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So When Exactly Should I Use a Corrective Action?

Definitely for customer complaints and issues that affect your product’s quality

Miriam Boudreaux
Wed, 09/26/2012 - 09:18
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Body

No matter how much effort we put into meeting a quality standard’s requirements for continual improvement, there are times when we are not sure whether to call for a corrective action. Although there is no instrument that points to yes or no and determines when a corrective action is needed, I have a few simple rules to make your decision easier and a bit clearer.

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When to generate corrective actions

Corrective actions are best suited for systemic issues or issues that affect the quality of your products or services. One-time issues usually aren’t suitable for corrective action unless they are customer complaints or they significantly affect the quality of your products or services.

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Comments

Submitted by kaiser87 on Tue, 10/02/2012 - 15:06

Corrective Actions

Hi Miriam,

 

I reviewed yur article on " when exactly should I use CAs?  Well, your article was prepared only for clients who are in the service industries. Do you have some good practical case studies or examples for using Corrective Actons in the Aircraft and Aerospace industries? Please reply back. My email address is: kaiser876@gmail.com

 

Thank you

 

Regards

Kaiser Saifudin

  • Reply

Submitted by Miriam Boudreaux on Thu, 11/08/2012 - 19:01

In reply to Corrective Actions by kaiser87

Corrective Action Sample for Aircraft and Aerospace

Hello Kaiser, Thanks for your readership! I was trying to show examples that could work accross various industries actually. But here are some quick examples that come to mind:

  1. One part that was received into the supplies room was not tagged with a white tag-->This one may be a CIP (our Web QMS version of Corrective Action) due to FAA regulations. But if you don't open a corrective action on the first incident, you should for sure after two incidents, again due to FAA regulations all parts must be tagged.
  2. One part that was received into the supplies room was tagged as required but some information was missing -->Again, maybe one issue should be recorded due to FAA otherwise if 2 or more, I would definitely make it a Corrective Action.
  3. A tool was found without a calibration sticker but the tool is found in the system to be in calibration: No corrective action.
  4. Several tools are found without stickers or stickers are torn: Yes Corrective action because this is definitely a trend and suspect also.
  5. A tool was found with the "calibration void if seal broken" sticker torn: Yes corrective action, because at this moment, this instrument is suspect for being out of tolerance. In this case I would also make sure that containment efforts are put in place due to the fact that product may have been inspected with the suspect tool.

Hope this helps.

Miriam

  • Reply

Submitted by umberto mario tunesi on Wed, 10/03/2012 - 02:44

Corrective action

To me, even a single lapse is a System's failure, therefore, corrective action is neither meat nor fish. I believe that the corrective PROCESS must start with Containment, but it has then to grow to Preventive Action, or, even more effective, Predictive Action.

  • Reply

Submitted by Miriam Boudreaux on Wed, 10/03/2012 - 14:30

In reply to Corrective action by umberto mario tunesi

Corrective Action

Hmmm, you have to be careful to not overwhelm the system, perhaps you may thinking about NCR? in which case a product nonconformity has to be tracked each time for proper disposition and accountability. But if you have time and resources to conduct a thorough root cause analysis for every single issue, whether or not is systemic, then sure, open a corrective or preventive action.
  • Reply

Submitted by QuicoG on Fri, 10/05/2012 - 14:28

Corrective Action Initiation

Thanks for this article.

I could not agree more.

We are managers of resources and must use judgment. I think the examples used show good judgment. Regulations, risk and customer satisfaction and other factors drive the appropriate response. If we do not respond appropriately, either by inaction or over reaction, events will end up managing us rather than us managing them.

  • Reply

Submitted by Biopharm QA on Mon, 10/08/2012 - 10:49

RE: When to use a Corrective Action

Hi

I read your article with great interest, but in the end i wasn't sure how to interpret your point.  I was left wondering:

  • If I make no record the first time something happens, then how can I know if it is in fact the first time, or second, or 3rd, 4th time, etc. it had occurred ? Given our busy, over scheduled lives, Human Memory is nototriously unreliable especially when the events are separated by more than a couple days.
  • If I am to decide whether or not to use a corrective action for only 'systemic issues', How am I to know which are systemic without some level of analysis or research which is presumably part of the Corrective Action Process ?
  • If i wait until the issue has resulted in some higher cost (Customer Complaint, Product Impact) then isn't my 'Corrective Action' too late ?   Aren't we just recovering and hoping to perform some Preventive Action at that point ?

I was very glad to read the "Take Two" section of the article - it helped me understand your point.  Though I wonder if a desire to maintain brevity left a couple assumptions as implicit.

  • That "Corrective Action" as you are using it are not 'actions' per se but a defined process of diagnostic analysis and procedural follow-up requiring given set of steps and time investments
  • That notifying the persons/groups of the incident isn't an allowed outcome of a 'Corrective Action Process'

Based on this - I also wonder if your point really was "Be sure to design a corrective action process to accomodate the scale and importance of the entire range of incidents".  With that understanding, we would be guided to the idea that we could create a Corrective Action Process small and light engough to note minor incidents (such as in example #1,2,3) with trivial amounts of time/effort investment, then close them with the corrective action of 'Correcting the form' or 'Notifying the person/group responsible for the error'.  We would also then be in a position to truly know if Example #4 ("Incorrect Form Error for 3rd consectutive time") truly did occur and recognize it as possibly systemic.

Of course we all need the flexibility to exercise judgment in Corrective Action Processes as with all other aspect of management.  A big part of that is deliberately designing the processes we all follow to provide appropriate guideance and record keeping so we can identify more significant issues quickly and easily.

  • Reply

Submitted by Miriam Boudreaux on Thu, 11/08/2012 - 19:13

In reply to RE: When to use a Corrective Action by Biopharm QA

Corrective Action is a process

Hello, thanks for your insighful feedback. Of what you mention, one thing strike me as overly important: the fact that Corrective action is indeed an entire process. This process does not end when a form has been filled out or even when actions have been put in place. Corrective Action goes all the way to verification and validation; the first being the mere checking of whether actions were indeed taken as proposed, the latter being whether the problem reoccur again or not. You should perhaps consider the impacts too:

  • What are the risk
  • What are the consequences

The ISO standard does say that after creating a corrective action (request) you can evaluate whether actions are necessary.

About your point of how do we know is the first time, or second time...well yes you got a point. You will think Process Owners will be in charge but that may not always be the case.

thanks

Miriam

  • Reply

Submitted by Anonymous (not verified) on Fri, 08/18/2023 - 07:32

In reply to RE: When to use a Corrective Action by Biopharm QA

CARs and NCRs

Hi,

I thought I'd give my two cents on answering your point a little better.  I had the same question about when is a corrective action needed.  With regards to your concern on logging occurrences, you document them in a nonconformance log.  Not every nonconformance will have a corrective action to follow though.

A corrective action can be taken depending on several factors.  It is more of a judgment call depending on negative company impact.  Here is an idea of when you should consider CA:

1) Problem resulting in high dollar amounts of rework/repair (user-defined base value)

2) A repeating trend of NCR

3) An audit finding in the quality process

4) A customer complaint

These aren't the only cases, but hopefully you get the idea.  If a solution to an NCR isn't too complicated, you might fix it and never hear of it again.  Conclusively, use your best judgment in weighing the severity of the problem when issuing corrective actions.

I hope this helps a little.

  • Reply

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