I need help creating a practical preventive action process

S

shane

#1
I've been involved with the implementation of ISO9000 quality systems since 1991. I lead teams that implemented the 1987 procedure at a very large company, and at the very small company that I've been with since 1993. We successfully upgraded to the 1994 standard, and have since added a second facility. All the while I've managed to get away with the fact that I really DON'T understand or perform Preventive Action.

With the additional focus on this clause in the new standard I know that we have a real process in place, just having it documented will no longer work.

Everything I've read to date basically repeats the standard. Nothing gives what I believe to be good real life examples.

We are a small contract manufacturing company that assembles SMT and Thru hole printed circuit boards. We have a solid "Blue Color" approach to our Quality System. We operate on a small and very tight budget, no fancy toys.

Is there anyone out there that is willing to share some practical, and very basic practices that I can use as building blocks to create a true working preventive action process?

Please remember, we are small, and we don't have the resources to have a person or group dedicated to reviewing data from all of our processes or customers on an ongoing basis.

Any practical examples would be greatly appreciated.

Thanks in advance,

Shane :bonk:

p.s.

Please excuse me if my message seems desperate, it's more the frustration of trying to make something that is so poorly defined into a working process.
 
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T

tarheel

#2
P. Action

Don't feel like the lone ranger. PA is a very difficult thing to wrap your hands around sometimes. After 20 years, I have come up with a system that has passed QS-9000, 1994 and 2000 ISO. I created a form on Access and I put it on the floor. I push our operators for suggestions that will help them do their jobs better. For example, I had an operator come up with a way to bypass some data entry that was taking up to 10 hrs per week of her job. I documented that as a preventive action. Another operator questioned why we were using a particular brand of very expensive wrap when another cheaper wrap would do. I documented that also. I have found this to be a gold mine for PA. I've also found with lots of auditors that they will generally be very broad in their definition if they see some system working. Try to broaden your horizon of what you consider corrective actions. For example, how about safety. If you have a safety program that fixes potential safety hazards, isn't that a preventive action. I actually included safety in my quality manual and my auditor loved the fact that I had broadened the very narrow definition that is in the ISO standards. Broaden your horizon, you may be surprised what you find.
 
M

M Greenaway

#3
tarheel

I hate the old corrective/preventive action argument, however arent suggestion scemes like yours actually corrective action, as you are changing something that has already occurred.

I personally feel that tools such as FMEA and SPC are more robust examples of preventive action, as you take actions on the system before you have made bad product. However if you have no resource for setting up, running and analysing such systems it is basically a non starter !
 
B

Bob_M

#4
Re: P. Action

tarheel said:

Don't feel like the lone ranger. PA is a very difficult thing to wrap your hands around sometimes. After 20 years, I have come up with a system that has passed QS-9000, 1994 and 2000 ISO. I created a form on Access and I put it on the floor. I push our operators for suggestions that will help them do their jobs better. For example, I had an operator come up with a way to bypass some data entry that was taking up to 10 hrs per week of her job. I documented that as a preventive action. Another operator questioned why we were using a particular brand of very expensive wrap when another cheaper wrap would do. I documented that also. I have found this to be a gold mine for PA. I've also found with lots of auditors that they will generally be very broad in their definition if they see some system working. Try to broaden your horizon of what you consider corrective actions. For example, how about safety. If you have a safety program that fixes potential safety hazards, isn't that a preventive action. I actually included safety in my quality manual and my auditor loved the fact that I had broadened the very narrow definition that is in the ISO standards. Broaden your horizon, you may be surprised what you find.
Your examples sound more like Continual Improvement of a process. The examples saved money and time, they did not prevent a non-conformance.

I'm new to this arena but this is my understanding of the terms:

Corrective: Correct a problem that HAS occurred and prevent it from happening again.

Preventive: Identify a POTENTIAL problem and correct it before anything actually happens. (I feel these are seperate from issues found during a corrective action).

Continual: Making improvements to any part of the company, Quality, Safety, Process, Timeliness, etc.

If I'm way off please tell me, because I just finished updating our procedures/forms to reflect this idealogy.

Bob M
 
L

Laura M

#5
Not the greatest, but it "passed"

I am working with a less than 100 people company. 15 "managment" - QC, Prod, Eng, PUrch, Sales, Accounting, Shipping and a couple schedulers and clerical help. The argument there was "we prevent problems everyday - you can't expect us to waste time writing it down." I told them I wanted the big magnitude stuff. I also heard people talk about things they wanted to do, but the CEO has tight purse strings, and only wanted "projects" as he called them, to occur when he authorizes it.

So our process is that once/month I send an email to everyone with an email account. I state: "It's time to update our monthly preventive action list. Please respond with any potential problems you have encountered. I will compile the list and forward to Mr. CEO for prioritizing."

It has actually turned into a CI and PA list - but I choose to not distinguish. It is the most comprehensive list of improvements I have seen since I started there 2 years ago. Plus, it puts the responsibility for updating the status of the list and providing the resources directly in the hands of the CEO - or "top management" review as required by the standard.

It worked for me. It was KISS, within the paperwork parameters that the company likes to deal with, and managed to get the CEO involved by meeting the above 2 conditions. I'd appreciate any feedback.

What is it lacking - real proof that it prevented a problem - but we have evidence of implementation.

Examples:

Create a bigger staging area in shipping to prevent shipping errors. Audited and unaudited parts are too close together.
(They've had shipping errors with unknown root cause, so I see this as preventive) Also - increase font size of part number on shipping label.

Put quality system documentation on the internet to "prevent inadvertant use of obsolete paper copies" (Guess who wrote that one - and implemented)


Laura
 
#6
Hullo Shane,

I have a feeling you're not the only one beginning to sound desperate when PA is discussed. Most of us are struggling with it, whether we admit it or not. Ok, how about this?

Have a good look at 4.1.

We have to identify our processes and their application (4.1a). Having done that... why not regularly go through them with the "what can be improved here?" eyes?(4.1f)

FMEA could be used to good effect with that set up, but there are other ways too. Anyway, actions taken as a result of this approach could be regarded as "true" preventive actions. Being based on our core processes they should also prove useful.

I have to say that I like Lauras approach too. Talk about getting people involved... How many replies do you generally get to that mail?

/Claes
 
M

M Greenaway

#7
My fear of suggestion schemes is that we may end up meddling with the process, and making things worse, i.e. overadjustment of the process. However some of what Laura has found through her suggestion scheme should have been picked up at audit (which is perhaps just another suggestion scheme).
 
V

VascO

#8
I´m sure your Quality System is based and running in a preventive point of view.
Why not take advantage on that.

The fact that your processes are running in a controled way, is because there are some PA behind.
Of course there are other ways to implement PA, but my sugestion is one of them
My sugestion: a table for each Process, with the following or other collums

Process: XPTO

Task;Pre conditions/control;Verification/registation; Corrective action


Sorry for my english.

VascO
 
#9
Hi Vasco, and welcome to the Cove. :bigwave: And do not worry about the english. It seems perfectly understandable, and that is all anyone asks for around here. I should know, I'm not a native speaker either ;)

Your setup sounds similar to what I had in mind.

/Claes
 

Mike S.

Happy to be Alive
Trusted Information Resource
#10
Shane,

PA/CA can get a bit confusing for sure. Here's another angle. Let's say you have a defect or customer return/complaint (I know, it is rare!) on a certain product "X". You figure out what went wrong, and fix it for product "X". That's CA. Now, let's say you have similar but different products "Y" and "Z" and you can imagine how it might be possible the same problem could happen to them someday, so you take the same actions on product line "Y" and "Z" as you did for "X". That's PA for lines "Y" and "Z", IMO. Make sense?
 
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