SQA Manual 2104 Rev 11.1
SQA Manual 2104 Rev 11.1
SQA Manual 2104 Rev 11.1
FOREWORD
Customer satisfaction is at the center of OKAYA 5 AXES and the Supplier Integration and Total Quality
AXES
are the two pillars promoted by OKAYA to ensure excellence in product develo
p ment and operations
Supplier Quality continuous improvement towards excellence is mandatory to achieve our common
objective of sustainable and able growth.
profit
This Supplier Quality Manual sets out OKAYA policy and procedures to support our supplier partners in
Their quest for EXCELLENCE fromhe selection and nomination to the ment of development and
t production. manage
Strict enforcement of the policies and procedures included in this mandatory condition to the
manual is a relationship between OKAYA and its Suppliers partners.
CONTENTS
I -ADVANCED QUALITY PLANNING for Product & Process (APQP) 4
I.1 APQP Procedure 5
I.2 APQP Stage 0 – Supplier pre selection 8
I.3 APQP Stage 1 – Supplier selection 9
I.4 APQP Stage 2 – Supplier nomination 10
I.5 APQP Stage 3 – Design validation 10
I.6 APQP Stage 4 – Process validation 12
I.7 APQP Stage 5 – Initial sample validation 15
I.8 APQP Stage 6 – Start Of Production & probationary period 16
I.9 APQP Stage 7 – Product Quality Assurance management 17
V- ACRONYMS 34
Advanced Quality Planning for product and process is a structured method of defining and establishing the
necessary steps, which supplements supplier quality policy and rules implemented to ensure that a
component will comply with OKAYA requirements.
The OKAYA APQP is attached in the Appendix 1 (all mentioned appendix are part of the Supplier Quality
Manual).
OKAYA APQP shall apply to all OKAYA suppliers listed here below:
Category of
Definition
supplier
Design components which will be fit for OKAYA project specific purposes and will meet
Designer OKAYA specifications. The supplier-designer is responsible for the definition and as the case
may be responsible for the supply of the components.
In a continuous improvement approach, OKAYA reserves the right to adapt the AQPpp in function of the
technologies.
The Advance Quality Planning procedure is a process which supplements supplier quality policy and rules
and aims at conducting a thorough validation of the design – product and process, in order to ensure that the
supplier will be in a position to deliver, as of the Start Of Production, the expected level of quality in line with
OKAYA requirements.
The Advance Quality Planning procedure includes 7 stages (excluding the stage 0 consisting in the supplier
pre- selection). These stages apply to all customer application projects and to components already used in
production (product process changes).
These 7 stages are followed-up in the Supplier Relationship Management (SRM) Portal
(https://suppliers.OKAYA.com/suppliers/) in the section called PQA module within scenarios adapted to each case.
The OKAYA buyer will select the supplier representative to take in charge the PQA Process initiated in the
Portal. From this moment the supplier is required to fulfil the corresponding actions on the deliverables of
each of the 7 stages.
Concerning car-maker application projects, the 7 stages are integrated into the milestones of the OKAYA project
development process and are planned as shown below:
The Appendix 1 describes a summary of the deliverables according to the category of component.
First category - Non OKAYA Specific Component : dedicated to validation of standard components
and catalogue components – as defined in the matrix below (OKAYA will accept ISO 9000
certification):
Raw materials Raw (steel, additives, plastic granulates, etc.) and standards
Second category - OKAYA Specific Component : dedicated to validation of components that are
specifically developed to satisfy OKAYA needs – as defined in the matrix below:
The following pages are describing the content and the specificity of each APQP stage.
The list of deliverables of APQP is detailed in Appendix 1.
The purpose of this stage is to validate that the performance of a potential supplier complies with OKAYA
expectations.
Supplier must:
guarantee the reliability of processes and keep records
have a process of continuous improvement
have a process to continuously capture what has been learned
It is based on:
a clearly defined quality policy
an organization capable of assuring quality at all stages of the component life, in line with OKAYA
project development phases
the willingness to work with OKAYA in a spirit of partnership and continuous improvement and
problem solving attitude
ISO TS 16949 certification obtained through a certification office, with a valid date.
EVAL assessment conducted by OKAYA according to the EVAL procedure with a score of at least 80%,
and with each of the mandatory questions qualified.
The purpose of the EVAL is to identify all process management related risks at the potential supplier,
along a supplier shopfloor evaluation (of its current processes) – this assessment will be conducted
by Group Purchasing and SQA Segment representatives.
EVAL is dedicated to assess new suppliers. EVAL assessment is not scheduled periodically with all
OKAYA panel suppliers. There are other programs (RSQ, SD&P, YIS) assessing current suppliers.
Commodity Check List assessment conducted by OKAYA SQA – performed for each and every new
supplier as well as current suppliers intended to deliver components for segment not previously
assessed – with a minimum score of 80% and all Critical Questions conform (CQ) . Any supplier rated
below will be requested to submit an action plan (with responsible & due date) to achieve a full
compliance with the requirements checklist.
►► For each project and each component to be purchased, OKAYA Purchasing will define the list of
approved suppliers which will receive the RFQ for such business.
The purpose of this stage is to define the OKAYA requirements that shall be addressed to the supplier.
OKAYA requirements and specifications specific to the parts, components, systems or material purchased are
detailed in the Specific OKAYA Requirement File (S-VRF) and includes:
the product specifications: set of functional, technical and general released specifications and
drawings including the SPPC (SPECIAL PRODUCT and PROCESS CHARACTERISTICS)
the applicable Commodity Check List (CCL)
the quality and logistics requirements
Standard Control Plan when applicable
Based on this released Specific OKAYA Requirements File, request for quotation are sent out and recovered from
Suppliers using OKAYA Purchasing Management tool (PuMa).
Supplier Design review maybe organized by OKAYA Buyer and chaired by OKAYA R&D to clarify technical
requirements or take into account possible Supplier improvement suggestions.
Following the above Supplier Design Review, S-VRF shall be updated and released to each Supplier
participating to the RFQ
OKAYA can possibly use auction process to make final Supplier Selection.
compare pre-selected supplier’s performance and answers vs. the latest released version of S-VRF,
including CCL and preliminary design review
review quality of the answers, dates and robustness of the quotation received
analyze strengths and weaknesses of the suppliers
select the supplier representing the best
OKAYA
►► SVRF has to be agreed and signed by supplier, with SPPCs, and CCLs’ self audit included.
►► THEN and ONLY THEN the Nomination Letter can be sent to the selected supplier
Purpose of this stage is to ensure that product and process quality requirements are met before launching the
tool.
For each Special Product Process Characteristic (SPPC) identified after FMEA review, the supplier will have to
implement the relevant control according to the above referenced rule.
The supplier will have to list both:
Customer SPPC characteristics: either customer interfaces or characteristics impacting OKAYA or / and
OEM assembly – visual aspect – product performance and / or reliability (the aim is to ensure
common understanding between Supplier and OKAYA)
Internal SPPC characteristics: fundamental supplier product characteristics that could impact supplier
manufacturing process and / or non respect of supplier internal standards
The validation results compliant with the approved plan will be reviewed and signed at least by the:
► Validation plan:
The validation plan template to be used by the supplier is attached in Appendix 4. The validation plan is
completed with the supplier on the basis of:
Once these documents have been examined and approved by OKAYA, the supplier undertakes to comply with
them. Any proposal for modifying or improving the product or process, including proposal related to transfer of
production or move or relocation of the production equipments, must be approved by OKAYA on the basis of
the documents modified by the Supplier respecting the Product and Process modification section of the
present manual.
Upon validation of End of Stage 3 validation sheet by supplier and OKAYA, the supplier shall be authorized
to kick-off tooling.
The purpose of this stage is to ensure that the process developed by supplier is capable to produce the
defined components in compliance with OKAYA requirements, that the targets are defined for the Full
Production Day, and consequently to demonstrate the following:
run at rate : proving that all committed volumes for OKAYA and other customers can be met on
shared equipments at all operations of the process
capability of the process
validation of the product / processes of sub-suppliers (Tier N management fulfilled)
build correct product in accordance with OKAYA approved work instructions and control plan.
► Off tool: the component produced out of the off tool has to be evaluated and approved by OKAYA in terms
of dimensional and assembling. If the component is approved at this stage of the project phase, it is not a
final approval of the component: the final approval will be given after Initial Samples submission (in stage 5),
out of the Full Day Production Run in serial conditions.
The FDPR readiness matrix (Appendix 6) shall be used and the supplier will need to fully comply with the
requirements in order to schedule the Full Day Production Run performed by OKAYA Team.
The self process audit should be achieved with a score of 80% without any critical CAR (Corrective Action
Request) and CCL approved prior requesting OKAYA SQA Engineer to attend to the Process Audit.
the duration must be sufficient to assess the stability of the process (minimum 3 hours of production
and 300 components) – However depending on the nature of the component OKAYA reserve the
right to require the supplier to run longer and more components than here referred.
the FPDR must include one or several changeover of version (include change of production shift)
for non audited shift(s), supplier will have to provide training reports and evidence of compliance at
run at rate target.
Following the full day production run, the following reports must be issued:
full production day report (Appendix 5): conditions, quantities produced and rejected, analysis of
defects, speed of the production line, Total Line Reject to be calculated (Appendix 8), with
decision accepted or refused
process audit report (OKAYA procedure - SQ 2102 and Appendix 7 of this manual) including
capabilities (Cmk ≥2, Cpk >1.67, target Ppk≥2) if requested.
Confirmation of a statistically Normal distribution of the product / process parameters and Ppk
results above 2 (Ppk: preliminary capability study calculated on components from the FDPR) or
Cpk results above 1.67 (Cpk: capability study calculated on components when in serial
production). Then process must be monitored through SPC when in production.
In case capability is not demonstrated, supplier to implement a Poka Yoke, 100% automatic
control… in order to put characteristics under control to meet specification.
OKAYA SQA Engineer will check on supplier site that the control plan:
o integrates the countermeasures listed in the PFMEA
o is respected on the shop floor, including Reinforced Control Plan.
It is expected that this method of tracking and reacting to issues will be also applied while in serial
production.
►► The process is qualified by OKAYA if the FDPR is accepted, and audit results are satisfactory
(“Process Audit” procedure ref. 2102). Otherwise, the supplier must draw-up an action plan and a
follow-up audit will be performed by OKAYA.
Action plan must be implemented within 10 days and must be sponsored by the Top Management of
the supplier.
►► Traceability:
Supplier must have a traceability system to trace back any component to the original batch of material
(raw material / primary components) used.
Along the process audit, OKAYA SQA Engineer will verify the supplier system to control traceability and
the respect of the product coding.
►► Contingency Plan:
Suppliers shall develop a contingency plan (ISO/TS 16949 – 6.3.2) for potential catastrophes disrupting
product flow to OKAYA, and advise OKAYA at the earliest in the event of an actual disaster.
In an actual catastrophe, suppliers shall provide OKAYA access to OKAYA’s tools and/or their replacements,
Contingency Plan shall contain as a minimum the following items:
Information system; breakdown problems, partial or total destruction, natural damage, central data
system, CAO, productions system, etc.
Supplying system: supplier delivery orders management, raw material stock management, supplier delivery
failure (strike, disaster…), external supply quality failure, transport failure (strike, accident, ….)
In the case of several processes at the supplier (e.g.: several cavities inside a plastic injection tool) – the supplier
is requested to keep 5 initial samples per process and have them properly saved and identified.
►► The supplier validation plan is considered completely executed when OKAYA have completed their share
of the validation respectively of the OKAYA product and of the vehicle utilizing a component supplied by
OKAYA supplier.
►► Therefore the supplier validation is deemed to be successful when OKAYA and OKAYA customer
have passed their share of the validation respectively of the OKAYA product.
Audit reports and corrective action plans are requested to be submitted to OKAYA at least once per year in
the scope of the Yearly Initial Samples approach.
To ensure continuous validity of the process audit, OKAYA reserves the right to perform process audits every
2 years and to carry out new audits whenever OKAYA consider the need.
The purpose of Supplier Initial Samples (IS) validation is (i) to check that the component (performance,
characteristics, reliability, capability, etc) comply with OKAYA requirements and (ii) that the process developed by
supplier is capable to produce the defined components in compliance with OKAYA requirements.
Mass production components must be in compliance with Initial Samples approved by OKAYA: no change on product,
process or packaging.
Master samples and initial samples file will be archived at the supplier plant during 10 years after the end of
lifetime of the manufactured product.
They will be used as reference for comparison on the YIS report
Process audit (including Reinforced Control Plan) and CCL, – validated by OKAYA
Full Day Production Run validation – validated by OKAYA
Dimensional report
SPPC Characteristics capability
Raw material Conformity
Test on OKAYA production Line to confirm no assembly issue on OKAYA line
Functional tests
Packaging validation
Report on subjective requirements (appearance – aspect – Buzz Squeak and Rattle noise) if applicable
IMDS Database data entry completed
If all the initial sample deliverables have been qualified, OKAYA SQA will release the ISR signed (Appendix
10 Initial Sample Report – ISR).
The initial sample approval decision will be communicated to the supplier by sending the OKAYA approved ISR.
In the case of IS not validated a deviation must be required to deliver components. The supplier will remain
responsible of the quality of the components delivered and will submit the request to OKAYA through the
Deviation module in SRM (see Appendix 14 as reference for content expectation).
In the case that Supplier is requested to deliver components and the Initial Samples were not accepted due
to a Process Audit not qualified, in addition to the deviation, a Control Shipment Level - CSL process has to
be implemented with same conditions than a Probationary Period of Stage 6 not validated (see Stage 6).
As soon as the Initial Samples have been accepted by OKAYA, the supplier is allowed to deliver components
to OKAYA according to the needs and to the logistic protocol as well as to the requirements of this chapter.
This is the serial production phase.
The supplier is fully responsible to deliver according the specifications and in line with the accepted ISR.
► Probationary period
In order to validate the effectiveness of control plan, OKAYA requires in this stage the implementation of a
Ramp Up Control Shipment Level (RUCSL). This additional control has to be done according to the following
conditions:
Zero bad parts detected during a minimum of two consecutive months within the Ramp Up CSL period,
All corrective actions resulting from bad parts detected during Ramp Up CSL were implemented and
validated by OKAYA SQA,
No quality incident
All SPPCs in Green status
TLR (Total Line Rejects) performance decreasing during the last 3 months
►► If the exit criteria are not achieved after OKAYA Customer SOP + 2 months, the Ramp up CSL is
renewed for one month.
►► If the exit criteria are not achieved within OKAYA Customer SOP + 3 months, a Control Shipment
Level 2 (CSL2) activity must be implemented without time limit.
This activity will be handled by a sorting company contracted by the supplier and approved by OKAYA.
When a component is granted the Product Quality Assurance (PQA) status, the component is no longer
subjected to a probationary control period.
PQA Management Flow purpose is to ensure that supplier fulfils OKAYA requirements and supplies quality-secured
purchased components along all the production period.
Any delivery of parts without respecting the requirements agreed must be formalized by requesting a
deviation. The supplier will remain responsible of the quality of the components delivered and will submit the
request to OKAYA through the Deviation module in SRM (see Appendix 14 as reference for content
expectation).
Initial Samples are re-validated on a yearly basis and shall be presented by the supplier to the OKAYA Site at
least 1 month prior the anniversary date of Initial Samples approval (the year before).
The deliverables requested by OKAYA for the Yearly re-qualification of the initial samples are outlined in the
stage 7 of the APQP matrix attached in the Appendix 1 section.
OKAYA will request the submission of a report with existing data of current production, including:
In case of a non conformity situation of the items mentioned above, the supplier will request a deviation to
OKAYA and must developed an action plan to come back to conformity.
Upon request, the supplier must provide OKAYA with the results of inspections carried out for each batch
delivered in line with the requirements of the APQP (Appendix 11 PQA Management Flow).
OKAYA non specific component workflow: for components such as raw materials / catalogue
components / standard electronic components / non specific packaging as defined in the APQP
definition section of the present manual.
OKAYA Specific component workflow: for components falling in the definition of the APQP definition
section of the present manual.
In addition, for Pass-Thru logistic flow (components delivered directly to OKAYA Customer), specific
actions has to be implemented as per OKAYA request.
All PQA component deliveries must be identified with a PQA label on each container box.
Upon request, the supplier shall inform OKAYA of the results of the inspections carried out for each batch
delivered in line with the requirements of the PQA management flow.
In all cases, OKAYA will give the supplier written notification of the date for resumption of PQA status
after the problem has been solved.
When PQA status is lost – the supplier must take off PQA identification and when applicable identify
with a label on each box and container, the level of control shipment (1 or 2) requested (Appendix 11
PQA Management Flow).
If the conditions agreed to remove the PQA suspension are achieved, the PQA status is recovered.
OKAYA SQA authorize the Supplier to re identify boxes with the PQA label
►► Case of a product or process modification or transfer of a supplier production line (see Chapter
II.5) – the PQA status is therefore lost and the PQA status will need to be re-granted going through
the stages 2 to 6 of the APQP
Supplier undertakes to use for incident treatment exclusively the PDCA / FTA methodology and answer
through the IMS (Incident Management System) Module of SRM Portal
(https://suppliers.OKAYA.com/suppliers).
►► Recurrent incident:
►►► CP1, CP2, C1 or C2: a recurrent incident is the same failure mode and the same
suspected or identified root cause coming from parts belonging to a batch produced after
implementation of the corrective actions of a previous incident.
►►► C1WR recurrent incident: occurs on the same component number, the same failure
mode, and the same suspected or identified root cause and for which production date is after
implementation of the corrective actions.
The logistic incident affects Production line shutdown at OKAYA due to shortage of
L2
the OKAYA production lines part deliveries
Perturbation detected at OKAYA receiving:
► Incident processing
When a defective component is identified, OKAYA will notify the supplier responsible of the incident using the
IMS (Incident Management System) Module of SRM Portal. No other notification will be issued.
All suppliers are required to install broadband Internet and to systematically consult and make use of the
SRM tool and associated documents. Their response time is measured and recorded by SRM according to
OKAYA Reactivity requirements:
In the case of a C1 and C1WR, the supplier is required to present to OKAYA plant the analysis. Physical
presence will be required when necessary. All answers (QR, PD, CA & LLC) must be formalized in English.
A process audit will be conducted by OKAYA supplier quality prior to incident closure.
Each category of incident shall not be closed without submission of LLC and verification on genba.
The Category Alerts shall not be closed without submission of agreed actions between OKAYA & the
supplier. Documented analysis will be required when necessary.
►► Cancelled incident:
If the Plan Do analysis concludes the supplier non-responsibility then the supplier incident is cancelled.
► Sorting activity:
For any sorting activity requiring a sub-contractor, the Supplier will have to select a sorting company
approved by OKAYA. Supplier shall ensure that the organization of the sorting shall enable an immediate
communication of any relevant information (including especially the sorting results) obtained by the supplier
and/or the sub-contractor during the sorting. All costs linked with the sorting, including costs to be paid to the
subcontractor, will be borne by the Supplier.
►►Sorting at OKAYA plant: the Supplier shall mandate a sorting company within the first 2 hours
following the incident notification in order to ensure that OKAYA is secured latest 4 hours following the
incident notification to the Supplier. In case of delay OKAYA will contract directly a sorting company
and shall charge back to the supplier all related costs.
► Supplier Liability
Supplier remains liable for all direct and indirect costs caused by any non conformity to contractual
specifications or applicable regulations.
► Quality indicators
Among other, the Quality performance of suppliers will be measured with the following indicators based on 3
months rolling ( M + (M-1) + (M-2) )
IPB – 3 Months:
Incidents C3M:
Quality
- Number of total incidents (C1+C1WR+C2)
► Logistic indicators
The Supplier Service Rate (SSR) indicator measures the level of delivery performance of a supplier to OKAYA
sites.
This indicator is measured in % at each delivery, so against each pick-up order, and
calculated as following:
The service rate indicator for a Supplier over a period (for example a month) is the
rating of cumulative NLOTIF divided by the cumulative NLR.
Every month, the Supplier Delivery Performance is published as part of the supplier
QCD performance. A continuous improvement plan is requested, and its progress
followed up.
OKAYA supplier drifting from quality performance has to define action plan to identify systemic
weaknesses and propose corrective actions – Systemic Recovery Plan
Systemic Recovery Plan is led by supplier top management and submitted to OKAYA on regular basis.
OKAYA makes available to each Supplier a set of tools (tool box) applicable according to Supplier Quality Performance
level:
● Supportively, when the supplier Quality performance is stagnating, the following activities: QRQC
Deployment, Fundamentals of Quality may be launched by OKAYA.
● Pro-actively, when the supplier Quality performance is identified at risk to drift, the following activities:
Supplier Development & Preventive (SD&P) program may be launched by OKAYA.
● Reactively, when the supplier Quality performance is worsening, the following activities: Recover Supplier
Quality (RSQ) program, NBOH Alert / NBOH Status may be launched by OKAYA.
Detection
Red Box
Red Box
Analysis
(FTA // Comparison)
(FTA Comparison)
OKAYA has deployed a SQA Strategy to support the supplier improvement activity by deploying 2 different
programs:
● Program to prevent named Supplier Development & Preventive (SD&P) dedicated to suppliers starting
to drift – support will be given by focusing on Production, Project and Logistics
● Program to repair named Recover Supplier Quality (RSQ) dedicated to top contributing suppliers to
help them to recover quality level.
Based on the Suppliers Quality performance level, OKAYA identifies RSQ and SD&P suppliers.
OKAYA assesses and monitors regularly suppliers’ quality performance in order to prevent potential risk.
Supplier assessment is based on 8 criteria covering project development, production quality and logistics
results. There are 4 Risk Levels: HR+ (High Risk Plus), HR (High Risk), MR (Medium Risk), NR (No Risk)
Suppliers being assessed with risk are requested to select quality tools to perform self assessment and start
to mitigate risk. OKAYA will audit selected quality tools and re-assess risk level at the end of program in order
to confirm effectiveness of supplier actions.
RSQ #
3
RSQ #3 level involves Supplier Production Team
Monthly follow-up on Genba addresses supplier product issues and knowledge with verification of
PDCA actions on Genba and Lessons Learnt Card cross fertilization. Yearly Initial Sample and
Project Management are also addressed.
This program will last 3 consecutive months.
RSQ #
2
In addition to RSQ 3 activities, RSQ 2 level involves Supplier Plant Management
Monthly follow-up on Genba addresses supplier ability to improve process knowledge support by
StEDE activities leading to Systemic Weaknesses on Plant level.
This program will last 6 consecutive months in order to ensure a sustainable improvement
RSQ #
1
In addition to RSQ 2&3 activities, RSQ 1 level involves Supplier Top Management (Group Senior
Management or Chief Executive Officer )
Bi-Monthly follow-up addresses Systemic Weaknesses of Organization leading to changes in
management, system and organization.
This is the highest level of escalation, this program will last 12 consecutive months in order to
ensure a sustainable improvement with strict follow up of defined exit criteria
The exit of RSQ Program or escalation to the next RSQ category will be decided by OKAYA upon satisfactory
achievement of the targets agreed at the beginning of the program with the supplier.
CSL1 and CSL2 will be required to the supplier in order to assure certified deliveries while awaiting the full
recovery of the conformance on the production process or /and the product.
►► CSL1 – Following a request from OKAYA, the supplier will implement a CSL1 in addition to the
sorting of his production.
The CSL1 and the sorting activity will be operated out of the production line in a dedicated zone and
in accordance with a specific control instruction approved by OKAYA – Supplier will make available
the evidence that sorting operators have been trained to the sorting and CSL1 Instructions – the
performance of the sorting activity will be monitored on a daily basis by the supplier. The supplier
formally guarantees the conformance of goods delivered for each delivery that takes place while
CSL1 is in the process of implementation. The cost of sorting will be borne by the supplier.
When the supplier fails to meet the commitments stipulated by CSL1 period, CSL2 is then required to
be implemented.
►► CSL2 – the supplier is required to put in place a sorting activity by an external company,
validated by OKAYA, in line with criteria defined along the CSL1. The cost of sorting will be borne by
the supplier. Sorting results will be communicated to both OKAYA and the supplier. OKAYA has
developed a panel of sorting companies that OKAYA suppliers will be required to work with.
►► Exit of CSL1 or CSL2: status can be lifted only after formal acceptance from OKAYA in accordance
with exit criteria defined in the CSL notification letter.
►►In case of recurrent non-conformance, where the supplier clearly does not have sufficient control of
his production process, the Control Shipment Level (CSL) procedure will be applied.
In case of continuous drift (RSQ program) or potential risk at OKAYA or its Customers, OKAYA will send a
notification letter to request further investigation or assessment at corresponding level.
If there is no appropriate reaction from the supplier, OKAYA may decide to apply a NBOH process.
► Phase OUT:
If the supplier is not showing improvements, OKAYA may decide to end the relationship with the Supplier.
The supplier has the obligation to communicate to OKAYA Project / Productivity Buyer and in a written form,
any product or process change intention (design, manufacturing process, material, colour …) prior to its
implementation, in order to obtain a written approval from OKAYA relevant people
If a component subject to a change (previously approved by OKAYA) is shipped to several OKAYA sites –
each of the sites have to be informed and each OKAYA site will advise the supplier on the validation to be
performed by the supplier to proceed with the change – shall the validation be successful. Upon reception of
written agreement from each OKAYA site, the supplier is authorized to implement the change.
The following chart is giving some examples of product and process changes – the list is not exhaustive:
A Yearly Initial Sample audit will be performed by supplier in accordance with the control plan approved along
the Initial Sample approval stage of the APQP process.
The quality system of the supplier will ensure that any production return of experience involving a product or
process change(s) is fed-back for a post mortem analysis.
Supplier
1 Year At supplier’s plant
(Self-Assessment)
Process Audit (*)
OKAYA reserves the right to
perform process audits every OKAYA SQA At supplier’s plant
2 years (after IS validation)
Supplier
Product Audit / YIS 1 Year At supplier’s plant
(Self-Assessment)
(*)
No limit except in case of
new incident or entering in Supplier
CCL the Supplier Quality (Self-Assessment) At supplier’s plant
Improvement Program or OKAYA SQA
along Process Audit
when it has to be re-assessed
(*): Supplier to provide results of the Product / Process Audit with the Yearly Initial Sample submission to
OKAYA.
The purpose of this chapter is to define how supplier ensures that once mass production is terminated, process
at Supplier is capable to provide for OES and Aftermarket.
6 months before end of mass production, supplier has the responsibility to fill-in the EMP changes evaluation
check list (Appendix 12 EMP – Section: Potential Changes Evaluation). This document aims at listing any process
changes that are planned to be executed by the supplier before EMP.
Supplier submits the check-list to OKAYA Buyer and SQA in charge to obtain a formal OKAYA approval.
Supplier will execute the required modifications, in line with the Product and Process change management
section and proceed with next step.
One month before EMP, the supplier has the responsibility to self assess its process through EMP process
assessment check list.
The EMP process assessment check list will then be submitted to OKAYA SQA to check respect of steps (Appendix 12
EMP - Section: Process Assessment)
PQA status has to still be managed in accordance with PQA management rules.
No more systematic yearly initial sample submission is then requested the year following the end of the OEM
life and no more systematic periodical OKAYA process audit will be performed.
OKAYA process audits and initial sample submission will be nevertheless required following a product or process
changes occurring at the supplier.
The supplier, a professional in its field, is perfectly aware of the demands and requirements of the Automobile
Industry, in particular in terms of quality. It is supplier responsibility to define and implement a quality policy in
compliance with this Industry's standards and customary practices, as well as with laws, regulations and standards
in force. This SQM shall supplement supplier quality policy.
Nothing under this SQM may be interpreted as relieving the Supplier from any of its obligations towards
OKAYA and especially its responsibility to deliver the Components in compliance with all documents that
govern the relationship between OKAYA and the Supplier in connection with the supply of the Components.
Activities performed by each Party under this SQM and especially, inspection, audit, validation, testing and/or
approval made or granted by OKAYA under this SQM as well as OKAYA decision not to enforce all or part of
this SQM shall not affect Supplier responsibility concerning the quality and reliability of the Component and
compliance with its contractual obligation.
V- ACRONYMS
Definition
ADVANCED QUALITY PLANNING for product and process: aim of APQP is provide OKAYA with all the
APQP guarantees concerning the means to achieve product quality. The APQP includes: OKAYA Requirements
File (VRF), Quality Assurance File (QAF), Initial Samples File (ISF) and a Quality Monitoring File
(QMF).
CAR CORRECTIVE ACTION REQUEST
Part already validated and used with same revision level in a project of any OKAYA Site in current or
CARRY OVER
stopped
mass production
CCL COMMODITY CHECK LIST
Notice given by an OFFICIAL organization on the basis of the appropriate procedures or documents
CERTIFICATION
by
which the component is recognized as being in compliance with STATUTORY requirements
Fulfilment of a requirement. Note: The term "CONFORMANCE" is a synonymous but deprecated. (ISO 9000
CONFORMITY
-
2000)
CONTROL PLAN Documented description of the systems and processes required for controlling component. (ISO TS
16949)
CONTROLLED SHIPMENT LEVEL 1 and 2: CSL1 and CSL2 are provisional procedures implemented with
CSL a view
to guaranteeing certified deliveries while awaiting the re-establishment of the conformance of the
production process.
OKAYA supplier evaluation tool taking into account 8 key criteria concerning operational and strategic
EVAL performances of the suppliers. This grid is used to select as well as to evaluate suppliers (present and
potential suppliers).
FULL DAY PRODUCTION RUN: Production run to validate the "full capacity / quoted rate" conditions. A
sufficient quantity of components shall be manufactured during this day to be considered statistically
FDPR
significant. It shall extend for a period between 1 hour and 8 hours (one shift). At least 300
components
shall be manufactured unless a specific quantity is specified in relation to the rate of manufacture.
FAILURE MODE and EFFECT ANALYSIS: Deductive method and tools used to identify potential failure
modes, their causes and effects, and assess criticality of these failure modes, based on severity,
FMEA
occurrence and detection probability criteria. Generic FMEA is applied on Product Design (DFMEA),
Process Design
(PFMEA), and Equipment. It can also be applied on Product functions (Concept FMEA)
A VPS tool for identifying simple solutions which can be applied immediately, to eliminate waste and
HOSHIN
produce just-in-time, carried out with the involvement of personnel in all the areas concerned.
INCIDENTS MANAGEMENT SYSTEM: Incident Management System (IMS) enables to notify quality
IMS incidents to suppliers and to receive and approve their Quick Response PDCA (launching an alert
after 24 hrs) and
their Analysis PDCA and Factor Tree Analysis (5 days to submit, 10 days to implement).
INITIAL SAMPLES: Units manufactured by final production methods and under "full production
IS conditions". IS approval shall validate the production equipment. After approval, they are used as
reference for the
volume production.
ISR INITIAL SAMPLE REPORT
A pass thru component corresponds to a part produced by a Supplier of OKAYA who delivers this very
PASS THRU
part
directly to OKAYA Customer
PDCA (PLAN, DO, CHECK, ACT): is a methodology to settle and solve problems effectively. Based on
continuous improvement, PDCA comprises four different steps: Plan: grasp the problem, analyze causes
PPB * Only parts that have entered the site; consignment stocks awaiting reception are not included.
** For raw materials, replace number of parts by number of delivery units, i.e. unit of weight in most
cases. Non conformance is determined in terms of specifications: identification, size, aspect, function,
mix, error in quantity, etc. Non conforming parts formally accepted by OKAYA are not included in the
measurement of defective parts; batches of products that have been destroyed or returned will be
recorded as non conforming. In the event that sorting operations have to be carried out at OKAYA to
which the supplier has agreed and paid for, only the defective parts will be recorded as non
conforming. In all other cases, the whole batch is recorded as being defective.
Recover Supplier Quality – Program dedicated to top contributing suppliers to help them to recover
RSQ
quality
level.
QRAP Board QUICK RESPONSE ACTION PLAN board
QUICK RESPONSE QUALITY CONTROL : It is a way of management of problems applicable in every area:
QRQC
Production, Projects, Logistics, Purchasing, etc
Supplier Development Program dedicated to suppliers starting to drift – support will be given by
SD&P
focusing on
Production, Project and Logistics
STATISTICAL PROCESS CONTROL: Consists of monitoring a process by the statistical measurement of key
parameters to detect process variations that impact the components ability to meet a required
SPC
function. The use of this method of control can therefore prevent the production of non-conforming
products. SPC
can only be used for capable processes (see also "capability").
SPECIAL PRODUCT and PROCESS CHARACTERISTICS: and measurable characteristics of a component,
System or assembly which may have an adverse or degrading effect on the function, quality or
SPPC
reliability if an out of tolerance condition occurs, Measurable elements of the process used to
manufacture or assemble a
component that have significant impact on the function, quality or reliability of that components.
SUPPLIER RELATIONSHIP MANAGEMENT: It is an Internet secured portal used to communicate with
SRM suppliers, through which, we can exchange several kinds of information (as for example: Quality
incidents,
performances, standards, suggestion, etc.). (https://suppliers.OKAYA.com/suppliers/)
A document attesting to OKAYA ownership when tooling has been placed at supplier premises
TOOLING LOAN for the production of components. This document must be signed by the supplier receiving the
AGREEMENTS tooling or equipment. This agreement addresses the following major aspects: Ownership of
tooling, term and
termination of the agreement, conditions on the use of the tooling, maintenance and insurance.
YIS Yearly Initial Samples (see APQP Stage 7 – Product Quality Assurance management)
Appendix 1 OKAYA Advanced Quality Planning for product and process - APQP
Appendix 7 Process Audit Questionnaire & Report - (Appendix 3 & 4 of Procedure SQ 2102)
Appendix 12 EMP Changes Evaluation checklist and EMP Process Assessment checklist