ISO/TS 16949

ISO/TS 16949 was developed by the International Automotive Task Force (IATF) to improve product quality to automotive customers worldwide. ISO/TS 16949 is a shared automotive quality system based on the ISO 9001, AVSQ (Italian), EAQF (French), QS-9000 (American), and VDA 6.1 (German) standards. With ISO/TS 16949, suppliers and subcontractors in the automotive industry can use a single document to comply with all these international standards.

The objective of ISO/TS16949 is to develop a quality management system that provides for continuous improvement while emphasizing defect prevention and the reduction of variation and waste in the supply chain. ISO/TS 16949 applies to the design/development, production, and, when relevant, installation and servicing of automotive-related products. It contains recommended automotive industry practices and examples.

ISO/TS16949 is relevant to all types of automotive supply companies, from small manufacturers to multi-site multinational organizations located anywhere in the world. However, it is only applicable to sites where production or service parts are manufactured.

Benefits

With ISO 9001 as the basic quality management system, organizations achieving certification to ISO/TS 16949 receive dual benefits. First, they benefit from the process approach with emphasis on continuous improvement. This means that the organization knows, understands, and practices a philosophy that is committed to quality in all actions, never settles for "good enough", and understands the dynamics and interactions that exist between the various processes that make up the quality management system. Second, the added requirements of ISO/TS 16949, although prescriptive in nature, are based on proven techniques that further enhance an organization's ability to achieve high quality levels in the challenging automotive sector.

ISO/TS 16949 certification offers the following benefits:

• Improved product and process quality.
• Apply common and consistent international quality system requirements for the automotive industry.
• Improved on-time delivery.
• Greater emphasis on supplier quality improvement efforts.
• Satisfies automotive mandates of IATF members on a global basis, when complemented by fulfillment of customer-specific requirements.
• Introduce process-based audits focusing on customer satisfaction.
• Gain global acceptance of the standard in place of national standards.
• Eliminate the need for multiple third-party registrations on a geographic basis.
• Enable companies to upgrade from QS-9000, VDA 6.1, etc. during regularly scheduled surveillance audits, provided the registrar is IATF-approved for ISO/TS 16949.
• Promises more consistent auditing performance. Auditors of recognized ISO/TS 16949 registrars must undergo extensive training, testing, and re-qualification to meet rigorous qualification requirements.

The Challenge

The following issues may impact a company in its registration efforts:

• Maintain or improve quality levels that have become the price of entry in the minds of consumers.
• Overlapping of responsibilities – employee most likely has multiple roles within the organization, thus limiting the amount of responsibility that can be placed on each person. The challenge for the company becomes in finding ways not to overburden its employees.
• Difficulty in adoption and standardization across the organization.
• Supporting cultural change throughout implementation.
• Time – the company may be pressured by customers to implement a quality management system within a certain time frame or potentially lose their business.
• Limited resources – when asked, most companies will normally identify money, personnel, and time as their most problematic resources.
• Implementing an effective team structure with management support.
• And many others…

These are significant challenges. However, the implementation and registration of a management system helps an organization achieve continuous performance improvement.

To deal with all the below listed challenges, SoftExpert has designed a configurable, easy-to-use, and integrated solution to help companies comply with ISO/TS 16949 and ISO 9001.

SoftExpert Excellence Suite is a web-based management system, designed to help you meet ISO/TS requirements easily and effortlessly. It will also help your organization make better decisions in managing the content and the processes that drive your business.

 

The following are some examples of how SoftExpert Excellence Suite addresses key ISO/TS16949 compliance issues:

Module	ISO/TS 16949 Compliance and Requirements
SE APQP-PPAP	Provides complete documentation on company products as well as process specifications. Provides a complete database of parts, revisions, and characteristics. Guarantees control plan for processes producing bulk materials. Automates document revision and automatically identifies changes. Identifies and controls special product and process characteristics. Provides a high quality product and helps to keep scheduled deadlines while reducing any related costs. Sends all APQP documents to customers through the Internet with electronic signatures of Submission Warrant and APQP results. Automatically creates APQP documents, FMEAs and Control Plans. Ensures simple and effective control of new product development. Generates APQP schedules in spreadsheets and Gantt charts. Assures full compliance with 8D and 5 steps. Builds PPAP templates for each customer to meet unique document requirements. Submits or receives any of the PPAP documents to/from customer. Manages all documents and tasks in the APQP and PPAP processes, allowing the team to focus on customer related matters. Manages and controls the entire PPAP including appearance approval, test results, process flow charts, measurement studies, design records, and others.
SE Document	Manages the creation, revision, approval, and distribution of quality documents, records, and others. Improves the control of role-based security rights for access to documents and contents. Documents the Quality Management System. Increases productivity by creating an electronic review and approval process and automating workflow steps based on document type, process area, and change level. Reduces the risk of deviations resulting from employee access to outdated or obsolete procedures and work instructions. Files, procedures, records, etc. are centralized and controlled according to company policies.
SE Action	Manages a closed-loop corrective and preventive action process with electronic workflow and built-in effectiveness checks. Identifies and records Process or audit problem causes. Ensures specific problems and their causes are corrected. Assesses the effectiveness of corrective actions. Nonconforming products are controlled in order to prevent inadvertent use or installation. Formalizes nonconforming product review and control. Guarantees that appropriate corrective action is decided upon and implemented. Ensures that responsibility for corrective action is clearly defined. Keeps records of all complaints and follow-up actions. Corrects any deficiencies before products or processes fail. Maintains records of defects, investigation of their cause, and corrective actions. Enforces consistent and harmonized processes and procedures across the organization.
SE Audit	Improves auditing program efficiency by providing a streamlined and fully electronic approach to managing audit schedules, documenting findings, generating and distributing reports, and tracking and monitoring corrective actions. Allows planning of all audits. Results of audits are communicated to management and all findings are corrected and recorded. Manages any required corrective action. Ensures corrective actions are carried out on time.
SE Competence	Identifies training needs. Keeps appropriate records of all employee training, skills, and experience. Automates employee qualification and training control. Ensures employee performance is regularly appraised and recorded. Guarantees that employees executing tasks directly affecting product quality are properly trained. Controls the effectiveness of previously conducted training.
SE MSA	Provides all the necessary tools for managing measurement systems within the organization. Compares equipment performance before and after being repair. Ensures complete analysis through the use of graph charts, such as average/range, errors, whiskers chart, scatter, histogram, linearity, and others. Provides guidance for developing a formal gage management system. Allows fixed and variable calibrations.
SE Calibration	Ensures all instruments are calibrated and have not exceeded their expiry date. Guarantees all instrument calibration is up to date at time of use. Arranges the instruments into a particular group or type for easy management. Plans and record periodic inspections. Guarantees all equipment validation controls. Assures measurement uncertainty and equipment capabilities are divulged and known by all. Identifies equipment which does not need to be calibrated. Ensures equipment measurements comply with national and international standards.
SE SPC	Verifies process capability and product characteristic acceptability. Ensures that the required process and product characteristics are monitored and measured. Documents procedures to implement and control the identified statistical techniques.
SE Inspection	Ensures Incoming materials are inspected or verified before use. Keeps records of all inspections. Ensures final inspection is performed prior to finished product release. Maintains a record of the results of supplier evaluations and follow-up actions.
SE FMEA	Automatically calculates the risk priority number (RPN) and the severity of the analyzed process aspects. Conducts FMEA risk analysis to manage potential issues. Defines FMEA for product design, process, or situation-specific issues. Automatically stores FMEA processes on all revisions performed and pinpoints any alteration recorded from each revision analysis. Provides managerial reports which display detailed information on most common failure causes in all products and processes. The number and effectiveness of preventive/corrective actions are also recorded in system reports.
SE Maintenance	Guarantees equipment preventive maintenance management. Keeps records of all maintenance work. Ensures unique identification of each piece of equipment. Keeps equipment calibration and maintenance records. Documents equipment instructions supplied by the manufacturer. Assures that equipment operates within specifications. Provides maintenance schedule to ensure no equipment is overlooked.
SE Risk	Creates well structured documentation relating to all aspects of each risk element. Provides complete support for defining teams and training for those responsible for risk management. Provides management risk monitoring tools on complete analytical chart.
SE Performance	Provides numerous comparative and performance charts. Automatically detects and warns of performance deviations. Records and controls action plans. Analyzes causes and effects (strategy map). Automates graphical scorecards & dashboards displaying KPI metrics. Increases visibility and transparency with personalized dashboards, integrated reporting tools, and automatic report distribution to management.
SE Process	Ensures production (and installation) processes are defined, planned, and documented. Guarantees that production is carried out under controlled conditions: documented instructions, in-process controls, process and equipment approval, and criteria for workmanship. Guarantees processes are monitored and controlled. Allows individuals, groups, business units and suppliers to be added to any process and ensures that they receive notification of tasks in their respective queue. Allows the building and management of business processes through the creation of process maps and process flows for all non-manufacturing processes.
SE Project	Ensures projects are initially planned then approved. Estimates initial project time, costs, and deliverables. Identifies, documents, and reviews and approves all project changes and modifications. Assures critical path assessment. Keeps record of all project meetings. Manages task requests from all departments - from large macro-projects down to the smallest routine tasks. Displays the entire project portfolio and applies key performance indicators for organizational strategic alignment. Manages the entire life-cycle of electronic documentation, including the drafting, approval, and release steps for viewing, revision, and canceling. Ensures project tasks are performed and verified.