Posts Tagged ‘faa regulations’

AS9100 Documentation

Wednesday, April 29th, 2009

AS9100 documentation structure is outlined in the ISO 10013 Standard – Guidelines for quality management system documentation. This standard recommends using a three-level hierarchy. In practice, many businesses use a 4-level documentation model that includes records: AS9100 Quality Manual, level 1; AS9100 Procedures, level 2; AS9100 Instructions, level 3, and AS9100 Records – level 4.

If we start from the manual, how are we going to write 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 SAE AS9100 QMS will contain five levels as in the following list:

9100 Quality Policy – level 1

AS9100 Quality Manual – level 2

SAE AS9100 Procedures – level 3

AS9100 Instructions – level 4

AS9100 Records – level 5

Document titles for your AS9100 QMS

As you may have noticed, the titles of AS9100 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 “SAE AS9100 Quality Management System Quality Manual.”

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.

Document number formats for AS9100 Management Systems.

In addition to long tiles, document numbering systems very often can be optimized too. No standard requires assigning a document its number. This practice is an industry standard. Similar to part titles that we discussed above, document numbering practices often may be simplified too. Look at the example below:

A company had some 45 employees. They had two part number formats: one for procedures, another for drawings. AS9100 Procedures used XX-XXX number format. Drawings were numbered as XXXXXXX-XXX. One of the drawings had a number 000077-009. Assemblers simplified the system and called it “seven-seven.”

One can certainly use these long-long numbers for their AS9100 QMS, but is it practical? So far I did not meet a single company that could justify such an approach. When I audited this client, the organization had less than 250 documents. There were no indications that the company will significantly grow in the foreseeable future. Therefore, to use document number format allowing hundreds of thousands of numbers could hardly be justified. The most unreadable part numbers I had to deal with was at a mid size company with 13-digit alphanumeric part number format! Try to write those in your AS9100 audit report!

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 AS document titles and numbers. Yet, there is another issue with part numbers. Many companies relate a document number to a document type. For example, AS20-xxxx indicates a procedure, AS30-xxxx indicates a drawing, ASPOP-xxxx indicates a Production Operating Procedure, etc.

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 AS9100 company I work with does not use part numbers at all – their AS procedures and instructions are simply identified by titles and a two-digit revision level.

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Documentation Structure for AS9100 QMS

Sunday, April 26th, 2009

ISO 10013, Guidelines for quality management system documentation, gives an example of a documentation structure for AS9100 quality management systems. While 10013 suggests using a three-level structure, most companies implement four-level documentation structures to include records, as required by element 4.2.4 Control of Records, of the AS9100 Standard. A typical four-level documentation structure includes: Quality Manual, level 1; Procedures, level 2; Instructions, level 3, and Records – level 4.

Actually, the documentation structure starts from the policy. The AS9100 policy defines, among others, the standards and regulations that an organization intends to comply with. If we choose to use this approach, our quality management system will have five levels, similar to the structure below:

9100 Quality Policy – level 1

AS9100 Quality Manual – level 2

SAE AS9100 Procedures – level 3

SAE AS9100 Instructions – level 4

9100 Records – level 5

Document titles for your AS9100 QMS

As you may have noticed, the titles of AS9100 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 “SAE AS9100 Quality Management System Quality Manual.”

This tendency to use long titles and document identifiers like “Standard Operating Procedure” most likely comes from regulated industries. Even though I could not find a requirement for such title formats, overwhelming majority of companies still use these apparently outdated and ineffective conventions. If a short name sufficiently describes a document, let’s use it. I suggest streamlining all elements of AS9100 management systems. Consider this and do not make your AS QMS more complicated than it can be.

Document number formats for AS9100 Management Systems.

It is not a specific requirement of the AS9100 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.

A company had some 45 employees. They had two part number formats: one for procedures, another for drawings. AS9100 Procedures used XX-XXX number format. Drawings were numbered as XXXXXXX-XXX. One of the drawings had a number 000077-009. Assemblers simplified the system and called it “seven-seven.”

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.

I hope it is clear that only when extensive part numbers are justified, we do not have other options. If you build helicopters or satellites, you, no doubt, will need millions of parts and therefore will need long part numbers. If not, make your life easy and stay away from all those zeros. The most practical system I worked with used a three-digit format for their part numbers. 202, 203, 204, and so on. Worked just fine!

Another debatable 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. My experience with a number of medical device manufacturers has convinced me in the benefits of a “no designation” system. Three systems that used designation I have worked with have failed.

My experience with a few airspace QMS that used designation approaches showed that “no designation” systems are more practical and flexible. Several QMS that used designation I have worked with have failed. Not long ago, one of our airspace clients mentioned that they ran out of range in their AS document numbering format. That management system in the beginning was set up to identify suppliers through a three-digit extension within the part number. While the company grew, the number of supplier increased beyond expectations and eventually the company needed more than 999 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 Supplier Qualification Record AA.

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