LG SOURCING VENDOR QUALITY MANAGEMENT SYSTEM REQUIREMENTS

Transcription

1 LG SOURCING VENDOR QUALITY MANAGEMENT SYSTEM REQUIREMENTS LG Sourcing QMS ver Page 1 of 16

2 PAGE INTENTIONALLY LEFT BLANK Copyright 2010, LF Corporation - All rights reserved No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from LG Sourcing Vice President of Quality. LG Sourcing QMS ver Page 2 of 16

3 Introduction: These requirements are set forth to ensure that all of LG Sourcing Vendors are successfully meeting the quality expectations of LG Sourcing and its customers. The vision of LG Sourcing Quality Assurance is to assure quality processes and manufacturing practices are in place within its vendor s manufacturing facilities resulting in the safest and highest quality product being provided to LG Sourcing and their customers. These requirements are meant to improve the vendor s quality systems whether already fully established or just being developed. While these requirements are meant to improve quality, they don t guarantee the quality of the final product. The vendor is still ultimately responsible for supplying quality product that meets LG Sourcing expectations and total customer satisfaction. This Quality Management System contains provisions that are fully required for compliance and others that are recommended best practices. All provisions referenced within this document and the ISO document that begin with shall are mandatory requirements to be implemented within the vendor s organization. All provisions that begin with should are recommended for implementation within the vendor s organization. These recommendations are applied to items that will establish a more robust Quality Managements System and will greatly benefit the vendor once implemented. The vendor must consider all provisions when establishing their Quality Management System. All vendors shall purchase copies of the ISO 9001:2008 standard to reference these requirements. All other referenced documents and manuals referenced herein should be purchased by the vendor to aid in the implementation of their QMS. LG Sourcing QMS ver Page 3 of 16

4 All vendors in establishing their Quality Management System shall implement and comply with all of the following paragraphs of the LG Sourcing Vendor QMS Requirements. Requirements in plain black text are from the ISO 9001:2008 standard. The vendor shall refer to the ISO 9001:2008 standard for these requirements. All paragraphs preceded by L and shown in RED Italics are LG Sourcing Quality Management System requirements. 4 Quality management system 4.1 General requirements 4.2 Documentation requirements General Quality manual Control of documents Control of records 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.4 Planning Quality objectives Quality management system planning 5.6 Management review General Review input Review output 6 Resource management 6.1 Provision of resources 6.2 Human resources General Competence, training and awareness 6.3 Infrastructure 6.4 Work environment LG Sourcing QMS ver Page 4 of 16

5 7 Product realization 7.1 Planning of product realization L7.1.1 L7.1.2 L7.1.3 L7.1.4 L7.1.5 L L L L In planning product realization, the vendor shall determine the required verification, validation of raw materials and the criteria for acceptance; In planning product realization, the vendor shall determine the required product packaging, preservation, identification, labeling, shipment method and criteria Advanced Product Quality Planning To meet LG Sourcing expectations the vendor shall establish and implement an Advanced Product Quality Planning (APQP) process. The vendor shall convene multi-disciplinary teams to prepare for production of new or changed products. These teams shall use appropriate techniques to satisfy these requirements. A source for these requirements is the Advanced Product Quality Planning and Control Plan-APQP Reference Manual (available at Similar techniques that accomplish the intent are acceptable. Team actions shall include: a) Development/finalization of special characteristics b) Development and review of FMEAs (Failure Mode and Effects Analysis, see 4.1.6) c) Establishment of actions to reduce the potential failure modes with high risk priority numbers d) Development and review of Control Plans Key Product/Process Characteristics (KPCs) The vendor s process control guidelines and similar documents (e.g. Control Plans, FMEAs, Operator Instructions, etc.) shall indicate which process steps affect Special Characteristics / Key Product/Process Characteristics (KPCs). Product Safety Due care shall be used and product safety shall be considered in the vendor s design control element and process control policies and practices. The vendor shall promote internal awareness of safety considerations relative to the vendor s product. LG Sourcing QMS ver Page 5 of 16

6 L7.1.6 L7.1.7 L7.1.8 L7.1.9 L L L L L L L Process Failure Mode and Effects Analysis (Process FMEAs) Process FMEAs shall consider all Special Characteristics / Key Product/Process Characteristics (KPCs). Efforts shall be taken to improve the process to achieve defect prevention rather than defect detection. Refer to the Potential Failure Mode and Effects Analysis Reference Manual (available at for guidelines in completing FMEAs. Mistake Proofing The vendor shall utilize appropriate mistake proofing methodologies during the planning of processes, facilities, equipment and tooling. Quality/Control Plans The vendor shall develop Control Plans at the system, subsystem, component and or material level, as appropriate for the product supplied. The Control Plan shall include the information required in the Control Plan form. The Control Plan shall document the product/process characteristics, process controls, tests and measurement systems that occur during production. The vendor shall use a multidisciplinary approach to development of the Control Plans. A multidisciplinary approach typically includes design, manufacturing, engineering, quality, production and other appropriate personnel. It may include sub-contractor personnel and customer personnel if appropriate or required. Control Plans shall be reviewed and updated as appropriate when any of the following occur: a) The product is changed. b) The processes are changed c) The processes become unstable. d) The processes become non-capable. e) Inspection method, frequency, etc is revised Master Sample Process 7.2 Customer-related processes The vendor shall plan for and fully comply with all requirements set forth in Master Sample Process document Determination of requirements related to the product Review of requirements related to the product Customer communication LG Sourcing QMS ver Page 6 of 16

7 7.3 Design and development Design and development planning 7.4 Purchasing Purchasing process L L L L L The vendor shall establish and maintain a supplier/subcontractor qualification process to ensure the above requirements are met. The vendor shall implement a supplier/subcontractor development program and qualification process to ensure the quality of supplied and subcontracted materials and product. The vendor shall implement a program to require 100% on-time delivery from suppliers/subcontractors. The vendor shall implement a system to monitor the delivery performance of its suppliers/subcontractors and require written corrective action when a supplier s/subcontractor s performance does not meet expectations. The vendor shall assure the conformance of purchased goods through any method deemed reliable. These methods may include, but are not limited to, supplier/subcontractor previous performance, demonstrated production process capability (with a capability index CpK 1.33, CpK 1.67 is desired), product and process inspections/tests, etc Purchasing information Verification if purchased product 7.5 Production and service provision Control of production and service provision L Maintenance of Premises: L The vendor shall ensure maintenance of premises in a state of order, cleanliness and repair appropriate to the product(s) manufactured. The vendor shall ensure the use of 5S activities to maintain production area order and cleanliness. LG Sourcing QMS ver Page 7 of 16

8 L Preventive Maintenance: L The vendor shall identify key process equipment and provide appropriate resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system. At a minimum, this system shall include: a) A procedure that describes planned maintenance activities b) Scheduled maintenance activities c) A procedure providing for packaging and preservation of equipment, tooling and gaging d) Availability of replacement parts for key manufacturing equipment e) Documenting, evaluating and improving maintenance objectives Validation of processes for production and service provision Identification and traceability Preservation of product 7.6 Control of monitoring and measuring equipment L7.6.1 Calibration: L Trained and qualified gage calibration personnel, accredited outside calibration services or original equipment manufacturer shall be used for all inspection, measuring and test equipment calibrations. L Measurement Systems Analysis (MSA): L Appropriate statistical, Measurement Systems Analysis (MSA), studies shall be conducted to analyze measurement system variation. These MSA studies shall be used on all measuring and test equipment used to measure Key Product/Process Characteristics (KPCs), characteristics that affect the quality of the product/process or other systems, including both variable and attribute measuring systems. L Acceptance criteria for variable measurements systems analysis Gage Repeatability and Reproducibility (GR&R) are as follows: 10% - The measurement system is acceptable >10% and < 30% - The measurement system may be acceptable or may require corrective action depending on importance of test, costs involved to improve, etc 30% - The measurement system is not acceptable and requires corrective action before acceptance or repeating the study. LG Sourcing QMS ver Page 8 of 16

9 L Acceptance criteria for attribute measurements systems analysis Gage Repeatability and Reproducibility (GR&R) are 100% agreement of all samples. Note: Guidelines and more specific information on measurement systems analysis can be found in additional ISO documentation. General information can be found in ISO/IEC 17025:2005. Specifics for carrying out Measurement Systems Analysis can be found in the Measurement Systems Analysis Reference Manual (available at 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement Customer satisfaction Internal Audit L Internal audits shall cover all shifts and be conducted on at least an annual basis. Internal audit frequencies should be increased when internal and external nonconformances are found or a customer complaint is received. L The vendor shall: a) be required to implement their own auditor program to assure an effective QMS. Note: The Third party audit is not to be considered as the vendor s audit program; b) be required to have Senior Management review all audit findings, implement improvements as appropriate, and keep records of decisions made. L8.2.3 Monitoring and measurement of processes L Process Monitoring: L The vendor shall prepare and maintain documented process monitoring (e.g. inspection and test procedures, etc) and operator instructions for all employees having responsibilities for operation of processes. These instructions shall be accessible at the work station. Job instructions should be available at the time needed without disruption to the job being performed by the operator. LG Sourcing QMS ver Page 9 of 16

10 L Process Changes: L The vendor shall maintain records of process changes, effective dates, and approvals. Changes to promote continuous improvement are encouraged. Process or product changes that may affect product integrity, safety, quality or raw materials shall be reported to LG Sourcing prior to implementation. L Changeovers: L The vendor shall verify job setups whenever a setup or changeover operation is performed (e.g. initial run of a job, material change, job change, significant time lapse between runs, etc). This verification shall be at least 3 pieces of fully conforming product for all attributes contained in the control plan and/or inspection instructions. Periodic comparison to Master Samples and last-off product is highly recommended. L Statistical Techniques: L The vendor shall identify the need for statistical techniques required for establishing, controlling and verifying process capability and product characteristics. L The vendor shall establish and maintain documented procedures to implement and control the application of the statistical techniques identified. L Statistical techniques, if applicable, for each process should be determined during Advanced Product Quality Planning (APQP) and shall be included in the inspection plan (Control Plan). Note: The vendor can refer ISO/TR :2003 for guidance on acceptable statistical techniques and their application. The bibliography of this text lists documents related to the use of specific statistical techniques. Additional information on Statistical Process Control (SPC) can be found in the Statistical Process Control Reference Manual (available at L8.2.4 Monitoring and measurement of product L The vendor shall assure that the product meets the quality requirements and intended function on a recurring basis. L Key Product/Process Characteristics: L The vendor shall identify, define, document, and plan for measurement, control and improvement of Key Product/Process Characteristics (KPCs). The vendor shall provide documentation showing compliance with these requirements when requested by LG Sourcing. LG Sourcing QMS ver Page 10 of 16

11 L Process Monitoring and Capability: L The vendor shall have a process to identify, document and understand Key Product/Process Characteristics and can demonstrate a statistically stable process for these Key Product/Process Characteristics and other product and process parameters, as required. Once into production, a minimum of a 30 piece sample shall be used to determine capability. This sample shall be selected from a minimum of 3 different production runs and account for as many types of process variation as practical. A CpK 1.33 shall be met and maintained on these Key Product/Process Characteristics and other product and process parameters, as required. A CpK 1.67 is desired. All KPCs and processes having a CpK <1.33 shall have a Continuous Improvement Plan and a Permanent Corrective Action plan in place. All KPCs and processes having CpK < 1.67 shall have a Continuous Improvement Plan and adequately enhanced Control Plan/Inspection Plan in place to prevent shipment of Non-conforming Product. L The vendor shall maintain statistical process control (SPC) charts on all Key Product/Process Characteristics and other product and process characteristics, as required. Significant process changes or events shall be documented on control charts. L Master Samples: L The vendor shall produce two (2) Master Samples representative of production intent product, meeting all acceptance criteria set forth. One of these is to remain at the vendor s location and used for verification purposes of production product. The other sample is to be provided to LG Sourcing QA for evaluation and retention for comparison purposes. L The vendor shall periodically compare production samples to the Master Sample retained at their facility. The vendor shall assure that the products being produced are identical to each other and to the Master Sample. The vendor shall assure the quality of the Master Sample is unaffected while being stored. L Use of Control Plans: L The vendor shall provide defined and documented Inspection and Test Plans (i.e. Control Plans) for the inspection of ongoing production. LG Sourcing QMS ver Page 11 of 16

12 L Final Audit Requirements: L The vendor shall conduct audits of packaged final product to verify conformance to all specified requirements (e.g. product, packaging, labeling, contents, etc) at an appropriate interval. L Annual Test Requirements: L All product shall be tested annually by a third party certified test facility approved by LG Sourcing unless otherwise directed in writing by LG Sourcing. L Regulatory Compliance: L The vendor shall assure compliance with international, national, local and LG Sourcing legal and social regulatory requirements, where applicable. L The vendor shall ensure that all product claims related to any regulatory standards, industry standards, or nationally recognized product listing (e.g. UL, CSA, ANSI, etc) or performance claims are certified by a 3rd party test lab approved by LG Sourcing. The vendor shall provide such evidence to LG Sourcing upon request. L LG Sourcing Intended Product Use: L The vendor shall have a process for determining and understanding the end use expectations and functionality of the product. Key features should be identified (and controlled per process assessment section). 8.3 Control of nonconforming product L8.3.1 Product Deviations: L The vendor shall obtain prior LG Sourcing authorization whenever the product or process is different from that of the currently approved product. Any changes from the approved Master Sample product require LG Sourcing approval prior to shipment. In cases where a final PO inspection must occur, this prior approval must be presented to the 3rd party inspector during the final PO inspection. LG Sourcing QMS ver Page 12 of 16

13 8.5 Improvement Continual improvement L Continuous Improvement: L The vendor shall continuously improve in quality and service (including timing and delivery) that benefit all customers. A continuous improvement philosophy shall be fully implemented throughout the vendor s organization. This continuous improvement philosophy shall extend to product characteristics, with the highest emphasis being placed on Key Product Characteristics (KPCs). L Vendors shall provide a system for continuous improvement of cost. L Possible techniques for continuous improvement may include, but are not limited to: Control Charts/SPC Six Sigma / Design of Experiments (DOE) Parts per million (PPM) defect analysis Value Analysis Benchmarking Mistake Proofing Preventive Actions L Process Performance Action Plans: L The vendor shall develop a prioritized action plan for continuous improvement in processes that have demonstrated stability, acceptable capability (CpK 1.33) and performance. Processes with unacceptable capability (CpK < 1.33) or performance require corrective action Corrective action L The procedures for corrective actions shall include: a) the effective handling of customer complaints and reports of product nonconformities; b) investigation of the cause of nonconformities relating to product, process and quality systems, and recording the results of the investigation. c) determination of the permanent corrective action needed to eliminate the cause of the nonconformities; d) application of controls to ensure that permanent corrective action is taken and that it is effective LG Sourcing QMS ver Page 13 of 16

14 e) interim containment evaluation and actions to ensure nonconforming product at the vendor s location, e.g. in-process, finished goods, etc is identified and contained to prevent shipment to LG Sourcing. Further containment actions may be required. f) where applicable, the vendor shall apply the permanent corrective action taken and controls implemented to eliminate the cause of the nonconformity to other similar processes. L Corrective Action Techniques: L Possible Corrective Action techniques may include, but are not limited to: Root Cause Analysis Fishbone 5-Why Brainstorming FMEA L Corrective Action Reporting: L All permanent corrective actions shall be reported to LG Sourcing. All vendors shall include in the Corrective Action report at a minimum the following: Preventive action a) item # and description, open, status and closed dates b) vendor contact information c) comprehensive problem description d) implemented and verified interim containment actions e) defined and verified comprehensive root cause analysis f) defined and verified corrective actions g) implemented permanent corrective actions taken h) systemic actions taken to prevent recurrence of problem LG Sourcing QMS ver Page 14 of 16

15 GLOSSARY OF TERMS Vendor: All references contained herein as Vendor are considered to be the direct supplier of finished goods to LG Sourcing. Supplier/Subcontractor: All references contained herein as Supplier/Subcontractor are considered to be any organization that supplies or subcontracts services for the Vendor that affects the quality of any component or finished good supplied by the Vendor to LG Sourcing. Process Capability: A method by where using statistics, you may predict the likelihood of producing key features of a product within specification over a period of time. A Process Capability (CpK) of 1.33 in the minimum acceptable level during production and a target of 1.66 is desired. Permanent Corrective Action: A corrective action that includes all of the controls, methodologies and actions necessary to ensure that the root cause is identified and corrective action has been implemented to ensure the problem does not reoccur. 8D: An eight step method for resolving and correcting product and process issues. Form the Team (define objectives of the team, scope the plan, and timetable) Clarify the Problem (state the problem as concisely as possible) Contain the Problem (quarantine all suspect product from all points of flow) Identify potential Root Causes (brainstorm potential reasons for failure) Generate Solutions (identify possible solutions for likely root causes) Implement Permanent Solutions (based off most likely failures) Prevent Recurrence (look at like product and processes, fix systems) Congratulate the Team (recognize and thank those who fixed the issue) FMEA (Failure Mode Effects Analysis): A rating methodology for evaluating and prioritizing potential failures of the product due to design or process issues. By determining the Risk Priority Number (RPN), weighted factors identify areas for improvement opportunities, reducing the likelihood of nonconforming product being shipped. (Likelihood of Occurrence x Likelihood of Detection x Severity of Occurrence=RPN) Manufacturing Control Plan (MCP)/Quality Plan: A document stating process parameters, product and process specifications, product and process characteristics and the controls and inspections associated with them. Anytime there are changes in specification, inspection criteria, or any other changes that affect the information contained in the MCP/Quality Plan the plan documents require update. This is considered a living document that changes and is utilized throughout the products life cycle. LG Sourcing QMS ver Page 15 of 16

16 Root Cause Analysis: Any of a variety of problem solving techniques that assist in determining the specific issue that caused the process or product to fail. Different techniques may include 5 Why (Ask Why 5 times), Fishbone (man, machine, materials, methods, etc.), Brainstorming, etc. Product Realization: All phases of the development of a product, including initial idea and planning, design, prototype, production and service. Permanent Corrective Action: A completed corrective action that includes all aspects needed, including proper mistake proofing and resolution of all failure modes are addressed, to ensure that the problem does not occur again. LG Sourcing QMS ver Page 16 of 16