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
Interestingly, how are we going to start our quality manual without knowing what standard this manual is for? The quality policy supposes to define it. The policy defines what standard or standards, a company wants to comply with. If you like this idea, your QMS will contain five levels as in the following list:
Quality Policy - level 1
Quality Manual - level 2
Procedures - level 3
Instructions - level 4
Records - level 5
Naming your documents
As you may have noticed, the titles of the documents in the structure above are quite short. Various companies use different conventions for their document titles. For example, one of my customers titled their quality manual as "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 and reduction of waste approach throughout this publication. Let's not make things more complicated than they practically need to be.
ISO 9001 - document No's
No standard prescribes to give a part or a document its number. It is an industry standard to give a document or a component its name, number and a revision level. Similar to part titles that we discussed above, document numbering conventions are often also may be optimized and simplified.
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.
Do these long numbers identify documents? Yes, they do! Are they economical? No, they are not! My customer's system above allowed seven digits and therefore could deal with ten million documents or part numbers. When I worked with this business, they used some 300 documents. If one plans to grow from 200 - 300 documents to a million, one has a long way to go! It is not only how many documents your QMS uses, reading these long strings with five sequential zeros gave everybody headache. Even though this example looks too complicated, "The Worst Part Number" Grand Prize won my other client. They used 14-digit alphanumeric part numbers!
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 sense. Otherwise, save yourself the trouble of reading all those zeros and make your numbering system practical. One of my customers, who won my "The Best Part Number" Grand Prize, numbered their documents as 101, 102, 103, and so on. Short and sweet!
So far we explored opportunities for improvements in the area of document titles and numbers. Yet, there is another issue with part numbers. Many companies relate a document number to a document type. For example, 20-xxxx indicates a procedure, 30-xxxx indicates a drawing, POP-xxxx indicates a Production 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 extension 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 not being able to support new needs.
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? Seriously, through my entire professional career, I worked only with one company that did not use even document numbers. Their documents were simply identified by titles and a two-digit revision level, like The Prefect Manual 01.
Quality Manual - level 1
Procedures - level 2
Instructions - level 3
Records - level 4
Interestingly, how are we going to start our quality manual without knowing what standard this manual is for? The quality policy supposes to define it. The policy defines what standard or standards, a company wants to comply with. If you like this idea, your QMS will contain five levels as in the following list:
Quality Policy - level 1
Quality Manual - level 2
Procedures - level 3
Instructions - level 4
Records - level 5
Naming your documents
As you may have noticed, the titles of the documents in the structure above are quite short. Various companies use different conventions for their document titles. For example, one of my customers titled their quality manual as "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 and reduction of waste approach throughout this publication. Let's not make things more complicated than they practically need to be.
ISO 9001 - document No's
No standard prescribes to give a part or a document its number. It is an industry standard to give a document or a component its name, number and a revision level. Similar to part titles that we discussed above, document numbering conventions are often also may be optimized and simplified.
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.
Do these long numbers identify documents? Yes, they do! Are they economical? No, they are not! My customer's system above allowed seven digits and therefore could deal with ten million documents or part numbers. When I worked with this business, they used some 300 documents. If one plans to grow from 200 - 300 documents to a million, one has a long way to go! It is not only how many documents your QMS uses, reading these long strings with five sequential zeros gave everybody headache. Even though this example looks too complicated, "The Worst Part Number" Grand Prize won my other client. They used 14-digit alphanumeric part numbers!
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 sense. Otherwise, save yourself the trouble of reading all those zeros and make your numbering system practical. One of my customers, who won my "The Best Part Number" Grand Prize, numbered their documents as 101, 102, 103, and so on. Short and sweet!
So far we explored opportunities for improvements in the area of document titles and numbers. Yet, there is another issue with part numbers. Many companies relate a document number to a document type. For example, 20-xxxx indicates a procedure, 30-xxxx indicates a drawing, POP-xxxx indicates a Production 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 extension 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 not being able to support new needs.
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? Seriously, through my entire professional career, I worked only with one company that did not use even document numbers. Their documents were simply identified by titles and a two-digit revision level, like The Prefect Manual 01.
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