GENERAL QUALITY REQUIREMENTS

Transcription

1 SUPPLIER QUALITY MANUAL Ref.: LIR Ind. : 3 Date : Page : 1 / 10 Modified by : Dumitrita DALEA Validated by : Gelu MATEESCU Verified by : Adina Halinga GENERAL QUALITY REQUIREMENTS This manual applies to suppliers of: Surface and heat treatment Compounds: POM, PBT, PA, PP, etc. (With or without glass fibre) Components (rods, springs, rivets, plastic components, seal) Cables Metals (steel, stainless steel, copper and copper alloys) LEMAN INDUSTRIE CALEA Buziasului Nr 11 I TIMISOARA jud TIMIS ROMANIA TEL FAX Doc.: LIR Indice : 0 Data : 13/08/2009

2 Ref.: LIR Ind. : 3 Date : Page : 2 / SCOPE The purpose of this document is to communicate Leman Industrie s requirements with respect to the quality management system of those companies that supply raw material and services to Leman Industrie. Leman s direct ship suppliers shall assure that quality and environmental requirements are applied and implemented by their suppliers (sub-suppliers LIR). Suppliers must implement appropriate actions to ensure 100% on -time delivery of defect free products to any Leman Industrie location. In addition to the requirements included in this manuel, supplier must take into account the following requirements: technical drawings, specifications, general purchasing requirements and those specified through orders. In case of conflict between documents to be signed by supplier, the following order must be taken into account: 1. Purchasing contract and/or order 2. Specification or drawing 3. Quality requirements expressed in product contract (nomination letter) 4. Supplier quality manual Once the supplier is approved in terms of quality management system, he becomes the supplier group and will be introduced in Leman group s data base. * The requirements of this manual which do not apply for non-automotive suppliers shall be specified in the product contract. It is the responsability of Leman Industrie s Purchasing Department to provide the manuel to the supplier by or by poste, once this was selected for process validation. 2. NORMATIVE REFERENCE DOCUMENTS It is the supplier s responsability to ensure that they adhere to the requirements of the following AIAG manuals available through ISO/TS16949:2009 Quality Management System ISO 9001:2008 Quality System APQP Advance Product Quality Planning and Control Plan FMEA Potential Failure Mode and Effects Analysis MSA Measurement System Analysis SPC Fundamental Statistical Process Control PPAP Production Part Approval Process The supplier shall always use the last version. 3. TERMS AND DEFINITIONS 8D Problem Solving Process/Report AIAG Automotive Industry Action Group APQP Advanced Quality Planning and Control Plan. CGC General Quality Requirements CSL1 Controlled Shipment Level 1 CSL2 - Controlled Shipment Level 1 CVP Increase of production volumes. FMEA Potential Failure Mode and Effect Analysis IMDS - Automotive Industry Material Data System ISO International Standard Organization MSA Measurement Systems Analysis PPAP Production Part Approval Process

3 Ref.: LIR Ind. : 3 Date : Page : 3 / 10 PPM Part Per Million LIR Leman Industrie Romania PSW- Part Submission Warrant SPC Statistical Process Control RPN Risk Priority Number 4. Validity It is the responsability of Leman Industrie s Purchasing Department to inform the supplier regarding any change in requirements specified in the manual. Leman Indsutrie may request the supplier to provide proofs regarding the implementation of new requirements. 5. Quality Management System 5.1 General requirements According to ISO TS16949/2009, current and potential Leman s suppliers must be at least certified ISO 9001:2008 by an accredited third-party provided that they should be able to fulfill the additional requirements demanded by LIR. These requirements will be specified at the beginning of contract and also following quality audits. Any deviation from the requirements specified in the contract will require upon request an action plan proposed by the supplier and which will be approved by Leman Industrie. The proposed actions are meant to respect entirely Leman s requirements specified in this manual. Upon request supplier may be required either to show interest in environement or to implement ISO System certifications and recertifications shall be submitted to LIR within 15 days maximum, any cancellation of certifications must be announced within 48h maximum. 5.2 Warranty For the automotive sector, unless otherwhise requested by LIR, the supplier will ensure the products for a period of two years from the date of coming into operation at the final consumer but not later than three years from delivery. For the non-automotive sector the supplier will ensure the products for a period of two years from the date of coming into operation at the final consumer. For any claim made within the warranty period, the supplier may be requested according to the problem severity to reconsider their process and to send again the PPAP file for approval. 5.3 Control of records Quality records should be preserved in electronic or paper format, these must be legible and available in case of any warranty or post-warranty claims. The suppliers are required to maintain quality records for 15 years after the end of life of the product for automotive, 7 years for non-automotive and 20 years for security parts, unless otherwise specified by Leman Industrie. Documents to be maintened: Part Approval process (PPAP) files, annual validation process records, traceability records, corrective actions records, quality performances records, initial samples, inspection and tests results. Regarding parts preservation, this will be established for each product in the contract of nomination. 5.4 Periodic inspections Leman Industrie reserves the right to visit suppliers to assure that the materials and products are conform to specified requirements. The visit shall be announced at least five days before. 5.5 Internal audit Suppliers shall audit annually all their manufacturing processes by using an appropriate approach. Auditors shall be qualified to assess and evaluate all processes. At request the suppliers shall provide proofs of internal audits.

4 Ref.: LIR Ind. : 3 Date : Page : 4 / Annual Revalidation Suppliers of components and cable shall annually revalidate their production and be able to provide results to Leman at request. Suppliers shall include revalidation plans and document this requirement in Control Plan for all parts supplied. Any changes regarding the revalidation criteria shall be submitted to Leman for approval. Supplier shall take into account the date of the first serial delivery (date can be changed with maximum +/-1 mounth). 5.7 Certificates of conformance Suppliers of metal, suppliers of compounds and suppliers of coating must provide at each delivery a certificate of conformance. Suppliers of components or cables will provide a dimensional report for the products delivered only upon request, unless otherwise specified by Leman. These suppliers will be analysed if they can meet the requirements following the PPAP file submitted to Leman. If the certificate of compliance is missing at incoming inspection, the batch involved will be blocked, as well as the corresponding invoice, untill the situation is solved. The supplier should have in place a system capable of sending the requested certificates within 24h since Buyer s request. 5.8 Identification and traceability Supplier will ensure throughout the production and delivery that all products are identified. Identification shall permit in the case of certain claims traceability back to the supplier raw material batch number, as well as inspection records. The packaging label must contain the batch/lot number. Supplier will use FIFO system (first in first out). Any batch unidentified found by LIR generates the opening of an 8D report and depending on the impact upon production, the products may be returned to supplier. 5.9 Regulatory Conformity Suppliers must provide MSDS (Material Safety Data Sheet). Suppliers for automotive must be registered in the International Material Data System - IMDS www. mdsystem.com and must submit for each product in question the number of IMDS to Leman Industrie Company Contingency plan Supplier shall prepare a contingency plan in case of emergency such as force majeur, labor shortages and equipement failure. When the supplier knows in advance of the production interruption, the supplier must notify Leman Industrie at least 24 hours, if possible, before the interruption. Upon request, the supplier shall provide their contingency plan to Leman. 6. APQP 6.1 Feasibility study Before issuing an offer price supplier must ensure that the product can be achieved and that requirements included in the documentation sent to Leman can be met. Before the start of any project, the supplier and LIR will hold a meeting of feasibility during which they will analyse the technical specifications of the project and they will determine the delay up to which the supplier must deliver samples, PPAP file and targets will be also set. 6.2 APQP Supplier must implement and follow APQP s steps. Supplier will designate a project manager, who will monitor the product untill approval, this person will be available to respond to Leman s demands.

5 Ref.: LIR Ind. : 3 Date : Page : 5 / Initial samples The supplier shall submit samples as required by the Leman s Buyer. Initial samples will be identified, in addition an inspection report and test material results will be sent (AIAG PPAP Manuel) see also 8.6. Besides initial samples, LIR may request the supplier, where necessary, samples of pre-serial production or samples after the ramp-up activity is closed (after the process is stable) or prototype samples. Further instructions required to supplier will be stipulated in the nomination agreement per reference. 6.4 FMEA Supplier shall asses all defects that might occur during process, but also its effects. If necessary, actions will be taken to prevent defects. FMEA is a living document that supplier will continualy update. If there are no additional requirements, RPN is 100, for any values that exceed this threshold, supplier shall take actions. The first varsion of FMEA shall be included in the PPAP package. FMEA s changes should be available to supplier and LIR can have acces whenever it is considered necessary. 6.5 Special characteristics Customer special characteristics will be identified in FMEA, Control Plan, work instructions, will be traced and identified in the process. Supplier will ensure that all special characteristics will be explained, identified and followed during subsuppliers process. 6.6 PPAP PPAP level will be established in the nomination agreement of each reference. If no other additional requirement is stipulated for automotive suppliers, PPAP level will be 3 and for nonautomotive Documentation language All documents submitted to Leman Industrie must be written in English. Specific instructions used in production are in the country language. Regarding romanian suppliers the audit and communication may be in Romanian. 6.8 Audit process For each product there will be conducted a VDA 6.3 audit for process approval, unless otherwise specified by the customer. All processes approved under derogation will generate corrective actions which have to be closed in 3 month period. 6.9 Process / PPAP file approval Supplier can deliver the products from the moment LIR signed the PSW, after this date any modification brought in the process must be announced and can be implemented only after LIR have consented it Supplier is accepted and can produce if all the steps below have been completed and there are no deviations: - Supplier evaluation system - requirements fullfillment - Process audit of pre-serial production - PPAP file signed Supplier shall be capable to provide information upon the process development stage whenever is requested by Leman.

6 Ref.: LIR Ind. : 3 Date : Page : 6 / 10 An action plan may be requested in case the supplier cannot fulfill the requirements specified in the product contract. 7. Ramp-up activity/ Increase production volumes Supplier shall plan and implement activities to ensure that during serial production, quality and delivery requirements are met. Activities that take place during ramp-up process have two distinct objectives: - achieve and maintain quality requirements. - achieve and maintain delivery requirements. The content of ramp-up activity should be planned before the production approval by LIR. The plan must cover a period of aproximatively 3 months after receiving approval to manufacture the parts. If between LIR and supplier there is an agreement for the ramp-up, the activity may continue untill LIR will sign the plan. During this stage all the quality problems shall be imediately identified, corrective and preventive actions shall be taken into account and implemented in production. For delivery, the activity of ramp-up is a stage that monitors and analyzes the effects that might have the increase of volumes and the follow-up of actions in respect of achieving delivery requirements. These activities are used to verify the production capacity. During this activity it must be ensured that all delivery and quality problems are imediately identified and disposed of. Ramp-up activity plan is a document which describes additional activities to be carried out to ensure quality and delivery requirements during serial production. This document will be completed according to control plan and production capacity plan. Activities to be included in the ramp-up stage: - stop of line production, individually controlled products during normal production, when possible. - check 100% (for 3 consecutive lots or untill problems are eliminated). - poisoned cake - increase frequency and/or number of products checked at incoming, during process and before delivery - add of control points if necessary. - increase checking of labeling, identification etc. 8. Serial production 8.1 Deviation approval for Product or Process If the supplier finds during production certain deviations from Leman requirements and considers that process can be approved under deviation, supplier shall submitt to the Buyer a deviation request for approval. A deviation request shall be accompanied by a Problem Solving Report (8D) where cause of problem will be analysed and actions will be taken so that the defect should no longer occur. If the deviation request is approved, the products sent by supplier will be clearly identified. A deviation request shall be approved only for a specific time period or for a certain quantity of parts. Permanent deviations are not allowed. 8.2 Special characteristics Special characteristics shall be included in the supplier s FMEA, Control Plan, Process Flow, Work instructions and all other associated documents. Supplier may be required to provide capability results according to a schedule defined by Leman Suppliers are required to meet the following for all Special Characteristics: Machine capability Cmk 1,67 Short term process capability Ppk 1,67 Long term process capability Cpk 1,33 Supplier shall implement appropriate process controls for Special Characteristics.

7 Ref.: LIR Ind. : 3 Date : Page : 7 / Problem solving methods The methods required by Leman Industrie to be used by supplier in order to prevent and remove noncompliances are: - Prevention: FMEA, SPC, MSA - Non-compliance analysis: 8D, 5M, 5Why 8.4 Analysis of non-conforming components/ Corrective actions Supplier must have implemented o procedure which describes in details how non-conformities are treated, how products in case are analysed, as well as the way in which corrective and preventive actions are implemented and followed. For each incident supplier shall submitt an 8D-Report and he shall assure that he is capable to respond with the time frame described below. Problem description/immediate actions: 24h Define root cause : 5 days Choose and implementation of corrective actions: 30 days. If the defect can cause the line stopping at Leman or at the final customer or the defect is discovered at the final customer, the time of treatment is the following: Step 1 : 24h/ Step 2: 48 h/ Step 3: 15 days. Description of 8D-Report: 1 TEAM NOMINATION 2 3 Problem description Implementation of immediate actions Identification of root cause Definition and implementation of corrective actions Results evaluation Prevention of repetition The team is congratulated Step 1: Supplier shall designate the working team, the team members must be trained in using the problem resolution tools. Step 2: Problem description. In case of missunderstandings, the supplier shall request additional information Step 3: Immediate actions will be implemented to avoid a possible delivery of non-conform parts untill implementation of corrective actions. Problem resolution tools to be used: R&R and SPC. Step 4: Identification of the root cause can be done by using 5M method (manpower, machine, environment, method or material). Other quality tools to be used are the following : - 5 why - ISIKAWA diagram - brainstorming - SPC - Process audits - FMEA Step 5: Choose and implementation of corrective actions. For each possible cause identified in step 4 corrective actions shall be taken. Several corrective actions can be taken for the same cause. Corrective actions will be prioritized according to impact, each action will have a deadline and responsible. The effect of permanent corrective actions must be checked. The team must analyse if actions do not have a negative actions upon the process. Corrective actions can influence the following: - FMEA - Control plan - Working instructions - poka yoke - Drawing Step 6 : Results assessment If corrective actions are evaluated and implemented, immediate actions which were set at step 3 can be canceled. Step 7: Prevention of repetition

8 Ref.: LIR Ind. : 3 Date : Page : 8 / 10 Preventive actions taken shall guarantee following deliveries of defect free products. Following the analysis an action plan shall be implemented and this shall be approved by LIR. The action plan may include: - Modification of FMEA. - Modification of control plan - Process modification - Modification of working instructions - Implementation of a poka yoke tool - audit (product, process, customer). Besides the tools described above, supplier may use any other tool for claims treatment. 9. Supplier performance assessment Below is the scorecard used to assess performance D Report For each incident found in the incoming inspection or during production and which is considered to be generated by the supplier, an 8D report shall be sent by LIR. For each non-compliance found in the items below, LIR will send a report nonconformity report INCF (8D). The target of response to 8D report in frame time of period requested is 100%. 8D=100-(N 8Dx1)-(N 8D NOK after 24h*3)-(N 8D NOK after 5 days*3)-(n 8D NOK after 30 days*3) 1a 1b 1c 1d 1 N of 8D Follow-up of product quality (24h - NOK x 3) (5j - NOK x 3) (30j - NOK x 3) (1a+1b+1 c) a) PPM= quantity of defect parts (quantity claimed by LIR)/total quantity delivered (in the month when the 8D report is opened) * PPM target will be set in the nomination letter for each product. In the absence of a nomination letter per reference, for automotive suppliers the PPM target is 50 and for non-automotive suppliers the PPM target is 100. For any non-compliance supplier will be informed in written for replacement of products, incriminated batches,etc. If LIR cannot wait for the products and/or raw material replacement, the incriminated batch can be used in production if the supplier had previously agreed with one of the two following solutions: - the parts produced with the defect componants will be sorted out by LIR. - supplier will provide personnel for sorting out. LIR will use these solutions only if following the production a percentage of 30% conform products can be recovered. All costs generated by line stop, sorting out as well as those generated by non-compliances will be charged to supplier. b) Quality incidents Incidents will be considered those complaints which do not cause defect parts, for example: reference mixture, wrong identifications etc. c) Logistics complaints In case of quantity differneces between delivery note and verified quantity, a logistics complaint will be made to supplier. Logistics complaints % = 100*logistics complaints/ total number of deliveries (in the month in whichthe complaint was sent). If the unappropriate quantity has negative effects upon LIR process, the supplier will pay the damages in case.

9 Ref.: LIR Ind. : 3 Date : Page : 9 / On time delivery The target is 100%, a delivery is considered on time if received at the date previously requested +4 /-1 days, provided that it does not have a significant impact on production. Delivery rate% = 100*deliveries late /total number of deliveries. 2 Follow up of delivery Number of orders % N of deliveries (+3/- 5 days) 9.3 Type of system certification 3 Certificate ISO / TS TS = 20 ISO 9001 = 15 Not certified= 0 ISO = Reactivity/ On-time Response Purchasing (4a)- supplier shall be assessed taking into consideration the flexibility of extra-orders, modification of quantity and delay etc. 4a Reactivity / Purchasing partnership Very cooperative = 15 Less cooperative = 10 Insufficient = 5 Not cooperative= 0 4b Reactivity / Quality partnership Very cooperative = 15 Less cooperative = 10 Insufficient = 5 Not cooperative= 0 Quality (4b) For any non-conformanec, supplier must submitt an 8D report. On time response % = N of complaints on which the response was in time/n of complaints. All 3 steps of response will be analysed. 9.5 Price 9.6 Total 5 Price Competitive= 40 Acceptable= 25 Average = 15 Low = 0 Global Note ( ) 3

10 Ref.: LIR Ind. : 3 Date : Page : 10/ Supplier performance evaluation Classification Process Audit Result Final classification * Class A - note > 85 Class B - 70 < note < 85 Class C - 50 < note < 70 Class D - note < 50 > 80 = Classification is not modified < 80 = Downgrading Class A Class B Class C Class D * Class A : Very good Development possible- Preferred supplier * Class B : Good Development possible with follow-up * Class C : improvement needed Development impossible * Clasa D : Unacceptable Supplier eliminated Evaluation will be made every 6 months, and results will be communicated upon request to the supplier classified A and B by the Buyer. Suppliers classified B may be requested to submitt an action plan within 10 days maximum. Suppliers classified C shall be included in the program Suppliers C If LIR is not satisfied with supplier evaluation results, the supplier may be requested to submitt an improvement action plan. In 48H after request receiving, supplier may be requested to be available to receive LIR visit. If the non-conformance claimed through an 8D report has a severe impact and/or is a repeat problem, Leman may require Controlled Shipping. Controlled Shipping is a method required to a supplier to implement additional inspection process to sort the non-conforming part. CSL 1 (Controlled Shipping Level 1) will be implemented to reduce the risk that nonconforming products will arrive to LIR, therefore supplier will check 100% all the internal batches. If LIR has products on stock, these will be checked 100%, if the raw material was transformed in parts, these will be checked 100%, products in transit will also be checked 100%. CSL1 costs shall be charged to supplier. If at LIR arrive nonconforming products while CSL1 is applied, CSL2 (Controlled Shipping Level 2) must be started. For CSL2 supplier will hire a third party for sorting out the non-conforming parts, implementation of actions, control etc. Products delivered following CSL1 and CSL2 will be identified by a label: CHECKED 100%. 9.9 Supplier eliminated If after the implementation of CSL1 and/or CSL2 the results are not satisfied and the situation has not improved, a meeting will be organised between purchasing department of LIR and that of supplier in order to decide if the supplier action plan can fulfill Leman s quality requirements, otherwise the supplier will be removed. 10 Cost recovery Supplier shall support all costs issued from non-conforming material and their effects. Cost recoveries may include rework, repair, sorting out labour, scrap material costs, customer charges etc.