Ts 16949 pdf standard

Examples of areas for using such a multidisciplinary approach include but are not limited to the following: a project management for example, APQP or VDA-RGA ; b product and manufacturing process design activities for example, DFM and DFA , such as consideration of the use of alternative designs and manufacturing processes; c development and review of product design risk analysis FMEAs , including actions to reduce potential risks; d development and review of manufacturing process risk analysis for example, FMEAs, process flows, control plans, and standard work instructions.

Applicable tools and techniques shall be identified by the organization. Using prioritization based on risk and potential impact to the customer, the organization shall retain documented information of a software development capability self-assessment.

Product design input requirements include but are not limited to the following: a product specifications including but not limited to special characteristics see Section 8. The organization shall have a process to deploy information gained from previous design projects, competitive product analysis benchmarking , supplier feedback, internal input, field data, and other relevant sources for current and future projects of a similar nature. The manufacturing process design shall include the use of error-proofing methods to a degree appropriate to the magnitude of the problem s and commensurate with the risks encountered.

The symbol conversion table shall be submitted to the customer, if required. When required by the customer, measurements of the product and process development activity shall be reported to the customer at stages specified, or agreed to, by the customer. The timing of design and development validation shall be planned in alignment with customer-specified timing, as applicable.

The organization shall use, whenever possible, the same suppliers, tooling, and manufacturing processes as will be used in production. When services are outsourced, the organization shall include the type and extent of control in the scope of its quality management system to ensure that outsourced services conform to requirements see ISO , Section 8.

The organization shall approve externally provided products and services per ISO , Section 8. The organization shall obtain documented product approval prior to shipment, if required by the customer. Records of such approval shall be retained. The organization shall verify the outputs against manufacturing process design input requirements.

These changes shall be validated against customer requirements and approved internally, prior to production implementation.

If required by the customer, the organization shall obtain documented approval, or a documented waiver, from the customer prior to production implementation. For products with embedded software, the organization shall document the revision level of software and hardware as part of the change record.

All requirements of Section 8. The process shall include the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product, material, or service risks. If the customer defines special controls for certain products with statutory and regulatory requirements, the organization shall ensure they are implemented and maintained as defined, including at suppliers.

Unless otherwise authorized by the customer a QMS certified to ISO is the initial minimum acceptable level of development. Using prioritization based on risk and potential impact to the customer, the organization shall require the supplier to retain documented information of a software development capability self-assessment.

At a minimum, the following supplier performance indicators shall be monitored: a delivered product conformity to requirements; b customer disruptions at the receiving plant, including yard holds and stop ships; c delivery schedule performance; d number of occurrences of premium freight. If provided by the customer, the organization shall also include the following, as appropriate, in their supplier performance monitoring: e special status customer notifications related to quality or delivery issues; f dealer returns, warranty, field actions, and recalls.

Second-party audits may be used for the following: a supplier risk assessment; b supplier monitoring; c supplier QMS development; d product audits; e process audits. The organization shall retain records of the second-party audit reports. Determination inputs shall include but are not limited to the following: a performance issues identified through supplier monitoring see Section 8. The organization shall implement actions necessary to resolve open unsatisfactory performance issues and pursue opportunities for continual improvement.

Monitoring and measuring resources include appropriate monitoring and measuring equipment required to ensure effective control of manufacturing processes. Family control plans are acceptable for bulk material and similar parts using a common manufacturing process. The organization shall have a control plan for pre-launch and production that shows linkage and incorporates information from the design risk analysis if provided by the customer , process flow diagram, and manufacturing process risk analysis outputs such as FMEA.

The organization shall, if required by the customer, provide measurement and conformity data collected during execution of either the pre-launch or production control plans. The organization shall review control plans, and update as required, for any of the following: f the organization determines it has shipped nonconforming product to the customer; g when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis FMEA see Annex A ; h after a customer complaint and implementation of the associated corrective action, when applicable; i at a set frequency based on a risk analysis.

If required by the customer, the organization shall obtain customer approval after review or revision of the control plan. The standardised work documents shall also include rules for operator safety. At a minimum, the system shall include the following: a identification of process equipment necessary to produce conforming product at the required volume b availability of replacement parts for the equipment identified in item a ; c provision of resource for machine, equipment, and facility maintenance; d packaging and preservation of equipment, tooling, and gauging; e applicable customer-specific requirements; f documented maintenance objectives, for example: OEE Overall Equipment Effectiveness , MTBF Mean Time Between Failure , and MTTR Mean Time To Repair , and Preventive Maintenance compliance metrics.

Performance to the maintenance objectives shall form an input into management review see ISO , Section 9. The organization shall establish and implement a system for production tooling management, whether owned by the organization or the customer, including: a maintenance and repair facilities and personnel; b storage and recovery; c set-up; d tool-change programmes for perishable tools; e tool design modification documentation, including engineering change level of the product; f tool modification and revision to documentation; g tool identification, such as serial or asset number; the status, such as production, repair or disposal; ownership; and location.

The organization shall implement a system to monitor these activities if any work is outsourced. The organization shall include relevant planning information during production scheduling, e. Alternatives are permitted if the status is clearly identified, documented, and achieves the designated purpose. Therefore, the organization shall implement identification and traceability processes as described below. The organization shall conduct an analysis of internal, customer, and regulatory traceability requirements for all automotive products, including developing and documenting traceability plans, based on the levels of risk or failure severity for employees, customers, and consumers.

The organization shall ensure that obsolete product is controlled in a manner similar to that of nonconforming product. Organizations shall comply with preservation, packaging, shipping, and labelling requirements as provided by their customers.

The effects of any change, including those changes caused by the organization, the customer, or any supplier, shall be assessed. The organization shall: a define verification and validation activities to ensure compliance with customer requirements; b validate changes before implementation; c document the evidence of related risk analysis; d retain records of verification and validation.

Changes, including those made at suppliers, should require a production trial run for verification of changes such as changes to part design, manufacturing location, or manufacturing process to validate the impact of any changes on the manufacturing process When required by the customer, the organization shall: e notify the customer of any planned product realization changes after the most recent product approval; f obtain documented approval, prior to implementation of the change; g complete additional verification or identification requirements, such as production trial run and new product validation.

The organization shall document the process that manages the use of alternate control methods. The organization shall include in this process, based on risk analysis such as FMEA , severity, and the internal approvals to be obtained prior to production implementation of the alternate control method. Before shipping product that was inspected or tested using the alternate method, if required, the organization shall obtain approval from the customer s.

The organization shall maintain and periodically review a list of approved alternate process control methods that are referenced in the control plan.

Standard work instructions shall be available for each alternate process control method. The organization shall review the operation of alternate process controls on a daily basis, at a minimum, to verify implementation of standard work with the goal to return to the standard process as defined by the control plan as soon as possible.

Restart verification is documented for a defined period based on severity and confirmation that all features of the error-proofing device or process are effectively reinstated The organization shall implement traceability of all product produced while any alternate process control devices or processes are being used e.

The organization shall ensure that the planned arrangements for initial release of products and services encompass product or service approval. The organization shall ensure that product or service approval is accomplished after changes following initial release, according to ISO , Section 8.

Results shall be available for customer review. NOTE 1 Layout inspection is the complete measurement of all product dimensions shown on the design record s. NOTE 2 The frequency of layout inspection is determined by the customer. For attribute data sampling, the acceptance level shall be zero defects see Section 9. If sub-components are reused in the manufacturing process, that sub-component reuse shall be clearly communicated to the customer in the concession or deviation permit.

The organization shall maintain a record of the expiration date or quantity authorized under concession. The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires. Material shipped under concession shall be properly identified on each shipping container this applies equally to purchased product.

The organization shall approve any requests from suppliers before submission to the customer. The organization shall ensure that all appropriate manufacturing personnel receive training for containment of suspect and nonconforming product.

If required by the customer, the organization shall obtain approval from the customer prior to commencing rework of the product. The organization shall have a documented process for rework confirmation in accordance with the control plan or other relevant documented information to verify compliance to original specifications.

Instructions for disassembly or rework, including re-inspection and traceability requirements, shall be accessible to and utilized by the appropriate personnel.

The organization shall retain documented information on the disposition of reworked product including quantity, disposition, disposition date, and applicable traceability information. The organization shall obtain approval from the customer before commencing repair of the product.

The organization shall have a documented process for repair confirmation in accordance with the control plan or other relevant documented information. Instructions for disassembly or repair, including re-inspection and traceability requirements, shall be accessible to and utilized by the appropriate personnel.

The organization shall obtain a documented customer authorization for concession for the product to be repaired. The organization shall retain documented information on the disposition of repaired product including quantity, disposition, disposition date, and applicable traceability information. Initial communication shall be followed with detailed documentation of the event. For product not meeting requirements, the organization shall verify that the product to be scrapped is rendered unusable prior to disposal.

The organization shall not divert nonconforming product to service or other use without prior customer approval. NOTE For some manufacturing processes, it may not be possible to demonstrate product compliance through process capability. Significant process events, such as tool change or machine repair, shall be recorded and retained as documented information. The organization shall initiate a reaction plan indicated on the control plan and evaluated for impact on compliance to specifications for characteristics that are either not statistically capable or are unstable.

These reaction plans shall include containment of product and percent inspection, as appropriate. A corrective action plan shall be developed and implemented by the organization indicating specific actions, timing, and assigned responsibilities to ensure that the process becomes stable and statistically capable. The plans shall be reviewed with and approved by the customer, when required. The organization shall maintain records of effective dates of process changes.

The organization shall verify that appropriate statistical tools are included as part of the advanced product quality planning or equivalent process and included in the design risk analysis such as DFMEA where applicable , the process risk analysis such as PFMEA , and the control plan.

Performance indicators shall be based on objective evidence and include but not be limited to the following: a delivered part quality performance; b customer disruptions; c field returns, recalls, and warranty where applicable ; d delivery schedule performance including incidents of premium freight ; e customer notifications related to quality or delivery issues, including special status.

The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency. The monitoring shall include the review of customer performance data including online customer portals and customer scorecards, where provided. The process shall include the development and implementation of an internal audit programme that covers the entire quality management system including quality management system audits, manufacturing process audits, and product audits.

Where the organization is responsible for software development, the organization shall include software development capability assessments in their internal audit programme. The effectiveness of the audit programme shall be reviewed as a part of management review.

Integrated with these audits, the organization shall sample customer- specific quality management system requirements for effective implementation. The complete audit cycle remains three years in length. Organizations shall maintain justification for the assigned audit frequency of their processes.

Where not defined by the customer, the organization shall determine the approach to be used. Within each individual audit plan, each manufacturing process shall be audited on all shifts where it occurs, including the appropriate sampling of the shift handover. The manufacturing process audit shall include an audit of the effective implementation of the process risk analysis such as PFMEA , control plan, and associated documents.

Where not defined by the customer, the organization shall define the approach to be used. Measurement system: the collection of operations, procedures, gauges and other equipment, software and personnel used to assign a number to a characteristic being measured; the complete process used to obtain a measurement.

Material Man Method. Gauge: any device used to obtain measurements, frequently used to refer specifically to the devices used on the shop floor. Calibration: a set of operations that establish under specific operating conditions, the relationship between a measuring device and a traceable standard of a known reference and uncertainty.

Reference Value: a reference for comparison, normally determined under laboratory conditions or using a more accurate instrument. Variability characterised by Location - bias, linearity, stability Width or spread repeatability, reproducibility. Bias: the difference between the mean measurement and the reference value.

Linearity: the difference in bias through the operating range Stability: the total variation in the measurements obtained from a single characteristic over time change in bias over time Check change in characteristic, such as values from Electrical Test Equipment, between calibration intervals Plot data and take action if bias outside a specified value. Repeatability: variation in measurements obtained with one measurement instrument, when used several times by one appraiser while measuring the identical characteristic on the same part.

Reproducibility: variation in measurements obtained with one measurement instrument, when used by different appraisers while measuring the identical characteristic on the same part.

Select appraisers people already using the instrument Select measurement instrument has it the required discrimination Select parts from the process that represent entire operating range e. Measurement System Analysis when? As processes change and improve, a measurement system must be reevaluated for its intended purpose For example, when there is a new product, capability improvement, skill level change, process change e.

A systematic group of activities to: Recognize and evaluate potential failures of a product or process and the effects of failure Identify actions that could eliminate or reduce the chance of the potential failure occurring Document the above process. Evidence from vehicle recalls has shown a fully implemented FMEA could have prevented many causes Enables action before the event Prevention , not after Detection.

Engineering specifications Multidisciplinary approach Special Characteristics Product design outputs Manufacturing process design outputs Control Plan. What risks are highest priority? Is there still a priority risk? What can go wrong?

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

Control plans shall be reviewed and updated when any change occurs NOTE Customer approval may be required. General Data; part no. Have customer requirements been adopted in Control Plan format and preparation? Are material specifications requiring inspection identified? Are engineering performance testing requirements identified Are gauges and test equipment available as required by the control plan? If required, has the customer approved the control plan? Open navigation menu.

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Jump to Page. Search inside document. GOAL: The goal of this specification is the development of a quality management system that provides for; continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.

Top management involvement including; implementing a business plan linked to defined measurable quality objectives Clear definition of responsibilities including; Authority to stop production to correct quality problems Top management review of the performance of the quality system including; reporting and evaluation of the cost of poor quality Focus on Human Resource management including processes for defining competence requirements, providing training including on the job training for employed, temporary and agency personnel , verifying effectiveness of actions taken A process to motivate employees achieve quality objectives, make continual improvement, and create an environment to promote innovation.

Distributions, differ in Location Spread Shape or any combination of these. If the shape of variable data is normal typical ; location is measured by the mean [ X ] spread is measured by the range [R] or standard deviation [sd] SPC can be applied to see if variation is unacceptable Variation in variable data can come from Common causes natural random events which affect all values of process output Special causes intermittent, often unpredictable causes making the process output unstable Control charts help identify special causes by showing Values beyond control limits Nonrandom patterns or trends e.

Terminology Measurement system: the collection of operations, procedures, gauges and other equipment, software and personnel used to assign a number to a characteristic being measured; the complete process used to obtain a measurement. Variability characterised by Location - bias, linearity, stability Width or spread repeatability, reproducibility Location Errors Bias: the difference between the mean measurement and the reference value. What are the effects? What are the causes? How often does it happen?

Date Rev. Rohit Janardanan. Ganesh Jagtap. P K Senthil Kumar. Demi Rama. Santoso Jokowaluyo. Abhishek Ranjan. Wes Westberg. Manan Bakshi. Lauris Zap. Raajha Munibathiran. Dana Williams. Ricardo Bocus. Giap le Dinh. Ankur Dhir.