IntroductionUnderstanding The ISO/TS 16949:2002StandardIntroduction0.1 General:The adoption of a QMS should be a strategic decision for your organization. Various factors influence the design and implementation of your QMS. These include varying needs; particular objectives; products provided; processes employed and size and structure of the organization. The ISO 9001 standard does not require uniformity of QMS structure or documentation. The QMS requirements specified in ISO 9001 are complementary to requirements for product. Information marked Note is for guidance in understanding or clarifying the requirement.This international standard can be used by internal and external parties, including certification bodies, to assess an organizations ability to meet customer, regulatory and the organizations own requirements.The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration in developing this standard.Key Explanation Points and Tips:The purpose of an organization is to identify and meet the needs and expectations of its customers and other stakeholders and gain competitive advantage. One of the strategies it might use to achieve this goal is to continually improve the effectiveness and efficiency of its capabilities. ISO 9001:2000 is a powerful business tool that organizations may use to achieve this. Organizations use ISO 9001 to achieve goals and objectives related to meeting customer and regulatory requirements and enhancing customer satisfaction.TS 16949:2002 is built upon all of the requirements, principles and concepts included in ISO 9001, and goes further in specifying additional and supplemental requirements that are specific to the automotive sector. We will continue with our introductory review of ISO 9001 concepts and principles before we get into the details of TS 16949 requirements. While the focus is on quality management, the ISO 9001 business model may be applied just as well to manage the entire organization. The standard embodies business concepts and principles universally recognized and applied for sound business management. As such, ISO 9001 should be used as a strategic business management tool. The ISO 9001 standard defines a generic set of requirements for all organizations, regardless of size, complexity or industry sector. These requirements define controls for your quality management system that focus on continually improving the effectiveness of your QMS in meeting customer requirements and thus enhancing customer satisfaction.It is important to note that the ISO 9001 standard does not specify requirements for product. The focus of all ISO 9001 requirements is on your QMS and its processes. By effectively controlling and continually improving your QMS processes, there will obviously be a positive impact on product quality performance and conformity to customer requirements.You must ensure that the scope of your QMS addresses all customer requirements. Customer requirements may show up in contracts, blueprints, their supplier quality manuals, or referenced to applicable industry and regulatory standards and codes, etc.It is important to state here that ISO 9001 certification must not be the ultimate goal of QMS implementation. Your constant goal must be to continually improve the effectiveness and efficiency of the organization for the benefit of all its stakeholders. Obtaining certification must be considered as just a stepping stone in this journey. Organizations that understand and follow this approach will get the most benefit from QMS development and implementation.Organizations implementing an ISO 9001 based QMS must conform to all applicable requirements that the standard specifies. This provides internal and external parties (customers, registrars and regulatory bodies), the basis (i.e. a benchmark) against which to assess the organizations ability to meet customer, regulatory and internal requirements. It is now a common practice to use ISO 9001 certification as a requirement for making contractual decisions. The automotive OEMs (subscribing to the TS 16949 standard) require their direct (tier 1) suppliers of manufactured product and related services to obtain TS 16949 certification. Tier 1 suppliers in turn are required to flow down conformity to TS 16949 requirements through supplier QMS development.QMS design and implementation will vary from organization to organization. ISO 9001 allows this flexibility because organizations may have differing - goals and objectives; business risks; range and complexity of products; processes and resources; organizational size and structure; workforce competence and stability; etc. This flexibility may relate to QMS scope; structure; documentation or application of ISO 9001 requirements.Personnel performing QMS assessments must - have adequate training on the requirements of the ISO 9001 standard and auditing practices as defined by ISO 19011; be familiar with your QMS, customer requirements and applicable regulatory requirements.The guidance documents ISO 9000 and ISO 9004 provide the eight quality management principles on which this standard is based. These are:

Principle 1 Customer-FocusYour organization depends on customers and therefore your organization should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations (see clause 5.2; 7.2; and 8.2.1).

Principle 2 Leadership Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives (see clause 5)

Principle 3 Involvement of PeoplePeople at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit (see clause 6.2).

Principle 4 Process Approach A desired result is achieved more efficiently when related resources and activities are managed as a process (see clause 4.1).

Principle 5 System Approach to ManagementIdentifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objective (see clause 4.1)..

Principle 6 Continual ImprovementContinual improvement of the organizations overall performance should be a permanent objective of the organization (see clause 8.5.1 and 4.1).

Principle 7 Factual approach to decision making Effective decisions are based on the analysis of data and information (see clause 4.1e and 8.4).

Principle 8 Mutually beneficial supplier relationshipsAn organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value (see clause 7.4).

These eight management principles form the basis for all QMS standards within the ISO 9000 family which includes TS 16949:2002. All of these principles are included as requirements in one or more clauses of the TS 16949 standard.

Major Clauses and ExplanationsMajor Clauses - Contents of the TS 16949:2002 Standard0. Introduction1. Scope2. Normative Reference3. Terms and Definitions4. Quality Management System5. Management Responsibility6. Resource Management7. Product Realization8. Measurement, Analysis and ImprovementMany, if not most of the sub-clauses within the above major clauses can be traced to the North American or European automotive standards such as QS 9000 or Germanys VDA 6.1.

Key Explanation Points and Tips:The first four clauses (clause 0. Introduction to clause 3. Terms and Definitions) do not provide any requirements for a QMS. They provide background information on the purpose; concepts and principles used in the standard (e.g. process approach; PDCA); guidance on the QMS scope; reference to related documents; and key terms and definitions used. These clauses will all be explained in more detail as we go through each section.The remaining five clauses numbering 4 through 8 provide the quality management requirements that a QMS must implement. The following is a summary explanation of these 5 major clauses or elements of the ISO/TS 16949 standard. Each major clause has several sub-clauses. Collectively, these five clauses set out the requirements for your QMS.

Clause 4- Quality Management System - sets requirements to identify, plan, document, operate and control QMS processes and to continually improve QMS effectiveness.

Clause 5- Management Responsibility - sets requirements for top management to demonstrate its leadership and commitment to develop, implement and continually improve the QMS.

Clause 6- Resource Management - sets requirements to determine, provide and control the various resources needed to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer satisfaction by meeting customer requirements

Clause 7- Product Realization - sets requirements to plan, operate and control the specific QMS processes that determine, design, produce and deliver an organizations product and services.

Clause 8- Measurement, Analysis and Improvement - sets requirements to plan, measure, analyze and improve processes that demonstrate product and QMS conformity and continually improve QMS effectiveness.The overall objective of your QMS must be to enhance customer satisfaction by meeting their requirements. This objective can be achieved by using the TS 16949 requirements to control your QMS processes and by continually improving QMS effectiveness.TS 16949:2002 requirements, structure and flow are built upon ISO 9001:2000 requirements as the foundation. To clarify this, I show the ISO clauses in regular print and the TS specific clauses in italics, both under the tan background.The TS 16949 specific clauses may:

Include new requirements over and above ISO 9001 requirementsSupplement or expand on the existing ISO 9001 requirementCall for prescriptive ways to address ISO or TS requirementsTo help you get the most out this e-Book, you might find it useful to follow key themes that the TS 16949 standard has emphasized. These include:

All QMS processes must be planned, implemented, measured and improved.TS 16949 requirements focus on controlling QMS processes, not product.QMS controls must emphasize prevention of nonconformities rather than detection.QMS processes focus on eliminating or reducing variation and waste in processes.QMS processes must be customer focused. Process personnel must be aware of and strive to meet internal and external customer requirements.You must continually improve the effectiveness of your QMS.

Process Approach10.2 Process ApproachThis Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a QMS, to enhance customer satisfaction by meeting customer requirements.For an organization to function effectively, it has to identify and manage numerous linked activities. Any activity, using resources and managed in order to enable the transformation of inputs into outputs, can be considered a process. Often the output from one process directly forms the input to the next.The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the process approach.Process Approach: Key Explanation Points and Tips: The process approach is the foundation upon which your QMS must be developed. Lets understand some basics about processes.

Figure 1 - All work generally involves a process - things go in (inputs); get worked upon (conversion); and come out differently (output). The value-adding conversion activity within a process transforms inputs into outputs, e.g. takes raw materials (the input) and manufactures (the value-adding conversion activity using various resources) a product (the output).Process inputs and outputs can be tangible (raw materials or finished product) or intangible (information e.g. computerized drawing or specification).

Figure 2 - All processes have a supplier and a customer. These suppliers and customers may be internal processes or external to your organization. Each process must have an accountable owner, i.e., having defined responsibility and authority to operate, control and improve their process.All processes require the use of resources, e.g. people, equipment, materials, technology etc. These resources can be used as inputs (raw materials or information such as a customer specification) as well as for the value-adding conversion activity (e.g. use of machinery, equipment, computers, technology, people, etc.) to transform raw material (input) into finished product (output).All processes must meet (customer, organizational and applicable regulatory) requirements. The performance of all processes can be monitored and measured. Gather performance data that can be analyzed to determine process effectiveness and whether any corrective action or improvement is needed.An organizations processes may be grouped or categorized in many ways. One logical way would include the following: Customer Oriented Processes (COPs) - These are product realization processes (see clause 7) that determine customer requirements (inputs), design, make and deliver product (outputs) to customers and determine customer satisfaction. These processes generally have the greatest degree of interaction with external customers. COPs include - marketing and sales; design and development; production; shipping; packaging; servicing/ warranty; customer satisfaction; etc., whether performed onsite or off-site.Support Oriented Processes (SOPs) These processes provide the necessary resources to COPs to facilitate product realization. These processes generally have the greatest degree of interaction at an operational level with COPs and to a lesser degree with other internal QMS processes. SOPs include - human resources; information technology; purchasing and receiving; laboratory; maintenance; tooling; facility management; etc, whether performed onsite or off-site. See clause 6 and 7.Management Oriented Processes (MOPs) - These processes provide the commitment, leadership, resources, review and decision-making by top management (see clause 5). These processes generally interact with all QMS processes at the QMS planning and review level. MOPs include business planning; management review; quality planning; resource planning; communication, etc., whether performed offsite or on-site. Quality Management Processes (QMPs) to document, measure, analyze and improve all processes These processes provide quality management support to and interact with all QMS processes. QMPs include - document control; records control; monitoring and measurement of processes and product; internal audits; control of nonconforming product; corrective and preventive action; continual improvement; etc whether performed onsite or off-site. See clause 4 & 8.Outsourced Processes (OPs) These are COPs or SOPs that are performed by a function or organization outside the ownership or managerial control of your facility. They may be performed onsite or off-site. These processes include - heat treating; painting; welding, calibration; testing; sort; HR; design & development, manufacturing, etc.

Process Approach 20.2 Process Approach (Continued)An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. When used within a quality management system, such an approach emphasizes the importance of:a) understanding and meeting requirementsb) the need to consider processes in terms of added valuec) obtaining results of process performance and effectiveness, andd) continual improvement of processes based on objective measurement.

Key Explanation Points and Tips: Process Approach Your QMS is made up of a network of value-adding processes that link, combine and interact with one another to collectively provide product or service (See Figure 2). These processes are inter-dependent and can be defined by complex interactions. For example, any of the COP processes, could interact with some or all of the MOPs, SOPs; QMPs. Also note that resources (SOPs) and QMPs may also be applied to all other processes. Interactions between processes generally have the following characteristics:Typically involve the flow of information (data, discussion, decisions, documents, etc.) or physical item (materials, product, supplies, resources, etc.).May take place between internal organizational processes; within a specific process; or with external organizations (customers, suppliers, outsourcers, regulatory bodies, Certification body (CB, etc.).May take place in many ways (e.g. human, computer, automated, etc. Interaction between processes may take place sequentially or concurrently between several processes. Interaction between processes may take place at any process stage as an input, output, process activity or resources needed for the process. Probably the root cause of many QMS process nonconformities could be traced to breakdown in the communication or interaction between processes. For example the sales function fails to notify the packaging function of a customers special packaging specification and the product is packaged and delivered in the organizations default mode. Therefore to control the interaction between and within processes, we need to identify and control:What is being communicated; who is communicating it; who is receiving it; how is it being communicated; how will the information, data or item being communicated be used; frequency and timeliness of info, data or item being communicated, etc.The controls should address the method of interaction or communication; its completeness, reliability and quality; frequency; timeliness; approval; understandability and usability of the info, data or item being communicated. Additionally, the responsibilities of the transmitter and receiver must be clearly defined.Therefore, in general, in order to plan and implement your QMS using the Process Approach, you must:Identify the processes needed for the QMS (see listing above) Determine their sequence and interaction (show the sequence and interaction of your COPs). There are many ways to document this, e.g., a flowchart or a process map. Determine the application of QMS processes throughout the organization (show how MOPs; SOPs and QMPs are applied to each COP and to each other). There are many ways of documenting this. A popular way is through graphical representation, e.g. process maps. Determine (plan) the criteria, methods, information, controls and resources needed for each QMS process. These include:Identify the internal/external customer-required output. Describe the process activity that produces the output. Identify the resources needed for the process activity. Identify the inputs for the process information, materials, supplies, etc. Define the process methods, procedures, forms etc., that may be needed to produce the output. Define the controls to prevent or eliminate risk of errors, omissions, or nonconformities in the process activity. These controls may come from the TS 16949 standard; customer; regulatory and your own organizational requirements (more details provided in clause 4.1).Interaction with sources that provide the inputs (internal process or external supplier); uses the output (internal process or external customer); or provide the resources (internal support process) to perform the process activity. Implement your QMS according to your plan.Monitor, measure and improve each QMS process and its interaction with other processes. Performance indicators to monitor and measure process performance may come from the TS 16949 standard; customer; regulatory and your own organizational requirements. Performance indicators may relate to the process output as well as the process activity. Performance indicators for process output must focus on meeting customer and regulatory requirements. Performance indicators for process activity should focus on measuring process effectiveness and efficiency. See clause 5.4.2 for quality objectives.It is useful to point out that while we do need to identify all QMS processes and describe their interaction, not all identified QMS processes need to be documented or documented in the detail described above. Review notes on clause 4.1 General Requirements in conjunction with the above notes on the process approach, for more insight on process documentation.For those interested in gaining a deeper insight into understanding and implementing the process approach, study the ISO guidance document on the concept and use of the process approach for management systems - Document: ISO/TC 176/SC 2/N544R2(r), issued 13 May 2004 on the ISO website. Also review the AIAG/IATF guidance on the automotive approach to QMS processes on the IAOB website.Keep in mind that the above notes and references are guidance documents and the manner and detail of application and documentation of the process approach will vary from organization to organization, due to a variety of factors such as size and complexity of the organization; products, processes; customers; etc. See clause 4.1 for more details on applying the process approach.

PDCAPLAN-DO-CHECK-ACT (PDCA) (Figure 3)0.2 Process Approach (Continued) NOTE:In addition, the methodology known as Plan-Do-Check-Act (PDCA) can be applied to all processes. PDCA can be briefly described as follows.

Plan: Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies.Do: Implement the processesCheck: Monitor and check processes and product against policies, objectives and requirements for the product and report the results Act: Take actions to continually improve process performance

Key Explanation Points and Tips:PLAN-DO-CHECK-ACT (PDCA) is a very effective tool for business management and the ISO 9001 standard strongly recommends its use. PDCA is a dynamic cycle that can be applied to each of the organizations processes, and also to the system of processes as a whole. It may be used to plan, implement, control and continually improve both product realization and other QMS processes.

Maintenance and continual improvement of QMS processes can be achieved by applying PDCA to processes at all levels within the organization from the executive high-level strategic processes, such as business planning or management review to operational processes such as product realization or calibration.

(PLAN) - For each QMS process you must establish:Process owner and his/her accountability Process inputs, outputs, value adding or conversion activities and sequence/interaction of these activities (sub-processes) within the process. Many of the COPs and SOPs may have sub-processes.Process policies, responsibilities and accountability.Process objectives and performance indicators and methods to monitor and measure process performance to these objectives and indicators.Resources needed (e.g. facility, equipment, labor, materials, time, etc).Preventive and detective controls needed for process activity, input, output and resources used.Process documentation (e.g. procedures, forms, work instructions, specification, etc.)The nature, method, frequency and timing of interaction with other processes and where this interaction will occur input, output, use of resources, conversion activity, etc. You must pay a lot of attention to this stage of your QMS development. Planning must also consider how you will meet customer, applicable regulatory, and your own organizational requirements, in addition to ISO 9001 requirements. We will look at QMS planning in more detail when we review clause 4.1 requirements. (DO) - Deploy and implement your QMS processes and manage and control them according to your plan as documented above. (CHECK) Monitor and measure the effectiveness of your QMS processes against policies, objectives and performance indicators that you established under PLAN. Monitoring and measuring activity may focus on any or all of a processs inputs; outputs; use of resources for conversion; and interaction with other processes. (ACT) Collect and analyze your monitoring and measurement information and use it to determine the effectiveness of each process as well as your overall QMS in meeting requirements. Use the information to correct problems and continually improve individual processes. As mentioned above PDCA is a dynamic cycle and so continual improvement must be an on-going process for improving your QMS and enhancing customer satisfaction.

Continual Improvement ModelThe Continual Improvement Model0.2 Process Approach (Continued) The model of a process-based quality management system shown in figure4 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs.Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure4 covers all the requirements of this Standard, but does not show processes at a detailed level. Key Explanation Points and Tips: Figure 4 - shows the macro level application of the PDCA model to an entire organization. The organizations QMS (as depicted by the processes within the circle) is used to PLAN the controls over all inputs, resources, value-adding activities and outputs. We DO implement our plan by using various resources to convert customer inputs (requirements) into outputs (product) that meet customer requirements. We CHECK - by monitoring and measuring QMS performance and through customer feedback. We ACT by using this information to continually improve QMS effectiveness. At the micro level, this same model can be applied to each QMS process. Controls for your processes come from the ISO 9001 standard, customer requirements, your organization or applicable regulatory requirements.. The five clauses of ISO 9001 provide control requirements for PDCA - planning, implementation; monitoring and measurement; and for improvement of each QMS process. The applicable requirements of these five clauses must be applied to each process (inputs; outputs; resources used; transformation activities; interaction with other processes) for effective control. In clause 4.1 we will discuss this in further detail.

Compatability with Other ModelsCompatibility With Other Business Management Systems0.3 Relationship with ISO 9004The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can also be used independently. Although the two standards have different scopes, they have similar structures in order to assist their application as a consistent pair.ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall efficiency, as well as effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.

NOTE Knowledge and use of the eight quality management principles referred to in ISO 9000:2000 and ISO 9004:2000 should be demonstrated and cascaded through the organization by top management.

0.3.1 IATF Guidance to ISO/TS 16949:2002This guidance document contains recommended automotive practices, examples, illustrations and explanations, and provides assistance in the application to conform to the requirements of TS 16949. This IATF guidance document is not intended for certification or contractual purposes.

Key Explanation Points and Tips: The difference between ISO 9001 and ISO 9004 are as follows: The ISO 9001 standard provides requirements for your QMS that can be certified by an accredited Registrar; whereas ISO 9004 provides guidance to improve your QMS and is not subject to Registrar certification. ISO 9001 focuses on improving QMS effectiveness alone ; whereas ISO 9004 focuses on improving an organizations overall performance and efficiency as well as its effectiveness. ISO 9001 provides the initial stepping stone for quality management; whereas ISO 9004 takes you further down the road towards total quality management . The scope of ISO 9001 focuses on requirements intended for certification and contractual purposes; whereas ISO 9001 provides guidance that addresses a broader range of stakeholders such as owners, community, personnel, suppliers, investors, etc.

The layout, structure and numbering sequence of the requirements in the two documents are similar. ISO 9004 includes the requirements of the ISO 9001 standard in boxed tables and further discusses concepts, principles, issues and ideas for QMS development and implementation, for each clause.

Keep in mind that ISO 9004 goes far beyond what may be required for initial ISO 9001 certification. Use it to gain knowledge and ideas, but be careful about trying to implement all that it covers, as it may be quite overwhelming if you are developing a QMS for the first time. Use ISO 9004 to continually improve the effectiveness and efficiency of your organization beyond certification.

Theeight quality management principles referred to in the note were covered under clause 0.1 General.

All of the automotive examples and explanations in the IATF ISO/TS 16949:2002 guidance document have been included in my key explanation points and tips for each sub-clause.

0.5 Goal of ISO/TS 16949:2002Your organization shall develop a QMS that:l Provides for continual improvement l Emphasizes defect preventionl Reduces variation and waste in the supply chainl Defines fundamental QMS requirements when coupled with customer-specific requirementsl Provides a common approach to a QMS for automotive and service part organizationsl Is intended to avoid multiple certification audits

Key Explanation Points and Tips: Focus on defect prevention and continual improvement of your products, processes, QMS and customer satisfaction Reduce variation and waste not only in your products, but also in the processes within your organization. Encourage your suppliers to do the same. Analyze the business and quality risks associated with variables (such as materials, labor, equipment, methods, etc) for each process within your QMS and take systemic measures to prevent them from occurring. It is important to note that the TS 16949 standard does not specify requirements for product. TS 16949 provides requirements for your QMS and its processes. By effectively controlling and improving your QMS processes, there will obviously be a positive impact on product quality performance. Product specific requirements come from your customer; your own organization and from applicable regulatory and industry standards and codes. TS 16949 QMS requirements supplement the product specific requirements. By providing a common approach to automotive sector QMS requirements capable of independent 3rd party certification, TS 16949 reduces the need for multiple OEM requirements, systems and audits, thus reducing unnecessary work and cost in the supply chain.

7.1.4 Change Control7.1.4 Change ControlHave a process to control & react to changes from internal, customer or supplier sources, that impact product realization. Your controls shall:Assess the changes and their effects.Define verification and validation activities (for these changes) to ensure compliance with customer requirements.Validate changes before implementation.Review with your customer, any changes to propriety designs, impact on fit, form and function, to ensure that all effects are evaluatedPerform any additional verification/ identification, when required by the customer, e.g. new product introductionNote 1 : Notify & get approval from your customer, for any product realization change affecting customer requirements.Note 2 : This clause for change control applies to changes to product as well as manufacturing processes.

Key Explanation Points and Tips: Clause 7.1 is essentially a repeat of clause 4.1, but applied specifically to product realization processes (see clause 4.1 explanation points COPs). The focus is on controls governing the making of product to meet customer requirements and all the QMS processes that, directly or indirectly, make this happen. Review specific product realization requirements at OEM customer or IATF websites. Product realization processes may include customer related processes (sales and marketing); design and development; production; shipping; receiving; packaging; measurement and monitoring of product and processes, customer satisfaction feedback; etc., whether performed onsite or off-site. Some of the support processes that apply to product realization processes include - document control; record control; human resources; infrastructure provision and maintenance; IT; purchasing and materials management; laboratory services; and control of monitoring and measuring devices, etc. You must show the sequence and interaction of these processes. The APQP is an excellent tool to accomplish this. Using the APQP methodology, your organization can identify the processes and controls needed to plan product realization from identification and understanding of customer requirements; product design and development if applicable; manufacturing design and development; manufacturing and delivery. The focus of APQP is defect prevention and continual improvement, as well show how the processes link and interact with one another. The notes to 7.1 also permit you to use other project management tools or clause 7.3 requirements to develop product realization processes. You may need to consult your customer to confirm such alternate methods. The Quality Plan (Control Plan) is the output of the APQP process and is used to deploy product realization. The Control Plan must include product details and control characteristics; process sequence and process control parameters; specific resources needed to make, verify and deliver product; product and process monitoring and measurement controls; plans to control and correct any product or process nonconformities. reference to support processes; documents needed (such as work instructions or engineering specifications, etc.) and details of records to be kept; Focus on defect prevention in planning the controls for product realization Quality objectives; product requirements as well as product realization process requirements may come from the customer, your own organization, regulatory bodies and industry standards or codes. Quality objectives may include defect rates; PPMs; scrap rates, etc. Requirements or criteria for the product may include physical; dimensional; functional, etc, and their related measurements, tolerances and acceptance levels. In many instances, depending on the nature of the product, the customer may specify objectives and requirements /criteria for the product realization processes as well. Obtain customer clarification and approval where required. Many customer requirements may come from the sources and reference documents I listed on page 1 of this document. You must pay careful attention to this listing as they may be as applicable as customer contracts and product specifications. Required verification, validation, monitoring, inspection and test activities must apply to all processes identified for product realization and must be defined in your FMEAs, Control Plan, work instructions, and other documents used for product realization. Access to storage of confidential documents and data (electronic or hard copy) should be controlled. Be extra careful of confidentiality requirements relating to new projects and changes. Obtain clarification and approval from your customer when outsourcing production or needing to disclose technical information when sourcing materials. Change control is a very important part of the product realization process. It applies to ANY change in product realization and includes product and manufacturing process changes. Uncontrolled changes lead to both customer and internal quality problems. The defined process must include authority for change and consistency of implementation and communication. For effective change control, follow the applicable requirements of the APQP methodology for assessing, verifying and validating product realization changes before implementing. Comply with any customer requirements for notification and approval of changes. Your change control process must include responsibility; evaluation; verification and validation; frequency; timing; method; communication; training; documentation; update of affected activities and documents; implementation; use of multi-disciplinary approach; checklists; etc., for product realization changes. Changes may arise from customer complaints; feedback from the field; new technology; supplier and material changes; internal or customer driven changes; process improvements; SPC data; etc. Product realization changes may affect several linked activities and documents. Such as clauses (4.2.3.1; 7.3.6.3; 7.3.2.3; 7.3.3.1; 7.3.3.2; 7.3.6.2; 7.5.1.1 and 7.5.1.2). These cover customer engineering specifications; FMEAs (design and process); Control Plans; design record; inspection instructions; machine process parameters; material specifications; measuring equipment; part approval requirements; technical drawings; and work instructions. Where any of the product realization processes are done off-site (e.g. at head-office), your QMS must include the off-site processes within your QMS and ensure that such processes comply with TS 16949 requirements. Evidence of the off-site facilitys compliance may include - a copy of their TS 16949 certification; results of their internal audits to TS 16949; auditing the outsourced facility; etc. The expectation is to flow down to the off-site facility, the relevant TS 16949 requirements that you would have to implement, had you carried out the process at your own facility. Performance indicators, (to measure the effectiveness of product realization in meeting requirements and achieving quality objectives,) will be specific to each realization process and focus on reducing variation and waste in realization processes and related use of resources. Objectives may be used to monitor and improve process productivity; reduction of cycle time, errors, omissions and failures; etc. You must also consider indicators to measure product performance such as - reduction in defect rates, PPMs (defective parts per million), scrap rates, waste and rework; improvement in on time delivery (see clause 7.1a); product returns from customer; etc.