Identifying Causes (book chapter 4 on problem solving)

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.

world quality said:

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.

Click to expand...

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

ccochran said:

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

Click to expand...

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

Just some clarification on earlier post -

Poster, v9991 is referring to the ICH Q9 - Quality Risk Management

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

ccochran said:

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!

Click to expand...

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.