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New CAPA Work Flow with Revised 8D Approach

greenlantern

Starting to get Involved
#21
"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.

I am going to revise the first step of the workflow based on all the feedback to have first pass containment as the first step.

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.
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...
That makes it much easier and from my last jobs I've seen that it speeds up the containment process greatly. My current job is at a start up so the ERP hasn't been configured to do that yet, It's all manual. On top of it, supply chain owns that process and will take a lot of convincing to share any of that responsibility unfortunately.
 

Mike S.

An Early 'Cover'
Trusted
#22
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.
We'll have to agree to disagree then. No one I know of (except you) defines correction in this way.

IMO, in your screw example, correction would be installing a screw that was not installed by mistake. Corrective action is installing the error-proofing or detection control so the problem does not recur.

ISO 9000:2015 defines correction and corrective action as follows:
3.12.3
correction
action to eliminate a detected nonconformity (.3...6..2)
Note 1 to entry: A correction can be made in advance of, in conjunction with or after a corrective action (3.12.2).
Note 2 to entry: A correction can be, for example, rework (ll2..B) or regrade (llZA).


3.12.2
corrective action
action to eliminate the cause of a nonconformity (3.6.9) and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action (3.12.1) is taken to
prevent occurrence.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#23
In the pure definition of the terms Mike S is right. Correction only corrects the created defect(s). It doesn't prevent (lower case p; a verb) or reduce future defects from occurring. Actions such as rework, repair, replacement are corrections. Action against an active causal mechanism is a corrective action. You are free of course to have your opinion and use your own definitions of words...:)
 

Jim Wynne

Staff member
Admin
#24
Nearly ten years ago, in this thread:
In this case, the noun form "correction" can't be extended to the logical adjective form "corrective," as we've made correction and corrective two separate ideas. There's an easy remedy for this. Get rid of the concept of "correction" and use "remedy" and "remedial." I would get rid of "corrective" action too, and use "preventive" in all cases where the cause of nonconformity has been neutralized or eliminated. This simple concept will never gain any traction though, because it makes sense.
Our TC176 friends long ago created all of this fear and loathing. There are instances and contexts where we must cleave to the nonsensical ISO 9001 definitions, but that doesn't mean we have to take them home with us and make them our own. In similar fashion, 8D is not a process. It's a method for reporting corrective action activities to interested parties. This is why I suggested to the OP that a linear flowchart is not a proper medium for describing use of an 8D report. Processes may be logically described with flowcharts, but report formats can't.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#25
You are free of course to have your opinion and use your own definitions of words...:)
Why, would we, as quality system professionals, allow this lack of rigor with concepts, definitions and meanings? Especially by people who want to teach quality systems? Imagine if medical doctors were given the same latitude and free to call organs, procedures, medications whatever they like.

Differently from Jim’s last post, I do think that definitions are critical and, for the lack of better ones, we should follow those coming from the ISO TC 176, as Mike mentioned above. Under the political correctness of “allowing” people to have and use their own definitions and meanings, we are doing a disservice to the quality profession, in my opinion.
 

Jim Wynne

Staff member
Admin
#26
Differently from Jim’s last post, I do think that definitions are critical and, for the lack of better ones, we should follow those coming from the ISO TC 176, as Mike mentioned above.
I didn't say that definitions aren't important (although I do think that standard denotations should suffice in most cases). I said that sometimes we're forced to use definitions that make no sense. There has never been a time when it was necessary to codify the idea that when I prevent something from happening, there are instances when I can't refer to it as preventive.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#27
There has never been a time when it was necessary to codify the idea that when I prevent something from happening, there are instances when I can't refer to it as preventive.
The problem is: PREVENTION OF RECURRENCE of a significant negative event is distinct from PREVENTION OF OCCURRENCE. Many organizations have cognitive challenges dealing with the prevention of something that has not happened yet.
 
#28
We'll have to agree to disagree then. No one I know of (except you) defines correction in this way.

IMO, in your screw example, correction would be installing a screw that was not installed by mistake. Corrective action is installing the error-proofing or detection control so the problem does not recur.

ISO 9000:2015 defines correction and corrective action as follows:
3.12.3
correction
action to eliminate a detected nonconformity (.3...6..2)
Note 1 to entry: A correction can be made in advance of, in conjunction with or after a corrective action (3.12.2).
Note 2 to entry: A correction can be, for example, rework (ll2..B) or regrade (llZA).


3.12.2
corrective action
action to eliminate the cause of a nonconformity (3.6.9) and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action (3.12.1) is taken to
prevent occurrence.

I am going by "action to eliminate the cause of a nonconformity (3.6.9) and to prevent recurrence." You are right, there is technically a difference between "correction" and "corrective action," so "correction" per 3.12.3 would be rework as opposed to removal of the root cause. I was thinking in terms of permanent corrective action for the problem.
 
#29
Nearly ten years ago, in this thread:

Our TC176 friends long ago created all of this fear and loathing. There are instances and contexts where we must cleave to the nonsensical ISO 9001 definitions, but that doesn't mean we have to take them home with us and make them our own. In similar fashion, 8D is not a process. It's a method for reporting corrective action activities to interested parties. This is why I suggested to the OP that a linear flowchart is not a proper medium for describing use of an 8D report. Processes may be logically described with flowcharts, but report formats can't.
My own inclination would be to call 8D (and the related CQI-20) processes because they have suppliers, inputs, a sequence of activities, outputs, and customers. It is in fact advantageous for IATF 16949 users to call them processes because this standard requires a process for problem solving. 8D and CQI-20 both generate reports (quality records) as you describe which then become part of organizational knowledge. The report (quality record) is another matter entirely and I agree that a flowchart is not the right tool for describing it. Quality records or forms are not processes, but instead reflect the output of processes.

Eight disciplines problem solving - Wikipedia definitely refers to it as a process. "Ford developed a revised version of the 8D process that they call "Global 8D" (G8D), which is the current global standard for Ford and many other companies in the automotive supply chain. "

AIAG calls CQI-20 a process. The New CQI-20:Effective Problem Solving Guide is Here! "The CQI-20: Effective Problem Solving Guide supports organizational efforts to develop and implement a robust problem solving process..." and adds, "Each section includes Inputs-Process-Outputs, Step Overview."
 

Jim Wynne

Staff member
Admin
#30
The problem is: PREVENTION OF RECURRENCE of a significant negative event is distinct from PREVENTION OF OCCURRENCE. Many organizations have cognitive challenges dealing with the prevention of something that has not happened yet.
And yet PREVENTION OF OCCURRENCE and PREVENTION OF RECURRENCE are both PREVENTION.
 
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