Document to be changed

Element

Additional clause

Quality Manual

Procedure

W.I.

Form & implementation

4.1.2.1.a

Note : It is recommended that the person responsible for quality have the authority to stop production, if necessary to correct quality problems.

Yes in Authorities

4.13, 4.14

J.D.

4.1.2.1.f

personnel who need the organizational freedom and authority to represent the needs of the customer in internal functions in addressing QS-9000 requirements (e.g. selection of special characteristics, setting quality objectives, training, corrective & preventive actions, product design and development).

Yes in Management J.D.

Check

Check

4.1.2.5

Management with responsibility and authority for corrective action shall be promptly informed of products or processes which become noncompliant with specified requirements.

Yes in Authorities

Check 4.13, 4.14

4.1.3.1

Management review should be conducted with a multi-disciplinary approach

Yes

4.1

Show attendant list in Minute of meeting

4.1.4

The Business Plan shall be a controlled document.

4.1.4

Control Biz Plan

4.1.5

The supplier shall document trends in quality, operational performance (productivity, efficiency, effectiveness, cost of poor quality)

Set as internal Measurables

4.1.6

Customer Satisfaction NOTE: Consideration should be given to internal, external and final customers.

Final: Thru OEM & service center

4.1.6.1

A supplier shall notify their certification body/registrar in writing within five (5) days when a customer places the site in any of the following statuses:

Yes

4.13, 4.14

4.2.3.2

The supplier’s process control guidelines and similar documents (e.g. FMEA’s, Control Plans, Operator Instructions) shall be marked with the customer’s special characteristics symbol

APQP Procedure

Check all

4.2.3.2 Note

Initially, the customer may determine Special Characteristics and identify them. Special Characteristics may be identified from any product characteristics category, e.g. dimensional, material, appearance, performance.

APQP Procedure

Check all

4.2.3.4

Due care and product safety shall be considered in the supplier ’s design control (element 4.4) and process control (element 4.9) policies and practices. The supplier should promote internal awareness of safety considerations relative to the supplier’s product.

APQP Procedure

Check all

Signs in front of affected production units

4.2.3.6

The supplier shall utilize appropriate mistake proofing methodologies during the planning of processes, facilities, equipment and tooling.

Facility Planning or APQP Procedure

evidence

4.2.3.7

The Control Plan shall include the information required in the Control Plan form in Appendix J.

APQP Procedure

Check all C.P.

4.2.3.7

Control Plans shall be revised or updated when products or processes differ significantly from those in current production.

APQP Procedure

Check all C.P.

Revised PPAPs or Waive letters

4.2.3.7

The Control Plan should list the controls used for process control (see 4.9).

APQP Procedure

Check all C.P.

4.2.3.7

The supplier shall have a prototype control plan if they are required by the customer.

APQP Procedure

Check all C.P.

4.2.3.7 Note

A multi-disciplinary approach typically includes the supplier’s design, manufacturing, engineering, quality, production and other appropriate personnel. For external suppliers, it may include the customer’s Purchasing, Quality, Product Engineering, customer plant personnel as well as subcontrators.

Check

Check

Feasibility Records

4.2.3.7

Process Change Procedure

Revised PPAPs or Waive letters

4.2.4.2

NOTE: Certain customers require that their suppliers use PPAP with their subcontractors (see Section II).

Subcontractor Development Procedure

As appropriate

4.2.4.3

NOTE: This applies equally to suppliers and subcontractors.

Process Change Procedure

ECN Log / Records (Customer/Subcontractor)

4.2.5.1 Note

A continuous improvement philosophy should be fully deployed throughout the supplier ’s organization.

Define

QOS Measurables in every area

4.2.5.1

Continuous improvement shall extend to product characteristics with the highest priority on special characteristics.

QOS Measurable

4.2.5.1 Note

Cost elements or price should be one of the key indicators within a continuous improvement system.

QOS Measurable

4.2.5.1 Note

For those product characteristics and process parameters that can only be evaluated using attribute data, continuous improvement is not possible until zero defects, it is by definition nonconforming product (see 4.10.1.1, 4.13, 4.14). Improvements made in these situations are by definition corrective actions, not continuous improvement.

Evidence of such understanding

4.2.5.1

Suppliers shall develop prioritized action plans for continuous improvement in processes that have demonstrated stability and acceptable capability and performance.

QOS Measurable

4.2.5.1 Note

Processes with unacceptable capability/performance require corrective action (see 4.14.2

Record

4.2.5.2

QOS Measurable

4.2.5.3

The supplier shall demonstrate knowledge of appropriate continuous improvement measures and methodologies and shall use those that are appropriate.

In QOS Measurable record

4.2.5.3 Note

The following list shows examples of possible techniques which might be used. There may be many other methods which meet specific supplier needs more appropriately.

Record of selected techniques

4.2.6.1 Note

The supplier should identify and define appropriate metrics to monitor the effectiveness of existing operations.

Metrics or other evidence

4.2.6.2

Tool modification, including tool design documentation

Check

Check

4.2.6.2

Suppliers shall provide appropriate technical resources for tool (see glossary) and gage design, fabrication and full dimensional inspection.

Check

Check

4.2.6.2

The supplier shall implement a system to track and follow-up these activities if any of this work is subcontracted.

Check Procedure

Gantt Chart

4.4

A supplier is defined as design-responsible if it has the authority to establish a new, or change an existing product specification for any product shipped to a customer, Customer approval of a design responsible supplier’s product does not waive the supplier’s design responsible status. Consult your customer for further clarification if needed.

N.A.

N.A.

N.A.

N.A.

4.4.1.1

The supplier shall have a process to deploy information gained from previous design projects to current and future projects of a similar nature.

N.A.

N.A.

N.A.

N.A.

4.4.8.1

Design validation shall be performed in conjunction with customer program timing requirements.

N.A.

N.A.

N.A.

N.A.

4.4.8.1

Validation results shall be recorded (see 4.16).

N.A.

N.A.

N.A.

N.A.

4.4.8.1

Design failures shall be documented in the validation records.

N.A.

N.A.

N.A.

N.A.

4.4.8.1

Procedures for corrective and preventive action shall be followed in addressing such design failures.

N.A.

N.A.

N.A.

N.A.

4.4.9.2

The supplier shall consider the impact of a design change on the system in which the product is used

N.A.

N.A.

N.A.

N.A.

4.4.10

When required by the customer, the supplier shall have a comprehensive prototype program.

N.A.

N.A.

N.A.

N.A.

Confidentiality - 4.4.11

The supplier shall ensure the confidentiality of customer-contracted products under development and related product information.

N.A.

N.A.

N.A.

N.A.

Element 4.5 Note

Document and data can be in the form of any type of media, such as hard copy or electronic media.

Clearly Define

Include in Master list

4.5.2.1

The supplier shall establish a procedure to assure the timely review (e.g. business “days”, not weeks or months.)

Link to Process Change procedure

ECN Log and cross link

4.5.2.1 Note

A change in these specifications should require an updated PPAP record when these specification are referenced on the design record (see Glossary) or if they affect PPAP documents (e.g. Control Plan, FMEAs, etc.) See PPAP.

Link to Process Change procedure

ECN Log and cross link

4.6.1.1

To be added to any existing customer “approved subcontractor list”, a company should contact the appropriate customer engineering function to be considered. These lists exist only for certain commodities and, where they do exist, they may be found in the customer design record (see Glossary).

Clearly define

AVL

4.6.1.2

All purchased materials used in part manufacture shall 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-Approved Materials).

Define

MSDS list

4.6.2.1 Note

The prioritization of subcontractors for development is dependent upon the needs of the subcontractor relative to the requirements of QS-9000 and the importance of the product or service they supply.

Record and Yearly development Plan

4.6.2.2

The supplier shall implement a system to monitor the delivery performance of subcontractors with corrective actions taken as appropriate. Records of premium freight shall include both supplier and subcontractor paid charges.

Define

Record

4.6.3.c

Check Procedure

Define

P.O.

4.7.1

4.7 and 4.2.6.2

Define

Evidence

4.7.1 Note

An affixed tag specifically containing the part number and/or customer name to identify ownership is the preferred approach. However, this requirement may be met by using a supplier designated number cross-referenced with clear traceability back to the customer.

Evidence

Element 4.8 Note

For QS-9000, the words “Where appropriate” above are not applicable.

Discuss with customer

4.9.b.1

The supplier shall maintain premises in a state of order, cleanliness and repair appropriate to the product(s) manufactured.

5S record and evidence

4.9.b.2

The supplier shall prepare contingency plans (e.g. utility interruptions, labor shortages, key equipment failure) to reasonably protect the customer’s supply of product in the event of emergency, excluding natural disaster and acts of God.

Define

W.I.

Assume probable scenario and their contingency plans

4.9.g.1

PM Procedure

Define

Record

4.9.1 Note

Job Instructions (see Glossary) should be available at the time needed without disruption to the job being performed by the operator.

Evidence

4.9.2

Record and MSA study plan

4.9.2

Significant process events (e.g. tool change, machine repair) should be noted on the control charts

Record

4.9.2

When process and/or product data indicate a high degree of capability (e.g. Cpk/Ppk 3), the supplier may revise the Control Plan, as appropriate (see PPAP and Section II)

As appropriate

4.9.2

The supplier shall initiate the appropriate reaction plan from the Control Plan for characteristics which are identified on the Control Plan and are either unstable or non-capable. Reaction plans should include containment of process output and 100% inspection. A supplier corrective action plan shall then be completed indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable (see 4.10.1.1). The plans are to be reviewed with and approved by the customer when so required..

May merge with contingency plan

Assume probable scenario and their contingency plans

4.9.3

In some cases, the customer may require either higher or lower capability requirements than the previously-stated default requirements. In these cases, the Control Plan shall be annotated accordingly (i.e. in the product/process Specification/Tolerance column of the suggested APQP Control Plan).

Control Plan

4.9.4

Job set-ups shall be verified whenever a setup is performed (e.g. initial run of a job, material changeover, job change, significant time periods lapsed between runs, etc.)

Define

Record

4.9.4

Job Instruction (see Glossary) shall be avaiable for setup personnel. Last-off part comparisons are recommended.

W.I.

Record

4.9.4

The supplier shall use statistical methods of verification where applicable (see Section II).

As applicable

4.9.5

The supplier shall maintain Records or process change effective dates

ECN Log

4.9.6

Define

AAR and Appearance Masters

4.10.3.c

c) direct process activities toward defect prevention methods, such as statistical process control, Mistake proofing, visual controls, rather then defect detection.

Set as QOS Measurable

4.10.4.1

A layout inspection and a functional verification (to applicable customer engineering material and performance standards) shall be performed for all products at a frequency established by the customer.

Define

Control plan and Records

4.10.4.2

The supplier shall conduct audits of packaged final product to verify conformance to all specified requirements (e.g. product, packaging, labeling) at an appropriate frequency.

Define in Packing or shipping W.I.

As required

4.10.4.2 Note

This activity, also known as a “dock audit”, is based upon sampling and is generally performed after final inspection but prior to shipment. Where customer PPM requirements are met, the frequency of Final Product Audits may be reduced.

As required

4.10.6 Note

NOTE: Element 4.10.6 applies to supplier in-house laboratory facilities, not inspection or testing performed outside of a laboratory facility.

4.10.6.1

The laboratory (supplier’s testing facility - chemical, metallurgical, reliability, test validation, e.g. fastener labs) shall have a laboratory scope (see Glossary).

Scope

4.10.6.1

The laboratory shall document all its policies, systems, programs, procedures, instructions and findings which enable the laboratory to assure the quality of the tests or calibration results it generates within the scope (see 4.2.1).

policies, systems, programs, procedures

Record

4.10.6.1 Note

Accreditation of supplier facilities to ISO/IEC Guide25 or national equivalent is not required by, nor does it satisfy, all QS-9000 requirements for laboratory. Therefore, the laboratory should be included in the on-site audits.

4.10 and 4.6

Laboratory Evaluation Record

4.10.6.2

The personnel making professional judgment with reference to testing and/or calibration shall have appropriate background and experience (see 4.1.2.2). Note: Such background should include both theoretical and recent practical experience

Define

4.18 record

4.10.6.3

The laboratory shall have procedures for receipt, identification, handling, protection and retention or disposal of test samples and/or calibration equipment items, including all provisions necessary to protect the integrity of the items (see 4.15).

Define

define

Dispositioned Test Samples

4.10.6.3

The items shall be retained until final data is completed throughout the life of the items in the laboratory, enabling traceability form final data to raw data (see Glossary and 4.10.1).

Dispositioned Test Samples

4.10.6.4

The laboratory shall monitor, control and record (see 4.16) environmental conditions as required by the relevant specifications or where they may influence the quality of results. Requirements for environmental conditions (e.g. biological sterility, dust, electromagnetic interference, radiation, humidity, electrical supply, temperature, and sound and vibration levels) shall be established and maintain as appropriate to the technical activities concerned.

Define

Necessary equipment as required and their records

4.10.6.5

The laboratory shall use test and/or calibration methods including those for sampling, which meet the needs of the customer and are appropriate for the tests and/or calibrations it undertakes, preferably the current issue of those published as international, regional, or national standards (see 4.11).

Check Procedure

Check all W.I.

4.10.6.5

The laboratory shall verify its capability to perform to the standard specification before carrying out such work.

Check Procedure

4.10.6.5

When it is necessary to employ methods not covered by standard specifications, these shall be subject to agreement with the customer.

Record for own designed equipment

4.10.6.6

Appropriate statistical techniques should be applied to verification activities whose deliverables are data (see 4.20).

Follow National Standard

Record

4.10.7

Commercial/independent laboratory facilities used by supplier shall be accredited laboratory (see Glossary) facilities. Reference the customer specific pages of this document and the Glossary.

4.11 and 4.6

Approved vendor

4.10.7 Note

NOTE: Commercial/independent laboratories can not be registered to QS-9000.

4.10.7 Note

NOTE: For further guidance on element 4.10.7, see ISO/IEC Guide 25 or national equivalent.

4.11.1 Note

The choice of the specific method to be used should be based upon sound technical knowledge of the complete measurement system, the conditions under which it will operate, and the uses for which the data are being produced.

Define

As appropriate

4.11.2 Note

“inspection, measuring and test equipment” include equipment in tooling departments used to qualify or maintain production tools regardless of ownership.

and Master list of Equipment

4.11.2.b.1

Calibration of inspection, measuring or test equipment shall be conducted by qualified in-house laboratory (see 4.10.6), a qualified commercial/independent laboratory (see 4.10.7), or a customer-recognized government agency.

Define

4.18 record

4.11.2.b.1

The laboratory scope shall include the calibration of such equipment.

Scope

4.11.2.b.1

NOTE: Where a qualified laboratory does not exist for a given piece of equipment, calibration services may be performed by the original equipment manufacturer.

Qualified lab with record

4.11.2.d

NOTE: A serial number traceable to the device calibration record meets the intent of this requirement.

Evidence

4.11.2.i

NOTE: Inspection, measuring and test facilities is generally understood to mean inspection, measuring and test equipment where test results can be invalidated by inappropriate adjustment at the audited site.

Safeguard as appropriate

4.11.3

Check all gages

4.11.4

The analytical methods and acceptance criteria used should conform to those in the Measurement Systems Analysis reference manual [e.g. bias, linearity, stability, repeatability and reproducibility (gage R&R) studies]. Other analytical methods and acceptance criteria may be used if approved by the customer.

Define

All MSA Records and MSA Schedule

4.12 Note

Latitude is permitted, beyond automated production transfer processes, if the test status is clearly identified, documented, and achieves the designated purpose.

As appropriate

4.12.1

When required by the customer, additional verification/identification requirements shall be met (e.g. new model introduction).

Discuss with customer

Evidence

4.13.1.1

This element shall apply to suspect material or product (see Glossary) as well as to nonconforming product.

Scope

4.13.1.2

The supplier shall provide visual identification of any nonconforming or suspect material or product (see Glossary), and any quarantine areas.

Define

evidence

4.13.2.1

The supplier shall quantify and analyze nonconforming product and establish a prioritized reduction plan. Progress toward the plan should be tracked

QOS Measurable to reduce Scrap, Rework, Repair, etc.

4.14.1.2

The supplier shall use mistake proofing methodology in their corrective and preventive action process to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered.

Evidence

4.14.2.2

Where applicable the supplier shall apply the corrective action taken, and controls implemented, to eliminate the cause of nonconformity to other similar processes and products.

Preventive action records

4.15.3.1

The supplier shall use an inventory management system to optimize inventory turns over time, assure stock rotation and minimize inventory levels.

Inventory Control Record and QOS Measurable

4.15.4.1

The supplier shall comply with all unique customer packaging standards/guidelines, including applicable service part packaging standards.

Define

Evidence

4.15.6.1

The supplier shall implement a system to monitor performance to the customer delivery requirements with corrective action taken as appropriate. Records of supplier responsible premium freight shall be maintained.

Define

Corrective Action Record and Premium Freight Record

4.15.6.2 Note

NOTE: If the supplier’s production is scheduled based upon a “forecast,” this would not meet the intent of the requirement. A “pull” system (parts/replenishment based upon consumption) utilizing an optimal level of inventory on hand which is commensurate with process cycle time satisfies the intent of an order-driven system.

Evidence of effective “pull” system Planning

4.15.6.3

The supplier shall have a computerized system for receipt of customer planning information and ship schedules, unless waived by the customer.

As applicable or Waive letter

4.16.1

Production part approvals, tooling Records, purchase orders and amendments shall be maintained for the length of time that the part (or family of parts) is active for production and service requirements plus one calendar year unless otherwise specified by the customer

Check with customers and define in procedure

4.16.1 Note

All customer purchase orders/amendments are included in this requirement. Supplier purchase orders/amendments for customer-owned tooling are included in this requirement.

Scope

Master list of records

4.16.1

Retention periods longer than those specified above may be specified by a supplier in their procedures. The supplier shall eventually dispose of records.

Define

4.17

NOTE: “Activity” can refer to departments, areas, processes, functions, etc. in a company.

Internal Audit Plan

4.17

NOTE: There is no specified checklist that MUST be used for internal auditing purposes

QSA with additional checklist

4.17.1

Internal auditing should cover all shifts and be conducted according to an audit schedule updated annually.

Define

Record as applicable

4.17.1

When internal/external nonconformances or customer complaints occur, the planned audit frequency should be increased.

Internal Audit Schedule

4.18.1

NOTE: Training effectiveness may be practical reviewed by various methods, such as pre-and post-testing and audits/appraisals of performance.

Define

Clearly define in W.I.

record