Preventive and Corrective Procedures - Separate Procedures? Special Procedures?

[sneekparty]

Hello Everybody,

I wondered if anyone knows if you need to make a documented procedure for preventive and corrective actions or that describing it in the procedures for non-conformities and complaint handling is sufficient?

Hope any can help me, thanks again....
Martin van Zanten

[M Greenaway]

Sneek

These items do not have to be seperate documented procedures, you could roll them into one, but be sure that you have properly addressed the differences.

[sneekparty]

Thanks,

But I still am worried about one thing. You said that I could roll them in to one, but that's just the problem I have described them in different procedures. An example is that I described in the non-conformities procedure that there have to be made corrective and preventive (if necessary) actions if there is a non-conformity.

Also an auditor I know said that we should have seperate procedures concerning preventive and corrective actions and that we then could refer to them in our flowchart for non-conforming products and complaints handling.

What's your opinion?

Thanks again,
Martin van Zanten

[M Greenaway]

Well this is just an opinion, as it that of your auditor, however we currently have seperate documents.

The reason for this is that although all these processes have some interaction they do not all necessarily follow each other.

For example although an instance of non-conforming product may trigger a corrective action it also might not. If the root cause investigation identifies a special cause of the non-conformance corrective action might be appropriate. If however the root cause is considered common cause then you might not take corrective action on that instant, but put the data forward into your overall analysis process from which systemic corrective actions might be initiated.

Preventive action should perhaps almost definately be a seperate document as it is by nature not triggered by instances of non-conformance, but is a more analytical approach to never doing things wrong in the first place.

[Russ]

We also use seperate procedures for corrective & preventive action. I find it's better that way. Though the processes are similiar, keeping them seperate helps draw the line between corrective action and what can be preventive action. It took a long time to get it through everyones heads that if it's happened you can't use preventive action for things in the future, or similiar products. That's corrective action impact. Preventive action is tough but can be done after the mindset is established.

[sneekparty]

Thanks everybody for the quick response,

I think it's quite clear for me know. The best solution is that I make a preventive action procedure and describe the CA's in the different procedures were it is concerned.

Just one question: Does anyone have an example for me? If you don't want to post it on this thread just email me at info@sneekparty.com

Thanks again guys...I hope I can be of some help in the near future for you...

Martin van Zanten

P.S. Jim: Your Dutch is pretty good en Dank je wel...

[gpainter]

Party, depending on the knowledge of your program you may want to have seperate procedures for CA and PA. This may help to distinguish between the two.

[anil2187]

The triggering point to initiate Corrective action could therefore includeReactive elements)
Customer complaints
Non conformity reports
Internal Audit reports
other relevant analysis of Data(8.4)
Can we say that these inputs can never trigger a preventive action and therefore triggering points for
preventive actions should be entirely different such as : (Pro-active elements)
outputs from design review
Review of customer needs and expectations
lessons learned from past
Proa-actively fixed Quality objectives with smart targets
Management Reviews
Customer perception survey results
FMEA analysis
This means the procedure for 8.5.2 Corrective action and that for Preventive action 8.5.3
have to be entirely different in its approach.

As per clause 8.5.2 Organisation shall take action to eliminate the cause of nonconformities in order to prevent recurrence.

Can we not say in a generic sense that the cause of any non conformity be due to any one of the following case:

Ambiguity in System
Lack of system
Lack of effective processes
Weakness in the interaction of Processes
Lack of Training
Lack of Motivation
Sheer indiscipline
In such cases taking action to eliminate causes indicated above(generic in nature) as a corrective action is the
expectation of the standard as per 8.5.2.


Anilkumar.s