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Internal-auditor.com [www.internal-auditor.com]
The only Internet-based periodical serving Quality
System Internal Auditors
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Brought to you by Ruth
Ellen Carey Communications...of course!
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January 2002
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Advertisement:

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This Month's Newsletter Contents:
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Feature Article.................................................................
Featured Book.................................................................
Question and Answers....................................................
Observations from the Field.........................................
Monthly Scenario Explained.......................................
Element Understanding.................................................
Internal Auditor Resources...........................................
The Back Page.................................................................
The Small Print................................................................ |
Auditing
the Audit Program
ISO 9000 at the Front Line
Audit Schedules
Changing Registrars
April 2001
Determining Audit Effectiveness
ASQ
A New Year
Copyright notice
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Internal Auditor Resources
The American
Society for Quality (ASQ) offers certification of internal
auditors (Certified Quality Auditor, or CQA). There are certain
education, experience and proof of professionalism requirements that
can be found on their website. You must also successfully pass a
written examination. I should remind you that certification of
internal auditors is not required, but does a lot to demonstrate your
professionalism and dedication to our field.
Also, if you are not a member of ASQ,
you should be ashamed of yourself. You can join when you visit them.
If you are a member, make sure you become active in your local
chapter.
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Featured Book of the Month:
Title: ISO
9000 at the Front Line
Author: William A. Levinson
Publisher: American Society
for Quality
Notes: Helps
leaders train frontline workers in basic principles and goals of the
new ISO 9000:2000 standard and the provisions for the QS-9000
standard, with short case studies, discussion questions, exercises,
and solutions. Includes guidelines for instructors and trainers, a
pre-class questionnaire, and an outline of a system for frontline
workers to initiate quality and safety improvement projects.
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You can order this book from internal-auditor.com at:
http://www.internal-auditor.com/books.htm
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Auditing the Audit Program
You are setting up your audit
schedule. As Management Representative, you are careful to assign
internal auditors that are completely independent of the activity
being audited and are free from bias. All areas and activities
have been covered but one. You stare at the nearly completed
schedule racking your brain trying to find a solution. How do you
audit the internal audit activity? Who can audit the auditing and
remain independent?
You are not alone. This is a common dilemma that all Management
Representatives face. So what can you do? The first thing to do is
to look at your program. You already know if it works or not. You
already know to some extent how effective the audit program is. If
this is true, you need not to be overly concerned. If neither of
the above are true, then you clearly need some help!
So, you know your system is working, how do you
assess the internal audit program and remain independent? Well,
actually there are only two ways. You can either assess it
yourself, or get an outside organization to assess it. Let's look
at each, beginning with external sources:
External Assessments
Typically, there are three ways we use external
resources to assess the audit program. These are:
- Use of external auditors
- Use of second-party auditors
- Use of third-party auditors
Use of external auditors
Last December,
we discussed the use of external internal auditors. External
assessments can be as simple as that. You might want to contract
out all of your auditing, or just a part of it. Perhaps auditing
the audit program is the only area where you use external auditors. You
can obtain external auditors from a variety of sources. Other
companies you can trust, local colleges even registrars can
provide resources. If you are in the US, look to your local Manufacturing
Extension Partnership, or MEP for assistance. Also, this could
be an ideal opportunity to engage a local consultant. Most will
offer this service, but some will use it as an opportunity to show
you what else they can help you with. That might not be a bad
thing.
When using external auditors to audit the audit
program make sure the scope of the audit is clear from the
beginning. They can be used in conjunction with your regular
auditors and scheduled as any other audit, or they could be a
special event. Use them in any way that meets your needs. Just
make sure your own documentation is not being violated! External
auditors should be using your procedures, your forms and your
reports.
Use of second-party auditors
Most companies in the automotive sector have
had to "endure" a customer audit. We usually do not
consider these to be pleasant experiences, but they should be.
Customer audits can give us valuable information because it is an
audit from "the customer's view", and our entire goal
should be to satisfy the customer. If prearranged, the customer
audit could also be used as part of your internal audit
assessment. They might even allow their auditors to specifically
audit your internal audit program. Some customers will even
provide this at no charge. Those that do charge may do so at a
lower cost than other external sources. It also demonstrates to
the customer your commitment to you QMS and their
satisfaction.
Just like with all external auditors, when
using second-party auditors make sure the agreement between you
and the customer clearly states what the audit scope will be. The
customer needs to know you will use the audit to asses your
internal audit program. As mentioned above, they should use your
documents, forms and reports.
Use of third-party auditors
This is the most controversial of all external
options. Some believe that this is automatic. Others believe that
it is placing the registrar in a compromising position. Chances
are your registrar will let you know if they are willing to be
used in this manner. Some registrars will allow you to use their
audit of the your internal audit program only when accompanied
with other internally generated data that shows the audit program
is being evaluated.
Internal Assessments
Internal assessments are by far the most common
method of auditing the audit program. They can be the most useful
as well. In order to use internal resources properly, you must
first decide on some ground rules. The first is:
All internal audits must be objective
The standard (pick one) clearly indicates that
audits shall be objective. Call this free from bias, independence,
or any other phrase. It all means the same thing. The auditor
needs to have no reason to alter the audit results, whether they
be good or bad. To ensure objectivity, auditors should be selected
who are the most removed from the audit process. Some companies
meet this by having one person only audit the audit program. This
is usually accomplished by assigning this task to the Management
Representative. Others feel the Management Representative is too
much involved in the process. They rely on someone from upper
management to audit the internal audit program. Whoever is
selected to perform the audit, they need to be in a position where
they can exhibit freedom from bias.
All internal audits must be comprehensive
Show me in the standard where it says internal
audits must be comprehensive! Even QS only says audits should cover all
shifts. Notice the "should" rather than a
"shall". The word "comprehensive" takes on a
different meaning when dealing with auditing the internal audit
program. Although all audits are merely samples, the sampling
technique must include the entire process in order to give a clear
picture of the auditing process.
Use all indicators
Part of the requirement is that the internal
audit program be effective. When we are auditing the internal
audit program, we need to determine what is being done to gauge
the effectiveness of the overall system. With internal auditing
that could be indicated by such things as conformance to the audit
schedule, turn-around time on nonconformances generated by the
internal audits, or even the turn-around time on audit reports.
[See Element
Understandin g]
Summary:
There are two very important points when deciding how to audit
the internal auditing program. First is regardless how you do it,
the system must work. The second point is one I push continually.
It is your system! There is no mandated method of meeting the
requirement. If your system is working, there is no need to change
it because someone else doesn't like it, or thinks it is not
enough!
As
always...Good Auditing! top
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Question and Answers:
Q –
We were recently audited by our registrar.
While auditing our internal audit system,
he noted that some of our internal audits
had not been completed "within a
year." Does this mean calendar year,
or within 12 months?
A
–
Thanks for the
email. Read the standard carefully, ISO
makes no mention of auditing each area
annually. QS only mentions "an audit
schedule updated annually."
Literally, this means that the schedule
needs to be revised once a year. There is
no requirement to audit all areas yearly.
But
wait.......There might be a stipulation in
your in your own documentation, or in your
agreement with your registrar, where you
agree to the registrar's requirement. If
that is so, then what ever rules the
registrar puts in place will dictate when
auditing must occur. Barring that, make
the auditor show you where IN THE STANDARD
it requires annual auditing. If he/she
finds it, let me know.
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Observations
from the Field
Should
you ever change registrars when
everything is going well? That's
exactly what one company did!
They felt that, although their
audits always went well, the
registrar might not be looking
deep enough. In most cases their
internal auditors found more
substantial things than their
registrar did [This should be
routine]. The registrar offered
to change lead auditors, but the
company felt their system would
grow stronger with a different
registrar. This kind of move
takes guts! To move past their
comfort zone and expose their
system to a whole new set of
eyes is a bit risky. They knew
their system was working and
that made all the difference!
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Element Understanding:
ISO-9001:1994
[QS-9000] Element
4.17 Internal Quality Audits
"...and
determine the effectiveness of
the quality system."
Determining
the effectiveness of the QMS
can be a daunting task. In our
Monthly
Feature, we examine a
couple of possibilities. Some
other indicators might be the
type, nature and number of
nonconformances found [from
either internal audits or
external audits]. Some
companies also look at what
parts of the internal audit
are considered in management
review, and what the review
outputs are. You might want to
avoid metrics that can easily
be manipulated, such as the
number of audits performed. If
you use the number of
nonconformances be careful,
they too could end up being
manipulated.
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Monthly Scenario Explained:
April
2001’s question:
Your
company manufactures and
sells industrial piping that
is sold in either 8 foot, or
20 foot lengths, depending
the application. Due to the
fact that the ends of the
piping tend to get nicked,
and the piping must have
threads cut at the
installation site, it is
customary to manufacture the
pipe with about 2 inches
extra length. For
consistency's sake, a stop
was added to the cut-off saw
at 8 feet 2 inches and 20
feet two inches. These
distances were measured
once, when installed [using
a common tape measure], and
have not been measured
since. The calibration
technician states that
because they cut the pipes 2
inches long, an in-house
specification, neither the
stops or the tape measures
need to be calibrated.
Should a stop move, it would
be obvious because the old
stop location would be
visible. Also, the
installers, company
employees, would complain if
the lengths were short. Long
lengths may cost more money,
but will not cause a
complaint. The calibration
technician says there are no
records of any type for
calibration of the stops, or
the tape.
The
answer:
This
in some form or another is a
common problem, especially
in instances where custom
installation may negate any
calibration. Here also is
where there is a separation
between intent and letter of
the standard. In this case,
QS-9000 was the applicable
set of requirements. 4.11.2
a) states "The supplier
shall: a) determine the
measurements to be made and
the accuracy required and
select the appropriate
...equipment that is capable
of the necessary accuracy
and precision." You
would be hard pressed to
find an escape clause in the
requirements that would
allow the type of
measurement used. In this
case, it was determined that
the actual measurement occurred
at installation and the
calibration used was the
installer hand fitting the
pipe. After all, that is
where the pipe was actually
measured for length. It was
decided that the actual
calibration standard was
really the gap the pipe had
to fill. No nonconformance
was written.
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The Back Page:
Well
2001 is finally behind us.
The new year is already
looking better. Indicators
show manufacturing picking
up a little. Any improvement
is welcome! Things I have
seen seem to suggest that
the improvement is the
beginning of a trend. Let's
hope so. Speaking of
improvement, this is also a
great time to take a good
look at your Quality
Management System. It makes
no difference if you are the
Management Representative,
the Lead Auditor, or an
Internal Auditor. The QMS is
the responsibility of each
of us. We all need to review
it, and find ways to
improve. If you are the
Management Representative,
then open yourself to idea
that others may have good
ideas. Let's all make this a
banner year.
Dave
...Good
auditing!
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Ruth Ellen Carey Communications
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Because this site uses information from
many different sources, it must be pointed out that any advice, tips,
information, etc., provided should be regarded as opinion and not fact! What
works well for one company may be a disaster for another. Also, what one
registrar, or auditor may allow, another may not. As always, reflect on what you
read, see if it fits into your own quality system, and if it conflicts with your
auditor...you've got to make a decision
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