THG Formulations

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.

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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.

Element 5.3 of ISO 9001 Standard requires an organization to establish a quality policy. More specifically, the standard requires: “The management” of an organization 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

Despite the fact that these requirements appear to be rather simple, most companies I worked with as a consultant or an auditor, had difficulties with documenting their ISO 9001 quality policies by not addressing all the requirements above. Establishing a quality policy that, as a minimum, addresses all the requirements above is important because of our commitment to establish a QMS that comply with a given standard. Therefore, we have to adhere to it’s requirements. What if our quality policy did not require its review “for continuing suitability”? Most likely that this review would never be done.

To demonstrate my point, let’s go to the Internet and check a few quality policies on the Internet. Search for “iso 9001 quality policy” and you will find a list of companies that posted their quality policies on their Websites.

“[Company name] is committed to serve it’s customers and meet their needs and expectations in the design, manufacture and supply of reliable and innovative technologies and products for [product descriptions] using modern management, engineering and material sciences. [Company name] is committed to continuing improvement of it’s products and services to achieve increased customer satisfaction as well as to ensure compliance with the requirements of the Quality Management System and it’s continuing improvement.” Assuming that this quality policy is appropriate to the purpose of the organization and is communicated, these two requirements are met. Customer needs and expectations may be considered as requirements, so this requirement is also addressed. However, commitment to continual improvement of the effectiveness of the QMS, provision of a framework for reviewing quality objectives and commitment to review quality policy for continuing suitability are apparent.

Another one: “Quality is the heart of our business and key to our goal of total customer satisfaction. Therefore it is our policy to: Consistently provide valued products and services that meet the current and future needs of our customers and suppliers; support each other in the daily use of quality systems, processes and methods to improve every activity constantly and forever; continuously look for means to construct change which provides for significant improvements in quality beyond what can be achieved by continuous improvement methods alone.” As you can see, this quality policy did not address any, I think, of the requirements of the standard. Can you imagine their quality manual or the entire quality management system?

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!

Mark Kaganov is a Director of Operations with Quality Works. Since mid 90th our business assisted hundreds of companies in the US and abroad in developing their quality assurance programs. With our focus on cost reduction and process optimization, our customers’ quality management systems showed continual improvement.

Just last January the oldest of the baby boomers began to turn 62. For the next 18 years a member of the baby boomer generation (the 78 million Americans born between 1946 and 1964) will reach that age every eight seconds. Boomers have long been famous for their desire to stay or at least act young. As an integral part of that effort to stay young is the ability to remember.

Many of us remember the Oscar winning performance of the late Henry Fonda in the movie On Golden Pond. In that movie he portrayed Norman Thayer. In the movie Norman learns not to take life for granted by enjoying it. He also learns not to be so crotchety, and not to dote on death. One unforgettable scene in the movie was when Norman got lost in the woods near his cabin. A place that he knew better than any other yet he became confused, lost and terrified

In an article written by Katie Hafner of the International Herald Tribune the global edition of the New York Times she reported the following “: When David Bunnell, a magazine publisher who lives in Berkeley, California, went to a FedEx store to send a package a few years ago, he suddenly drew a blank as he was filling out the forms.

“I couldn’t remember my address,” said Bunnell, 60, with a measure of horror in his voice. “I knew where I lived, and I knew how to get there, but I didn’t know what the address was.”

Bunnell is among tens of millions of baby boomers who are encountering the signs, by turns amusing and disconcerting, that accompany the decline of the brain’s acuity: a good friend’s name suddenly vanishing from memory; a frantic search for eyeglasses only to find them atop the head; milk taken from the refrigerator then put away in a cupboard.

“It’s probably one of the most frightening aspects of the changes we undergo as we age,” said Nancy Ceridwyn, director of educational initiatives at the American Society on Aging. “Our memories are who we are. And if we lose our memories we lose that groundedness of who we are.”

The possibility of losing ones’ memory is freighting. Not too long ago it was believed that there was not much that could be done to prevent such an occurrence. Now we know that there are things that we can do and foods that we can eat that will help us.

In an article by Wendy Hodsdon, ND she shares that foods and supplements can support memory.

“A balanced diet with protein, good fats and complex carbohydrates can balance the activity in the temporal lobes of the brain. Eating protein at every meal can help stabilize blood sugar levels and help prevent the brain fog that sometimes happens after high carbohydrate or high sugar meals.”

Antioxidants play a pivotal role for memory improvement.Antioxidants in the diet can improve memory by decreasing the free radical damage that can occur with age. Foods highest in antioxidants include fresh, colorful fruits and vegetables. Some of the best antioxidants are found in berries (such as acai, blueberries, strawberries, raspberries and blackberries), spinach, brussel sprouts, plums, broccoli, beets, avocados, oranges, goji, red bell peppers and cherries. Eating many colors of fruits and vegetables ensures a wide variety of antioxidants to nourish and protect the brain.

Supplements can improve memory, learning and verbal skills. Some of these Supplements that support memory include antioxidants such as alpha-lipoic acid, vitamin E and vitamin C. Ginkgo biloba is an herb that enhances circulation in the brain, which can improve memory and concentration. Phosphatidylserine is a nutrient that is found in food and in cell membranes in the body. In studies where it is given as a supplement, it increases the metabolic activity in the brain and improves memory, learning and verbal skills.

Sharon Begley wrote in an article dated Wednesday, February 25, 2009 3:07 PM that “there is more than enough evidence that physical exercise is good for the brain, bringing benefits like lower cholesterol and blood pressure, but here’s more: it can increase the size of your hippocampus, the structure responsible for the formation and storage of new memories as well as for spatial navigation–finding your way around.

In a paper to be published in the journal Hippocampus, scientists report that elderly people who are physically fit generally have a larger hippocampus and better spatial memory than peers who are less fit. Previous studies have shown that challenging the hippocampus—exercising its spatial skills and its memory abilities—can increase its volume, too. London cabbies have bigger ones than your average Londoner, and experienced cabbies have larger ones than newbies, suggesting that making the hippocampus find its way through London’s labyrinth can boost its size. And exercising its memory-making skills seems to do the same thing: a study of German medical students found that the hippocampus got larger as they studied for finals. This is the first study, however, to show that plain old physical exercise, which does not engage the hippocampus to any real extent, can also give it a boost.”

As we progress through this mortal experience there is no escaping the effects of time and age. However there are things that we can do to optimize our health so as to take full advantage of our own allotted time. Staying fit with regular exercise and eating foods and utilizing dietary supplements rich in antioxidants can help us keep our minds sharp and our memories active as we make the most of our life experience.

Timothy S. Hollingshead, DPM
President, CEO
THE HOLLINGSHEAD GROUP
640 East 700 South, Suite #304
Saint George, Utah 84770
Office (435) 628-3005
Cell (435) 668-4348
Fax (435) 628-2254
timhdpm@msn.com