Responding to QA documents "Corrective Action"

[winpop123]

This question is for those of you that operate in a AS9001 Quality envirnonment or similar. I have a situation where I need to respond as to how to "prevent future occurences".

The situation simply is that we designed a new system. During the assembly of the first system by Production personel, some minor design issues were noted. These items were then written up on a corrective action report. The "preventative action to prevent future occurences" has me stumped. The real answer is human error on the design side. The QA types hate that. They also didn't like the suggestion of building a prototype first before they attempt to apply the QA rigors. We intergrate and build a variety of systems that are never exactly the same so I don't really know how to "eliminate future occurences", heck I'm suprised that things work at all with the schedules we work under....suggestions?

thanks

 

[gordyclarke]

As obstructive as QA types are, and they are definitely obstructive, I've found that if you ask their opinion they will provide the QA "tick in a box" for you.

If the majority of your work surrounds one-off projects then your QA bod will (probably) have a number of stock answers to that problem.

Fight fire with fire, get him to do your part of his job!

 

[KENAT]

Two ideas, do you have design reviews and detail drawing (or if it applies MBD) checking.

If not then instituting these may help address QA concerns and actually reduce the issues that get found.

Design reviews in case you don't know are when you get a bunch of the great and good together, typically at least one member from each affected departement (QA, Design, Manufacturing, Purchasing etc, not typically accounting or HR;-)), and go over the design at a fairly high level.

You'll typically do at least 2 of these over the course of the project, the most important being the 'Preliminary Design Review' which you typically do once you have a basic scheme but before you fully detail all the drawings etc; and the 'Critical Design Review' which you typically do when design is finished but before formally releasing the design for manufacture.

Obviously depending on your timescales and if you need to order parts before finishing design to meet schedule it may not be this simple but that's the basics.

The other idea is detailed drawing checking. In this case you have someone go over the entire drawing pack and check it for completeness, adherance to relevant drawing standards (both internal and national/international standards) and errors. Ideally the person doing it has it as there full time job. They'll obviously need extensive experience as a designer and be familiar with industry standards, GD & T etc.

I'm lucky enough to work somewhere that has a dedicated checker, with many years experience of both design and checking, who is easy to get along with and makes you feel like you're learning something when he corrects your work. From my experience this is FAR superior to peer checking. A good compromise if you can't justify a dedicated checker is to only allow the 1 or 2 most suitably qualified designers to conduct check.

If you look at the GD & T/Standards forum you'll find a few threads on drawing checking which will give you other viewpoints if you're not willing to accept mine as gospel;-)

Ideally you'd implement both if you don't have them already.

 

[gordyclarke]

winpop123 - Has the future occurence been negated by the fact that there, um, will be no future occurence?!

 

[KENAT]

Ooh I just thought of a good one.

How about a 'virtual prototype'.

We have what we call a 'master model' (I didn't make up either of these terms, I think they're just to impress management) which is the CAD model of the entire assembled tool.

In theory creating this model and then doing things like interference reports etc would spot some of the problems.

Of course in reality it's not quite that simple but maybe it will satisgy QA.

I used to love battles with QA at my old place, especially on development projects or prototypes. At my current place I sometimes think I'm more QA conscious than the QA director!

 

[HgTX]

From the QA side, I must say I get annoyed at seeing screwup after screwup and being repeatedly told, "It's just human error". I want to know what's being done to make there be fewer screwups (like training the humans a little better).

I'm not saying this applies to your situation. Just wanted to give a bit of perspective from the evil QA side. (Customer QA rather than internal QA in my case.)

And I'll accept a certain number of "human error" excuses before I start getting annoyed. Then again I don't live in an ISO world; I may have a little more leeway to let CA ride a little.

Hg

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[plasgears]

A too simple answer to Corrective Action can be deadly on QA reviews.
Seek to get some elaboration in the answer, and don't provide the answer immediately. Give it some time. That is the usual expectation. Provide a prelim plan, timeline, progress report, etc. That's how the game is played.

 

[MadMango]

What type of "design issues" were noted? Were they assembly related, service related, cost reductions, or functionality? Each instance would require different types of corrective action.

Design reveiws, if the proper personnel are involved, can go a long ways to catching problems before they manifest in the physical items. Your corrective action may be to add key personnel to design reviews, assuming that you are already holding design reviews.

We have 3 design reviews in our company: Virtual, Preliminary and Critical. Virtual is pretty much as Kenat stated, a review of the 3D model with Engineering and Manufacturing personnel present. Tooling requirements, manufacturing feasability, assembly processes are considered. The Preliminary review adds Purchasing, Service, QA/QC, Sales, and Operations to the mix. Prototypes are made, tested, validated, etc. Once we get the green light, we'll do a limited production run of 50 or so products to work out the kinks in the supply chain, assembly, manufacturing, etc. Finally we have our Critical review, sort of a "lessons learned" exercise, crossing T's, dotting I's... that sort of thing.

"Art without engineering is dreaming; Engineering without art is calculating."

Have you read faq731-376 to make the best use of Eng-Tips Forums?

 

[ewh]

Design reviews and dedicated checkers are both excellent sugestions. Both seem to be more scarce than they used to be.

 

[winpop123]

A lot of good information here. To elaborate:

We do have CDR's and PDR's. We do not have a dedicated drawing checker; I agree they are nice to have and I long for the good ole days.

I have taken the tact that some have suggested (ie) let QA provide the response.

To clarify the issue was
1. Minor
2. Something the customer will never see or be aware of
3. The issue involved a label on a purchased part that was not in concert with information we had stenciled on a mating assembly.
4. The fix was to simply paint over the information on the purchased part
5. Designer didn't have the vendor part in hand to review

Thanks for the input

 

[KENAT]

So given the further explanation then do you at least have peer checking and do you have a procedure/process that covers it?

Implementing or improving your drawing check process may actually reduce this kind of occurance.

In theory, though not always in practice, we're expected to supply back ground data with our prints for checking. In your example if the vendor information was part of this background information then drawing check might have spotted the mis match.

So your corrective action could just be to review your drawing/design checking process and if necessary make changes.

This might satisfy QA without backing you into a corner before you've had a chance to investigate/think about it.

It won't be a 100% fix but might help satisfy QA, especially if it has a flow chart;-).

 

[KENAT]

I just thought of something.

If QA are present at the CDR then you can throw the blame back on them, they didn't spot it then when they had a chance to prevent the problem.;-)

I knew there was a reason we used to invite them!

 

[drawoh]

winpop123,

I would like to see more design checking by qualified professionals too.

The problem with design checking is that it consumes time and resources which might be better spent at something else. Your design checkers need to justify their existence by catching errors that cost more than they do.

Your response to QA's request should be to say "Here is how to eliminate the errors." and "Here is what it will cost us to eliminate the errors."

This leaves it all up to management. They know what the errors cost. Perhaps they should commit the resources!

JHG

 

[ewh]

drawoh,
You are starting to sound like management - "resources which might be better spent at something else". In an ideal world, this is true. In the real world, dumb mistakes are made and end up costing much more than they would have if they were caught early. Yes, a dedicated checker consumes resources. A quality product also consumes resources, as does a poorly made one. Unfortunately, industry today only looks at the immediate bottom line and gives little or no consideration to the long term (such as a reputation for quality, which requires continual investment).

 

[zuccus]

Let your QA guys check your fabrication drawings before they go to the shop floor. That will keep them busy.

Our QA guys developed a form that has several differnt categories for change. They are

Drafting Error
Design Error
Customer Change
Fabrication Error
Checking Error
Purchasing Error
QA Error (I forced them to put this one on)
Unkown Error (I forced them to put this one on also when we had a pipe misalignment and we couldn't figure out why after checking everything for two days.)

This has allowed us to track errors without singling out an individual.

Zuccus

 

[KENAT]

Madmango,

I actually also prefer at least 3 design reviews but at my new place everyone mainly talks about CDR and occasionally PDR.

At my last place, which took the design process a bit more seriously and was ISO9001 etc it went like this.

PDR covered the basic scheme. There would usually be drawings presented but they wouldn’t necessarily be complete and certainly didn’t need to have gone through drawing check or stress approval etc.

IDR (intermediate design review) was typically immediately prior to releasing drawings for prototype manufacture. These were full drawings and had gone through drawing check etc.

CDR was once the prototype(s) had been built and evaluated (including any destructive or non destructive testing) and all required changes incorporated in the drawing pack; and was immediately before the drawings were ‘frozen’ for manufacturing.

For large/high value/complex programs we’d have extra design review as required, typically at every major step in the design process such as at completion of stress analysis, completion of each testing phase etc.

This process may not really fit if you’re only building one offs but I think it would still form the basis.

zuccus

QA checking drawings, that’s kind of scary although my current checker tells me that on the level 3 government contracts he used to work the check group actually had to report to QA. The government wouldn’t let them be part of the design/engineering group!

Drawoh

Ewh is right, you do sound like management ;-). To me as long as you maintain a good ratio then money saved is as good as money earned. Obviously there’s no point only trying to save money, you have to earn some in order to be able to save it. However, drawing check is effectively a way to improve efficiency.

 

[zuccus]

Kenat,
That was kind of written as a joke. Long story, but that almost happened at my company.

As long as the checker knows how to and what to check, I am guessing that reporting to QA isn't the worse thing.

Zuccus

 

[winpop123]

Hey - I think I've got it licked now...the magic word I was missing was "Training".

We are going to train the person not to make that mistake again.

I can see I'll be using that word alot.

 

[KENAT]

So does that mean the magic QA words are no longer 'flowchart/diagram' and 'metrics'.

Or does this add to the list?

I thought 'training' was the HR keyword.

zuccus, I figured you were joking, guess I should have put a smiley.

I can see the justification for putting checkers in QA along with doc/configuration control. However I prefer a more 'cooperative' relationship with my checkers than I've ever achieved with even the best QA guys. And since checkers are always experienced designers/engineers I like to get their engineering ideas and input, not just a list of drawing errors that need fixing. I suspect this would be more difficult if they're in a separate department.

 

[zuccus]

Kenat,

I agree completely about getting the checkers buyin into designs, and that is why my checker still works in our design department.

Companies that don't have a dedicated competent checker don't understand the full value that they bring to the table.

Also maybe I should have been the one to put the smiley face by my joke.