Manufacturing Today - November/December 2016 - 133

TECHLAB

ity products and quality service. Quality
- that's the main word we like to hear
and we hear it from our customers."

would sell it overseas. Today, the company says the level of reporting is more
involved and the tests need to meet that
country's regulatory requirements.

Quality Development
As a worldwide manufacturer of diagnostic tests, TECHLAB consistently
works to ensure its products meet the
requirements of each country it serves.
"I think some of the FDA testing guidelines have gotten stricter where it's a
little harder to get products through,
but we are working in conjunction with
them to achieve a resolution," Harvey
explains. "Overseas is where we see the
major differences."
Europe, China and Brazil are some of
the company's larger markets that used
to be non-prohibited - TECHLAB manufactured a test to FDA standards and

'we build in quality
from the moment the
raw material comes
in the door, through
every process until it
leaves our hands."
TECHLAB employs four regulatory
employees who work to meet international regulations, Day notes. "It takes
gap analysis in our quality auditing
process to identify the differences for
Canada, Europe, etc., and we create a

South

technical file for clinical data to put in
definitive formatting," he explains.

Lean Processes
TECHLAB's patented cassette technology allows for different tests to be manufactured on the same platform. The basic platform allows for relatively minor
adjustments in changeovers from one
product to another.
The company has been proactive in
adopting lean principles in manufacturing but, Harvey says, TECHLAB is just
starting to scratch the surface. "I was
asked one time, on a scale from one to
10 where we fell in lean processes, and
I said one," he adds. "It's been a long
journey, but we have seen lots of benefits by incorporating those. Science has
steered away from lean manufactur-

NOVEMBER/DECEMBER 2016 manufacturing-today.com

133


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Table of Contents for the Digital Edition of Manufacturing Today - November/December 2016

Table Of Contents
Manufacturing Today - November/December 2016 - Cover1
Manufacturing Today - November/December 2016 - Cover2
Manufacturing Today - November/December 2016 - 1
Manufacturing Today - November/December 2016 - Table Of Contents
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Manufacturing Today - November/December 2016 - Cover3
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