09.01.01.07 KNA Supplier Quality Manual Rev 0

Download as pdf or txt
Download as pdf or txt
You are on page 1of 22

October 13

Revision 0
Supplier
Quality
Manual 2016
We shall contribute to the future of mankind by the continuous creation of new value.
We shall challenge ourselves to any matter with ambition and vitality
We shall give importance to theory, ideas and time.
We shall respect sincere conduct and endeavors.

US.108495552.01
Title:

Supplier Quality Manual


Category: Policy: Sub-Policy: Procedure: Support/Form:
09 01 01 07
Date Effective: Keihin North America, Inc. Revision:
11/30/16 Business Policy & Procedures Manual 0
Prepared By: Presented By: PRB Meeting: Date Approved: Approved By:
S Sullivan Kevin McCarley 11/30/16

Revision History
Revision Date Description of changes Requested By
0 11/30/16 Initial Release J. Bilbrey

1
US.108495552.01
Table of Contents
1.0 INTRODUCTION ........................................................................................................................................................................... 3
1.1 Purpose .................................................................................................................................................................................... 3
1.2 Scope........................................................................................................................................................................................ 3
1.3 Acronyms .................................................................................................................................................................................. 3
2.0 GENERAL REQUIRMENTS .......................................................................................................................................................... 4
2.1 Contact Information................................................................................................................................................................... 4
2.2 Registration ............................................................................................................................................................................... 4
2.3 Continuous Improvement .......................................................................................................................................................... 4
2.4 Record Retention ...................................................................................................................................................................... 4
2.5 Sub-Supplier Control................................................................................................................................................................. 4
3.0 QUALITY SYSTEM ....................................................................................................................................................................... 4
4.0 ADVANCED QUALITY PLANNING ............................................................................................................................................... 5
5.0 QUALITY PROCESS DOCUMENTATION .................................................................................................................................... 5
5.1 Past Problem History ................................................................................................................................................................ 5
5.2 Process Failure Mode & Effect Analysis ................................................................................................................................... 5
5.3 Process Quality Control Table .................................................................................................................................................. 5
5.4 Operation Standards ................................................................................................................................................................. 6
5.5 Process & Equipment Check Sheets ........................................................................................................................................ 6
5.6 Training ..................................................................................................................................................................................... 6
5.7 Trial Maturation Results ............................................................................................................................................................ 6
5.8 Minimum Process Requirements .............................................................................................................................................. 7
6.0 QUALITY PROCESS CONTROL .................................................................................................................................................. 7
6.1 First Piece Confirmation and Retain ......................................................................................................................................... 7
6.2 Poka-Yoke & Inspection Devices .............................................................................................................................................. 7
6.3 EP100 ....................................................................................................................................................................................... 7
TABLE A - Basic Development Flow .................................................................................................................................................... 10
7.0 PACKAGING AND LOT CONTROL & TRACEABILITY .............................................................................................................. 11
7.1 Packaging and Lot Control Sheet ........................................................................................................................................... 11
8.0 PROCESS CAPABILITY DATA COLLECTION / SUBMISSION ................................................................................................. 11
9.0 MEASURING AND TEST EQUIPMENT ...................................................................................................................................... 12
9.1 Calibration ............................................................................................................................................................................... 12
9.2 Measurement System Analysis ............................................................................................................................................... 12
10.0 QUALITY ASSURANCE VISIT .................................................................................................................................................... 12
10.1 Initial Evaluation ...................................................................................................................................................................... 12
10.2 QAV1 – Development Evaluation............................................................................................................................................ 13
10.3 QAV2 - Trail Readiness Evaluation......................................................................................................................................... 13
10.4 QAV3 – Approval Evaluation .................................................................................................................................................. 13
10.5 Quality Approval Notification ................................................................................................................................................... 13
10.6 Special Audit – Continual Improvement Evaluation ................................................................................................................ 13
11.0 NONCONFORMING MATERIAL................................................................................................................................................. 14
11.1 Nonconforming Material at the Customer ............................................................................................................................... 14
11.2 Advanced Notice ..................................................................................................................................................................... 14
11.3 Disposition / Sort / Rework ...................................................................................................................................................... 14
11.4 Corrective Action..................................................................................................................................................................... 15
11.5 Corrective Action System ........................................................................................................................................................ 15
11.6 Costs of Nonconforming Material ............................................................................................................................................ 15
12.0 QUALITY WAIVER/DEVIASION ................................................................................................................................................. 16
13.0 CHANGEPOINT CONTROL SYSTEM ........................................................................................................................................ 16
13.1 Initial Production Parts Advance Approval Request (IPPAAR) Procedure .............................................................................. 17
13.2 IPPAAR Planning .................................................................................................................................................................... 17
13.3 IPPAAR Supporting Documents and Approval ....................................................................................................................... 17
IPPAAR Change Point Approval Flow .................................................................................................................................................. 19
13.4 Identify the First Lot for IPP Tag ............................................................................................................................................. 19
13.5 New Model IPP Shipment ....................................................................................................................................................... 19
14.0 MARKET / WARRANTY QUALITY.............................................................................................................................................. 20
15.0 SUPPLIER QUALITY RANKING ................................................................................................................................................. 20
15.1 Determine Supplier Class Ranking ......................................................................................................................................... 20
15.2 Quality Improvement Program (QIP)....................................................................................................................................... 20
16.0 REQUIRED DOCUMENTATION FOR ANNUAL SUBMISSION ................................................................................................. 20
17.0 QUALITY REGULATION REVISIONS ........................................................................................................................................ 21
18.0 ACKNOWLEDGMENT ................................................................................................................................................................ 21

2
US.108495552.01
1.0 INTRODUCTION

1.1 Purpose
This Keihin Supplier Quality Manual (the “Manual”) defines the basic quality requirements/standards for
companies supplying material to Keihin North America, Inc. ("KNA") as agent for its subsidiaries Keihin IPT Mfg.,
LLC ("KIM"), Keihin Carolina System Technology, LLC ("KCST"), Keihin Aircon North America, Inc. ("KAC") and
Keihin Michigan Manufacturing, LLC ("KMM"); hereafter KNA, KIM, KCST, KAC, KMM collectively sometimes may
be referred to the "Keihin Companies", “Customer”, or “the Customer”. All sales by the Supplier to each of the
Keihin Companies shall be covered by this Manual.
Assuming the Supplier and KNA have executed the KNA Supply Agreement, if there is any inconsistency
between the Supply Agreement and this Manual, the Supply Agreement shall control.
As a condition of sales to the Keihin Companies, the Supplier acknowledges and agrees to achieve or implement
a system to achieve: (1) 100% on time delivery; (2) zero defects in all products sold to Keihin Companies; (3)
immediate and complete failure analysis and countermeasures; (4) an aggressive cost containment policy; (5) a
continuous improvement system; (6) products/services that are environmentally conscious in accordance with
KNA policies.

1.2 Scope
Where KIM, KCST, KAC, KMM is the Customer, KNA has authority to act on its behalf.
Through the remainder of this Manual, the Supplier shall be referred to as "Organization" or “the Organization”.
Through the remainder of this Manual, any entity receiving products from Keihin Companies will be referred to as
“Subsequent Customer” or “the Subsequent Customer”.
This Manual shall apply to all parts, components, raw materials, etc. that are intended for use in the Keihin
Companies’ or the Subsequent Customers’ manufacturing processes.
The requirements contained herein are part of the purchase agreement and supplemental to any other purchase
terms, conditions or specifications. No action taken by the Customer or the Organization shall relieve the
Organization of the responsibility to supply useable product that conforms to all purchase orders, agreements,
quality agreements, prints, and requirements.
Organizations are encouraged to use the Customer-supplied forms, however, alternative forms maybe be used
providing they contain all required information and are approved by the Customer prior to use.
http://www.keihin-na.com/suppliers

1.3 Acronyms
GR&R - Gage Repeatability & Reproducibility QAV - Quality Assurance Visit
IPP - Initial Production Parts QCS - Quality Check Sheet
IPPAAR - Initial Production Parts Advanced Approval QCSS - Quality Characteristic Summary Sheet
Request QIP - Quality Improvement Process
KCM - Keihin Change Management QLVS - Quality Level Verification Sheet
LNDD - Lot Number Display Detail QMP - Quality Maturation Plan
MCS - Machine Check Sheet QSD - Quality System Database
MPR - Minimum Process Requirements SPQ - Supplier Part Quality
MSA - Measurement System Analysis TMR - Trial Maturation Results
OEE - Overall Equipment Effectiveness
PFMEA - Process Failure Mode & Effects Analysis
PLCS - Packaging & Lot Control Sheet KAC - Keihin Aircon North America, Inc.
PPH - Past Problem History KCST - Keihin Carolina System Technology, Inc.
PPLH - Parts Per Labor Hour KIM - Keihin IPT Mfg, LLC.
PQCT - Process Quality Control Table KMM - Keihin Michigan Manufacturing, LLC.
QAN - Quality Approval Notification KNA - Keihin North America, Inc.
QAS - Quality Assurance System

3
US.108495552.01
2.0 GENERAL REQUIRMENTS

2.1 Contact Information


All Organizations must submit contact information in its entirety and return it to their respective Supplier Part
Quality representative. The Organization’s primary quality contact information shall be the contact who will
respond to any quality inquiries. Additionally, the Organization shall provide an organizational chart including
senior management with phone numbers.

2.2 Registration
The completed contact information will allow registration of the Organization to have access to review supplier
quality rating and non-conformances. For further information and assistance in the registration process refer to
SPQ representative.

2.3 Continuous Improvement


The Organization shall continually improve quality, cost, delivery and other services provided. Continuous
improvement efforts shall include error-proofing methods in an effort to further reduce defects, part variability, and
processing cost.

2.4 Record Retention


The Organization shall establish a documented procedure to define the controls needed for the identification,
storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily
identifiable and retrievable. The control of records shall satisfy statutory, regulatory and customer requirements.
Key Record Retention Schedule:
Record Type Retention Time
Development (SAP, Project Planning) 15yrs
Training 15yrs
Manufacturing / Traceability 20yrs
Change Point Control (IPPAAR, IPP) 15yrs
Nonconforming / Corrective Action 10yrs
Quality Documentation (PQCT, MCS, QCS) 20yrs

This is a list of key record and their retention schedule. For a complete list of record types and current retention
schedule consult the Customer SPQ representative.

2.5 Sub-Supplier Control


The Organization shall be responsible for Sub-Supplier Control and the quality of components supplied by sub-
suppliers and shall enter into similar agreements.
The Customer and Subsequent Customer reserves the right to request and perform on site visits at sub-supplier
to confirm manufacturing conditions, manufacturing changes or as a result of nonconforming product reaching the
Customer.
The Organization is responsible for all sub-suppliers’ lot control / traceability. Sub-suppliers’ lot control /
traceability is periodically audited by and clearly understood by the Organization. The Organization must ensure
that the sub-suppliers’ procedures are established in a method that enables lot control / traceability information to
be easily obtained.

3.0 QUALITY SYSTEM


The Quality System requirements are based on the latest edition of IATF16949/ISO9001 and Customer-specific
requirements. Environmental Systems Requirements are based on the latest edition of ISO14001.
The Organization shall be responsible for planning, implementing and maintaining a Quality System that conforms
to these standards.
The Customer and Subsequent Customer reserve the right to audit and assess the Organization’s conformance
to the standard regardless of the Organization’s registration status.
The latest revision of this Manual and its referenced forms will be available on the Customer’s website. It is the
Organization’s responsibility to maintain and comply with the latest version of this Manual. This Manual is subject
to change by the Customer.

4
US.108495552.01
4.0 ADVANCED QUALITY PLANNING
The Organization shall be responsible for planning, generating, implementing, and maintaining a Quality
Assurance System (QAS).
The QAS shall assure the production of parts that conform to all specified requirements. These requirements shall
include the following:
• Verification of compliance to all standards, procedures, and quality requirements
• Systems to prevent the production of nonconforming parts
• Defining and recording of quality problems
• Implementation of timely and effective corrective actions
The Organization shall establish a Quality Maturation Plan, (QMP), which shall be a system of tracking the
development of Supplier's Quality System status. The QMP shall be developed and maintained by Supplier for
each new part or model development. Consult the supplier quality representative for the minimum tooling
maturation level requirements for each new model trial build.
The QMP shall show development / testing schedules for the following items:
• Trial and / or production schedules, including EP100 (Section 6.4)
• Tooling / machine / equipment, purchasing and development schedules
• Part testing / qualification plans
• Quality document / systems implementation schedules
The Organization shall reference the 09.01.01.07.01 QMP on the KNA Quality Portal under “Forms” for the
Quality Maturation Plan document, and also below Table A for the documentation timing and basic development
flow.

5.0 QUALITY PROCESS DOCUMENTATION


The Organization must have a documented process that describes how quality system documents (i.e. QMP,
PFMEA, PQCT, QA Matrix, OPSTD’s, etc.) are created, controlled, approved and revised. This system shall be
linked to the Change Point Control and Corrective Action procedures.
The Organization is required to inform the Customer of any changes made to the quality documentation after
mass production start via IPPAAR approval (Section 13).
The Organization shall develop and maintain the following Quality documents for each new part / model to aid in
the development of the part and associated Quality systems.
These documents shall be:
• subject to Customer review during QAVs,
• submitted to the Customer for approval prior to mass production of the related part(s), and
• available for review upon Customer request.

5.1 Past Problem History


The Organization shall identify, summarize and periodically review past problems related to the product / process
in the Past Problem History (PPH) form. Issues to be confirmed include customer and market trouble reports and
in-house rejects for all global operations of similar products / processes. All history of high severity issues (A
rank) and recent history (3yrs) for lower severity items (B and C rank) must be included.
PPH must be incorporated into the quality system documents (PFMEA, PQCT, OpStd, etc.) and countermeasure
effectiveness confirmed at each trial build event.
The Organization shall reference 09.03.01.01.06 PPH on the KNA Quality Portal under “Forms” for the Past
Problem History document.

5.2 Process Failure Mode & Effect Analysis


The Process Failure Mode & Effect Analysis (PFMEA) shall identify all potential failure modes, severity and
detection of defects in the manufacturing process. The results of the PFMEA shall be reflected in the
Organization's quality planning, such as, but not limited to, the PQCT, OpStd and the QMP.
The Organization shall reference 09.03.01.07.02 PFMEA on the KNA Quality Portal under “Forms” for actual
Process Failure Mode Effects Analysis documents and instruction sheets.

5.3 Process Quality Control Table


The Process Quality Control Table (PQCT) shall identify all part controls (material, dimensional, functional, etc.)
and all process controls (temperatures, feed rates, pressures, etc.) in the manufacturing process. The PQCT must
be based on the PFMEA and used as the basis for operation standards.
The Organization shall reference the 09.03.01.01.07 PQCT on the KNA Quality Portal under “Forms” for actual
Process Quality Control Table documents and instruction sheets.

5
US.108495552.01
5.4 Operation Standards
The Organization shall create an operation standard for each distinct job process. The OpStd shall be linked back
to the PQCT.
Operation standards shall be controlled documents and on hand near the work covered by the standard.
Operation standards do not have to be on display at all times, but they shall be accessible by operators in
seconds, not minutes. The Organization must have a documented procedure for the creation, control, approval &
revision of operation standards.
Operation standards shall include:
• list of materials and components;
• description of process steps and sequence;
• list of tools/measuring equipment to be used in the process
• description of process settings;
• part specifications;
• lot control, first in-first out, or labeling requirements;
• critical points in the process, including failure modes if operation standard is not followed;
• limit samples, master samples or poka-yoke samples;
• abnormal handling procedures;
• control points from past problem history (PPH);

5.5 Process & Equipment Check Sheets


Detailed check sheets shall be created and implemented for recording (in writing or electronically) quality checks,
equipment parameters and verification of process controls including alarms, preset wrenches, poka-yokes, etc.
Check sheets shall be completed at the beginning of each shift and after any process change including
maintenance, or as described in the PQCT.
All operator checks shall be recorded. Where possible, entries to the records should be quantifiable (e.g. actual
numbers) rather than ‘OK’ or a checkmark.
Any time data is found to be outside specified requirements, there shall be evidence the condition was recognized
and a clear record of who, when, and what action(s) was (were) taken.

5.6 Training
The Organization must have a documented procedure for training, qualification and re-qualification of associates
using predetermined objective criteria. Training records shall be maintained, including a training matrix of
associates and which stations they are trained on.
Training shall include start up (including quality checks, machine checks, poka-yoke checks, etc.), normal
processing, change point control, handling suspect/non-conforming material, abnormal handling, repair/rework,
recovery and shutdown.
The Organization must have a documented procedure for when it is necessary to use an associate that is less
than fully qualified. This procedure must include required safeguards, data collection and approval requirements.

5.7 Trial Maturation Results


The Trial Maturation Results sheet, (TMR), will be used in conjunction with the QMP to track the development and
results of the Organization's trials, including any concerns, causes and resultant countermeasures.
Organization shall reference the 09.03.01.01.08 TMR on the KNA Quality Portal under “Forms” for the Trial
Maturation Results documents and instruction sheets.

6
US.108495552.01
5.8 Minimum Process Requirements
The Customer requires the Organization and its sub-supplier’s to meet minimum process requirements (MPR).
These requirements present the controls and methods that are required for manufacturing parts to prevent future
process related defects. The MPR’s shall be reflected in the PQCT and the PFMEA. The MPR’s will be
evaluated during QAV1and QAV2 (Section 10). If a supplier cannot meet the requirements, they shall submit a
concern in writing to SPQ. The concern will be reviewed by SPQ and an agreement will be reached. If an
agreement cannot be reached; the issue will be escalated to the Customer’s management.
This procedure applies to the following processes:
• Casting • Machining
• Stamping • Electronics (Printed Circuit Boards)
• Injection Molding • Welding (Projection, Mig, Resistance)
• Wire Harness • Wire Harness
• Heat Treatment • Error Proofing
• Fluid Fill • Hot Plate Welding
• Label • Painting
• Leak Test • Part Marking
• Torque
Organization shall reference the 09.01.01.07.## MPR on the KNA Quality Portal under “Minimum Process
Requirements” for the Minimum Process Requirements documents.

6.0 QUALITY PROCESS CONTROL

6.1 First Piece Confirmation and Retain


The Organization shall have a documented system whereby the first production part after any equipment
changeover, tooling or fixture change, shift or other personnel change, etc. is reviewed and approved.
For Plastic or Rubber Molding (including injection and extrusion), Machining, and Casting, the first approved part
from each discrete production run shall be identified and retained. At a minimum, the part shall be retained until
an approved part is produced on the next subsequent production run.
For Stamping, the last piece from each discrete production-run shall be identified and retained. At a minimum, the
part shall be retained until and approved part is produced on the next subsequent production run.

6.2 Poka-Yoke & Inspection Devices


The function of each poka-yoke shall be confirmed periodically, based on the relative importance of the condition
the device checks. The frequency and method shall be documented on the PFMEA (if applicable), the PQCT, and
the operation standard and/or equipment check sheet.
Each device shall be confirmed independently of other devices for both positive (device detects abnormality
intended) and negative (does not alarm for non-abnormality) results.
Master parts used for confirming poka-yoke devices shall be approved by appropriate authority, uniquely
identified and labeled for intended use, issued and stored in designated locations, and inspected periodically. A
log shall be maintained of all such master parts.
Completion of a poka-yoke confirmation shall be recorded. An attempt that is unsuccessful shall trigger a
response to be defined by the supplier’s policies regarding Suspect and Nonconforming Parts.
An attempt that fails initially, but is successful in multiple attempts thereafter, shall still be considered a failure
unless and until the situation is reviewed by appropriate authority.

6.3 EP100
EP100 is a production simulation event to provide early verification of process maturation and capability of
meeting mass production targets to help ensure a smooth startup. The EP100 verification process applies to new
model projects and significant mass production change points. Keihin’s SPQ representative will determine if
EP100 is required.
EP100 Planning
Establish the timing for EP100 verification and enter it on the QMP and project SAP during project
development. EP100 should occur at least two months prior to the first MP-level customer trial for NM
(E2 for MP change points).
The Organization will utilize the Capacity Planning / Confirmation form to estimate targets for
CT/DT/SR/OEE prior to Die-Go / Maker Layout. These targets will be verified at each trial build and
finally at EP100. By EP100 the Organization’s process must meet or exceed the targets set. If the
Organization’s process does not meet the set targets explanation must be submitted to the Customer’s
purchasing representative.
7
US.108495552.01
Set the EP100 verification quantity. Reference the commodity matrix (Appendix A) for minimum
quantities. Any deviation from minimum quantity must be approved by the SPQ representative.
The team should have a minimum of two training builds prior to EP100, one for equipment verification and
one (or more) for associate training maturation.
Communicate EP100 quantities and requirements to sub-suppliers to ensure an adequate number of MP
level supplied parts are available at EP100. Monitor sub-supplier progress and report any concerns to
SPQ as soon as possible.

Expectations for EP100 Event and Reporting:


• Tooling and Equipment: MP level with preventative maintenance plan and spare parts list
established, safety confirmation complete, MP cycle time achieved and quality requirements met.
• Supplied Parts: tooling and part quality at MP level.
• Associates: Associates fully trained using MP level documents and processes (no temporary
processes)
• Documents: MP level, controlled and available on line (PFMEA, PQCT, OPSTD’s, MCS/QCS,
Visual Aids, etc.)
• Measurement: MP level QA equipment, with MSA complete, masters developed and calibration
plan established. Data collection plan for Key Performance Indexes established with correlating
targets.

* If maturation levels are not met, schedule additional EP100 verifications as necessary to ensure
proper maturation.

Do
Assign roles and responsibilities for the EP100 Team. Suggested Roles and Responsibilities for
verification are:
• ENG – Die and Equipment Condition (MP level)
• MFG – Associate Condition (Head count & MP level)
• MFG – Performance Verification (Cycle Time / Down Time / Straight Rate / OEE)
• QA – Quality Verification (Cpk)
• S.Mgr – Overall Evaluation
Establish a data collection plan for EP100 performance verification. Identify resources to ensure proper
data collection is achieved during EP100. Establish a plan for collecting sample pieces for quality
verification. Quality data (n=30 minimum) should be collected from the last 100pcs of the build.
Performance data shall be taken for each process. Summarize findings on the Trial Maturation Results.

Action
Develop an action plan for concern items identified during EP100 verification audit and record
countermeasures on the Trial Maturation Results. Review root cause analysis and proposed
countermeasures with SPQ representative for approval. Review the status of countermeasures during
regularly scheduled team meetings. Follow up on the EP100 verification action plan. EP100 Verification
is not complete until all action items have been implemented and judged effective by SPQ.
Prepare EP100 Summary Report per Appendix B.

8
US.108495552.01
Appendix A: Commodity Matrix MIN Quantities
Process Category Guideline
Molding Die cast 500 pcs / 1 shift
Molding 500 pcs / 1 shift
Machining Precision Cutting Tooling Change
Frequency
General 500 pcs / 1 shift
Assembly Light Assembly / 200 pcs / 2hrs
Electronics

Appendix B: EP100 Report Content Requirements


No Verification item Report material Viewpoint
・SAP
Is the project progressing
1 Overall SAP ・Production Preparation Plan
as planned?
・Quality Maturation Plan
・Casting, Machining and Assembly Is MP flow established with
flow no temporary
1. Tooling & Equipment
2 ・Tool & Equipment verification result processes/equipment?
2. Process Flow
・Production capacity (Cycle Time, Does equipment meet
Down Time) requirements?
Are all planned Quality
Systems in place with no
・Quality Assurance System
3 Quality Assurance Control temporary processes?
・Past Problem History Reflection - It is possible to report as
process flow
Is there any issue with
4 Sub-Supplied Parts ・Sub-Supplier approval status
supplied parts?
・PFMEA, PQCT, QA Matrix Are Manufacturing Control
1. MFG Control Documents
5 ・Documentation creation status documents and Associates
2. Associate Training
・Associate Training Status at MP level?
・Straight Rate, Pass/Fail Ratio
1. Process Performance Was there any trouble at
6 ・OEE, Parts / Labor Hr (PPLH)
2. Capability the EP100 Event?
・Process Capability
Are all concern items
・Concerns / CM’s
7 Concerns and Open Items identified with clear, timely
・Production Concern Items & Trouble
countermeasures?

9
US.108495552.01
US.108495552.01
RASIC
Responsible Basic Development Flow
Acccountable
Support
Inform Year 1 Year 2 Year 3

Consult 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11

RASIC -105 -101 -97 -92 -88 -83 -79 -75 -70 -66 -62 -57 -53 -48 -44 -40 -36 -31 -27 -22 -18 -14 -9 -5 -1 4 7 10

Keihin Dev. Schedule - DO TS IA DF MPG PR

QAV Schedule - Initial QAV1 QAV2 QAV3 QAN

Tooling Level Required - PT T2 T3 MP


CONFIRMATION ITEM
(See quality manual for complete Project Build Schedule - P0 P1 P2 P3 EP100 L1 L2 L3 L4 MP
descrition of requiremements)
QUOTING AND MAKER LAYOUT
RFQ Maker Lay out
Quao ting and maker layo ut pro cess
R S
QUALITY MATURATION PLAN
Supplier QMP
Quality based actio n plan to align with custo mer requirements fo r audits,
R S critical co ntro ls, pro blem preventio n and training.

INSPECTION STANDARD
QCSS CCP 5pcs CCP 30pcs Trial Data Trial Data Trial Data Trial Data Trial Data Trial Data MP Data Handling
Use Keihin issued bubble dwgs and QCSS. Determine CCP measurement
R R S metho d and the inspectio n frequency to guarantee in spec parts ship to the
custo mer.
QUALITY ASSURANCE VISIT
Initial Ev al QAV1 QAV2 QAV3 QAN
Keihin visits to the supplier to judge current pro cess readiness. QA V1, judge
R R S supplier capability to meet Keihin requirements. QAV2, judge pro cess is M P
level and ready fo r trials. QAV3, judge pro cess ready fo r M P .
DESIGN FMEA
Analysis fo r critical co ntro l po ints to be used to develo p PFM EA, Draft Documents Updated Documents Final Documents
R I Equipment specs, and Quality co ntro ls.

PROCESS CONTROL PFMEA / PQCT


Develo p pro cess failure mo des and pro cess co ntro ls to prevent in-ho use
Draft Documents Updated Documents Final Documents
R I failures reach the custo mer. A ll pro cess co ntro ls reflected to o n-line quality
do cuments, Wo rk Instrcutio ns, M achine Check Sheets, Quality Check
MINIMUM PROCESS REQUIRMENTS
Rev iew Draft Documents Updated Documents Final Documents
Keihin minimum requirements fo r specfic types o f manufacturing. These
R I requirements capture the co ntro ls and metho ds that are needed fo r
manufacturing to prevent pro cess related defects.
PAST PROBLEM HISTORY
Review previo us pro blems (M arket and Line Claims) and develo p metho ds
Draft Documents Updated Documents Final Documents
R I to prevent these issues fro m reo ccuring.

TRACEABILITY / LNDD
Co nfirm traceability o f units pro duced and co mpo nents used.
Draft Documents Updated Documents Final Documents
R I
TABLE A - Basic Development Flow

GAGE DEVELOPMENT
Draft Documents Updated Documents Final Documents
Gage co ncept appro val and Gage M SA
R I
TRAINING
Draft Documents Updated Documents Final Documents
Develo p and implement a technical training plan fo r QA asso ciates to
R I assure co mplete understanding o f QA equipment, pro per usage, and QA
metho ds fo r smo o th trial and start up quality and custo mer claim
PACKAGING SPECS
Draft Documents Updated Documents Final Documents
Co nfirm pro per packaging spec. P LCS
R I I S
EP100
Co nfirm M P pro cess by evaluating that Cycle time, Direct Ship Rate, Defect EP100
R S S Rate, Pro duct Co nfirmatio n, etc. meet pro ject targets as a result o f M P
quality maturatio n.

10
7.0 PACKAGING AND LOT CONTROL & TRACEABILITY
The Organization shall establish a comprehensive system that ensures traceability from end product supplied to
the Customer continuing back through supplied product to the Organization. All product supplied to the Customer
must be clearly identified on a bar coded label with the following information unless otherwise specified by the
Customer:
• Part Number and Part Name
• Quantity
• Organization Name, City and State
• Serial Number
All information must be submitted to the Customer as a readable bar code entry. The Serial Number, which will be
a sequential number for each container of a lot, must be traceable back to the Organization’s lot number.

7.1 Packaging and Lot Control Sheet


The Organization shall develop and maintain an accurate Packaging and Lot Control Sheet, (PLCS) that shall list
and explain the meaning of all fields on the bar code label. This includes initials, dates, and any coded information.
The PLCS shall be submitted to the Customer for approval prior to mass production.
The Organization shall reference the 09.01.01.07.04 PLCS on the KNA Quality Portal under “Forms” for the
Packaging and Lot Control Sheet document and instruction sheet.
Traceability and Lot Control Contents:

8.0 PROCESS CAPABILITY DATA COLLECTION / SUBMISSION


The Organization shall verify the repeatability of each manufacturing process by collecting and analyzing data.
The Customer will issue the Organization a Quality Characteristic Summary Sheet (QCSS), specifying the data
requirements for each part submission before and after mass production approval. Items to be analyzed shall
include critical features, items specified by the Customer based on past problem history and items suggested the
Organization based on manufacturing expertise.
All capabilities studies shall be documented on a Quality Level Verification Sheet (QLVS) and reflected by the
Cpk and the CP. These are defined as the followed:
Cpk = Minimum of Cpk Upper and Cpk Lower
Cpk Upper = (Upper Specification - Sample data average) / (3 x Sample Standard Deviation)
Cpk Lower = (Sample data average – Lower Specification) / (3 x Sample Standard Deviation)
CP = (Upper Specification – Lower Specification) / (6 x Sample Standard Deviation)

11
US.108495552.01
All critical features shall have a Cpk of at least 1.33 to be considered acceptable. Any critical feature with a Cpk
below 1.33 but higher than 1.0 must have increased inspection, lot acceptance testing and countermeasure plan
by the Organization. Any critical feature with a Cpk below 1.0 must be 100% inspected by the Organization.
The Organization shall supply a complete QLVS with each trial shipment. The data must be identified with the lot
number and correlate to the actual parts in the shipment. Failure to supply the necessary data, as determined by
the Customer, may result in the rejection of the affected shipment.
In addition, the Organization shall provide 100% dimensional layout of at least one part per cavity, tool, machine,
etc. This data must be accompanied by a ballooned (numbered) print.
The Organization shall reference the 09.03.01.01.04 QCSS on the KNA Quality Portal under “Forms” for the
Quality Characteristics Summary Sheet document.
The Organization shall reference the 09.03.01.01.09 QLVS on the KNA Quality Portal under “Forms” for the
Quality Level Verification Sheet document.

9.0 MEASURING AND TEST EQUIPMENT


The Organization shall provide adequate means of performing all measuring and inspections required for each
part. Each tool shall have the required accuracy, repeatability, and resolution per the specified tolerances.
Organization shall implement and maintain a calibration procedure (6.3 Calibration), which shall be adequate to
recall measuring and test equipment in a timely manner; track all measuring and test equipment; and provide
clear historical records of each piece of equipment. All tools used by the Organization shall be clearly identified as
to their current calibration status.

9.1 Calibration
Where applicable, the Organization shall periodically assure the continuing acceptability of master samples,
inspection and error-proof device test samples, and process jigs and fixtures. The Organization shall maintain a
list of such samples and process items requiring confirmation and a schedule for confirmation. Responsibility for
confirmation shall be documented and a report of confirmation results issued to management on periodic basis.

9.2 Measurement System Analysis


The Organization shall have a documented gauge Measurement System Analysis (MSA) program for all tools,
inspection devices, and check fixtures used for applicable measurements (e.g. critical measurements or those
designated by the Customer).
Organization shall reference the 09.03.01.10.01 MSA Grid on the KNA Quality Portal under “Forms” for the
Measurement System Analysis Grid document.

10.0 QUALITY ASSURANCE VISIT


The Quality Assurance Visit (QAV) is a quality audit conducted at the Organization’s or sub Organization facility.
QAV’s are conducted to judge if minimum requirements for quality assurance are being met and to promote
continuous improvement in the Organization’s processes and/or systems.
QAV’s are defined as follows:
• Initial Evaluation for a potential new organization to evaluate quality system and manufacturing capability
• Development Evaluation for new the new Organization or Organization making large process changes
• Approval Evaluation for new model and expansion development
• Continual Improvement Evaluation for process/systems review, problem solving or C/M follow-up
Organization shall reference the 09.03.01.01.10 QAV on the KNA Quality Portal under “Forms” for the Quality
Assurance Visit documents.

10.1 Initial Evaluation


An Initial Evaluation QAV audits the Organization's quality assurance system to evaluate their manufacturing
capability. Important check items include but are not limited to:
• Companywide quality strategy • Calibration systems
• Quality plan • Quality documentation
• Process design • MP process control
• Cp documentation for equipment • C/M follow-up and parallel analysis
• Lot control system / Traceability • Change control (IPP system)
• Training • Sub-supplier control
• Information feedback/feed forward system • Plant wide organization
• Preventative maintenance • Quality Control Manual / regulations

12
US.108495552.01
10.2 QAV1 – Development Evaluation
After initial product development, the Customer shall meet with the Organization at the Organization's facility to
conduct a Development Evaluation. The following are pre-requisites for the QAV:
• Customer may witness actual production of a similar part(s).
• Organization shall provide documentation per the similar part(s).
• Organization shall provide process capability data per the QLVS.
All of the above items shall be as close to mass production levels as possible. When one of the above is not at
mass production level, the Organization shall provide a detailed schedule for the completion date of mass
production readiness.

10.3 QAV2 - Trail Readiness Evaluation


After the initial product development, members of the Customer’s SPQ department and or New Model Parts
Development department shall meet with the Organization at the Organization’s premises to conduct QAV2. The
following are pre-requisites for QAV2:
• Customer may witness actual production of the related part or parts.
• Organization shall provide initial drafts of documentation according to TABLE A
• Organization shall provide process capability data per the QLVS.
The Customer shall judge the Organization readiness based on, but not limited to the above items. If the
Organization is judged not acceptable, then the Organization shall develop and implement a corrective action plan
as to their readiness. This plan must be consistent with the Customer’s schedules and acceptable to the
Customer.

10.4 QAV3 – Approval Evaluation


After the Organization is ready for mass production, and before the production of significant inventories, the
Customer shall meet with the Organization at the Organization’s facility to conduct an Approval Evaluation. The
purpose of this QAV is to judge the Organization’s mass production readiness. The following items must be at
final mass production level as planned by the Customer and the Organization:
• All quality documentation.
• All manufacturing equipment.
• All measuring and testing equipment.
• All handling and packaging procedures and materials.
• Associate / Manpower training records
• Customer shall witness the production of related part(s) continuously for 200pcs / 2hrs.
• Confirm MPR(s)
If the Organization is judged not acceptable for mass production, then the Organization shall develop and
implement a corrective action plan to address any concerns. This plan must be consistent with the Customer’s
schedules and approved by the Customer. The Customer may request a follow up QAV based on the results of
the Approval Evaluation.

10.5 Quality Approval Notification


If the Organization is judged acceptable for mass production after the Approval Evaluation, the Customer will
initiate the approval procedure. The Organization must submit a Quality Approval Notification (QAN) package to
the Customer. This must include, but is not limited to, the following information:
• QAN Cover Page • Process capability data or certifications
• PFMEA • Trial Maturation Results
• PQCT • Material Certification
• QA Matrix • Coating/Plating Certification
• PLCS and LNDD • Sub-Supplier approval status
• QAV reports/results
• Additional information as required

The Customer will notify Organization as to their approval by signing and issuing the QAN.
Organization shall reference the 09.03.02.04.01 QAN on the KNA Quality Portal under “Forms” for the Quality
Approval Notification document.

10.6 Special Audit – Continual Improvement Evaluation


During the course of development or mass production, it may be necessary to perform Special Audits at the
Organization’s facility to address existing or potential problems, concerns or opportunities based on severity
and/or occurrence. When this occurs, the Customer may visit the Organization’s facility to conduct the following
audits:
13
US.108495552.01
CM Audit - In the incidence of the Organization delivering one or more unacceptable parts to the Customer, or an
unacceptable part reaches the market; the Customer may visit the Organization’s facility to verify the following:
• Accurate identification of root cause, possibly including a re-creation of suspected cause.
• Verification of implemented countermeasures.
• Judgment of the effectiveness of implemented countermeasure.
• Parallel analysis of cause and countermeasures to similar product or processes
A-rank Audit - To verify that the proper testing and manufacturing methods are being used to prevent a defect
that might cause a fire or a fatality to the end user of the part.
QIP Audit - To verify the implementation of corrective actions specified in The Organization’s Quality
Improvement Plan (QIP).
Customer Attach Point Audit - To verify the prevention and/or 100% detection of defects that might occur in an
area in which the Customer or the Subsequent Customer(s) attach a mating part.
Special Process Audit - To verify a process that is additional to and different from the main forming of the part.
This includes, but is not limited to, the following:
• Welding • Torque verification
• Surface Treatment • Leak testing
• De-burring • Heat Treating
• Assembly
The Customer reserves the right, based on the discretion of management, to perform any additional audits not
mentioned above or outside the normal audit scope.

11.0 NONCONFORMING MATERIAL


All parts delivered to the Customer shall conform to all quality specifications made by the Customer, including
parameters called out on the drawing/spec, any agreements made with the Organization, and any specifications
of the purchasing agreement and orders (the “Specifications”).
The Organization shall establish sufficient controls so that nonconforming parts are not tendered to the Customer.
This system must include a process to clearly identify and segregate any suspect or nonconforming materials.
All parts received by the Customer are subject to the Customer’s inspection. Payment by the Customer for parts
shall not constitute acceptance of the parts and neither payment nor inspection shall relieve the Organization of
its obligation to deliver conforming parts.

11.1 Nonconforming Material at the Customer


It is the sole responsibility of the Organization to guarantee the product to the Customer’s line. In the event that
the Organization fails to prevent delivery of nonconforming material to the Customer or creates a delivery / market
issue for the Customer, a Quality Systems Database Occurrence (QSD) will be generated and issued to the
Organization. The contents of the report will include a brief description of the defect and a request for corrective
action from the Organization. It is the Organization’s responsibility to review updates and any change in status
that may occur while a QSD is open or unresolved.
In the event that the Customer detects nonconforming material, the Organization shall be immediately notified as
to the details of the Customer’s observations. The Organization may be notified initially by phone, however the
Organization shall also be given written notification of the problem by use of a “Corrective Action Request” form,
(a “CAR”), to be provided to the Organization by the Customer in the event of the Organization ‘s delivery of
nonconforming parts.
The Organization may be required to respond using the “5 Principles for Problem Solving” form. When
determined by the Customer, an on-site audit may be required, (see section 10.6 Special Audit - C/M QAV).

11.2 Advanced Notice


The Organization shall give notice as soon as possible to the Customer of any nonconforming material shipped to
the Customer. Due to the nature of our product, these parts could result in bodily harm or injury to Keihin
Companies’ final customers. This communication must be in written form.

11.3 Disposition / Sort / Rework


The Customer may make one of the following judgments on suspected or nonconforming parts:
• Scrap/return to the Organization
• Use after waiver
• Use after repair or rework
• Use after 100% inspection

14
US.108495552.01
It is the sole responsibility of the Organization to guarantee the product to the Customer’s line. In the event that
the Organization’s QAS has failed to prevent delivery of nonconforming parts to the Customer, the Customer, at
its sole discretion, may require the Organization to do one of the following:
• The Organization personnel arrive at the Customer in order to inspect or repair suspect parts.
• The Organization representative and Customer approved temporary personnel arrive at the Customer in
order to inspect or repair suspect parts. (Contact Quality for approved source.)
• Replacement parts are immediately shipped to the Customer. These parts must be guaranteed to be free
from the defect. To guarantee these parts, the Organization must 100% inspects these parts prior to
shipment, or have already isolated root cause and proved to the Customer why the replacement parts are
not affected. An identification method must be in place for easy part identification at the Customer.
• The Organization to provide additional data showing critical control points and customer attach points are
conforming to specification and capability for up to 3 lots after occurrence

11.4 Corrective Action


In addition to containment activity, temporary and permanent corrective action will be requested to ensure quality
problems are addressed. The Organization shall provide a schedule detailing actions to be taken to resolve the
issue. The Organization may be required to respond using the “5 Principles for Problem Solving” (5P) form. The
Customer will use the table below as a guideline for counter measure activity:
Rank Initial Response IPP Tag Temp C/M Cause & Perm C/M Report
A Same Day Next Shipment 2nd day ≤5 days 5P
B/C Same Day Next Shipment 2nd day ≤10 days Customer
Discretion
R N/A N/A Customer Discretion Customer Customer
Discretion Discretion
The Organization may be required to present the countermeasure report at the Customer.
If countermeasure activities are deemed inadequate, the Organization shall re-evaluate and submit
countermeasures until judged acceptable by the Customer.
When determined by the Customer, an on-site Continual Improvement QAV at the Organization’s facility (10.6
Special Audit)
Organization shall reference the 09.01.01.06.03 5P for the 5 Principles for Problem Solving.

11.5 Corrective Action System


The Corrective Action System shall apply to both internal and external problems. This system shall be
documented and linked to the Organization’s Change Point Control System where appropriate. A log is to be
maintained for corrective action management. The status of these issues shall be reviewed periodically (monthly
minimum) by top management.

11.6 Costs of Nonconforming Material


Actions taken to address nonconforming material must be taken without delay. Any cost incurred by the Customer
after the receipt of nonconforming material, and before the actions of the Organization, are the responsibility of
Organization. These costs may include, but are not limited to:
• Part Cost • Shipping
• Inspection • Labor; direct and indirect
• Rework Repair • Warranty – cost of parts and analysis
• Material
The Customer may hold the Organization liable for any costs, claims, or damages arising from the Organization’s
delivery of nonconforming parts. Upon notification the Organization will have ten business days to acknowledge
and discuss charge incurred for such activities. If no response is received, the Customer will automatically debit
the Organization’s account for these costs.

15
US.108495552.01
12.0 QUALITY WAIVER/DEVIASION
It is the Customer's policy to not use any part that does not meet the Specifications. However, due to extenuating
circumstances, the Customer may agree to use a waiver for a specific period of time or quantity of parts assuming
the below criteria has been met:
The Organization may request for nonconforming parts to be used.
• The Organization has isolated and documented the scope of the problem (i.e. suspect lot #'s).
• The Organization has documented the severity of the problem (i.e. measured actual parts).
• The Organization has found root cause and has already determined C/M. Note: the problem must have a
C/M before the Customer can give waiver approval.
• The Customer has had sufficient time to do testing that guarantees functional and durability performance.
• Quality Waiver shall not violate end users’ requirements.
Organization shall reference the 09.01.01.07.05 Quality Waiver on the KNA Quality Portal under “Forms” for the
Quality Waiver document.

13.0 CHANGEPOINT CONTROL SYSTEM


Over the life of a part or product, changes in design, specification or process will occur. The Initial Production
Parts (IPP) system is used to approve and/or track changes to parts or processes. When the IPP system is used
correctly the Customer and Organizations have documented approval and accurate records of any change that
occurs to parts or products. The IPP system helps to ensure final product quality by providing a way to identify,
approve and control change points. This control is necessary to safeguard the quality of finished products.
The IPP system applies to all parts, components and materials that are shipped to the Customer that are part of a
finished product. The Organization’s quality department is responsible for understanding the contents of any
change and ensuring the change has no negative effect of the overall product quality.
In the case of a design change, the Organization will receive an email notification from the Keihin Change
Management (KCM) system. This system is used to inform the Organization of a design change and for the
Organization to feedback important information (i.e. 1st delivery date, production start date, and cost).

There are three levels of control in the IPP Process. These are defined in the chart below. If unsure consult your
Quality Representative.
RANK PROCEDURE CONTROL METHOD
A IPPAAR • The Organization initiating the IPP must • Delivery of IPP parts must be
obtain the Customer approval prior to use in done according to FIFO
MP (use the IPPAAR form) • The Organization must keep the
• An IPP tag must accompany the first IPP following information
parts for MP and the parts must be properly o Content of the IPP tag
labeled. o Date of IPP’d parts
Note – if the first shipment of changed parts is for production
cage stock (in-process parts), additional IPP o Date of delivery
tag needs to be placed on the first shipment o Quality confirmation data
that will go directly to the Customer production. such as inspection or testing
data
B IPP • The Organization must document, verify and
approve the change internally. (This
documentation must be made available upon
Customer request.)
• An IPP tag must accompany the first IPP
parts for MP and the parts must be properly Same steps as level A
labeled
Note – if the first shipment of changed parts is for
cage stock (in-process parts), additional IPP tag
needs to be placed on the first shipment that will
go directly to the Customer production.
C Organization Internal at the Organization The Organization tracks these
changes. Information is made
available to the Customer upon
request.

16
US.108495552.01
13.1 Initial Production Parts Advance Approval Request (IPPAAR) Procedure
It is necessary to issue an IPPAAR when there are A Level changes to parts or processes that make those parts.
The IPPAAR form is used when a change requires advance approval form the Customer prior to the Organization
shipping the part for MP.
The table below explains each change type; list some examples changes (change type not limited to examples),
and how to determine the level of control (A, B, or C).

13.2 IPPAAR Planning


The Organization is responsible to create a quality confirmation plan and schedule to verify the change. This plan
will outline all activities needed to implement the change. For example – when test parts will be available, when
the dimensional confirmation will take place, when any outside testing will be performed and completed, etc.
When establishing a quality confirmation plan and schedule:
• The Organization is responsible to contact the Customer to reach agreement on the target ship date.
• The Organization is responsible to review the plan with the Customer prior to implementation, so that
Customer input can be integrated into the plan.
• The Organization is responsible to submit the completed IPPAAR form and confirmation plan/schedule
prior to implementation.
• The Organization is required to maintain stable production and consistent quality for current MP parts
while implementing the change, keeping in mind that the period of confirmation could be up to several
months depending on the confirmation requirements.
• The Organization is responsible to contact the Customer if the target ship date will not be met to receive
additional instructions and requirements.

13.3 IPPAAR Supporting Documents and Approval


IPPAAR submission may include any or all of the following:
• Capability study (number determined by the Customer)
• Sample parts (number determined by the Customer)
• Material testing results, if applicable
• Characteristics testing, if applicable
• Documentation updated as a result of the change
• Information from the Organization showing that the changed part meets all quality requirements and is fit
for use, including a summary of confirmation activities and results
• Other information as requested by the Customer (e.g. layout or complete dimensional data)
When the Organization submits the IPPAAR and related materials for approval:
• The Customer will review the IPPAAR documents to determine if other confirmation items are needed,
such as a QAV or additional testing.
• The Customer evaluates the IPPAAR results and sample parts. The Customer’s judgment is noted in the
Pass/Fail block on the form. Approved IPPAAR is given a reference number, which must be listed on IPP
tag for first shipment.
• Once all requirements have been met, and approval given, the Organization is permitted to ship the initial
production parts (MP). Be sure to follow IPP tag procedure.
Important ideas to keep in mind:
• If changed parts which require advance approval are shipped without that approval, those parts may be
rejected and/or counted against the Organization’s index rating. Rejecting or indexing may occur whether
or not an IPP tag was sent.
• MP parts are not to be shipped until the Organization receives the approved IPPAAR or other formal part
approval (e.g. QAN used at NM timing). If the Organization has not received approval and MP shipment
delay is possible, the Organization is responsible to contact the Customer immediately.
• An approved IPPAAR has IPPAAR #, Pass circled and the Customer approval signatures.
• The IPPAAR is sent with appropriate lead-time prior to delivery of the first lot. If the Customer requires a
check or testing of the part, the Organization needs to submit the IPPAAR early enough to allow sufficient
time for processing.
• A majority of IPPAARs submitted to the Customer must be sent out for approval, which requires a
minimum of two weeks for approval.

17
US.108495552.01
Item Explanation / Examples A B C
Design Change A design change is done when a new part drawing or a manufacturing X
instruction has been issued.
• New part design
• Design change that affects the part
• Design change with no effect to the part,(name/number, etc.). X
New Sub- A sub-supplier, who has never produced the part or component, X
Supplier begins manufacturing this part for the Organization.
• Addition or change of a sub-supplier
• Addition or change in delivery/manufacturing location
• Change from in-house to external production (or vice-versa)
Material Change The material(s) used to manufacture the part is changed. X
• Change of material type
• Change of supply from outside to self-supplied (or vice-versa)
• Change of composition (including anti-rust or lubrication oil)
Manufacturing A process method, setting or condition used in manufacturing the part
Change is changed or modified. This includes any change which effects the
way the parts are produced as reflected in the PQCT. This applies
when the normal control range changes, not for routine adjustments.
• Process method
• Process standards or setting method
• Process order
• Jig/Fixture (New, Revised, Repaired, etc.)
See Note
• Die/Mold (New, Revised, Repaired, etc.)
• Inspection Method

Note: If the IPPAAR process cannot be completed before parts are to


be shipped (e.g. a welding robot breaks down and the process is
done by hand), contact the Customer immediately. The Customer will
provide instructions and requirements to Organizations in this
situation.

Note: Example changes above could be A, B or C level changes.


For clarification contact the Customer quality representative.
• Associate change on a critical process X
Machine Change When the machine initially used to produce the parts during the X X X
approval process has been changed or replaced by another machine.
• Initial use of a new machine
• Modification or major repair of a machine
• Equipment relocation within the same plant
Transportation / The method of transporting the part to the Customer, or the X
Packaging packaging of the part deviates from the initially approved method.
Change • Change in delivery method, packaging material or containers
Sort To be used at the direction of the Customer for the parts that are X
sorted or re-inspected outside the PQCT.
Other Only to be used as directed by the Customer quality department. X

Note: If used, an explanation must be written on or provided with


the IPP Tag.

Organization shall reference the 09.01.01.07.02 IPPAAR on the KNA Quality Portal under “Forms” for Initial
Production Parts Advanced Approval Request submission document and instructions.
Organization shall reference the 09.01.01.07.03 IPP Tag on the KNA Quality Portal under “Forms” for Initial
Production Parts tag document, instructions and order information.

18
US.108495552.01
IPPAAR Change Point Approval Flow

Organization Customer reviews Organization


initiates / the IPPAAR and produces samples,
completes IPPAAR agrees on approval completes the
form and sends to requirements with requirements,
Customer Organization updates quality
documents and
issues to Customer
with the IPPAAR

Organization Customer reviews


Customer states
completes the IPPAAR, marks
the reason(s) and
requirements a judgment and the
further action
and/or the IPPAAR is
required
countermeasures forwarded to
and updates the Organization
IPPAAR

Organization
produces parts for
Customer Approval Designated By: mass production
• IPPAAR# utilizing IPP tags
• PASS circled on IPPAAR form with the initial
• AND the Customer approval signatures shipment of
changed parts
including IPPAAR#

13.4 Identify the First Lot for IPP Tag


The Organization confirms the first lot conforms to all quality requirements before shipping. Confirmation data is
retained by the Organization and may be required to be included with the first lot.
The Organization identifies the first lot shipment with properly completed IPP tags attached in a conspicuous
location. Organizations must control or track IPP tags sent to the Customer:
• Wrap labels around opposite corners so they can be seen from all sides
• Label containers on the outside to show an IPP tag is enclosed.
• Do not cover any other labels when attaching the IPP tag (e.g. part number or bar codes)
• Use the area on the tag reserved for attachment, and do not tape over areas of the tag with a bar code or
IPP number.
• When a shipment contains both the first lot and older parts, label all containers in the shipment to indicate
whether they contain old or new parts. (Material must be shipped in FIFO order.)

13.5 New Model IPP Shipment


The Organization shall issue an IPP tag, or under the Customer directions issue some other type of label, for
every new model parts.
IPP tags must be attached to each trial part shipment and the first three MP lots of new model year parts. The
first 3 MP lots are to be accompanied by data and certifications that show the parts conform to specifications and
capability for all critical control points and customer attach points.
Note: A completed, approved IPPAAR form is required for all "A" level changes prior to shipment of the changed
part. All "A" level changes also require an IPP tag on the first production shipment to the Customer.

19
US.108495552.01
14.0 MARKET / WARRANTY QUALITY
The Customer receives warranty parts and information weekly from Subsequent Customers. The Customer
analyzes the parts and data and maintains records of the results. When a potential defect has been identified
related to the Organization’s product, the Customer will forward those parts and information to that Organization
for analysis.
The Organization has responsibility for the quality of its products sold to Customer and is financially responsible
for any and all product that is returned to the Customer under the Customer’s current warranty system. A 5
principle of problem solving report may be required for any defects that are determined to be the responsibility of
the Organization or Organization’s sub-supplier. In addition, the Organization may be financially responsible for
any costs related to the warranty claim including but not limited to the costs of parts, labor, shipping, etc.
This quality requirement and reimbursement applies to product determined to be defective within the vehicles
basic warranty period as determined by the Subsequent Customer.

15.0 SUPPLIER QUALITY RANKING


At the end of each fiscal year, KNA QA will review the Organization’s quality and warranty data using 12 months
rolling data to determine supplier class ranking. This information will be shared with Plant Supplier Quality and
KNA Purchasing as input to the supplier scorecard.

15.1 Determine Supplier Class Ranking


Class ranking will be set based on average supplier performance. Suppliers less than half the average tend to be
Class 1. Suppliers greater than twice the average tend to be Class 3. Remaining suppliers tend to be Class 2. A
class ranking will be established for each of the following metrics: quality index per million (QIPM), quality
occurrence per million (QOPM), WRPM & W$PM$. The worst of these will be used as the supplier’s overall class
ranking. Management may change a supplier's class ranking based on actual performance or extenuating
circumstances. These types of changes must be documented in writing and approved by KNA QA and plant
management. KNA Purchasing will share class ranking with suppliers, via the supplier scorecard, on an annual
basis. This information will also be used for maker layout decisions.
Supplier Index points = Index Value (based on rank) + Nuisance Points
Rank Index Value Standard
A 100 Defect that may lead to fire hazard, loss of function of safety related systems
and or parts.
B 20 Defect other than A Rank that may impair the function of the product and has
a high potential for affecting the customer.
C 4 Defect other than A or B Rank, not a functional problem.
Note: A nuisance point is assessed to a failure for every hour of work the Customer spends working on the issue
with a minimum of 1 point and a maximum of 50 points assigned to one failure.

15.2 Quality Improvement Program (QIP)


QIP is a process by which the Customer partners with the Organization to improve their quality performance and
strengthen their quality constitution. Some Organizations may be required to participate in the Keihin Global QIP.
All other Organizations will be considered for QIP based on the following criteria:
• An overall class ranking of 3
• Impact to customer
• A-Rank issues or index greater than 150 in two consecutive months
• Customer recommendation based on performance issues
The Organization will conduct a situation analysis and develop a Specific Action Plan (SAP) to address concern
items and recommended themes. Past Problem History focusing on customer and market issues, will be
reviewed and related countermeasures verified as part of the QIP.

16.0 REQUIRED DOCUMENTATION FOR ANNUAL SUBMISSION


The Organization is responsible and required to submit the following documentation on an annual basis:
• Up-to-date PQCT
• Up-to-date PFMEA
• Current part data for critical control points and customer attach points

20
US.108495552.01
17.0 QUALITY REGULATION REVISIONS
Any changes or modifications to this agreement must be mutually agreed to and memorialized in writing executed
by Customer and Organization.

18.0 ACKNOWLEDGMENT (09.01.01.07 KNA Supplier Quality Manual Rev 0)


The Organization acknowledges receipt of this quality agreement. Any exceptions and/or deviations must be
agreed upon by the Customer and Organization in writing prior to Die-Go.

Witness Organization _____________________


Signature / Date ___________________ Signature / Date __________________
Print ____________________________ Print ___________________________
Title ___________________________

Witness Organization _____________________


Signature / Date ___________________ Signature / Date __________________
Print ____________________________ Print ___________________________
Title ___________________________

Witness Organization _____________________


Signature / Date ___________________ Signature / Date __________________
Print ____________________________ Print ___________________________
Title ___________________________

21
US.108495552.01

You might also like