Formal written response to a corrective action?

[Sigsbee502]

Does anyone know of any training for how to write/respond to a corrective action?

 

[ScottK]

Hi Sigsbee502 - welcome to the cove.

There are many ways to answer a corrective action request some of the most common steps are:

Problem Statement
Verification of the problem
Containment (do you have affect product that you need to quarantine or recall?)
Correction (can you repair or replace the product?)
Root Cause Analysis (why did this happen?)
Actions to Prevent this problem from happening again
Evidence that actions were taken
Verification that the actions were effective.

(The assumption here is that the request is from a customer due to a defective product.)

depending on your industry and customers is could be a very formal process or fairly informal email. There is a lot of ways to do this.

 

[John Broomfield]

Does anyone know of any training for how to write/respond to a corrective action?

Sigsbee,

Not sure where you are but you could try searching for 8D problem solving training where you can learn how to determine and remove the root causes of nonconformity from the system or systems responsible.

Some training organizations also provide opportunities for online learning.

Once you’ve completed this training you should be able to:

D1: Form a Cross Functional Team
D2: Define the Problem (nonconformity)
D3: Contain the Problem (limit its impact)
D4: Determine the Root Causes
D5: Determine the Corrective Actions (to remove root causes)
D6: Implement and Verify the Corrective Actions (and remove containment)
D7: Reassess Risks and the Risk Treatments (and complete that form)
D8: Congratulate and Thank the Team

You may use this rough description of the 8 disciplines to select your course.

Let us know how you do.

John

PS: I now see that Scott has answered your question

 

[Sigsbee502]

All,

Thank! I know all of the tools for the corrective action process. What I am looking for is some for of training for my Quality personnel in how to actually write a good corrective action report. Presently, I have been reviewing an rejecting most of the CA responses. All are poorly written with insufficient data.

Thanks.

 

[John Broomfield]

All,

Thank! I know all of the tools for the corrective action process. What I am looking for is some for of training for my Quality personnel in how to actually write a good corrective action report. Presently, I have been reviewing an rejecting most of the CA responses. All are poorly written with insufficient data.

Thanks.

Sigsbee,

To initiate the corrective process you could teach your team the three parts of a nonconformity statement:

A. The applicable requirement;
B. Evidence of not meeting the requirement; and
C. Description of the nonconformity (its nature).

Emphasize how the system failed the human, not the other way around.

John

 

[Al Rosen]

This presentation has some information that you may find useful for your training. It has an example and explains what's wrong with it.

 

[Jim Wynne]

All,

Thank! I know all of the tools for the corrective action process. What I am looking for is some for of training for my Quality personnel in how to actually write a good corrective action report. Presently, I have been reviewing an rejecting most of the CA responses. All are poorly written with insufficient data.

Thanks.

If the people responsible for writing the reports lack the required writing skills, there might not be much that you can do about it. Basic English (or whatever the language is) composition skills should be a prerequisite for such a job.

What you can do is identify some person who does have the necessary skills and have him/her do the actual writing, with the other people supplying the details. Most people can be trained in fact-gathering.

 

[Ninja]

... Presently, I have been reviewing an rejecting most of the CA responses. All are poorly written with insufficient data.

Howdy,

Consider HOW you are rejecting the CA responses.
- Are you sitting down with the person and explaining what is missing or insufficient?
- Are you talking through what each piece should have said?
- Are you encouraging them to supply the missing data, and giving examples of the types of data required and how to present it?
- Or are you stamping it "Rejected" and putting it in their mailbox?

I was taught how to "properly" respond to a CA by the person reviewing my first attempt (which was rejected). It took about 30 minutes where we filled it out together. That's where the real teaching happens. I honestly had no idea what they were looking for.

As a process owner, some QMS dude asked me for evidence of containment and I pointed to a pile of stuff in a trash can...I didn't know what they wanted until they explained it.

The second time, it was also rejected and took 5min of explanation.
Never had another one rejected after that...I had been taught well.

The first one handed to me for review (4 years later), I rejected...then sat with the person and taught them...

You want them to write it the way you want it...they need you to teach them how. The training course you are looking for is run by you...
HTH

 

[Golfman25]

"As a process owner, some QMS dude asked me for evidence of containment and I pointed to a pile of stuff in a trash can...I didn't know what they wanted until they explained it."

That's awesome.

 

[Sidney Vianna]

All,

Thank! I know all of the tools for the corrective action process. What I am looking for is some for of training for my Quality personnel in how to actually write a good corrective action report. Presently, I have been reviewing an rejecting most of the CA responses. All are poorly written with insufficient data.

Thanks.

the root cause analysis component of a corrective action is the key ingredient. One shall not prescribe a fix until they understand what the problem is. In my experience, the weakest link to devise and write good corrective action is the investigative skills necessary to understand the underlying cause(s) for the problem. There are much material available online for RCCA.