1.

0 - Scope
Organisation shall establish the scope as per the organizational requirements and Processes involved

2.0

Normative Reference

For ISO/TS 16949:2009,the reference standard used ISO 9000:2005, QMS Fundamentals and Vocabulary

3.0 Terms and Defination, 3.13.1-Terms and Defination related to Automotive Industry

14. Determine the interaction between these process.4. Establish the control methods required for these process.1.0 Quality Management System 4. Any outsourced processes shall be included in the perview of organizational QMS .QMS requirements -General Determine and Establish process needed for QMS. Monitor the established controls are efficient and Effective Take necessary actions if the planned results are not achieved.

1.QMS requirements -Supplemental Organisation shall own the consequences arising out of outsourcing process. (i. shall not obselve from the responsibility related to outsourced process) .1.4.14.e.1.

e for Control of documents.Documentation requirements 4. CA .4. Internal Audits . Control of records . Establish a Quality Manual.2.1 Documentation requirements . PA .General Establish Documented statements of Quality Policy and Objectives.2. .24. Establish Documented procedures needed by this International Standards. ( I. Control of NC product and Training ) Establish the Documents and records needed by the organization for the effective planning. operations and control of its processes.

.2 a) Quality Manual Quality Manual Shall include a) Scope.4.2. b) Documented procedures established for QMS or references to them c) Sequence and interaction of the process established or references to them. including the justification for any exclusions.

Identify and the externally originated documents.Approval and re-approval of documents re2. 5.4. . Establish a documented procedure for control of documents.Review. This shall include 1.3 Control of Documents The requirements of this clause are.Control the distribution of these documents.2.Latest Version of Documents are available at the work area.Obselete the old documents and keep the latest revisions at the point of use. 3. 4.

2.3.4. . shall be reviewed. Contents in the updated Customer drawings /specifications received from the customer. The date of change implementation in production shall be recorded. Relevant personnel involved in control of customer property shall be made aware of the changes .1 Engineering Specifications The requirements of this clause are. Distributed within two working weeks.

properly stored.4. identifiable. Records shall be Legible. .4 Control of Records The requirements of this clause are The organization shall establish a documented procedure for control of records. Retention period inline with customer specific requirements. Readily available.2.

4.2.4. .1 Records retention The requirements of this clause are Records retention shall be in line with Statutory and regulatory requirements and Customer Specific requirements.

Conducting Management reviews at periodical intervals.5.1 Management Commitment The requirements of this clause are Top Management shall be commitment towards To establish the Quality Policy . Quality Objectives are established at relevant levels and functions and reviewed on periodical basis. . Committed towards satisfying the applicable statutory .regulatory and customer specific requirements to enhance customer satisfaction.0 Management Responsibility 5.

Top Management shall review the organization's Manufacturing and other process to check its effectiveness and Efficiency.5.1. .1 Process Efficiency The requirements of this clause are .

2 Customer Focus The requirements of this clause are. Top Management shall ensure that customer specific requirements are determined and identified with an aim of enhancing the customer requirements.5. .

3 Quality Policy Management shall establish a documented quality policy which should include the following.5. Commitment towards improving the effectiveness of QMS. . Shall be inline with processes and activities carried out by the organization Commitment towards continual improvement. Shall provide a framework for establishing and reviewing the quality objectives . Shall be understood and communicated within the organization.

4 Planning 5.15.1. Quality objectives shall be SMART.4. Top Management shall establish quality objectives in line with established quality policy .5. .4. at relevant levels /Functions in the organization to meet the product requirements as well as requirements as per the planned arrangements.Quality Objectives The requirements of this clause are.

.4 Planning 5.4.Quality Objectives -Supplemental Quality Objectives shall be included an essential part of Business Plan.1.1.5.1.15.4.

5.5. Responsibility and Authority matrix to be established for each personnel in the organization and shall be communicated adequately.Responsibility and Authority The requirements of this clause are.5. Authority and Communication 5.1.5 Responsibility.15. .

1.5 Responsibility.1. it should be communicated to the respective managers to take corrective and Preventive actions . Authority and Communication 5. .1.5.5.Responsibility for Quality Quality personnel shall be authorized to stop production in case of any non conformities.5. Quality personnel shall be made available in all working shifts In case of any non conformities observed .15.

Shall create an awareness regarding Customer specific requirements to enhance customer satisfaction.2 Management Representative Organization shall appoint a member from the management group as MR.5.5. . Also a part of MR s responsibility shall be liaison with external parties like ( certifying body) related to QMS . His primary responsibilities as a MR shall include other than his regular work To ensure that all processes required for QMS are established. Reporting to the top management on effective performance of QMS and recommends need for any changes to QMS.

His primary responsibilities as a CR shall include other than his regular work a) Identification of Special characteristics at the time of NPD.for initiating Corrective and preventive actions . b) Establishing the Quality Objectives at the time of NPD c) Shall be a part of MDA.1 Customer Representative Organization shall appoint/designate a personnel from the management group as CR.2.5. .5.

5.5.3 Internal Communication Organisation shall establish a communication process in order improve the effectiveness of QMS Communication methods shall include Email Notice Boards Communication Corners Review Meetings Traininings etc .

continuity.15.6.1.Review General Organization shall conduct Management reviews at planned intervals to ensure whether QMS is adequate. effective .6. This MRM shall also includes assessment for Opportunities for improvement . .6 Management Review 5.5. Any changes to QMS integrity.

1. .6. c) All requirements of QMS requirements. b) Assessment of Quality Objectives.1.5.15.6.1-QMS Performance a) These MRM s shall also includes a) Evaluation of Cost of Poor Quality.

Changes that could affect the integrity of QMS. Customer satisfaction feedback. Status of Preventive and Corrective actions.5.25.6. Resource requirements.2. Conformity to Product and Process Performance .6.Review Input a) These MRM s Agenda shall include Results of Internal Audits. Action points pending from Previous MRM.

.5.1Input- a) These MRM agenda shall also include a) Customer Notifications.6.2.2.Review Input.1.6.Supplemental 5. if any b) Potential field failures which could have an impact on safety. Quality and Environment.

.3. Any Resource requirements.Review Output Review Output shall include Any actions / decisions which improve the effectiveness of QMS performance.6.35.5.6.

1 Provision of Resources Organisation Shall provide resources to improve effectiveness and Efficiency of the QMS. .6.0 Resource Management 6.

6. Skill.1 Human Resources Organization Shall provide competent Human resource which affects the conformity to product requirements.2. This competence shall be based on Experience. . Education and Qualification.

e) Ensure that the personnel are aware of their work and ensure that how they will contribute in achieving established Quality Objectives.6. Competence. a. . d) Determine the effectiveness of the actions initiated .2. c) Where applicable. Training and Awareness. Organisation Shall a) Determine competence which affects the conformity to product requirements b) Carry out the Gap Analysis. Provide training or other things to bridge the Competence Gap.2.

6.2. Persons involving in Delivery management shall be aware of SAP.ASN etc . catia.2. BarBar-coding .1 Product Design Skills The requirements of this clause are a) Personnel Performing Product Design related activities shall be competent / Versatile in the respective Tools like Pro-e. ProDrawing Interpretations etc. b) Persons Performing Audits shall be qualified to do the Audits.

2. .2 Training The requirements of this clause are. Organization shall establish a documented procedure for identifying the training needs for the personnel performing work which affects the conformity to product requirements. How to achieve the required competency.2.6. Personnel performing some assigned jobs shall be qualified to do so.

how their work affects customer dissatisfaction.2. which results in customer dissatisfaction.3 On the Job Training The requirements of this clause are.( shall also be include contract agency personnel ) The Organisation shall made aware of these personnel . . The Organisation shall provide on the job training for any new or modified job.2.6.

6.4 Employee Motivation and Empowerment The requirements of this clause are.2.2. This employee Motivation and Empowerment shall be done with an aim of promotion of technological and quality awareness. c) To create innovative Environment. The Organisation shall identify methods for employee motivation which results in a) To achieve the established Quality objectives . . b) To make continual improvements ( Kaizens / Suggestion scheme). The organization shall also identify monitoring and measurement methods to know how they contribute in achieving the established quality goals.

The Organisation shall identify & provide resources. . Communication and Transportation). c) Supporting Services (Information systems. workspace and Utilities b) Process equipments (Both software and Hardware).3 Infrastructure The requirements of this clause are.6. This shall include a) Building.

1 Plant facility and Equipment Planning The requirements of this clause are.Synchronous material flow.6. c) Methods to establish the effective operations ( OEE) Shall use Lean Techniques. b) Shall ensure Optimal material travel . a) Organization shall use MDA while plant. 3. Facility and Equipment Planning. . Value added use of floor space.

6.3 Infrastructure 6.26.3. .3. Shall establish contingency plans in case of a) Labour shortage b) Utilities Interruptions c) Key equipment failures and d) Customer field returns.2.Contingency Plans The requirements of this clause are.

6. .1.4.Personnel safety affecting conformity to product requirements.4 Work Environment 6.4. Personnel safety shall be taken care especially while a) Product Design and development .16. and b) Manufacturing process activities. Organization shall identify methods with aim to avoid potential injuries for a personnel affecting conformity to product requirements.

26.6.4.4. . Like 5S.2.Cleanliness of the premises Organization shall identify methods to keep the work place tidy and in a state of order.

f) The records resulting in the planning of product realization shall be maintained.monitoring.This shall include a) Required Process establishment and necessary documentation.7.Validation. inspection and Testing with respect a product.1 Planning of Product Realization The requirements of this clause are. c) Necessary resources required product specific. e) The required acceptance criteria. PFC. The Organisation shall plan and develop process/methods for product realisation. b) Quality Objectives and requirements. d) Required Verification. Control plan.0 Product Realization 7. Measurement. Gauge List etc) . Timing plan.

1 Planning of the product realization Supplemental Customer Specific requirements shall be referenced / included while making Quality plan .7.1.

7.1.2 Acceptance Criteria

Acceptance Criteria shall be established to approve the product, where required, acceptance criteria shall be approved by the customer. For attribute samplings, the acceptance criteria shall be zero.

7.1.4 Change Control

The requirements of this clause are Organization shall ensure adequate controls are established in case material change, Supplier source change, Change in specifications Respective Personnel shall be made aware of the changes. Proprieties' items shall be confirmed with customer.

7.1.3 Confidentiality

Agreement shall be established to ensure the confidentiality. This includes Customer Drawings / Intellectual Property.

1 Determination of Requirements related to the product The requirements of this clause are.2.7. b) Applicable statutory and regulatory requirements wrt product. d) Any other requirements stated by the customer. c) Requirements not stated. but required for an intended use/applicationuse/application-where known.2 Customer Related Process 7. . The organization shall determine requirements related to the product which includes a) Functional and Performance requirements.

1 Determination of Requirements related to the product Supplemental The organization shall use the same symbols for the designated special characteristics which are used in the customer design records. .7.1.2.

2.It is the organization's responsibility to take the concurrence before acceptance. This shall be done prior to the organization's commitment to supply the product / Service. The organization shall review the requirements related to the product. If the customer requirements are not given by the customer .7. The organization shall ensure that any earlier issues are resolved. .2 Review of Requirements related to the product ( Contract Review ) The requirements of this clause are .

It is the organization's responsibility to take the concurrence before acceptance. .1 Review of Requirements related to the productproductSupplemental The organization shall ensure that any earlier issues If the customer requirements are not given by the customer .2.2.7.

Risk Analysis.Capacity Verification.7. Manufacturing Feasibility in contract review etc.2 Organizational Manufacturing Feasibility The requirements of this clause are . .2. The organization shall ensure its manufacturing capability before acceptance.2. This shall include investigation .

3 Customer Communication The organization shall establish methods for customer communication.7. .2.

Customer communication.3communication- The organization shall ensure the communication shall be consistent with customer requirements.2. .3.Supplemental 7.2.7.

Required reviews at each stage. . Required Verification and Validation at each stage.7.3.3Design and development-Planning development- The organization shall plan and determine Required design and Developmental stages.Design and Development 7. The organization shall maintain records of planning output.

b) While recommending actions for reducing the RPN .e CFT approach) while a) Establishing and reviewing FMEA and Control plan.7.3.3.1- The organization shall use multi disciplinary approach (I.1. .1. 7. c) Identification . Finalization and Monitoring of Special characteristics.1-Multi Disciplinary Approach.

Product Design -Inputs 7.7. Identification.2. .maintainability.reliability.2.timing and cost.1- The organization shall determine the inputs for product design and development.durability.1.Tracebility and packaging. Targets for life.3.3. This shall includes Experience gained from previous projects Customer requirements such as special characteristics.

2.3.2- The organization shall determine the inputs for Manufacturing process design and development.2.7.Manufacturing Process Design -Inputs 7. Customer specific requirements . capability and cost Experience gained from previous development.2. This shall includes Product Design output details Targets for productivity.3.

PFMEA and Control plan.2.3.7. . b) Shall comply with customer designated symbols.2.3. determine and include the special characteristics in a) PFC.3.Special Characteristics 7. c) Customer specific requirements.3- The organization shall identify.

3.which includes Meet the design and development inputs. determine design and development .3. Contain or reference product acceptance criteria Specify the characteristics that affects the safety and proper use.3- The organization shall identify. .Design and Development -Outputs 7. Provide appropriate information to purchasing and manufacturing.7.3.

1 Product Design Outputs -Supplemental The organization shall express product design and development data that can expressed and verifiable against product design inputs. Diagnostic guidelines . as appropriate.3.where applicable Product definition including math data.3. Reliability results Product Special characteristics and specifications Product error proofing. This shall include DFMEA. Product design review results. .7.

2 Manufacturing process design output The organization shall express manufacturing process design and development data that can expressed and verifiable against process design inputs. as appropriate.and measurability (gauges. reliability.3. equipments . Floor plan Layout PFMEA Control plan Work instructions Data for quality (quality Targets) . maintainability (I.3. .7.e.measuring methods etc) Results of error proofing activities. Users manual ). This shall include PFC.

3. 2.4 Design and Development -Review The organization shall review the design and development as per the planned arrangements. This shall include 1. . Review plan vs. actual Appropriate actions in case of any problems /delay Review shall be conducted in CFT which includes all depts. Evaluate the ability to meet the requirements.7.

7.4. .analyzed and reported with summary results as an input to management review.3.1 Monitoring Measurements at specified stages shall be defined .

fit /function . regulatory conformance against drawing.3.5 Verification of Design and Development. (I.7. .e Verify for dimensional results.) Records shall be maintained. Verification shall be carried out in accordance with the planned arrangements to ensure that the design and development outputs have met the input requirements.

Results of Design and Development validation shall be maintained. Validation shall be carried out in accordance with the planned arrangements to ensure that the resulting product is capable of meeting the specified /intended use(I. .6 Validation of Design and Development.e Validation of actual results like performance results with customer specified values.7.) Where known. this validation shall be carried out prior to delivery or implementation of the product.3.

including program timimg.7. .3.6.- Design and Development validation shall be performed in accordance with customer requirements .1 Validation of Design and Development.-Supplemental Development.

7. The organization shall conform to a product and manufacturing process approval process recognized by the customer .3 Product Approval Process.e.6. This PPAP process shall also be applicable to organization's suppliers in a similar manner. PPAP submission Level 1 to 5 as described in PPAP reference manual of 04th Edition.3.) Note : Product Approval process should be subsequent to verification of manufacturing process. . (I.

7 Control of Design and Development changes This requirement is usually termed as Engineering Change Management. tool modifications. introduction of new process.7. (like changes in process. introduction of better controls in terms of guges / instruments etc) Requirement of the above clause : Do the revalidation of the changes by conduction PPAP. fit /functional requirements. Any changes affecting product quality like in dimensional / performance requirements. Any changes in manufacturing process design. changes affecting product quality. .3. changes in PFD.

evaluation to be done based on the performance . Select the supplier based on the ability of the supplier to meet the organizational requirements consistently.4 Purchasing Process.e conduct supplier QMS audit / Process audit ) ReRe. Selection process shall include evaluation of suppliers (I. The requirements of this clause.7. Criticality of the supplied product on the subsequent operations.

1.( Like traceable to IS / ASTM / DIN ) .1 Statutory and regulatory conformity. The requirements of this clause. Purchased material shall confirm to either statutory or regulatory requirements / Customer specifications.4.7.

The selected supplier shall be certified to ISO /TS 16949 or 9001:2008 by third party accredited CB.4. conducting audits to identify the gaps to improve the performance.7.2 Supplier QMS development. The requirements of this clause.1. sharing information etc ) . The organization shall carry out supplier up gradation program ( in terms of training.

3 Customer approved sources.1.7. . Also it does not absolve/ relieve the organizations from the responsibilities .4. This requirement also applicable to the suppliers like Tool / gauge .by procuring from the customer designated sources. equipment manufacturer. The requirements of this clause. The organization shall procure the materials from the customer approved / Designated sources only.

7. Terms & conditions Delivery.4.2 Purchasing Information. Method of packing . installation and commission. The type of qualification required for a personnel if it is related to a service or operating . Traceable standards . Cost . Required acceptance criteria for the purchased material. The requirements of this clause. Customer designated names /codes. Types of quality records required for acceptance / approval. The organization shall clearly define the purchasing material requirements ( like Technical names . transportation. mutually accepted /agreed codes .

e) Terms & conditions wrt Delivery. material Test reports . f) Quality Management System requirements ( like COC .2 Purchasing Information. Method of packing . The requirements of this clause. b) Required acceptance criteria for the purchased material. mutually accepted /agreed codes . Customer designated names /codes.4. d) Types of quality records required for acceptance / approval for purchased product. Traceable standards . Cost . The organization shall a) clearly define the purchasing material requirements ( like Technical names . installation and commission. c) The type of qualification required for a personnel if it is related to a service or operating .7. transportation. performance test results where applicable etc ) .

The requirements of this clause are.7. . The organization shall Establish / implement inspection process to ensure the part quality against the established acceptance criteria / purchasing requirements. If required Verification should be carried out on site in presence of customer with prior intimation to the supplier.4.3 Verification of purchased product quality.

4.7. The requirements of this clause. d) By receipt of . b) Inspection carried out by Second / Third party. a) Introducing receiving inspection on sampling basis.1 Incoming product conformity to requirements. etc) . The organization shall utilize one or more following methods to ensure the part quality against the established acceptance criteria / purchasing requirements.3. SPC data . evaluation of stastical data from the supplier ( Self certificates. c) Inspection / Verification carried out by designated laboratory.

7. . The requirements of this clause. c) Customer line stoppages / Field returns. The organization shall monitor the supplier performance based on a) Delivery rating.2 Supplier Monitoring.4.3. b) Quality rating. d) Customer notifications related to quality / Delivery.

preservation . Drawings. f) Qualified / Competent personnel.1 Control of Production and Service Provision The requirements of this clause. The organization shall establish and ensure the following a) information which describes the characteristics of product ( Quality Check Sheet . c) Do s and Don ts related to handling. doing an activity in a controlled atmosphere. g) Acceptance criteria for product either through CP s Quality Plans . d) Capable machine and equipment to produce the part and how to use the machine /equipment.5. etc . etc) b) SOPs/ Work Instructions for carryout an activity in a correct way.7. e) Correct instruments and gauges to monitor and measure. Control Plan . Quality Check sheets.

5.7.1. Subsystem level / part specific level / Raw Material specific level for all the process which produces the parts including for bulk material producing process. b) Establish Control plans for prototype level( if required only ) / Pre launch level (Before mass production stage . a) Establish Control plan at system level.1 Control Plan The requirements of this clause. if required) / Production level by taking inputs from DFMEA / PFMEA .

1.5. d) Shall include all Manufacturing process controls to produce the defect free product. a) Include all special characteristics which are identified in Customer design record( I.7. . .1 Control Plan Continued The requirements of this clause. c) Establish and include the relevant Control methods like SPC / Control charts / PM / Calibration / MSA etc to control the special characteristics. b) Include all Special characteristics which are identified internally by the organization based on process criticality.e Drawing). e) Shall include reaction plan / Corrective action in case of any deviations / Non Conformities.

5. c) These work instructions shall be derived from Quality plan or Control plan . and customer specific requirements.1. a) Shall prepare the documented work instructions for all the employees having the responsibilities for the operation of processes that impact conformity to product requirements. FMEA.2 Work Instructions The requirements of this clause. b) These work instructions shall be made available at the point of use for effective operations.7. .

(I. A) Job Set approval shall be carried out whenever Initial run of a job( I. job change. Material Change. conducting initial process capability study etc ) .e. Wherever possible use stastical data for approval of job setups.7.1.e.5. First piece inspection) . Work Instructions shall be mandatory for Job set verification process.3 Job Set Verifications The requirements of this clause.

Temperature monitoring. Vibration analysis. i) Maintain the critical spares as per minimum as per the established minimum order qty. h) Identify the critical spares list. Daily. with an aim of avoiding the recurrence of maintenance problems and breakdowns. k) Shall use predictive maintenance techniques like Noise analysis.4 Preventive and Predictive Maintenance The requirements of this clause.7. e) carry out the root cause analysis for breakdowns.equipments. j) Adequately preserve .1. b) Provide adequate resources (Personnel. f) Monitor MTBF. g) Carryout the machine capability studies after any major overhaul / Major breakdowns.the equipment tooling and gauges by proper Preventive Maintenance. a) Identify and prepare list of Key process equipments.MTTR to improve the effectiveness and efficiency of the PM process. Ageing analysis etc ) . Annually). Monthly.e. c) Establish PM plan (I.5.etc) for carrying out effective PM activity. d) Carry out the PM as per plan.

.5 Management of Production tooling The requirements of this clause. under repair / maintenance . f)Shall maintain history card for any tool change modifications.5. Rejected / not to be used etc. h) Shall identify the each tool status like ready for use / production. b) Shall carryout maintenance activities ( preventive .1.7.Predictive ) c) Shall be equipped with resources for breakdown maintenance. d) Shall be properly stored for easy recovery. e) Shall establish the tool change frequency for perishable tools. a) shall provide resources for tool and gauge design .fabrication and verification activities . g)Shall identify each tool with unique identification number and name.

a) Organizational Production planning shall be in such a way that it meets the customer requirements are met consistently .e stock available at each production stage).5.6 Production Scheduling The requirements of this clause. c) Shall establish an information system that shall be accessible at all stage of production in order to meet the customer requirements. b) Scheduling shall be towards Just in Time methods in order to reduce the inventory.7.1.( I. .

1. Not Understoos .7.5.7 Feedback of information from service The requirements of this clause.

1.5.8 Service agreement with customer The requirements of this clause.7. Not Understoos .

5. acceptable % of rejection . Productivity. c) Qualification records of competent personnel.2 Validation of Process for production and service provision The requirements of this clause. This validation shall be carried out for production process ( like welding process .7.electroplating . d) Use of Some specific methods and procedures ( SOP s /WI /Guidelines etc) e) Revalidation frequency . Shall validate( means establish standard process parameters and their specifications with the help of DOE /or by experience /or by manufacturers recommendations ) such that these established process parameters should be able to demonstrate the ability of meeting the required results.e. defects / problems will appear only after some time . or when processing next operation / when it is in use etc ) Validation data shall be typically includes a) Records of acceptable PPM levels. b) Records of equipment approval.painting etc ) and service provision processes ( like surface treatment process ) where verification for acceptance can not be able to do immediately / after the process is over (I.

7. .2 . Process validation shall cover not only for special process but also for all manufacturing process.1 Validation of Process for production and service provision -supplemental The requirements of this clause.5.

7. Batch # . Based on rejection /rework / OK .( with the help of status cards / route cards and with clear reasons of status). . Ready for dispatch . Identify the status of the product based on monitoring measurement requirement throughout product realization (i. Where appropriate.3 Identification and Traceability The requirements of this clause.e. Tool #.Heat # etc ) These traceability records shall be maintained.5. Where traceability is mandatory requirement . Produced Date. Ready for Next operation . the product shall be identified with Unique identification number ( cavity #.

Identification and Traceability is mandatory at all stages of product realization.3 Identification and Traceability The requirements of this clause. .7.5.

Fixtures. Shall identify. . Shall maintain records of the same. Note : Customer Property may include but not limited a) Packaging materials like trolleys. material handling equipments b) Tools . protect and safeguard the customer property when it is under organizational control. damaged or found unusable condition .5. Measuring and test equipments and Gauges c) parts or constituents of parts which are used for an producing parts.7. Shall notify to the customer when the customer property is lost. Shall exercise care of customer property when it is under organizational control. bins. verify.4 Customer Property The requirements of this clause.

Establish master list of customer property.inspection tooling and equipment so that ownership is visible clearly.7.5. . Shall identify permanently the customer owned tools.4 Customer Owned production Tooling The requirements of this clause.test . manufacturing .

Handling. Shall preserve the product during internal processing and till delivery to the intended destination in order to maintain the conformity to requirements. . storage and protection.5 Preservation of the product The requirements of this clause.7. Preservation shall typically includes identification . Packaging .5. This requirement shall also applicable to the constituents of the product.

. Shall include the condition verification at planned interval in order to detect the deterioration.( I.5.1 Storage and Inventory. Shall use Inventory Management techniques to optimize the ITR. Shall establish FIFO with primary intention of stock rotation.7. Any obsolete product shall be handled similar to NC parts handling.e. The requirements of this clause. Shelf life Verification at planned intervals).5.

7. deterioration during handling. Each instrument /test equipment shall be protected from external damages . Calibration and verification status to clearly identified on the instrument. Gauges. Carry out the calibration / verification as per the established frequency and maintain the records of the same. Each instrument / test equipment shall be safe guarded from adjustments that will lead to invalid results.6 Control of monitoring and measuring equipments. the software s ability to give consistent results shall be conformed before / prior to its use.maintenanace and storage. Establish Master list of Equipments . Establish the acceptance criteria based on international standards or criticality of usage. Instruments and test equipments. If any software being used for calibration/verification . Each instrument / test equipment shall have unique identification number. . Establish the calibration / Verification frequency based on the usage. The requirements of this clause.

Other analytical methods shall be be carried out in concurrence with Customer.6.1 Measurement System Analysis The requirements of this clause. . The acceptance criteria and Analytical methods shall be in line with Customer reference MSA Manual or follow AIAG MSA manual of 3rd Edition. Analyze the variation present in the results of each type/category of measuring and test equipment.7. Measurement System analysis to be carried for the instruments/ test equipments which are referenced in quality plan / Control Plan .

2 Calibration /Verification records. Statements of conformity to specification after calibration / Verification.6. . An assessment of impact on product quality affected due to this out of calibration. Any out of calibration situation at the time of receiving for calibration . The requirements of this clause. including the identification status for the master standard which is used for Calibration / Verification.7. Notification to the customer if any suspect material is shipped to customer. Each equipment shall have identification .

This defined Lab scope shall include the laboratory s capability to perform the required inspection .This Lab scope shall be included in organization's QMS documentation. b. It should have defined LAB Scope.3.7. Capability to perform these services correctly.technical requirements for adequacy of the lab procedures. d. If an organization having internal laboratory facility.The lab shall specify and implement as a minimum .6.1 Internal Lab requirements The requirements of this clause. then a. c.traceble to the relevant process standards ( such as ASTM . test or calibration services.EN etc ) . Competency of the lab personnel. Testing of the product.

2 External Lab requirements The requirements of this clause.e.6. then the organization shall procure the lab scope that includes the capability to perform the required inspection. NABL ) . The external lab shall be approved / acceptable to customer OR The external lab shall be accredited to ISO/IEC 17025 or national equivalent ( I. test or calibration.7. test or calibration from an external organization . If an organization getting services like inspection.3.

measurement .1 General The requirements of this clause. Analysis and Improvement. .8. analysis and improvement in order to determine a. The organization shall plan and implement processes for monitoring . Conformity to the QMS requirements. 8. c.0 Measurement . b. Conformity to the product requirements. to improve the effectiveness of Quality Management System requirements.

The organization shall use appropriate stastical tools to determine the effectiveness for monitoring .8.measurement .1 Use of Stastical tools. . The requirements of this clause. analysis and improvement.1.

The requirements of this clause. control. stability. over adjustment shall be understood and implement through the product realization.8. The stastical concepts like variation . .1. Knowledge about basic stastical concepts.2.

e) Lost Business analysis. The data used for determining the customer satisfaction shall be based on objective data. This Customer satisfaction will indicate how exactly the organization has understood and met the customer specific requirements. C) Competitor Analysis. d) Bench marking .2. 8. f) End user perception. . The methods used for determination of customer satisfaction shall be defined . Typically customer sattisfaction includes a) Customer data wrt to quality product delivered.1 Customer Satisfaction The requirements of this clause.8. b) Customer satisfaction surveys.2 Monitoring and measurement. The organizational monitor the customer satisfaction as one of the performance indicator for measuring the effectiveness of Quality Management System .

8.2.1.1 Customer Satisfaction -Supplemental

The requirements of this clause.

The data used for determining the customer satisfaction shall be based on objective data. The data used for calculating customer satisfaction shall be based on following factors , but not limited to those points only.

A) Delivery Rating B) Quality Rating C) Any premium freight include the customer line disruptions. D) Customer Notifications if any , from the supplied product.

8.2.2 Internal Audits
The requirements of this clause. Documented procedure shall be established for carrying out internal audits which should contain responsibilities and requirements for planning and conducting audits ,establishing records and reporting results. Internal Audits shall be conducted on planned intervals in order to determine effectiveness of a) Planned arrangements specified according to 7.1 b) requirements of this international standard. c) QMS requirements established by the organization. Internal Audits shall be planned , based on the importance of the area to be audited and corrective actions status from the previous internal Audits. Audit scope, criteria , frequency, and methods of audit shall be established. Auditors shall not audit their own area.

8.2.2 Internal Audits

continued

.

The requirements of this clause.

The management ( I,e Manager or HOD responsible for a process ) to be auditted. Necessary corrections / Corrective actions are taken without undue delay . Follow up activities shall be carryout in order to verify the effectiveness of the actions taken .

8.2. The organization shall audit its QMS to verify compliance to this Technical specification and any additional QMS requirements.1 QMS Audit The requirements of this clause. .2.

Training . Establish the list of qualified process Auditors based on their competence ( I. The requirements of this clause. . Prepare Unique process Audit checklist for each process. established controls yielding the required results ).8.2. Raise Process audit Non conformities in case of any mismatch .2 Manufacturing Process Audit. internal rejection status . Note : Planning of process audits shall be based on customer complaints trends .e. Prepare a plan to cover all manufacturing process .e Based on Education . List the various manufacturing processes carried out in the organization . status of O & T s achievement .2. Carryout the manufacturing process audit to know the effectiveness ( I. Initiate Corrections and corrective actions without any undue delay. skill & Experience).

Establish the list of qualified product Auditors based on their competence ( I.8. Establish the master list of active parts.3 Product Audit. Initiate Corrections and corrective actions without any undue delay. skill & Experience). Packaging and labelling Note 2 :Planning of product audits shall be based on customer complaints trends . Prepare a plan to cover all active parts in a defined time interval.e Based on Education . Establish Product Specific check list. Raise Product audit Non conformities in case of any mismatch . : Product Audit check list shall include product dimensions . The requirements of this clause. . internal rejection status . Carryout the product audit at appropriate stages of production and delivery to verify the conformity to the specified requirements.2. Training . Note 1.Functionality.2.

Preventive Maintenance activities ) . internal audits shall be planned as per annual plan and carried out in all three respective shifts. In process Quality assurance . internal rejection status .8.4 Internal Audit Plans .2. The internal Audit plan shall cover all processes and activities as defined in the QMS Manual. Planning of internal QMS audits shall be based on customer complaints trends . .2. For the processes which are carried out in shifts ( like Manufacturing. The requirements of this clause.

5 Internal Audit Qualification . . The requirements of this clause. Training .Training : The Personnel shall undergone a two days of IAT wrt this Technical Specification according to ISO 19011:2002 guidelines. Establish the competence of internal audits ( I.2. Note 2 Skill and Experience The personnel shall aware of customer specific requirements of their customers.e Based on Education .8. skill & Experience) to carry out internal audits as per the requirements of this Technical Specification ISO/TS 16949: 2009. Note 1 .2.

8.3 Monitoring and Measurement of process. . The requirements of this clause. These identified methods shall demonstrate ability of these processes to achieve the planned results. adequate corrections / Corrective actions shall be initiated.2. The organization shall identify suitable methods for monitoring and measuring the effectiveness or Efficiency of the QMS Processes. When planned results are not achieved.

measurement and testing . The requirements of this clause. for improving efficiency maintenance activities.67 or what ?) .3.2.e Cpk or Ppk index > 1. maintainability . ( I. These capability information shall be documented with specifications and shall be used for process improvements.1 Monitoring and Measurement of Manufacturing process. and availability . ( I. This capability information shall be used as additional process control at the time mass production stage. reliability . The organization shall carryout process studies on all new manufacturing processes to verify their capability.8. These capability studies shall have objectives for manufacturing process capability. The acceptance criteria for the capability index shall be established.e. for what purpose we are conducting these studies ).

a) measurement techniques b) Sampling plans c)acceptance criteria d) reaction plan when acceptance criteria are not met. Significant process events such as tool change . as documented in the control plan. The organization shall maintain the Cp / Cpk or Pp /Ppk studies for all special characteristics which are mentioned in customer approved PPAP documents .2. etc shall be captured / recorded for future references. .3. machine repair . The organization shall also ensure compliance to the following.1 Monitoring and Measurement of Manufacturing process. New operator.8. Continued . The organization shall ensure that controls established in control plan/PFD are 100% implemented or adhered. The requirements of this clause.

3.8.2. . Corrective action plan shall be initiated with clear defined responsibilities /time bound for ensuring the process is stastically stable.1 Monitoring and Measurement of Manufacturing process. introduction of new activity . If any process changes implemented ( Eg TIG welding instead of MIG welding . deletion of an activity. The requirements of this clause. This reaction plan shall include containment of the product or 100% inspection. the organization shall maintain the records of effective dates of implementation. The organization shall initiate reaction plan which is derived from Control for the characteristics which are not stastically capable or unstable. etc). Continued . This corrective action plan shall be reviewed with customer if required.

8. Evidence of conformity with the acceptance criteria shall be maintained.4 Monitoring and Measurement of Product The requirements of this clause. These records shall indicate the peroson(s) authorizing the release of product for delivery to the customer. by respective customer. . the release of the product shall be approved by a relevant authority. if required . In case of any such situations. The release of product and delivery of service to the customer shall not proceed until the planned arrangements have been satisfactorily completed. The organization shall monitor / measure the product characteristics to verify that product requirements have been met . This monitoring /Measurement shall be carried out at appropriate stages of the product realization process as mentioned in PFD / Control plan.2.

2.4.1 Layout inspection and Functional Testing The requirements of this clause. A layout inspection ( complete measurement of all product dimensions as shown in the design records) and Functional verification to applicable customer Engineering material and Performance standards shall be performed for each product as specified in the control plan. The records of layout inspection & functional testing shall be available for customer review.8. .

2. b. d. Qualify and evaluate the personnel who perform the appearance evaluations. c. DOI. the organization shall provide a. Appropriate resources . including lighting . maintenance and control of appearance masters and evaluation of equipment. .texture.4. grain. metallic brilliance. Gloss . The organisations which manufacture the parts . Masters for color. which are designated as Appearance items in the design records. for evaluation.8.2 Appearance items The requirements of this clause.

The organization shall establish a documented procedure for control of NC product . B. By taking action appropriate to the effects . A.8. This documented procedure shall include the controls established . By authorizing its use . The organization shall identify and control the product which does not meet the specified requirements to prevent any unintended use or delivery.By taking actions to preclude its original or intended use or application. . If required this authorization shall be taken from the customer. D. clearly defined responsibilities and authorities for the personnel who deal with NC products.3 Control of Non conforming Product. C. The non conforming products produced shall be dealt with following one or more ways. Potential effects if the NC product is already delivered to the customer or the product already in use. release or acceptance under concession by a relevant authority. By taking actions to eliminate the detected NC product. The requirements of this clause.

Records of the nature of NC s and any subsequent actions taken including concessions obtained . Continued The requirements of this clause continued When NC product is corrected . shall be maintained. it shall be subject to re-verification to redemonstrate conformity to the requirements.3 Control of Non conforming Product. .8.

1 Control of Non conforming Product.- The requirements of this clause product with unidentified or suspect status shall be treated as NC product.. .3.8.Supplemental Product.

3.8.2 Control of reworked Product. These Work Instructions shall contain re-inspection requirements. The requirements of this clause Work Instructions shall be established for carrying out Rework activity. . reThese work Instructions shall be accessible to and utilized by the personnel who does this rework acivity.

3. .8. if it is already shipped to customer. The requirements of this clause Customers shall be promptly informed about the details of NC product .3 Customer Information.

3. The organization shall approve any such requests from suppliers before submission to the customer.4 Customer Waiver. These Concession / Deviation permits shall include exact qty of authorization or Defined time frame( expiry date of authorization).if the products are not manufacturing as per earlier approvals.8. The material shipped with concession / deviation permits shall have a proper identification on each shipping container. . The above requirements also applicable to purchased material. The requirements of this clause The organization shall obtain concessions or deviation permits from the customer .

8.4 Analysis of Data
The requirements of this clause The organization shall determine ,collect and analyze appropriate data to a) demonstrate suitability and effectiveness of QMS b) evaluate the continual improvement in the effectiveness of QMS. This data shall generated as a means of monitoring and measurement of processes and product. This analyzed data shall provide information related to a) customer satisfaction b) Conformity to product requirements. c) Characteristics and trends of processes and products (shall include OI s for PA). d) Suppliers.

8.4.1 Analysis and use of Data

The requirements of this clause Trends related to quality and operational performance shall be compared with established objectives and targets. These comparison trends shall lead to actions to support a) development of priorities for prompt solutions to customer related problems. b) determination of key customer related trends and correlation for status review , decision making and long term planning. c) an information system for the timely reporting of product information arising from usage.

8.5.1 Continual Improvement

The requirements of this clause The organization shall continually improve the effectiveness of QMS through the use of a) Quality Policy b) Quality Objectives c) Analysis of data d) Corrective actions e) Preventive actions f) Internal Audits g) Management reviews.

8. .1.1 Continual Improvement of the organisation The requirements of this clause The organization shall define a process for Continual Improvement.5.

product characteristics are predictable and meet customer requirements. Imp Note : This continual improvement of manufacturing process shall be carried out once the process is stastically capable or stable.1.8.5.e. (I.2 Manufacturing process Improvement The requirements of this clause The manufacturing process improvement shall continually focus on a) Control and reduction of variation in product characteristics. . improvement in Cp/Cpk values for special characteristics) b) Control and reduction of variation in process characteristics.

b) the methods to determine the causes for non conformities.this NC do not recur again.2 Corrective Action The requirements of this clause The organization shall establish a documented process for initiating a corrective action. . c)evaluating the need for an action to ensure that . d) determining and implementing the actions . This documented procedure shall include a) mechanism for reviewing of non conformities including customer complaints.8. action taken to eliminate cause(s) of a detected non conformity to prevent its recurrence. e) records of actions taken f) reviewing the effectiveness of actions taken.e.5.( I.

If a customer prescribed format exists for problem solving .5.the organization shall use that same format. G 8D. ( e.g.8.1 Problem solving The requirements of this clause The organization shall establish a process for problem solving which leads to root cause identification and its elimination.2. CA format etc ) .

.2 Error Proofing The requirements of this clause The organization shall use error proofing methods in their CA process.2.5.8.

3 Corrective action Impact The requirements of this clause The organization shall horizontally deploy the corrective actions and controls implemented for similar process and products in order to eliminate the cause of detected NC .8. .2.5.

4 Rejected product test/analysis The requirements of this clause The organization shall analyze the parts which are rejected at customers site. .5. The organization shall carryout analysis and initiate CA to prevent recurrence. Aim towards cycle time reduction of rejected part analysis .2. Engineering facilities and dealerships. Records of these analysis shall be kept and made available upon request.8.

3 Preventive action The requirements of this clause The organization shall establish a documented process for initiating a Preventive action. .( I.5. c)evaluating the need for an action to ensure the NC occurrence d) determining and implementing the actions needed.e.8. action taken to eliminate cause(s) of a potential non conformity to prevent its occurrence. This documented procedure shall include a) the methods to determine the potential non conformities and their causes. e) records of actions taken f) reviewing the effectiveness of preventive actions taken.

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