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include:
Replacement of ‘preventive
action’ with ‘risk assessment’
Increased focus on metrics and
goal achievement
Implementation
of
control
processes, like APQP, in design and
development
Anti-Counterfeit and Product
Safety measures
Emphasis on Leadership and
identifying ‘affected parties’ and
their interactions
Risk Assessment:
The change from preventive action
to risk assessment is part of a
more forward-thinking approach.
The objective is to step away
from the traditional, retroactive
mentality of ‘fixing’ problems to
actually anticipating them before
they occur and building in the
necessary controls or tests to detect
and mitigate them. One of the
most common techniques for Risk
Assessment used in the industry is
Failure Mode Effect Analysis (FMEA)
which can be done for design,
process or materials.
Mini-Circuits has used FMEA for
several years, building on our
wealth of collected data to predict
failure and marginal designs or
processes. This is used to identify
the risk of outliers passing through
our system and propels a solution
to block these outliers. Having this
requirement built into the standard
validates our historic methods
and will improve the quality of the
industry as a whole.
Metrics and Goal
Achievement:
Use of metrics and data is the
very foundation of any technical
enterprise. Without them, everything
would just be guesswork. Mini-
Circuits is a data-driven company,
and we make use of this data to
continuously improve our products.
One of the main uses of the data we
collect is to ensure that our devices
perform consistently in lot-to-lot
and within-the-lot comparisons,
without relying solely on ‘meeting
spec.’ This is done with proprietary
software to compare current lot
performance with historical data,
flagging any shift of sigma value
greater than 0.25.
In addition, every major activity
within the company is assigned a
goal, such as throughput, first pass
yield, etc. The difference in the new
standard, however, is that actions
are now required if the goal is not
being met. Failure to take such
actions, or the absence of visible
improvement from actions taken,
is now considered as a ‘finding’ or
non-conformance to the standard.
Again, this tightening of the system
will result in positive improvement
and higher levels of technical
excellence.
Design and
Development:
The revised AS9100 standard
includes a ‘suggestion’ that
operational planning and control use
Advanced Product Quality Planning
(APQP) as a method for creating
a structure for timed events and
sequences of approval in the product
development process. This will
enable review of risks, robustness,
cost and delivery scheduling.
APQP is not a new concept, and
Mini-Circuits has been using an
internal form of this technique for
decades. Nevertheless, having it
included in the revised standard will
elevate all suppliers’ quality.
Anti-Counterfeit/Product
Safety:
The immense growth of counterfeit
materials in the RF and microwave
industry within the past five years
is the result of uncontrolled and
unscrupulous suppliers using ‘back-
door’ channels to infiltrate the
market. This is enabled by use of
unauthorized distribution, and the
use of sub-standard or counterfeit
parts can have a devastating impact
in an industry where lives are at
stake.
Mini-Circuits has long recognized
this as a major problem and has
even seen products being falsely
represented as ours. Our policy has
always been to aggressively pursue
false claims and misrepresentations
in the marketplace.
We also require that all suppliers
to
Mini-Circuits
be
OEMs,
Franchised Distributors or provide
letters of authentication from
the manufacturers. We maintain
laboratory facilities and analytic
capabilities to verify raw materials
as needed.
Leadership and Affected
Parties:
Perhaps the most significant change
to the standard is also the most
subtle one. This is the change
from ‘management’ to ‘leadership,’
and a new look at how we interact
with ‘affected parties’. This is a
dramatic departure from the ‘top-
down’ approach typically used in
management review meetings,
evolving to a wider distribution
of leadership throughout the
organization.
All Mini-Circuits members have
a stake in the ongoing success
and growth of our company. This
growth can only be achieved when
we all work together to satisfy the
customer. This includes our drive
to achieve the technical excellence,
outstanding quality and service that
exceed customer expectations.
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