to the Elsmar Cove!
ISO 9000 - QS-9000 Information Exchange
The following document is provided as a service to those seeking to achieve and/or maintain QS 9000 compliance. Note that approval of this specific document by one specific registrar. Does NOT mean YOUR registrar will approve it! Nor does it mean that 'NO MISTAKES' are contained herein... Each registrar is different, each auditor is different, and each audit/review is different.
Please help by contributing to the collective effort.
This Manual is Circa 1997
--Company X -- Quality Systems Manual
ISO 9000:1994 BASED REQUIREMENTS
Management Responsibility Element 4.1
Management Responsibility - Element 4.1
Quality Policy - 4.1.1
--COMPANY--'s management with executive responsibility has defined and documented its policy for quality, including objectives for quality and its commitment to quality. The quality policy is relevant to - --COMPANY--'s organizational goals and the expectations and needs of its customers. --COMPANY-- ensures that this policy is understood, implemented and maintained at all levels of the organization.
Organization - 4.1.2
Responsibility and Authority - 220.127.116.11
The responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality is defined and documented, particularly for personnel who need the organizational freedom and authority to:
Resources - 18.104.22.168
--COMPANY-- identifies resource requirements and provides adequate resources, including the assignment of trained personnel (see 4.18) , for management, performance of work and verification activities, including internal quality audits.
Management Representative - 22.214.171.124
--COMPANY--'s management with executive responsibility has appointed a member of --COMPANY--'s own management who, irrespective of other responsibilities, has defined authority for:
NOTE 5: The responsibility of a management
representative may also include liaison with external parties on
matters relating to --COMPANY--'s quality system.
--COMPANY-- has systems in place to ensure management of appropriate activities during concept development, prototype and production (refer to Advanced Product Quality Planning and Control Plan reference manual) . --COMPANY-- uses a multi-disciplinary approach for decision-making and has the ability to communicate necessary information and data in the customer-prescribed format.
Management Review - 4.1.3
--COMPANY--'s management with executive responsibility reviews the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of QS 9000 and --COMPANY--'s stated quality policy and objectives (see 4.1.1) . Records of such reviews are maintained (see 4.16) .
The Management Review requirement includes all elements of the entire quality system, not only those specifically required in other elements, e.g. 4.14.3d.
Business Plan - 4.1.4
--COMPANY-- has a formal, documented, comprehensive business plan. This plan includes as applicable:
The content of the Business Plan is not subject to third party audit.
Goals and plans cover short-term (1-2 years) and longer-term (3 years or more) . The goals and plans are based on analysis of competitive products and on benchmarking inside and outside automotive industry and --COMPANY--'s commodity. Methods to determine current and future customer expectations are in place. An objective valid process is used to collect information, which defines what information is ought, the frequency and methods of collection.
Methods to track, update, revise, and review the plan are documented to ensure that the plan is adhered to and communicated throughout the organization as appropriate.
Analysis and Use of Company-Level Data - 4.1.5
--COMPANY-- documents trends in quality, operational performance (productivity, efficiency, effectiveness) and current quality levels for key product and service features. These are compared with those of competitors and/or appropriate benchmarks.
Trends in data and information are compared with progress toward overall business objectives and translated into actionable information to support:
Customer Satisfaction - 4.1.6
--COMPANY-- has a documented process for determining customer satisfaction, including frequency of determination, and how objectivity and validity are assured. Trends in customer satisfaction and key indicators of customer dissatisfaction is documented and supported by objective information. These trends are compared to those of competitors, or appropriate benchmarks, and reviewed by senior management.
General - 4.2.1
--COMPANY-- has established, documented and maintains a quality system as a means of ensuring that product conforms to specified requirements. --COMPANY-- maintains a quality systems manual covering the requirements of QS 9000. The quality manual includes or makes reference to the quality system procedures and outline of the structure of the documentation used in the quality system.
NOTE 6: Guidance on quality manuals given in ISO 10013 is utilized.
Quality System Procedures - 4.2.2
NOTE 7: Documented procedures make reference to work instructions that define how an activity is performed.
Quality Planning - 4.2.3
--COMPANY-- has defined and documented how the requirements for quality will be met. Quality planning is consistent with all other requirements of --COMPANY--'s quality system and is documented in a format to suit --COMPANY--'s method of operation. --COMPANY-- has given consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or contracts:
--COMPANY-- utilizes the Advanced Product Quality Planning and Control Plan reference manual.
During the advanced product quality planning process, and particularly during the preparation of FMEAs and Control Plans, the planning team finalizes Special Characteristics. Appropriate process controls are established for all Special Characteristics.
NOTE: Customers use unique symbols to designate special characteristics that can affect safe vehicle operation, compliance with government regulations, fit/function, etc. Initially, the customer may determine Special Characteristics and identify them.
Use of Cross-Functional Teams
--COMPANY-- has established and implemented an advanced product quality planning process. - --COMPANY-- convenes internal cross-functional teams to prepare for production of new or changed products. These teams use appropriate techniques identified in the Advanced Product Quality Planning and Control Plan reference manual. Similar techniques that accomplish the intent are acceptable.
Team actions include:
NOTE: Cross-functional teams typically include --COMPANY--'s design, manufacturing engineering, quality, production, and other personnel. These teams may include the customer's Purchasing, Quality, Product Engineering, customer plant personnel as well as subcontractors.
--COMPANY-- investigates and confirms the manufacturing feasibility or proposed products prior to contracting to produce those products. Feasibility is an assessment of the suitability of a particular design, material, or process for production, while conforming to al engineering requirements at the required statistical process capability and at specific volumes.
Feasibility reviews are documented using the Team Feasibility Commitment in the Advanced Product Quality Planning and Control Plan reference manual.
Process Failure Mode and Effects Analysis (Process FMEAs)
Process FMEAs consider all special characteristics. Efforts are taken to improve the process to achieve defect prevention rather than defect detection. Certain customers have FMEA review and approval requirements that are met prior to production part approval. --COMPANY-- utilizes the Potential Failure Mode and Effects Analysis reference manual as a guide.
The Control Plan
--COMPANY-- develops Control Plans at the system, subsystem, component and/or material level, as appropriate for the product supplied.
The Control Plan requirement encompasses processes producing bulk material (e.g., steel, plastic resin, paint) as well as those producing parts.
The output of the advanced quality planing process, beyond the development of robust processes, is a Control Plan. Control Plans may be based on existing plans (for mature products and capable processes) . New plans are required when products or processes differ significantly from those in current production.
The Control Plan covers three distinct phases as appropriate:
NOTE: Prototype control plans may not be required if a contract specifically specifies the relief.
--COMPANY-- has established cross-functional teams to develop Control Plans for approval by the appropriate customer engineering and quality personnel unless this approval requirement is waived by the customer. In some cases, the customer will establish a cross-functional team to develop the Control Plan.
Control Plans are living documents and are reviewed and updated as appropriate when any of the following occur:
Contract Review - Element 4.3
General - 4.3.1
--COMPANY-- has established and maintains documented procedures for contract review and for the coordination of these activities.
Review - 4.3.2
Before the submission of a tender, or the acceptance of a contract or order (statement of requirement) , the tender, contract or order is reviewed by --COMPANY-- to ensure that:
Amendment to a Contract - 4.3.3
--COMPANY-- identifies how an amendment to a contract is made and correctly transferred to the functions concerned within --COMPANY--'s organization.
Records - 4.3.4
Records of contract reviews are maintained (see 4.16) .
NOTE 9: Channels for communication and interfaces with the customer's organization in these contract matters are established.
General - 4.4.1
--COMPANY-- has established and maintains documented procedures to control and verify the design of the product in order to ensure that the specified requirements are met.
Design and Development Planning - 4.4.2
--COMPANY-- has prepared plans for each design and development activity. The plans describe or reference these activities, and define responsibility for their implementation. The design and development activities are assigned to qualified personnel equipped with adequate resources. The plans are updated, as the design evolves.
--COMPANY--'s design activity is qualified in the following skills as appropriate:
Organizational and Technical Interfaces - 4.4.3
Organizational and technical interfaces between different groups which input to the design process is defined and the necessary information documented, transmitted and regularly reviewed.
Design Input - 4.4.4
Design input requirements relating to the product, including applicable statutory and regulatory requirements, are identified, documented and their selection reviewed by --COMPANY-- for adequacy. Incomplete, ambiguous or conflicting requirements are resolved with those responsible for imposing these requirements.
Design input takes into consideration the results of any contract review activities.
Design Input - Supplemental
--COMPANY-- has appropriate resources and facilities to utilize computer-aided product design, engineering and analysis. If these functions are subcontracted, --COMPANY-- provides technical leadership. The CAD/CAE systems are capable of two way interface with customer systems. The requirement for computer-aided systems can be waived by the customer.
Design Output - 4.4.5
Design output is documented and expressed in terms that can be verified and validated against design input requirement.
Design output documents are reviewed before release.
Design Output - Supplemental
--COMPANY--'s design output is the result of a process that includes:
Efforts to simplify, optimize, innovate, and reduce waste
(e.g., QFD, DFM/DFA, VE, DOE, tolerance studies, response surface
methodology, or appropriate alternatives)
Utilization of geometric dimensioning and tolerancing as applicable
Design Review - 4.4.6
At appropriate stages of design, formal documented reviews of the design results are planned and conducted. Participants at each design review include representatives of all functions concerned with the design stage being reviewed, as well as other specialist personnel, as required. Records of such reviews are maintained (see 4.16) .
Design Verification - 4.4.7
At appropriate stages of design, design verification is performed to ensure that the design stage output meets the design stage input requirements. The design verification measures are recorded (see 4.16) .
NOTE 10: In addition to conducting design reviews (see 4.4.6) , design verification may include activities such as the following:
Design Verification - Supplemental
--COMPANY-- has a comprehensive prototype program, unless this requirement is waived by the customer or the product being supplied is a standard item. --COMPANY-- uses the same subcontractors, tooling and processes, as will be used in production wherever possible.
Performance tests consider and include as appropriate product life, reliability and durability.
All performance testing activities are tracked to monitor timely completion and conformance to requirements.
Where these services are contracted, --COMPANY-- provides technical leadership.
Design Validation - 4.4.8
Design validation is performed to ensure that product conforms to defined user needs and/or requirements.
Design Changes - 4.4.9
All design changes and modifications are identified, documented, reviewed and approved by authorized personnel before their implementation.
Design Changes - Supplemental
All design changes, including those proposed by subcontractors, have written customer approval, or waiver of such approval, prior to production implementation. See the Production Part Approval Process manual.
For proprietary designs, impact on form, fit, function, performance, and/or durability is determined with the customer so that all effects can be properly evaluated.
Document and Data Control - Element 4.5
General - 4.5.1
--COMPANY-- has established and maintains documented procedures to control all documents and data that relate to the requirements of QS 9000 including, to the extent applicable, documents of external origin such as standards and customer drawings.
Where customer drawings of specifications reference other documents, --COMPANY-- has currently released editions of these documents available at all appropriate manufacturing locations. Examples of documents that are available are:
NOTE: --COMPANY-- may consolidate customer reference documents locally; however, the customer source documents are readily available.
Document Identification for Special Characteristics
--COMPANY--'s process control guidelines and similar documents are marked with the customer's special characteristics symbol (or --COMPANY--'s equivalent symbol or notation) to indicate those process steps that affect special characteristics, when required by the customer.
NOTE 15: Documents and data can be in the form of any type of media, such as hard copy or electronic media.
Document and Data Approval and Issue - 4.5.2
The documents and data are reviewed and approved for adequacy by authorized personnel prior to issue. A master list or equivalent document control procedure identifying the current revision status of documents is established and be readily available to preclude the use of invalid and/or obsolete documents.
This control ensures that:
--COMPANY-- has established a procedure to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes. --COMPANY-- maintains a record of the date on which each change is implemented in production (subject to record control, see 4.16) . Implementation includes updates to all appropriate documents.
Where practicable, the nature of the change is identified in the document or the appropriate attachments.
Purchasing - Element 4.6
General - 4.6.1
--COMPANY-- has established and maintains documented procedures to ensure that purchased product (see 3.1) conforms to specified requirements.
Approved Materials for Ongoing Production
Where the customer has an approved subcontractor list, --COMPANY-- purchases the relevant material from subcontractors on the list. Any additional subcontractors are only be used after they have been added to the list by the customer's Materials Engineering activity.
All materials used in part manufacture satisfy current government 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 (see Glossary) .
Evaluation of Subcontractors - 4.6.2
--COMPANY-- performs subcontractor quality system development using Sections I and II of QS-9000 as the fundamental quality system requirement. Assessments, if part of subcontractor development, occur at a defined, specific frequency. Subcontractor assessments to QS-9000 by the OEM customer, and OEM customer-approved second party, or an accredited third party registrar are recognized in lieu of audits by --COMPANY--.
The use of customer-designated subcontractors does not relieve --COMPANY-- of the responsibility for ensuring the quality of subcontracted parts, materials and services.
--COMPANY-- requires 100% on-time delivery performance from subcontractors. --COMPANY-- provides appropriate planning information and purchase commitments to enable subcontractors to meet this expectation.
--COMPANY-- has implemented a system to monitor the delivery performance of subcontractors, including tracking of premium or excessive freight.
Purchasing Data - 4.6.3
Purchasing documents contain data clearly describing the product ordered, including where applicable:
--COMPANY-- reviews and approves purchasing documents for adequacy of specified requirements prior to release.
--COMPANY-- has a process to assure that governmental and safety constraints on restricted, toxic and hazardous substances are complied with relative to purchased products and the manufacturing process.
Verification of Purchased Product - 4.6.4
--COMPANY-- Verification at Subcontractor's Premises (ISO) - 126.96.36.199
Where --COMPANY-- proposes to verify purchased product at the subcontractor's premises, --COMPANY - specifies verification arrangements and the method of product release in the purchasing documents.
Customer Verification of Subcontracted Product (ISO) -
Where specified in the contract, --COMPANY--'s customer or the customer's representative is afforded the right to verify at the subcontractor's premises and --COMPANY--'s premises that subcontracted product conforms to specified requirements. Such verification is not used by --COMPANY-- as evidence of effective control of quality by the subcontractor.
Verification by the customer does not absolve --COMPANY-- of the responsibility to provide acceptable product, nor does it preclude subsequent rejection by the customer.
Control of Customer-Supplied Product - Element 4.7
--COMPANY-- has established and maintains documented procedures for the control of verification, storage and maintenance of customer-supplied product provided for incorporation into the supplies of for related activities. Any such product that is lost, damaged or is otherwise unsuitable for use is recorded and reported to the customer (see 4.16) .
Verification by --COMPANY-- does not absolve the customer of the responsibility to provide acceptable product.
Product Identification and Traceability - Element 4.8
Where appropriate, --COMPANY-- has established and maintains documented procedures for identifying the product by suitable means from receipt and during all stages of production, delivery and installation.
Where and to the extent that traceability is a specified requirement, --COMPANY-- has established and maintains documented procedures for unique identification of individual product or batches. This identification is recorded (see 4.16) .
Process Control - Element 4.9
--COMPANY-- identifies and plans the production, installation and servicing processes which directly affect quality and ensures that these processes are carried out under controlled conditions. Controlled conditions include the following:
Government Safety and Environmental Regulations
--COMPANY-- has a process to ensure compliance with all applicable government safety and environmental regulations, including those concerning handling, recycling, eliminating or disposing of hazardous materials. This is evidenced by appropriate certificates or letters of compliance.
Designation of Special Characteristics
--COMPANY-- complies with all customer requirements for designation, documentation and control of special characteristics. --COMPANY-- provides documentation showing compliance with these customer requirements as requested by any customer.
NOTE: All product and process characteristics are important and need to be controlled. However, some characteristics, herein referred to as "special", are given extra attention because excessive variation in them might affect a product's safety, compliance with government regulations, fit, function, appearance or quality of subsequent manufacturing operations.
--COMPANY-- identifies 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 includes:
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 are carried out by qualified operators and/or require continuous monitoring and control of process parameters to ensure that the specified requirements are met.
The requirements for any qualification of process operations, including associated equipment and personnel (see 4.18) , are specified.
Records are maintained for qualified processes, equipment and personnel, as appropriate (see 4.16) .
Process Monitoring and Operator Instructions - 4.9.1
--COMPANY-- prepares documented process monitoring and operator instructions for all employees having responsibilities for operation of processes. These instructions are to be accessible at the work station. These instructions are derived from the sources listed in the Advanced Product Quality Planning and Control Plan reference manual.
Process monitoring and operator instructions may take the form of process sheets, inspection and laboratory test instructions, shop travellers, test procedures, standard operation sheets, the part number Control Plan, or other documents normally used by --COMPANY-- to provide the necessary information.
Process monitoring and operator instructions include or reference, as appropriate:
Preliminary Process Capability Requirements - 4.9.2
Preliminary process capability studies are required for each --COMPANY-- or customer-designated special characteristic for new processes. The data meets customer requirements. If no requirements have been specified, a Ppk value of more than 1.67 is achieved for preliminary results (less than 30 production days) and for chronically unstable processes. If these requirements are not met, --COMPANY-- proceeds in accordance with the Production Part Approval Process manual.
This information is reviewed with the customer as required through the various stages of quality planning.
Unacceptable preliminary capability results trigger re-evaluation of mistake-proofing activities. See Section II, Techniques for Continuous Improvement for additional techniques.
Inherent limitations of attributes data prevent their use for preliminary statistical studies. Attributes data from early production runs are used to prioritize process improvements and to begin control charts.
Ongoing Process Performance Requirements - 4.9.3
Ongoing process performance requirements are defined by the customer. If no such requirements have been established, the following default values apply:
For stable processes and normally distributed data, a Cpk value of more than 1.33 is achieved.
For chronically unstable processes with output meeting specifications and a predictable pattern, a minimum Ppk value of 1.67 is achieved.
For non-normal data, methods other the Cpk such as parts per million (PPM) , non-parametric analysis, or index techniques are utilized to determine performance based on customer requirements.
Significant process events (e.g., tool change, machine repair) are noted on the control charts.
When data from control charts and functional tests indicate a high degree of capability, --COMPANY-- may revise the Control Plan with customer concurrence.
Characteristics identified on the Control Plan that are either unstable of non-capable trigger initiation of the appropriate reaction plan from the Control Plan. Customer specified reactions are complied with. Reaction plans include containment of the process output and 100% inspection. --COMPANY-- corrective action plan will then be completed indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans are reviewed with and approved by the customer when so required.
Regardless of the capability requirement of the demonstrated process capability, continuous improvement isutilized, with the highest priority on special characteristics.
Modified Preliminary of Ongoing Capability Requirements -
In some cases, a customer may require either higher or lower capability requirements than the previously stated default requirements. In these cases, the Control Plan is annotated accordingly.
Verification of Job Set-Ups - 4.9.5
Job set-ups are verified as producing parts that meet all requirements. Documentation is available for set up personnel. Last-off part comparisons are recommended. Statistical verification is utilized where applicable.
Process Changes - 4.9.6
Production part approval is granted for a part number, engineering change level, manufacturing location, material source(s) and production process environment. Changes in any of these factors may require prior approval from the customer parts approval activity. --COMPANY-- refers to the Production Part Approval Process manual and customer-specific pages of QS 9000 for unique customer requirements.--
--COMPANY-- maintains a record of process change effective dates (see 4.5.3) .
NOTE: Changes to promote continuous improvement are encouraged.
Appearance Items - 4.9.7
For parts designated by the customer as "Appearance Items", --COMPANY-- provides:
General - 4.10.1
--COMPANY-- has established and maintains documented procedures 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 quality plan (Control Plan) or documented procedures.
Acceptance criteria for attribute data sampling plans is zero defects. Appropriate acceptance criteria for all other situations (e.g., visual standards) are documented by --COMPANY-- and approved by the customer.
--COMPANY-- uses accredited laboratory facilities when required by the customer.
Receiving Inspection and Testing - 4.10.2
188.8.131.52 --COMPANY-- ensures that incoming product is not used or processed (except in the circumstances described in 184.108.40.206) until it has been inspected or otherwise verified as conforming to specified requirements. Verification of conformance to the specified requirements is in accordance with the quality plan (Control Plan) and/or documented procedures.
220.127.116.11 In determining the amount and nature of receiving inspection, consideration is given to the amount of control exercised at the subcontractor's premises and the recorded evidence of conformance provided.
18.104.22.168 Where incoming product Is released for urgent production purposes prior to verification, it is positively identified and recorded (see 4.16) in order to permit immediate recall and replacement in the event of nonconformity to specified requirements.
Incoming Product Quality
--COMPANY--'s incoming quality system uses one or more of the following methods:
In-Process Inspection and Testing - 4.10.3
Final Inspection and Testing - 4.10.4
--COMPANY-- carries out all final inspection and testing in accordance with the quality plan (Control Plan) and/or documented procedures to complete the evidence of conformance of the finished product to the specific requirements.
The quality plan (Control Plan) and/or documented procedures for final inspection and testing require that all specified inspection and tests, including those specified either on receipt of product or in-process, have been carried out and that the results meet specified requirements.
No product is dispatched until all the activities specified in the quality plan (Control Plan) and/or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized.
Layout Inspection and Functional Testing
A layout inspection and a functional verification (to applicable customer engineering material and performance standards) is required for all products at a frequency established by the customer. Results are available for customer review upon request.
Inspection and Test Records - 4.10.5
--COMPANY-- has established and maintains records which provide evidence that the product has been inspected and/or tested. These records show clearly whether the product has passed or failed the inspections 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 apply (see 4.13) .
Records identify the inspection authority responsible for the release of the product (see 4.16) .
General - 4.11.1
--COMPANY-- has established and maintains documented procedures to control, calibrate and maintain inspection, measuring and test equipment (including test software) used by --COMPANY-- to demonstrate the conformance of product to the specified requirements. Inspection, measuring and test equipment is used in a manner which ensures that the measurement uncertainty is known and is consistent with the requirement measurement capability.
Where test software or comparative references such as test hardware are used as suitable forms of inspection, they are checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production, installation, or servicing, and are rechecked at prescribed intervals. - --COMPANY-- has established the extent and frequency of such checks and maintains records as evidence of control (see 4.16) .
Where the availability of technical data pertaining to the inspection, measuring, and test equipment is a specified requirement, such data is made available, when required by the customer or customer's representative, for verification that the inspection, measuring, and test equipment is functionally adequate.
NOTE 17: For the purposes of this document, the term "measuring equipment" includes measurements devices.
Control Procedure - 4.11.2
NOTE 18: The metrological confirmation system for measuring equipment given in ISO 10012 is used for guidance.
Inspection, Measuring and Test Equipments Records -
Records of the calibration/verification activity on all gages, measuring, and test equipment, including employee-owned gages, includes:
Measurement System Analysis - 4.11.4
Evidence is maintained that appropriate statistical studies have been conducted to analyze the variation present in the results of each type of measuring and test equipment system. This applies to all measurement systems referenced in the customer approved Control Plan. The analytical methods and acceptance criteria used conforms to those in the Measurement Systems Analysis reference manual [e.g., gage repeatability and reproducibility (gage R&R) studies]. Other analytical methods and acceptance criteria may be used if approved by the customer.
Inspection and Test Status - Element 4.12
The inspection and test status of product is 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 is maintained, as defined in the quality plan (Control Plan) and/or documented procedures, throughout production, installation and servicing of the product to ensure that only product that has passed the required inspections and tests [or released under an authorized concession (see 4.13.2) ] is dispatched, used or installed.
Location of product in the normal production flow does not constitute suitable indication of inspection and test status unless inherently obvious (i.e. material in automated production transfer process) .
When required by the customer, additional verification/identification requirements are met (e.g., early launch control) .
General - 4.13.1
--COMPANY-- has established and maintains documented procedures to ensure that product that does not conform to specified requirements is prevented from unintended use or installation. This control provides for identification, documentation, evaluation, segregation (when practical) , disposition of nonconforming product, and for notification to the functions concerned.
This element applies to suspect as well as to nonconforming product.
Review and Disposition of Nonconforming Product - 4.13.2
The responsibility for review and authority for the disposition of nonconforming product is defined.
Nonconforming product is reviewed in accordance with documented procedures. It may by
Where required by the contract, the proposed uses or repair of product (see 4.13.2b) which does not conform to specified requirements are reported for concession to the customer or customer's representative. The description of nonconformity that has been accepted, and of repairs, is recorded to denote the actual condition (see 4.16) .
Repaired and/or reworked product is reinspected in accordance with the quality plan (Control Plan) and/or documented procedure.
Control of Reworked Product - 4.13.3
Rework (see Glossary) instructions are accessible and utilized by the appropriate personnel in their work areas.
--COMPANY-- quantifies and analyzes nonconforming product and has established a prioritized reduction plan. Progress towards the plan is tracked.
No rework visible on the exterior of the product is permissible on those products supplied for service applications without prior approval of the customer service parts organization.
Engineering Approved Product Authorization - 4.13.4
Prior written customer authorization is required whenever the product or process is different from that currently approved (see Production Part Approval Process manual) . This applies equally to products or services purchased from subcontractors. --COMPANY-- concurs with any requests by a subcontractor before submission to the customer. --COMPANY-- maintains a record of the expiration date or quantity authorized. --COMPANY-- also ensures compliance with the original or superseding specifications and requirements when the authorization expires. Material shipped on an authorization are properly identified on each shipping container.
General - 4.14.1
--COMPANY-- has established and maintains documented procedures for implementing corrective and preventive action.
Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities is to a degree appropriate to the magnitude of problems and commensurate with the risks encountered.
--COMPANY-- uses a disciplined problem solving methods when an internal or external nonconformance to specification or requirements occurs. When external nonconformances occur, --COMPANY-- responds in a manner prescribed by the customer.
Corrective Action - 4.14.2
The procedures for corrective action include:
Returned Product Test/Analysis
--COMPANY-- analyzes parts returned from the customer's manufacturing plants, engineering facilities, and dealerships. Records of these analyses are kept and made available upon request. --COMPANY-- performs effective analysis and where appropriate, initiates corrective action and process changes to prevent recurrence.
Preventive Action - 4.14.3
The procedures for preventive action include:
General - 4.15.1
--COMPANY-- has established and maintains documented procedures for handling, storage, packaging, preservation and delivery of product.
Handling - 4.15.2
--COMPANY-- provides methods of handling product that prevent damage or deterioration.
Storage - 4.15.3
--COMPANY-- uses designated storage areas or stock rooms to prevent damage or deterioration of product, pending use or delivery. Appropriate methods for authorizing receipt to and dispatch from such areas are stipulated.
In order to detect deterioration, the condition of product in stock is assessed at appropriate intervals.
An inventory management system is established and documented to continuously optimize inventory turns over time, assure stock rotation and minimize inventory levels.
Packaging - 4.15.4
--COMPANY-- controls packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements.
Customer Packaging Standards
Refer to unique customer packaging standards/guidelines, including applicable service part packaging standards.
--COMPANY-- has a system to ensure that all materials shipped are labeled according to customer requirements.
Preservation - 4.15.5
--COMPANY-- applies appropriate methods for preservation and segregation of product when the product is under --COMPANY--'s control.
Delivery - 4.15.6
--COMPANY-- arranges for the protection of the quality of product after final inspection and test. Where contractually specified, this protection is extended to include delivery to destination.
--COMPANY-- Delivery Performance Monitoring
--COMPANY-- has established systems to support 100% on-time shipments to meet customer production and service requirements. If 100% on-time shipments are not maintained --COMPANY-- implements corrective action to improve delivery performance, including communication of delivery problem information to the customer.
--COMPANY-- uses a systematic approach to develop, evaluate and monitor adherence to established lead time requirements. --COMPANY-- has implemented a system to track performance to the customer delivery requirements.
--COMPANY-- ships all materials in conformance with customer requirements, adhering to up-to-date customer-specific transportation mode, routings and containers.
--COMPANY--'s production scheduling activity is order-driven.
NOTE: The use of small lots with a goal of one piece flow in a synchronous manner is encouraged.
Shipment Notification System
--COMPANY-- has a computerized system for on-line transmittal of advance shipment notifications (ASNs) , transmitted at the time of shipment, unless waived by the customer.
--COMPANY-- has a back-up method in the event that the on-line system fails. --COMPANY-- verifies that all ASNs match shipping documents and labels.
--COMPANY-- has established and maintains documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition (DISPOSAL) of quality records.
Quality records are maintained to demonstrate conformance to specified requirements and the effective operation of the quality system. Pertinent quality records from the subcontractor are an element of these data.
All quality records are legible and are stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of quality records are established and recorded. Where agreed contractually, quality records are made available for evaluation by the customer or the customer's representative for an agreed period.
NOTE 19: Records can be in the form of any type of media, such as hard copy or electronic media.
Production part approvals, tooling records, purchase orders and amendments are maintained for the length of time that the part (or family of parts) is active for production and service requirements plus one calendar year.
Quality performance records (e.g., control charts, inspection and test results) are retained for one calendar year after the year in which they were created.
Records of internal quality system audits and management review are retained for three years.
These requirements do not supersede any governmental or customer requirements. All specific retention periods are considered "minimums".
Copies of documents from superseded parts required for new part qualification are retained in the new part file.
--COMPANY-- has established and maintains documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.
Internal quality audits are scheduled on the basis of the status and importance of the activity to be audited and are carried out by personnel independent of those having direct responsibility for the activity being audited.
The results of the audits are recorded (see 4.16) and brought to the attention of the personnel having responsibility in the area audited. The management personnel responsible for the area take timely corrective action on the deficiencies found during the audit.
Follow-up audit activities verify and record the implementation and effectiveness of the corrective action taken (see 4.16) .
Inclusion of Working Environment
Suitable working environment is considered as part of the internal audit process.
--COMPANY-- has established and maintains documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality. Personnel performing specific assigned tasks and/or experience, as required. Appropriate records of training are maintained (see 4.16) .
Training as a Strategic Issue
Training is viewed as a strategic issue affecting all of --COMPANY--'s personnel. Training effectiveness is periodically evaluated.
Where servicing is a specified requirement, --COMPANY-- has established and maintains documented procedures for performing, verifying and reporting that the servicing meets the specified requirements.
Feedback of Information from Service
A procedure for communication of information on service concerns to manufacturing, engineering and design activities are established and maintained.
Identification of Need - 4.20.1
--COMPANY-- identifies the need for statistical techniques required for establishing, controlling and verifying process capability and product characteristics.
Procedures - 4.20.2
--COMPANY-- has established and maintains documented procedures to implement and control the application of the statistical techniques identified in 4.20.1.
Selection of Statistical Tools
The selection of appropriate statistical tools for each process is determined during advanced quality planning and are included in the Control Plan.
Knowledge of Basic Statistical Concepts
Basic concepts such as variation, control (stability) , capability and over-adjustment is understood throughout --COMPANY--'s organization as appropriate.
Consult the Fundamental Statistical Process Control reference manual.
General - 1.1
--COMPANY-- fully complies with all requirements set forth in the Production Part Approval Process (PPAP) manual.
Production part approval is granted for a part number, engineering change level, manufacturing location, material subcontractor(s) and production process environment. Change to any of these triggers customer notification and possible resubmission. See PPAP.
--COMPANY-- is responsible for subcontracted material and services.
IF THERE IS ANY QUESTION CONCERNING THE NEED FOR PRODUCTION PART APPROVAL, - --COMPANY-- CONTACTS THE RESPONSIBLE CUSTOMER PART APPROVAL ACTIVITY.
ADDITIONAL APPROVALS ARE SECURED FOR PARTS DESIGNATED BY THE CUSTOMER AS "APPEARANCE ITEMS".
Engineering Change Validation - 1.2
It is --COMPANY-- 's responsibility to verify that changes are properly validated. See 4.12, 4.16 and PPAP.
General - 2.1
A comprehensive continuous improvement philosophy is fully deployed throughout --COMPANY--'s organization. --COMPANY-- continuously improves in quality, service, (including timing and delivery) and price for all customers. This requirement does not replace the need for innovative improvements.
--COMPANY-- has specific action plans for continuous improvement in processes that are most important to the customer once those processes have demonstrated stability and acceptable capability.
For characteristics that can only be evaluated using attribute data, continuous improvement means perfection of process methods to ensure that the requirement is always met.
NOTE: For those product characteristics and process parameters that can be evaluated using variables data, continuous improvement means optimizing the characteristics and parameters at a target value and reducing variation around that value.
NOTE: --COMPANY-- extends continuous improvement philosophy to all business processes and support services.
Quality and Productivity Improvements - 2.2
--COMPANY-- identifies opportunities for quality and productivity and implement appropriate improvement projects. Examples are:
Techniques for Continuous Improvement - 2.3
--COMPANY-- has a demonstrated knowledge of the following measures and methodologies and uses those that are appropriate:
Facilities, Equipment, and Process Planning and Effectiveness - 3.1
--COMPANY-- uses a cross-functional team approach for developing facilities, processes and equipment plans in conjunction with the advanced quality planning process. Plant layouts minimize material travel and handling, facilitate synchronous material flow, and maximize value-added use of floor space. --COMPANY - evaluates 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.
Mistake Proofing - 3.2
Mistake proofing is the use of process or design features to prevent manufacture of nonconforming product. When potential sources of nonconforming units are identified by FMEAs, capability studies and service reports, these sources are addressed using mistake proofing methodology during the planning of processes, facilities, equipment and tooling as well as during problem resolution.
Tool Design and Fabrication - 3.3
--COMPANY-- provides appropriate technical resources for tool and gage design, fabrication and full dimensional inspection. If any of this work is subcontracted, a tracking and follow-up system is required. Customer-owned tools and equipment is permanently marked so that ownership of each item is visually apparent.
Tooling Management - 3.4
--COMPANY-- has established and maintains a system for tooling management, including:
If any of this work is subcontracted, a tracking and follow-up system is established.
Acronym -- Meaning