Desk Reference Guide For the TS Introduction E-Learning class at

Transcription

1 Desk Reference Guide For the TS Introduction E-Learning class at Content Provider: Elizabeth Bild Instructional Design By: J.P. Russell For: QualityWBT Center for Education Table of Contents LESSON 1: BENEFITS AND BEGINNINGS... 2 A. ISO/TS BENEFITS... 2 B. HISTORICAL BACKGROUND... 3 C. ISO/TS FUTURE...6 LESSON 2: CERTIFICATION REQUIREMENTS... 7 A. OEM REQUIREMENTS FOR ISO/TS CERTIFICATION... 7 B. GOALS AND OBJECTIVES OF ISO/TS C. REASONS TO BECOME CERTIFIED TO ISO/TS D. HOW TO APPROACH REGISTRATION LESSON 3: OVERVIEW OF ISO/TS CLAUSE 4: QUALITY MANAGEMENT SYSTEM CLAUSE 5 MANAGEMENT RESPONSIBILITY SECTION 6: RESOURCE MANAGEMENT SECTION 7: PRODUCT REALIZATION SECTION 8: MEASUREMENT, ANALYSIS AND IMPROVEMENT Note: The Desk Reference Guide for online TS Introduction class includes some images but does not include: marking key phrases, direct links to glossary, interactive exercises, quizzes, graded tests with feedback, animations, hyperlinks to handouts, and EG Bag examples. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 1 of 24

2 Lesson 1: Benefits and Beginnings In Lesson 1 we will review the benefits of implementing ISO/TS 16949, how this standard was developed, who is responsible for maintaining this standard, and the future of automotive industry standards. A. ISO/TS Benefits There are many motivations for implementing ISO/TS There are the benefits associated with implementing any quality management system and there are benefits associated strictly with ISO/TS Key benefits for implementing any quality standard include: Improved productivity 1. Productivity is improved: RAB News & Notes (Spring2003, Volume 8, Number 2) reported that firms who attained ISO registration showed improved performance while firms who did not pursue ISO 9001 saw declines in return on assets, productivity, and sales during the same time period. We were shocked by the magnitude of the effects, said David Kirsch of the University of Maryland. While the performance of firms that attained ISO 9001 registration improved, firms that didn t seek registration experienced deterioration in returns on assets, productivity, and sales. RAB News & notes 2. System and processes are defined: Management defines essential management processes, roles and responsibilities. Defining processes results in more consistent performance. 3. Goals and objectives are set: Management sets goals and objectives and ensures they are monitored, 4. Compliance is measured: Compliance with the defined quality system is continuously monitored (management review and internal audits), 5. Continuous improvement: The organization continuously improves because of corrective and preventive action, and continuous improvement requirements, 6. Customer focus: All modern quality standards recognize the importance of customer requirements and customer feedback. In addition to the above benefits, Implementing ISO/TS has the following benefits: 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 2 of 24

3 1. Automotive industry requirements: ISO/TS will be required for many suppliers in the automotive industry if they plan to continue to supply the automotive chain. 2. Enhanced customer focus: In addition to supplemental requirements related to customer focus, ISO/TS also defines performance standards that automotive customers want and has additional customer satisfaction requirements, 3. Enhanced communication links and interaction between processes: ISO/TS has additional requirements, which improve efficiency by clearly defining/optimizing the interactions between processes and people. 4. Improved performance: ISO/TS has many additional requirements to demonstrate continuous improvement in product, process, and system characteristics. B. Historical Background The basis for current quality system standards was started by the United States military in World War II to control the consistency of ordnance and supplies. Many problems resulted when there was too much variation in individual parts. These standards started by the U. S. military were introduced into Europe after the war through NATO as NATO standards. During the 1960's, companies in the United Kingdom seeking to improve productivity started looking at the NATO standards. After developing several intermediate standards, the British Standards Institute published BS 5750, Parts I, II, and III in Major purchasers in the United Kingdom adopted this standard. In 1987, the International Organization for Standardization (ISO) issued the ISO 9000 series, which was closely modeled on BS5750. However, after the ISO 9000 was issued, the BS5750 standard was revised to correspond exactly with the ISO standard. Since that time, ISO 9000 has been widely accepted around the world. By 1990, more than 15,000 companies in Europe were registered to ISO 9001, ISO 9002 or ISO By 2003 there were over 500,000 registered worldwide to ISO 9000 standards. The US started slowly with only about 400 registered sites in the United States in By 2003, however, there were more than 30,000 companies registered in the USA. In 1994 a revised version of ISO 9001 was issued with only minor changes from the 1987 version. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 3 of 24

4 ISO 9000 registrations include ISO 9001, ISO 9002, and ISO Quality standards in the United States automotive industry were developing on a similar but separate path about the same time. The Original Equipment Manufacturers (OEMs) issued their own requirements, for example: General Motor s (GM) Targets for Excellence (1987) Chrysler Quality Assurance (1983) Ford Q-101 (1981) During the 1980 s, automotive companies and suppliers alike realized the need for a common standard. Differences in the quality systems of the Big Three (Ford, GM, and Chrysler) caused many automotive suppliers to maintain multiple quality systems and quality manuals which resulted in multiple supplier audits to different standards. These were often done by unqualified and inconsistent auditors. The drive to harmonize the different standards was initiated at the 1988 ASQC (now ASQ) Automotive Division Summer Conference. The OEM s sanctioned the creation of a task force to address this issue. The ASQC/AIAG Task Force was formed in 1990 to begin to create a common supplier quality assessment system for Ford, Chrysler, and GM. The result of the task force 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 4 of 24

5 was that numerous tactical documents, such as the Production Part Approval Process (PPAP) manual and the Advanced Product Quality Planning (APQP)/ Control Plan manual were issued. The task force also issued the first version of QS-9000 in the third quarter of QS-9000 was based on ISO but included many additional requirements related to the automotive industry. Although QS-9000 addressed the need for harmonization, it resulted in numerous problems for suppliers. The Big Three required their suppliers to adopt QS-9000 as their quality standard, but many of the supplier contacts in the Big Three had only a limited understanding of the standard and sometimes gave misinformation to suppliers. Instead of doing their own audits, customers were required to get third party certification by accredited registrars and so a cadre of qualified auditors needed to be trained and qualified. In addition, some parts of the standard were not clearly written and so a series of Sanctioned Interpretations was required to insure consistent understanding and application of the standard. By the time QS-9000 Third Edition was issued in March 1998, many of these issues had been resolved. The last set of sanctioned interpretations was issued 7/1/2002. Worldwide suppliers, however, still had the problems associated with the use of different standards in Europe and Japan. Those differences have now been addressed with the issue of ISO/TS This standard is a merging of requirements from: ISO 9001:2000 AVSQ (Italian) EAQF (French) QS-9000 (U.S.) VDA6.1 (German) PROBLEMS WITH QS-9000 ROLLOUT Conflicting information from customers Developing qualified 3 rd party auditors Inconsistent interpretations ISO/TS was prepared by the JAMA and the IATF with support from ISO/TC 176. The first edition of ISO/TS issued in 1999 was not widely used. The second edition issued in 2002 has received a much higher level of interest because the automotive OEM s are transitioning from QS-9000 to ISO/TS QS-9000 was based on ISO (obsolete, December 15, 2003). ISO/TS is based on ISO 9001: D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 5 of 24

6 ISO/TS16949 has been issued as a Technical Specification (TS). There is a difference between a technical specification and an approved international standard. An ISO Technical Specification is an agreement between the members of a technical committee and is accepted for publication if approved by 2/3 of the committee members casting a vote. The Technical Specification is reviewed after three years to determine if it should be confirmed for another three years, revised to become an international standard, or withdrawn. C. ISO/TS Future The IAOB, on behalf of the IATF, is active in implementing and managing the ISO/TS registration process worldwide. The IAOB is the source of information about OEM specific requirements. They coordinate with worldwide oversight offices to ensure consistency in the registration scheme, and as an arm of the IATF, they continue to seek harmonization with other automotive manufacturers. The IAOB web site ( is an important source of revised and updated information about ISO/TS The site has OEM-specific requirements, answers to frequently asked questions, information on IATF approved third party registrars, and sanctioned interpretations. In the next lesson we will discus requirements for ISO/TS certification. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 6 of 24

7 Lesson 2: Certification Requirements A. OEM Requirements for ISO/TS Certification The OEM s have specific requirements for their suppliers relative to implementing ISO/TS 16949:2002. The most up-to-date information is available on the International Automotive Oversight Bureau (IAOB, Web site: The web site contains specific automotive company requirements from Ford Motor Company, General Motors, DaimlerChrylser and several European automotive companies. The current requirement for GM suppliers is to be registered to ISO/TS 16949:2002 and the requirements in the GM Customer Specifics document by an IATF-recognized certification body by December 14, Supply organizations that fit the requirements in the Scope and are not registered by December 14, 2006 are subject to New Business Hold Quality status. GM Customer Specifics is a thirteen-page document available on the IAOB web site ( December2003fnl.pdf ). Registrations to QS-9000 will be accepted until December 14, Unless waived in writing, Ford requires their tier one suppliers of production or service parts or services to be third-party registered to QS-9000 Third Edition or ISO/TS 16949:2002 and the Ford Motor Company Customer-Specific Requirements (25-page document available on the IAOB web site ). Ford will only recognize ISO/TS after December 14, Suppliers to Chrysler must be registered to ISO/TS 16949:2002 by July 1, 2004 and their specific requirements are available at If a supplier organization is currently registered to ISO/TS 16949:1999, GM, Ford, and Daimler Chrysler generally require their registration to be upgraded to ISO/TS 16949:2002 by December 14, 2004 (a one-year grace period after the expiration of ISO/TS16949:1999). The customer is the final authority on ISO/TS registration requirements. Any questions about registration requirements for your organization should be directed to your customer contact, which frequently is the customer purchasing function. Big Three QS-9000 Transition to ISO/TS 16949:2002 Registration Deadlines Chrysler July 1, 2004 Ford December 14, 2006 GM December 14, D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 7 of 24

8 Who Can Be Certified to ISO/TS 16949? Per Section 1.1 of ISO/TS 16949: This Technical Specification is applicable to sites of the organization where customerspecified parts, for production and/or service are manufactured. Supporting functions, whether on-site or remote, form part of the site audit as they support the site, but cannot obtain stand-alone certification to the Technical Specification. This Technical Specification can be applied throughout the automotive supply chain. What does this mean? It means that if you supply automotive parts for production or service, anywhere in the automotive supply chain, you can become certified to ISO/TS If you are in an organization that supplies accounting, or calibration services, or purchasing, you cannot receive a stand-alone certificate. Here are some examples of organizations that can be certified to TS 16949: 1. Foundry supplying castings (made per customer requirements) to a machine shop, which in turn will supply parts to an automotive assembly plant. 2. Electronics facility manufacturing and assembling harnesses to be used in a vehicle. 3. Rubber manufacturer supplying a timing belt manufacturer. The belts are used in an automobile. 4. Chemical plant producing transmission oil for original fill. Here are some examples of organizations that cannot receive stand-alone certifications to TS 16949: 1. Electronics firm supplying equipment maintenance and/or calibration to an automotive parts manufacturer. 2. Company that makes gaskets. One of their gaskets is purchased by a company that makes electric motors and a third company purchases the motor to be installed in an off-road construction vehicle. 3. Corporate purchasing providing purchasing for a foundry. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 8 of 24

9 4. Company that supplies tote bins to a machine shop that makes parts that are used in vehicles 5. Warehouse providing remote storage, handling, and shipping services of automotive supply chain products. According to the standard, anyone in the supply chain involved in manufacturing automotive customer-specified products can use ISO/TS as the quality management system standard and become certified regardless of the type or quantity of product. More information about quality management system requirements for suppliers to manufacturing sites is covered in Section 7.4 of ISO/TS Below is a model to show which organizations can be certified/registered to ISO/TS and those which can not be registered. Figure 1 - Theoretical supply chain and who in the supply chain can be certified. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 9 of 24

10 B. Goals and Objectives of ISO/TS The technical committee responsible for drafting ISO/TS has several goals for the standard. The first goal is to define a quality management system that provides for continual improvement, emphasizing defect prevention and reducing variation and waste in the supply chain. Continual improvement is addressed throughout the standard, particularly the requirements in 8.5 Improvement. Preventing defects and reducing variation and waste are covered in the planning, product realization, and measurement sections. Another aim of the standard is to provide a common approach to quality system management for the automotive production supply chain which should result in the avoidance of multiple certification audits for suppliers to the automotive supply chain. If requirements are incorporated from OEM s around the world, customers can use the same standard, whether they are across the globe or across town. C. Reasons to Become Certified to ISO/TS You may have had a customer express interest (or require) that you become certified to ISO/TS You may be interested in ISO/TS because you are currently using QS and know it is being phased-out and you wonder what the next requirement will be. You may already be registered to ISO 9001:2000 and supply parts to automotive supply chain and want to know what additional requirements would be necessary to become certified to ISO/TS This class will address all of those situations. This class is self paced so that where appropriate, based on your knowledge of ISO 9001:2000 (basis for TS 16949:2002) and QS 9000 (based on ISO 9001:1994), you may only need to focus on key points for the remainder of this lesson and lesson 3. D. How to Approach Registration Section 0.1 of ISO 9001:2000 states that implementing a quality management system is a strategic decision of an organization. This is also true for ISO/TS ISO/TS cannot be looked upon as an additional activity for quality. ISO/TS is the management system. It defines how a company will address all aspects of its business, including: planning, design, production, customer communication, measurement, continuous improvement, employee development, facilities, etc. Implementation may require structural changes in the organization. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 10 of 24

11 The standard is based on a process approach for quality management. If your organization is not already aligned in this manner, then reorganization should be considered. What is meant by a process approach? There are really two uses of the process approach. First, is that the ISO 9001:2000 standard was written using the process approach. The process approach is simply arranging the standard clause (requirements) in the way that one would carry out an activity, similar to the Plan-Do-Check-Act (PDCA) cycle. ** ** Please note that several parts of this section are provided with permission from ASQ Management Systems, Inc., QualityWBT Center for Education and J.P. Russell and Assoc. training materials. Parts of this section came from ISO 9001:2000 Certified Lead Auditor training as The Plan-Do-Check-Act cycle (PDCA) can be applied to all processes: Plan - Establish the objectives and processes necessary to deliver results Do - Implement the process Check - Monitor and measure processes and products against requirements Act - Take action to continually improve the process improvement Secondly, the ISO 9001:2000 standard promotes the adoption of a process approach when developing, implementing and improving the QMS. To function effectively, an organization must identify and manage numerous linked activities A process is an activity (using resources) that is managed to enable the transition of inputs to outputs Outputs from one process often provide inputs to the next process Multiple processes create a system of processes The aim of the process approach is to achieve customer satisfaction by fulfilling customer requirements. The systematic identification and management of processes employed and their interactions are referred to as the process approach. The process approach strings activities together that result in an output such as a product or service. The process approach provides ongoing control over: 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 11 of 24

12 Linkages between processes The system of processes The combination and interaction of processes When used within the QMS, the process approach emphasizes: The understanding and fulfillment of requirements The need to consider processes in terms of added value Obtaining results of process performance and effectiveness Continual improvement of processes based on objective measurement Simply, an organization s management system is more effective if structured using the process approach as opposed to an element or department approach. A process represents action. The processes are normally collected under a system (clause 4) or subsystems to a bigger system. To become certified to ISO/TS16949, the organization must be willing to align with this process approach. As seen by the diagram, processes interact, so the effectiveness of one process may have a big impact on other processes. For example, if the purchasing process is not efficient, there may not be raw materials for the production processes, or maintenance services for the equipment. The output from one process is frequently the input to subsequent processes. The personnel, information, and resources involved in these links need to be identified and controlled. The linkages and possible interactions need to be identified for consistency and effectiveness. Defining linkages between remote departments or with the customer is especially important. A very common problem is getting conflicting information about input requirements for a process. If communication links and authorities have been defined, many of these problems can be avoided. In Lessons 1 and 2, we covered the background and development of ISO/TS 16949, and requirements related to certification to ISO/TS that are in the Introduction and Scope sections of ISO/TS 16949:2002. The next three lessons will focus on the quality system requirements of the standard contained in clauses D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 12 of 24

13 Lesson 3: Overview of ISO/TS ISO/TS is organized into nine sections: 0 Introduction 1 Scope 2 Normative Reference 3 Terms and definitions 4 Quality management system 5 Management responsibility 6 Resource management 7 Product realization 8 Measurement, analysis and improvement Sections 0 3 give general information and information on how to approach implementation. The actual requirements are contained in Sections 4 8. Information contained in Sections 0 3 was reviewed in Lessons 1 and 2. In this lesson we will briefly discuss the contents of Sections 4 8. Image: L3TSmodel1 Clause 4: Quality Management System This section addresses the establishment of a quality management system meeting all the requirements of ISO/TS and document control. First clause (4.1) lists to-do items for establishing a management system using the process/system approach. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 13 of 24

14 The quality management system must meet the following criteria: 1. It must be documented. Section defines what needs to be documented. Section defines what must be documented in the quality manual. The standard identifies several elements that require documentation such as: control of documents identifying training needs and achieving competence of all personnel internal audits corrective action preventive action There are numerous other requirements for documentation throughout the standard such as: quality policy and objectives a business plan rework instructions process capability studies internal laboratory scope process work instructions control plans These will all form part of the documented quality system. 2. It must be implemented, maintained and continually improved. Section of the standard describes how the system shall be continually improved. 3. It must be managed. The system is managed by: identifying the processes involved, their sequence and interaction, monitoring the systems and processes to ensure effectiveness, providing adequate resources and information taking action as necessary Quality System Criteria Documented Implemented, maintained and continually improved Managed 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 14 of 24

15 Clause gives specifics about control of documents, engineering specifications, and records. These controls will be included in a documented procedure. Plain Talk Review Management system Clause 4 is about establishing a management system to take you where you want to be in the future and determining the minimum documentation you will need. There are good reasons to develop a formal and structured approach to your operations. First, you need to identify the important tasks and establish the sequence in which they should be performed. You will need to identify measures and record information so that you know how you are doing from time to time. This is the big picture view of the quality management system Once you have the general direction laid out, you can now write some procedures for the important tasks to be done. You should create documents where you need them to ensure an effective operation. Clause 5 Management Responsibility Six key management functions are covered in this section: Commitment Customer focus Quality Policy Planning ( including setting objectives) Defining responsibility, authority, and communication processes System review and performance 1. Commitment The most important management function is defining how management shows evidence of its support for the quality system. The standard lists six specific ways in which management must demonstrate its commitment: 1. Communicating the importance of meeting customer, statutory and regulatory requirements 2. Establishing the quality policy 3. Establishing quality objectives 4. Conducting management reviews 5. Providing resources 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 15 of 24

16 6. Assuring efficiency of product realization and support processes 2. Focus Management is also responsible for ensuring the organization s focus remains on the customer. This is achieved by meeting customer requirements and by enhancing customer satisfaction. (Note: Determining customer requirements is addressed in section 7.2 and measuring customer satisfaction is addressed in section of the standard.) 3. Quality Policy The Quality Policy defines how the organization approaches quality and continual improvement. It must be understood throughout the organization since it is the basis for the quality system. SAMPLE QUALITY POLICY XYZ Corporation is committed to supplying aluminum castings to meet or exceed all customer requirements. XYZ has implemented systems to ensure continual improvement in the quality system and product effectiveness. The sample quality policy, appropriate to an organization supplying castings, includes the commitment to comply with customer requirements and continually improve. It also provides the framework for establishing and reviewing quality objectives. Management would need to ensure the policy is understood throughout the organization and to review the policy for continuing suitability. 4. Planning and quality objectives Setting quality objectives defines the short-term priorities for the organization. The objectives need to be measurable and utilized throughout the organization, at all relevant functions and levels. The quality objectives must be included in the business plan and be used to deploy the quality policy. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 16 of 24

17 XYZ Quality Objectives 1. Monthly casting rejects will be less than 5 PPM due to porosity. 2. Monthly inventory working capital will average less than $25M annually. 3. Revenues will increase by 8% this year. 4. Continual improvement projects totaling $10M in annual cost savings will be identified. The objectives shown above could be overall company objectives. These could be used to set departmental objectives shown below. XYZ Design Department Objectives 1. Identify the top five causes of porosity rejects and recommend solutions by the end of 1Q. 2. Implement design changes to reduce porosity rejects by 5% on AA line by 3Q. 3. Qualify two suppliers for on-site inventory. 4. Implement new mold design to reduce waste by 3% by year-end. The objectives are measurable and support the company quality policy. Once the objectives are defined, management needs to plan how to meet the objectives and quality system requirements. Management also needs to address how the quality system will be maintained in response to system changes. Management should plan for ever-changing customer requirements and expectations. Changes in technology must be anticipated and included in the planning process. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 17 of 24

18 5. Defining Responsibility and Authority Responsibility and authority for every aspect of the quality system must be defined and communicated throughout the organization. Personnel with direct responsibility for quality particularly need to have clearly defined authority. The standard requires the organization to identify a management representative responsible for the quality system. A customer representative also needs to be selected to ensure customer requirements are met. This individual should be looked upon as the voice of the customer within the organization. Personnel responsible for quality must be assigned to all shifts and must have the authority to stop production to correct quality problems. Is the customer rep the same as the management rep? If not where does the customer rep fit in? Also, rep should be spelled out. Internal lines of communication must be defined to ensure communication regarding quality system effectiveness is taking place. Plain Talk Review Management responsibility Quality improvement is most effective when it is initiated from the top. Top management determines the vision, communicates the vision, provides the resources, and checks on the vision from time to time. Top management may be one person, the board of directors or the corporate officers. You need to start by defining quality as it applies to your business. The act of defining a quality policy makes you thing about what you want to achieve. Discussions between the members of your organization will lead to a clearer understanding of your business and your customers. The policy will lead to objectives and the objectives will lead to a plan to achieve the objectives. Remember, planning is the first step in the plan-do-check-act cycle. Of course, there are success factors other than customer satisfaction, such as safety and financial controls, which are also important. These may have their own plans or be integrated into an overall organization plan. The next step is to define the duties and responsibilities of your people and their roles and interaction with each other. Once everyone has their assignment, keep them informed of their progress. You must assign one person for overall responsibility and authority for quality and one person to be the customer representative. 6. Management Review 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 18 of 24

19 Top management shall review the quality system to ensure its continuing suitability. Data about the performance of all aspects of the quality system should be reviewed. Reviews include: 1. audit results 2. quality objectives 3. cost of poor quality 4. customer feedback 5. process performance 6. product conformity 7. corrective and preventive actions 8. follow-up for actions from previous meetings 9. anticipated changes 10. recommendations for improvement 11. analysis of potential and actual field failures At management reviews, management defines the actions needed for quality system improvement, product improvement, and resource needs. Results of management reviews must be recorded. Plain Talk Review Management review You have defined your quality policy, planned for its implementation, identified responsibilities, and defined authority to achieve your goals. Now it is necessary to periodically measure your progress and take steps to continually improve. This is called management review. It should be formal and needs to look at the bigger picture of your operations. Typical items to be reviewed might be identification of internal problems, customer complaints, customer satisfaction survey results, employee turnover, new and repeat orders, and supplier performance. The outcome of your review should be a determination of the need to change the system for improvement. Just as human bodies need periodic medical checkups that may result in a change in your habits, businesses also need an examination to determine the health of the business and its future direction. Section 6: Resource Management Section 6 covers human resources and physical resources, such as the buildings, utilities, facilities and equipment. Management is responsible for supplying adequate resources to maintain and improve the quality system and to enhance customer satisfaction. 1. Human resources must be competent. Competency requirements must be defined and records must show that personnel meet these requirements. Requirements for design personnel are specifically listed. Training needs must 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 19 of 24

20 be identified and on-the-job training provided. Employee motivation and empowerment are also addressed in this section. Product safety and personnel safety shall be addressed by the organization. 2. The section on physical resources covers the design and planning methods to be used. Contingency plans must be prepared to meet customer requirements in the case of an emergency that might disrupt production. The work environment shall be controlled as need to meet customer requirements. This includes safety issues, cleanliness and state of repair. Plain Talk Review Organization resources You need resources to manufacture a product or provide a service. Resources include people, equipment, supplies, and facilities. You must balance resource needs between what you want and what you can afford and still satisfy the customer. Resources include people and people need to be trained to run the processes. To know what kind of training to provide, you should perform a job needs assessment. A training and development plan can then be tailored to the individual, so that he may receive the training and experience needed to properly perform the job and for future advancement. The next step is to fill those needs. Sometimes, training can be provided through the use of internal employees and sometimes it is more effective to take web-based asynchronous training programs such as the one you are taking now. In all cases you need to find out the effectiveness of the training provided. Once we place the people in the facilities, we have a work environment. People work better and stay healthy when there are good work conditions relative to the task. Look at everything you need to provide a proper work environment for the people performing the processes. Section 7: Product Realization This is the longest section of the standard with the most requirements. It covers: 7.1 Planning of product realization This is self-explanatory. It covers taking customer requirements and the quality system as input criteria and converting them into a product. 7.2 Customer-related processes Customer-related processes include communicating with the customer about their requirements for the product and determining their stated or implied requirements. Communication links with the customer must be determined and implemented per any specific customer requirements for information exchange Statutory or regulatory requirements should also be identified. The organization must review all of the 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 20 of 24

21 requirements and determine whether they have the capability to meet all the requirements, including documenting the manufacturing feasibility. 7.3 Design and development planning All aspects of the design process are covered, for both the product design and process design. This section is very prescriptive defining in great detail all the design inputs, processes, and outputs. Product design and development planning is the only section of ISO/TS that can be excluded from the quality system and only then if the organization is not responsible for design. 7.4 Purchasing This covers not only the relationship with the suppliers, but also verification of purchased product. Suppliers must be able to deliver the product per defined requirements, meeting all applicable regulatory requirements and suppliers must also have a quality system conforming to ISO 9001:2000, as a minimum. Supplier development is to be performed with the goal of conformance to ISO/TS Production and service provision This defines all of the processes required to produce the product or provide the service. These include defining production methods and controls, maintenance of equipment (preventive maintenance {PM} and predictive maintenance), control of production tooling, product preservation, storage, inventory management, handling and packaging. 7.6 Control and monitoring devices This section covers what is typically considered calibration. In addition to defining the requirements for a calibration system and calibration records, it defines the requirements for determining the variation in every type of measuring and test equipment (GR&R studies). Requirements for internal and external laboratories are defined. Plain Talk Review Product manufacturing or providing the service This is the largest clause with the most requirements. For the purposes of this introduction it is sufficient to say that the realization processes are the core business processes for manufacturing a product or delivering a service. Taking orders, designing, purchasing and manufacturing exist in most all organizations. First you must define and record the customer requirements. Then design and provide a part the meets those requirements. The final clause in this section of the standard is about control of devices for measuring and monitoring. The only way we can get good data is through the use of good equipment. Clause 7.6 is about DATA and how we can get the data needed for decisions. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 21 of 24

22 Section 8: Measurement, Analysis and Improvement Measurements are critical in determining whether or not the quality system, processes, products, services, i.e., important characteristics meet customer requirements and show continual improvement. 8.1 General This section covers planning of measurements and use of statistical techniques. 8.2 Monitoring and measurement This section defines measurements that are required to verify quality system effectiveness. The required measurements are: 1. Customer satisfaction 2. Internal audits (quality system) a. Manufacturing process audit b. Product audit 3. Manufacturing processes 4. Product characteristics a. Layout inspection and functional testing b. Appearance items 8.3 Control of nonconforming product Nonconforming product is product that does not conform to defined requirements. Suspect or unidentified product is also included in this category. Nonconforming product must be controlled to prevent unintended use. The organization must have options to deal with nonconforming product: 1. take action to eliminate the nonconformity 2. authorizing its use by concession and agreement with the customer (customer waiver) 3. use for another application (or dispose of) 8.4 Analysis of data Once the measurements are in place, the data must be analyzed to demonstrate the suitability and effectiveness of the quality system and to evaluate where continual improvement of quality system effectiveness can be made. The organization is required to analyze data related to customer satisfaction, product conformance, processes and products, and suppliers. Results of the analysis must be compared with progress toward objectives and lead to action. 8.5 Improvement The final section in the standard covers improvement. Continual improvement of the quality system and reduction in product/process variation are required. The process for continual improvement must be defined. Corrective action and preventive action are to be used to support continual improvement. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 22 of 24

23 Plain Talk Review Measuring and improving This clause is about taking measurements and using that data to control and improve the organization. Measuring and monitoring is something that happens during or after a process is completed. You need measure and monitor customer satisfaction, products, processes and your suppliers. The analysis of the data should be actionable. Internal audits must be conducted as a management tool to ensure progress and conformance to TS requirements. Findings from audits are input into corrective and preventive action. You will need to establish strong, management supported, corrective and preventive action programs to improve. This concludes the overview of ISO/TS The next lessons allow you to assess the changes that will be needed to transition from ISO 9001:2000 to ISO/TS These lessons will give guidance on the changes required to upgrade an ISO 9001 quality management system to meet the requirements of ISO/TS For those new to quality management systems, the next several chapters will give you greater understanding of the types of requirements organizations will be expected to implement. The ISO 9001:2000 is imbedded in the TS standard. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 23 of 24

24 The road to ISO/TS will take you to improved effectiveness and efficiency. Image: L0401increasereq Sometimes organizations can lose sight of the reason for the standards and view them as a necessary cost to secure business. Adherence to standards provides consistency for customers and establishes controls that can be used to improve an organization. Continual improvement may not be easy, but organizations are better off if they strive for it and avoid doing the minimum just to pass an audit. JP Russell 3/5/2004 This concludes the class material. 40D0B0CC-630D-18E76B.doc 2004 Elizabeth Bild and J.P. Russell & Assoc. Page 24 of 24