SCOPE This section describes the responsibility, authority, and management structure of the facility. 1.1 QUALITY POLICY The President has the ultimate responsibility for the facility s products and services. The President is responsible for setting the facility s Quality Policy. ABC Metals, Inc. has defined and documented its policy for quality and ensures that this policy is understood, at all levels of the organization. To accomplish this ABC Metals, Inc. has posted the Quality Policy in the warehouse and office areas and include a review of the Quality Policy in the New Employee Orientation process. 1.2 ORGANIZATION 1.2.1 Responsibility and Authority The President is ultimately responsible for establishing, and maintaining the quality system. Specific responsibilities include defining the organizational structure; assigning authorities and responsibilities; reviewing the quality system; and making available the resources and personnel necessary to maintain the system. The responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality are defined and documented. System procedures and work instructions define the responsibilities and authority in greater detail. Job descriptions are available which also define the level of empowerment for each employee. These all work together to support personnel who, in particular, need the organizational freedom and authority to: Initiate action to prevent the occurrence of any nonconformities relating to product, process and quality system. As appropriate, ABC Metals provides personnel responsible for quality the authority to stop production and when necessary to correct the problems. Identify and record any problems relating to the product, process and quality system through appropriate organizational channels. Initiate, recommend or provide solutions through designated channels. Verify the implementation of solutions. Control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected. Represent the needs of the customer in internal functions in addressing QS-9000 requirements. (Refer to ABC Metals, Inc.-Lg., Organizational Chart Section F) Section Title: Management Responsibility Revision No: 2 Section No: 1.0 Page 1 of 4 Approved by: Dan Kendall QSMR Reviewed: Dan Kendall Date: 9/14/01
1.2.2 Resources Resource requirements are reviewed during the Management meetings, at least annually, in order to evaluate adequacy of overall resources and the assignment of trained personnel for management, performance of work and verification activities, including internal quality audits. Reference of this review is documented in the meeting minutes for the month it is reviewed. 1.2.3 Management Representative The Vice President & General Manager also functions as the facility s Management Representative. The Management Representative has sufficient authority to ensure that the quality system is established, implemented and maintained in accordance with ISO 9002/QS 9000 International Standard. In the absence of the Management Representative, a qualified designee is appointed. This appointment is documented in the Management Review meeting minutes when appropriate. The Management Representative, or designee, is responsible for reporting on the performance of the quality system to the management group for review and as a basis for improvement. The responsibility of the Management Representative may also include liaison with external parties on matters relating to the quality system. 1.2.4 Organizational Interfaces ABC Metals, Inc. has systems in place to ensure the management of appropriate activities during concept development through production. ABC Metals, Inc. uses a multi-disciplinary approach for decision-making and has the ability to communicate necessary information and data in the customerprescribed format. (Guidelines established in the Advanced Product Quality Planning and Control Plan reference manual are applied, as appropriate.) Participants in APQP meetings include: Vice President & General Manager, Purchasing Manager, and Warehouse Manager. Other personnel such as inside or outside sales personnel, Production Lead supervision or the Quality Assistant may be included as needed. 1.2.5 Information to Management Management with responsibility and authority for corrective action are promptly informed of products or processes, which become noncompliant with specified requirements. 1.3 MANAGEMENT REVIEW Regular Management Review meetings, chaired by the President or Vice President & General Manager are conducted with a multi-disciplinary approach. These meetings include monitoring the suitability and effectiveness of all of the elements of the quality system to satisfy the requirements of the QS- 9000 and the stated quality policy and objectives. The designated management staff attends these meetings. Records of such reviews are maintained as Management Review Meeting Minutes and are circulated among attendees. Meetings are conducted by agenda. (Refer to Quality System Procedure 1.1 Management Review.) Section Title: Management Responsibility Revision No: 2 Section No: 1.0 Page 2 of 4 Approved by: Dan Kendall QSMR Reviewed: Dan Kendall Date: 9/14/01
1.4 BUSINESS PLAN ABC Metals, Inc. has a formal, documented, comprehensive business plan. The Business Plan is a controlled document. Goals and plans cover short-term (6 mo.-1 years) and long-term (2-5 years or more) planning. The goals and plans are based on the analysis of competitive products and on benchmarking. Methods to determine current and future customer expectations are in place. Methods to track, update, revise and review the plan are documented to ensure that the plan is followed and communicated throughout the organization as appropriate. Data and information drive process improvement plans. ABC Metals, Inc. provides the means for employee empowerment in meeting business goals. All managers may contribute experience, information, and suggestions to the development of the business plan. Each year the President and/or Vice President & General Manager updates the business plan. 1.5 ANALYSIS AND USE OF COMPANY-LEVEL DATA The designated Department Heads analyze company-level performance data during each Management Review meeting. Trends in quality, operational performance (productivity, efficiency, effectiveness, cost of poor quality) and current quality levels for key product and service features are documented as appropriate. Trends in data and information are compared with progress towards overall business objectives and lead to action to support: Development of priorities for prompt solutions to customer-related problems. Determination of key customer-related trends and correlations to support status review, decisionmaking and longer-term planning. 1.6 CUSTOMER SATISFACTION ABC Metals, Inc. has a documented process for determining customer satisfaction, including frequency of determining customer satisfaction, and how objectivity and validity are assured. Trends in customer satisfaction and key indicators of customer dissatisfaction are documented and supported by objective information. These trends are compared to appropriate benchmarks and reviewed by senior management. Consideration is given to internal, external and final customers. Results are presented, when appropriate, at the management review meeting. Customer satisfaction is reviewed, as appropriate, through specific feedback from sales personnel and/or through annual Customer Satisfaction Surveys. 1.6.1 CERTIFICATION BODY/REGISTRAR NOTIFICATION ABC Metals, Inc. will notify the certification body/registrar in writing within five (5) working days when a customer places the site in any of the following statuses: Chrysler Needs Improvement Ford Q1 Revocation General Motors Level II Containment Section Title: Management Responsibility Revision No: 2 Section No: 1.0 Page 3 of 4 Approved by: Dan Kendall QSMR Reviewed: Dan Kendall Date: 9/14/01
1.7 REFERENCE QS-9000, Element 4.1 ANSI/ASQC Q9002, 4.1 1.8 RELATED DOCUMENTATION Details of the approved methods are contained in Quality System Procedures: 1.1 Management Review 1.2 Business Plan 1.3 Analysis and Use of Company-Level Data 1.4 Customer Satisfaction Section Title: Management Responsibility Revision No: 2 Section No: 1.0 Page 4 of 4 Approved by: Dan Kendall QSMR Reviewed: Dan Kendall Date: 9/14/01
SCOPE This section describes the components of ABC Metals, Inc. quality system. 2.1 GENERAL ABC Metals, Inc. has established, documented and maintained a quality system as a means of ensuring that product conforms to specified requirements. The covers the requirements of QS-9000. The quality system is structured as follows: Level I - Level II - Quality System Procedures Level III Work Instructions Level IV - Records/Data, Forms, etc. Described below is an overview linking together all documents and records within these four levels. All employees are obligated to work in accordance with the specific requirements of the documented quality system. 2.2 QUALITY SYSTEM PROCEDURES All quality related activities are governed by procedures and written instructions and are circulated for use by management and employees as needed. ABC Metals provides for procedures with adequate detail that relate appropriately to the complexity of the work, the methods used, and the skills and training needed to carry out the activity. Procedures are consistent with the requirements of the QS- 9000 and the stated quality policy. 2.3 QUALITY PLANNING As appropriate, for each process, specific quality planning is performed using a multidisciplinary approach. Quality System Procedure 2.1 Advanced Product Quality Planning references the Advanced Product Quality Planning and Control Plan reference manual as a guideline to developing control plans (quality plans). Consideration is given within the quality system, as appropriate, to the following activities in meeting the specified requirements for products, projects or contracts: the preparation of quality plans* the identification and acquisition of controls, processes, equipment, resources, and skills needed to achieve quality the compatibility of procedures for design, production process, installation, servicing, inspection and test the updating of quality control, inspection, and testing techniques, including the development of new instrumentation Section Title: Quality System Revision No: 4 Section No: 2.0 Page 1 of 5 Approved by: Dan Kndall QSMR Reviewed:Dan Kendall Date: 9/14/01
2.3 QUALITY PLANNING (CONT.) the identification of future measurement requirement capabilities the identification of suitable verification at appropriate stages the clarification of standards of acceptability the identification and preparation of quality records *Some quality plans may be in the form of a reference to a documented procedure forming an integral part of ABC Metal s quality system. 2.3.1 Advanced Product Quality Planning During the Advanced Product Quality Planning process, internal multidisciplinary activities are used to prepare for production of new or changed processes. The internal multidisciplinary activities may include, but not be limited to: development or review of special characteristics development or review of FMEAs establishment of actions to reduce the potential failure modes with high risk priority numbers greater than 100 development or review of Control Plans 2.3.2 Special Characteristics The process control guidelines and similar documents such as FMEA s, Control Plans, Work Instructions will be marked with the customer s special characteristic symbol to indicate those process steps that affect Special Characteristics, when Special Characteristics are identified on the customer s design record. Special characteristics may be identified from any product characteristic category such as dimensional, material, appearance, or performance. 2.3.3 Feasibility Reviews ABC Metals, Inc. will investigate and confirm the manufacturing feasibility of proposed products submitted into the APQP process prior to contracting to produce those products. Feasibility reviews are documented using the Team Feasibility Commitment (QA014) as referenced in the Advanced Product Quality Planning and Control Plan reference manual. 2.3.4 Product Safety Appropriate care and product safety is considered in our process control policies and practices. ABC Metals, Inc. promotes internal awareness of safety considerations relative to our products and services. Section Title: Quality System Revision No: 4 Section No: 2.0 Page 2 of 5 Approved by: Dan Kndall QSMR Reviewed:Dan Kendall Date: 9/14/01
2.3.5 Process Failure Mode and Effects Analysis Process Failure Mode and Effect Analysis are documented to improve the process to achieve defect prevention rather than defect detection. PFMEA s (QA013) consider special characteristics as applicable and efforts taken to improve the process as referenced in the Potential Failure Mode and Effect Analysis reference manual. ABC Metals considers specific customer FMEA review and approval requirements prior to production part approval. 2.3.6 Mistake Proofing ABC Metals, Inc. utilizes appropriate mistake proofing methodologies during the planning of processes, facilities, equipment and tooling. 2.3.7 The Control Plan Control Plans will be developed at the system, subsystem, component and/or material level, as appropriate for the product supplied. Control Plans will include the information required in the control plan form in Appendix J of the QS-9000 Manual. The output of the advanced quality planning process is the Control Plan. Control Plans will be revised or updated when products or processes differ significantly from those in current production. Control Plans will cover the prototype, pre-launch and production phase, as appropriate, for the product supplied. Control Plans are reviewed and updated, as appropriate, when any of the following occur: Product is changed. Processes are changed. Processes become unstable. Processes become non-capable. Inspection method, frequency, etc. is revised. 2.4 PRODUCT APPROVAL PROCESS ABC Metals, Inc. fully complies with all requirements set forth in the Production Part Approval Process (PPAP) manual. 2.4.1 Subcontractor Requirements ABC Metals, Inc. utilizes a part approval process for subcontractors, when appropriate. 2.4.2 Engineering Change Validation ABC Metals, Inc. verifies that changes are properly validated. Section Title: Quality System Revision No: 4 Section No: 2.0 Page 3 of 5 Approved by: Dan Kndall QSMR Reviewed:Dan Kendall Date: 9/14/01
2.5 CONTINUOUS IMPROVEMENT ABC Metals, Inc. employs a continuous improvement philosophy throughout the entire organization. Efforts to continuously improve in quality, service and price for all customers is practiced and encouraged. Innovative improvements are encouraged and implemented when applicable. Continuous improvement extends to product characteristics with the highest priority on special characteristics. Cost elements are a key indicator within the continuous improvement system. Specific action plans for continuous improvement are developed in processes that are most important to the customer once those processes have demonstrated stability and acceptable capability. ABC Metals, Inc. will develop a prioritized action plan for continuous improvement in processes that have demonstrated stability, acceptable capability and performance. 2.5.1 Quality and Productivity Improvements ABC Metals, Inc. will identify opportunities for quality and productivity and implement appropriate improvement projects. Examples of situations which might lead to improvement projects are: Unscheduled machine downtime Machine set up and changeover times Excessive cycle time Scrap, rework and repair Non value-added use of floor space Excessive variation Less than 100% first run capability Process averages not centered on target values Testing requirements not justified by accumulated results Waste of labor and materials Cost of poor quality Excessive handling or storage New target values to optimize customer processes Marginal measurement system capability Customer dissatisfaction 2.5.2 Techniques for Continuous Improvement ABC Metals, Inc. will demonstrate knowledge of appropriate continuous improvement measures and methodologies and will use those that are considered to be most appropriate. Possible techniques which might be used are listed below. Control Charts Design of Experiments Overall Equipment Effectiveness Value analysis Benchmarking Mistake Proofing Section Title: Quality System Revision No: 4 Section No: 2.0 Page 4 of 5 Approved by: Dan Kndall QSMR Reviewed:Dan Kendall Date: 9/14/01
2.6 FACILITIES AND TOOLING MANAGEMENT 2.6.1 Facilities, Equipment, and Process Planning Effectiveness A multi-disciplinary approach for developing facilities, processes and equipment plans in conjunction with the advanced quality planning process is used. Plant layouts will minimize material travel and handling, facilitate synchronous material flow, and maximize value-added use of floor space. Methods are developed for evaluating the effectiveness of existing operations and processes considering the following factors: overall work plan, appropriate automation, ergonomics and human factors, operator and line balance, storage and buffer inventory levels, value-added labor content. ABC Metals, Inc. has identified and defined appropriate metrics to monitor the effectiveness of existing operations. Refer to Work Instruction 1.1 Key Measurables. 2.7 REFERENCE QS-9000, Element 4.2 Advanced Product Quality Planning and Control Plan reference manual Potential Failure Mode and Effects Analysis reference manual Production Part Approval Process reference manual Work Instruction 1.1 Key Measurables 2.6 RELATED DOCUMENTATION Details of the approved methods are contained in: Quality System Procedure 2.1 - Advanced Product Quality Planning Quality System Procedure 2.2 - Product Approval Process Quality System Procedure 2.3 - Continuous Improvement Quality System Procedure 2.4 - Tool Design & Fabrication Quality System Procedure 2.5 - Tooling Management Section Title: Quality System Revision No: 4 Section No: 2.0 Page 5 of 5 Approved by: Dan Kndall QSMR Reviewed:Dan Kendall Date: 9/14/01
SCOPE This section describes the method used by the facility to assure that the customer needs are understood by the facility throughout the production and delivery process including review of the availability of resources and the facility s capacity to meet customer requirements. 3.1 GENERAL Documented procedures have been established and maintained for contract review and for the coordination of these activities. 3.2 REVIEW The Sales function is responsible for the contract review activities. Before the contract or order will be accepted, the contract or order will be verified to ensure that: the requirements are adequately defined and documented, where the requirements have been communicated by verbal means, the order requirements will be documented and agreed upon before their acceptance; any differences between the contract or order requirements are resolved; the company has the capability to meet the contract or order requirements; all customer-specific requirements can be met. 3.3 AMENDMENT TO A CONTRACT Amendments to contracts will be identified and communicated to the functions concerned within the organization by submitting a sales order. 3.4 RECORDS Records of contract review are maintained. (4.16) 3.5 REFERENCE QS-9000, Element 4.3 ANSI/ASQC Q9002-4.3 3.6 RELATED DOCUMENTATION Details of the approved methods are contained in Procedures: 3.1 Contract Review 3.2 Amendment to a Contract Section Title: Contract Review Revision No: 2 Section No: 3.0 Page 1 of 1 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/14/01
THIS ELEMENT APPLIES TO DESIGN RESPONSIBLE SUPPLIERS ONLY. ABC Metals, Inc. does not design any product of its own, therefore is not design responsible and this element does not apply. Section Title: Design Control Revision No: 1 Section No: 4.0 Page 1 of 1 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/14/01
SCOPE This section describes the method for controlling all documents and data that relate to the requirements of the QS-9000. 5.1 GENERAL ABC Metals, Inc. has established and maintains documented procedures for the control of all documents and data that relate to the requirements of the QS-9000 including, to the extent applicable, documents of external origin such as standards and customer drawings. 5.2 DOCUMENT AND DATA APPROVAL AND ISSUE Documents and data whether electronic media or hard copy, will be reviewed and approved for adequacy by authorized personnel prior to use. Master lists and/or procedures identify the current revision status of documents and are readily available to preclude the use of invalid or obsolete documents. This control ensures that: Pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed. Examples of appropriate documents include: Engineering drawings Engineering standards Math (CAD) data Inspection instructions Test procedures Work instructions Operations sheets Quality manual Operational procedures Quality procedures Material specifications Invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use. Any obsolete documents retained for legal and/or knowledge-preservation purposes are suitably identified. 5.2.1 Engineering Specifications Procedures exist to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes. A record of the date on which each change is implemented in production will be maintained and the implementation will include updates to all appropriate documents. Section Title: Document and Data Control Revision No: 2 Section No: 5.0 Page 1 of 2 Approved by: Dan Kendall QSMR Reviewed: Dan Kendall Date: 9/14/01
5.3 DOCUMENT AND DATA CHANGES Changes to documents and data are reviewed and approved by the same functions that performed the original review and approval, unless specifically designated otherwise. The designated function will have access to pertinent background information upon which to base their review and approval. Where practicable, the nature of the change is identified in the document or the appropriate attachments. 5.4 REFERENCES QS-9000 Element 4.5 ANSI/ASQC Q9002-4.5 5.5 RELATED DOCUMENTATION Details of the approved methods are contained in Quality System Procedures: 5.1 Document and Data Control 5.2 Document and Data Approval and Issue 5.3 Document and Data Changes Section Title: Document and Data Control Revision No: 2 Section No: 5.0 Page 2 of 2 Approved by: Dan Kendall QSMR Reviewed: Dan Kendall Date: 9/14/01
SCOPE This section describes the manner used to ensure that purchased product conforms to specified requirements. 6.1 GENERAL Procedures exist to ensure that purchased product conforms to specified requirements. 6.1.1 Approved Materials for Ongoing Production Where the customer has an approved subcontractor list, ABC Metals, Inc. will purchase the relevant materials from subcontractors on the list. Any additional subcontractors may only be used after they have been added to the list by the customer s Materials Engineering activity. 6.1.2 Government, Safety and Environmental Regulations All purchased materials used in processing will satisfy current governmental and safety constraints on restricted, toxic and hazardous materials; as well as environmental, electrical and electromagnetic considerations applicable to the country of manufacture and sale. 6.2 EVALUATION OF SUBCONTRACTORS ABC Metals, Inc. will: evaluate and select subcontractors on the basis of their ability to meet subcontract requirements including the quality system and any specific quality assurance requirements; define the type and extent of control exercised over the subcontractor. This will be dependent upon the type of product, the impact of subcontracted product on the quality of final product and, where applicable, on the quality audit reports and/or quality records of the previously demonstrated capability and performance of subcontractors; maintain quality records of acceptable subcontractors. 6.2.1 Subcontractor Development ABC Metals, Inc. will perform subcontractor quality system development with the goal of subcontractor compliance to QS-9000 using Section I of the QS-9000 as their fundamental quality system requirement. Assessments, if part of subcontractor development, will occur at a specified frequency. Subcontractor assessments to QS-9000 by the OEM customer, an OEM customerapproved second party, or an accredited third party certification body/registrar will be recognized in lieu of audits. Acceptance of the above audits is not intended to limit more specific subcontractor quality system and product development. The prioritization of subcontractor development is dependent upon the needs of the subcontractor relative to the requirements of QS-9000 and the importance of the product or service they supply. Section Title: Purchasing Revision No: 2 Section No: 6.0 Page 1 of 3 Approved by: Dan Kendalll QSMR Reviewed: Jim Wells Date: 9/14/01
6.2.2 Scheduling Subcontractors ABC Metals, Inc. requires 100% on-time delivery performance from subcontractors and will provide appropriate planning information and purchase commitments to enable subcontractors to meet this expectation. ABC Metals, Inc. will monitor the delivery performance of subcontractors with corrective actions taken as appropriate. Records of premium freight will include both ABC Metals, Inc. and subcontractor paid charges. 6.3 PURCHASING DATA Purchasing documents will contain data clearly describing the product ordered, including where applicable: the type, class, grade or other precise identification; the title or other positive identification, and applicable issues of specification, drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel; the title, number and issue of the quality system standard to be applied, if appropriate. Purchasing documents are reviewed and approved for adequacy of specified requirements prior to release. 6.4 VERIFICATION OF PURCHASED PRODUCT 6.4.1 Supplier Verification at Subcontractor s Premises Where ABC Metals, Inc. proposes to verify purchased product at the subcontractor s premises, ABC Metals, Inc. will specify verification arrangements and the method of product release in the purchasing documents. 6.4.2 Customer Verification of Subcontracted Product Where specified in the contract, a customer of ABC Metals, Inc. or the customer s representative will be afforded the right to verify at the subcontractor s premises and the supplier s premises that subcontracted product conforms to specified requirements. Such verification will not be used by ABC Metals, Inc. as evidence of effective control of quality by the subcontractor. Verification by the customer will not absolve ABC Metals, Inc. of the responsibility to provide acceptable product, nor will it preclude subsequent rejection by the customer. 6.5 REFERENCES QS-9000, Element 4.6 ANSI/ASQC Q9002-4.6 Section Title: Purchasing Revision No: 2 Section No: 6.0 Page 2 of 3 Approved by: Dan Kendalll QSMR Reviewed: Jim Wells Date: 9/14/01
6.6 RELATED DOCUMENTATION Details of the approved methods are contained in Quality System Procedures: 6.1 Evaluation of Subcontractor 6.2 Purchasing Data 6.3 Verification of Purchased Product Section Title: Purchasing Revision No: 2 Section No: 6.0 Page 3 of 3 Approved by: Dan Kendalll QSMR Reviewed: Jim Wells Date: 9/14/01
SCOPE This section describes the control of verification, storage, maintenance, and incorporation of customersupplied products. 7.1 GENERAL ABC Metals, Inc. has established and maintains documented procedures for the control of verification, storage and maintenance of customer-supplied product provided for incorporation into the supplies or for related activities. Any customer-supplied product that is lost, damaged or is otherwise unsuitable for use will be recorded and reported to the customer. Customer supplied products are treated as purchased items and protected to prevent loss, damage or deterioration. Nonconformances are so identified and held for review with customer prior to disposition. Verification does not absolve the customer of the responsibility to provide acceptable product. 7.1.1 Customer Owned Tooling Customer-owned tools and equipment will be permanently marked so that ownership is visually apparent. 7.3 REFERENCES QS-9000, Element 4.7 ANSI/ASQC Q9002, 4.7 7.4 RELATED DOCUMENTATION Details of the approved methods are contained in Quality System Procedures: 7.1 Control of Customer-Supplied Products Section Title: Control of Customer-Supplied Product Revision No: 2 Section No: 7.0 Page 1 of 1 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/14/01
SCOPE This section describes the system for identifying products from receipt and during all stages of production and delivery. 8.1 GENERAL ABC Metals, Inc. has established and maintains documented procedures for identifying the product by suitable means from receipt and during all stages of production, delivery, and installation. To the extent that traceability is a specified requirement, individual product, or batches will have unique identification. This identification is recorded. 8.2 REFERENCES QS-9000, Element 4.8 ANSI/ASQC Q9002, 4.8 8.3 RELATED DOCUMENTATION Details of the approved methods are contained in Quality System Procedure: 8.1 Product Identification and Traceability Section Title: Product Identification and Traceability Revision No: 2 Section No: 8.0 Page 1 of 1 Approved by: Dan Kendall QSMR Reviewed: Dan Kendall Date: 9/18/01
SCOPE This section describes the method in which production processes and process equipment directly affecting quality are maintained and controlled. 9.0 GENERAL ABC Metals, Inc. will identify and plan the production processes that directly affect quality and will ensure that these processes are carried out under controlled conditions. Controlled conditions will include: documented procedures defining the manner of production where the absence of such procedures could adversely affect quality use of suitable production equipment and a suitable working environment Cleanliness of Premises ABC Metals, Inc. maintains the premises in a state of order, cleanliness and repair appropriate to the products processed. Contingency Plans ABC Metals, Inc. has prepared contingency plans to reasonably protect the customer s supply of product in the event of emergency, excluding natural disaster, etc. compliance with reference standards/codes, quality plans and/or documented procedures monitoring and control of suitable process parameters and product characteristics Designation of Special Characteristics As requested by the customer, ABC Metals, Inc. will comply with all customer requirements for designation, documentation and control of special characteristics. Documentation will be maintained showing compliance with these customer requirements. the approval of processes and equipment, as appropriate criteria for workmanship, which will be stipulated in the clearest practical manner suitable maintenance of equipment to ensure continuing process capability Preventative Maintenance Key process equipment will be identified and appropriate resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system will be provided. At a minimum, this system will include: a procedure that describes planned maintenance activities scheduled maintenance activities predictive maintenance methods procedure providing for packaging and preservation of equipment, tooling & gaging availability of replacement parts for key manufacturing equipment. documenting, evaluating and improving maintenance objectives Section Title: Process Control Revision No: 4 Section No: 9.0 Page 1 of 4 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/18/01
Preventative Maintenance Where the results of processes cannot be fully verified by subsequent inspection and testing of the product and where, for example, processing deficiencies may become apparent only after the product is in use, the processes will be carried out by qualified operators and/or will require conditions monitoring and control of process parameters to ensure that the specified requirements are met. Records will be maintained for qualified processes, equipment and personnel, as appropriate. 9.1 PROCESS MONITORING AND OPERATOR INSTRUCTIONS ABC Metals, Inc. has prepared process monitoring and operator instructions that are available for all employees having responsibilities for operation of processes. These instructions are accessible at the workstations and are derived from the sources listed in the Advanced Product Quality Panning and Control Plan reference manual. Process monitoring and operator instructions will include or reference, as appropriate: Operation Name and Number keyed to process flow chart Part name and part number, or part family Current engineering level/date Required tools, gages and other equipment Material identification and disposition instructions Customer and supplier designated special characteristics SPC requirements Relevant engineering and manufacturing standards Inspection and test instructions Reaction plan Revision date and approvals Visual aids Tool change intervals and set-up instructions 9.2 MAINTAINING PROCESS CONTROL ABC Metals, Inc. maintains process capability or performance as approved via PPAP. To accomplish this, ABC Metals Inc. ensures that the Control Plan and Process Flow Diagrams are implemented, including but not limited to adherence to the specified: Measurement technique Sampling plans Acceptance criteria Reaction plans when the acceptance criteria is not met Significant process events are recorded on the control charts as appropriate. When process or product data indicate a high degree of capability, ABC Metals, Inc. may revise the Control Plan as appropriate. Section Title: Process Control Revision No: 4 Section No: 9.0 Page 2 of 4 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/18/01
9.2 MAINTAINING PROCESS CONTROL (CONT.) ABC Metals, Inc. will initiate the appropriate reaction plan from the Control Plan for characteristics that are identified on the Control Plan and are either unstable or non-capable. Reaction plans include containment of process output and 100% inspection. A corrective action plan is completed indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. These plans are reviewed with and approved by the customer when required. 9.3 MODIFIED PROCESS CONTROL REQUIREMENTS In some cases, the customer may require either higher or lower capability or performance requirements. In these cases, the Control Plan will be annotated accordingly. 9.4 VERIFICATION OF JOB SET-UPS Job set-ups will be verified as producing product that meet all requirements. Set-up instructions will be available for set-up personnel. Statistical methods of verification are used where applicable. 9.5 PROCESS CHANGES ABC Metals, Inc. maintains records of process change effective dates. Changes to promote continuous improvements are encouraged. As appropriate, customers are consulted for guidance on approval requirements for such changes. 9.6 APPEARANCE ITEMS When processing material designated by the customer as Appearance Items, ABC Metals, Inc. will provide: Appropriate lighting for evaluation areas Masters for color, grain, gloss, metallic brilliance, texture, distinctness of image as appropriate Maintenance and control of appearance masters and evaluation equipment Verification that personnel making appearance evaluations are qualified to do so. Note: Currently there are no appearance items required by our customers. When required, ABC Metals will address as detailed above. Section Title: Process Control Revision No: 4 Section No: 9.0 Page 3 of 4 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/18/01
9.7 REFERENCES QS-9000, Element 4.9 Advanced Product Quality Planning and Control Plan reference manual Production Part Approval Process reference manual 9.8 RELATED DOCUMENTATION Details of the approved methods are contained in Quality System Procedures: 2.3 Continuous Improvement 9.0 Contingency Plan 9.1 Preventative Maintenance 9.2 Process Monitoring and Operator Instructions 9.3 Ongoing Process Performance Requirements 9.4 Verification of Job Set-Ups 9.5 Order Verification Section Title: Process Control Revision No: 4 Section No: 9.0 Page 4 of 4 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/18/01
SCOPE This section describes the method for inspection and testing activities in order to verify that the specified requirements for the product are met. 10.1 GENERAL Documented procedures exist for inspection and testing activities in order to verify that the specified requirements for the product are met. The required inspection and testing, and the records to be established, are detailed in the Control Plan and/or documented procedures. 10.1.1 Acceptance Criteria for Attribute Characteristics Acceptance criteria for attribute data sampling plans is zero defects. Appropriate acceptance criteria for all other situations will be documented in the Control Plan and approved by the customer. 10.2 RECEIVING INSPECTION AND TESTING Incoming product is not used or processed until it has been inspected or otherwise verified as conforming to specified requirements. Verification of conformance to the specified requirements will be in accordance with the Control Plan and/or documented procedures. In determining the amount and nature of receiving inspection, consideration will be given to the amount of control exercised at the subcontractor s premises and the recorded evidence of conformance provided. Where incoming product is released for urgent production purposes prior to verification, it will be positively identified and recorded in order to permit immediate recall and replacement in the event of nonconformity to specified requirements. 10.2.1 Incoming Product Quality The incoming quality system will use one or more of the following methods: Receipt and evaluation of statistical data Receiving inspection and/or testing Second or third party assessments or audits of subcontractor locations when coupled with records of acceptable quality performance Product evaluation by accredited laboratories Section Title: Inspection and Testing Revision No: 3 Section No: 10.0 Page 1 of 4 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/18/01
10.3 IN-PROCESS INSPECTION AND TESTING ABC Metals, Inc. will: inspect and test the product as required by the Control Plan and/or documented procedures; hold product until the required inspection and tests have been completed or necessary reports have been received and verified, except when product is released under positiverecall procedures; direct process activities towards defect prevention methods, such as statistical process control, error proofing, visual controls, rather than defect detection. 10.4 FINAL INSPECTION AND TESTING Final inspection and testing will be carried out in accordance with the Control Plan and/or documented procedures to complete the evidence of conformance of the finished product to the specified requirements. The Control Plan and/or documented procedures for final inspection and testing will contain all specified inspection and tests, including those specified either on receipt of product or inprocess, have been carried out and that the results meet specified requirements. No product will be dispatched until all the activities specified in the Control Plan and/or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized. 10.4.1 Layout Inspection and Functional Testing When required by the customer, layout and functional verification will be performed for all products at a frequency established by the customer. Results will be available to the applicable customer for review. 10.4.2 Final Product Audit ABC Metals, Inc. conducts audits of packaged final product to verify conformance to all specified requirements at an appropriate frequency. 10.5 INSPECTION AND TEST RECORDS Records which provide evidence that the product has been inspected and/or tested will be established and maintained. These records will show clearly whether the product has passed or failed the inspection and/or tests according to defined acceptance criteria. Where the product fails to pass any inspection and/or test, the procedures for the control of nonconforming product will apply. Records will identify the inspection authority responsible for the release of the product. Section Title: Inspection and Testing Revision No: 3 Section No: 10.0 Page 2 of 4 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/18/01
10.6 SUPPLIER LABORATORY REQUIREMENTS 10.6.1 Laboratory Quality Systems ABC Metals, Inc. maintains a limited laboratory scope. All applicable related policies, systems, programs, procedures, instructions and findings which enable the laboratory to assure quality of the calibration test results generated within the scope are documented. 10.6.2 Laboratory Personnel The personnel making professional judgement with reference to testing and/or calibration has appropriate background and experience. 10.6.3 Laboratory Product Identification and Testing The laboratory has procedures for the receipt, identification, handling, protection for calibration equipment items, including all provisions necessary to protect the integrity of the items. The calibration records are retained until final data is complete throughout the life of the item in the laboratory, enabling traceability from final data to raw data. 10.6.4 Laboratory Process Control ABC Metals, Inc. laboratory monitors, controls and records environmental conditions as required by relevant specifications or where they may influence the quality of results. Requirements for environmental conditions are established and maintained as appropriate to the technical activities concerned. 10.6.5 Laboratory Testing and Calibration Methods ABC Metals, Inc. laboratory uses test and/or calibration methods, including those for sampling, which meet the needs of the customer and are appropriate for the tests and/or calibrations undertaken. The laboratory verifies its capability to perform to the standard specifications before carrying out such work. When it is necessary to employ methods not covered by standard specifications, these will be subject to agreement with the customer. 10.6.6 Laboratory Statistical Methods Appropriate statistical techniques are applied, as appropriate, to verification activities whose deliverables are data. 10.7 ACCREDITED LABORATORIES ABC Metals, Inc. uses accredited laboratories when independent testing is required. Section Title: Inspection and Testing Revision No: 3 Section No: 10.0 Page 3 of 4 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/18/01
10.8 REFERENCES QS-9000, Element 4.10 ANSI/ASQC Q9002, 4.10 10.9 RELATED DOCUMENTATION Details of the approved methods are contained in Quality System Procedures: 10.1 Receiving Inspection and Testing 10.2 Inspection and Testing 10.3 Final Inspection 10.4 Laboratory Scope Section Title: Inspection and Testing Revision No: 3 Section No: 10.0 Page 4 of 4 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/18/01
SCOPE This section describes the methods to control, calibrate and maintain inspection, measuring and test equipment used to demonstrate the conformance of product to the specified requirements. 11.1 GENERAL Procedures to control, calibrate and maintain inspection, measuring and test equipment used to demonstrate the conformance of product to the specified requirements are maintained. Inspection, measuring and test equipment will be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability. Where test software or comparative references such as test hardware are used as suitable forms of inspection, they will be checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production and will be rechecked at prescribed intervals. The extent and frequency of such checks will be established and records as evidence of control will be maintained. Where the availability of technical data pertaining to the inspection, measuring, and test equipment is a specified requirement, such data will be made available, when required by the customer or customer s representative, for verification that the inspection, measuring, and test equipment is functionally adequate. 11.2 CONTROL PROCEDURE ABC Metals, Inc. will: determine the measurements to be made and the accuracy required, and select the appropriate inspection, measuring and test equipment that is capable of the necessary accuracy and precision identify all inspection, measuring and test equipment that can affect product quality, and calibrate and adjust them on prescribed intervals, or prior to use, against certified equipment having a known valid relationship to internationally or nationally recognized standards. Where no such standards exist, the basis used for calibration will be documented Calibration Services The calibration of inspection, measuring or test equipment will be conducted, as appropriate, by a qualified in-house laboratory, a qualified commercial independent laboratory, or a customer-recognized government agency. The ABC Metals, Inc. laboratory scope includes the calibration of such equipment. define the process employed for the calibration of inspection, measuring and test equipment, including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria and the action to be taken when results are unsatisfactory identify inspection, measuring and test equipment with a suitable indicator or approved identification record to show the calibration status Section Title: Control of Inspection, Measuring & Test Eqmt. Revision No: 2 Section No: 11.0 Page 1 of 2 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/18/01
11.2 CONTROL PROCEDURE (CONT.) maintain calibration records for inspection, measuring and test equipment; assess and document the validity of previous inspection and test results when inspection, measuring or test equipment is found to be out of calibration; ensure that the environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out ensure that the handling, preservation and storage of inspection, measuring and test equipment is such that the accuracy and fitness for use is maintained safeguard inspection, measuring and test facilities, including both test hardware and test software, from adjustments which would invalidate the calibration setting 11.3 INSPECTION, MEASURING, AND TEST EQUIPMENT RECORDS Records of the calibration/verification activity on all gages, measuring, and test equipment, including employee-owned gages, will include: revisions following engineering changes (if appropriate) any out of specification readings as received for calibration statements of conformance to specification after calibration notification to customer if suspect material has been shipped. 11.4 MEASUREMENT SYSTEM ANALYSIS Appropriate statistical studies will be conducted to analyze the variation present in the results of each type of measuring and test equipment system. This requirement applies to all measurement systems referenced in the Control Plan. The analytical methods and acceptance criteria used conform to those in the Measurement Systems Analysis reference manual. Other analytical methods and acceptance criteria may be used if approved by the customer. 11.5 REFERENCES QS-9000, Element 4.11 ANSI/ASQC Q9002, 4.11 Measurement Systems Analysis reference manual 11.6 RELATED DOCUMENTATION Details of the approved methods are contained in Quality System Procedures: 10.4 Laboratory Scope 11.1 Control of Inspection, Measuring and Test Equipment 11.2 Inspection, Measuring, and Test Equipment Records 11.3 Measurement System Analysis Section Title: Control of Inspection, Measuring & Test Eqmt. Revision No: 2 Section No: 11.0 Page 2 of 2 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/18/01
SCOPE This section describes the method in which the inspection and test status of the product will be identified, which indicates the conformance or nonconformance of product with regard to inspection and tests performed. 12.1 GENERAL The inspection and test status of product will be identified by suitable means, which indicates the conformance or nonconformance of product with regard to inspection and tests performed. The identification of inspection and test status will be maintained, as defined in the Control Plan and/or documented procedures, throughout production to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is released or used. The location of the product in the normal production flow will not constitute suitable indication of inspection and test status unless inherently obvious. 12.1.2 Supplemental Verification When required by the customer, additional verification/identification requirements will be met. 12.2 REFERENCES QS-9000, Element 4.12 ANSI/ASQC Q9002, 4.12 12.3 RELATED DOCUMENTATION Details of the approved methods are contained in Quality System Procedures: 12.1 Inspection and Test Status Section Title: Inspection and Test Status Revision No: 2 Section No: 12.0 Page 1 of 1 Approved by: Dan Kendall QSMR Reviewed:Dan Kendall Date: 9/18/01