Complaint VS CAPA report

agrpyl

Starting to get Involved
If my complaint report has provision for root cause investigation, immediate action taken, risk analysis, reporting to authority, is a trend observed and product & process change (if any), why do I really need to initiate a CAPA report for the trend of complaints? what extra information/ analysis do I get by initiating a CAPA?
 

shimonv

Trusted Information Resource
If indeed your complaint form includes all the elements of complaint handling plus CAPA, then you don't need to open a CAPA. Your SOPs should reflect that.

However, it's not a good practice because the complaint process becomes cumbersome and the distinction between compliance and CAPA not so clear.
 

Bev D

Heretical Statistician
Leader
Super Moderator
Can you clarify what you are being told that CAPA and “trend analysis” mean?
Trend analysis implies graphing the number of complaints in a time series run chart. This is trending.
Analysis means using some statistical approach such as control charts to analyze if the number of complaints are increasing, decreasign remaining stable, etc. It also means breaking down the number of complaints by type of complaint (usually defect type) to prioritize improvement projects.
A typical trend approach is to trend the overall complaints (control chart), breakdown by defect type (Pareto), then trending each defect type or at least the top ones…
Trend analysis is not about words, sentences and paragraphs…
 

yodon

Leader
Super Moderator
A single complaint probably doesn't warrant a CAPA. If your trending shows there's a systemic issue, then that may warrant opening a CAPA. If you do open a CAPA, it's good to have linkage between the relevant complaints and the CAPA.
 

Tidge

Trusted Information Resource
The medical device company I work for treats Complaints and CA/PA as separate systems, with different purposes. Complaints can feed the CAPA System.
If my complaint report has provision for root cause investigation, immediate action taken, risk analysis, reporting to authority, is a trend observed and product & process change (if any), why do I really need to initiate a CAPA report for the trend of complaints? what extra information/ analysis do I get by initiating a CAPA?

In medical device industry, it is necessary to show the effectiveness of a Corrective Action. Is this what you mean by a "CAPA Report"?
 

LUFAN

Quite Involved in Discussions
The medical device company I work for treats Complaints and CA/PA as separate systems, with different purposes. Complaints can feed the CAPA System.

I've never worked for a company that considered them the same system. Is that a thing?
 
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