ISO/TS 16949
  • The implementation of SE Action streamlined our continuous improvement process for managing actions, especially through the workflow functionality. This facilitates the verification of occurrence causes and drafting correction actions.
    Gustavo Martins – Quality Department Assistant
         
    Coca-Cola
  • SoftExpert Solution has streamlined data sharing for our quality system and has contributed to reducing impacts on the environment through doing away with the need for storing piles of original and obsolete paper documents for auditing purposes.
    Solange Amaral – Human Resource Analyst
         
    Carrier
  • SE Document has provided the means to streamline our document control, through excellent drilldown options for searching and registering documents, a systematic workflow
    tool for sending pending tasks to system users, as well as really cutting down on the need for printed copies.

    Ângela Fischer
         
    CTA-Continental
  • SE Document manages ISO standardization documentation to facilitate compliance, as well as all other document types. The workflow system provides great distribution copy control, approval, revision, printed copies, and document retrieval search capabilities. Currently, there are over 1,100 users and 3,500 registered documents.
    Carla Regina Schmitt
         
    Universal Leaf Tabacos
  • SE Document completely meets our document control requirements, facilitates retrieval, and manages the entire document revision process.
    Janaina Salatti – Quality Supervisor
         
    Group Roullier
  • We have achieved improved dependability as well as standardization in our processes to assure measurement consistency and the required monitoring to verify conformity in our products. This adds enhanced safety and quality to our customers.
    Helton Calaça – SPC Technical Support
         
    Mitsubishi Motors
  • Our productivity and reliability increased greatly. The software helped us to meet the ISO/TS 16949 standard requirements, providing security in the daily routine of the Engineering area and auditing, while easily proving full compliance with the standard and customer requirements.
    Jeferson R. F. dos Santos – MENFUND Unit Manager
         
    Menegotti
  • Online access to wherever we offer services ensures us speedy responses, through reliable and updated information, which, in turn, facilitates decision making and customer satisfaction.
    José Andrade – Opetrec Manager
         
    Opetrec
  • The SE Project was implemented quickly and the time required for the adoption of the solution by the users was quite natural, considering that the pharmaceutical segment is legally required to work with reliable and secure records that guarantee the quality of products and do not represent risks to the population.
    Randel Moreira – IT Manager
         
    Laboratório Globo
  • The SoftExpert facilitates and speeds up activities, and the system was considered highly suitable for the renewal of ISO/TS 16949 and ISO 14001.
    Cristina Pereira – Gerente adjunta de Informática
         
    Coindu
  • The ISO / TS 16949 is an ISO Technical Specification that aligns standards of quality automotive existing systems - Brazilian, American, German, French and Italian - within the global automotive industry. It specifies the quality system requirements for the design / development, production, installation and servicing of automotive related products.

    The global automotive industry requires world-class levels of product quality, productivity and competitiveness, as well as for continuous improvement. To achieve this goal many vehicle manufacturers insist that suppliers adopt the strict technical specifications laid down in a standard quality management system for automotive suppliers, known as ISO / TS 16949.

    ISO/TS 16949 was jointly developed by the IATF members and submitted to the International Organization for Standardization (ISO) for approval and publication, to encourage improvement in both the supply chain and in the certification process. In fact, for most major vehicle manufacturers, certification to this specification is a mandatory requirement for doing business.

    This specification aligns and supersedes existing standards of the American automotive quality system, German, French and Italian, including QS-9000, VDA6.1, EAQF and ASQ. It specifies the quality system requirements for the design / development, production, installation and servicing of automotive related products. First published in March 1999 and revised in 2002, there are now more than 25,000 certificates issued in 80 countries and economies.

    The ISO / TS 16949 is relevant to all types of automotive supply companies, from small manufacturers to large organizations with multiple sites (multi-site), multinationals located anywhere in the world. However, it applies only to sites where there are production or service parts. Organizations that wish to enter the automotive market must wait until entering an automotive customer list as a potential supplier, before they can proceed with the certification in this specification.

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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:

    • License to sell: For most vehicle manufacturers, certification is a mandatory requirement that is internationally recognized - helping your company to do business globally.
    • Reduces waste and prevents defects: The specification is based on ISO 9001 and encourages a process approach. Understanding the interaction of processes through the use of the standard can enable improved product and process quality, and basically prevents variations in the supply chain.
    • Flexible and easy to adopt: The ISO / TS 16949 is based on ISO 9001, making the process approach easy to adopt and integrate with other key management systems, including ISO 14001 - Environmental and OHSAS 18001 - Occupational Health and Safety. It also complements many existing tools to improve the business, such as FMEA, PPAP and Six Sigma.
    • Brand reputation: Certification can provide additional confidence and consistency for all stakeholders in global sourcing, enabling greater business opportunities and attracting more investment prospects.
    • Saves money by avoiding duplication: For suppliers of a number of different vehicle manufacturers, certifying to ISO / TS 16949 avoids the need for multiple certificates in VDA6.1, EAQF, QS-9000 AVSF and, thus eliminating duplication in the preparation and documentation, as well as auditing second and third parts.
    • 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.

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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.

    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.

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Each SoftExpert component addresses key compliance issues as shown below:

Module ISO/TS 16949 Compliance and Requirements
SE APQP-PPAP
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
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 Audit
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
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
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
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
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
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
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
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
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
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
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
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.

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