4. reproducibility.
The first two factors (accuracy and stability) are usually quite small, so we really do not need to concern ourselves with them. The opposite is true for the last two factors (repeatability and reproducibility). These are generally large, will cause problems with acceptance or rejection of product, and can be analyzed rather easily.
Note: May need to consider all 4 factors first time through. This will be a mutual decision by Philips SQA and supplier.
Gauge System Error - Is the combination of accuracy, repeatability, reproducibility and stability.
Percent Repeatability and Reproducibility (% R&R) - Is the percentage of the specification tolerance that is lost to gauging error.
3.5. PROCESS CAPABILITY (CP/CPK) (appendix E)
3.5.1.1. Equipment and processes will be qualified using sound statistical techniques.
CPK values will meet the goal as noted below. Processes that are below <1.0 CPK will be rejected for use in the manufacturing product for Philips without
approval from the Philips SQA. For those processes that meet the 1.0-1.32 CPK minimum a corrective action plan is required will enable the process to meet the stated goal and the appropriate quality process controls will be in place during the CA implementation period.
3.6. FMEA (appendix E1)
3.6.1. FMEA: Process FMEA’s will be conducted to identify high-risk areas. Once high-risk
areas are identified a corrective action plans must be instituted to ensure risks are resolved. FMEA’s will be sent to the Philips SQA Prior to Mass Production of each manufacturing facility. Additional manufacturing lines that are not “copy exact” will require a process FMEA.
N/A
3.7. FIRST ARTICLE INSPECTION ( FAI )
3.7.1. The supplier will provide a test plan for IQC of critical components and product level
inspection Prior to RTS. Suppliers are required to perform a First Article Inspection (FAI) to assure all products meet design-engineering parameters. FAI will be completed based on the following:
? New Product Introduction
? New Manufacturing facility/Site
? EC/CP/FN as required by the Philips LSQA on critical components ? As requested by the Philips LSQA ? Changes to Critical Components ? New Sub-Supplier/Sub-Supplier Site ? New tool/mold/dies
? Major tooling or equipment refurbishment ? Relocated tooling or production equipment
? Revised or modified process flow or production sequence ? Changes in materials or material sources
? Product following a stop-ship order due to a quality issue
First Article Inspection may include verification of mechanical dimensions, chemical finishes, solder workmanship verification, configuration, and test data. A First Article inspection report is generated that defines the Supplier, part number, and revision.
Included in this report is a list of inspection characteristics to be verified, either visually or through the use of standard inspection tools. An inspector or quality engineer will perform the First Article. Final approval of the success of the First Article Inspection will be the responsibility of the Philips SQA. The supplier will submit FAI data to the Philips SQA for approval Prior to RTS. Approval will be given from the Philips SQA prior to the implementation.
3.7.2. IQC Data for Critical Components (Appendix E3)
3.7.2.1. The purpose of the FAI is to verify compliance of a part produced in a normal
production environment to the Supplier’s design specifications. Supplier to provide documented proof that critical components were inspected and meet Supplier design specifications.
3.7.3. Test Data at the Product Level (appendix E2)
3.7.3.1. FAI will be performed using the latest revision design and product
specification. FAI will be performed at the Supplier’s site or equivalent Philips approved configuration center. Each Manufacturing site will require product level
st
FAI. Supplier to use validated test procedures/software to provide data that 1 pilot lot meets product specification.
4. CHANGE MANAGEMENT 4.1. ENGINEERING/PROCESS CHANGE NOTIFICATION (appendix G)
4.1.1. The supplier will submit EC/CP/FN to Philips PAC Engineer and LSQA that affect
Internal changes to improve yields. All appropriate documentation will be provided to ensure the change is qualified for implementation. The supplier will submit an EC/CP/FN log on a Weekly basis giving visibility to the proposed changes see appendix G.
5. QUALITY CONTROL 5.1. IQC/Incoming Quality Control (appendices H, I)
5.1.1. The supplier will provide for incoming quality controls for Critical Component.
5.1.1.1. The Supplier will utilize sound statistical techniques at IQC. The supplier will
provide a matrix that indicates the critical components and sampling plan criteria Prior to RTS see appendix H. The Philips SQA must give prior approval of IQC plan. Any changes to the plan will be processed via EC/CP/FN process. On a Weekly basis the supplier will submit an IQC report that details the product performance as compared to the goal. In instances where components are beyond the set goal containment and corrective action will be completed see appendix I.
5.2. In-Process (appendices J, K, L)
5.2.1. The Supplier will provide the Philips SQA with a listing of critical inspection
checkpoints. Only sound statistical techniques will be utilized. Statistical Process Control (SPC) will be used wherever applicable. The supplier will submit an SPC test plan that includes containment, corrective action if the trend is negative and/or out of goal. Within the listing of checkpoints the supplier will provide the control limits and set goals by quarter. The Philips SQA prior to implementation must approve this information. The Philips SQA must also approve any changes to the in-process
controls via EC/CP/FN process. In instances where in-process goals are beyond the set goal containment and corrective action will be completed. The Supplier will report in-process results Weekly & Monthly and critical component results on a Weekly basis see appendices J, K, L.
5.3. PQE/ONGOING RELIABILITY TEST (appendix M)
5.3.1. The Supplier will develop a PQE process that will meet the following requirements. A
test plan will be provided to the Philips SQA prior to RTS. A report of the results will be submitted to the Philips SQA on a Monthly basis on appendix M. The supplier will measure all SPC parameters before and after reliability testing. Supplier will also provide acceptable drift limits for each of the test parameters.
N/A
TEST
MINIMUM FREQUENCY, SAMPLE SIZE
? PQE Test 25/day/line/shift ? ESD Testing 1/week/line
5.4. OQC /OUT GOING QUALITY CONTROL (appendices N, O)
5.4.1. The Supplier will provide a quality plan for out going quality inspection to the Philips
SQA Prior to RTS. The Philips SQA will approve the plan prior to implementation. Any change to the OQC plan must be processed via the EN/CP/FN change request. This will include critical inspection points, sampling plan, out of control procedures, limits of lot reject rates and DPPM levels. The supplier will provide containment and corrective action for critical out of control situations. A Weekly and Monthly report will be generated and submitted to the Philips SQA appendices N, O.
5.5. OBA/OUT OF BOX AUDIT (appendix P)
5.5.1. The Supplier will provide a quality plan for out of box audits to the Philips SQA Prior
to RTS. The Philips SQA will approve the plan prior to implementation. Any change to the OBA plan must be processed via the EC/CP/FN change request. The product sampled will be from finished goods inventory. The following are the requirements: ? Inspection Characteristics ? Packaging Inspection ? Contents Inspections
? All Test Measurements performed in OQC ? Sample Size is 1 piece per lot
The Supplier will provide the Philips SQA a summary report of the OBA data on a
Weekly basis see appendix P. In cases where the performance is beyond the set goal the supplier will implement containment, corrective and preventive action.
5.6. LINE STOP AND STOP SHIP CRITERIA (appendix Q)
The supplier will provide the Philips SQA their Line Stop and Stop Ship processes for approval Prior to RTS. Only after Philips has approved it can it be implemented. Changes to the process will be requested through an EC/CP/FN. When the
procedures are invoked a summary will be submitted to the Philips SQA on a Weekly basis see appendix Q. Containment CA and PA requirements apply. The Philips SQA will be immediately notified of line stop or excessive line down situations. N/A
5.7. CLOSED LOOP CORRECTIVE ACTION PROCESS (appendix R, S)
The Supplier will use the CLCA approach to resolve all problem issues including failure to meet monthly DPPM goals, Purges, OBA failures, and ORT failures. All CLCA issues will be documented in the CLCA log and provided by the Philips SQA on a Weekly basis see appendix R. The supplier will use the standard 7/8D format (steps noted below, see
appendix S). All Philips CLCA timelines will be adhered to as noted below. For high priority failures and/or that are initiated by the SQA the Supplier should provide 7/8D to Philips SQA.
N/A Timelines
? Problem identification and action plan within 48 hours of problem notification. ? Containment plan within 24 hours of problem identification.
? Corrective action plan within 48 hours of root cause identification. ? Problem closure verification within 24 hours of corrective action
CLCA Process
Issue description Containment Root Cause
Corrective action Preventive Action Verification
Effectiveness Review
5.8. REWORK/SCREENING OF PRODUCT
The supplier will provide for rework/screening operations at each of the Philips Manufacturing locations. The Philips SQA must approve rework/screening operations prior to use.
Rework and screening procedures will be documented and validated to ensure product form, fit and function is maintained. The supplier will submit any rework and screening
process/procedures along with validation documentation to the Philips SQA for approval before implementation.
6. NEW PRODUCT READINESS REVIEW (appendix T)
6.1. Each Supplier manufacturing line will require a New Products Readiness Review Prior to
Mass Production. Any deficiencies that are found during the review will require the supplier to develop a corrective action plan, date to complete and person responsible. All CA’s will
be closed and approved by the SQA prior to mass production.
6.2. New Manufacturing Lines
6.2.1. The supplier will provide 30-day notification to the Philips SQA of any new
manufacturing line that will be implemented. An NPRR will be require and closed Prior to Mass Production.
7. REPORTING 7.1. SUPPLIER
7.1.1. QMP REPORTING
7.1.1.1. The supplier will provide the Philips SQA the appropriate reports as outline in
this QMP.
? Weekly reports will be submitted no later than Tuesday for the Prior Week. ? Monthly report will be submitted no later that the First Week for the Prior
Month.
? Other updates such as Critical Contacts will be provided to the Philips SQA
when changes occur
7.2. PHILIPS PAC FAILURE REPORT
7.2.1. The Philips SQA will provide Delivery Quality performance reporting to the Supplier
on a Monthly basis. The following reports will be generated. ? PIC Chungli
? PAC Suzhou\\Dalinsan\\PMJ\\PMMH
N/A
7.2.2 . Each subcontractor should provide CAR for above line reject by weekly and monthly for Quality Continually Improvement. APPENDIX f – Report format
N/A
8. EXCEPTIONS TO PHILIPS REQUIREMENTS
8.1.1. Any exceptions to this QMP will be noted in this section.