FRONTKEN MALAYSIA SDN BHD DOC NO.

: QA-SMP-008
REVISION :0
DATE : 28.11.2016
TITLE: STATISTICAL PROCESS CONTROL
PAGE NO. : 1 OF 7

REVISION DATE ORIGINATOR DESCRIPTION OF CHANGE(S)

0 28.11.2016 Rafina Initial

PREPARED BY REVIEWED BY APPROVED BY

SIGNATURE

NAME Rafina Kogilavanan Simon Lee

TITLE QAQC Asst Manager QAQC Manager General Manager/Director

DATE
 FRONTKEN MALAYSIA SDN BHD DOC NO. : QA-SMP-008
REVISION :0
DATE : 28.11.2016
TITLE: STATISTICAL PROCESS CONTROL
PAGE NO. : 2 OF 7

1.0 PURPOSE

1.1 To provide guidelines for the implementation of a Statistical Process Controller (SPC) system.

1.2 These guidelines are aimed primarily at increasing production efficiency and inherent capability
and reducing interval and cost.

2.0 SCOPE

2.1 Statistical Process Control (SPC) concerns the use of statistical techniques or control algorithms

To achieve one or more of the following objectives.

2.1.1 To increase knowledge about a process.

2.1.2 To steer a process to behave in a desired way.

2.1.3 To reduce variations of parameters, or in other ways improve performances of a

process.

3.0 DEFINITION

3.1 SPC - Statistical Process Control

3.2 Cpk Process Capability Index

3.3 Ppk Preliminary Process Capability Index

4.0 RESPONSIBILITY

4.1 Management.

4.1.1 Determine factory SPC direction and implementation plan.

4.1.2 Commit necessary resource to SPC implementation.

4.1.3 Review SPC implementation performance.

4.2 Operation Manager / Asst Operation Manager / Executive.

4.2.1 Responsible for successful implementation and correct application of SPC.

4.2.2 Liase with Engineering on the qualification of new process/ equipments using
appropriate statistical technique.

4.3 Engineer.

4.3.1 Identifying the key parameter for SPC implementation using existing process data.

4.3.2 Use the SPC where necessary for the process /product qualification and data analysis.
 FRONTKEN MALAYSIA SDN BHD DOC NO. : QA-SMP-008
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DATE : 28.11.2016
TITLE: STATISTICAL PROCESS CONTROL
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4.3.3 Initiate SPC chart implementation and utilize SPC data for process change
identification and improvement.

4.3.4 Establish statistical control process and take corrective action to eliminate abnormality,
poor Cpk performance and record corrective action.

4.3.5 Shall investigate and identify the problem and recommend the solutions upon process
deviation or abnormalities.

4.3.6 Perform process capability study for new process changes.

4.3.7 Monitor the process as assigned.

4.3.8 Record and plot the SPC chart.

4.3.9 Inform supervisor. technician / Engineer on out of control conditions.

4.4 Production Supervisor.

4.4.1 Understand SPC concept and simple statistical techniques.

4.4.2 Ensure correct actions are taken on all out of the control conditions.

4.4.3 Shutdown the equipment according to the out of the control response loop.

4.5 QAQC Manager.

4.5.1 Act as a coordinator to provide supports of the appropriate statistical technique

implementation.

4.5.2 Conducts random audits on the correct implementation and effectiveness of the
system.

4.5.3 Continuously drive for SPC awareness to employee .

5.0 PROCEDURE

5.1 SPC for Process Control

5.1.1 The Engineering HOD/Process engineer shall develop the SPC process flow and
approve the relevant standard charts needed for SPC implementation.

5.1.2 The engineering HOD/ Process engineer shall determine the critical parameters to be
monitored using the appropriate statistical control charts

5.1.3 Operation Manager / Prod.Exec shall ensure the effective implementation of the SPC
technique selected.

5.1.4 Process Engineer shall decide on the containment action for the unstable process and
identify all the source of variation and take necessary corrective action.
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TITLE: STATISTICAL PROCESS CONTROL
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5.1.5 Review and update the statistical control limits half yearly where applicable.

5.2 Interpretation of Preliminary Process study result.

5.2.1 Stable Process Table:

Cpk Interpretation
a) The process is not capable and does not meet acceptance requirements.
<1.33
b) Improvement required to remove source of variation.
c) Do not proceed to SPC monitoring stage.
a) The process is acceptable.
> 1.67
b) Proceed to SPC monitoring stage.
a) Omit inspection
>3
b) Revise Control Plan, FMEA

5.3 Training

5.3.1 Training shall be given to all level of employees who involved in implementing or
maintain the SPC.

5.4 SPC implementation.

5.4.1 The implementation of SPC shall be bought off by Operation Manager / Asst Operation
Manager and Engineering.

5.4.2 Refer to General response loop for SPC abnormal pattern. If the following
abnormalities are detected.

5.4.2.1 One or more points below the control limit.

5.4.2.2 9 points in a row on one side of average.

5.4.2.3 9 point in a row that are consistently increasing or consistently decreasing.

5.4.2.4 Non-random patterns.

6.0 CROSS REFERENCE

6.1

6.2
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DATE : 28.11.2016
TITLE: STATISTICAL PROCESS CONTROL
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