THG Formulations

21 CFR 820 documentation structure may be developed as 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), 21 CFR 820 Procedures (level 2), Instructions (level 3), and QMS Records (level 4)

Actually, the documentation structure for a medical device manufacturer starts from the policy, required by section 820.20 (a). The policy, among others, defines the regulations and standards that a company intends to comply with. If you choose to use this approach, your quality management system will have five levels, similar to the structure below:

21 CFR 820 Policy – level 1

Quality Manual – level 2

Operating Procedures – level 3

Instructions – level 4

Quality Records – level 5

21 CFR 820 – Naming your documents

As you may have noticed, the titles of the documents in the structure above are quite short. Various medical device manufacturers use different conventions for their document titles. For example, one of my customers titled their quality manual as “Quality Management System Quality Manual.”

Regulated industries, including medical device manufacturers, are known for calling the 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 21 CFR 820 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.

Numbering your 21 CFR 820 documents

It is not a specific requirement of the 21 CFR 820 or any other regulation or standard to uniquely number a part or a document. It is 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 long document titles that we discussed earlier, document numbering formats very often are also an opportunity for optimization.

One of my clients runs a small company of some 120 employees. Their documentation control procedure prescribed two numeration systems that dependent on the type of a document. 21 CDR 820 QMS documents had numbers like XX-XXX, and production parts required part number format as XXXXXX-XXX. One of the drawings had a number 000076-003. Folks on the floor called it “seventy six.”

One can certainly use these long-long numbers, 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 200 documents. There were no indications that the company will significantly grow. 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 medical device manufacturer with 13-digit alpha-numeric part number format! Try to write those in your audit report!

I hope it is clear that when extensive part numbers are not justified, we do not have to use them. If you build helicopters or space probes, you, no doubt, will need millions of parts and therefore will need long document 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. 502, 503, 204, and so on. The system worked just fine!

Part Number designators

Another debatable issue with the part-numbering is part number designation. Some management systems associate a part number with a particular part type. For example, 20-xxx indicates a procedure, 30-xxx indicates a drawing, P-xxx indicates a policy-level document, and so on. My experience with a number of 21 CFR 820 medical device manufacturers has convinced me in the benefits of a “no designation” system. Three of my clients’ systems that used P/N designators have failed. Just recently, one of my customers reported that they ran out of range in their part numbering format.

The QMS initially permitted for identifying paint color through a two-digit extension within the part number. While the company grew, the number of paint options increased beyond expectations and eventually the company needed more than 99 colors. This resulted in the document number format not being able to support the requirements.

To get around this issue, there is a simple solution – a “no designation” system. Document numbers in such systems are simply assigned unique numbers. Areas of use, materials, suppliers, and other attributes are not reflected in part numbers. Moving in this direction, you can simplify your system even more. I worked with a company that did not use document No’s at all. That documentation system used just document names followed by their revision numbers, like Process Validation Protocol AB.

If you are working on your 21 CFR 820 quality management system, check out our 21 CFR 820 Quality Assurance consulting services.

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 practice, neither one of these approaches result in a consistent result. In the 1st instance when a modified quality manual is used for a location, methods for updating local quality manuals are not defined. This disconnect arises from the fact that the corporate office manuals are controlled by the home office, while local quality manuals are facilities’ responsibility.

In the case of companies choosing their facilities to develop their own ISO 9001 manuals, discrepancies in numerous quality manuals result in visible differences between the home office and facilities’ quality manuals.

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

One of our large customers demonstrated this point well. The corporate ISO 9001 quality manual addressed majority of the requirements of the standard and referenced appropriate regulations. At the same time, one of their US locations did not reference required ISO 13485 standard, Mexico facility missed a commitment to compliance with regulatory requirements, yet Costa Rica site failed to document their ISO 9001 quality policy all together!

As one can see, both approaches above to development of site quality manuals as copies of the corporate manuals or independent quality manuals do not appear to be practical or economical.

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,

This method of referencing supporting procedures is very common for quality manuals for companies with single location. Interestingly, it also works for a multi-site business for those documents that are common for all sites. For instance, Audit Procedure, CAPA Procedure, and others may be the common for your all sites and be referenced in your quality manual as demonstrated in previous paragraph.

However, what if our locations need to use different organizational charts, product realization procedures, and other site-specific quality management system documents? If we use the model above and want to keep a common ISO 9001 quality manual, we have to reference in the manual corresponding documents for all locations which may not be practical. Below we will explore how a corporate quality manual can practically reference location-specific documents to support commitments of the company’s common ISO 9001 quality manual.

A method identical to a single-site organization can be used when the number of facilities is relatively small, let’s say 2 – 3. For example, clause 5.2, Customer focus, of our ISO 9001 quality manual may state: Your Company, Inc’s Management Team ensures that customer requirements are determined and met with the objective of enhancing customer satisfaction per the Design Management Procedure, Contract Review Procedure HO and the Contract Review Procedure SP. This example references to the common Design Management Procedure and facility-specific Contract Review Procedure HO (Home Office) and Contract Review Procedures SP (St. Petersburg). This approach works well for a company with limited number of locations, but it becomes unworkable when the number of facilities grows.

When an enterprise has significant number of facilities and needs to reference in its manual numerous procedures including those controlled by its sites, we have another choice. We can develop a matrix to connect our quality manual elements with the location-specific supporting documents. We will title this document a Manual Reference Matrix and establish the following documentation reference structure.

Corporate ISO 9001 Quality Manual section

Manual Reference Matrix Table of Contents (ToC)

Facility Manual Reference Matrix

Facility-specific document

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)

Toronto (Canada)

St. Petersburg (Russia)

Buenos Aires, (Argentina)

Portland OR USA

etc,

Let’s see how this model works. We will document element 8.4, Analysis of data: Sunrise, LLP has established and maintains documented Management Review Procedure and site-specific data analysis procedures per the Manual Reference Matrix ToC to determine, collect and analyze appropriate data to determine the suitability and effectiveness of the Quality Management System to evaluate areas where continual improvements of the effectiveness of the ISO 9001 QMS can be made This element states that the company uses common Management Review Procedure and site-specific data analysis procedures. To locate a site-specific data analysis procedure, we simply need to consult the Manual Reference Matrix ToC.

Clicking the hyperlink Ontario (Canada), for example, we will find a site-specific Manual Reference Matrix. Locating a specific element in the location’s Manual Reference Matrix, we will find a particular, location-specific document that corresponds with this clause of out ISO 9001 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.

If you are developing an ISO 9001 quality manual for a large corporation with multiple sites, check the links below for samples of Quality Manual Reference Matrix.

If you are tuning up your ISO 9001 Quality Manual for a company with multiple locations and wish to keep your documentation simple, check our Quality Assurance Manual Reference Matrix. If you have questions or need help with implementation of your Corporate Manual, check our Quality Management ISO 9001 consulting services

Lean Six Sigma is an altered form of Six Sigma Training, but also a process all its own in many capacities. Knowing the vital differences that come with Lean can prove to add more to your quality improvement projects than you might have thought possible. There are basic fundamentals of Six Sigma that will not be absent in the Lean process, but there are also a few additions to the process that make it what it is.

There are eight elements of waste that Lean Six Sigma focuses on. It has been proven that once these areas are removed from a company, their quality has improved. The following is a list of what the Lean process considers to be waste and examples to each area.

-Wasted Human Talent: This category includes any employee that is not pulling their weight, thus slowing the process down. It also includes anyone without a specific job function within the process.

-Defects: This can be products or processes that are not right. These obviously need solutions to fix them before they can be eliminated.

-Inventory: This refers to an over sized “To Do” list of work. You never want to have to much product waiting to be worked on. A doctors office, for example, does not want to have to many patients in the waiting room at one time.

-Overproduction: Having too much of anything before it is needed can get in the way of efficient process operation.

-Wasted Time: The amount of time that is spent waiting for a product. Any down time should be spent on needed areas of various activities or process. For example, you should never have five employees just standing around waiting for a supply truck to arrive, instead find other areas that they can be useful while they wait.

-Motion: When talking about motion, it is pretty self explanatory. It refers to the moving around of people when there is absolutely no need for it. An great example of this is when you make an appointment for a clinic and you are sent to triage, then back to the waiting room and then to the exam room. Everything should just be down right in the exam room.

-Transportation: Any form of ineffective transportation that is used to move people or a product. If it is not necessary then it is wasteful and not needed.

-Process Waste: Process Waste refers to any that a company requires to be complete, however it has no impact on the process, product or service that the company offers.

Understanding these waste products will enhance the quality improvement projects that you approach using Lean Six Sigma processes.

Create the most of your business skills with six sigma. Getting six sigma certification online will benefit yourself in addition to your business. To learn more check out www.sixsigmaonline.org.

A guideline for Developing Quality Manuals, ISO 10013 Standard, suggests a documentation structure for ISO 13485 QMS. The model in the standard proposes use of a 3-level arrangement. Most companies I worked with utilize four-level structures to include records, A typical 4-level documentation structure consists of:

Manual – level 1

Procedures – level 2

Instructions – level 3

QMS 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 would you know what standard this manual should cover? The quality policy defines it and therefore it should be included into the structure:

Policy – level 1

Manual – level 2

ISO 13485 Procedures – level 3

Instructions – level 4

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.

One of my clients runs a small company of some 120 employees. Their documentation control procedure prescribed two numeration systems that dependent on the type of a document. QMS documents had numbers like XX-XXX, and production parts required part number format as XXXXXX-XXX. One of the drawings had a number 000076-003. Folks on the floor called it “seventy six.”

One can certainly use these long-long numbers, 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 200 documents. There were no indications that the company will significantly grow. 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 medical device manufacturer with–digit alpha-numeric part number format! Try to write those in your audit report!

I hope it is clear that only when extensive part numbers are justified, we do not have other options. If you build helicopters or space probes, 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. 502, 503, 204, and so on. Worked just fine!

Another debatable issue with the part-numbering is part number designation. Some management systems associate a part number with a particular part type. For example, 20-xxx indicates a procedure, 30-xxx indicates a drawing, P-xxx 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 of my clients’ systems that used designation failed. Just recently, one of my customers reported that they ran out of range in their part-numbering format. The documentation system allowed for assigning materials through a two-digit designator within the part number. When the system was designed a few years ago, needing more than 99 materials was not considered possible. Unfortunately, company’s needs changed over time, and just a few years later, the quality management system needed more than 99 materials causing the existing part number format to fail.

To get around this issue, there is a simple solution – a “no designation” system. Document numbers in such systems are simply assigned unique numbers. Areas of use, materials, suppliers, and other attributes are not reflected in part numbers. Moving in this direction, you can simplify your system even more. I worked with a company that did not use document No’s at all. That documentation system used just document names followed by their revision numbers, like Process Validation Protocol AB.

If you are working on your ISO 13485 quality management system, and want to avoid common mistakes, check out our ISO 13485 Quality Management consulting services.

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”.

Very often, companies use forms as lower-level documents. Frequently, we really do not have to write a “standard” instruction with the purpose, the scope and details if a simple table will do the job. Often companies receive audit non-conformities because their forms are not controlled.

Frequently, being asked about not controlled forms, my clients reply: This is “just a form”. I always wonder why a form should 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 two-column table

- enter your business name into the 1st 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.

Now, let’s imagine that we were given a two-column form, only being asked to complete it. The first column is titled ‘You company name’ and the second column ‘Company’s URL’. Obviously, we would enter our company name and our Website address in the table. It means that we interpreted the table as an instruction.

If we concur that the 1st three-line instruction written in English was a “real” instruction that needs to be controlled, the other, blank form, resulting in the same output, must also be an instruction! Shouldn’t this type of an instruction be controlled as well?

I think that the confusion regarding forms is based on the fact that forms serve two purposes. Blank forms are concise instructions written in tabular language. After a form is filled out, it becomes a record. Unlike instructions, records are not expected to have a part number or a revision level. Records are managed in a different manner. Let us remember this and treat our blank forms as instructions letting the documentation management process govern them. There are a couple of simple tests you may take when you are tempted to use a form that has not been assigned a part number:

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

- If you changed your, let’s say, test results form, would you like personnel to use the most resent revision?

- If you were out for awhile, would you like folks to be able to find your form just by following 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.

Tuning up your ISO 9001 documentation system? Quality Works will be glad to help! Visit our quality management documentation page.