Guideline – Quality Supply Chain Management.
Transcription
Guideline – Quality Supply Chain Management.
CLAAS KGaA mbH Postfach 1163 33426 Harsewinkel Tel.+49 (0)5247 12-0 www.claas.com Guideline – Quality Supply Chain Management. CLAAS Fertigungstechnik GmbH, Beelen BRÖTJE Automation GmbH, Wiefelstede The CLAAS Group – Locations worldwide. AGROCOM GmbH & Co. Agrarsystem KG, Bielefeld CLAAS U.K. Ltd., Saxham/Great Britain CLAAS Selbstfahrende Erntemaschinen GmbH, Harsewinkel CLAAS Service and Parts GmbH, Hamm CLAAS Vertriebsgesellschaft mbH, Harsewinkel CLAAS Global Sales GmbH, Harsewinkel Usines CLAAS France S.A.S., Metz-Woippy/France CLAAS Industrietechnik GmbH, Paderborn CLAAS Automation GmbH, Nördlingen CLAAS Tractor SAS, Vélizy/France CLAAS Hungaria Kft., Törökszentmiklós/Hungary CLAAS Saulgau GmbH, Bad Saulgau CLAAS Réseau Agricole S.A.S., Vélizy/France CLAAS Tractor SAS, Le Mans/France CLAAS Omaha Inc., Omaha/Nebraska/USA CLAAS France S.A.S., Paris/France 000 CLAAS, Vostok, Moscou/Russia 000 CLAAS, CLAAS of America Inc., Omaha/Nebraska/USA CLAAS Ibérica S.A., Madrid/Spain CLAAS Italia S.p.A., Vercelli/Italiy CLAAS India Ltd., Chandigarh/India CLAAS India Ltd., Faridabad/India BRÖTJE Automation USA Inc., Omaha/Nebraska/USA CLAAS of America LLC., Columbus/Indiana/USA CLAAS Argentinia S.A., Sunchales/Argentinia Agr i cul t ur al equi pment Stand 28.08.2008 Agr i cul t ur al equi pment Product companies Product companies Sales companies Sales companies Pr oduct i on t echnol ogy Pr oduct i on t echnol ogy I ndust r i al I ndust r i al engi nee- Stand 28.08.2008 engi neer i ng CLAAS Group 2 3 The system solutions, products and services of the CLAAS group represent technical innovation, highest quality and absolute reliability. Quality as a Principle. Worldwide. CLAAS. The image of the CLAAS products and the loyalty of our customers provide evidence for extraordinary performances of CLAAS products and are also spur to continue our effort for quality and our pursuit of progressive system solutions. In particular the high customer satisfaction contributed to the continuous growth of the CLAAS group worldwide. Continuous improvement of our quality standards over the entire supply chain process is our declared objective. The competence and motivation of our suppliers influences significantly the reliability and quality of our products and services. Hence fundamental elements of our quality understanding (philosophy) regarding our suppliers are - robust processes and their permanent enhancement - proactive, open and fast communication - professional project management and - the willingness for assumption of responsibility Dr. Theo Freye Speaker of the Executive Board The following quality guideline for the entire CLAAS group explicitly documents the valid QM elements for the buying process to be applied. Effective adherence to the described procedures for identifying concerns early will make error elimination possible. Collaboratively we will agree to the relevant elements for the respective business with you and use this as the base for our common supply relationship. The rigid application of this agreement leads to a continuous improvement of the quality of our products and services. The achieved customer satisfaction is a guarantee for both parties for a long-term and positive business development. Quality policy We are determined to exceed the expectations of our customers. We are committed to maintain peak customer satisfaction with faultless products and services. Quality is the guiding principle in the way we do business. Dr. Cornelius Weiß Head of Corporate Quality Management Rüdiger Mohr Head of Corporate Purchasing Editorial 4 5 No Compromises. Worldwide. Content I. General description .............................................................. 8 II. General criteria .................................................................... 9 Overview QM elements in the procurement process.......10 III. Selection and Qualification Process ...................................12 1. Self assessment/References .....................................12 2. Audit ........................................................................ 12 3. FMEA ....................................................................... 13 4. Process Control Plan ................................................14 5. First Samples ............................................................14 6. Process Capability ....................................................16 7. Product audit ............................................................17 8. Reliability Testing ...................................................... 18 Supplier qualification process Flow Chart ......................20 • Flow chart Component supplier...................................20 • Flow chart System Supplier.........................................22 IV. Series Monitoring ............................................................. 24 1. Continuous Evaluation ..............................................24 2. Processing of complaints ......................................... 24 V. Further Agreements ...........................................................26 1. Special Release ........................................................26 2. Logistic Agreement .................................................. 26 3. Emergency Plan ....................................................... 27 4. Quality Assurance Agreement (QAA) ........................ 27 5. Agreement of confidentiality ..................................... 27 VI. Appendix ......................................................................... 28 1. Definitions ................................................................ 28 2. Abbreviations............................................................ 29 3. Sources ................................................................... 29 Content 6 7 I. General description. II. General criteria. Purpose Responsibility Supplier CLAAS This guideline explains the CLAAS quality standards to suppliers. The individual elements between the contractual partners will be fixed individually in our negotiation process. The supplier is required to adhere to the demands as laid out in the agreement and described in this guideline. Documented and certified QM system conforming to: • Clear and complete information to the supplier • Clear communication channels and responsibilities • Specific, clear and generally comprehensible documentation according to product-specific requirements • Precise definition of volumes and delivery schedules including the expected deviations • Support and advice The quality management standards, which are documented here, are designed to ensure that: - The produced components meet the CLAAS specifications in every aspect - The process capability and control of the supplier are such that the specifications are adhered to consistently. Area of Application These requirements enter into effect with the agreement of the establishment of a business between CLAAS and the supplier. The purchasing organisations of the individual locations ensure that the agreed standards are implemented and adhered to. Support documentation The processes and techniques referred to in the guideline use defined standards as reference (VDA, QS 9000 regulations). • ISO / TS 16949, DIN EN ISO 9001, VDA 6.1 or upon approval by CLAAS Audit System • Development of a “Zero-Defect-Strategy” within the quality planning. Elaboration of measures to achieve the quality objective “Zero-Defect” • Understanding and acceptance of CLAAS requirements • Qualified QM personnel • Carrying out of required planning and test procedures, analyses, first samples, process control plan, process capability, etc. • Open communication and information in regard to - Problems that arise - Demands that cannot be met - Capacity bottlenecks • Qualification of sub-suppliers If a quality assurance agreement (QAA) is concluded between CLAAS and the supplier, the supplier commits himself to provide a similar QAA with other CLAAS companies. Premises 8 9 Overview QM elements in the procurement process II. Series monitoring I. Selection and qualification process QM elements in the procurement process 1. Sel f assessment / r ef er ences 2. Audi t s - Syst em - Pr ocess 3. FMEA 4. Pr ocess cont r ol pl an Information for the supplier Documents Questionnaire Information provided by supplier Filled out by supplier CLAAS audit catalogue Basis VDA 6 Carried out by CLAAS auditor at supplier FMEA Analyses VDA 4.1 / 4.2 or QS 9000 FMEA Risk analyses carried out by supplier Process control plan (QM-Plan / Control plan) To be produced by the supplier to ensure process reliability 5. Sampl es VDA Volume 2 QS 9000 PPAP To be produced by supplier prior series production launch 6. Pr ocess capabi l i t y VDA Volume 4 QS 9000 SPC To be carried out by supplier for all marked * or seperate aligned characteristics VDA Volume 6 (Part 5) / audit system of the supplier Certificate of effectiveness of the QM system 7. Pr oduct audi t 8. Rel i abi l i t y *Symbol 1: Safety Critical Characteristic VDA Volume 3 To be carried out by supplier if requested by CLAAS QM elements in the procurement process 1. Cont i nous eval uat i on 2. Pr ocessi ng of compl ai nt s Documents CLAAS Supplier Assessment 8D-Report / CLAAS Form "Problem analysis" Information for the supplier Supplier performance is constantly monitored by CLAAS To be done by supplier with every complaint III. Additional agreements 1. Except i onal Appr oval 2. Logi st i c Agr eement 3. Emer gency pl an 4. QAA 5. Agr eement of conf i dent i al i t y Exceptional Approval CLAAS Logistic Agreement VDA 6.1 VDA 6.4 Request for approval at CLAAS before delivery Agreement between CLAAS and supplier Supplier responsibility CLAAS QAA Agreement between CLAAS and supplier Agreement of confidentiality Agreement between CLAAS and supplier *Symbol 2: Key Characteristic / Functional Size Premises 10 11 III. Selection and Qualification Process. 1. Self assessment/References 2. Audit Self assessment System audit Process audit Objective Information about the supplier to complete the company profile on following points. - General company data - Technical information - QM-System Objective Evaluation of the QM system of the supplier in respect of - Completeness - Implementation Objective Assessment of process quality capability. Support of the continuous improvement process. References Objective • General information about the customer base of a potential supplier • Additional input based on information gleaned from existing customers. Note: only when both parties agree. Implementation Auditing of the QM system by CLAAS auditors Basis: - VDA Volume 6.1, Material Products - VDA Volume 6.2, Service Timing and scope of the audit will be mutually agreed between CLAAS and the supplier. 3. FMEA Implementation Process audits can be carried out in agreement between the supplier and CLAAS. Basis: - VDA Volume 6, Part 3 - CLAAS process audit questionary Objective Early recognition of potential for error in design and/or production. Implementation The supplier is requested to carry out a systematic analysis of potential errors within design and/or production planning. (Basis VDA 4.1 / 4.2, QS 9000 FMEA) After completion of the engineering- / process- and / or system-FMEA the documented risk priority numbers (RPN) may not be higher than 125. A process audit is carried out either on individual components or on component families, if they are manufactured using the same process. Implementation The questionnaire about supplier self-assessment is to be filled out by the supplier and to be returned to the purchasing department. Selection and Qualification Process 12 13 4. Process Control Plan 5. First Samples Objective Assurance that CLAAS quality standards are complied with by describing the planned processes, methods and checking procedures. Objective The supplier provides proof that the products have been produced under series conditions and that they comply with the CLAAS specification. Components for series production require a written approval for first samples. Implementation The supplier plans and documents the procedures for parts and component groups (QM-plan / Control plan). CLAAS supports the supplier with the review of CLAAS documents (e.g. drawings, instructions, standards). Preventive action Manufacturing procedures must be checked beforehand for possible errors (e.g. by use of FMEA or similar weakness analysis). Implementation The supplier provides the samples and documents to CLAAS quality organisation. (Based on VDA Volume 2) Sample selection Samples must be produced and tested under serial conditions (machinery, equipment, machining conditions) Testing of production samples (Dimensions, Material testing). The supplier is responsible for checking all the parameters on five parts. The supplier is responsible for compliance to the material specifications of the product (including labelling, physical characteristics etc.) All test results have to be recorded in the sample report. The supplier has to assure for himself that all characteristics comply with CLAAS specifications. Complete filled and signed sample report and, if requested by CLAAS, inclusive process control plan. The test samples are to be tagged clearly so that they can be easily matched to the test results. Even in cases where the supplier is not able to carry out dimensional or material checks, the responsibility stays with the supplier. Then the checks have to be carried out by a suitably qualified, reputable organisation. Clear matching of drawing parameters to test results by markings in the drawings as well as clear matching of test results to the proband. When components have been pre-assembled the highest level of completion has to be sent to CLAAS. If requested the documentation for the single components has to be marked accordingly and attached. Any deviation from these specifications requires an approval by CLAAS. *Symbol 1: Safety Critical Characteristic *Symbol 2: Key Characteristic / Functional Size Supporting documentation for process capability for all marked * characteristics and reliability data, if specified in the drawings. 14 Selection and Qualification Process 15 6. Process Capability Objective Proof of process capability by use of statistical methods for the critical characteristics as defined * in the drawings or separately aligned characteristics. • Reduction of checking effort for customers and suppliers • Early recognition of process changes (Trends) Implementation At marked * or separately aligned parts, which have a major impact on function, safety, assembly and reliability of the product. Proof The supplier at least has to prove that all marked parts have been produced under controlled process conditions (controlled and stable). *Symbol 1: Safety Critical Characteristic 16 7. Product audit Minimum requirement Machine Capability / Short term Capability – Cmk ≥1,67 Process Capability / Long term Capability – Cpk ≥ 1,33 The shape of distribution has to be checked, e.g. Gaussian Distribution. Process capability analyses The supplier checks the capability on at least 125 production parts produced in sequence. Preferably the sample batch should be produced in 25 lots of five units each. The process capability calculation takes place with familiar statistical methods (VDA Volume 4, QS 9000 SPC). Documentation During production, the documentation is provided by the methods of statistical process control (SPC). Attributive critical characteristics In cases of attributive characteristics, which are marked characteristics * in the drawings (“safety critical” or as “important”), all of the samples selected for the capability tests have to meet the specifications. Objective Inspection of the level of effectiveness of the QM activities installed by the supplier in respect on components or families involved. Implementation • The supplier is requested to plan and carry out product audits. Basis: VDA Volume 6.5 • The results are to be analysed and documented in a comprehensible manner, which includes target definition • Deviations have to be eliminated by fault analysis and corrective actions Variances If the characteristic does not comply with the given criteria, a selection test has to be carried out until 100% compliance is reached. The planned and implemented corrective actions are to be documented in action plans with schedules and responsibilities and made available to CLAAS if requested. *Symbol 2: Key Characteristic / Functional Size Selection and Qualification Process 17 8. Reliability Testing Implementation Reliability test procedures The supplier refers to the specifications and drawings from the CLAAS R&D function for the test procedure. In the case that CLAAS R&D gives no clear specifications the missing information has to be requested by the supplier. Reliability tests The supplier carries out reliability tests on the products that have been attributed a specific lifetime in the CLAAS drawings and documentation. Reliability analysis methods The analysis and interpretation of the results are analysed using the Weibull method. Basis: VDA Volume 3, reliability testing Calibration of the reliability test equipment The test rigs must be calibrated in accordance with the manufacturer’s instructions with reference to the relevant national norms. Documentation Test conditions and test results have to be recorded and when required to be presented by CLAAS. Objective Confirmation that the product involved meets the lifetime specified by CLAAS. Minimum standards A minimum product conformance level of 0.95 (95%) has to be attained in order to carry out the reliability data analysis. Products, which fail to meet the minimum specified lifetime would not be accepted under any circumstances. Selection and Qualification Process 18 19 Supplier qualification process Flow chart component supplier 1 Self assessment by supplier Supplier information, no further action Not O.K. Checking of correction and documentation Not O.K. Supplier self assesment is checked 2 3 Drawings are prepared for quotation purposes Negotiation with supplier Not O.K. 5 11 Finalisation of quotation and time schedule 13 Checking of quotation and time schedule 14 Order of first samples 16 Samples are shipped 17 Not O.K. 15 C* Checking of process control plan and drawings O.K. O.K. 4 10 1 12 3 Checking of drawings and preparation of a process control plan Revision of the quotation Quotation is checked Not O.K. O.K. 6 O.K. 7 Responsible 1) Supplier 2) Supplier qualification team 3) Purchasing 4) Purchasing 5) Purchasing 6) Supplier 7) Supplier qualification team 8) Supplier qualification team 9) Supplier 10) Supplier 11) Supplier qualification team 12) Supplier 13) Supplier 14) Purchasing 15) Purchasing 16) Purchasing 17) Supplier 18) Supplier qualification team 19) Supplier 20) Supplier qualification team QM system and / or product audit O.K. 8 Audit results checked A* * A, B, C – Supplier classification 1 B* Corrective action defined and carried out 9 19 Release for series production Checking of first samples 18 Not O.K. O.K. Release for series production 20 Selection and Qualification Process 20 21 Supplier qualification process 1 Flow chart system supplier 1 Supplier self assessment 17 Supplier information, no further action 3 Not O.K. Supplier self assessment is checked Corrective action Not O.K. 2 Checking of documents and drawings 16 O.K. O.K. 4 QM System and / or product audit 17 Checking of calculation Corrective action Not O.K. 5 Review of audit results C* B* O.K. Definition and implementation of corrective actions. 6 A* 17 Agreement of confidentiality concluded 18 Corrective action Not O.K. 7 Checking the test results of the prototypes 19 O.K. Handing over of required specifications to supplier 8 17 Specifications are checked with the supplier in order to clarify open points and make quotation Supplier information, no further action 11 Not O.K. Feasibility evaluation and costs Responsible 1) Supplier 2) Supplier qualifiation team 3) Purchasing 4) Supplier qualifiation team 5) Supplier qualifiation team 6) Supplier 7) Purchasing 8) Purchasing 9) R&D / Purchasing 10) R&D / Purchasing 11) Purchasing 12) Supplier 13) R&D / Project Management 14) Supplier 15) R&D / Project Management 16) R&D / Purchasing 17) Supplier 18) R&D / Purchasing / Management 19) R&D 20) Supplier qualifiation team 21) R&D 22) Supplier qualifiation team Corrective action Not O.K. 9 10 O.K. 17 Corrective action Not O.K. First sample process (see flow chart component supplier) 20 O.K. Evaluation of the results of the field tests / pre-series 21 O.K. Handing over of specification book including detailed project plan is given to CLAAS 12 Reworking of specifications and / or the project plan 14 Not O.K. Release for series production Checking of specifications of the project plan 22 13 O.K. Follow up of project plan including defined development steps 15 * A, B, C – Supplier classification 1 Selection and Qualification Process 22 23 IV. Series Monitoring. 1. Continuous Evaluation 2. Processing of complaints Objective Basis for intensive and steadily improving business relationship is the optimisation of the testing process at CLAAS and the supplier. It is important to give feedback to the supplier on the level of quality supplied including improvement potential. Objective Rapid elimination of the fault at CLAAS. Damage limitation by narrowing errors down. Resolution of the problem, no repetition. Implementation • Continuous monitoring of the relevant data - Quality - Logistics - Costs - Innovation - Motivation • Analysis of the data and continuous information to supplier • In the event of unsatisfying evaluations the supplier is required to formulate a written statement about cause and corrective action including proof of efficiency Implementation • Rapid detailed information to the supplier by CLAAS • Joint agreement about immediate measure • Analysis of the problem by supplier • Documentation by the supplier of at least - Problem - Cause - Immediate measure - Elimination measure • Or conform to the VDA 8D - systematic Series Monitoring 24 25 V. Further Agreements. 1. Special Release 2. Logistic Agreement 3. Emergency Plan 4. Quality Assurance Agreement (QAA) Objective Avoid that components, which are nonconforming, get, without a special release, into the production process. Objective • Minimal carrying costs by bundling of supply transports and intelligent carrying concept • Improvement of inventory by coordinated supply frequency • Improvement of the process by standardised container concept and shipping documentation (according to VDA recommendation 4902) Objective Continuity of supply in case of crisis, as for example may result from: - machine or tool breakdown - breakdown of computer system - power failure - damage to buildings and equipment (natural disasters) - supply bottlenecks of material Objective Approval of direct delivery to the place of use in the factories. Decreasing of CLAAS goods incoming inspection. Implementation CLAAS Logistics Agreement Implementation Joint agreement on components that are essential for an emergency programme. 5. Agreement of confidentiality • Securing the delivery capability Implementation After detection of a deviation the supplier has to inform CLAAS (purchasing / procurement) immediately in written form. CLAAS decides on further action and informs the supplier in written form. Implementing of the decision For the case of a delivery approval for a limited lot size these lots have to be marked clearly and precisely in the shipping documents regarding to the exceptional approval. Basically the delivery only can be carried out after submission of the approval. • Development of an emergency plan • Joint checking and approval of the emergency plan Implementation The QAA will be agreed as an addition of the basic supply agreement. The QAA relevant products will be specified and documented accordingly. Objective With this agreement both parties ensure the confidential handling of all information and data, which will be exchanged between CLAAS and the supplier. Implementation CLAAS Agreement of confidentiality. Further Agreements 26 27 VI. Appendix 1. Definitions DIN EN ISO 9001 New certification norm for quality management systems, which was edited by the German (DIN), European (EN) and International Organization for Standardization (ISO). Critical Characteristics Characteristics of a product or production process that have a considerable influence on safety, function, assembly, adherence to legal safety standards and customer satisfaction. Lifetime Period from initial use to the point of failure after which the product cannot be returned to a functional state. Supply Reliability Adherence to the requirements regarding on date of delivery and delivery quantity. 3. Sources 2. Abbreviations Capability of measurement Measuring of the degree of inaccuracy in relation to the tolerance of the characteristics to be measured. System supplier Takes responsibility for development and production of an assembly, which can be separated functionally, such as cutter bars, brakes, steering, hydraulics Component supplier Works on the basis of documents, drawings, specifications etc. provided to them with no development responsibility. Cp/Cpk value R&D FMEA PCP QM QAA RPV SPC VDA - Process capability value - Research and development - Failure potential and influence analysis - Process control plan - Quality Management - Quality assurance agreement - Risk priority value - Statistical Process Control - German Automotive Industry Association VDA Volume 2: VDA Volume 3: VDA Volume 4: VDA Volume 6 (Part 1): VDA Volume 6 (Part 2): VDA Volume 6 (Part 3): VDA Volume 6 (Part 4): VDA Volume 6 (Part 5): QS 9000 PPAP QS 9000 APQP QS 9000 FMEA QS 900 SPC QS 9000 MSA Quality Assurance of Supplies Reliability assurance of car manufacturers and suppliers Quality assurance during product realisation QM system audit Material Products QM system audit Service Process-audit QM system audit Production Equipment Product audit Guideline Production Part Approval Process Guideline Advanced Product Quality Planning and Control Plan Guideline Failure Mode and Effects Analysis Guideline Statistical Process Control Guideline Measurement System Analyses Weibull media rank method Statistical method used in calculating product and component reliability. Appendix 28 29 Forward-looking. Worldwide. CLAAS. Future 30 31