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WHAT IS QUALITY? QUALITY IS CONFORMANCE WITH REQUIREMENTS

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Presentation on theme: "WHAT IS QUALITY? QUALITY IS CONFORMANCE WITH REQUIREMENTS"— Presentation transcript:

1 WHAT IS QUALITY? QUALITY IS CONFORMANCE WITH REQUIREMENTS
QUALITY IS FITNESS FOR PURPOSE/USE

2 TOTALITY OF CHARECTERISTICS OF AN ENTITY THAT BEAR ON ITS
DEFINITION OF QUALITY TOTALITY OF CHARECTERISTICS OF AN ENTITY THAT BEAR ON ITS ABILITY TO SATISFY STATED AND IMPLIED NEEDS

3 PRODUCT QUALITY CHARECTERISTICS
ACCESSIBITY FUNCTIONALITY SIZE AVAILABILITY INTERCHANGEABILITY SUSCEPTIBILITY APPEARANCE MAINTAINABILTY STORABILITY ADAPTABILITY ODOUR TASTE CLEANLINESS OPERABILITY TESTABILITY CONSUMPTION PORTABILITY TRACEABILITY DURABILITY PRODUCIBILITY TOXICITY DISPOSABILITY RELIABILITY TRANSPORTABILITY EMITTANCE REPAIRABILITY VULNAREBILITY FLAMMABILITY SAFETY WEIGHT FLEXIBILITY SECURITY SERVICE QUALITY CHARACTERISTICS ACCESSIBILITY CREDIBILITY HONESTY ACCURACY DEPENDABILITY PROMPTNESS COURTSEY EFFICIENCY RESPONSIVENESS COMFORT EFFECTIVENESS RELIABILITY COMPETENCE FLEXIBILITY SECURITY

4 ISO/TS QUALITY MANAGEMENT SYSTEM FOR AUTOMOTIVE PRODUCTION AND RELEVANT SERVICE PART ORGANIZATIONS

5 What is TS ? TS is an ISO Technical Specification Which aligns following existing automotive quality systems: American QS 9000 German VDA 6.1 French EAQF Italian AVSQ TS IS EXPECTED TO REPLACE ABOVE STANDARDS

6 Evolution of ISO/TS 16949 Standard
US MIL Standards US 1963 AQAP – 1, 4, 9 NATO 1969 DefStan-05/21, 05/24,05/29 UK 1973 UK BS Pt 1, Pt2, Pt3 1979 ISO ISO 9000 Standards – 1987 (1994; 2000) GM; Ford; Chrysler QS 9000 Standards 1994 IAOB; AIAG; VDA; ANFIA; CCFA; FIEV; SMMT ISO/TS/16949 Standards 1999

7 What is ISO/TS16949? ISO/TS/16949 has been issued for provisional application in the automotive sector. ISO/TS/16949 was prepared by the International Automotive Task Force (IATF) and representatives from ISO/TC 176, Quality management and quality assurance, and its sub committees. The first edition of ISO/TS in 1999 was based on 1994 edition ISO 9001 standard along with sector specific requirements and customer specific requirements. The standard is revised in line with SIO 9001:2000 and the second edition was published in 2002

8 Implementation requirements
QMS in line with ISO Advanced product quality planning. (APQP) Control Plan. (CP) Production part approval process. (PPAP) Statistical Process Control. (SPC) Measurement system analysis. (MSA) Failure Mode & Effects Analysis.(FMEA)

9 QMS in line with ISO 9001:2000 Standard
There are 5 operative clauses. Along with these the following additional five requirements of the auto sector have to be complied with: 1.Advanced product quality planning (APQP). A structured method of defining and establishing the steps necessary to develop new product and assure that the product satisfies the customer. Addresses the methodology for implementation of all elements of quality planning.

10 2.Measurement System Analysis(MSA)
To obtain information related to the amount and type of measurement error. 3.Failure Mode & Effective Analysis. (FMEA) A systematic approach to recognize and evaluate the potential failure of a product or process prior to its production. Identification of actions which could eliminate or reduce the chance of failure occurring. prevents failure before they occur.

11 5.Production part approval process.(PPAP)
4.Control Plan(CP) A written description of system to control product and processes. A living document. 5.Production part approval process.(PPAP) PPAP is a systematic approach for submission of a new or modified parts for approval to customer prior to full production.

12 ISO/TS 16949 - Genesis TS 16949 was authored by :-
a) IATF – International Automotive Task force b)ISO / TC 176 Quality Management &Quality Assurance.(committee)b C) Automobile manufacturers Association- d)Jama-Japan It is truly an internationally accepted specification

13 Process Approach TS Standard promotes process approach in Quality Management System. Process approach is defined as the application of a system of processes within the organization together with the identification and interactions of the processes and their management to achieve a common goal

14 Continual Improvement. Defect Prevention. Reduction of Variation.
Goal of TS Continual Improvement. Defect Prevention. Reduction of Variation. Reduction of waste in supply chain. Eliminating Multiple certification audits.

15 TS 16949 – 2002 CONTENTS Scope. 2. Normative reference.
3. Terms and definitions. 4. Quality Management System. 5. Management Responsibility. 6. Resource Management. 7. Product Realization. 8. Measurement Analysis and Improvement Appendix ‘A’ - Control Plan A1- Phases of Control Plan. A2- Elements of Control Plan.

16 1. Scope TS is applicable to organizations engaged in design, development, production, installation and service of Automotive related products. Design centers, corporate head quarters & distribution centers can not obtain stand-alone certification for TS16949 but can be part of a certified organization. TS is applicable through out the automotive supply

17 1.2 Application All TS requirements are generic and therefore applicable to all automotive related organizations regardless of type, size & product.

18 OPERATIVE CLAUSES 4. Quality Management Systems
Establish, Document, Implement and maintain a Quality Management System as per TS – 2002. b) Continually Improve its effectiveness. c) Identify the processes needed and determine the sequence and interactions between processes. d) Determine the criteria and methods to control effectiveness of the processes. e) Provide resources required. f) Monitor, Measure & Analyse processes& results. g) Maintain control on outsourced processes. Conformity of outsourced product is entirely organizations responsibility

19 Quality System Documentation
ISO/TS Defines International Requirements Customer Specific requirements “Approach & Responsibility” Defines Customer Requirements Auto sector Reference Manuals APQP FMEA MSA SPC -P-PAP 1 Level Quality Manual Level Quality Systems Procedures Level Work/Job Instructions Level Forms, Checklists Level 5 - Records 2 “Who, What When” 3 “How” 4 “Where it is written down” 5 “Keeping track”

20 SEVEN MANDATORY PROCEDURES
BESIDES APEX MANUAL ,TS16949 MANDATES SEVEN MANDATORY PROCEDURES NAMELY: CONTROL OF DOCUMENTS CONTROL OF RECORDS TRAINING INTERNAL AUDIT CONTROL OF NONCONFORMING PRODUCT CORRECTIVE ACTION PREVENTIVE ACTION

21 4.2.3 Control of Documents Establish a procedure to control documents & records. The procedure should include:- a)Approval of Document. b) Current revision status. c) Distribution to required points of use. d) Control of external Documents (Drawings, Specifications & Manuals). e) Prevention of use of obsolete documents.

22 4.2.3.1 Engineering Specifications
Changes in customer Standards/ Specifications/ and drawings should be implemented at the earliest and shall not exceed two working weeks after communication from customer. Records of date of implementation of changes shall be maintained. Related process review documents & P- PAPs should be updated accordingly

23 A procedure is required for : -
Control of Records. A procedure is required for : - Identification, Storage, Retrieval, Retention, Disposal, of Records Regulatory and customer requirements should be met.

24 5. Management Responsibility
Commitment to continually improve its effectiveness Establishing & ensuring implementation of Quality policy & Objectives. Periodical Management Review.Provision of resources d) Review of effectiveness of product realization processes.

25 5.2 Customer Focus 5.3 Quality Policy
Identify Customer requirements and continually enhance customer satisfaction. 5.3 Quality Policy Establish an appropriate Quality policy. Communicate the same throughout the organization. Review Quality Policy for Continuing Suitability.

26 5.4 Planning 5.4.1 Quality Objectives Establish:-
Measurable Quality Objectives at Various functions of the organization. The objectives should be consistent with the Quality policy. Quality objectives and measurement of performances shall be included in the business plan. Quality objectives should adress customer expectations and be achievable with in a defined time period.

27 5.5 Responsibility, Authority & Communication
Responsibility and Authority of key personnel should be defined & Communicated. When process/product nonconformities occur prompt information to managers should be ensured in the system Personnel responsible for Quality should be authorized to stop production to correct quality problem. Each shift should have a person in-charge of product Quality.

28 5.5.2 Management Representative
A member of the management staff should be appointed as MR with responsibility and Authority to: – Implement Quality Management System Report Management on the status of Quality System. Ensure awareness of customers requirements through out the organization.

29 5.5.2.1 Customer Representative
Designate a responsible person with authority to ensure:- Customer requirements are met. Selection of special characteristics. Corrective & preventive action. Product design & development as per customer requirement.

30 5.5.3 Internal Communication
Ensure constant communication with employees on the status & effectiveness of quality management system

31 5.6. Management Review Review Management System at Planned intervals.
Asses need for changes in QMS, including Quality Policy & Quality Objectives. Maintain Records of MRM. Review measures of performance and the process of continual improvement. Review reports of product nonconformity and cost of poor quality. Review achievement of objectives specified in the business plan Review achievement of customer satisfaction

32 5.6.2 MRM Inputs Results of Internal Audits. Customer feed back.
Product non-conformity reports. Status of corrective and preventive action. Follow up action of previous MRM. Changes & Improvements required in QMS. Actual & potential field failures & their impact on safety quality and environement.

33 5.6.3 MRM Output Improvement to Quality Management System & Processes.
Improvement of product to meet customer requirement. Resource needs.

34 6. Resource Management Identify and provide resources:-
To Implement Quality Management System effectively. To enhance customers satisfaction. Of competent personnel at various functions & levels. Personnel in design should process specific skills. To impart necessary training to improve competence level at all level of employees.

35 6.2.2 Competence Awareness and Training
Provide competent personnel at various levels Provide training to meet short-comings. Evaluate Training effectiveness. Determine necessary competence of persons at various levels & functions Maintain records of education ,Training, Skills & Experience. Applicable design tools & techniques should be identified and design personnel should be skilled in those techniques

36 Training Establish and document a procedure to:-
Identify training needs. Train personnel in special skills needed by customer. Impart on-the- job training to permanent and contract personnel In new and modified jobs MOTIVATION Establish a process of motivation of personnel to achieve quality,continual improvement and innovation Measure quality awareness of personnel

37 6.3 Infrastructure 6.3.1. Plant Facility & Equipment Provide :-
Building , work space & utilities. Process equipment (Hardware & Software). Transport and communication. Plant Facility & Equipment a)Plant layout should ahieve minimum material travel,material handling and floor space ocupation Planning of infrastruture should focus on lean manufaturing Principles v

38 Prepare contingency plan to over come production stoppage due to:-
Contingency Plans Prepare contingency plan to over come production stoppage due to:- Utility Interruptions. Labour Shortages. Key equipment failure. Field returns.

39 6.4 Work Environment Ensure:-
Required work environment to meet product Quality. Safety of personnel. State of order, cleanliness consistent with needs of the process.(5S)

40 7. Product Realisation Plan & develop process to meet specified requirements. Develop process as per APQP Manual which Includes: Process flow chart. FMEA Control Plan. P-PAP MSA Control plans should include customers specification & requirements Control plans should specify ‘0’ as AQL where ever sampling inspection is employed Confidentiality of customer product and developments should be ensured

41 7.1.4 Change Control Changes to product and manufacturing processes should be validated before implementation. For proprietary designs impact of changes on form, fit & function should be reviewed and approved by customer. Additional verification/ Identification requirements of customers should be met. Any changes which affect customer requirements should be notified to customer and approval should be obtained

42 7.2.1 Define Product Requirements
Obtain & define product related requirements. Define packaging & delivery specifications. Determine and ensure all regulatory requirements. Define after sales servicing if agreed in contract Identify special characteristics as per customer requirements.

43 7.2.2 Review of product requirements
Review product specifications. Review contract/order requirements. Subject all contract & product requirements to a review by a cross functional team. Record all unwritten requirements and obtain confirmation from customer. Where product requirements are changed, amend related documents and communicate the same to all concerned. Maintain records of Feasibility review. Feasibility review may be waived by customer Feasibility review including risk analysis should be carried out during contract review.

44 7.2.3 Customer Communication
Establish a communication system with customer The communication system should accommodate: Product Information. Contract details. Customers feed back & complaints. Establish customer specified mode of communication like CAD,electronic data exchange

45 Establish and Maintain:
7.3 Design & Development Establish and Maintain: A standard design & development process. Design review & Verification. Design Validation. Organization should use multidiscipline approach to prepare Process Flow, FMEA and Control Plans.

46 7.3.2 Design & Development Inputs
The Design should meet and /or consist of:- Functional & performance requirements. Statutory requirements. Inputs from similar proven designs. Special characteristics. The designs should be reviewed to make it complete, unambiguous and achievable

47 7.3.2.1 Product Design Inputs Products design should meet:-
Customers requirements on special characteristics. Identification, traceability and packaging. Targets for product quality, life, reliability, durability, maintainability. d)Cost and delivery requirement.

48 7.3.2.2 Manufacturing process design input
The manufacturing process should meet:- Design specification. Productivity, Process capability & Cost targets. Additional customer Requirement. Requirements derived from development of similar previous processes

49 7.3.2.3 Special Characteristics
Process Flow, FMEA, Control Plan and other process related documents should identify special characteristics. Special characteristics should be identified by symbols specified by customers. Special characteristics can include process parameters also.

50 7.3.3. Design & Development Output
Product Designs/ Drags should be reviewed to verify their ability to fully meet requirement criteria. Designs/Drags should be approved by authorized persons. They should contain all relevant information required for purchasing, production, servicing & inspection.

51 7.3.3.1. Product Design Outputs
Design process should include:- Design FMEA & Reliability tests. Special characteristics. Error proofing against failures. Drgs. & Mathematical calculations. Design review records. Inspection & Test guidelines.

52 7.3.3.2. Manufacturing Process Design Output
Manufacturing Process documentation should include:- Specifications & Drgs. Process Flow Charts. Process FMEA. Control Plans. Work Instructions. Process approval, acceptance criteria & data on quality. Error proofing as appropriate . Feed back method on product & process non conformities

53 7.3.4./7.3.5 Design & Development Review
Design review summaries should be reviewed in management review meetings. Design Should be reviewed by a cross functional team. Designs should be verified to confirm their ability to meet requirements. Records of verification should be maintained

54 7.3.6 Design & Development validation
Designs should be validated by appropriate tests. Records of validation should be maintained Verification and validation process applies for both product & process designs. Prototypes if specified by ustomer should be produced wth the the same suppliers,tooling and manufacturing processes as in reguler production Product approval should be as per P-PAP P-PAP is appliable to suuppliers also

55 7.3.7. Control of Design & Development Changes.
Changes should be identified and records maintained. Changes should be reviewed and approved by competent authority. Effect of changes on other parts and product already delivered should be reviewed.

56 7.4. Purchasing Suppliers should be evaluated before being approved.
Evaluation criteria should be established. Records of evaluation should be available. Verify purchased product to confirm with purchase requirements Suppliers who provide services like inspection, assembly, network and calibration should also be evaluated before approval When management changes take place with supplier verify continuity of the management system

57 7.4.1.2 Supplier Quality Management System
Supplier QMS Should conform to ISO 9001 – 2000 & Preferably be certified by III party. Supplier quality development process should be carried out with the aim of conforming it to TS CUSTOMER APPROVED SOURCES Where specified,puchases should be made from customer approved sources

58 7.4.2 Purchasing Information
Purchase Terms should include requirements of:- Products, procedures, Process & equipment. Qualification of personnel. Quality Management System. The above requirements should be ensured before placing purchase orders.

59 7.4.3 Verifications of Purchased Product
Necessary inspection and verification activities should be established and completed before acceptance of purchased product. When required, verification of product at supplier premises shall be carried out.

60 7.4.3.1 INCOMING PRODUCT QUALITY
Assure quality of purchased product by one or more of following methods: Evaluation of reports and data received from supplier Receiving inspection and testing Second and third party audit & inspection report Laboratory test reports Any other method agreed with the customer

61 SUPPLIER MONITORING Include following indicators in Supplier rating : Product quality Delivery schedule performance Previous performance lapses & field returns

62 7.5 Production & Service Provision
Ensure control of production by establishing &providing:- Drgs & specifications. Work Instructions Suitable equipment for production and measurement. Quality assurance prior to release for delivery.

63 Control Plans Prepare and establish process review documents on standard formats. Process Flow Chart. Design FMEA. Process FMEA. Control Plan. Work Instructions Process review documents should be updated when changes are made

64 7.5.1.3 Verification of Job Setups
Work Instruction should be available for Job set ups. All Job set ups should be verified and approved. Last off inspection and statistical method should be applied wherever appropriate

65 7.5.1.4 Preventive and Predictive Maintenance
Key production & utility equipment should be provided with:- Planned preventive Maintenance. Preservation of equipment, Tools & gauges. Replacement spares. Improvement Maintenance. Predictive Maintenance.

66 7.5.1.5 Management of Production Tooling
Tooling Management System Should include:- Maintenance & Repair facilities. Storage & Issue. Tool Change Programme for Perishable Tools. Tool design & Engineering .

67 7.5.1.6 Production Scheduling
Production scheduling should meet customer requirements (e.g. just in time.) A communication system should be established to provide process & schedule related information to concerned personnel. Feed back on field performance/failures should be communicated to all concerned.

68 Servicing When service is a part of contract the organization shall maintain:- Effectiveness of Service centers. Special purpose Toolings. Training for service personnel.

69 7.5.2 Validation of Processes
All Production processes should be validated to ensure: Defined criteria for approval of processes. Approval of equipment & personnel. Specific methods & procedures. Records are required.

70 7.5.3 Identification & Traceability
Product should carry Identification at all stages of process. Where Traceability is specified,special recorded identifications should be employed. Identification should include Inspection and Test status

71 7.5.4 Customer Property Customers Property Should be identified, verified and preserved. Any loss damage, or unsuitability should be reported to customer. Records of current status should be maintained and updated regularly. Customer property includes intellectual property( drgs, software,etc.) and returnable packaging. Markings on customer owned production equipment, Tools, Inspection devices should be permanent and visible

72 7.5.5 Preservation of Product
Preserve conformity of product till it reaches intended destination Preservation includes identification, handling packaging, Storage & protection. Condition of stock should be assessed at planned intervals. Stock rotation should be ensured through FIFO. Obsolete product should be treated as non-conforming product.

73 7.6 Control of Monitoring & Measuring Devices
Measuring devices should be calibrated at planned intervals.vice. Calibration records should be available. Calibration should be safeguarded to prevent changes & adjustments which invalidate results. When a measuring device is found defective, all product affected should be verified for conformity. Customer should be informed If such product is already shipped . Software used for measurement should be verified for conformity

74 7.6.1 Measurement System Analysis
All Types of Measuring devices mentioned in control plan should be statistically anlysed for variations. Methods described in MSA manual or any other customer approved method can be used

75 7.6.3 Laboratory requirements (Both internal & external)
The organization should document a Laboratory scope which contains: Laboratory Procedures. Competency of Laboratory Personnel. Accuracy and Traceability of results. Recording System. The above requirements apply to external laboratory also. External laboratory used should be acceptable to customer. External laboratory should be accredited to NABL. When Qualified Laboratory is not available, equipment manufacturers calibration is acceptable

76 8. Measurement Analysis and Improvement
The organization should analyse & monitor:- Product Quality. Quality Management System. Continual Improvements. Statistical Techniques should be used for above

77 8.1.1 Statistical Tools Statistical Tools Should be identified during APQP stage. Personnel should be trained on basic statistical concepts of variation, process capability etc.

78 8.2.1 Customer Satisfaction
Constantly monitor customer concerns on product / service quality. Obtain & compile following information :- Quality of Delivered parts. Field returns & assembly distruptions. Delivery schedule adherence. Customer feed back & complaints.

79 8.2.2 Internal Audit Carry out internal audits as per a documented procedure which should cover:- Audit criteria, scope, frequency and methods. Selection of Auditor. Reporting methods & records. Prompt corrective Action. Quality Management System Audit. Manufacturing Process Audit. Product Quality Audit.

80 Internal Audit Plans Annual Internal Audit Schedules should be prepared. Internal Audits should cover all activities, processes and shifts of work. Frequency of Audits should increased when non-conformities increase. Specific checklists should be used . Personnel Trained to Audit requirements of TS should carry out Internal Audits

81 8.2.3 Monitoring and Measurement of Process
Quality Management System Processes should be monitored to achieve planned results. Process capability of Manufacturing process should be monitored. Process flow and process specifications, documented in control plan should be adhered to. Corrective action plans should be initiated for processes which are either not statistically capable or unstable . Reaction Plan for deficient processes should include 100% Inspection. Records of effective dates of process changes should be maintained.

82 8.2.4 Monitoring and Measurement of product
Product characteristics should be monitored and measured at critical stages of production. Records of inspection/ tests should be maintained Productions should be released for delivery by authorized persons after verifying satisfactory completion of all planned processes. Determine suitable measuring devices,methods & skills after assessing the product requirements

83 8.2.4.1 Layout Inspection & Functional Testing
Complete measurement of all product dimensions shown in the drawing should be carried as per a quality plan at specified intervals for each product. Functional Test to applicable performance parameters should be carried out as per a plan.

84 Appearance Items Parts designated as appearance items by customers should be provided with:- Suitable environment for Inspection. Reference master for comparison. Competent & qualified Inspection personnel. Preservation of reference masters & evaluation equipment.

85 8.3. Control of Non Conforming Product
Document a procedure to control nonconforming product. Identify nonconforming product & establish control to prevent their use or delivery. Non conforming product may be:- 1) Rejected. 2) Accepted on concession by Authorized persons. 3) Used or Converted for alternative application. d)Records of rejections & rework should be maintained e)Unidentified & Suspect parts shall be treated as non-conforming parts.

86 8.3.2/8.3.3 Control of Reworked Products
Rework Instructions should be available to personnel performing rework. Reworked product should be reinspected. Customer should be informed if non-Conforming product is shipped to them .

87 8.3.4 Customer Waiver Customer Concessions or deviation permits should be obtained for products deviating from requirements. Deviating products should be identified on packaging with expiration date & permitted Quantity ‘acceptable on concession’.

88 Collect and analyses data on:-
8.4 Analysis of Data Collect and analyses data on:- Customer satisfaction. Product acceptance, rejection & rework analysis. Process capability of key equipment. Supplier rating. Priorities for corrective actions. Trends & comparisons of performance data. Data should be compared with competitors or bench marks

89 8.5 Improvement 8.5.1 Continual Improvement
Trends of Performance data should be used & Continual improvement plans should be in place. Manufacturing Process Improvement. Manufacturing Processes should continually focus upon reduction of variation. Continual Improvement are implemented on stable and capable processes.

90 Establish a Documented procedure for:-
8.5.2 Corrective Action Establish a Documented procedure for:- Reviewing non-conformities & Customer Complaints. Determine Causes & Corrective Actions. Implement Corrective actions. Record & review corrective actions.

91 8.5.2.1 Problem Solving 8.5.2.2 Error Proofing.
Follow a disciplined problem solving process which will lead to root cause elimination. Use customer prescribed formats if any. Error Proofing. Implement error-proofing wherever possible

92 8.5.2.3 Corrective Action Impact.
Corrective actions found for one problem should be explored and applied all to other similar processes and products.

93 8.5.2.4 Rejected Product -Test/Analysis
Customer returned rejected parts should be analysed as per problem solving procedure. The cycle time for determing root cause, corrective action- implementation and monitoring should be consistent with customer expectations.

94 8.5.3 Preventive action Document a procedure to eliminate the causes of potential nonconformities The procedure should cover:- a)Identification of potential non-conformities b)Determining root causes c)Fixing priorities d)Determining and implementing preventing actions e)Reviewing actions and maintaining records


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