
The following application article is part of a larger set of articles
published under the title ISO 9000 in Scientific
Computing as a special supplement to Scientific Computing & Automation
magazine.
Almost without exception companies need to implement an internal audit procedure.
This entails assigning internal auditors to scrutinize processes and drive
corrective actions. Selecting internal auditors, and determining how many
you should have, can be a creative and innovative process. Many companies,
for instance, use their consultant to help perform internal audits.
"We've got 11 auditors for the 150 staff here," observes Rob Ireland,
Beckman. "Initially, we chose two from each department but found that
was not enough. So we created a core team of eight with additional back-ups
to take the burden off the core team. Using so many auditors gives more
people a better understanding of the business and improves communications.
In addition, Beckman does partnerships with other companies where we trade
internal auditors to get a fresh pair of eyes."
"We had no set number of auditors," states Will Cowan, Hewlett
Packard. "But we wanted to have all 20 functions covered sufficiently
to ensure that there were no major nonconformances. Sometimes we had three
to four people, sometimes only one. It's important to select internal auditors
so that they audit a different area. Don't have engineers audit engineering.
Also, we've found it's best to set up a rotating schedule."
Thermo's Ron Haynes remarks that "we selected people who were articulate,
amenable, had a good understanding of the business, and who were well-respected
by their peers. Altogether we plan to have anywhere from 10 to 20 people
from all areas, including people who would not be obvious choices."
"In fact, internal auditing is a great cross-training and cross-pollination
opportunity," Haynes points out. "People start to recognize the
entire process and help each other. It gets people more involved and out
of meetings and onto the floor."
Determining the number of internal audits to perform depends on the intensity
level you choose to assign to the auditing process. The fewer the audits,
the more extensive each must be. Most organizations opt for quarterly audits
of all departments.
The number of internal audits performed at HP depends on the frequency of
external audits according to Tony Cox. "They're usually one day against
a particular department."
Because Beckman has so many internal auditors, they audit frequently and
spread the responsibility around. "Right now we're averaging about
one audit per person every six to eight weeks," Ireland adds.
"We were three-quarters of the way through the process and the engineers
and programmers still didn't understand what ISO was about and they weren't
using the system," recalls Richard Sisk, PE Nelson. "This is where
internal audits really push ownership. One of the things that helped bring
the design guys around was having our customers ask them questions during
validation audits. The customer would ask if they were doing design reviews
and if they could see evidence of it. That really drove home the importance
of ISO requirements."
It's interesting to note that internal audits can also create peer pressure
and competition. No one wants to belong to the department that doesn't pass
an audit.