I found this article here.

It’s unintentionally hilarious … well it was to me!

Congratulations to all of us quality managers. We have a new standard. ISO 9001: 2008. This is really an exciting moment for quality managers. To celebrate this event in a way that only quality managers know how, I prepared here a comparison article between the ISO 9001:2000 and the new born ISO 9001:2008. I also included my comments regarding my experience and my perspective of things.

At the end of it I will summon the new requirements from the new ISO 9001:2008 standard.
Paragraph number 0.1 - Changes here are a statement about whom and where the standard is including any statutory requirements and have the same scale as any customer or regulatory requirements. It’s also clarified that these requirements are restricted to those applicable to the product.

Paragraph number 0.4 - There is a comment that state that the new standard is made due consideration to ISO 14001:2004.

My comment - Of course. The world is getting greener every day so they must remind you of the ISO 14001 standard. I believe and recommend to any organization that is needed of the ISO 14001 standard to implement also the 9001. There is a big correlation between these two. They actually help one another.

Paragraph number 1 - Statutory requirements had been referred in connection with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.

My comment - After so many years of auditions the long last debate had been settled. Statutory legal requirements and statutory requirements are obliged to the purchasing processes. It was always an open area that no one had the correct answer: is your supplier must follow the law or not? Apparently yes.

Paragraph number 2 - Normative reference - the ISO 9000 is now referred to ISO 9000:2005

Paragraph number 3 - Explanation about what is a customer and what is an organization and what is a supplier had been removed.

Paragraph number 4.1 - Clause a - The word “determine” is replacing the “identify”. A note had been added stating that a purchased processes are regarded as purchasing products and another note that demand that these processes would be controlled as far as products.
My comment - Come on, like it wasn’t obvious before….

Paragraph number 4.2.1 - Slight change of words but when you examine the change you realize the meaning is the same. Note2 was changed - a single document may include requirements for more than one procedure and requirements of one procedure may appear in more than one document.

My comment - It’s about time. A lot of headaches are vowed to be save. If your audit was one of the old school and demanded everything by the book - now you may combine two quality procedures to one document: Job description and training for example or you can split one document into two. How ever it is suitable for you as long as you provide the demands.

Paragraph number 4.2.3 - A clarification that external documentation are the ones needed for the quality management system.

Paragraph number 5.1 - Clause a - the word “statutory” had been added.

Paragraph number 5.5.2 - An addition for a demand that the management representative would be a member of the organization’s management.

My comment - That addition puts all external consultants at risk - you can no longer be the management representative. That sets a whole new line of forms and documentations for you to develop in order that the external consultants would be considered as a management representative.

Paragraph number 6.2 - Change of words from “affecting product quality” to “affecting
conformity to product requirements”

Paragraph number 6.2.2 - Clause b -”provide training or take other actions to satisfy these needs” changed to “where applicable training needs to be provided to achieve the
necessary competence”.

My comment - It all goes back to defining .You defined what is necessary now you must provide it - nothing is new.

Clause c - you must ensure that the training is with competence rather than if it was an effective training.

My comment - On one hand it is an improvement. The training must be reviewed before. But I think it’s not such an improvement. Instead of testing your employees if they got anything of the training you must now check the training itself before. Only time will tell…

Paragraph number 6.3 - Clause c - information systems are included.
My comment - They are totally right!

Paragraph number 6.4 - A new note: noise, humidity, temperatures are part of a working environment.

My comment - That also puts an old debate aside. No longer can cruel owners of factories ignore these factors. Wait until they will combine OHSAS 18001…

Paragraph number 7.1 - Clause c - measurement had been added to the activities.

Paragraph number 7.2.1 - Clause a - change of words - not of the meaning. Clause c- the word ‘applicable’ replaces ‘related’. Clause d - change of words - not of meaning. A note has been added to explain what is the meaning of “post delivery activities”.

My comment - I agree with the “post delivery activities” - it wasn’t clear enough for my opinion.
Paragraph number 7.3.1 - A note had been added clarifying that design review, verification and validation are separated processes but they might be conducted together.

Paragraph number 7.3.3- A change of wording. A note had been added clarifying what is included in “preservation of product”.

Paragraph number 7.5.3 - A requirement added specifying that product traceability must be included throughout the product realization.

My comment - That actually means that the product must be identifying not only on the shelves but also throughout the realization process.

Paragraph number 7.5.4 - A change of words to in the requirement to inform the customer of any problem regarding his property. The note had been amended that also personal data is included as customer’s property.

Paragraph number 7.5.5 - A change of words: from “conformity of” to “in order to maintain conformity to requirements”

Paragraph number 7.6 - A change of words: from “devices” to “equipment” The reference to paragraph 7.2.1 had been removed. Clause c - from “be identified to enable the”to ” identification to enable their”

Changes in the notes: Note 1 - the reference to ISO 100012-2 had been removed. Note 3 - explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.

My comment - That means that from now on a computer that provides any kind of measurements services is considered a monitoring and measuring device. How can one calibrate a computer? Ask the supplier or your system administrator. They will know better than anyone.

Paragraph number 8.2.1 - A note had been added to suggest some means of conducting customer satisfaction evaluation.

Paragraph number 8.2.2- Requirements for the audit evidence and results had been added and also that the management is responsible for ensuring preventive and corrective action to be taken.
The reference to the ISO 10011 is changed to ISO 19011.

Paragraph number 8.2.3 - A change of words: “to ensure conformity of the product” had been removed.
A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.

Paragraph number 8.2.4 - A change of word: “maintain evidence of conformity with acceptance criteria” had been removed but it is still a requirement.

Paragraph number 8.3 - An addition - Clause d - specify how to deal with a nonconforming product that was discovered after delivery - but actually there nothing new only that they moved it to a new clause.

So, what are the new requirements of the new standard?

• Statutory requirements are given scale as any other legal or customer’s requirements.
• The statutory requirements are including the suppliers as well.
• A purchased process is just like any other product that the organization purchased. If it’s affecting the product it must be under the quality system.
• You may include two quality processes in one document and split one process to two documents.
• The management representative must be a member of the management.
• A requirement to ensure that trainings are suitable for the product in advance and not to check if the training was effective after it was taken.
• Information system in now officially considered as a substructure.
• Parameters such as humidity, noise and temperatures, concerning the employees’ health are considered as working environment.
• Measuring is considered as one of the activities of product realization.
• The product must be identifying not only on the shelves but also throughout the realization process.
• The management is now responsible for preventive and corrective actions regarding nonconformities that were discovered during audit.
• The organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.

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• Six Life Lessons Learned from Triathlon Training | Zen Habits

November 21, 2008 - Triathlons are a satisfying, challenging, addictive sport that attracts a fun, adventurous, open, and interesting kind of person. I’m a triathlete in my second year, and was right were you are last January. I can tell you unequivocally that you can do it, that any and all technique and gear problems can be surmounted by just - keeping - going, and that the whole journey is fun.

I’m giving you the single best resource out there for someone at your stage:

Beginner Triathlete (http://www.beginnertriathlete.com)

This is a comprehensive, free website that has an amazing number of functions. Training plans for all distances and levels of experience. Articles on specific performance/workout/training issues by elite athletes. Active, useful message boards on which you can ask any of the types of questions you’re asking here, and more. A daily training log where you can track your workouts and let others leave you feedback and encouragement. Regional meetups and training sessions. Race-day coordination so you can connect with people you’ve been in touch with on the site at your events. I can’t say enough about this site: it got me through season one with flying colors, and I met some wonderful people and made a commitment to stay with the sport. Enjoy it.

As to books: Most triathletes really favor the Triathlete’s Training Bible. It’s a one-stop book, but very technical. Don’t let it scare you, take what you need. I also really enjoyed Triathloning for Ordinary Mortals. That’s an older book, but very simple and low-stress for newbies.

There are a lot of fine points and finesse to triathloning, and a million questions to ask. And you’re going to need to ask every one throughout this first season. But at the end of the day, remember — what we now call a “Sprint Triathlon”, and train for over the better part of the year, is also what at the age of 10 I called “a normal summer day” — swim a half mile, bike 12, run 3. It’s doable. You don’t need to spend a fortune and you don’t need to obsess. It can be fun to do so, but at the most basic level, start with confidence. You can do it.

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November 20, 2008 - 1. Determine Your Desired Outcome

There are 4 types of email:

1. Self Fulfilling Email - The email itself is the point. You want to tell the receiver something, either a compliment or information. No reply is necessary.
2. Inquiries - You need something from the receiver in the form of a reply. For example, advice, or questions answered. The reply is your desired outcome.
3. Open-Ended Dialog - to keep communication lines open, for the purpose of some future result or benefit.
4. Action Emails - The goal is not the reply, but some action on the part of the receiver. For example, a sales pitch, or asking for a website link exchange.

2. Quickly Answers, “What’s the Point?”

People want to know “what do you need from me?” And if no action or reply is expected, say that! “No reply necessary.”

3. State Benefits Clearly
Too many pitchy emails focus solely on the sender and why the action will benefit the sender. If you don’t present incentives, or they are difficult to understand, the receiver will say no - resulting in a waste of time for both.

4. Remember to KISS

KISS = Keep it simple, stupid

Using as little words as possible, introduce who you are, context if necessary, and why you are emailing.

5. Save the Whole Story - Stick to the Facts.

Simply stick to the facts - it’ll help you keep your message short.

6. Pretend Face-to-face Intro

Treating email introductions as if you are meeting them in person is another trick to keeping messages short.

7. Text Message Trick

Pretend you’re on a mobile device.

8. Avoid Excessive Compliments

Compliment only if you really mean it. And remember to be brief if you need action from the receiver.

9. Be Personal and Personable

Personalize email with relevant remarks to the receiver, put in a quick comment about their site, product or work. Address the person by name, sign email with your own name, and a friendly comment like “Enjoy your weekend!”

10. Make it Easy to Be Found

In your signature, include appropriate URLs for your website, blog, portfolio or product. Make sure the links are functional so they can read more about you in one-click.

11. Use Simple English

Write like you talk, using conversational English. Be authentic and realistic.

12. Font Matters

Do not bold the entire email, use easy to read fonts (ie. Arial), and use a standard size.

13. Formatting Matters

Make emails easy to read and quick to scan by using bullet points, numbered lists, and keeping paragraphs short. Highlight keywords (bold or italic) for emphasis, without over doing it.

14. Minimize Questions

Ask questions that matter, and limit the number of questions and favors you ask in an email (one or two max). The more questions (especially open-ended ones) asked in one sitting, the less likely you are to get a response, and the less likely all your questions will be answered.

Also, ask specific questions instead of a general open-ended ones. Be reasonable and thoughtful when asking.

15. Trimming of Words

Like grooming a garden, read through the finished email and trim out words, sentences, and paragraphs that do not contribute towards your desired result.

Check for potential ambiguities and unclear thinking. Can you rephrase sentences for clarity using fewer words? Check for excess commentary that doesn’t add to the email’s main point. Remove extra details disclosed, unnecessarily.

Take Home Points:

* No rambling stories or long intros.
* Get to the point quickly.
* Next action clearly stated.
* Present benefits.
* Fonts and formatting matter.
* Review for conciseness, simplicity and clarity.
* One question per email.
* Be yourself - that is, the concise version of yourself.

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Anybody with expertise using SPC in a healthcare/hospital setting?

Perhaps you need to read the articles/books via the attached links?

A basic guide to introduction of the technique is in three chronological phases:

* Phase 1: Stabilisation of the process by the identification and elimination of special causes:
* Phase 2: Active improvement efforts on the process itself, i.e. tackling common causes;
* Phase 3: Monitoring the process to ensure the improvements are maintained, and incorporating additional improvements as the opportunity arises.

• http://www.wales.nhs.uk/sites3/page.cfm?orgid=379&pid=13438
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I’m amazed at how rapidly lean six sigma is spreading across non-traditional industry sectors, rather like a particularly virulent case of chicken pox. Firstly, in aviation: for example, the is the fastest-selling new airplane in aviation history and uses composites on the airframe to allow the huge structure to be built in just one piece. This means essentially there are six major end items coming together in final assembly — the forward, centre and aft fuselage sections, the wings, the horizontal stabilizer and the vertical fin.

Since the 787 is assembled from these large assemblies rather than many smaller pieces, traditional monument assembly tools are not necessary. Portable tools, designed with ergonomics in mind, move the assemblies into place. No overhead cranes are used to move airplane structure. A composite airframe also means less waste in production and fewer hazardous materials used during the assembly process. Boeing aims to improve the production time from seven weeks to one airplane every three days.

Still on aviation, Mark over at Lean Blog has spotted a great story relating to kaizen-type activities at Southwest Airlines.

Next to pharmaceuticals, Meikah at sixsig.info reports that Sanofi Aventis are deploying six sigma and are so proud of it they have produced a case study to download. A summary of the key points are:

• Training, facilitated by Motorola, of employees to be Six Sigma Black Belts.
• Broadening of Six Sigma activities by incorporating Lean Six Sigma Tools.
• Boost of the morale of employees when they saw Six Sigma as part of their job to continuously improve processes. Six Sigma has pervaded the whole organization as employees took ownership of the initiative and got rewarded by their efforts.

Finally, six sigma is also making gains in financial services however the focus here is on revenue enhancing projects and not just cost reduction initiatives, why? –

Labour and material are some of the largest cost contributors in manufacturing. Compare that to a lending institution or a bank: their largest expense is not labour or material, but cost of funds. So, the key is to focus on occurrence - once you get a customer in-house, how to make sure that you keep them and get the most value from the relationship.

Do you work in a market sectors where lean or six sigma is being deployed? Leave a comment below.

The originators of the Six Sigma initiative use a unit of measurement, a ‘Sigma’, to measure performance, the higher the value of Sigma the better the performance. For example, a 6 Sigma process is rated better than a 5 Sigma one. This meaning contrasts with the standard statistical meaning and usage of the term, sigma. The symbol, sigma, a Greek letter symbolizing a statistical measure of variation, termed the standard deviation is in universal use. The lower the value of the standard deviation, ‘sigma’, the less the variation present and the better the performance of a characteristic. The opposing meanings inevitably cause confusion. This confusion can be compounded as the internationally accepted standard ‘sigma’ provides the derivation of the Sigma metric used in Six Sigma projects and also the relationship between non-conformities per million opportunities and the Six Sigma, Sigma.

Thoughts
An advantage of the Sigma measure is its simplicity and practicality. This appeals to all those who do not wish to get too embroiled in statistical niceties but just want a simple readily understandable scale of performance measurement. The fact that 6 Sigma denotes something better than 5 Sigma and that 5 Sigma is better than 4 Sigma, and so on makes good practical sense to them and they are quite prepared to run with it. Others, who are already actively engaged in the application of statistical process control, will readily understand the use of Sigmas in a different way to sigmas but may feel uncomfortable and uneasy with both the frailty of the underlying concept and the outcome. This is because an alternative soundly based approach is available with the use of the internationally defined measured data process capability indices such as Cp. A Cp of 3 indicates less variation than a Cp of 2, and so on. Such measures require the pre-establishment of both process stability and a knowledge of the underlying pattern of variation.

Do you have any suggestions to help the project manager with scoping a project and getting the team working together right from the start of a project? [link]

Project managers obviously face many issues when starting a project. Gaining appropriate sponsorship, acquiring necessary resources, and determining correct customer requirements are the kinds of issues that if not handled correctly can easily result in eventual project failure. Additionally, two important issues project managers face on just about every project have to do with determining the correct project scope and quickly getting the project team working together. Fortunately, there is an effective and often used Six Sigma tool which addresses those two very issues. Project managers can greatly benefit from using the “SIPOC” diagram at the start of every project

Basically loans don’t require a lot of effort to turn into bad credit loan category, especially with a bad track record of home equity loans as well as other personal loans being borrowed in place of car loans, something that is forbidden in the debt relief guide.

[link]

Leadership Tips
#L1 Fix The Problem, Not The Blame.
#L2 Tell People What You Want, Not How To Do It.
#L3 Manage the function, not the paperwork.
#L4 Don’t DO Anything.
#L5 You never have to make up for a good start.
#L6 Get out of your office.
#L7 Lead by example.
#L8 Delegate the easy stuff.
#L9 Don’t get caught up in looking good.
#L10 Quality is just conformance to requirements.
#L11 Learn from the mistakes of others.
#L12 Set S.M.A.R.T. Goals.
#L13 Set an example.
#L14 Know Your GPM.
#L15 Train Your Supervisors.
#L16 You Can’t Listen With Your Mouth Open.
#L17 Practice what you preach.
#L18 Leaders create change.
#L19 Don’t Limit Yourself.
#L20 Anyone can steer the ship in calm waters.
#L21 You have to make a difference.

[link]

Six Sigma uses a number of specialized measures (metrics). The most fundamental is the Defects Per Million Opportunities (DOMO) measure. The aim of six sigma is to achieve less than 3.4 DPMO. A process that gives 3.4 DPMO has achieved ’six sigma’.

The Rolled Throughput Yield (RTY) is a key tool in achieving this. The individual yields at each process step might look, at first site, quite good, but the First Pass Yield might be significantly lower. Even when the First Pass Yield at each process step looks satisfactory the overall or Rolled throughput Yield may be low.

The sigma metric is an alternative to the traditional process capability and process performance measures used in Statistical Process Control.

• Defects per Million Opportunities
• Defects per Unit
• DPMO
• DPU
• First Pass Yield
• Rolled Throughput Yield
• Sigma
• Sigma Level
• Yield

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Here’s a question:

Wouldn’t it be interesting to have a Six Sigma exercise to measure a person’s innate aptitude and passion for a customer-facing role from pre-sales, to sales, through service, at all management levels?

Erm, not to me but possibly to some (but not all) dumb leaders. They may read in a book, understand what R-Squared is and then think they get the concept of variation. Whilst I’m all for a bit of guidance I’m a great believer in “education through action”. Learn the basics from a great sensi, roll-up your sleeves and get your hands dirty. “Tell me and I will forget, show me and I may remember, involve me and I’ll understand” - that’s what its about!!

Some companies believe that existing lean six sigma initiatives are not good enough and others stress that six sigma reduces innovation and as innovation relies on variation (what Six Sigma is supposed to remove), so therefore organisations who adopt six sigma are doomed never to product innovative products or services. This is baloney of the highest order and I’m sick of hearing this. What all of this shows is that some companies clearly don’t get six sigma while some do.

I stress again: six sigma is not about tools or even statistics its about adopting the right philosophy in the business. This is about training, understanding its fundamental principles and avoiding the most common types of failure.

In fact, lean six sigma, applied successfully, is being increasingly adopted outside of manufacturing. In healthcare for example:

You could say that, where a manufacturer seeks to produce quality products, a hospital seeks to produce healthy patients. If a patient falls victim to an infection while in the hospital, that is a defect that undermines the hospital’s mission and causes rework (having to cure the infection, in addition to the original illness). Therefore, reducing or eliminating infections is equivalent to eliminating waste in the form of defects and rework. And that is fundamentally lean.

What’s your understanding of lean and six sigma?

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There are a number of games which can be played in a classroom to simulate or teach lean principles:

The Nickel Game and the Dollar Game are useful in demonstrating some of the principles of the Theory of Constraints (ISO-8859-1&oe=ISO-8859-1&q=TOC&btnG=Search&cx=partner-pub-3820832056591464%3A8vu6mif8mj7">TOC) — also useful for some related Lean principles …

Here here are videos (in “RealPlayer” format) that describe the Games:

• Nickel Game
• Dollar Game

The Dice Game can be useful in explaining variability as well as several other Lean Six Sigma concepts, such as Kanban and the Theory of Constraints (ISO-8859-1&oe=ISO-8859-1&q=TOC&btnG=Search&cx=partner-pub-3820832056591464%3A8vu6mif8mj7">TOC).

There is also a short video (in “RealPlayer format) showing how to do the Dice Game, at this link

The Bean Game can be completed in as little as an hour, and is useful for demonstrating some of the concepts of the Theory of Constraints.

Any more games to share?

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Toyota Motor has 10x the market value of the Big Three combined. Toyota’s management system is one of the most studied and emulated in North America, yet no other company is as highly revered for their management style as Toyota is, with the exception of perhaps, GE. The question is what company will be the next Toyota and why? In this post I present my ideas: