Carsem Quality System Reference

Incoming Quality Assurance . In-Process Control
At Carsem Incoming Material is categorised as :
      1. Carsem Purchased
      2. Customer Consigned


Controls in Place
arrrbull.jpg (699 bytes) Visual Check
arrrbull.jpg (699 bytes) Dimensional/ Functional Test
arrrbull.jpg (699 bytes) Test Report/Certificate of Conformance
arrrbull.jpg (699 bytes) Use of Qualified Supplier
arrrbull.jpg (699 bytes) Periodic Supplier Audit Program
arrrbull.jpg (699 bytes) Supplier Corrective Action Management
arrrbull.jpg (699 bytes) CPK Reporting for Key Characteristics
. arrrbull.jpg (699 bytes) Mainly by Statistical Process Control(SPC)
arrrbull.jpg (699 bytes) Use of Process Control/Positrol Plans & F.M.E.A.'s
arrrbull.jpg (699 bytes) Machine Set-up Checklist
arrrbull.jpg (699 bytes) QA In-process Audits
Flow Responsible Action
Description
Set-up Check Technician/ Proceed upon Zero Defect
Operator
In-Process
Monitor
SPC
Operator
Alert Technician/Supervisor for
Investigation if Results Exceed
Statistical Control Limits
QA Parameter
Audit
QA Audito/
Supervisor
Stop Activity for Correction.Issue D.P.R.
to Technician/Supervisor and Ensure
Action taken before Resuming Process
QA Gate QA Inspectors Rejected Lot will Undergo 100%
Re-inspectioin and QA Rebuy-off
. . .
Calibration . Equipment Control & Maintenance
arrrbull.jpg (699 bytes) To Control and Maintain the Accuracy of Measuring
   and Testing Equipment per the Prescribed Standards.
.
arrrbull.jpg (699 bytes) Calibration System with Reference to :
  • ISO Guide 25
  • Measurement System Analysis(AIAG Manual)
arrrbull.jpg (699 bytes) Systems in Place :
  • Master Instruments Traceable to National Standards
  • Computerized Report Updating/Recall/ Retention System
  • Identification of Equipment Status Through Labels
  • Controlled Environment During Calibration
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Lot Traceability System . Control of Non-Conforming Materials
Features :
arrrbull.jpg (699 bytes) Lot Numbering System
arrrbull.jpg (699 bytes) Record Retention(Retrieve within 24 hours)
arrrbull.jpg (699 bytes) Data Logging Requirements
arrrbull.jpg (699 bytes) W.I.P. Material Part Numbering

Travellers Recording :
arrrbull.jpg (699 bytes) Traceable to Inspectors/Operators
arrrbull.jpg (699 bytes) Piece Part Number
arrrbull.jpg (699 bytes) Equipment/Machine Identification
arrrbull.jpg (699 bytes) Date of Manufacturing
arrrbull.jpg (699 bytes) Sub-Lot Identification
arrrbull.jpg (699 bytes) Device Identification
arrrbull.jpg (699 bytes) QA Gate Acceptance Status
.
Incoming In Process & Test QA Gate
. . .
Materials is On-hold
Segregated and
Identified
Product is Segregated
and Identified
Identify/Tag Material
and Segregate
. . .
QA/Engineering
is Notified
Corrective Action is
Required Before
Resuming Production
Production 100%
Re-Screening
. . .
Inform Customer if
Consigned Material
Recapture and Screen
Affected Parts
. . .
QA Initiate Material
Review Board(MRB)
.
Disposition per MRB Notify Customer if
Rescreening is Not
Possible for
Customer Disposition
Notify Customer if
Re-Screening is Not
Possible for Disposition
.
Internal Audits . Environmental Control

Objective :
To Determine Compliance to Carsem's and Customer

Requirement. Carried out on Systems and Manufacturing
Steps.

Audit Items Frequency
In-Process Procedure/
Critical Process
Minimum once per Month
Preventive Maintenance Minimum once per Month
E.S.D. Minimum once per Month
S.P.C. Minimum once per Month
Calibration Minimum once per Month
Warehouse Audit Minimum once per Month
Quality System Audit Once per Year



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Particle
Count
Temperature Humidity DI-Water
Monitor
Instrument Lazer Particle
Counter
Thermo-
Hygrograph
Thermo-
Hygrograph
Resistivity
Meter
. . .
Frequency Min 2X/wk Real Time
Monitoring
Real Time
Monitoring
Real Time
Monitoring
. . .
Limits Cleanroom
= 10k
Semi-Cleanroom
=100k
(Particle Size :
= 0.5micron)
23 +/- 4oC 50 +/- 10%RH 12.5 M-ohm cm