STANDARDS
Top 10 Tips
For Shop Floor
Audit Readiness
by Peter E. Pylipow
W
endy, a shift supervisor at fictitious Skyko
Industries, was notified her manufacturing
area was going to be added to the scope of
Skyko’s ISO 9001 registration. On hearing the news, she
scheduled a meeting with Stan, the ISO 9001 coordina-
tor, to ask him how to assess her work center. She want-
ed to make sure it had an effective quality management
In 50 Words
Or Less
• This auditing short list covers the issues most
relevant to the manufacturing floor.
• The list will help supervisors, operators and
inspectors get started and set priorities.
• The result may be shop floor employees who
actually enjoy telling an ISO 9001 auditor what
they do.
52 I NOVEMBER 2003 I www.asq.org
system (QMS) and workers were able to demon-
strate that fact.
Stan arrived at her office with a copy of the stan-
dard and suggested she read through it, pass it
around to some of her key people and get back to
him if they had any questions.
Wendy and a few others read the standard. They
came up with only one question for Stan: “Would
you please boil this down to a one-page, top 10 list
of things we need to do—in plain language?”
No one had ever asked Stan to do that before.
“I’ll have to get back to you,” he replied.
Stan went back to his office and dove into the
standard. “I don’t think I can do this alone,” he
thought; so he went to see Marge, the lead internal
auditor, for assistance. They huddled over the stan-
dard for days, trying to address the question posed
by Wendy and her workforce.
The request seemed reasonable enough. They
searched the Web to see what other people might
have done, but couldn’t find exactly what Wendy’s
staff wanted. After much discussion and hair
pulling (their own, not each other’s), they were
pretty comfortable they had distilled the most
important issues for a shift supervisor and his or
her troops to address to demonstrate an effective
QMS. They decided to present the issues as a series
Top 10 Topics for an ISO 9001
Manufacturing Auditor
(References to sections of ISO 9001:2000 are in
parentheses.)
1. Responsibility: Ask the supervisor/inspector/
operator, “Who is responsible for product quality?
What is your quality policy?” (4.2.1a, 5.3, 6.2.2d)
2. Resources and performance: Ask the supervisor,
“What work is performed in this area? Do you
have adequate resources (personnel, equipment)
to perform the work expected of this work cen-
ter? What are the performance goals for the work
center, and how do you measure them? Please
show me.” (6.1, 8.5.1)
3. Training: Ask the supervisor, “What job titles
exist in this area? What training is required for
each job title? Please show me your training
records.” (6.2.2)
4. Document and records control: Ask the supervi-
sor, “What is your system for controlling docu-
ments and records? Please show me your
document control procedure and your records
control procedure. Where do you keep the
approved master documents? Please show me.
Where do you keep documents and records in this
work center? Please show me.” (Compare docu-
ments from the work center against the masters
to make sure they match. Check records for com-
pleteness and retention time.) (4.2.3, 4.2.4)
5. Manufacturing equipment: Ask the supervisor,
“Who maintains the equipment? May I see the
procedures for equipment maintenance? May I
see the schedule for equipment maintenance?
May I see the records of completed mainte-
nance?” (6.3b, 7.5.1b, 7.5.1c, 4.2.4)
6. Measurement equipment: Make sure all mea-
surement equipment is under calibration control
(perhaps indicated by a sticker). Ask the operator
or inspector, “How do you know the gage (or
meter or other device) you are using is accu-
rate?” (7.6)
7. Identification and traceability: Look around the
work center to ensure all products have identifi-
cation such as part numbers and have identifi-
able measurement status labels, especially if
unattended. Ask the operator or inspector, “What
traceability requirements do you have?” (7.5.3)
8. Operating procedures: Ask the operator or
inspector, “What are you working on? May I see
the procedure for how you perform that job?
What records do you maintain?” (Observe the
person doing the job for several minutes to see
whether the procedure is followed.) (7.5.1b,
7.5.3, 4.2.4)
9. Specifications: Ask the operator or inspector,
“How do you know when a product is good or
bad? May I see the specifications or samples?”
(Look to see if the specs and samples are under
control—signed and dated.) (7.1c, 7.5.1a, 7.6a,
8.2.4, 4.2.3)
10. Nonconforming product and corrective and
preventive action: Ask the operator or inspector,
“What do you do with nonconforming product?
May I see the procedure that addresses how you
handle it? How do you try to reduce the number
of nonconformities? How do you try to prevent
nonconformities from occurring in the first
place?” (8.3, 8.5.2, 8.5.3)
QUALITY PROGRESS I NOVEMBER 2003 I 53
STANDARDS
of questions. In essence, they developed an audi-
tor’s short list (see “Top 10 Topics for an ISO 9001
Manufacturing Auditor,” p. 53).
Stan and Marge went to see Wendy. “Here you
go! If you and your people can answer these ques-
tions, it is likely your QMS is in good shape and
you have the proper foundation to satisfy your
customers,” Stan explained. “You will also be
ready when an auditor comes around. We tried to
organize the list with a logical flow, starting with
questions for the shift supervisor and moving on to
ones for operators or inspectors.”
Wendy took a quick look at the list. It was 10 items
all right—just what she had asked for, and it was one
page, too. “At first glance this looks like it could
help,” she said. “Let me bring in the lead operators
so we can all go through it together, item by item, to
make sure we understand what is needed.”
The group assembled. “Before we get started,”
Stan began, “I need to point out this list of questions
addresses only a portion of the standard, the issues
most relevant to the manufacturing floor—what you
asked for. And it’s just a top 10 list; it doesn’t cover
everything that might come up. Last, it does not
address important topics that would be handled by
other groups in the company such as management,
design and development, or purchasing.”
With those cautions in mind, the group began to
dissect the auditing short list.
Responsibility
Ask the supervisor/inspector/operator,
“Who is responsible for product quali-
ty? What is your quality policy?”
“The answer that an auditor will be looking for
here is that everyone is responsible for product
quality,” indicated Marge. “This is just a simple
warmup question anyone may be asked, but it is
important nevertheless. The quality policy should
be posted somewhere in the work center. People
don’t have to be able to recite it—they can put it
into their own words or describe what it means to
them or their job.
“At a minimum, all an employee needs to know
is where the policy is posted so he or she can walk
the auditor over to it and read it. However, it
would be good if, on the way over to the policy, the
person could at least relate the two key themes we
have in it—customer satisfaction and continuous
54 I NOVEMBER 2003 I www.asq.org
improvement. Those are two of the principles on
which the standard is based, and an auditor will be
most impressed if you know them.”
Resources and Performance
Ask the supervisor, “What work is per-
formed in this area? Do you have ade-
quate resources (personnel, equipment) to
perform the work expected? What are the perfor-
mance goals for the work center, and how do you
measure them? Please show me.”
Stan explained this one. “Tell the auditor what
operations are performed here. Detailed explana-
tions aren’t necessary. Just provide a brief descrip-
tion of the main transformations that take place.
Show a flowchart if you have one.” As for the
question about having adequate resources, the
answer should be a simple ‘yes.’ If that is not the
case, you will need to describe the problems
caused by being short of resources. You will need
to explain how you are working with management
to address the shortcomings, and show a docu-
mented plan to get more people or machines.
“The performance goals and measurement ques-
tion can be answered by showing the safety, quality,
schedule attainment and other charts you maintain.
The charts should have goals on them. If perfor-
mance isn’t meeting the goal, be prepared to explain
what improvement efforts are under way. You don’t
have to have all the project documentation yourself,
but it would be good to know which engineer or
manager does have it so you can direct the auditor
to him or her.”
Training
Ask the supervisor, “What job titles
exist in this area? What training is
required for each job title? Please show me your
training records.”
Wendy spoke up. “We’ve got this covered. We
have a document listing all our job titles and the
training requirements we’ve identified for each
position. I can show how I track each employee vs.
the requirements. I keep a spreadsheet with job
titles and their training requirements as rows and
track each employee by column.”
“That’s great,” said Stan. “But do you have back-
up situations covered in the matrix? Are people
trained for more than one position, and does your
matrix show that? We don’t want people performing
functions for which they haven’t been trained, not
even for a day. That could jeopardize product quality
and customer satisfaction. And we wouldn’t want an
auditor to talk with someone who is doing a backup
job and then look at the tracking matrix to find out
the required training hasn’t been done.”
“No problem,” said Wendy. “The matrix shows
at least two jobs, and sometimes more, for each
person and his or her training status against each
set of requirements. And I never assign someone to
a job for which he or she hasn’t been trained.”
“Beautiful! Let’s move on,” said Stan.
Document and Records
Control
Ask the supervisor, “What is your
system for controlling documents and records?
Please show me your document control procedure
and your records control procedure. Where do you
keep the approved master documents? Please
show me. Where do you keep documents and
records in this work center? Please show me.”
(Compare documents from the work center against
the masters to make sure they match. Check
records for completeness and retention time.)
“We’re OK here,” indicated Walt, one of the lead
operators. “We use the same systems the rest of
the plant uses. We’ll take the auditor to see Marie,
the document controller. She can share the docu-
ment control and records control procedures and
show the file cabinets of signed master documents.
And before the audit, I’ll compare our procedure
books against the masters to make sure they’re all
up-to-date. If there are any discrepancies, I’ll work
with Marie to try to understand and correct the
breakdown in the document distribution system.”
“A caution here,” began Marge. “Does the train-
ing matrix we talked about earlier show release
dates for procedures that are listed as training
requirements? It should. Those dates must match
the master documents in Marie’s files. That would
indicate all personnel are trained against the latest
procedures.”
“When an updated procedure comes in, I insert
a row for it in the training matrix right under the
row for the prior version,” Wendy explained. “I
don’t delete the old row until everyone is trained
on the revision.”
Manufacturing Equipment
Ask the supervisor, “Who maintains the
equipment? May I see the procedures
for equipment maintenance? May I see the sched-
ule for equipment maintenance? May I see the
records of completed maintenance?”
Julius, another lead operator, handled this one.
“I work with the maintenance group. We have a
document describing the preventive maintenance
plan, and I schedule downtime in the production
planning system for the equipment accordingly.
Records of completed work are maintained in the
maintenance shop—I can show them to you.”
“What about procedures for maintenance?”
asked Marge. “Do they have documented proce-
dures? Are they controlled?”
“They use checklists for the most part,” replied
Julius. “I think they’re controlled. I’ll check with
Marie to make sure they are part of her system,
and if not, I’ll follow up with the maintenance
supervisor.”
Measurement Equipment
Make sure all measurement equipment
is under calibration control (perhaps
indicated by a sticker). Ask the operator or
inspector, “How do you know the gage (or meter
or other device) you are using is accurate?”
“I can address this, because one of the hats I
wear is that of gage coordinator,” said Hadley, the
third lead operator. “I have a list of all gages in the
work center and their due dates for calibration.
Each month, I take the ones that are due over to the
calibration guys on the other side of town and get
them checked out. I don’t bring them back unless
they get a new sticker. For the equipment I can’t
transport, I have the appropriate calibration person
come here. If any of the equipment turns out to
have been out of calibration, I notify the product
engineer, and we determine whether any product
needs to be returned. ”
“Great!” exclaimed Marge. “Anything else?”
“For some of the gages, we have test pieces we
measure every shift or every 24 hours, and we
record the results on control charts,” answered
Hadley. “We can show the procedures we have for
them if asked. The procedures cover what to do
when an out-of-control situation arises.”
“That’s right on,” responded Marge. “There is one
QUALITY PROGRESS I NOVEMBER 2003 I 55
STANDARDS
other requirement, however. Your gages not only
have to be accurate, but they also must have the pre-
cision necessary for the specs with which you work.
We usually ask the engineering staff that question,
but I thought I’d make you aware of this today.”
“We have done a lot of measurement studies
involving repeat readings in the past year, but I
didn’t save copies of the reports that were issued,”
Hadley said. “You’re right—you’d better ask the
engineers for them.”
Identification
And Traceability
Look around the work center to ensure
all products have identification such as part num-
bers and have identifiable measurement status,
especially if unattended. Ask the operator or
inspector, “What traceability requirements do you
have?”
“Hmm, we may have an issue here,” indicated
Wendy. “We keep all work in process in trays per-
manently labeled with part numbers, but that’s not
the case for components used to make the assem-
blies. They’re just kept in unmarked bins at each
assembly station. Is that a problem?”
“Well, it’s really up to us because ISO 9001 uses a
‘where appropriate’ qualifier on this requirement,”
said Stan. “So why don’t you all discuss where
there might be risks of mixing up components and
then create new labels where they might help.”
“We can’t forget about the measurement status
requirement,” Marge reminded the group. “How
do people know what has or hasn’t been measured
or inspected?”
“Since the recent rearrangement of the depart-
ment for more logical flow, people generally work
from left to right,” answered Wendy. “Each station,
whether it’s for inspection, assembly or machining,
is set up and marked that way whenever possible.
Work arrives to designated locations on people’s
left sides. After doing their inspection or other
work, they pass their finished work to the desig-
nated location on their right.”
“That’s all quite logical,” said Marge. “As long
as your work instructions describe it that way,
you’ll be fine. What about traceability—are there
any requirements?”
“Yes, we have to record lot numbers of certain
components for some products,” Wendy explained.
56 I NOVEMBER 2003 I www.asq.org
“The particulars are spelled out on the product
spec sheets that travel with each job.”
Operating Procedures
Ask the operator or inspector, “What are
you working on? May I see the proce-
dure for how you perform that job? What records
do you maintain?” (Observe the person doing the
job for several minutes to see whether the proce-
dure is followed.)
“This is pretty straightforward,” commented
Stan. “Each job should have a procedure that
describes how it should be done—the one best way
decided on by the workgroup. Of course a job can
evolve, but the procedure must be kept up-to-date.
The requirements for record keeping, such as how
often to take measurements and where to record
them, should be included in the procedure—such
as on a form, in a computer or similarly.
“How to react to the measurements—what indi-
cates a problem, what to do with suspect product
and what to do with the equipment that created
it—should also be included,” Stan added.
Specifications
Ask the operator or inspector, “How do
you know when a product is good or
bad? May I see the specifications or samples?”
(Look to see if the specs and samples are under
control—signed and dated.)
“This is critical,” said Marge. “Specifications can
be woven into your procedures, be on separate spec
sheets or found on drawings. The format doesn’t
matter as much as their being readily available to
the operators and inspectors who need them and
being current and controlled through the documen-
tation system. If there are any visual samples in the
work center, they too must be controlled.”
“We have several boxes and a couple of displays
of limit samples for various imperfection condi-
tions,” Wendy said. “What kind of control do they
need?”
“They should be signed and dated, as if they
were a paper document,” answered Marge. “Have
Marie create a document title for them in her sys-
tem, determine who officially authorizes them, and
establish a review cycle. On the sample boxes or
boards themselves, put the corresponding docu-
ment numbers and latest review dates and have
them signed. Regular review is necessary because
samples can change over time, especially if they
are handled a lot.”
Nonconforming Product
And Corrective
And Preventive Action
Ask the operator or inspector, “What do you do
with nonconforming product? May I see the pro-
cedure that addresses how you handle it? How do
you try to reduce the number of nonconformities?
How do you try to prevent nonconformities from
occurring in the first place?”
“Things have recently changed along that front,”
said Walt. “We’ve given each operator the respon-
sibility of repairing his or her own nonconforming
work—work returned from the next station or
from an external customer. Operators have a desig-
nated area taped off in their workspace to place it.
“The process is described in a procedure we have
called ‘nonconforming product and corrective
action,’ which includes a log for recording each
occurrence—date, part number, quantity, returned
from, reason, action taken on the product, improve-
ment made to the quality system and name. There’s
a supply of forms at each workstation.
Walt continued, “We tally up the entries weekly
and discuss the corrective actions at our team
meeting. The technical staff works with us quite a
bit. We need to make sure the root causes of prob-
lems are uncovered. That helps us with continual
improvement.
“Before we went to this system, we used to pile
up all nonconforming work on some shelves in the
hallway near the loading dock. We had a lot more
of it then. Bert used to repair it. I miss him since he
retired.”
“What about preventive action?” reminded Stan.
“When we put in the pull system, we trained the
workforce in mistake-proof and fail-safe tech-
niques,” Walt responded. “We embrace the old phi-
losophy that an ounce of prevention is worth a
pound of cure. We frequently change the way we
do things. It’s kind of fun to discover a better way.
In addition, I know the engineering staff pays a lot
of attention to preventing defects. Sometimes the
operators or inspectors get invited to design for
assembly or failure mode and effects analysis
meetings.”
Wrap-up
“I think we’re about done then,” said Marge.
“We’ve hit the major QMS topics you need to
address and those an auditor would be interested
in when visiting the manufacturing floor. It sounds
as if you’re in pretty good shape already. If you
take care of the few items that came up, your cus-
tomers will be better off for it. And when audit
time comes, you should pass with few or no non-
compliances.
“By the way,” Marge said. “Thanks for asking us
to boil it all down to a one-page list of issues. I’ve
been auditing internally here for years, using a
much longer form, and I didn’t realize it could be
as simple as a top 10 auditing short list.”
“Well, we know it’s really not simple,” Wendy
responded. “We just needed help in getting started
and setting priorities. I’ll study the standard and
look for anything else that might be relevant. In the
meantime, I’m going to make copies of the question
list for everyone in the work center and ask each
person to review it before our next team meeting.
“We can go over it as a group, just as we did
today. Some of our employees can’t read, so the
group discussion will be vitally important. I think
this would be a good way to get everyone prepped
for an audit. If people know the type of questions
that will be asked, they will be a lot more comfort-
able, and they will understand we indeed comply
with the requirements of ISO 9001. No one will be
afraid of failing, and some people may even enjoy
explaining what we do,” Wendy concluded
“That’s the spirit!” concluded Marge.
PETER E. PYLIPOW is a senior quality assurance engineer
with the Eastman Kodak Co. in Rochester, NY. He earned
a master’s degree in management engineering from
Rensselaer Polytechnic Institute in Troy, NY. Pylipow
is a Senior Member of ASQ and an ASQ certified quality
manager, quality engineer and quality auditor.
Please
comment
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QUALITY PROGRESS I NOVEMBER 2003 I 57