Quality Progress - March 2013 - 64
One GOOD IDea
BY Lance B. coLeman
Form by Design
Using flowcharting techniques for robust form design
filling out simple forms should be
Using process mapping to help create a
consider, shown in Table 1.
We also had to consider that individuals
easy, right? Yet, how many of us have had
clear and concise form with a logical flow
the experience in which a simple and easy-
is one way of addressing this concern.
could play more than one role in the pro-
to-follow form took more than one time to
The first step in this evolution is to ask
cess. The corrective action team that was
fill out 100% correctly?
yourself: What is the form designed to do?
to determine root cause, corrective action
A truly robust form should not only be
and effectiveness verification had to consist
cated and the stakes higher. For example,
clear and concise, but should also provide
of, at a minimum, the process owner and a
when you’re documenting records for the
needed information in fields that are easily
member of the quality assurance depart-
medical device industry, there is huge po-
searchable if the form were to be convert-
ment. Additionally, a subject matter expert
tential for costly mistakes. End users could
ed into an electronic format.
was required if neither the process owner
Now, let’s make the forms more compli-
While recently seeking to improve how
nor the quality assurance representative
we process and document corrective action
was an expert on the issue under review.
be harmed because of errors associated
with poor documentation.
Even in instances such as this, form
and preventive action (CAPA) requests,
design is an often underappreciated skill.
my manager and I were struggling to come
Strategy that works
With forms and their associated instruc-
up with a system that was robust, yet still
After we had completed the process map-
tions, there is a balance to maintain: too
streamlined and easy to use. This was chal-
ping, designing the form was easy. We
little information and the instructions
lenging due to the nature of most CAPAs,
wound up with a four-page form, one page
aren’t useful, and too much detail and us-
which require input from multiple users and
for each phase of the process.
ers will skim over them, possibly missing
disciplines and must have the potential for
multiple feedback loops due to some steps
Roles and tasks in the
CAPA process / Table 1
occasionally needing to be repeated.
As we struggled with format,
we decided to step back, map the
entire process and begin again. Be-
3. Corrective action/effectiveness verification.
Having one page of the CAPA form for
1. Corrective action and
preventive action (CaPa)
Identifies issue and
cause of how our system worked,
each phase of the process allowed us to
we decided to depict how it func-
save the form on a shared drive, type in
2. Process owner
area manager where
expert with knowledge of
phase of CaPa for
Qa personnel who is part
tions using a swim lane diagram,
information for greater legibility and print
also known as a cross-functional
it out for signatures after completion of
flowchart, shown in Online Figure
that phase. An email alert was sent to all
1 on this article’s webpage at www.
CAPA participants as each phase of the
CAPA process was completed.
3. Subject matter expert
4. Quality assurance (Qa)
5. Qa corrective action
team (CaT) member
6. CaPa coordinator
7. Qa manager
8. engineering manager
10. Document control
assigns CaPa numbers,
maintains log and tracks
Reviews CaPa for
Reviews CaPa for
Determines root cause,
corrective action and
Receives and files closed
records; maintains files.
64 QP • www.qualityprogress.com
Going through the mapping
We were able to design a form that was
process and asking the questions
user friendly, flowed logically, reflected our
that we had to ask to properly
process and provided needed information.
map our process made us think
It wasn’t master control, but it was the next
hard about how it should work
best thing, and it worked great for us. QP
and allowed us to identify several
opportunities to improve how we
do things that had been previously
overlooked. Per our procedures,
we had eight individual roles and
two group/department roles to
Lance B. coLeman is a quality engineer and lean leader for Tech Group in
Tempe, aZ. He has an associate degree
in electrical engineering technology
from Southern Polytechnical University
in marietta, Ga. coleman is a senior
member of aSQ and an aSQ-certified
quality auditor and biomedical auditor.
Table of Contents for the Digital Edition of Quality Progress - March 2013
Mr. Pareto Head
The Right Ingredients
Before the Fact
Apples to Oranges?
Five at the Forefront
Measure for Measure
Quality in the First Person
One Good Idea
Quality Progress - March 2013