Preventive Action (PA) and Corrective Action (CA) - One or Two Procedures?

[asutherland]

Re: Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?

I am not a quality guru. I devote most of my time with lean.

I seem to sense that we're missing the point when addressing CA and PA.

Systematically, we have leak cause, system cause, process cause. Depending on the cause, shouldn't we be looking at this first before deciding if we need to implement a CA or a PA.

Of course if a defect has been discovered . . . its too late, the defect already leaked out. From my perspective, this must first address CA.
Then depending on whether it is a system cause or process cause, we must then address a PA.

All other actions on defects that have not happened would be classified as PA.

Getting back to the origional question, 1 or 2 procedures . . . Since the process is simular, ie. . . (problem solving). . are we not using one procedure to address defects in two different forms? Leak cause (CA), System / process cause (PA)?

Well . . . thats my two cents for what ever its worth.

 

[Andrey]

Eliminate misunderstanding

First, it shall be pointed out clearly: both actions are preventive in nature, but CA prevents REcurrence of the problem, PA prevents OCcurrence.
Second: correction is essential part of CA, but it shall not be limited to it.
Third: if you try to invent relevant "processes", you go to nothing. The problem is that both CA and PA shall be carried out on various levels. On top management level it is a part of management review , which is part of the strategic planning process. On operation level, it is essential part of each business process - when we monitor and /or measure process output, we can arrive to necessity for PA or CA, if the output don't conform to the established requirements and/or other process criteria. So in fact the procedures for CA and PA may be described in QM as an approach, and in details - in some particular cases, connected with some specific process. Separate paper procedures and CAR sheets never works - at least in CIS countries practice. What is working - when each process manager has a special log for recording some operational information, and each person (operator, technologist, foreman, quality inspector, etc - may write his/her observations, which are then discussed at regular meetings - and if required - necessary CA or PA are recorded in the same log in special column, together with terms of implementation and person(s) responcible. Follow up and effectiveness verification may be recorded at the same log by relevant personnel. If you use SPC - it's obvious that CA and PA are essential part of each operational process. If some actions are required on the level of top management and enterprize as whole, that it is appropriate to review these issues at the management review meeting or by another suitable procedure (e-mail conference, etc) and take necessary decisions.
General guidance may be formulated as such:
Look attentively at your business flow and all necessary to support and control it, and the last thing to look at - ISO 9001 clauses and sequence of them. Don't treat each clause as separate "process" - it's just a requirement you have to follow, in the way, suitable for your business and activity.

 

[Manix]

Re: Eliminate misunderstanding

CA prevents REcurrence of the problem, PA prevents OCcurrence.

Urm? Correct me if I am wrong but isn't prevention of reoccurrence the same as preventing occurrence?

How can you prevent something you do not know could exist!?

I see it as this:

Corrective action is stopping the bleed. Correcting something that is wrong. What oyu do with something you have found to be wrong.

Preventative Action is stopping the cause of the bleed from occuring again. How will you prevent it from happening. This PA can then be carried over for future Cont Imp activities to ensure the occurence cannot OCCUR!!!!

 

[Jim Wynne]

Re: Eliminate misunderstanding

Urm? Correct me if I am wrong but isn't prevention of reoccurrence the same as preventing occurrence?

Your problem here is that you are applying logic and common sense, and that's not always allowed by the standard (although it is most of the time).

How can you prevent something you do not know could exist!?

You can't, at least not intentionally, but that's not the question. Although no one in my office has ever, to my knowledge, slipped and fallen because of oil being spread all over the floor, I know that if oil is spread all over the floor, someone is likely to slip and fall. I can prevent an accident from happening by refraining from spreading oil, even though the accident in question has never happened. We know that some conditions A and B in combination have been known to result in phenomenon C, or that there are properties of the combination that might allow C occur.

 

[Manix]

Re: Eliminate misunderstanding

I know that if oil is spread all over the floor, someone is likely to slip and fall. I can prevent an accident from happening by refraining from spreading oil, even though the accident in question has never happened

But just to be a bit anal, if you had never known oil spread all over the floor was a hazard (I.e. no one on earth has ever had this unlikely accident) then you would not know that spreading the oil would indeed be a hazard! Going back to my original thoughts, that you can carry over common sense and TGW from not only your's or your companies experience but those of others!

Going back to the original reason this thread was started. We have 1 document that deals with implementing CA and then looking at PA.

 

[Sidney Vianna]

Re: Eliminate misunderstanding

I see it as this:

Corrective action is stopping the bleed. Correcting something that is wrong. What oyu do with something you have found to be wrong.

Preventative Action is stopping the cause of the bleed from occuring again. How will you prevent it from happening. This PA can then be carried over for future Cont Imp activities to ensure the occurence cannot OCCUR!!!!

The way you see it is not in line with the ISO 9000:2005 definitions of correction, corrective action and preventive action. Since ISO 9000 is a normative reference for ISO 9001, one should follow the definitions of ISO 9000, before claiming compliance with ISO 9001.

 

[chaosweary]

Re: Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?

Yea, a lot of folks get stuck on the actions to eliminate "potential" nonconformities....that could be anything right? Wrong! Do a PFMEA, P = "potential" not "process" in this case. Implement detection for the highest RPN, hope that it doesn't happen and if it doesn't, bingo bango, you have proved its effectiveness, life is good!

 

[Dave N]

Re: Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?

I changed ours to one procedure, but having two separate processes.
It made more sense, since in my opinion they are related but different processes.
It worked for us. Hope this helps.
Dave N

 

[HDIGuy]

Advisory Notice procedure

Thanks for pointing me to that thread, Al.

I figured that it is just a preference of the ISO consultant that we are using but always good to get other opinions.

I am working for a very small medical device contract manufacturer trying to get ISO 13485 certification. Our company name does not appear on any finished product - does the advisory notice process apply to us? Is it permissible to just state that advisory notices are the responsibility of the company whose name appears on the label? I am really struggling with this advisory notice procedure.

Does anyone have an advisory notice procedure that they'd be willing to share? I'm looking for one that does not address product recalls.

Does anyone have any ISO guidance docs that explain the intent of the advisory notice system a bit better?

I am having a tough time with this and would appreciate advice.

Thanks again,
Jeff

 

[Vu Nguyen]

Re: Corrective Action (CA) and Preventive Action (PA) - One or Two Procedures?

Dear Sir,

Per my idea, as ISO 9001:2000 requirements, it is no mention about 1 or 2 separate procedures, so 1 or 2 is belong to the user. With the meaning of corretive and preventive action, I did combined into one procedure and one form, with this I can write down what preventive actions for each problem if we have.

Vu Nguyen