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Top 10 Tips
For Shop Floor
Audit Readiness
by Peter E. Pylipow
W
endy, a shift supervisor at fictitious Skyko system (QMS) and workers were able to demon-
Industries, was notified her manufacturing strate that fact.
area was going to be added to the scope of Stan arrived at her office with a copy of the stan-
Skyko’s ISO 9001 registration. On hearing the news, she dard and suggested she read through it, pass it
scheduled a meeting with Stan, the ISO 9001 coordina- around to some of her key people and get back to
tor, to ask him how to assess her work center. She want- him if they had any questions.
ed to make sure it had an effective quality management 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
In 50 Words of things we need to do—in plain language?”
Or Less 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
• This auditing short list covers the issues most
standard. “I don’t think I can do this alone,” he
relevant to the manufacturing floor. thought; so he went to see Marge, the lead internal
auditor, for assistance. They huddled over the stan-
• The list will help supervisors, operators and dard for days, trying to address the question posed
by Wendy and her workforce.
inspectors get started and set priorities. The request seemed reasonable enough. They
searched the Web to see what other people might
• The result may be shop floor employees who have done, but couldn’t find exactly what Wendy’s
staff wanted. After much discussion and hair
actually enjoy telling an ISO 9001 auditor what
pulling (their own, not each other’s), they were
they do. 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
of questions. In essence, they developed an audi- improvement. Those are two of the principles on
tor’s short list (see “Top 10 Topics for an ISO 9001 which the standard is based, and an auditor will be
Manufacturing Auditor,” p. 53). most impressed if you know them.”
Stan and Marge went to see Wendy. “Here you
go! If you and your people can answer these ques- Resources and Performance
tions, it is likely your QMS is in good shape and Ask the supervisor, “What work is per-
you have the proper foundation to satisfy your formed in this area? Do you have ade-
customers,” Stan explained. “You will also be quate resources (personnel, equipment) to
ready when an auditor comes around. We tried to perform the work expected? What are the perfor-
organize the list with a logical flow, starting with mance goals for the work center, and how do you
questions for the shift supervisor and moving on to measure them? Please show me.”
ones for operators or inspectors.” Stan explained this one. “Tell the auditor what
Wendy took a quick look at the list. It was 10 items operations are performed here. Detailed explana-
all right—just what she had asked for, and it was one tions aren’t necessary. Just provide a brief descrip-
page, too. “At first glance this looks like it could tion of the main transformations that take place.
help,” she said. “Let me bring in the lead operators Show a flowchart if you have one.” As for the
so we can all go through it together, item by item, to question about having adequate resources, the
make sure we understand what is needed.” answer should be a simple ‘yes.’ If that is not the
The group assembled. “Before we get started,” case, you will need to describe the problems
Stan began, “I need to point out this list of questions caused by being short of resources. You will need
addresses only a portion of the standard, the issues to explain how you are working with management
most relevant to the manufacturing floor—what you to address the shortcomings, and show a docu-
asked for. And it’s just a top 10 list; it doesn’t cover mented plan to get more people or machines.
everything that might come up. Last, it does not “The performance goals and measurement ques-
address important topics that would be handled by tion can be answered by showing the safety, quality,
other groups in the company such as management, schedule attainment and other charts you maintain.
design and development, or purchasing.” The charts should have goals on them. If perfor-
With those cautions in mind, the group began to mance isn’t meeting the goal, be prepared to explain
dissect the auditing short list. what improvement efforts are under way. You don’t
have to have all the project documentation yourself,
Responsibility but it would be good to know which engineer or
Ask the supervisor/inspector/operator, manager does have it so you can direct the auditor
“Who is responsible for product quali- to him or her.”
ty? What is your quality policy?”
“The answer that an auditor will be looking for Training
here is that everyone is responsible for product Ask the supervisor, “What job titles
quality,” indicated Marge. “This is just a simple exist in this area? What training is
warmup question anyone may be asked, but it is required for each job title? Please show me your
important nevertheless. The quality policy should training records.”
be posted somewhere in the work center. People Wendy spoke up. “We’ve got this covered. We
don’t have to be able to recite it—they can put it have a document listing all our job titles and the
into their own words or describe what it means to training requirements we’ve identified for each
them or their job. position. I can show how I track each employee vs.
“At a minimum, all an employee needs to know the requirements. I keep a spreadsheet with job
is where the policy is posted so he or she can walk titles and their training requirements as rows and
the auditor over to it and read it. However, it track each employee by column.”
would be good if, on the way over to the policy, the “That’s great,” said Stan. “But do you have back-
person could at least relate the two key themes we up situations covered in the matrix? Are people
have in it—customer satisfaction and continuous trained for more than one position, and does your
other requirement, however. Your gages not only “The particulars are spelled out on the product
have to be accurate, but they also must have the pre- spec sheets that travel with each job.”
cision necessary for the specs with which you work.
We usually ask the engineering staff that question, Operating Procedures
but I thought I’d make you aware of this today.” Ask the operator or inspector, “What are
“We have done a lot of measurement studies you working on? May I see the proce-
involving repeat readings in the past year, but I dure for how you perform that job? What records
didn’t save copies of the reports that were issued,” do you maintain?” (Observe the person doing the
Hadley said. “You’re right—you’d better ask the job for several minutes to see whether the proce-
engineers for them.” dure is followed.)
“This is pretty straightforward,” commented
Identification Stan. “Each job should have a procedure that
And Traceability describes how it should be done—the one best way
Look around the work center to ensure decided on by the workgroup. Of course a job can
all products have identification such as part num- evolve, but the procedure must be kept up-to-date.
bers and have identifiable measurement status, The requirements for record keeping, such as how
especially if unattended. Ask the operator or often to take measurements and where to record
inspector, “What traceability requirements do you them, should be included in the procedure—such
have?” as on a form, in a computer or similarly.
“Hmm, we may have an issue here,” indicated “How to react to the measurements—what indi-
Wendy. “We keep all work in process in trays per- cates a problem, what to do with suspect product
manently labeled with part numbers, but that’s not and what to do with the equipment that created
the case for components used to make the assem- it—should also be included,” Stan added.
blies. They’re just kept in unmarked bins at each
assembly station. Is that a problem?” Specifications
“Well, it’s really up to us because ISO 9001 uses a Ask the operator or inspector, “How do
‘where appropriate’ qualifier on this requirement,” you know when a product is good or
said Stan. “So why don’t you all discuss where bad? May I see the specifications or samples?”
there might be risks of mixing up components and (Look to see if the specs and samples are under
then create new labels where they might help.” control—signed and dated.)
“We can’t forget about the measurement status “This is critical,” said Marge. “Specifications can
requirement,” Marge reminded the group. “How be woven into your procedures, be on separate spec
do people know what has or hasn’t been measured sheets or found on drawings. The format doesn’t
or inspected?” matter as much as their being readily available to
“Since the recent rearrangement of the depart- the operators and inspectors who need them and
ment for more logical flow, people generally work being current and controlled through the documen-
from left to right,” answered Wendy. “Each station, tation system. If there are any visual samples in the
whether it’s for inspection, assembly or machining, work center, they too must be controlled.”
is set up and marked that way whenever possible. “We have several boxes and a couple of displays
Work arrives to designated locations on people’s of limit samples for various imperfection condi-
left sides. After doing their inspection or other tions,” Wendy said. “What kind of control do they
work, they pass their finished work to the desig- need?”
nated location on their right.” “They should be signed and dated, as if they
“That’s all quite logical,” said Marge. “As long were a paper document,” answered Marge. “Have
as your work instructions describe it that way, Marie create a document title for them in her sys-
you’ll be fine. What about traceability—are there tem, determine who officially authorizes them, and
any requirements?” establish a review cycle. On the sample boxes or
“Yes, we have to record lot numbers of certain boards themselves, put the corresponding docu-
components for some products,” Wendy explained. ment numbers and latest review dates and have