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Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation
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Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation
Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation
Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation
Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation
Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation
Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation
Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation
Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation
Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation
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21 cfr part 820 - med. device mfger. qsr requirements, complaint handling process, corrective action systems
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  Post Number #1  
Old 18th April 2014, 05:39 PM
Aphel

 
 
Total Posts: 116
Please Help! Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation

Dear all,

Can you please help me clarifying the following questions by using an example...

What kind of actions and documentation have to be done in case of a complaints (21 CFR Part 820 ?198) during:


1. complaint evaluation? What does it mean exactly?

2. complaint investigation? What does it mean exactly?

3. CAPA investigation including root cause?
What is the difference to the complaint investigation (considering that not every complaint triggers CAPA...)


Thanks a lot for any advise!

Best regards,
Aphel

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  Post Number #2  
Old 18th April 2014, 11:08 PM
Richard Regalado's Avatar
Richard Regalado

 
 
Total Posts: 278
Re: Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation

Dear Aphel,

My responses are based on my understanding of ISO-based management systems in particular ISO 9001. There are others who are knowledgeable in 21 CFR Part 820 ?198.

1. Complaint evaluation - anyone and everyone can file complaints e.g. the soup is too cold, the music is too loud, the cutleries are too shabby, the coffee is not piping hot, the head waiter is too tall, etc. The organization needs to evaluate which complaints are valid and within their scope of control.

2. Complaint investigation - valid complaints are investigated. Theoretically, an organization must look for the root cause/s of the complaint.

3. CAPA investigation - From my understanding, CAPAs are established against the determined root cause. Unless at some point in your organization, you have a process where you investigate CAPAs to verify if they are (a) implemented, and (b) effective in addressing the valid complaints.

One can also do an investigation from the perspective of risk. Did we establish CA on the high-risk items first? From a financial perspective - do the CA cost less than the consequence of the complaint?

Hope you get more scholarly answers.

Good morning.

p.s. Gotta get coffee.
Thank You to Richard Regalado for your informative Post and/or Attachment!
  Post Number #3  
Old 19th April 2014, 02:13 PM
Aphel

 
 
Total Posts: 116
Re: Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation

Hello,

Thanks for the reply...

The thing that is confusing me a little bit is the investigation issue.

There is the requirement, that every complaint requests an investigation, as long as there did not start another investigation before...

From a practical point of view - what is documented as result of the investigation of a complait (required in ?820.198) ...and what is documented as result of the investigation as part of CAPA (required in ?820.100)?

Perhaps anyone can share an example?

Thanks a lot in advance for your support!

Best regards,
Aphel
  Post Number #4  
Old 19th April 2014, 06:48 PM
Ronen E

 
 
Total Posts: 3,736
Re: Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation

Quote:
In Reply to Parent Post by Aphel View Post

Hello,

Thanks for the reply...

The thing that is confusing me a little bit is the investigation issue.

There is the requirement, that every complaint requests an investigation, as long as there did not start another investigation before...

From a practical point of view - what is documented as result of the investigation of a complait (required in ?820.198) ...and what is documented as result of the investigation as part of CAPA (required in ?820.100)?

Perhaps anyone can share an example?

Thanks a lot in advance for your support!

Best regards,
Aphel
Hi,

Your understanding is incorrect.

21 CFR 820.198:

Quote:
(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.
(Emphasis added)

Not every complaint requires an investigation.

Evaluate = Collate all relevant known information, review it as a whole, and based on clear pre-set criteria decide whether the evaluation object is over the set threshold or not (in this case, requires an investigation or not).

Cheers,
Ronen.

Last edited by Ronen E; 23rd June 2017 at 07:51 PM. Reason: Typo
Thank You to Ronen E for your informative Post and/or Attachment!
  Post Number #5  
Old 19th April 2014, 07:25 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,201
Re: Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation

Ronen is spot on as always

Aphel, also refer this presentation for your clarification - http://fmdic.org/wp-content/uploads/...owski-CAPA.pdf
.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf Lewandowski-CAPA.pdf (170.1 KB, 253 views)
Thank You to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #6  
Old 26th April 2014, 05:47 AM
Aphel

 
 
Total Posts: 116
Question Re: Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation

Dear all,

Thanks a lot for your comments!
Thanks Ajit for the pdf file, I knew that already.

I try once more to find the point...

In your quality systems - do you make a difference between "complaint investigation" and "CAPA investigation"?

If yes - could you explain the these differences? Perhaps by using a simple example?

Have a nice weekend!

Kind regards,
Aphel
  Post Number #7  
Old 3rd June 2014, 04:10 PM
Aphel

 
 
Total Posts: 116
Question Re: Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation

Hi all,

Does anybody wants to make a comment to my last post on 26th April?


The topic was:

Investigation of received complaint vs. Investigation during CAPA

Where/How do you make differentiation?


BR
Aphel
  Post Number #8  
Old 3rd June 2014, 05:09 PM
Ronen E

 
 
Total Posts: 3,736
Re: Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation

Quote:
In Reply to Parent Post by Aphel View Post

Hi all,

Does anybody wants to make a comment to my last post on 26th April?


The topic was:

Investigation of received complaint vs. Investigation during CAPA

Where/How do you make differentiation?


BR
Aphel
It's pretty much like the difference between driving a bus with one passenger and driving it full. The difference is not so much in the practice, but in the context.

Not every complaint leads to a CAPA, or even to an investigation.

Cheers,
Ronen.
Thank You to Ronen E for your informative Post and/or Attachment!
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