Detection Potential (D) for the validation of the Process Design

Ability to
D Detection Method Maturity Opportunity for Detection
Detect
No testing or inspection method has The failure mode is not or cannot be detected
10
been established or is known.
Very Low
9 It is Unlikely that testing or inspection The failure mode is not easily detected through random or sporadic
method will detect the failure mode audits

Human Inspection (visual, tactile, Audible), or use of manual gauging

8 Test or inspection method has not
been proven to be effective and
reliable (ie, plant has little or no
Low
experience with method, gauge R&R
7 result marginal on comparable process
on its application, etc.)
(attribute or variable) that should detect the failure mode or failure
cause.
Machine-based detection (automated or semi automated with
notification by light, buzzer etc.), or use of a inspection equipment such
as a coordinate measuring machine that should detect failure mode or
failure cause

Test or inspection method has been Human Inspection (visual, tactile, Audible), or use of manual gauging
6 (attribute or variable) that will detect the failure mode or failure cause
proven to be effective and reliable (i.e.
plant has experience with method; (including product sample checks)
Moderate
gauge R&R results are acceptable on
Machine-base detection (semi automated with notification by light,
comparable process or this application
5 buzzer etc), or use of inspection equipment such as a coordinate
etc.)
measuring machine that will detect failure cause (including product
sample checks)

Machine-base automated detection method that will detect failure

4 the product as discrepant and allow it move forward in the process until
System has been proven to be effective
and reliable (i.e.; plant has experience
with method on identical process or
this application), gauge R&R results are
High acceptable, etc.
3
mode downstream, prevent further processing or system will identify
the designated reject unload area. Discrepant product will be controlled
by a robust system that will prevent outflow of the product from the
facility.
Machine-based automated detection method that will detect failure
mode in-station, prevent further processing or system will identify the
product as discrepant and allow it move forward in the process until the
designated reject unload area. Discrepant product will be controlled by a
robust system that will prevent outflow of the product from the facility

Detection method has been proven to

Machine-based detection method that will detect the cause and prevent
2 be effective and reliable (ie; plant has
failure mode (discrepant part) from being produced.
experience with method, error-
proofing, verification etc.)
Failure mode cannot be physically produced as designed or processed, or detection methods proven to always
1 Very High
detect the failure mode and failure cause.