Seeking 'True' Preventive Action Examples

[Ken K]

Thanks Lucinda

Just thought I'd throw the testing out for an opinion.

You mentioned the little things. Things you'd just normally do in the course of a day. Things you never documented.

I'm working on trying to document a preventive action procedure for ISO17025. Sort of like you know what you do but you can't put it into words where it would make any sense.

Thanks for your reply.

 

[M Greenaway]

Ken

Dont think the testing undertaken by a test lab could be PA.

When talking of a test lab, and considering ISO/IEC17025 one must consider the product of the test lab to be accurate test data/reports. As such any PA must be targeted at achieving accurate test data.

The testing itself may be a PA for the general company, but not the lab.

PA in this instance should be things like ensuring the test method is valid, environmental conditions are properly controlled, suitable equipment is employed, uncertainty of measurement is known, etc, etc. In fact all the things that ISO/IEC17025 tells you to do !

 

[gpainter]

Alf and Russ, Ihate to throw in another term, but here goes. Corrective Action Impact - Learning from our mistakes. The mold would fall under this.

 

[Ken K]

Just one more...

If a PA is to prevent a problem that hasn't happened yet (or any of the before mentioned definitions) how do you document the fix you put in place actually worked?

Maybe the problem you defined would never have happened anyways?

Just curious as to how you would handle this.

 

[Russ Kochis]

Ken,
Why and when are you testing materials? If it is for verifying conformance then, as Lucinda stated, it is not a preventive action. If you are testing materials in the design and development phase of a project to determine the window of acceptance for the product it would be a preventive action. Its not the type of activity or action that determines if it is preventive, it is the purpose, and perhap timing, of the action. Many actions that are taken in the design phase are preventive while the same action in the production phase would be corrective.
Russ

 

[Ken K]

Russ, we do annual material certifications on all products we produce and we also do quite a bit of development work for new materials.
The reason I asked the questions is because I am trying to write a Quality Manual for ISO17025. This is what the guidance manual I'm using states for 4.11 - Preventive Action:

Preventive action is a pro-active process to identify improvement opportunities, rather than react to the identification of existing problems or complaints. The policies and procedures should reduce the likelihood that a non-comformance will occur. Apart from the review of the operational procedures, the preventive action might involve analysis of data, including trend and risk analyses and proficiency testing results. Once a need to improve has been identified, an action plan should be developed, which includes tasks, assigned responsibility and timing.

Once the plan is implemented, it should be monitored to verify that the needed improvements have been realized and effective. There should be some evidence that a follow-up of the effectiveness of the preventive action has been performed. Several methods exist for doing a follow-up. One method is a formal process by which each preventive action is reviewed and the effectiveness is evaluated. The effectiveness of the actions should be evaluated within a reasonable amount of time to assure that the activity has not slipped into nonconforming activities. If it is discovered that the corrective actions are not effective, the laboratory should have a process for ensuring that further investigation is performed to determine why the actions were not effective.


Whew! OK - have you read this over...do you understand why I'm confused. How do you write a policy and procedure to cover this?

 

[Chris May]

Ken,

This sounds like the Design of Experiments approach to me...but I could be wrong.

FMEA maybe??

Also, if you find a problem and fix this, then that is corrective action, but when you have fixed it so it doen't recurr, it can also be preventive action.

In an SPC environment, one of the data required is the number of Defect Opportunities.
Analyse what could possibly go wrong and prevent it. (Risk Analysis ??).

Regards,

Chris

 

[rak]

Per me -

Corrective action is - to prevent recurrence
Preventive action is - to prevent occurence

Some sources of preventive actions are :

1. Employee suggestions
2. Internal Audits
3. FMEAs

 

[Tom W]

I agree with the earlier post - throw out the term "Corrective Action Impact" and you get into a bigger discussion. QS (the big three) in their wisdom brought this corrective action impact into the picture and now the picture is even more cloudy. What we use to call preventive now could fall under corrective action impact. It is harder and harder to find a true preventive action without tying it back to some type of corrective action. It has to be addressed in a practicle method that allows for the understanding of what your organization accepts as CA, PA, and CAI. Then through in mistake proofing and continuous improvement, which really all of the projects should be CI or you are wasting your time. For all of the audits I have been on, this is one of the biggest discussion during the audit.

We have developed an "Actions Matrix" in where we list at a minimum one of each of the types of actions - corrective, preventive, corrective action impact, continuous improvement, and mistake proofing. We try to draw a line between them so as to clearly and confidently call them what we feel is the best catagory. Our facilities have gained an understanding as to our definitions of these actions and it has been effective during our quality team meetings and audits. We require at least one type of action for each catagory to be open and being worked on. This helps us with continuous improvement and problem solving.

Just my thoughts.