9 replies to this topic

[Djelas]

I am in the process of building a system document for Food Safety Management system with a view to getting certified for ISOO 22 000 or FSCC. I would like to away with pen and paper documents and a food safety management software which is now available. I would like to get advice or inputs from others who are familiar with both systems of paperless and the old pen paper system. What do others think

[olenazh]

I have all FSMS doc's developed myself without software, working fine over many years with necessary revisions & updates when needed. May be, that's fine for me because I love creating/managing/updating/revising/etc. documents:)

[zoelawton]

I would also love to do this - i hate how much paper i waste.

 

I'm struggling to see how i can make signed documents etc. electronic and make sense to both the user and the auditor without making it more complicated due to dates and frequency of signing things. 

 

I will be following this thread for advice 

[SQFconsultant]

Just one suggestion for anyone going over to electronic paperless systems - don't install one of these when your next audit is coming up fast.  Take the time to learn the system, knowing where everything is so that when an Auditor comes in you can readily pull things up for review.

 

As an Auditor I sat at a conference room table one day watching the QA Manager anguish thru a new system that had only been set up three weeks prior - that audit (just the documentation phase) took over 7 hours to the point of having to bring dinner in and it was completed at 11pm that evening.

[MsMars]

A word of advice from someone who has had to work through several network and computer crises - make sure you also have a way to do it with pen/paper as a backup in case of emergency. 

[Padfoot]

A word of advice from someone who has had to work through several network and computer crises - make sure you also have a way to do it with pen/paper as a backup in case of emergency. 

This happened to me during my pre-assessment  audit and it was so embarrassing. Luckily i had every document behind me so i was able to transition back and forth smoothly. During my table audit we had no problems and I didn't pull out a single piece of paper. Make sure you know where everything is so you can pull documents up when they ask and it will go great and fast. 

[MsMars]

This happened to me during my pre-assessment  audit and it was so embarrassing. Luckily i had every document behind me so i was able to transition back and forth smoothly. During my table audit we had no problems and I didn't pull out a single piece of paper. Make sure you know where everything is so you can pull documents up when they ask and it will go great and fast. 

 

Yes - also happened to me during a certification audit.  Murphy's Law. 

[zoelawton]

Yes - also happened to me during a certification audit.  Murphy's Law. 

 

 I just had to google this!  We say 'Sod's Law' 

[QM-OS]

We're a relatively small company and have worked with BRC/HACCP since 2012.

I'm the person in charge of the documentation and two years ago I felt it was time to minimize our paper piles. 

 

It took about six months to do the convertion and I did it so I had about eight months before next BRC audit.

I felt I was well prepared during the audit but had the old folders ready if needed, but it wasn't neccessary.

 

We're not completely paper free. Production and cleaning documentation has not been converted electronic. Both due to the factory environment is not desirable (wet, humid and cold) and also, some of the staff are not at all willling to even try using other devices except pen and paper.     Maybe it's something we can look into when they've retired... 

After production, the filled in documents are scanned so we can access them electronically.

 

I looked at different ready-made-systems but the quotes I got were ridiculous and to make changes for it to fit us would make it even more expensive, so in the end we went with Sharepoint. 

Since it's already part of our Office-subscription our financial department liked the idea of no additional expenses.  

It doesn't fulfill all needs but almost, so I see it as a good start. Also, all employees now have access to documents etc, wherever they are (as long as they have internet connection).

I download all documents as well so I have access even when the internet's not working (it's been useful the two or three times we've been connectionless these past two years).

 

At the start, the system consisted of some 6000 files. Don't know if this is a big number or not, but for us it certainly is!

It's a weird feeling, not to have so much paper lying around anymore! 

[Jeffrey Ort]

I have gone paperless for one of my previous facilities. YES, it can be done, but there are a few of things that are required.

• Ensure there is a redundant system to save all documents and records.
• All electronic documents need to meet CFR 11 for electronic documents (www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1&subpartNode=21:1.0.1.1.8.2)
• Ensure Electronic records are identifiable to the person that is performing the documentation step and the verification review step, this would be having separate login and passwords for each person that is able to create or complete documentation similar to signature/initial logs).
• Use the login and password as the completion step to lock the document and information.
• Once information is input, the data cannot be edited by the person performing the task, a retest of task can be completed in the case of a mistake or out of specification
• Use comments at the review step indicating an issue of incorrect data or if a task was not completed with reason, additionally, the reviewer is not able to edit or correct the data. 
• Strong system of storage and map the locations of completed verifcation records, this will assist greatly in audits.
• MOST IMPORTANT - a back up redundent system of PAPER documents for the emergency sitaution of internet loss, server loss, or other IT issues.