Hello, all:

I think I'm finally getting a little momentum on this book project. Here's Chapter 4, Identifying Causes. As always, I greatly value any feedback and criticism you might have.

Talk to you soon,
Craig

Hello, all:

I think I'm finally getting a little momentum on this book project. Here's Chapter 4, Identifying Causes. As always, I greatly value any feedback and criticism you might have.

Talk to you soon,
Craig

I like the Opportunity Priority function you have described. We've done a similar thing in the past but didn't have a good name for the 'control' factor. We tried calling it 'ease of fix' and 'impact'.
If you can get people who understand risk assessments, this is easy. [it's a BIG if, though]

ab001,

Yes, that's a big if. In the past, I've used a multi-voting process for prioritizing causes, but it really doesn't produce consistently good results. The evaluation using the 3 factors of frequency, likelihood, and control works quite well, and it's fairly intuitive to most people.

Thanks for taking a look at the chapter!

Craig

Craig - thanks again.

Your article is very good nad has analysed the concept deeply.

Craig,


Thanks for posting this. It couldn't come at a better time. We are currently triing to eliminate rework and it is moving slowly. We just decided to try a brainstorming session with the employees that perform the actual rework. Hopefully this will shine a brighter light than our other attemps.

Ajit and Charlie--

Thanks for taking a look at the article. Your comments are very encouraging. Charlie: Yes, I hope your brainstorming goes well! If the chapter is of any assistance then I'll be extremely gratified.

This chapter does have a couple of quirks worth mentioning:

1) Cause and Effect Diagrams (aka Fishbone Diagrams) are not mentioned at all. I have never found a great deal of value in these, so I just skipped over any mention of them. They're very popular tools, though, and my guess is that some people might be disappointed that they're not addressed.

2) There's no mention of common cause variation versus special cause variation. I would have launched into a explanation of the central limit theorum and control charts, and it seemed to un-focus the chapter. So I left it out.

3) The use of data is described and encouraged, but it isn't the overriding focus of the chapter. For a chapter on problem causes, this could bug some people.

Thanks again,
Craig

Ajit and Charlie--

1) Cause and Effect Diagrams (aka Fishbone Diagrams) are not mentioned at all. I have never found a great deal of value in these, so I just skipped over any mention of them. They're very popular tools, though, and my guess is that some people might be disappointed that they're not addressed.

2) There's no mention of common cause variation versus special cause variation. I would have launched into a explanation of the central limit theorum and control charts, and it seemed to un-focus the chapter. So I left it out.

3) The use of data is described and encouraged, but it isn't the overriding focus of the chapter. For a chapter on problem causes, this could bug some people.


At the level where this chapter is written, it is easy to understand without going into the more technical tools for problem solving and decision making. I see what you are wrestling with. Quality tools such as histograms, discrete and continuous probability distributions (binomial, poisson, hypergometric, normal, uniform, exponential), but where does it stop? I don't think it should bug people that you don't go too much into data analysis because then you would have more of a stats book.
I might reference that there are whole professions dedicated to breaking down the headings in your brainstorming spreadsheet. Moreover if the frequency, likelihood and control numbers are too difficult to write down then professional statiticians or quality personnel can be hired for the low low price of $19.99 :D Just poking fun, but the only time we had some breakdowns using this method is when there were some bias toward frequency and likelihood between managers.... otherwise I think it reads fine, it just depends on your target audience.

Qualityboi,

You nailed my thinking exactly. Keep the thing lean and focused, and if people want to go whole hog with sophisticated tools then they'll have to go elsewhere. (By the way, the $19.99 statistics consultants are now going for $9.99.) In the vast majority of companies I visit, they need basic problem solving...and that's really the target audience for this. A good dose of "Get off your butt and really try to address the causes of your biggest problems." They might be flying the six sigma flag out front, but they are still poor at nuts-and-bolts problem solving in the back.

I appreciate you taking a look at the chapter. If you think of anything I should add or change, please let me know. I'll get cracking on the next chapter soon: Planning & Implementing Solutions.

Craig

Easy to identify with and wish more people would go to lean and understand simplicity, and Looking at PM on equipment is great. Most people would not even look at this. This is a must for tooling, machinery, etc.

Also would you look at this word doc. and i think you could reflect and creat a cause matrix with it for your chapter 4.

World Quality: I like your Root Cause Matrix. It certainly looks like it could be a good tool for spurring creativity around potential causes. Yes, maybe I could incorporate something like this into the chapter. Thanks for your suggestion, and thanks for taking a look at the material. Hope all is well in Knoxville. --Craig

Craig,

It was was given to me by a friend and I am trying to train and explain the Gamitt, on CQI-10 to ISO/TS personnel, both for Automotive and ISO.

I try and give a overall view of all CA & PA objectives.

I enjoy your Quality enhancements atricles.

Looking forward for when you have you book completed.

Craig,

I liked it, and thought the OPN a useful idea, although I wish you would consider a shorter and catchier name or an acronym, as an eleven syllable name is quite a mouthful!

I've never found fishbones terribly useful either - it might possibly be worth mentioning them just to say what you said: ie, you know some people use & swear by them but you don't.

Good stuff.

Craig,

It was was given to me by a friend and I am trying to train and explain the Gamitt, on CQI-10 to ISO/TS personnel, both for Automotive and ISO.

I try and give a overall view of all CA & PA objectives.

I enjoy your Quality enhancements atricles.

Looking forward for when you have you book completed.


I know CQI 9, 11 and 12, but what is CQI 10?

Hello, all:

I think I'm finally getting a little momentum on this book project. Here's Chapter 4, Identifying Causes. As always, I greatly value any feedback and criticism you might have.

Talk to you soon,
Craig


Nice work, Craig. Written in an reasy to understand style. I appreciate that you stress to start on the system, not the people side.

I have not seen chapter 3, which appears to discuss 5-Why's. I always suggest everyone should learn at least 2 techniques - "5-Why's" and Process of Elimination" (Is/Is-Not). If 5-Why's does not work, then Process of Elimination probably will. If the problem is bigger than that, then some of the more complex tools may be needed.

Helmut,


CQI 8 is layered Audits
CQI 9 2nd edition Heat Treatment
CQI 10 Problem Solving Report or (8D) 200 Pages AIAG, , I like it.
CQI 11 Plating
CQI 12 Coatings

I find the Cause and Effect diagram useful in the manner that use can start to see trend occur. The cause may not be the root cause however, if the same cause is mentioned on mutliple C&Es it may be worth looking into to see if it is a problem.

i hope reviewing this chapter in the context of ICH Q9 will be appropriate.
especially wrt
1. OPN number and prioritizing/sequencing the causes for CAPA
2. and defining the acceptable risk or cut-off for no-action.

and coming to the problem in the OPN suggested for prioritizing the risk is that one can arrive at the number of "60" by many combination there of...3x5x4; 5x4x3; 5x3x5...etc., how do we discriminate the cause with a 'control-value' of 3 and 'control-value' of 5, or similarly the values withother components of risks...

procedure outlined in ICH Q9 , for Prioritizing the risks is as follows [refer 13,14 slides of enclosed document]:
1. all the causes identified, are mapped onto a matrix with frequency & likelihood on X & Y axis respectively;
2. subsequently the matrix is grouped into 3 sections of I-II-III risk-classes of risk as per appropriate logic.
3. these causes grouped in risk-classes are now mapped onto second matrix with above risk-classes and Control on X & Y axis respectively.
4. second matrix is again grouped into 3 sections of high-medium-low priority of risks.

the suggested procedure may not be a straight/simple procedure for implementation, but it is certainly a evolved procedure which has definite advantages over a simple OPN calculations.

of course OPN could be still relevant in terms of Pareto analysis of the causes/group of causes leading to failure scenarios.

you can refere the ich website for ICH-Q9: Quality Risk Management ICH Q9 Briefing Pack (http://www.ich.org/cache/compo/276-254-1.html)

Just some clarification on earlier post -

Poster, v9991 is referring to the ICH Q9 - Quality Risk Management (http://www.ich.org/LOB/media/MEDIA1957.pdf)

Q9 is the one of the documents issued by the INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE.

Jane,

Yes, I need something catchier than an eleven syllable name. I tried to say it...and it doesn't exactly roll off my tongue. Here's an idea: I might call it The Jane. Now that's hot and catchy! Thanks for taking a look at the chapter, madam. Hope all is well down under.

Helmut,

You're exactly right: start with the simple tools you mentioned, then move on to more complex stuff only as needed. Chapter 3 knocks the "5-whys"...only insomuch as people will often go through the 5 whys without any real understanding of the process. Thanks for taking a look at the chapter, man. Hope you're doing well.

World Quality,

I like your approach to improvement and problem solving. Thanks so much for your encouragement on the book. Keep up the fine work.

Charlie,

That sounds like a good, common-sense way to implement a cause and effect diagram. It's not the final tool, but an intermediate tool that could point you in the direction of where the fires are hot. Good thinking.

v9991,

Hello! You have expanded my horizons. I must admit that I had never heard of ICH Q9, but it sounds like something I'd better read. Thanks for taking a look at the chapter. Your point about the control factor being pivotal is right on the mark. Control really should be assigned more priority, maybe not through the point score, but through something. Thanks for the slides and explanation of the method in ICH Q9.

Ajit,

Thanks for the further clarification. This is a powerful document.

Cheers, all!
Craig

I tried to say it...and it doesn't exactly roll off my tongue. Here's an idea: I might call it The Jane. Now that's hot and catchy!

:lmao: :o

The 'OP' might work well - could be called 'Oppie'. OK, keep the N in the full name, but the short form to me would stand for s/thing like Opportunity Priority - but this way it's only 1 syllable!! I know this might sound too trivial to bother with, but when trying to get a general audience on side, anything that makes it more user friendly I think is worth it.

The equivalent term used in ICH-document is RPN:- risk priority number [the calculation/formula used is exactly the same as suggested for OPN, the multiplication of all the three components of risk]

thanks.
valiveti.

Hi Craig,

Nice work -- nice of you to post it.

One comment:

You slam the term "root cause" pretty hard. You don't have to define it as going back to the big bang. You can easily define root cause and contributing causes such that we can address multiple causes and still avoid creationism vs. evolution as the two potential root causes. :bigwave: