Complaint Evaluation vs. Complaint Investigation vs. CAPA Investigation

[Aphel]

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

 

[Richard Regalado]

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.

 

[Aphel]

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

 

[Ronen E]

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:

(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.

 

[Ajit Basrur]

Ronen is spot on as always

Aphel, also refer this presentation for your clarification - http://fmdic.org/wp-content/uploads/2012/05/Lewandowski-CAPA.pdf
.

 

[Aphel]

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

 

[Aphel]

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

 

[Ronen E]

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.

 

[isoalchemist]

If a complaint is deemed valid (yes it is our Product)
It needs to be investigated
If the complaint investigation determines you have a systemic problem rather than an oops or if you have a trend of oops
You have a CAPA

IMHO they build upon each other. In some cases a complaint may drive a CAPA directly, but those usually rare in my experience.

 

[Ajit Basrur]

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

Some highlights from Preamble -

QS Preamble, Comment 190

Section 820.198(b) discusses the initial review and evaluation of the complaints in order to determine if the complaints are ?valid.? ?this evaluation is not the same as a complaint investigation. The evaluation is performed to determine whether the information is truly a complaint or not and?whether the complaint needs to be investigated or not. If the evaluation decision is not to investigate, the justification must be recorded.