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

Controls in Place
 Visual Check
 Dimensional/ Functional Test
 Test Report/Certificate of Conformance
 Use of Qualified Supplier
 Periodic Supplier Audit Program
 Supplier Corrective Action Management
 CPK Reporting for Key Characteristics

 Mainly by Statistical Process Control(SPC)
 Use of Process Control/Positrol Plans & F.M.E.A.'s
 Machine Set-up Checklist
 QA In-process Audits

Flow Description Responsible Action
Set-up Check Technician / Operator Proceed upon Zero Defect
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
 To Control and Maintain the Accuracy of Measuring and Testing Equipment per the Prescribed Standards.
 Calibration System with Reference to :
  • ISO Guide 25
  • Measurement System Analysis(AIAG Manual)
 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
Lot Traceability System Control of Non-Conforming Materials
Features :
 Lot Numbering System
 Record Retention(Retrieve within 24 hours)
 Data Logging Requirements
 W.I.P. Material Part Numbering

Travellers Recording :
 Traceable to Inspectors/Operators
 Piece Part Number
 Equipment/Machine Identification
 Date of Manufacturing
 Sub-Lot Identification
 Device Identification
 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
  Particle Count Temperature Humidity DI-Water Monitor
Instrument Lazer Particle
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