Document #
QA-0010
ISOTS16949
Title:
7.4.0 Purchasing
Department Owner of Document:
General Requirements for Tier 1 SuppliersExternal Document
Rev: B
Document Type: Quality Assurance
Specification
Quality, Purchasing
APPROVAL (Signed off Electronically through CATSWeb or by Attending
Members of CCB)
See QP-4.2.3 Table 1 Approval Matrix
REVISION RECORD
Rev.
Date
A
A1
B
08/08/14
10/3/14
1/16/14
FlipChip International
Change Description
ECN# 69163 (SCP) New Issue
ECN# 70455 (SCP)Administrative changes only.
ECN#73447 (SCP) Changed definition of Tier 1 Supplier. Removed PCN form.
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Document #
QA-0010
Title:
General Requirements for Tier 1 SuppliersExternal Document
Rev: B
Table of Contents
1
PURPOSE
3
2
SCOPE
3
3
RELATED DOCUMENTS
3
4
DEFINITIONS
3
5
GENERAL INFORMATION
3
6
TIER 1 SUPPLIER QUALIFICATION
5
7
NON-CONFORMANCES AND CORRECTIVE ACTION
8
8
SUPPLIER PROCESS CHANGE CONTROL
11
9
PRODUCT DISCONTINUANCE
12
10
ATTACHMENT
12
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QA-0010
Document #
1
4
The purpose of this document is to define requirements for qualifying Tier 1 suppliers, materials, and services and to provide
guidelines for Tier 1 supplier management.
This document will apply to all Tier 1 suppliers of products and services at FCI.
RELATED DOCUMENTS
3.1
QA-0002, Quality Survey for Tier 1 Suppliers
3.2
QA-0006, Qualified Supplier List
3.3
QA-0009, New Supplier Survey
3.4
QA-0043, Quality Survey for Calibration and Laboratory Testing Suppliers
3.5
QA-0050, Corrective Action Request Handling Procedure
3.6
QA-0061, Request for New Material/Supplier Qualification
DEFINITIONS
4.1
5
Rev: B
SCOPE
2.1
3
General Requirements for Tier 1 SuppliersExternal Document
PURPOSE
1.1
2
Title:
Tier 1 Supplier– Supplier who provides products that are incorporated into the finished product/bumped wafer/die (e.g. spheres, solder
paste, RDL metal, polymer, backside laminate), and supplier who provides outsourced process(es) (e.g. backgrind process and test
services) and calibration. Tier 1 Suppliers have priority for supplier management and development.
GENERAL INFORMATION
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Document #
5.1
QA-0010
Rev: B
All suppliers providing production-related products and services to FCI must be formally qualified.
5.1.1
FCI purchases production materials and production-related services only from the Qualified Supplier List.
5.1.2
If circumstances require FCI to purchase non-qualified production material, the material must meet all the requirements of
the pertinent material specification and receive approval for use from FCI’s Quality Department and the affected
customer(s).
5.1.2.1
5.2
General Requirements for Tier 1 Suppliers
Title:
Production-related materials or services may be obtained from a non-qualified supplier for research purposes or
as part of supplier qualification.
5.1.3
Once a material is on the Qualified Supplier List, it must be produced using the same conditions and processes as used
during qualification.
5.1.4
No significant change in process or product, as defined by Supplier, can be applied without written notice to FCI.
5.1.5
Suppliers who have been qualified under previous qualification criteria remain qualified pending their next evaluation.
During their next evaluation, such suppliers are requalified under current guidelines.
5.1.6
Any significant quality issue or history of issues may result in an on-site audit, subject to mutual agreement between
Supplier and FCI on timing and agenda.
Quality Documentation
5.2.1
As defined in applicable MS Spec, FCI requires suppliers to send a Certificate of Analysis (C of A) demonstrating that the
product meets the requirements of FCI’s Material Specification. A Certificate of Compliance may be submitted in lieu of a
C of A only with prior approval by FCI.
5.2.2
In the event a material seems suspect or non-conforming. FCI Quality shall ensure an internal or external lab is used to cross
check and verify the material C of C for direct materials match.
5.2.3
Any new direct materials suppliers must be verified to ensure proof of the accuracy of the C of C.
5.2.4
FCI, upon request, requires in-process data such as SPC charts, Cpk values for key processes and defect rates to be provided
periodically by Tier 1 suppliers (usually quarterly but as requested). Cpk less than 1.67 as requested are to submit
improvement plans. FCI and the supplier will mutually determine the exact data and submission frequency.
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5.2.5
5.3
6
Title:
General Requirements for Tier 1 Suppliers
Rev: B
FCI, upon request, requires independent laboratory reports such as ICP/RoHS/IMDS/REACH/EICC to be provided
periodically by Tier 1 suppliers (usually yearly). FCI and the supplier will mutually determine the exact data and submission
frequency, typically as requested by the customer.
All purchased materials used in processing must satisfy current governmental and safety constraints on restricted, toxic and hazardous
materials, as well as environmental, electrical and electromagnetic considerations applicable to the country of manufacture and sale,
including ICP, RoHS, IMDS, REACH, and EICC principles and guidelines.
TIER 1 SUPPLIER QUALIFICATION
6.1
Overview
New supplier qualification consists of four stages:
6.1.1
Initial supplier selection
6.2
6.3
6.1.2
Quality system assessment
6.1.3
Materials and/or services qualification
6.1.4
Final supplier selection
Initial Supplier Selection
6.2.1
The Purchasing Department sends out a request for bids based on requirements provided by Quality, Engineering, and other
appropriate departments.
6.2.2
Under certain circumstances FCI may choose to personally meet with suppliers and further evaluate each applicant’s ability
to meet our needs.
Material Qualification:
6.3.1
Material qualification may take place before; during or after the quality system assessment (see section 6.5).
6.3.2
Materials under consideration for use in production must be qualified by Engineering and Environmental Health & Safety.
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Document #
6.4
6.5
QA-0010
Title:
General Requirements for Tier 1 Suppliers
Rev: B
6.3.3
Along with the material qualification lot, Supplier must provide a Material Safety Data Sheet (SDS) and a Certificate of
Analysis (C of A), demonstrating that the product meets the requirements of FCI’s Material Specification. A Certificate of
Compliance may be submitted in lieu of a C of A only with prior approval by FCI.
6.3.4
The qualification lot will be tested at FCI per the material qualification section of the applicable Process Specification.
6.3.5
The FCI originator provides Purchasing and Materials the Supplier’s material information.
6.3.6
The material information is entered into FCI’s PO and Inventory systems.
6.3.7
Supplier is qualified for production use by FCI.
Service or Product Qualification
6.4.1
Service qualification may take place before; during or after the quality system assessment (see section 6.5).
6.4.2
All production-related services must be qualified prior to implementation.
6.4.3
Qualification procedures depend on the nature of the service (e.g., calibration), but will include accuracy, consistency and
impact on the production environment. A Technical Review Board from FCI comprised of applicable department
representatives will devise a qualification plan for a given service or product.
6.4.4
Upon meeting the qualification requirements, Supplier’s service or product is qualified for use by FCI.
Quality System Assessment for Tier 1 Suppliers
6.5.1
The quality system assessment determines the comprehensiveness and functionality of the supplier’s quality systems. To
complete this assessment, Supplier must:
6.5.2
Complete and return a New Supplier Survey (QA-0009). FCI’s Purchasing and Quality Departments will review the survey
results.
6.5.3
Complete and return a self-assessment (QA-0002 or QA-0043). FCI’s Quality Department will review the completed selfassessment. Supplier may not be required to fill out the self-assessment if ISO9000 and/or TS16949 certified. Copy of
certificate may be submitted to FCI in lieu of the self-assessment.
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Document #
QA-0010
6.5.4
6.6
Title:
General Requirements for Tier 1 Suppliers
Rev: B
An on-site audit may be performed (QA-0002 or QA-0043). The on-site audit may be waived under the following
circumstances.
6.5.4.1
If Supplier is ISO 9000 and/or TS16949 certified.
6.5.4.2
The supplier scores 80% or above on the self-survey overall AND no separate area scores below 70%.
6.5.4.3
There have been no SCARs with regard to product or delivery with materials or services provided OR if SCARs
or issues have been quickly and completely resolved.
6.5.5
ALL criteria must be met for on-site audit to be waived.
6.5.6
If Supplier scores below 70% on the self-survey, an on-site audit is required.
6.5.7
If Supplier scores below 70% on the on-site audit, the criteria cited in section 6.6.2 will be used to determine whether
Supplier should be granted a conditional pass if the material/service is qualified.
6.5.8
Results of the New Supplier Survey, the self-assessment results, and the on-site audit report (if an on-site audit was
performed) will be used to determine whether a supplier meets FCI’s quality system requirements for Tier 1 Suppliers.
Qualification Status for Tier 1 Suppliers: Once FCI has completed all qualifications and quality assessments; a supplier is assigned
to one of four qualification categories:
6.6.1
Pass—Supplier scores  70% on quality assessment. Supplier’s quality system meets FCI’s requirements. Supplier’s
materials and/or services which passed FCI’s qualification testing are acceptable for use with production-related activities.
6.6.2
Conditional Pass—Supplier scores < 70% on quality assessment and/or materials/ services do not fully meet FCI’s
requirements. Other circumstances unique to the supplier indicate that the situation can be quickly improved. Such evidence
might be (but not limited to):
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6.6.2.1
Demonstrated willingness to meet FCI’s quality requirements and/or material/ service needs in a reasonable
timeframe, with evidence;
6.6.2.2
An established schedule and plan to meet ISO 9000 and/or TS16949 or ISO/IEC 17025 certification, especially
if progress toward the plan is evident;
6.6.2.3
The Quality or material/service issues clearly result from a temporary situation that is being resolved;
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Document #
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Title:
6.6.2.4
6.7
7
General Requirements for Tier 1 Suppliers
Rev: B
Supplier provides a unique material or service (sole-source).
6.6.3
Additional requirements for such suppliers will be customized to the situation, but may include monthly/quarterly progress
reports or status reports of progress to schedule for quality system certification.
6.6.4
Conditionally qualified suppliers who do not attain full qualification status within a year may be converted to Probationary
status.
6.6.5
Probationary (For existing suppliers only) - Supplier no longer meets FCI’s quality criteria. Examples of issues leading to
probationary status and methods for regaining regular status are given in section 7.
6.6.6
Disqualified - Supplier does not meet FCI’s quality system, delivery and/or material/ services requirements and there is no
reason to consider granting Conditional Pass or Probationary status. Supplier may not provide production-related materials
and/or services to FCI. An existing supplier who receives this status is removed from the Qualified Supplier List. Section
7.5 gives provisions under which a disqualified supplier may be requalified.
Post Qualification Activities
6.7.1
Once all qualification activities are completed, Quality reviews the results and, with input from Engineering and Purchasing
determines Supplier’s qualification status. Section 6.6 describes the qualification status categories awarded by FCI for Tier 1
Suppliers.
6.7.2
If Supplier has been qualified, the company is added to the Qualified Supplier List along with a list of qualified products
and/or services. If selected to provide these products and/or services, Purchasing will contact Supplier and begin contract
negotiations.
6.7.3
FCI may qualify and contract with more than one supplier for a given product or service.
7.7.5
Supplier scorecards will be kept and maintained by FCI Quality department as a continuing assessment of supplier’s
performance.
NON-CONFORMANCES AND CORRECTIVE ACTION
7.1
FCI expects 100% on-time delivery of materials and services in conformance with specifications provided to the Tier 1 supplier. This
section presents FCI’s response to delivery and quality issues.
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Document #
QA-0010
Title:
General Requirements for Tier 1 Suppliers
Rev: B
NOTE: The term “occurrence” may refer to either an observed pattern of minor incidents or a single incident with major impact on
production.
7.2
7.3
7.4
7.5
Late delivery or servicing
7.2.1
The Purchasing Manager is responsible for initially contacting the supplier regarding occurrences of late material shipments
or services not rendered in a timely manner.
7.2.2
The Purchasing Manager notifies Quality about the delivery or servicing issue and Quality requests a corrective action plan
from Supplier and updates the Material Incoming Inspection Form choosing NO for “Material Received On-Time”.
7.2.3
A Tier 1 supplier may be reduced to “probationary” qualification status and ultimately disqualified as an FCI supplier for
repeat occurrences of late delivery or servicing issues.
Non-conforming Materials
7.3.1
Quality issues a Supplier Corrective Action Request (SCAR) to the supplier and notifies Purchasing.
7.3.2
Purchasing may return non-conforming materials for a refund or credit.
7.3.3
A Tier 1 supplier may be reduced to “probationary” qualification status and ultimately disqualified as an FCI supplier for
repeat occurrences of material quality issues.
Non-conforming Services
7.4.1
Quality issues a Supplier Corrective Action Request (SCAR) to the supplier and notifies Purchasing.
7.4.2
Purchasing may request a refund or credit for the services in question.
7.4.3
A Tier 1 supplier may be reduced to “probationary” qualification status and ultimately disqualified as an FCI supplier for
repeat occurrences of service issues.
7.4.4
FCI will work with suppliers who are implementing corrective action plans to assist them in resolving nonconformance
issues.
Probationary Supplier Status
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QA-0010
7.5.1
7.5.2
7.5.3
7.6
7.7
Title:
General Requirements for Tier 1 Suppliers
Rev: B
A qualified Tier 1 supplier may be reduced to “probationary” status if their quality system, products or services deteriorate
from acceptable levels. This deterioration may be detected through several means including (but not limited to):
7.5.1.1
Continuing quality or delivery issues with materials or services;
7.5.1.2
Lack of timely response to requests for corrective action or a corrective action plan;
7.5.1.3
Failure to address audit non-conformances;
7.5.1.4
Other supplier issues deemed significant by FCI.
Quality will notify probationary suppliers about their reduction in status. Notification will include:
7.5.2.1
A description of the issues which led to probation;
7.5.2.2
FCI’s requirements and deadlines which Supplier must meet to regain regular qualification status;
7.5.2.3
Notification that failure to address FCI’s area(s) of concern may result in supplier disqualification.
Supplier status will be logged in FCI’s Qualified Supplier List.
Tier 1 Supplier Disqualification
7.6.1
Qualified suppliers may be disqualified if the issue(s) of concern which led to “probationary” status are not addressed in a
timely manner by the supplier, or are not addressed as required by FCI.
7.6.2
Disqualified suppliers will receive official notification of their status. Notification will include provisions under which FCI
will consider requalifying the disqualified supplier.
7.6.3
Disqualified suppliers will be promptly removed from the Qualified Supplier List
Requalification of Disqualified Suppliers
7.7.1
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A disqualified supplier may requalify as an FCI qualified Tier 1 supplier after completing the new supplier qualification
process for Tier 1 suppliers, including an on-site audit by FCI personnel, who will look for clear evidence of corrective
action implementation to resolve the original disqualification issue(s).
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Document #
8
QA-0010
Title:
General Requirements for Tier 1 Suppliers
Rev: B
SUPPLIER PROCESS CHANGE CONTROL
8.1
The supplier must formally -notify FCI’s Purchasing Department about changes to materials, tools, processes or services.
8.2
Any change in material/chemical/dimensional properties, raw material composition, site of manufacture, addition or deletion of
process step, delivery lead time, tools or equipment, discontinuation or replacement of material requires pre-notification and or FCI’s
approval prior to its implementation.
Any changes in materials, tools, processes or services which are proprietary of FCI require approval by FCI prior implementation.
8.3
Allowable time to pre-notify FCI prior implementation of the change:
Type of Changes
Material/Chemical/Dimensional Properties
Raw Material Composition
Site of Manufacture
Addition/Deletion on Process Step
Delivery Lead Time
Tools or Equipment
Discontinuation and/or Replacement of Material
Allowable Time
(Days)
90
90
90
90
30
90
365
8.4
Any other changes not listed in section 8.3, FCI’s Purchasing Department should be contacted by supplier for disposition of the
proposed change prior to implementation.
8.5
The supplier sends notification to FCI’s Purchasing Department. The supplier can use their own PCN form provided that it covers all
the information required by FCI’s SPCP/A (Supplier Process Change Pre-Notification /Approval) form, otherwise the supplier may
use FCI’s SPCP/A form, refer to Figure 1.
8.6
FCI’s Purchasing sends the SPCP/A form to the Quality Department.
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Document #
QA-0010
Title:
General Requirements for Tier 1 Suppliers
Rev: B
8.7
The Quality Department will determine which department Manager needs to review to determine the classification of the proposed
change considering the impact to product and process applications.
8.8
FCI’s Purchasing Department will contact the supplier with specific instructions regarding qualification sample size and shipping
destination.
The qualification plan and schedule will be communicated to Supplier within 30 days after the change request was received at FCI.
9
10
8.8.1
If the qualification is completed successfully, the supplier will be notified through a SPCP/A form that the proposed change
may be implemented on the materials, tools or services provided to FCI. The sign-off and releasing of SPCP/A form depends
on the qualification schedule.
8.8.2
If the test sample fails to meet qualification requirements, the supplier will be notified through SPCP/A form, that the
proposed change cannot be implemented to the materials, tools or services provided to FCI. The sign-off and releasing of the
SPC/A form by FCI depends on the qualification schedule.
PRODUCT DISCONTINUANCE
9.1
Suppliers shall notify FCI of product discontinuance, allowing a minimum of 6 months from the notice to place final orders, and 12
months from the notice for final shipments.
9.2
The product discontinuance notice shall be sent, in writing or electronically, to FCI Purchasing and Quality Department.
9.3
The product discontinuance notice shall include, as a minimum: (a) the effective date for placing last purchase orders, and (b) the
affected Manufacturer part numbers and FCI Material Spec number, if available.
9.4
Supplier shall assist FCI by providing information and technical data to help locate alternate sources.
ATTACHMENT
10.1
Figure 1. Score Card Evaluation Criteria
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Title:
General Requirements for Tier 1 Suppliers
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General Requirements for Tier 1 Suppliers
Rev: B
Figure 1. Score Card Evaluation Criteria
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