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.
One of the first things the standard requires is the appointment of a management
representative, or project leader, to organize the ISO process. The project
leader chairs the ISO steering committee that spearheads the project.
Steering committees can be a handful of top management or a diverse collection
of managers and supervisors. Assigning area coordinators to work with the
steering committee can ensure constant communications with applicable departments.
"You can't suddenly change the whole operation overnight," remarks
Richard Sisk, Quality Manager for Perkin-Elmer (PE) Nelson. "You have
to deal with what you've got and go forward. Our ISO team was composed of
people from engineering, manufacturing, and management. We had both weekly
and monthly meetings to discuss different levels of quality issues. Initially
we had monthly meetings of the ISO team with representatives from each area.
Those area teams then had weekly meetings to address issues within their
areas and do the writing."
"There were three of us who composed the steering committee task force
at Beckman," states Jim Quirk, Vice President of Technical Services
and Manufacturing. "We came up with a three-pronged approach to quality.
First, that ISO would be the minimum acceptable standard for the company.
Second, that we would pursue Baldridge criteria. And, third, that we would
implement continuous process improvement for a global quality system. To
this end, division managers were made responsible, and they delegated down
through their staff to document and improve processes."
Five things are always needed to achieve ISO registration according to Marq
Ransom, Director of Regulatory Affairs for Waters Chromatography. "First,
documented procedures. Second, trained people. Third, good material. Fourth,
good equipment both for manufacturing and gaging purposes. And, fifth, a
facility that fits the intent and purpose. We put together a team of managers
to focus on those issues and reviewed the issues each month, particularly
who was to do what and when. The project leader acts as the conduit to ensure
that the managers have the resources to do the job."
Because Fisons Instruments has a diverse range of business activities, Quality
Manager Gary Miyahara divided the ISO certification process into three major
areas with each section seeking a separate certificate. "A project
leader and steering committee was formed for each group with the intent
of getting most of the procedural or work instruction writing performed
at the work level, and approvals made at the management level. One thing
we didn't want to do was to disassociate the employee from the process."
ISO process ownership should permeate all levels of the organization. Everyone
will be audited, therefore everyone should be involved to some degree. As
a result, it's important to not only get outside training to develop an
understanding of how to interpret the standards, but to inform your organization
about the changes ISO registration will require.
ISO Program Manager Will Cowan explains that Hewlett Packard breaks the
registration process into five phases: discovery, assessment, formalization,
operations, and registration. Selecting the project leader and steering
committee occurs during the discovery phase, in addition to identifying
costs, determining the scope and level of your registration, and developing
project timelines and milestones.
Cowan observes that the assessment phase is a critical part of the process,
because you need to "study what you have and compare it to what you
need to have. Focus on how to make it work, particularly, say what you do,
do what you say, and possess data that you can prove. Almost always people
rush into it and have someone write down everything. That's the wrong approach.
To avoid this, we make the writing task a process improvement task. Ask
yourself what you should be saying. Most important, you'll find that many
processes are no longer useful and very often you just get rid of old processes."
Hewlett Packard writes the documents during the formalization phase, implements
the system during the operations phase, and undergoes the audits during
the registration phase.