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New CAPA Work Flow with Revised 8D Approach

Mike S.

An Early 'Cover'
Trusted
#11
I hope this post is not too far off the path. I think I recall long threads here discussing what is the difference between corrective action (CA) and preventive action (PA). IIRC as much heat as light was generated.

One thing I think needs to be clarified is that correction is not the same as corrective action. Correction does not "remove a root cause"as stated above, corrective action does. Correction is, for example, rework - eliminating the defect created. If you order coffee black and the waiter gives you tea, correction is the waiter taking away the tea and giving you black coffee.

Now, with respect to Bill's example above about the machine guard, consider this: Some people may say that the CA is the installation of the guard on the machine that caused the injury - let's say it was a bandsaw. Add a guard to the bandsaw and call it CA. Great.

But let's say guards were added to all saws in the company, bandsaws, chop saws, and radial arm saws. Still corrective action?

Let's say someone said, "Hey, let's look at every machine in the company and see if there are other areas where a guard might help" and guards were subsequently added to drill presses and bench grinders as well. Still CA, or is that PA? That's where I think it can get gray between CA and PA.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#12
Confusion regarding CA and PA occurs in my not so humble opinion but in my experience when people refuse to think deeply about things and become defensive about their opinions and beliefs which are not knowledge. They use word definitions as their shield from thought or action (they are contract lawyering...)

In the end what matters is not what words you use but what actions you take and that is the real rub: too often people will make corrections (= rework, repair, scrap) but will not take the actions against a causal mechanism that will stop that cause from creating the problem again. But they call it corrective action. And too often people will also refuse to take true Preventive action because the problem 'can't' occur if only the operators or the Customers would pay attention or they believe - often mistakenly - that the cost of the prevention is not worth the defects that 'may' occur.
 
#13
I think Bev's "In the end what matters is not what words you use but what actions you take..." answers Mike's question. It doesn't matter what we call it (correction or prevention) as long as it suppresses, mitigates, or disables the problem's root cause as opposed to telling people to "be careful," ("...the problem 'can't' occur if only the operators or the Customers would pay attention..."). Shigeo Shingo case studies often begin with the premise that defects were avoided through "worker vigilance" which tells us immediately that defects were being produced right and left. AIAG's and VDA's new FMEA manual makes it clear that behavioral or administrative controls are inferior to engineering controls (or machine-based controls per the manual) that make the problem impossible.

The question as to whether read across/replicate process is correction or prevention when the initial CAPA was correction is interesting. The action taken on the first machine is definitely correction but similar actions taken to make other machines safe before they have caused injuries could perhaps be construed as either, but it doesn't really matter as long as it gets done.

CQI-20 also says to investigate the systemic root cause, or why the problem was not prevented in advance. In this case, we would ask why the machines had not been previously assessed for safety.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#14
As for the ERP system comments: we also have to have QA and/or SQEs 'flip the switch' in our systems to stop shipment, quarantine material, return to supplier or allocate by lot and Customer or make a Customer notification (recall, restriction of use etc.) for initial and more thoughtful containment actions. Since we have global manufacturing and warehouse/distribution locations the ERP system makes it much faster and much less prone to error than if we didn't have it. we don't consider this part of 'forming a team'. these are individuals who's job it is to do these things and there are standing teams that responds immediately when a problem is detected to quantify the situation and decide on the necessary actions. they are empowered and held accountable to do this...
 

Jim Wynne

Staff member
Admin
#15
One of the things we spend too much time on is arguing about whether a carnivorous reptile is a crocodile or an alligator while we're being eaten by it. Also, what's been missed here is the most important part of any corrective action effort, and I can't emphasize it strongly enough. The first action to be taken is to do whatever it takes to get the customer out of trouble, and to do it rapidly.
 
#16
"The first action to be taken is to do whatever it takes to get the customer out of trouble, and to do it rapidly" is containment, and I can see how the process flow for CAPA might confuse people (as it is about the 4th step). The truth is that containment can and should take place as quickly as possible, as required by ISO 9001 and IATF 16949 clauses on segregation of nonconforming output. This segregation could, in fact, be what initiates CAPA in the first place.

Figure 6 of AIAG's CQI-20, in fact, says "contain symptoms begins as soon as practical to mitigate relative Risk" and can coincide with awareness of the problem.
 

Mike S.

An Early 'Cover'
Trusted
#17
Yes of course, substance over style, quickly start to help the customer and all that.

But at the same time, we as quality professionals, like any professionals, should be able to agree on some basic definitions where little or no gray area exists. Especially considering newbies reading this stuff might get very confused if we don't. And customers/auditors reviewing our CA responses have a right to expect to understand what we're saying.

To say correction removes a root cause is just plain wrong. I would question an electrician who told me he was going to install 10 amp wire to the new outlet for the microwave oven in my house. If he simply misspoke and says "Sorry, I meant 10 gauge wire" I can handle that. If he insists he is gonna install 10 amp wire, I'm gonna find another electrician.
 

greenlantern

Starting to get Involved
#18
What is important is that the action taken suppresses, disables, or removes the root cause, and this needs to be ensured because inadequate CAPA is responsible for the greatest portion of ISO 9001 and IATF 16949 audit findings. In addition, the lessons learned must be deployed to related processes (read across/replicate process or, as stated by Henry Ford, "the benefit of our experience cannot be thrown away.") In the example cited above, we would then look for other machines with exposed moving parts to ensure that guards are installed for them as well.
Hi Bill,

Good point on stakeholder initiated CAPA. Thanks for your suggestions.

So in terms of preventive action, is there a separate workflow for recording that? For instance, when there was a near miss at my previous job we would open a CAPA and follow the same general steps.
 
#19
Yes of course, substance over style, quickly start to help the customer and all that.

But at the same time, we as quality professionals, like any professionals, should be able to agree on some basic definitions where little or no gray area exists. Especially considering newbies reading this stuff might get very confused if we don't. And customers/auditors reviewing our CA responses have a right to expect to understand what we're saying.

To say correction removes a root cause is just plain wrong. I would question an electrician who told me he was going to install 10 amp wire to the new outlet for the microwave oven in my house. If he simply misspoke and says "Sorry, I meant 10 gauge wire" I can handle that. If he insists he is gonna install 10 amp wire, I'm gonna find another electrician.
Correction can remove, mitigate, or disable a root cause. Suppose for example that workers sometimes forget to install a screw in a product (as described in a Shigeo Shingo case study). The correct root cause is probably "it is possible to forget" as opposed to "the workers are careless" because "worker vigilance" is rarely if ever an adequate control. If you install an error-proofing or detection control that makes it impossible for the product to leave the workstation, and/or generates a visual or audible alarm if the screw is not placed, you have pretty much removed or disabled the root cause so the problem will not recur.

Another example is inserting a feeding tube into an intravenous line, which will kill the patient. Nestle developed the SpikeRight enteric feeding system which is physically impossible to connect to an IV line. This removes the root cause ("the enteric feeding system is compatible with the IV line") and makes the mistake impossible.
 
#20
Hi Bill,

Good point on stakeholder initiated CAPA. Thanks for your suggestions.

So in terms of preventive action, is there a separate workflow for recording that? For instance, when there was a near miss at my previous job we would open a CAPA and follow the same general steps.
The process for corrective and preventive action is the same process except, in the case of preventive action, no quality problem has occurred so the containment step can be omitted. That is what is so great about 8D and Effective Problem Solving (CQI-20); they will work on almost any imaginable problem and can even be extended to all forms of waste (by treating the waste as an undesirable situation with one or more root causes).
 
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