Key Insights_ Process Capability in Devices Manufacturing.pdf

Process capability for Medical Devices- Handout by AptSkill

1. Key Insights:
Process Capability and Its Role in Medical
Device Manufacturing Excellence

2. What is Process Capability?
The term ‘Process Capability’ is a numerical measureof
how capable a process is of meeting its specifications
In simple terms, it’s a measure of process reproducibility,
ruggedness, robustness and output accuracy(all combined)
A Capable Process yields a product which meets the
predetermined specifications, thus, contributing to the
Product Quality

3. A Capable Process:
Consistentlymeets the process specifications
Produces output which consistently meets the
output specification
Providesconfidencethatifprocess iscorrectly
followed, the output will be desirable

4. The Process Capability Values (CpK/PpK)
are based on an assumption of normality
of the data
Ifthe data set under evaluation does not follow a normal distribution,
CpK/PpKvalues can misleadandare insignificant to draw any
statistical conclusion

5. What’s the difference between two measures
of Process Capability, CpKand PpK
The formulasused for CpKand PpKare fundamentally
the same
The only differencebetween Ppkand Cpkcalculation is
the standard deviationused for the calculation.
CpKutilizes the narrow variation windowin Standard
Deviation value, making it ideal for short term
variabilities, like variation in one of the raw materials.

6. What’s the difference between two measures
of Process Capability, CpKand PpK
PpKutilizes the wider variation windowin Standard
Deviation value, making it ideal for long term
variabilities, like variation in all the raw materials used
for manufacturing a lot
Forastableprocess, CpKandPpKvaluesare almost
same

7. Wanttolearn moreand get hands on
experiencein calculating process capability
using Minitab?
Reach out to us at [email protected]
Contact:8262083746

8. Thanks for reading!
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