shall be competent on the basis of applicable education, training, skills and experience.
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6.2.2 Training, awareness and competency

The organisation shall: determine competency needs for personnel performing activities affecting quality;
provide training, or other actions, to satisfy these needs; evaluate the effectiveness of the actions taken; ensure that its employees are aware of their role in contributing to the achievement of the quality objectives; maintain appropriate records of education, experience, training and qualifications (see 5.5.7).
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6.3 Infrastructure
The organisation shall identify, provide, and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes as applicable:
buildings, workspace and associated utilities; process equipment (hardware and software); supporting services (transport,etc).
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6.4 Work environment

The organisation shall determine and manage the work environment needed to achieve conformity of product.
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7 Product realization
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7.1 Planning of realization processes

The organisation shall determine the following as appropriate: quality objectives and requirements for the product need to establish processes, documents, and provide resources specific to the product inspection and testing activities specific to the product and the acceptance criteria records to provide evidence that the realisation processes and the resulting product meet requirements planning output shall be in a form suitable for the methods of operation of the organisation
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7.2 Customer - related processes
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7.2.1 Identification of customer requirements

The organisation shall determine: customer requirements including requirements for delivery and post-delivery activities requirements not specified by the customer but necessary for intended or specified use including regulatory and legal requirements any additional requirements determined by the organisation
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7.2.2 Review of product requirements

The organisation shall review the requirements related to the product The review shall be conducted prior to the commitment to supply a product to the customer (e.g. submission of a tender, acceptance of a contract or order) to ensure that: the requirements are defined contract or order differences are resolved the organisation has the ability to met the defined requirements Records of the review shall be maintained
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7.2.2 Review of product requirements

The organisation shall ensure that: where requirements are changed, relevant documentation is amended. relevant personnel are made aware of the changed requirements.
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7.2.3 Customer communication

The organisation shall identify and implement arrangements for communication with customers relating to: product information; enquiries, contracts or order handling, including amendments; customer feedback, including customer complaints.
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7.3 Design and development
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7.3.1 Design and/or development planning

Shall plan and control design and/or development of the product. Design and/or development planning shall determine: the design and development stages review, verification and validation activities appropriate to each design and/or development stage
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7.3.1 Design and/or development planning

responsibilities and authorities for design and development activities. interfaces between different groups involved in design and development shall be managed to ensure effective communication and clarity of responsibilities. Planning output shall be updated, as appropriate, as the design and development progresses.
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7.3.2 Design and/or development inputs

Inputs requirements shall be defined and documented. These shall include: functional and performance requirements; applicable regulatory and legal requirements; applicable information derived from previous similar designs, and other requirements essential for design and development. Inputs shall be reviewed for adequacy. Incomplete, ambiguous or conflicting requirements shall be resolved
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7.3.3 Design and/or development outputs

The outputs shall be documented in a manner that enables verification against the design and development inputs. Output shall: meet the input requirements provide appropriate information for purchasing, production, and service operations contain or reference product acceptance criteria specify the characteristics that are essential for safe and proper use. Output documents shall be approved prior to release.
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7.3.4 Design and/or development review

At suitable stages, systematic reviews shall be conducted to: evaluate the ability of the results of the design process to meet requirements; identify problems and propose necessary actions. Participants shall include representatives of functions concerned with the design stage(s) being reviewed. Results of the reviews and any necessary actions shall be recorded
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7.3.5 Design and/or development verification

Verification shall be performed to ensure that the design outputs meets the input requirements. The results of the verification and any necessary actions shall be recorded.
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7.3.6 Design and/or development validation

Validation shall be performed to confirm that resulting product is capable of meeting the requirements for the intended use. Wherever applicable, validation shall be completed prior to the delivery or implementation of the product. Validation records shall be maintained.
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7.3.7 Control of design and development changes

Changes shall be verified and validated, and approved before implementation. Control includes evaluation of the effect of the changes on constituent parts and products already delivered.
Identified, documented and controlled The results of the review of changes and any necessary actions shall be documented.
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7.4 Purchasing
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7.4.1 Purchasing process

Shall control purchasing processes to ensure purchases product conforms to requirements.
The type and extent of control shall be dependent upon the effect on subsequent realisation processes and to the final product. The organisation shall evaluate and select suppliers, in accordance with specified criteria, based on their ability to supply in accordance with the requirements. Records shall be maintained
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7.4.1 Purchasing control

Criteria for supplier selection and periodic evaluation shall be defined. The results of evaluations and any necessary actions arising shall be recorded.
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7.4.2 Purchasing information

Purchasing documents shall contain information describing the product to be purchased, including where appropriate: requirements for approval or qualification of
- product, procedures, processes, equipment and personnel; quality management system requirements. Shall ensure the adequacy of specified requirements contained in the purchasing documents prior to their communication to the supplier.
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7.4.3 Verification of purchased products

Shall identify and implement the activities necessary for verification. Where the organisation or its customer proposes to perform verification activities at the supplier's premises, the organisation shall specify the intended verification arrangements and method of product release in the purchasing information.
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7.5 Production and service provision
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7.5.1 Operations control

The organisation shall control operations through:
the availability of information that specifies the characteristics of the product; where necessary, the availability of work instructions; the use of suitable equipment the availability and use of measuring and monitoring devices., the implementation of monitoring activities; the implementation of release, delivery and post- delivery activities.
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7.5.2 Validation of processes

Shall validate any production and service processes where the resulting output cannot be verified by subsequent measurement or monitoring. This includes any processes where deficiencies may become apparent only after the product is in use or the service has been delivered.
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7.5.2 Validation of processes

Validation shall demonstrate the ability of the processes to achieve planned results by the following, as applicable: qualification of processes; qualification of equipment and personnel; use of defined methodologies and procedures; requirements for records; re-validation
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7.5.3 Identification and Traceability

Shall identify, where appropriate, the product by suitable means throughout production and service operations. Shall identify the status of the product with respect to measurement and monitoring requirements. Shall control and record the unique identification of the product, where Traceability is a requirement.
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7.5.4 Customer property

Shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. Occurrence of any customer property that is lost, damaged or otherwise found to be unsuitable for use shall be recorded and reported to the customer. NOTE Customer property may include intellectual property (e.g. information provided in confidence).
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7.5.4 Preservation of product

Shall preserve conformity of product with customer requirements during internal processing and final delivery to the intended destination. Include identification, handling, packaging, storage and protection. Shall also apply to the constituent parts of a product.
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7.6 Control of measuring and monitoring devices

Shall identify the measurements to be made and the measuring and monitoring devices required to assure conformity of product to specified requirements. Processes shall be established to ensure that measuring and monitoring devices are used in a manner that is consistent with the measurement requirements.
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Where applicable, measuring and monitoring devices shall: be calibrated and adjusted periodically or prior to use, against devices traceable to international or national standards; where no such standards exist, the basis used for calibration shall be recorded;
be safeguarded from adjustments that would invalidate the calibration; be identified to enable the calibration status to be determined
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be protected from damage and deterioration during handling, maintenance and storage; have the results of their calibration recorded (see 5.5.7); have the validity of previous results re-assessed if they are subsequently found to be out of calibration, and corrective action taken.
Software used for measuring and monitoring of specified requirements shall be validated prior to use.
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8 Measurement, analysis and improvement
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8.1 General
Shall define, plan and implement the measurement, monitoring, analysis and improvement processes: needed to ensure conformity of the product needed to ensure conformity of the management system needed to continually improve the effectiveness of the management system Shall include the determination of the need for, and use of, applicable methodologies including statistical techniques.
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8.2 Measurement and monitoring
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8.2.1 Customer satisfaction

Shall monitor information on customer satisfaction and/or dissatisfaction as one of the measurements of performance of the quality management system. The methodologies for obtaining and using this information shall be determined.
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8.2.2 Internal audit

Conduct periodic internal audits to determine whether the system has been effectively implemented and maintained. Plan the audit program taking into consideration the status and importance of the activities and areas to be audited as well as the results of previous audits. The audit scope, frequency and methodologies shall be defined.
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Shall be conducted by personnel other than those who performed the activity being audited. Documented procedure shall include the responsibilities and requirements for conducting audits, ensuring their independence, recording results and reporting to management.
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Management shall take timely corrective action on deficiencies found during the audit. Follow-up actions shall include the verification of the implementation of corrective action, and the reporting of verification results.
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8.2.3 Monitoring and measurement of processes

Shall apply suitable methods for measurement and monitoring of the management system processes necessary to meet customer requirements. When results are not achieved, corrective actions shall be implemented.
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8.2.4 Monitoring and measurement of product

Measure and monitor the characteristics of the product to verify that requirements are met. Carried out at appropriate stages of the process. Evidence of conformity with the acceptance criteria shall be documented.
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8.2.4 Measurement and monitoring

Records shall indicate the authority responsible for release of product Product release and service delivery shall not proceed until all the specified activities have been completed, unless otherwise approved by the customer.
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8.3 Control of Non-conformances
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8.3 Control of nonconforming product

Product which does not conform is identified and controlled to prevent unintended use or delivery. Defined in a documented procedure. Nonconforming product shall be corrected and subject to re-verification after correction to demonstrate conformity.
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8.3 Control of nonconformity

When nonconforming product is detected after delivery or use has started, appropriate action shall be taken regarding the consequences of the nonconformity. The proposed rectification of non-conforming product be reported for concession to the customer, the end user, regulatory body or other body.
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8.3 Control of nonconformity

Non-conforming product shall be : reworked to met the original requirements re-graded or re-categorised the subject of a concession
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8.4 Analysis of data

Collect and analyse appropriate data to determine the suitability and effectiveness of the management system and to identify where continual improvements may be made. Data generated by measuring and monitoring activities and other relevant sources
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8.4 Analysis of data

Shall analyse this data to provide information on: customer satisfaction and/or dissatisfaction; conformance to customer requirements; characteristics of processes, products and opportunities for preventive action
suppliers.
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8.5 Improvement
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8.5.1 Continual improvement

The organisation shall continually improve the effectiveness of the management system through the use of: the quality policy quality objectives audit results analysis of data corrective and preventive actions management review.
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8.5.2 Corrective action

The organisation shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective action shall be appropriate to the effect of the non-conformities encountered.
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8.5.2 Corrective action

A documented procedure shall be established to define requirements for: reviewing non-conformities (including customer complaints), determining the causes of nonconformity; evaluating the need for actions to ensure that nonconformities do not recur, determining and implementing the corrective action needed; recording results of action taken; reviewing of corrective action taken.
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8.5.3 Preventive action

Preventive action to eliminate the causes of potential nonconformities to prevent occurrence and be appropriate to the effects of the potential problems. A documented procedure shall define identifying potential nonconformities and their causes
evaluating the need for action to prevent occurrence of nonconformities determining and implementing the actions needed recording results of action taken reviewing preventive action taken
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An Introduction to ISO/TS 16949:2002
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ISO/TS 16949:2002 Basics What is ISO/TS 16949:2002?

Incorporates ISO 9001:2000 Replaces US, and European Standards
QS-9000, VDA, etc.
Document reflecting worldwide automotive requirements US, Europe, and Asia
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What is ISO/TS 16949:2002?

TS 16949 is a Technical Standard expressing particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations which means...
ISO 9001:2000 requirements plus additional requirements specific to automotive production
In the standard document ISO 9001:2000 text is shown in boxes

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ISO/TS 16949:2002 Basics Documents Auditors and Implementers need to Know

ISO/TS 16949:2002 Technical Standard ISO/TS 16949:2002 Guidance Document Rules for Automotive Certification Scheme Quality System Checklist Customer Specific Requirements
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Outline
ISO/TS 16949:2002 Transition Overview
ISO 9000 Background and Evolution TS 16949 Background and Objectives Overview of Quality Management Principles Overview of the TS 16949/ISO 9000 Standards
Transitioning to ISO/TS 16949:2002
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ISO 9000 Is . . .
An international quality management system standard which adopts a process approach for: developing, implementing and improving the effectiveness of a quality management system
enhancing customer satisfaction by meeting customer customer requirements
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ISO/TS 16949:2002 Is . . .
A process approach for:
Implementing an effective and efficient quality management system, and

Enhancing customer satisfaction through continual improvement of the QMS and customer-owned processes (primarily manufacturing process) Includes all requirements of ISO 9001:2000 and: Automotive / customer specific requirements
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The Objectives of ISO 9000 are to...

Achieve, sustain, and improve product quality by managing the processes that create them
Give the organization confidence that customer requirements are being met Give the customer confidence that products consistent meet requirements Provide or sustain market entry
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The Objectives of TS 16949 are to ...

Specify Automotive Customer requirements
Provide automotive industry with revised ISO 9001:2000 based QMS standard
Provide a worldwide, standardized approach for all automotive suppliers Expand ISO 9001:2000 focus on process management by emphasizing
- defect prevention and - reduction of variation in the supply chain

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ISO 9000:2000 standards include ...

ISO 9000:2000
Quality Management Systems Fundamentals and Vocabulary
Quality Management Systems Requirements
ISO 9001:2000
Quality Management Systems Guidelines for Performance Improvements

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ISO 9004:2000
TS 16949 incorporates all ISO 9000:2000 standards and ...

Quality Management Systems - particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations
ISO/TS 16949:2002
Customer Requirements / Guidance

Advanced Product Quality Planning (APQP) & Control Plan Failure Mode Effects Analysis (FMEA) Production Part Approval Process (PPAP) Fundamental Statistical Process Control (SPC) Measurement Systems Analysis (MSA) Quality System Assessment (QSA) Checklist
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A Quality System must be SEDA

Effective Auditable
Suitable Documented
Words of wisdom from Victor Schur (Sears)
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ISO 9000 Status

500,000+ Companies Registered Worldwide 37,000+ Companies Registered in the U.S. 20,000+ U.S. Companies pursuing Registration DoD, Big 3 & many other sectorsor industries have adopted ISO 9000 based standards Automotive manufacturers have imposed deadlines on Tier 1, 2 and 3 suppliers to achieve ISO 9001:2000 and/or ISO/TS 16949:2002 registration at various times over the next three years
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Deadlines
ISO 9001:2000 (replaces ISO 9001/2:1994)
- All ISO 9001/2:1994 registered companies must make the transition by December 2003
ISO/TS 16949:2002 (Replaces QS- 9000:1998)
- DaimlerChrysler suppliers must make the transition by July 2004 - General Motors and Ford suppliers must make the transition by December 2006
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Performance Excellence Starts with an Effective QMS

Business Vision
Performance Excellence Nation Quality Award Criteria (such as Baldrige) Performance Improvement ISO/TS 16949:2002 Baseline Performance: ISO 9001:2000
Competitive Advantage
#1
Efficient Quality Management System
Effective Quality Management System

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The Basis of a Quality System is to ...

say what you do, do what you say, record what you did, check the results, and act on the difference
Words of wisdom from Ian Durand (US Technical Advisory Group to ISO TC 176)
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ISO/TS 16949:2002 and ISO 9004 are the Consistent Pair

comprised of the following 8 clauses:
1. Scope 2. Normative references (part of the requirements) 3. Terms and definitions 4. Quality management system 5. Management responsibility 6. Resource management
7. Product (and/or service) realization

8. Measurement, analysis & improvement
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Clause 4.1 QMS General Requirements

4.1 The organization must establish, document, implement, maintain and continually improve the QMS processes; this includes:
define processes to be managed (including out-sourced processes - which typically include design, training, calibration, heat treat, etc.) define the sequence and interaction of these processes determine the criteria and methods needed to manage these processes and ensure their effectiveness; take actions to improve these processes.
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TS 16949 and ISO 9000 are based on Eight Quality Management Principles
Customer Focus Leadership Involvement of People Process Approach System Approach Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships
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Customer Focus
Organizations depend on their customers and therefore should:
understand current and future customer needs, meet customer requirements, and strive to exceed customer expectations.
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Leadership
Leaders should:
establish unity of purpose and direction of the organization, and
create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives.
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Clause 5.1 Management Commitment

Top management must demonstrate commitment to development and implementation of the quality system and continually improving its effectiveness through specific activities: communicate importance of meeting customer (and statutory/regulatory) requirements establish quality policy and objectives conduct management reviews ensure availability of necessary resources TS also requires management be committed to continual improvement of the effectiveness and efficiency of customer oriented manufacturing processes
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Clause 5.2 Customer Focus

Top management must:
ensure customer needs and expectations are determined, turned into requirements, and
ensure customer requirements (identified per Clause 7.2.1) are met with the aim of enhancing customer satisfaction (a perception that must be measured per Clause 8.2.1)
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Clause 5.3 Quality Policy

5.3 Top management must establish quality policy that: is appropriate for the organizations purpose, includes a commitment to meeting requirements and continual improvement of the effectiveness of the QMS,
provides a framework for establishing/reviewing measurable quality objectives, and,

is communicated and understood and implemented at appropriate levels, and
is periodically reviewed for continuing suitability
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Clause 5.4 Planning

5.4 Top management must establish quality objectives and identify resources needed to meet them: 5.4.1 Quality objectives. First, measurable quality objectives consistent with the quality policy must be established at relevant functions and levels in the organization; TS 16949 also requires these objectives to be included in the organizations Business Plan; and specifies minimum metrics that must be monitored 5.4.2 Quality management system planning. Secondly, resources required to meet the objectives and carry out the processes (identified per clause 4.1) must be identified and planned
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Clause 5.5 Responsibility, Authority and Communication

5.5 Top management must establish clear responsibilities, authorities and communication systems regarding the QMS: 5.5.1 Responsibility and authority. First, responsibilities and authorities must be defined and communicated with the organization. 5.5.2 Management representative. Secondly, a management representative appointed by top management must ensure the QMS is implemented, report to top management on performance of the QMS, and promote awareness of customer requirements throughout the organization. TS 16949 also requires a customer representative be designated to ensure compliance with all applicable requirements.
5.5.3 Internal communication. Finally, internal communications regarding the effectiveness of the quality system must be established
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Clause 5.6 Management Review

5.6.1 Top management must review the suitability, effectiveness, and adequacy of the QMS at planned intervals; and must evaluate the need for change, including changes to policy and objectives. 5.6.2 Review input. Specific review inputs are required including current performance and improvement opportunities related to audit results, customer feedback, performance of product and processes, status of actions, changes that could affect the QMS, and recommendations for improvement. TS 16949 also requires Business Plan objectives be reviewed, including an evaluation of the cost of poor quality and progress in reducing variation in customer owned manufacturing processes 5.6.3 Review output. Specific review outputs must be recorded including actions and resources related to improvement of product, the QMS, and QMS processes
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Involvement of People
People at all levels are the essence of an organization, and

their full involvement enables their abilities to be used for the organizations benefit.
- TS also requires that the organization define their system for employee motivation and empowerment
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Process Approach
Organizations need to do more than simply monitor process outputs, (typically
through inspection activities)
they must also control all process inputs, (people,
facilities/equipment, material and methods)
and, they must establish appropriate controls over the transformation activities (if desired results are to be
consistently achieved)
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Process Approach and TS 16949

Organizations need to provide evidence that the control of product realization processes is effective AND efficient
they must document, measure, monitor and improve customer oriented processes
i.e. processes used to create and produce products or services for the customer from concept to delivery
and, they must ensure the availability of resources and information to support functioning of these processes
NOTE: ISO/TS 16949;2002 audits will almost entirely consist of process based assessments which consist of auditing the process, its objectives and linkages to related processes.
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What is a Process?
Activity that transforms input into output
Input Resources:
Activity
Output Results:
Products Services Performance
People Facilities/Equipment Material Methods
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How is a Process Managed?

Monitor & Measure the Process
make sure the inputs are right, the transformation activities consistently work, and the desired results are achieved, then - improve the process as needed
Input
Activity
Output
Right Resources:
Qualified People Right Facilities/Equipment Correct Materials Proven Methods
Desired Results:
Quality Products Quality Services Customer Satisfaction
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How is a Process Measured?

Efficient
No Waste Desired Results Achieved
Effective
Input
Activity
Output
Desired Results:
Quality Products Quality Services Customer Satisfaction
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Right Resources:
Qualified People Right Facilities/Equipment Correct Materials Proven Methods
System Approach
Organizations must understand a system is a set of interrelated processes, and the output of one process is the input to one or more subsequent processes, so ... It is critical to manage the white space (or interface) between processes to ensure that the overall system is effective
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C U S T O M E R R E Q U I R E M E N T S
Continual Improvement of the Quality Management System
Management Responsibility
C U S T O M E R S A T I S F A C T I O N
Resource Management
Measurement Analysis & Improvement
Product Realization
Input
Product Output
The Process-Based Quality Management System
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Continual Improvement
Continual improvement of the organizations overall performance should be a permanent objective: improvement must be a planned activity if the organization desires to improve overall performance and capabilities.
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TS 16949 implements the PDCA improvement cycle

Plan
Clause 5. Management responsibility - everything flows from Management who define the requirements for the system Clause 6. Resource management - from these requirements the resources will be identified and management must ensure they are provided and applied within the system
Do
Clause 7. Product (and/or service) realization - the necessary process are established and carried out
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TS 16949 implements the PDCA improvement cycle

Check
Clause 8. Measurement, analysis and improvement - processes and products will be monitored and measured against policies, objectives and requirements for the product and results/opportunity for improvement reported
Act
Clause 8. Measurement, analysis and improvement - acting upon data reported in the check cycle, improvement actions can be taken - directly, or as an output of the Management Review process (Clause 5.6)
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The QMS must be used for continual improvement ...

Improve Process through PDCA Cycle
Plan Act
QMS
Do Check
Results
Measure/Monitor Results Against Objectives Improve Process and Change QMS as Needed to Achieve and Sustain Desired Results
Improvement Objective Baseline Performance

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Factual Approach to Decision Making

Effective decisions are: based on the analysis of data and information.
- TS 16949 also requires the monitoring of certain metrics including but not limited to:
- parts per million (PPM) defect rate reduction, - product cost reduction, - improved delivery performance, and - shortened product launch cycle times
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Mutually Beneficial Supplier Relationships

An organization and its suppliers are truly inter-dependent, and a mutually beneficial relationship enhances the ability of both to create value.
- TS 16949 also requires that all suppliers achieve ISO 9001:2000 registration (note: the jury is still out on if/how this requirement can/should be enforced as long as meaningful supplier development activities are in place)
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the Role of Internal Audits has also shifted to a process approach...

ISO 90011 994 Internal audit
Effectiveness of Quality System Elements assessed in audit report

Management determines effectiveness of their processes by analyzing all available data and information
Management review
Internal audit ISO 9001 2000 Customer satisfaction Other data
Management review
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Conducting Process Audits

Identify QMS Process Owners
Deployment Flowcharts can be invaluable in defining the sequence, interrelationship and responsibilities associated with QMS Processes
Evaluate Conformance
Checklists can be invaluable in verifying that the documented procedure or process complies with ISO 9001:2000 requirements
Evaluate Performance
Verify that the organization is collecting and using process performance data to monitor, measure and improve processes in accordance with objectives
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IATF View on ISO/TS 16949:2002

Automotive Industry Value added requirements Global Quality System Content Global Recognition Certificate Common Registration Requirement and Oversight Body for registrars Reduced number of registrars- one contract and certification committee centralized in one office Common Auditor Qualification
Process Approach to auditing is key to the transition from QS-9000 to ISO/TS 16949:2002!
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Comparison of ISO/TS 16949 and QS-9000

QS-9000
Released in 1994 22,500 Certifications 174 Registrars with multiple offices 22 Accreditation Bodies
ISO/TS 16949
First edition released in 1999 1724 Certifications 48 Registrars 5 Regional Offices for Accreditation
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Facts About ISO/TS 16949:2002

QS-9000 goes away 2006, Dec. 15
Note: DCX deadline is July, 2004
Past Dec. 15, 2003 the organization needs to get QS-9000 audits and ISO 9001:2000 audits to maintain ISO standing
Chads note: If you are going to implement QS with ISO 9001:2000, why then not go directly to ISO/TS 16949:2002. Imagine the conflicts between the ISO 1994 version and the ISO 2000 version.
Includes Vehicle Assembly Centers

For all practical purposes, ISO/TS 16949:2002 deadline is Dec. 15, 2003.
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What happens after Dec. 15, 2003?

ISO 9001:1994 will no longer be a certifiable standard QS-9000 will become a stand alone certificate
Note if you seek ISO 9001:2000 registration you must get a separate certification
ISO/TS 16949:1999 will end in 2004
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QMS Process Model

Continual improvement of the quality management system
Management responsibility
5.0
Customers
Customers
Resource management
6.0
8.0
Measurement, analysis and improvement
Satisfaction
7.0
Requirements
Input
Product realization Product
Output
Key Information flow Value-adding activities Figure 1 - Model of a process-based quality management system ISO 2000
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Business Excellence Model

Knowledge Management
Customer Expectation & Requirements
Customer Satisfaction
Interested Parties
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Customer Oriented Processes

This is a process O Organization I
Check input against output. Notice how this is a literal application of the process model.
An interface Organizational/ External environment input (I) An interface Organizational/ External environment output (O)
Continual improvement of the quality Continual improvement of the quality management system management system
Management responsibility
Customers Customers
Measurement, analysis and improvement
Customers Customers
Key Information flow Value-adding activities
Requirements
Resource management
Satisfaction
Input
Product realization
Product
Output
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The Octopus Model
4 5
3 2 1 10
7 8 9
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Examples of COPs
Finished Prototype Product Specifications Determined Production Run and Optimized Product Analyzed and Request for Change Issued
Prototype Delivered
Product Validation
Product Realization
Warranty Request
Prototype Requested
Warranty Product Design
Warranty Request Accepted
Customer Feedback Order Accepted Order / Request
Performance Reports
Market Analysis Bid Awarded with Specifications Bid / Tender
Corrective actions, Preventive actions, Continual Improvement
Bid Proposal Request for Quote from Customer Information about Product Line(s)
Sales and Marketing Research of Market
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Our View of the Processes

Our believes there are four types of processes.
Customer Oriented Processes (COPs) Management Oriented Processes (MOPs) Support Processes (SOPs) ISO/TS 16949:2002 Related Processes
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Documentation Approach
Document BMS Quality Manual
Need for process map or equivalent
Document Processes including COPS, MOPS, and SOPS

Use flow charts
Document all requirements of the ISO/TS 16949:2002 including customer specific requirements Ford, GM, and DCX Requirement Document work instructions and forms/checklists
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Learning objectives
Appreciating key aspects of ISO/TS 16949 + market drivers Comparing ISO/TS 16949:2002 with ISO 9001:2002 Approaches to assessing where you are now Appreciating the techniques to support ISO/TS 16949; Statistical Analysis
Statistical Process Control Measurement Systems Analysis

FMEA Control Plans Considering the next steps
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Where did ISO/TS 16949:2002 come from?

Prepared by International Automotive Task Force (IATF) + Japan Automobile Manufacturers Assoc. (JAMA)
EAQF AVSQ Automotive
VDA 6.1
QS 9000
ISO/TS 16949:1999
ISO/TS 16949:2002
ISO 9000 series
ISO 9001:1994 1994 1999
ISO 9001:2000 2000 2002

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Key Aspects Scope & goal

SCOPE: This technical specification is applicable to sites of the organization where production and/or service parts
specified by the customer are manufactured

throughout the supply chain.
GOAL: The goal of this specification is the development of a quality

management system that provides for; continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.
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Key Aspects Overview

Top management involvement including;
implementing a business plan linked to defined measurable quality objectives
Clear definition of responsibilities including;

Authority to stop production to correct quality problems
Top management review of the performance of the quality system including;

reporting and evaluation of the cost of poor quality
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Focus on Human Resource management including processes for defining competence requirements, providing training (including on the job training for employed, temporary and agency personnel), verifying effectiveness of actions taken A process to motivate employees to achieve quality objectives, make continual improvement, and create an environment to promote innovation.
A process to measure the extent to which personnel are aware of the relevance & importance of their activities - how they contribute to achieving the quality objectives
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Focus on product & process design to meet requirements Use of automotive core tools Statistical Process Control (SPC), Measurement System Analysis (MSA) Failure Mode Effect Analysis (FMEA) Controlling production processes by use of control plans work instructions Ensuring effective control of internal & external laboratories
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Focus on process for measurement of customer perception and satisfaction
All processes need to take into account any customer specific requirements
Development of suppliers using ISO/TS16949: 2002
Focus on continual improvement Undertaking effective system, process & product audits Effective analysis of data to drive improvement Evidence of continual improvement throughout the organisations processes, not just manufacturing
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Key Aspects 8 QM principles

Process Approach Customer focus Leadership Involvement of people System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationship [ 4.1, 5.1.1 ] [ 5.1, 5.2, 5.6.1.1, 8.2.1, [ 5.3, 5.4.1 ] [ 5.5.3, 6.2.2.4 ] [ 4.1, 5.1.1, 5.4.1, 5.6.1 ] 8.3.3 ]
[ 5.1, 5.3, 8.5.1 ] [ 5.6.1, 8.2.2, 8.4 ] [ 7.4.1.2 ]
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Key Aspects Process focus

Process any activity or set of activities that uses resources to transform inputs into outputs.
[4.1] The organisation shall identify processes needed for the quality management system and their application throughout the organisation determine the sequence and interaction of these processes measure, monitor and improve these processes.
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Examples of customer orientated processes Bid/Tender, Order/Request Production Product/Production verification For your own operations, consider such processes inputs outputs possible indicators of process effectiveness from the customer and/or organisations (internal customer) perspective what management/support processes are needed for this process to work effectively
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Management & support processes examples Management Review & Business Planning Internal Audit Production Engineering Quality Purchasing Finance Maintenance Human Resources
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Customer measures of process effectiveness Delivered part quality performance Customer disruptions including field returns Delivery schedule performance (including instances of premium freight) Customer notification of quality or delivery issues Organisation measures of process effectiveness Reports & reviews of performance against objectives Evaluation of the cost of poor quality
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Key Aspects Customer focus

Customer specific requirements are included in an audit for ISO/TS 16949
Customer specific quality management system requirements supplemental to ISO/TS 16949 shall be included in the audit in order to obtain customer recognition of such certification
What is your process for identifying and using customer specific quality management system requirements?
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Key aspects required documents

Quality policy & objectives [4.2.1] + Quality manual [4.2.2] Procedures & documents to ensure effective planning, operation and control of processes + records [4.2.1] Procedure for document control [4.2.3] Procedure for identifying training needs and achieving competence of all personnel performing activities affecting product quality [6.2.2.2] Procedure for internal audits, reporting results & keeping records [8.2.2] Procedure for control of nonconforming product + responsibilities [8.3] Procedure for reviewing nonconformities, determining causes with action to prevent recurrence [8.5.2] Procedure for determining potential nonconformities & causes, action to prevent occurrence [8.5.3]
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Market Drivers the goal

The goal of this Technical Specification is the development of a quality management system that provides for;
- continual improvement - emphasising defect prevention and - the reduction of variation and waste in the supply chain.
Process approach of ISO 9001:2000 complements ISO/TS 16949:2000 many common requirements (less paper?)
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Comparing ISO/TS 16949 with ISO 9001
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Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000
Applying to
Quality Management System Management Responsibility Resource Management Product Realisation Measurement, Analysis and Improvement
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Quality Management System

Retain responsibility for all outsourced processes [4.1.1] Review customer engineering specifications & changes within 2 weeks [4.2.3.1] Control records of regulatory and customer requirements [4.2.4.1]
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Management Responsibility
Top management shall review product realisation and support processes [5.1.1] Top management shall define quality objectives in the business plan and their use to deploy quality policy [5.4.1(.1)] Managers responsible for corrective action shall be promptly informed of products or processes that do not conform to requirements. appoint quality representatives with authority to stop production (all shifts) to correct quality problems [5.5.1.1]
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Management Responsibility (contd)

Top management shall appoint customer representatives with specific responsibility to ensure compliance with customer requirements, including selection of special characteristics, corrective/preventative actions and design/development. [5.5.2.1] Management reviews shall include;
monitoring of performance trends, the cost of poor quality, the achievement of quality objectives, [5.6.1.1] review of actual and potential field failures. [5.6.2.1]
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Resource Management
Personnel with product design responsibility shall be competent to achieve design requirements and skilled in applicable tools and techniques. [6.2.2.1] Document procedures for identifying training needs and achieving competence of personnel [6.2.2.2] Provide on-the-job training, including the consequences to the customer of nonconformities [6.2.2.3] Have a process to motivate employees to; achieve quality objectives, make continual improvements & create an innovative environment. [6.2.2.4]
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Resource Management (contd)

Ensure all skilled staff in the factory are involved in deciding plant layout and handling methods; include lean manufacture using minimum work in progress & minimum movement of parts [6.3.1] Have contingency plans for emergency situations that could affect customer requirements, including power failure, communication failure, raw material or parts supply failure, equipment failure, labour shortage and handling returned product. [6.3.2] Ensure that the plant layout and working methods are designed with safety to employees in mind. [6.4.1] Ensure that workplaces are tidy and appropriately clean. [6.4.2]
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Product Realisation
Include customer requirements and reference to spec.s in the planning of product realisation [7.1(.1)] Define and approve acceptance criteria with the customer [7.1.2] Ensure confidentiality of customer contracted products and product information during design & development and production. [7.1.3] Have change control process that;
prevents any change to product, materials or processes without customer approval, includes testing the validation or effectiveness of the change before implementation. For a proprietary design, review impact on form fit and function with the customer. [7.1.4]
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Product Realisation (contd)

Obtain customer approval for any waiving of a review of requirements related to the product [7.2.2.1] Review manufacturing feasibility within contract review [7.2.2.2] Communicate necessary information in a customer specified language and format [7.2.3.1] Document and include the following in product design input
customer requirements including performance and special characteristics experience from previous products targets for product quality, life, reliability, durability, maintainability, time scales and cost. [7.3.2.1]
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Document and include the following in manufacturing design input
product design outputs that have to be met by manufacturing experience from previous products targets for productivity, process capability and cost. [7.3.2.2]
Identify special characteristics [7.3.2.3]
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Document and include the following in product design output in ways that demonstrate that all design inputs have been met
design FMEAs including diagnostic guidelines to predict failure modes reliability results special characteristics an analysis of error proofing product drawings, specifications and calculations product design reviews [7.3.3.1]
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Document and include the following in manufacturing design output in ways that demonstrate all design inputs have been met
design FMEAs including diagnostic guidelines to predict failure modes a control plan, specifications, drawings, instructions and flowcharts plant & workstation layouts an analysis of error proofing manufacturing process validity and approval method including acceptance criteria [7.3.3.2]
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Report measurements of design & development at management review [7.3.4.1] Perform validation in accordance with customer requirements [7.3.6(.1)] Prototype programme required using manufacturing processes [7.3.6.2] Approval procedure required as recognised by the customer [7.3.6.3] All purchased products shall conform to regulatory requirements [7.4.1.1]
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Work in partnership with suppliers to develop the supplier quality management system. Conformity to ISO 9001:2000 is required. [7.4.1.2] As specified in the contract, use approved sources for purchased material [7.4.1.3] Monitor the quality of purchased product by one or more of the following;
evaluation of the statistical data received from the supplier receiving inspection 2nd or 3rd part audits with records of acceptable delivered performance part evaluation by a designated laboratory [7.4.3.1]
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Monitor supplier performance by;
delivered product quality performance customer disruptions that have occurred returns or other feedback from end users delivered schedule performance [7.4.3.2]
Use Control Plans to the format specified in Appendix A [7.5.1.1] Work instructions for operations that impact on quality are required [7.5.1.2] Verify job set ups [7.5.1.3]
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Use predictive and preventative maintenance for key processes [7.5.1.4] Resources for tool and gauge design, fabrication and verification are required [7.5.1.5] Schedule production to meet customer requirements e.g. just-in-time [7.5.1.6] Establish a process for communication of information on service concerns [7.5.1.7] Verify the effectiveness of any customer service agreements [7.5.1.8]
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Validate all processes for product and service provision to demonstrate the ability of these processes to achieve planned results where applicable through;
defined criteria for review and approval of the process approval of equipment and qualification of personnel use of specific methods & procedures requirements for records revalidation [7.5.2(.1)]
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In all cases;
identify the product throughout product realisation identify the product status with respect to monitoring & measurement requirements where traceability required, control and record unique product identification [7.5.3(.1)]
Permanently mark customer owned tooling Assess the condition of stock. Assure stock rotation (FIFO). Control obsolete stock as nonconforming. [7.5.5.1] Perform statistical studies on measuring equipment to analyse variation [7.6.1]
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Maintain calibration records including
Equipment identification The standard against which the equipment is calibrated Revisions following changes to equipment Assessments of the impact of out-of-specification equipment Notifications to customer of any product that may have been affected by out-ofspecification measuring equiment A positive statement of the acceptance of the calibration for the intended purpose [7.6.2]
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Define the scope of any internal laboratory to include its ability to perform the required duties and be managed by a documented management system either within or separate from the main system [7.6.3.1] Use only external laboratories that
have a suitable scope are accredited to ISO 17025 or acceptable to the customer [7.6.3.2]
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Measurement, Analysis and Improvement

Identify appropriate statistical tools for each process [8.1.1] Understand statistical concepts [8.1.2] Monitor customer satisfaction and produce performance indicators [8.2.1(.1)] Audit the quality management system to verify compliance with the standard [8.2.2.1] Audit each manufacturing process [8.2.2.2] Include in internal audits all quality management related processes, activities and shifts [8.2.2.4]
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Measurement, Analysis and Improvement (contd)

Internal auditors shall be suitable qualified [8.2.2.5] Perform process capability studies and include the conclusions in the quality or control plan. Studies shall include the;
stability of the process capability of the inspection and test process capability of the reaction plans to contain the effect of any nonconformity [8.2.3]
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Conduct product audits [8.2.2.3] and layout inspections i.e. checking every measurement and parameter shown on the approved design drawings. [8.2.4.1] Conduct appearance inspections on items for which customer specifies this i.e. checking every aspect of the appearance of the finished product as perceived by the end user. Maintain master samples and means of making comparisons. [8.2.4.2] Class product with unidentified status as nonconforming. Make instructions for rework available. [8.3(.1), 8.3.2] Inform customers promptly if nonconforming product is shipped [8.3.3]
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Obtain a customer concession before proceeding with any further processing if any part or material is not fully in accordance with approved requirements. This shall apply to product or material still being processes by a supplier. [8.3.4] Analyse trends in quality & operational performance; use data to:
manage progress towards overall objectives identify priorities provide a factual basis for decision making anticipate and predict problems arising from the end users. Establish benchmarks to measure performance against competitors or other appropriate recognised criteria.[8.4.1]
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Define a programme for continual improvement [8.5.1.1] Focus manufacturing improvement on reducing variation [8.5.1.2] Define a process for problem solving [8.5.2.1] Use error proofing methods in the corrective action process [8.5.2.2] Apply corrective action to other similar processes and products [8.5.2.3] Minimise the time for corrective action [8.5.2.4]
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Assessing where you are now
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Techniques to support ISO/TS 16949
Statistical Analysis
- Statistical Process Control (SPC) - Measurement Systems Analysis (MSA)
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Statistical Analysis - SPC

Statistical Process Control (SPC) The use of statistical techniques such as control charts to analyse a process or its outputs so as to take appropriate actions to achieve and maintain a state of statistical control and to improve process capability.
Detects variation in process measures to enable;
reduction of variation, and, prevention of defects / waste.
Applied to all processes whose output measures offer

Variable data e.g. part dimensions Attribute data conforming; yes/no - that can be counted e.g. parts received on-time
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ISO/TS 16949:2002 requirement for Statistical Analysis
8.0 Measurement, analysis and improvement
8.1.1 Identification of statistical tools 8.1.2 Knowledge of basic statistical concepts 8.2.3.1 Monitoring and measurement of manufacturing process 8.5.1.2 Manufacturing process improvement
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Variable data forms a pattern that, if stable, can be described as a distribution. Distributions, differ in Location Spread Shape or any combination of these. If the shape of variable data is normal (typical); location is measured by the mean [ X ] spread is measured by the range [R] or standard deviation [sd] SPC can be applied to see if variation is unacceptable
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Variation in variable data can come from Common causes natural random events which affect all values of process output Special causes intermittent, often unpredictable causes making the process output unstable Control charts help identify special causes by showing Values beyond control limits Nonrandom patterns or trends e.g. 7 points increasing/decreasing, 7 points one side of the average
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Before assessing process capability, special causes must be removed Process Capability then measures How variable the process is [ Pp, Cp ] How process variation fits within the specified limits [Ppk, Cpk] - how well it meets a customer requirement
Cpk 1.00 1.33 1.67 2.00
Approx parts per million out of specification
66,000 6,000 233 4.6 (Six sigma)

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Attribute data can be analysis using
p chart for proportion of nonconforming parts u chart for nonconformities per unit np chart for the number of nonconforming parts c chart for the number of nonconformities
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Statistical Analysis SPC

Benefits of Statistical Process Control (SPC) Show how successfully a process is adjusted & controlled to achieve consistent and therefore predictable outputs e.g. conforming products Flag any special causes of variation which need to be identified and eliminated by local action
Quantify the effects of improvements in quality, leading to reductions in waste (poor quality costs)
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- Statistical Process Control (SPC) - Measurement Systems Analysis (MSA)
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Statistical Analysis - MSA

Why Measurement System Analysis? The purpose of any analysis of a measurement system should be to better understand the sources of variation that can influence the results produced by the system.
To quantify and communicate the limitations of specific measurement systems.
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ISO/TS 16949:2002 requirement for Measurement Systems Analysis (MSA) [7.6.1] Statistical studies shall be conducted to analyse the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis. Other analytical methods of acceptance criteria may be used if approved by the customer.
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Terminology
Measurement system: the collection of operations, procedures, gauges and other equipment, software and personnel used to assign a number to a characteristic being measured; the complete process used to obtain a measurement.
Material Man Method
MEASUREMENT SYSTEM
Machine (Time) Environment
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Terminology
Gauge: any device used to obtain measurements, frequently used to refer specifically to the devices used on the shop floor.
Calibration: a set of operations that establish under specific operating conditions, the relationship between a measuring device and a traceable standard of a known reference and uncertainty.
Reference Value: a reference for comparison, normally determined under laboratory conditions or using a more accurate instrument.
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Quality of measurement data
If measurements are close to the reference value the quality of the data is high
Measurement systems
Must be in statistical control Must have small variability compared with specified tolerance or manufacturing process variability* Descrimination: the amount of change from the reference value that an instrument can detect and faithfully indicate. Typically the smallest graduation on the scale of the instrument *Descrimination should be one tenth of the tolerance range, however recently the descrimination target is one tenth of the process variation significantly less.
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Variability characterised by
Location - bias, linearity, stability Width or spread repeatability, reproducibility
Location Errors
Bias: the difference between the mean measurement and the reference value. Linearity: the difference in bias through the operating range Stability: the total variation in the measurements obtained from a single characteristic over time (change in bias over time) Check change in characteristic, such as values from Electrical Test Equipment, between calibration intervals Plot data and take action if bias outside a specified value
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Spread Errors (Gauge R & R)
Repeatability: variation in measurements obtained with one measurement instrument, when used several times by one appraiser while measuring the identical characteristic on the same part. (Equipment Variation)
Under 10% considered acceptable To improve, instruments may need maintenance or redesign
Reproducibility: variation in measurements obtained with one measurement instrument, when used by different appraisers while measuring the identical characteristic on the same part.
Under 10% considered acceptable To improve, appraiser(s) may need training, or more ease of use
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Measurement System Study
Select appraisers people already using the instrument Select measurement instrument has it the required discrimination Select parts from the process that represent entire operating range e.g. several days production and number each part.
Measurement System Analysis when?

As processes change and improve, a measurement system must be re-evaluated for its intended purpose For example, when there is a new product, capability improvement, skill level change, process change e.g. new equipment, change in work environment, change in test method/procedure.
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Failure Modes & Effects Analysis
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Failure Mode and Effects Analysis

Failure Mode and Effects Analysis (FMEA)
A systematic group of activities to:
Recognize and evaluate potential failures of a product or process and the effects of failure Identify actions that could eliminate or reduce the chance of the potential failure occurring Document the above process
Evidence from vehicle recalls has shown a fully implemented FMEA could have prevented many causes Enables action before the event (Prevention), not after (Detection)
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ISO/TS 16949:2002 requirement for FMEA
4.2.3.1 7.3.1.1 7.3.2.3 7.3.3.1 7.3.3.2 7.5.1.1 Engineering specifications Multidisciplinary approach Special Characteristics Product design outputs Manufacturing process design outputs Control Plan
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Item Potential Function Failure Mode Requirements Potential Effect(s) of Failure S e v C l a s s Potential Cause(s)/ Mechanisms of Failure O c c u r Current Controls (Prevention / Detection) D e t e c Responsibility & R P N Recommended Action(s) Target Completion Date Action Results Actions Taken S e v O c c D e t R P N
What are the customer related functions or requirements?
What are the effects?
How can cause or effect be prevented & detected?
What should be done, by whom & when? -design/ process change -special controls, changes in procedures/ guides
What can go wrong? -No function -Partial/over/ degraded function -Intermittent function -Unintended function
How bad is it?
How good is this method at detecting / preventing?
What are the causes? What risks are highest priority?
What has been done? Is there still a priority risk?
How often does it happen?
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Design FMEA Focuses on designing out Potential Failures in Product Design causing detrimental effects on functional performance Applies when products design is created or revised Uses test, production, quality, supplier & customer experience TEAM EFFORT Assumes manufacturing process would achieve specification Process FMEA Focuses on preventing Potential Failures in manufacturing Process causing detrimental effects on functional performance Applies when manufacturing process is applied to new product or changed TEAM EFFORT Uses test, design, quality, supplier & customer experience Assumes if design made to spec., it would otherwise succeed
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Design FMEA used to address potential risks in the design achieving functional performance, by:
Identifying potential design failures, their causes & effects

Rating the;
Severity of effects; 1 to 10 (10 = most severe), Occurrence of effects; 1 to 10 (10 = most likely), Detection/prevention of effects by current controls eg. analysis, test; 1 to 10 (10 = not likely to be detected/prevented),
using guidance available in DFMEA manuals.
Using the Risk Priority Number (RPN)

RPN = Severity rating x Occurrence rating x Detection rating
to prioritise action focussing on designing out failure

Customers may define triggers for action e.g. RPN >100, Severity > 8
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Process FMEA used to address potential risks in the manufacturing process achieving functional performance, by: Identifying potential process failures, their causes & effects Rating the;
Severity of effects; 1 to 10 (10 = most severe), Occurrence of effects; 1 to 10 (10 = most likely), Detection/prevention of effects by current controls eg. test; 1 to 10 (10=unlikely to be detected/prevented),
using guidance available in PFMEA manuals.
Using the Risk Priority Number (RPN)

RPN = Severity rating x Occurrence rating x Detection rating
to prioritise action focussing on preventing failure

Customers may define triggers for action e.g. RPN >100, Severity > 8
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FMEA is successful as a process & living document, if: All links to external (& internal) customer requirements from Design and Process elements are understood and systematically reviewed for risk of potential failure Informed team approach leads to multidisciplinary experience being shared to evaluate risk consistently Actions are planned at an early stage before changes are considered too costly Actions are taken as planned and the resulting effect on the risk is evaluated and documented
Slide 233 of 244

FMEA appears difficult, if:
Team does not have
common understanding of the FMEA process agreement/guidance on ratings multidisciplinary experience particularly a history of customer concerns or internal failures to consider in evaluating a new item time to work through sufficient detail and agree actions
Relationship between Design and Process elements and external (& internal) customer requirements is not understood Actions are not
Planned early enough Followed through to achieve reward in better satisfying customer
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Control Plans
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Control Plans - Overview

Control Plans
summarize the systems used to minimize process and product variation, guiding manufacturing on how to control the process and ensure product quality
structure the approach to design, selection and implementation of value-added control methods
describe the actions required at each phase of the process to ensure all process outputs will be in control are living documents - updated as measurement systems and control methods are evaluated and improved.
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Control Plans - Requirement

ISO/TS 16949:2002 requirement for Control Plans [7.5.1.1]
The organization shall - develop control plans (see Annex A) for the product supplied - have a control plan for pre-launch & production that takes into account the design FMEA and manufacturing process FMEA outputs. Control plans shall be reviewed and updated when any change occurs NOTE Customer approval may be required
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Control Plans - Content

ISO/TS 16949:2002 requirement for Control Plan content [7.5.1.1]
The control plan shall - list the controls used for the manufacturing process control, - include the methods for monitoring of control exercised over special characteristics - include the customer required information, if any, and, - initiate the specified reaction plan when the process becomes unstable or not statistically capable.
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Control Plans - Content

ISO/TS 16949:2002 requirement for Control Plan content [Annex A]
General Data; part no. & name, process step descriptions, etc Product Control; characteristics for control; specifn tolerance Process Control; process parameters, manufg m/cs & tools Methods; evaluation of meast technique, sample size & freq. Reaction Plan & corrective actions
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Control Plans - Example

Control Plan Example format
minimum elements required by ISO/TS 16949:2002 Annex A
CONTROL PLAN
Prototype Control Plan Number Part Number / Latest Change Level Part Name/Description Supplier/Plant Supplier Code Characteristics Process Name / Part/ Machine, Operation Process Device, Jig, Description Number Tools for Manuf. No. Product Process parameters Pre-launch Production Key Contact/Phone Core Team Supplier/Plant Approval/Date Other Approval/Date (if Req'd) Date (orig.) Date (Rev.) Customer Engineering Approval/Date (if Req'd) Customer Quality Approval/Date (if Req'd) Other Approval/Date (if Req'd) Methods Special Evaluation Product/Process Sample Sample Char. Measurement Control Method Specification/Tolerance Size Frequency Class Technique Reaction Plan / Corrective Action
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Control Plans
Control Plan Checklist
Have customer requirements been adopted in Control Plan format and preparation? Have all known customer concerns been identified to facilitate the selection of special product/process characteristics? Are all special product/process characteristics included in the control plan? Are material specifications requiring inspection identified? Does the control plan address incoming material/components through processing/assembly including packaging? Are engineering performance testing requirements identified Are gauges and test equipment available as required by the control plan? If required, has the customer approved the control plan? Are gauge methods compatible between supplier & customer?
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Control Plans - Benefits

Benefits of Control Plans
Improved quality of products during design, manufacturing and assembly, by identifying sources of variation Resources focussed on process and product characteristics important for customer satisfaction Communication of
changes in product/process characteristics and their control & measurement prepared responses to nonconformities (Reaction Plan)
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Thank You for being Patient
Slide 243 of 244

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ISO/TS 16949 :2002

Quality Management System Awareness Programme

INTRODUCTION OF ISO 9001:2000

Standards & Importance of ISO

Standards - A history of development

ISO 9001:2000 (Dec 2000)

The new family of standards

ISO 9000:2000 family of standards

Reasons for Revision

ISO 9000:2000 family of standards

Reasons for Revision

Promoting use of Quality Management Principles

Need to restructure the Standards.

Major Changes in ISO 9001:2000

ISO 9001, 9002 & 9003 combined into one Standard

Major Changes in ISO 9001:2000

Major Changes in ISO 9001:2000

Clause 4 Clause 5 Clause 6 Clause 7 Clause 8

New Requirements in ISO 9001 : 2000

New Requirements in ISO 9001 : 2000

Management Principles ISO 9001:2000

System approach to management

Factual approach to decision making

The Process diagram

Service Information Records

Managing the inputs - Prevention

Process Control System

System approach to management

System approach to management

System approach to management The Systematic Approach

Quality Management Systems

1.2 Permissible exclusions

8. Measurement, analysis & improvements

4 Quality management system

4.1 General requirements

4.1 General requirements

4.1 General requirements

4.2 General documentation requirements

4.2 General documentation requirements

4.2.2 Quality Manual

4.2.3 Control of documents

changes and revision status are identified

4.2.3 Control of documents

4.2.4 Control of records

5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

5.4.1 Quality objectives

5.4.1 Quality objectives

5.4.1 Quality objectives

5.4.2 Quality Planning

5.4.2 Quality planning

5.5 Responsibility, authority, and

5.5.1 Responsibility and

5.5.2 Management representative

5.5.3 Internal communication

5.6 Management review

5.6.2 Review input

5.6.3 Review output

6.1 Provision of resources

6.2 Human resources

6.2.1 Assignment of personnel

6.2.2 Training, awareness and competency