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QW Academy - Numbering your Documents
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Naming your documents
Various companies use different document title formats
for their levels of documentation structure. For example, one of
my customers titled their quality manual “Quality Management
System Quality Manual.”
It is a very typical convention in the medical device
manufacturing and other regulated industries to call the
second-level documentation Standard Operating Procedures, known
as SOPs. Unless one has a level called “Non-standard Operating
Procedures,” I really do not see a practical or economical
reason for long titles like these. As long as the short name
conveys the idea and leads us to the right place, let’s use it.
I will promote this optimization approach throughout this
publication. Let’s not make things more complicated than they
practically need to be.
Numbering your documents
It is not a specific requirement of the ISO 9001 or any other
standard to uniquely identify a part or a document. It is more a
common-sense measure, and a worldwide practice in any
documentation system, to give a document or a component a number
and a title, and to identify its revision level. As
documentation titles, document numbering is an area for
creativity and an opportunity for optimization.
I once worked with a company of less than 100 people,
manufacturing fairly simple devices. Their documentation system
consisted of a few numeration systems depending on the type of
document. One of the procedures had a number 0000057-001, which
they simply called “fifty seven.” A drawing was numbered
327-856-99-17. Some companies obviously want to feel like the
“big boys.” If numbers are long and complicated, one might think
that they make complex and important products.
Is it acceptable to have long and difficult-to-read and remember
numbers? Yes, of course! Is it practical? I do not believe so!
In the example above, the procedure numbers, without the tab,
contained seven digits. This meant that the system was prepared
to handle almost 10 million part numbers (PN). The company had
approximately 250 documents and probably would never go beyond
300. If nothing else, just reading these numbers with five
sequential zeros may give one a headache. Those folks figured it
out too - that is why they called document 0000057-001 “fifty
seven.” Surprisingly, this is not the worst case I have
experienced! The company that won my “The Worst Part Number”
Grand Prize assigned 12 (!) digits to their part numbers in
alphanumeric format.
If you are designing and building a Trident-class submarine, a
MIG-27 jet fighter or an international space station, you, most
likely, will need millions of parts, so a long part number
format would be needed and will make sence. Otherwise, save
yourself the trouble of reading all those zeros and make your
numbering system practical. Our Documentation Management
Procedure shown in Chapter 3 prescribes part numeration with a
four-digit part number format that allows for 9,999 parts, which
is probably enough for majority of companies. If your operation
is small, drop it to three digits – you may always change it
later if you need to. One of my customers, who won my “the Best
Part Number” Grand Prize, numbered their documents as 201, 202,
203, and so on. Short and sweet!
Another issue with the part-numbering format is part number
designation. Some systems associate a part number with a
particular part type. For example, 10xxx indicates a procedure,
20xxx indicates a drawing, PLxxx indicates a policy-level
document, and so on. An alternative approach to part numbering
is a “no designation” system, where parts are given sequential
unique numbers within a specified format, regardless of their
type, material, application or other attributes. After all,
isn’t the part title the best designator?
My experience with a number of medical device manufacturers has
convinced me in the benefits of a “no designation” system. Three
designation systems I have worked with have failed. Just
recently, one of my customers reported that they ran out of
range in their part-numbering format. The system allowed for
assigning materials through a two-digit designator within the
part number. When the system was designed, needing more than 99
materials was not considered possible. Unfortunately, things
changed, and just a few years later, the company needed more
than 99 materials causing the existing part number format to
fail.
An overwhelming majority of companies use designation based
part-numbering systems. A Design Management Procedure, for
example, may be numbered as SOP 4.4-1. With ISO 9001:1994, it
meant that this document related to element 4.4, design
management.
Well, it does not mean the same with the new ISO 9001:2000
revision, simply because design management clause now has a
different number: 7.3. What is the solution? The jury is still
out on this issue. The part-numbering format either becomes
designation-free, or one needs to change all the existing
quality system documents within the company, with no financial
compensation for this Herculean task! Customers and shareholders
definitely will not see any rewards for this project.
Call us
today if you have questions about ISO 9001, ISO 13485 or ISO
14001 management systems!
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