Complaint, NC and CAPA handling - Manual process in a small IVD company

dolly

Registered
Hi everyone,

I have been trying to see if there is already any discussion thread in how to handle NC, CAPA and complaints without a eQMS, but I could not find anything. so please excuse me if this is something that is already in another thread.

I have started recently in a small IVD company (Class A devices), where the company is also transitioning to ISO 13485, but we have been struggling with the whole process because we still do everything in excel files and local directories.
Having this, I found some issues like having excel lists to track NC, CAPA and complaints, where is not clear who did changes and when that happen ( has the team doesn't save the file with a new version and there is no history track in the document.
does anyone certified under ISO 13485 still use excel files to handle NC, CAPA and complaints? if yes, how do you handle this?

I am fine to use the excel files, but I don't agree with the files being updated by several people without a proper track of changes. Is it acceptable if only 1 person update this lists, and there is a regular meeting to discuss the open topics and next steps and this is recorded either in a Action plan log, meeting minutes or in the NC, CAPA, complaint list?

If there is a meeting, should the meeting minute be signed? or is enough to send the meeting minutes in the end of the meeting, and keep it as recorded?

Thank you for the help and hopefully is not a confusing text :)
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
I was not dealing with ISO 13485, but one facilty I dealt with tracked their corrective action management on a simple Excel spreadsheet. Now, it was maintained by ONE person (in response to inputs from owners of actions) so there were some controls on it in that manner. They also archived it frequently as I remember. They sent the file to me monthly to do analysis and trending on their performance.

It is possiblle to put controls on an Excel spreadsheet, such as passwords to edit the file, and you could build a comparison generator from an archived version of the spreadsheet to see what cells changed. You could also add fields for people to record why they made their changes. I believe you can also set up windows to track who made changes to the file.

I googled "tracking changes to an Excel file" and got (among many links) this: Beginners' Guide to Track Changes in Excel [Step-by-Step] - QuickExcel I do not know if these would meet the requirements you are working to. It does sound like you may need at least some "administrative controls" put in place on your current process.

As an alternate example, SQL allows for tracking who changed an entry and when, and provide audit reports. And there are plenty of commercial products out there for corrective action management.
 
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dolly

Registered
Hi Steve,

Thank you for your reply, I was not aware we could also track changes in excel, I thought it was only in word :)

All of what you described could be quite easy to keep for ISO 9001, the problem for ISO 13485 will be the validation of all controls implemented in the spreadsheet.

I am still trying to convince administration to get an eQMS, so all of this will be easier to handle

But you gave me some ideas, thank you :)
 

chris1price

Trusted Information Resource
If an eQMS is not available, Excel can be used. However you run into the issues you raised over traceability, tracking of changes and the need to validate the system. There is a lot to be said for staying with paper based systems, or entering the information into forms created in excel then printing them for approval and signature.

It may be old-fashioned, but a surprisingly number of large companies in device a pharma still use paper records.
 

dolly

Registered
Hi chris1price,
I thought that medical device companies were a little bit more advanced, and not using paper records, but unfortunately this is still happening.
And to add to this, I am the only person in the quality department.

There is nothing in the standard requiring the complaint records to be signed/approved. So I can continue to use my excel complaint log to list the complaints we receive and have their actual status. Regular meeting are held, but how to record this meetings and decisions without overloading me on additional document is what I am looking for. We always have the tendency to create so many documents to answer the standard and satisfy all different auditors, and we end up overloading us with a lot of documents
 

yodon

Leader
Super Moderator
medical device companies were a little bit more advanced, and not using paper records
Still a lot of Part 11 fear.

Given the amount of information that goes with an individual complaint, I'm not sure if a single spreadsheet would work well. Generally, what I see, is that the spreadsheet is mostly just a log but all the content is managed through individual (Word) records. That alleviates the change tracking on the spreadsheet.

If the complaint drives an AE report or CAPA, I recommend providing some way to link those things with the complaint - and the Excel spreadsheet (log) could certainly do that.
 

FRA 2 FDA

Involved In Discussions
We are compliant with 13485 (so I cannot claim that our system has satisfied an audit yet) but it has worked pretty well for us so far... for CAPAs, Change Notes (Engineering Changes), complaints and NCRs, I act as the process owner/controller. We are also small and paper based. As @yodon mentioned above, we simply use the spreadsheet as a log of changes and I am the only one who updates this. The corresponding forms are pretty robust and walk the users through the process. They also include approval spots at the end of each section. The initiator fills out the form on their own, prints the section and the signed section is returned to me. This way I can track where each thing is in its process and keep the log up to date. At the end, when each change/complaint investigation, etc is complete, I compile all the sections and scan as one complete record.

As for meeting minutes, we do not use those for these processes but if you do, the minutes could simply be saved in the folder for the applicable change/investigation along with all other supporting documentation. Should really be no extra work for you.
 
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