Professional Documents
Culture Documents
1.0 PURPOSE: This procedure was established to define the proper use of statistical process control
needed to ensure monitoring of product/process characteristics results to variation that are
statistically in-control and stable and ensure that process demonstrates capability that meets the
customer requirements.
2.0 SCOPE: Implementation of this procedure applies to critical product/process characteristics specified
in the control plan. Monitoring shall include variable and attribute data gathered during production and
inspection processes.
3.0 DEFINITION:
3.1
STATISTICAL PROCESS CONTROL The use of statistical techniques such as control charts
to analyze a process or its outputs so as to take appropriate actions to achieve and maintain a
state of statistical control and to improve the process capability.
3.2
3.3
ATTRIBUTE DATA Qualitative data that can be counted for recording and analysis. Attribute
data have only two values (conforming/nonconforming, pass/fail, go/no go)
3.4
VARIABLE DATA Quantitative data where measurements are used for analysis. Example
includes diameter of a bearing in millimeters, the concentration of electrolyte in percent, or the
torque of a fastener in Newton-meters.
3.5
COMMON CAUSE A source of variation that affects all the individual values of the process
output being studied; if only common causes of variation are present and do not change, the
output of a process is predictable.
3.6
3.7
3.8
CONTROL LIMIT A line (or lines) on a control chart used as a basis for judging the stability of
a process. Variation beyond a control limit is evidence that special causes are affecting the
process.
4.0 REFERENCE:
5.0 RESPONSIBILITIES:
5.1
QC personnel shall be responsible for gathering the inspection data based on the results of
monitoring and measurements performed.
5.2
Production personnel shall be responsible for providing actual and factual measurements data
for proper analysis of process controllability and capability.
5.3
QC / Production Supervisor shall be responsible to review the established control chart and
assure that analysis and corrective actions are carried out when the data have gone out of the
control limits.
6.0 PROCEDURE
6.1
Appropriate statistical techniques will be identified during product quality planning and included
in the appropriate sections of the Control Plan.
6.2
Personnel performing statistical process control activities shall be trained or oriented on the use
of control charts and interpretation of process capability.
6.3
Specific statistical techniques shall be used during capability studies, incoming and outgoing
inspections, and ongoing process control monitoring.
6.4
Capability studies shall be performed on processes that involve characteristics specified in the
Control Plan, on characteristics as requested by the customer and for internal problem
resolution or continuous improvement as necessary.
6.5
Improvement efforts shall be implemented in accordance with Corrective and Preventive Action,
QCD.QSP.005, for machine and processes that do not demonstrate acceptable capability.
6.6
Capability Studies
6.6.1 Initial Process Capability (Short-term)
6.6.1.1
6.6.1.2
6.6.1.3
6.6.1.4
6.6.1.5
6.6.1.6
6.6.1.7
6.6.2.3
6.6.2.4
6.6.2.5
6.7
Capability indices shall be calculated from the data collected from the on-going
process control monitoring where process stability and product variation
monitoring are being carried out.
Interpret the capability value.
6.6.2.4.1
If Cpk = or > 1.33, The process capability is good. Continue
charting for long term capability confirmation. No corrective action
is necessary.
6.6.2.4.2
If Cpk = or > 1, but < 1.33, the capability of the process is
acceptable. Continue to monitor on going capability and consider
continuous improvement efforts.
6.6.2.4.3
If Cpk < 1, the process is not acceptable and the process is not
capable of running all parts within specification limits. Corrective
actions shall be documented and 100 percent inspection for the
special characteristics not capable shall be done.
After the process capability has been completed and the capability has been
determined to be acceptable, continue to monitor using SPC to confirm
ongoing capability.