Your ISO 9001 Quality Management System documentation
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By :
Noel Swanson
Submitted
2008-08-24 00:00:00 |
A guideline for Developing Quality Manuals, ISO 10013 Standard, suggests a documentation structure for ISO 9001 QMS. This model in the standard proposes use of a three-level arrangement. Most companies I worked with utilize four-level structures instead to include records, A typical four-level documentation structure consists of:
Quality Manual - level 1
Procedures - level 2
Instructions - level 3
Records - level 4
While auditing systems like the one above, I always asked clients about the position of their quality policy in this structure. If you start from a quality manual, how go you know what standard this manual should cover? The quality policy defines it and therefore it should be included into the structure:
Quality Policy - level 1
Quality Manual - level 2
Procedures - level 3
Instructions - level 4
Records - level 5
Naming your documents
Companies use various approaches to titling their manuals, procedures, instructions, etc. For example, one of my customers titled their quality manual as "Quality Management System Quality Manual." This very descriptive title does define the document, but does not appear to be efficient.
It is common in regulated industries, such as medical device manufacturing and airspace to call 2nd-level documents Standard Operating Procedures or SOP. Do these companies have "Non-standard Operating Procedures", so long these titles differentiate them? Since a short name identifies a document, I really cannot justify long-named documents. I preach management system optimization and reduction of waste in all elements of management systems. I invite you too not to make things more difficult than they have to be to deliver the message.
ISO 9001 - document No's
It is not a specific requirement of the ISO 9001 or any other standard to uniquely identify a part or a document. It is perhaps 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.
Once I 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.
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 number, without the tab, contained seven digits. This meant that the system was prepared to handle almost 10 million document or 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. 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 the alphanumeric format.
If you are developing or optimizing your ISO 9001 quality management system, consider a simple rule: "The shorter - the better". If you are constructing a hydro electric plant or building an aircraft carrier, you will need millions of parts. To number this kind of inventory, one will definitely need long numbers. If not, think optimization. Once I audited a company that numbered their documents 303. 304, 305, etc. They deserve applauds!
There is another opportunity for improvement of many QMS - part number designation. Many companies relate a document number to a document type. For example, 20-xxxx indicates a procedure, 30-xxxx indicates a drawing, SOP-xxxx indicates a standard operating procedure, etc. My practice with a few QMS that used designation approaches showed that "no designation" systems are more practical. Several QMS that used designation I have worked with have failed. Not long ago, one of my clients mentioned that they ran out of range in their document numbering format. The QMS initially permitted for identifying suppliers through a two-digit identifier within the part number. While the company grew, the number of supplier increased beyond expectations and eventually the company needed more than 99 suppliers. This resulted in the document number format to being able to support new needs.
There are good news and bad news. The bed news is that designation systems can fail. The good news is that there is another way of dealing with document numbers: no designation at all! Using such systems, you give documents or parts sequential numbers. Going further, isn't the part title the best identifier of the part? One company I know did not use part numbers at all - their procedures and instructions were simply identified by titles and a two-digit revision level.
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