CMQS Internal training

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CMQS Internal training

What is CMQS & what you need to do to achieve level 3?

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Introduction

What is CMQS ? CMQS stands for Contract Manufacturing Quality System Objectives Introduce you to Quality System : Contract Manufacturing Quality System Discuss your roles in planning , preparing and conducting a manufacturing partner quality system assessment Familiarize you with the CMQS audit structure

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CMQS LEVEL

Meet 100% requirements in Level 1 and 2 Meet 90% requirements in Level 3

LEVEL 1 The Quality System is in the beginning stages and CM has the ability to monitor their processes using a process control method. LEVEL 2 Certification at this level indicates a stable quality system, enabling CM to meet HP quality standards. LEVEL 3 CM has a fully mature quality system, both at their site and at sub-tier supplier sites, and leads improvement efforts.

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Quality System Expectations Types of Audit PC - Process Control DetaitSi 1) Fundamental Process Control & Quality System 2) Target: HP NPI / Extended Manufacturing Line 1) HP customized Quality standards QSA — Quality Systems Assessments Achieve PC Level 1 at WKO (before MR) 2) Target: MPa & Supplier Achieve PC Level 2 at Achieve QSA Level 3 in FY21

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Who is involved ?

CMQS 2021 team

CMQS working committee has been established to ensure smoothness of CMQS audit for 2021, however in achieving level 3 for CMQS’21 all FTM employee are involved in ensuring we achieve highest quality system required by HP

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Categories Topics Dept Involved Management Responsibility Topic 1: Quality Policy & Management Responsibility QA Topic 2: Contract/Purchase (PO) Order Review SCM Topic 3: Training HR & QA Production Control Topic 4: Metrology & Calibration QA , ENG Topic 5: Material Control & Qualification, Supplier Management SCM Topic 6: Process Control ENG Topic 7: Equipment & Tooling Control ENG Inventory Control Topic 8: Traceability PROD Topic 9: Material Disposition ENG, SCM Topic 10: Finished Goods Inventory, Packaging & Shipping ENG , SCM Quality Management Topic 11: Record & Document Control QA Topic 12: Corrective, Preventative Action & Improvement Plans QA , ENG Topic 13: Internal Audits QA Quality Control Topic 14: Product Planning ENG Topic 15: Process Capability ENG Topic 16: IT Risk Management HR & IT

Who is involved ?

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CMQS flow

Audit date setup Self – assessment audit Obtain HP approval for exclusion (if any) Actual Audit (Desk & Line Audit)

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CMQS Topics

4. Metrology & Calibration 5. Material Control & Qualification, Supplier Management 6. Process Control 7. Equipment & Tooling Control

8. Traceability 9. Material Disposition 10. Finished Goods Inventory, Packaging & Shipping

11. Records & Document Control 12. Corrective, Preventative & Improvement Plans 13. Internal Audits

14. Product Planning 15. Process Capability 16. Test & IT

Production control

Inventory control

Quality Management

Quality control

1. Quality Policy & Management 2. Contract / PO Order Review 3. Training

Management Responsibility

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MANAGEMENT RESPONSIBILITY

Topic 1: Quality Policy & Management Responsibility Topic 2: Contract/Purchase (PO) Order Review Topic 3: Training

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MANAGEMENT RESPONSIBILITY

To fulfill PC Level 1 Requirements: Quality Policy exist Organization chart is exist especially that effect quality, inspection and process control To fulfill PC Level 2 Requirements: Quality policy deploy and understood by employee

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MANAGEMENT RESPONSIBILITY

What we need to do to achieve full score for TOPIC 3? On the job training provided for all employees . Training and/or certification records maintained, up to date, and available to the auditor. Employees are knowledgeable about the training program and can connect skills to specific training programs

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Example of On Job Training Schedule for operator

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PRODUCTION CONTROL

Topic 4: Metrology & Calibration Topic 5: Material Control & Qualification, Supplier Management Topic 6: Process Control Topic 7 : Equipment & Tooling Control

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PRODUCTION CONTROL

LVL1 Equipment in Control Plan are SHOULD BE calibrated LVL2 Procedure of Calibration exist (Gauge Identification, Calibration Schedule , Frequency, Method, R&R on Calibration, done by Competent Personnel) LVL 3 Out Of Calibration Reaction Plan EXIST 1 st GR&R should be done before line MR Gauges are Capable . (GR&R /KAPPA Result) 2 sided spec = R&R <30% If found INCAPABLE GAUGES, improvement plan with specific completion date exist which agreed by HP Calibration System being Review (Improvement on Calibration Frequency, Method, Capability, Process Stability) Gauges inside Control Plan must exist – Refer to SPS Actual Practice , Equipment , Process Setting = Document Out of Control Process are identify & well response to bring back OOC in a timely manner Archive plan include retain samples for future potential problem solving purpose where appropriate. Statistical Process Control (SPC) – Control limit (understand on data crunching) , Being Review after process changes, Drive for Process Improvement for Out of Control (OOC)

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PRODUCTION CONTROL

Software Revision Control started Preventive Maintenance (PM) procedure establish AND well defined ( Safety, PM, Start Up & Emergency Shutdown Preventive Maintenance Schedule (PM) establish, documented & followed (Monthly PM Checklist exist)

General preventive Maintenance Checklist (Wet Lcn») —tat'" . n to WA Low

Example of PM checklist

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INVENTORY CONTROL

Topic 8: Traceability Topic 9: Material Disposition Topic 10: Finished Goods Inventory, Packaging & Shipping

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INVENTORY CONTROL

What we need to do to achieve full score? Documented method is use to identify and control NC /Suspect NC Material. Documented deviation procedure exist & linked to Corrective Action process. Documented disposition method for NC/Suspect Material exist (How to Control, Trace, Any unintended use/delivery). Lock Out system to prevent NC /untested material from moving to subsequent process step.

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INVENTORY CONTROL

Records for NC are maintain (Disposition/Waiver). Rework material is traceable in material tracking /system A good housekeeping program is documented and most areas appear neat, organized, well lighted and safe. Work environment such as temperature, humidity, lighting, vibration is suitable for inspections and tests being performed.

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QUALITY MANAGEMENT

Topic 11 : Record & Document Control Topic 12: Corrective, Preventative Action & Improvement Plans Topic 13: Internal Audits

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QUALITY MANAGEMENT

What we need to do to achieve full score? Need to have documented procedure. Do we have it ? Yes. QSP-ENG-002 Change Management. All changes should be communicated to related stakeholder and acknowledged. Records/ Forms should be traceable, kept inside easily accessible folder

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QUALITY MANAGEMENT

4. Record Retention is exist and documented. Do we have it? Yes, all record retention was listed inside Document and Record Master list 5. Records include all process and product related information including: Internal audit results Customer issues/ complaints Corrective actions Management Review Quality plan

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Example of record retention

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QUALITY MANAGEMENT

What we need to do to achieve full score? All documents (QSP, WI, HP Documents) should be reviewed and checked, with “CONTROLLED” stamp and the revision number must tally with FTM Document master list. Only latest revision should be used at production line. QM will be reviewed by our QMR and revision will be made if there is need of changes All materials must have traceability records (as per HP requirements)

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QUALITY CONTROL

Topic 14: Product Planning Topic 15: Process Capability Topic 16: IT Risk Management

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QUALITY CONTROL

Do we have control plan? Yes. HP Document called SPS (Supplier Product Specification. Sampling Plan defined SHOULD be followed (CPM , EOL ). What type of document will be audited? Can be quarterly reports, meeting minutes, quality reports or other documents that include plans to achieve quality goals. Document on Qualification of Changes  Eval , Special Work Request (SWR)

Special Work Request (SWR)

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QUALITY CONTROL

Document on Inspection & Test  WI on CPM/IPAC Culture to improve quality effectiveness should be in place. Continual Improvement need to be documented. (with evidence & leveraging) Cp Cpk  Understand & able to demonstrate how CP CPK calculated. CPK > 1.33. If incapable, statistically based/verify improvement cycle are required OR waiver by HP should be given.

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CMQS SCORING HISTORY FTM

CMQS 2014 2015 2016 2017 2018 2019 2020 No of elements 193 196 238 238 238 238 238 Elements achieved 160 192 233 235 236 238 NA % 82.9% 98.0% 97.9% 98.7% 99.2% 100.0% NA Level 0 0 0 1 1 3 NA

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FTM CMQS (2019) : RESULTS

No Clause Finding Corrective action plan Owner/ Target Date Status 1 6.2.3 Defined and adequate sampling plans must be used for inspection and testing. No sampling audit was defined in HP QAC Doc #de791001474. However, FTM is doing audit sampling at the line. Sampling plan should be establish in the document. At current, 0.195% for bulk pens (15 out of 7680 pens) was used to perform sampling audit check from FTM initiatives. HP to provide updated HP QAC document 1) TEE : eCMS 89845 2) Add : 0.195% for bulk pens (15 out of 7680 pens) was used to perform sampling audit check from FTM initiatives. (13 Sep 2019) HP ( End of Sept) CLOSED 2 3.2.2 Management requires the assessment of ongoing training needs for all employees that affect quality. Training has been implemented and is tied to quality objectives. -No training records on current OJT form implemented 3 years ago on modular and calibration training for TSes who has worked for more than 5 years. -No tracking record for their competency in addressing line issue and preventive maintenance task effectively ( e.g calibration of BP transducer). Revise p rocedure of OJT and state the frequency for refresher training Hamizan CLOSED

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FTM CMQS (2019) : RESULTS

No Clause Finding Corrective action plan Owner/ Target date Status 3 6.1.6 Actual practice, equipment, and process settings agree with documentation. -AN1 Laser Weld HP CPS Document ref# 80086404 states that maximum velocity 13mm and 13A is 2500 mm/s but machine setting is run at 2600 mm/s. -For J815 body, they should be running at 2600 mm/s based on CM note issued but CPS document is not updated. -CM Note was issued under General Awareness which is not align with general guideline that for CPS we cannot use this option to communicate. -This is however not a critical product specification and parts will get rejected if it fail Collapse Height. Request HP to update CPS 1) eCMS 88624 HP CLOSED 4 15.2.3 Processes are capable ( Cpk > 1.33 for normally distributed data, PPM < 64 for others or as specified). For incapable control parameters, statistically-based/verified improvement cycles are required or a waiver must be provided by HP. AN1 Laser Weld collapse height and LSA spring force out of Cpk shared with HP monthly but no waiver obtained from HP. Improvement project for both module have been implemented. Title: AN01 LASER COLLAPSE HEIGHT ANALYSIS Q1 Mazwan CLOSED

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FTM CMQS (2019) : RESULTS

No Clause Finding Corrective action plan Owner Status 5 NA Engineering and production recipe should have different naming convention, so that no one will call out the wrong recipe to use (through the system has a gate to call out the correct recipe) Interlock in place on HMI so that Operator / Ts unable to perform to a changes of the index number directly. TS/ENG will not able to call out wrong recipe. Hasbullah CLOSED .