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Welcome
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
Section I
ISO 9000:1994 BASED REQUIREMENTS
SECTION ORGANIZATION
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 - 4.1.2.1
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 - 4.1.2.2
--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 - 4.1.2.3
--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.
Organizational Interfaces
--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) .
Management Review
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
--COMPANY-- has
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:
Quality Planning
--COMPANY-- utilizes the Advanced Product Quality Planning and
Control Plan reference manual.
Special Characteristics
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.
Feasibility Reviews
--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.
Required Skills
--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:
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.
NOTES
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.
Reference Documents
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:
Engineering Specifications
--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--:
Subcontractor Development
--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.
Scheduling Subcontractors
--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.
Restricted Substances
--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) -
4.6.4.1
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) -
4.6.4.2
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.
Preventative Maintenance
--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 -
4.9.4
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
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.
Accredited Laboratories
--COMPANY-- uses accredited laboratory facilities when
required by the customer.
Receiving Inspection and Testing - 4.10.2
4.10.2.1 --COMPANY-- ensures that incoming product is not used
or processed (except in the circumstances described in 4.10.2.3)
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.
4.10.2.2 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.
4.10.2.3 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
--COMPANY--:
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
--COMPANY--:
NOTE 18: The metrological confirmation system for measuring equipment given in ISO 10012 is used for guidance.
Inspection, Measuring and Test Equipments Records -
4.11.3
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.
Product Location
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) .
Supplemental Verification
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.
Suspect Product
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.
Inventory
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.
Labeling
--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.
Production Scheduling
--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.
Record Retention
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".
Superseded Parts
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) .
NOTES
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.
ORGANIZATION
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
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