Posts Tagged ‘quality assurance’

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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Quality Manual Review Checklist for ISO 9001:2000 QMS

Tuesday, March 24th, 2009
by Mark Kaganov

Some people call it “senior moments”, some people call it “spaced it out”, simply speaking, we all sometimes forget something – human nature.

The same thing happens when writing ISO 9001 quality manuals – very often some of the requirements of the standard are forgotten and not addressed.

Fortunately, there is a simple solution – use a checklist. A quality manual for ISO 9001 standard can be a somewhat complex document. It is not unusual that some of requirements may be missed and not addressed in the quality manual. Using a checklist will help you remember to address all the requirements. This is why many registrars use quality manual review checklists. If you are in the process of developing or tuning up your quality manual, you might ask your registrar for a checklist. If your registrar doesn’t have it, we will develop our own.

Actually, designing a quality manual review checklist is a pretty straightforward process. You may begin from establishing, so to speak, a table of contents or a top-level list containing section titles. Element eight, for example, may be started as 8 – Management, analysis and improvement; 8.1 General, 8.2 – Monitoring and measurement, etc.

Obviously, there are numerous ways to design a checklist. Most typical format I have seen through my auditing career was a 3-column table allowing documentation of the number of the clause, the content of the requirement and the location of response to this particular clause. Take a look at the following example: Element 5 of the standard starts from the title: “Management responsibility”. Clause 5.1 is a title also. Numbering these titles 5 and 5.1 respectively, placing these titles in the checklist and indicating where in the QMS these titles are located will give us a starting point.

After creating this Table of contents, continue adding other requirements for the corresponding clauses of the standard. We will review element 6.2.2 as an example. The first requirement of this element is: “Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.” Depending on how detailed you want your checklist to be, you may include the entire requirement or split it into sub-elements: 6.2.2.i – Personnel performing work affecting product quality shall be competent on the basis of appropriate education; 6.2.2.ii – Personnel performing work affecting product quality shall be competent on the basis of training, etc.

When you document all applicable requirements of ISO 9001 standard in your checklist, you will be able to verify if your quality manual meets the requirement of your company and the standard.

The process above described a way to prepare a checklist for verifying quality manual for one standard. In fact, many organizations develop management systems for more than one standard. As an auditor, very often I see integrated ISO 9001 / ISO 14001 management systems. Don’t panic! The process is the same: integrate specific clauses on the second standard into your list which is based on the starting standard.

Want to save time and get your ISO 9001 quality manual review checklist fast? Click links below to see how we can help you get started in no time!

About the Author:
Working on your Quality Manual? Visit our ISO Checklist page to see how this publicatioon can help you writing your ISO 9001 Quality Manual.

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Quality Control – Common ISO 9001 Manuals for large corporations.

Sunday, March 8th, 2009
by Mark Kaganov

Since introduction of ISO 9001 Standard for quality management systems the market has developed numerous practical models of quality manuals for organizations with single sites. At the same time, formats for management system structures for multi-facility businesses are limited at best in technical publications. This paper discusses a model for structuring a top-level documentation that allows an organization with multiple sites to use common ISO 9001 quality management system manual. Discussed approach noticeably improves consistency of the organization’s quality policies.

Through my work as a Lead Auditor with major registrars, I observed dozens of large multi-location companies struggling with connecting their corporate ISO 9001 quality manuals with the supporting, location-specific, documents. To develop a quality manual for a company with numerous facilities, organizations take two routes. Some organizations create site-specific quality manuals as copies of the corporate manual; others create site-specific ISO 9001 quality manuals that are entirely different from the corporate manual.

In the first case, when a site-specific quality manual is a copy of the corporate manual with modifications specific to a given site, mechanisms to keep these documents coordinated are rarely defined. Difficulties of keeping these documents in sync are due to the fact that corporate quality manuals are controlled by the home office, while local quality manuals are responsibility of site’s documentation control departments.

The 2nd approach, when companies choose their sites to establish their own quality manuals, differences in all those quality manuals lead to noticeable disconnect between the corporate and site-specific quality manuals.

If an organization wishes to deliver a consistent message regarding its quality policies, the deficiencies of discussed methods become obvious.

As an example, we can examine one of our international clients with facilities in the United States, Mexico and Europe. This organization established pretty complete quality manual for their corporate office in the US. When we visited their plant in Mexico, we found that their quality manual did not include reference to Canadian regulations; the facility in Italy did not address the design process, etc.

Summarizing my consulting experiences, I am convinced that these approaches to design of the corporate quality manual and sites’ manuals do not provide a solid consistent way to document organization’s quality manuals.

Fortunately, there is a solution. Let’s review an example of ISO 9001 2008 quality manual model that references procedures. Our quality manual references supporting documents within the text of the manual. For example, element 4.2.1, Documentation requirements, general, may read: Your Company, Inc.’s QMS documentation includes: documented statements of the quality policy per the Quality Policy and quality objectives per the Key Indicator Matrix,

The same method will also work for a multi-site organization for those documents that are used at all locations. For example, such processes as Management Review, NC-CAPA Procedure, Documentation Management Procedure, Audit Procedure, and others may be the same for all locations and therefore be referenced in the quality manual as shown above.

But, what if your sites use their own service procedures, incoming procedures, in-process test criteria and other unique documents different form corporate procedures? Let’s examine how an organization’s ISO 9001 quality manual can reference corporate and site-specific procedures.

The same document reference structure as for a single-location company that we discussed above, can be used if the number of locations is small, let’s say two or three. In this case, clause 5.5.1 of our corporate ISO 9001 quality manual may state: QW Enterprises, LLP’s Management Team ensures that the responsibilities and authorities are defined and communicated within the organization per the Resource Management Procedure, Organizational Chart HO and Organizational Chart Ontario. This example shows references to the common Resource Management Procedure and site-specific organizational charts for the Home Office (HO) and the Ontario locations. While this model works well for a limited number of facilities, it becomes impractical when the number of locations is significant.

For companies with a large number of locations, where we need to reference numerous documents in the manual, including those controlled by satellite locations, we have another option. We can establish a document to connect corporate quality manual commitments with the site-specific supporting documents. Let’s name this document a Manual Reference Matrix and consider the following document reference structure.

Corporate ISO 9001 Quality Manual element

Manual Reference Matrix Table of Contents (ToC)

Location Manual Reference Matrix

Location-specific procedure

The Manual Reference Matrix is simply a list of all facilities and their Manual Reference Matrixes, as shown below:

Manual Reference Matrix Table of Contents

Home Office (Denver, Colorado, USA)

Millburn (Australia)

Jacksonville, IL (USA)

Guanajuato (Mexico)

Los Angeles, CA, USA

etc,

To illustrate this model, let’s document element 5.5.1 of our corporate ISO 9001 quality manual with references to site-specific organizational charts: QW Enterprises, LLP’s Management Team ensures that the responsibilities and authorities are defined and communicated within the organization per the Resource Management Procedure and site-specific Organizational Charts per the Manual Reference Matrix ToC. This statement tells us that the company uses common Resources Management Procedure and site-specific organizational charts. To locate a site-specific organizational chart, we need to refer to the Manual Reference Matrix Table of Contents (ToC).

Let’s say we need to locate a Data Analysis Procedure for our Los Angeles plant. When we find this location in our Manual Reference Matrix table of contents, we actually will connect to the location’s Manual Reference Matrix. Finding the corresponding clause number in the site’s Manual Reference Matrix, we will find a site-specific procedure title that addresses our clause of the quality manual.

Quality Manual Reference Matrix may be formatted as a three-column table with the Manual Clause in the first column, HO References in the second and Location References in the third column. For example, for the element 8.4, Data Analysis, the Los Angeles plant’s Matrix indicates that the manual references Data Analysis Procedure HO for the corporate office and Data Analysis Procedure LA for the Los Angeles plant.

Looking for samples of a quality Manual Reference Matrix for ISO 9001 QMS? Check links below.

About the Author:
If you are developing an ISO 9001 Quality Manual for a large corporation and wish to keep your documentation simple, check our Quality Assurance Manual Reference Matrix. If you need help with implementation of your Corporate Manual, check our Quality Management ISO 9001 consulting services

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Dimensional Verification of Steel and Iron Castings

Friday, February 20th, 2009
by Richard Palmer

One key benefit of steel and iron castings is the ability to be formed into complex, organic shapes that are not easily duplicated in fabricated, or even forged parts. Because of this, castings can achieve significant cost and labor savings, but these complex shapes can be quite difficult to inspect with traditional dimensional inspection techniques. The typical dimensional testing toolbox begs for a few specialty items to complete the task adequately.

In addition to the complex shapes that are common for castings, a steel or iron cast surface will be textured by the molding material that the molten metal was poured into, typically bonded sand. This surface texture can affect the repeatability and accuracy of the inspection if care is not taken during the measurement process.

One important issue that complicates the dimensional inspection of iron and steel castings is the draft angle that is required on patterns that are used in sand molds. Draft angles are a manufacturing requirement of the sand mold process that allows the pattern to be drawn back out of the sand after the impression is made. These draft angles are rarely shown on casting blueprints and solid models but are usually noted on the prints as: Draft not to exceed 1.5 Degrees, or something similar.

The dimensional inspection of castings has traditionally relied on the standard hand-tools that reside in most inspectors toolboxes: height gauges, calipers, radius gauges, snap gauges, tape measures, etc. These hand tools continue to play an important role in the inspection process, but, because of the unique issues with castings as noted above, they cant always be relied upon for the complete dimensional inspection that may be required. In addition to standard hand tools, Spokane Industries uses both a traditional, table-based Mitutoyo CMM (Coordinate Measuring Machine) that has a 24x24x18 working volume and a Faro-Arm with an 8-foot sphere working volume.

The traditional CMM is primarily used for the measurement of smaller, investment castings produced in our lost-wax facility as well as for the castings that are further processed by machining. The Faro Arm is a portable, articulating-arm CMM that allows for much more complete and detailed measurements than would be possible with either hand tools or the traditional CMM. Spokane Industries uses a Faro Arm that has an accuracy of plus or minus .003 of an inch. Although this accuracy is not as precise as a standard, table-based CMM it is more than acceptable for the tolerances usually applied to iron and steel castings.

The Faro Arms measurement software contains all the standard measurement tools that are common in most measurement software packages: plane, line, distance, circle, etc., but the Faro Arm gives the dimensional inspector the ability to digitally trace the contours of the casting and compare the CAD data directly against the trace. This tracing capability of the Faro Arm is accomplished by moving the tip of the arm against the feature of the casting that needs measuring.

The software will record the path of the tip as digital points or small, stitched-line segments. These points or line segments can then be measured in the software. Because of this free-form recording of the actual shape of the casting within the software, the dimensional inspector is able to record the true shape of the casting that can be measured, viewed on-screen, emailed for review, and rechecked even if the casting is no longer present. These features allow Spokane Industries quicker, more accurate dimensional inspections of castings that can be communicated with our customers via traditional dimensional reports, CAD/actual casting scan overlay, or a combination of both.

David Jolin, Quality Assurance Manager at Spokane Industries states, Another advantage of this scanning capability is to reverse-engineer existing castings that may not have a blueprint or cad-data. This is especially helpful if a customer has only a casting to provide to Spokane Industries to copy. Spokane Industries can scan the casting with the Faro Arm, generate a blueprint and CAD model and submit these back to the customer for review and approval. Once approved, Spokane Industries would then create the pattern for the molding operation, and then pour a first part sample. This sample can then be confirmed back to the created and approved blueprint, as well as against the scan of the original part.

The realm of dimensional inspection has moved far beyond the days of hand-written dimensional reports listing the results to the nearest fraction of an inch. The advancements that computer-aided inspection systems and the digital age have spawned allow us to produce parts and inspect them with more precision and detail than ever before. This increased detail results in a better understanding of the casting process that encourages engineers to design even more complex castings. As customer expectations grow, so does the ability of our QA department to meet and exceed them.

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Spokane Industries high quality Dimensional Verification department is state of the art. Always on-time, our highly trained staff prides itself on Dimensional Verification that meets and often exceeds our customers expectations.

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