Posts Tagged ‘international standards’

AS9100 Documentation

Wednesday, April 29th, 2009
by Mark Kaganov

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.

About the Author:
If you are working on your AS9100 Quality Management System (QMS), check out our AS9100 Quality System documentation. With over 25 years of experience in quality management systems, the author is a Director of Operations and a Lead Consultant with Quality Works. The company provides solutions for AS9100 and other quality management systems.

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Documentation Structure for AS9100 QMS

Sunday, April 26th, 2009
by Mark Kaganov

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.

About the Author:
If you are improving your AS9100 Quality Management System (QMS), check out our AS9100 Quality System documentation. With over 25 years of experience in quality management system, the author is a Director of Operations and a Lead Consultant with Quality Works. The company provides solutions for AS9100 and other quality management systems.

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A Quality Policy for ISO 9001 Standard

Wednesday, April 15th, 2009
by Mark Kaganov

ISO 9001 Standard requires a business to establish a quality policy. Specifically, “The management” of a company to “ensure that the quality policy”:

- Is appropriate to the purpose of the organization;

- Includes a commitment to comply with requirements;

- Includes a commitment to continual improvement of the effectiveness of the QMS;

- Provides a framework for establishing and reviewing quality objectives;

- Is communicated and understood within the organization;

- Is reviewed for continuing suitability

One may ask, why we started talking about this requirement. There is a very good reason. Quality policy defines the top-level commitment of your company’s management to establish a QMS in accordance with a particular standard. The reason to talk about it is that most quality policies, per my more than decade long experience as a consultant and an auditor, did not meet requirements of the standard.

Let’s take a look at a few examples of quality policies. If you open your browser and type “iso 9001 quality policy”, you will see a list of companies that placed their quality policies on their Websites. For example, let’s take a look at a few of them:

“It is the policy of [Company name] to provide a range of [services] which is reliable and consistent with the expectations and requirements of its clients; the Company’s objective of consistent high quality performance is met by mandatory adherence to protocol, through staff training and the development of personal responsibility for all personnel, together with the provision of adequate resources, according to the principles of Quality Assurance. Company policy is to review and update as necessary the Quality System through the mediation of a Quality Team, whose members undertake the responsibility of ensuring that the Quality policy is understood, implemented and maintained at all levels within the Company.” Can we say what standard this company is compliant with? Do you see a commitment for continual improvement of the effectiveness of the QMS? Do you understand how this company establishes and reviews their quality objectives? I did not find answers to these questions. However, the policy does commit to communication and understanding of its quality policy and review for suitability.

Let’s take a look at another quality policy: “We at [Company name] are committed to value oriented quality from the perspective of the customer. Quality of workmanship and service are encouraged without adding unduly to cost. Quality is primarily dependent upon individual commitment and acceptance of responsibility by each employee for the quality of the products and services offered, both internal and external to the company. Efforts of continuous improvement focus on enhancement of product and process reliability and customer satisfaction.” Besides questionable language, this quality policy really does not have anything to do with ISO 9001 2000 standard requirements. If we compare it to the set of requirements, we probably will not find a single requirement that is addressed in this policy.

I did not select these examples because they did not comply with the standard. I picked them from the top of the search results, just to show that most quality policies were not written to meet requirements of the standard. If you think these examples are bad, wait a moment. One of my clients came up with a quality policy that is out of this world: “I improve the Quality of Patient Care and all things [Company name]” No! I am not kidding and I did not misspelled or took any words out of this regretful quote!

About the Author:
Mark Kaganov is a Director of Operations and a Lead Consultant with Quality Works. The company specializes in consulting in the areas of ISO 9001 quality management systems and other QMS. If you are working on your quality policy or quality documentation, make sure you check our ISO 9001 quality policy article.

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ISO 9001 Controlling forms

Wednesday, April 15th, 2009
by Mark Kaganov

Do you control your forms within your ISO 9001 quality management system? If you do, you are on the right track. One of the divisive issues with interpretation of ISO 9001 and other standards is control of forms. Various organizations treat forms differently than other QMS documents and do not control them. Per ISO 9001, element 4.2.3, “Documents required by the quality management system shall be controlled.” Let’s investigate if a form qualifies to be a “document” that “shall be controlled”.

Forms and tables are frequently used as quality management system documents. Very often, it is not necessary to write a traditional instruction with the purpose, scope and instruction sections, if a simple table is sufficient to provide these instructions. One of the typical nonconformities that companies get during audits of their quality management systems is against forms that are not part of the documentation system.

Frequently, being asked about not controlled forms, my clients reply: This is “just a form”. I always wonder why should a form be treated differently than any other instruction or a document? If a form is not controlled, how would we know that we need it to begin with? If a form is not part of your ISO 9001 QMS, it cannot be referenced! If your forms are not controlled, how would anyone know that you use the latest revision? Well, exactly what is a form? A quick test will help answer this question. If we have a list of directions telling us to:

- use a 2-column table

- enter your company name into the first column

- enter your company’s Web address into the 2nd column

Most likely, we all would call this three-line guidance an instruction. So, since this is an instruction, it shall be controlled, right?.

OK, now, let’s assume, somebody gave us a two-column table. We also were asked to fill it out. The first column was titled “You company name” and the second column “Company URL”. I bet, most of us would enter our business name in the first column and our URL in the second. Does it mean that we treated this table as an “instruction”? We just did!

These two examples, demonstrate that our first three-line instruction in English (that needs to be controlled), serves the same function, resulting in the same output, as the second form. Therefore, the form as an instruction and “shall”: be controlled as well.

It appears that the puzzlement about forms and their control comes from the fact that forms serve 2 purposes. Blank forms are instructions in tabular language. After a form is filled out, it becomes a record. Records, as a rule, do not have a part or document number or a revision level. Records are controlled by different processes. Remember this and treat your forms as instructions controlled by your documentation procedure. There are a couple of tests you may take when you are thinking about not controlling your form.

- If you created a helpfull form and found it had been changed, would you like to know who did it and why?

- If you changed your form, would you like your employees use the most resent revision?

- If you were on vacation, would you like folks to be able to find your form just by using a reference to it?

If you answered, “yes” at least once, your form is a definite candidate for revision control, and falls under the scope of your ISO 9001 2008 documentation management process.

About the Author:
Many companies ask: What is total quality management? Visit our QW Academy ISO page to learn about International Organization for Standardization.

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ISO 13485 Documentation

Sunday, April 12th, 2009
by Mark Kaganov

ISO 13485 documentation structure is outlined in the Guidelines for Developing Quality Manuals (ISO 10013 Standard). This standard recommends using a three-level structure. In practice, many companies use four-level documentation model that includes records. 4-level quality management system is shown below:

Manual – level 1

Procedures – level 2

Works Instructions – level 3

Quality 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 business wants to comply with. If you like this idea, your ISO 13485 QMS will contain five levels as in the following list:

Policy – level 1

Quality Manual – level 2

Operating Procedures – level 3

Instructions – level 4

Quality Records – level 5

Document titles for your ISO 13485 QMS

Companies use various approaches to titling their manuals, procedures, instructions, etc. For example, one of my customers titled their documentation management procedure as “Documentation Management – Document Control Operating Procedure.” This very descriptive title does define the document, but does not appear to be efficient.

Regulated industries, including medical device manufacturers, are known for calling 2nd-level documents Standard Operating Procedures or SOPs. Do these companies have “Non-standard Operating Procedures”, so these long titles differentiate them? Since a short name identifies a document, I really cannot justify long names for 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 13485 QMS document numbers

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 simplified.

A company had some 75 employees. They had two part number formats: one for procedures, another for drawings. Procedures used AA-NNN number format. Drawings were numbered as NNNN-NNN. One of the drawings had a number 00011-003. Assemblers simplified the system and called it “Eleven.”

Do these long numbers identify documents? Yes, they do! Are they economical? No, they are not! My customer’s system allowed six digits and therefore could deal with one 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 four 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 or constructing a top-end X-ray machine, a jet fighter or a satellite, you will need millions of parts and procedures, so a long part number format would be needed and will make business sense. Otherwise, save yourself the trouble of writing all those zeros and make your numbering system practical. One of my customers, who won my “The Best Part Number” Grand Prize, numbered their ISO 13485 quality management system documents as 401, 402, 403, and so on. Short and sweet!

There is another opportunity for improvement of many ISO 13485 QMS – part number designation. Many companies relate a document type to the document number. For example, WI-xxxx indicates an instruction, DR-xxxx indicates a drawing, SOP-xxxx indicates a standard operating procedure, etc. My practice with a few ISO 13485 QMS’s 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 not 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 just 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 their revision levels.

About the Author:
If you are working on your ISO 13485 quality management system, and want to avoid common mistakes, take a look at our ISO 13485 Quality Management consulting services.

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