QUALITY ASSURANCE
Get back to basics Practical management of quality system elements is the key to using ISO 9001 and applying quality management effectively. Advances in technology certainly assist in the maintenance of management systems and overall quality.
amidst tech advances
By Andrea Mammes, Intertek Aston Manor
change management and approval by
motors, relays and solenoids) were not
specified personnel.
formally recorded, and only anecdotal evidence of performance and reliability
CORRECTIVE ACTION SYSTEM
was available. This resulted in incorrect
The implementation of a formal system
decisions being made on supplier
to record issues proved to be an eye-
selection, as unreliable motors were
t is easy to get tantalised by technology.
opener for management. Non-reporting of
sometimes sourced. These eventually
While it’s necessary to utilise technology
problems, complaints and issues assured
proved problematic, including repairs
for efficiency, mistake-proofing and
an ongoing stream of complications, which
being undertaken at client installations.
control, it cannot replace the basic
costed money and directly affected the
I
principles of quality management in any
company's bottom line.
of components testing provided realistic
manufacturing environment from pharma and cosmetics to mining. One illustration comes from an established manufacturing company in Wynberg, Joburg, South Africa. The company designs, manufactures and installs turnstiles and booms for various industries. As the family owned business grew, controls became more difficult and systems were informal at best. In the first year of operating a formal quality management system, the company
THE IMPLEMENTATION OF A FORMAL SYSTEM TO RECORD ISSUES PROVED TO BE AN EYE-OPENER FOR MANAGEMENT
information about the performance of specific components and situations (e.g. reliability of motors in heat-stressed environments and the number of cycles of operation of relays before failure). Fully assembled products were tested inhouse and records have been retained of pertinent information such as the number of cycles and operating temperatures (i.e. winter and summer performance). This has reduced incorrect procurement decisions dramatically. This meant the current cost of
reduced the cost of poor quality by 90 percent, a saving of over R145 000. How
The implementation of documented test protocols and performance tracking
The basic principles embodied in the
poor quality is < R20 000, amounting to an
could it achieve this, without implementing
‘improvement’ clauses of ISO 9001 were
annual saving of over R120 000. Ongoing
anything else than a formal QMS? It
established. All problems were logged.
efforts will further reduce this. •
applied the basic principles of quality.
Root causes of each problem were assessed and identified, using established
DOCUMENT CONTROL
techniques, such as 5-Why and Fishbone
Being a design and manufacturing
Analysis. These solved over 90 percent of
operation, technical manufacturing
the existing issues in one year.
drawings issued to the floor were
The company’s corrective action system
previously issued without any form of
now includes calculating the cost of every
version control, or control over design
NC recorded (e.g. labour hours, materials
changes. This resulted in parts being
used for repair and the replacement cost
processed incorrectly, due to drawing
of components etc.). This enables the
errors, or confusion over which version to
company to focus on addressing the issues
use. In many cases, the individually and
with the biggest cost implications (using
separately manufactured parts could
Pareto analysis). This system has matured
not be assembled correctly until further
from a fire-fighting mechanism to one of
rework could be done. This was addressed
continual improvement.
through strict control over drawings. Version were issued to specific work stations. Design
DESIGN CONTROLS AND RETENTION SAMPLES
changes to drawings could only
Trials conducted on components used
be achieved after a formal process of
in the turnstile manufacture (such as
controls were established, and drawings
ABOUT THE AUTHOR Andrea Mammes is a lead auditor for business assurance at Intertek subSaharan Africa. She qualified in QMS ISO 9001 and has evolved into an ISO 22716 (GMP) auditor for cosmetics manufacturing. Send an email to info.africa@intertek.com for more information on the services offered by Intertek.
Intertek – www.intertek.com
P C Africa | QUARTER 2 2019 |
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