Does anyone out there have a successful electronic method of capturing non-conformances? If so, please describe it in detail.

Are you familiar with the Microsoft Access Data Base program ? We are using it with moderate success. We are logging the basic information from the paper Incident Reporting system, and tracking it through the Access Data Base. It is capable of performing DB queries, setting flags, and producing reports. Feel free to e-mail me directly: e-mail address removed by admin, spammers get too many new ones this way. Please send a private message to Elaine Viggiano to learn the e-mail address.

We also use an Access database. We capture the information on a 2-sided form which is scanned into the database. There is minimal typing (e.g. written description or comment) that I manually enter into the databse. Reports are then generated - monthly, FDA BPD's, occurrence type, tech code, etc.

It is really helpful, though, to have someone at your facility who is knowledgeable with the Access program. I personally am not, so I have to rely on the help of others.

Thanks for the great responses. We actually use a database and a web site to track our (I work with Dawn) Occurrences too. This gives us a few additional benefits, such as we can track who each Occurrence is with and the site sends automatic e-mails reminding them to finish processing them and turn them in. The problem we face is more a timeliness issue. The staff seem to take a long time processing the Occurrences and returning them to me.

Do you have success with getting them completed?

Cliff, this is a two part answer to your question.. First, we establish specific timelines for the Occurrence Reports' closures. That way, the responsible Department Heads know when this timeline is looming. Second, a query can be set up in your Data Base to provide interval reports (weekly, monthly,, etc) on the ones that are outstanding. That's how we do it. The Dept Heads are then responsible for completing the Occurrence Reports in a timely way. This information is presented at our monthly QA meetings. Believe me, no Dept Head wants to be the laggard !! Hope this helps.

anyone willing to share their access database? krugh.1@osu.edu

I would also be interested in seeing how someone has set up the access program. My current process is very labor intensive (I have been using a spreadsheet in Excell). One of my goals was to learn access this year. If willing to share, please send to dmmeeks@sentara.com. Thanx

I am also interested in seeing how your access is set-up. If willing to share, please send to maharlikan@aol.com . Thanks.

Sorry, there really is no way I could share mine. It no longer exists in an access database. We have moved it to a SQL server that interacts with our website.

The website is what gives us the functionality. The site is fully integrated with employee tables as well as the Occurrence data tables.

There are systems in use at several blood donor organizations that track and manage adverse events, deviations, non-conformance, SOP audits, documents and CAPA (corrective and preventative action). Is this what you are looking for?

Maybe, I'd be interested in learning more!

There are software systems that conform to the FDA rules for 21 CFR and specifically Part 11 (electronic signatures). They have built in workflow processes so managers, supervisors, donors and the FDA can be notified either via letter or email whenever an adverse event happens. They all work with both paper and electronic copies of records, the processes can be validated and they hold audit trails of all records. These are not donor, lab, or temperature control systems. They are used for 1) recording an adverse event 2) investigating why or how it happened (3 putting a CAPA plan together to make sure it doesn't happen again and 4) making sure the action plan works. They also can be used for document control (SOPs, etc.), training records and auditing of the departments to make sure they are following the SOPs.

check out www.sparta-systems.com for info on one of the products.

Dawn, I am not too sure that I am answering your question, but maybe this will help. We have a program called the "Safety Registry" that we use to record non-compliance. This is a very versatile program. The hospital uses it the track medication errors, falls, etc. You can pull reports monthly, quarterly, etc. If you are interested, e-mail me at kathy_hadaway@eamc.org and I will be able to give you more information. Hope this helps.

Hi all,

I realize this is an old thread, but I'm wondering what people are using lately for their nonconformance tracking. I've seen Sparta Systems TrackWise, QPulse, and Master Control mentioned. Do any of you use these systems, or something similar? What have your experiences been?

Thanks!

Hi all,

I realize this is an old thread, but I'm wondering what people are using lately for their nonconformance tracking. I've seen Sparta Systems TrackWise, QPulse, and Master Control mentioned. Do any of you use these systems, or something similar? What have your experiences been?

Thanks!

We use QPulse5 within the National Health Service Blood and Transplant of England and, much as I am usually completely phobic about doing anything more than the simplest thing on a computer, it is a really fatastic system (albeit that Quality hound ou if you automatically if you don't get your CAPA in on time!!!!!!!!); but then, I suppose that is true for any computer system that tracks non-conformances - and at least it means that they do not stagnate.

All in all, I would recommend it.

:D:D:D:D

Hi Dawn,

I currently work with NHS, Private Healthcare, Medical Device and Clinical Trials organisations consulting on their compliance activities. With a continued focus on the delivery of quality improvements based on the latest evidence based practice and a robust monitoring of performance. One of the key focus is managing non-conformance in an electronic format.

The company I work for is Gael Ltd, http://www.gaelquality.com/healthsector_bloodservices.asp if you wish to discuss your requirements further, please let me know.