Records: Paper or Electronic

Currently our production areas record everything on paper. By everything, I mean EVERYTHING. Throughout the course of the day, they have written the date and time about 100 times. A couple of years ago I experimented using Excel to input the date and time when a temperature was entered. This was good, but that's all the further it went. Currently we do not have a database.

I want to know what you're doing and how it's working for you:

If using paper, is there any hope to go electronic?

If using electronic, how did you choose what to use? A basic database and forms or complete FSMS?

All of our production records is on paper.

Other things may be in different computer programs like our PM program, CAPAs, training reports, etc.

All of our processing and production records are on paper except for customer complaints and trending etc. which is handled electronically. Our processing room, at least part of it, is a very wet area and a lot of the records end up covered in water from the gloves that the staff wear, which makes them even more reluctant to fill the forms out (CCP means little to them apart from requiring more paperwork). 

I saw on these forums that there are programs you can buy to manage paperwork and thought that maybe an iPad with one of those toddler drool-proof cases might be a solution. I've been working on designing an app specific to the needs that my workers have, and the processes that we go through to make everything easier for them - but it's yet to make it off paper.  

maybe an iPad with one of those toddler drool-proof cases might be a solution

You can have your tablet sent to a company which will submerge it in a solution leaving a waterproof coating right around the device. A little on the pricey side but more effective than a case.

http://www.mactrast....no-case-needed/

You can have your tablet sent to a company which will submerge it in a solution leaving a waterproof coating right around the device. A little on the pricey side but more effective than a case.

 

http://www.mactrast....no-case-needed/

Thank you Philip! The staff do have an incredible knack for destroying things (pH meters, temperature probes) that are supposedly waterproof so I was concerned about how a case would work. One problem down! :)

Ugh, I'm in the process of switching to Excel.  Which is a bummer, because eventually I'll have to switch to a company program.   Some of my staff is terrified and angered by computers.  I actually have this awful tension with another supervisor becuase it HAS to be electronic now and he lacks the self confidence to try (but he'd be so damn useful! Just click on shit, you can't break it!) . All of the info in the company programs are so buggy becuase it's still being built by another corporation who doesn't understnad our products and specs... sigh....

Electronic FTW, I can read, search, spell check, reference, and trend you easily!   I can move you about to the conference room without a small cart!  You only take up lap top space instead of BINDER space!  You aren't a fire hazard!  I can keep you *forever* instead of 5 years!  You let me avoid co-workers under the guise of "We need a compliance record, so I'll email you instead of talking face to face or picking up the phone"!  You make pretty charts and a quick audit!  I HAVE A SELF AUDIT WITH A HYPERLINK TO EVERY PLACE IN EVERY DOCUMENT WHERE EVERY REQUIREMENT IS MET.  But...

Terrible for signatures though, anything with that is paper, then scanned, then usually entered into a matrix or Excel for trending/reference linking.  I timed the amount of time it took me to open a pdf today and it was 108 seconds.  Then I called our awesome IT staff and they made it instantaneous for me :spoton: But still.  Scanning = sucktastic.

-MM

Electronic FTW, I can read, search, spell check, reference, and trend you easily!   I can move you about to the conference room without a small cart!  You only take up lap top space instead of BINDER space!  You aren't a fire hazard!  I can keep you *forever* instead of 5 years!  You let me avoid co-workers under the guise of "We need a compliance record, so I'll email you instead of talking face to face or picking up the phone"!  You make pretty charts and a quick audit!  I HAVE A SELF AUDIT WITH A HYPERLINK TO EVERY PLACE IN EVERY DOCUMENT WHERE EVERY REQUIREMENT IS MET.  But...

 

Terrible for signatures though, anything with that is paper, then scanned, then usually entered into a matrix or Excel for trending/reference linking.  I timed the amount of time it took me to open a pdf today and it was 108 seconds.  Then I called our awesome IT staff and they made it instantaneous for me :spoton: But still.  Scanning = sucktastic.

 

-MM

I totally agree with magenta_majors. There are so many advantages to going electronic. My last workplace had no paper records and it was wonderful. Everything was so easily accessible from any computer and it had fantastic search functions. I was so disappointed at having to sift through reams of paper where I work now.

My last workplace though, signatures were not an issue. Nothing was scanned and uploaded for signature purposes. We all had a login with a password and an electronic signature was recorded. Even in the factory all the quality and production results were recorded straight into a touch screen.

Unfortunately it was the work of one amazing IT guy who had developed a system particularly for the company so I can't recommend it either to my current workplace or the forum.

There are some great systems out there but they are generally pricey.  We have some programs for specific data capture but still print out the information relating to CCPs at least so that it can be signed.  This results in more paper not less,  Records that used to be on one sheet now generate up to 12 pages per shift. ;-(

The records we have signed & scanned are -
Documents (Controlled vresion of SOPs)

Training & Policy Acknowledgement / Validation

Corrective Actions & Deviation Requests

Records I would like to make fully electronic but can't are -

Quality and CCP checks

Work Orders

Sanitation Validation

UPDATE - After I showed the other supervisor how to use a computer, he is in love with it now  :shades: .  Which means I have to fix errors on the double.  :doh:

We were just recently looking at a system that does all of the input electronically and while it looked nice I was still a bit put off about the possibility that their internet might go down, our internet might go down, their servers could have an issue, etc.  They had an option for us having a computer for a local backup but I still like paper records... call me old fashioned.

I don't like change.

We were just recently looking at a system that does all of the input electronically and while it looked nice I was still a bit put off about the possibility that their internet might go down, our internet might go down, their servers could have an issue, etc.  They had an option for us having a computer for a local backup but I still like paper records... call me old fashioned.

 

I don't like change.

I assume you're talking about a "cloud based" system? I do a lot of research pertaining to software solutions on a weekly basis and everything is in the cloud. I'm in the generation where I (mostly) grew up with internet technology but I'm wary of utilizing the cloud for managing our information.

I ask myself a lot of questions like, where does it go? Who can see it (other than the NSA :sleazy: )? How secure is it? How is it backed up? Seems a lot of these solutions leave me with more questions than answers. Sometimes it's just easier to push some paper around...

I do a lot of research pertaining to software solutions on a weekly basis and everything is in the cloud.

We were just recently looking at a system that does all of the input electronically and while it looked nice I was still a bit put off about the possibility that their internet might go down, our internet might go down, their servers could have an issue, etc.

Internet is ubiquitous for most food businesses. The GO’s on your line have as much internet accessibility in their jeans pockets, or locker room (if you are doing your job!) as the DSL connection coming into your comms room. Internet is everywhere. If you believe that you cannot get online when your primary internet connection goes down then I suggest you reconsider this, and speak with your IT dept.

As for the vendors systems going down, yep this is also a very real possibility. Nearly every enterprise cloud vendor experiences downtime at some point. However because there is a whole team supporting the software from a dedicated data center, instead of your internal IT guy supporting two dozen software systems from a rack of servers in that ‘room at the end of the hall’, cloud software solutions are generally far more reliable, and even far more secure, than their in-house counterparts.

I can understand and respect this. However it does mean that your whole company may pay the consequences if it is being put at a disadvantage.

For those using electronic devices in production areas, what are you using? Laptops? Tablets? Desktop computers?

What type of protection from the elements?

One of our rooms is a dry room with flour dust. My concern is that the flour dust will cause issues with the electronic device. Anyone have any ideas/suggestions?

We were just recently looking at a system that does all of the input electronically and while it looked nice I was still a bit put off about the possibility that their internet might go down, our internet might go down, their servers could have an issue, etc.  They had an option for us having a computer for a local backup but I still like paper records... call me old fashioned.

 

I don't like change.

While I like electronic and not shuffling a lot of paper, I totally understand this opinion.  First I don't like cloud period.  Secondly how many times in electronic systems is there a challenge of not being able to document what you need to or add a comment later.  On a piece of paper, I can write a note and it is there for posterity.  I like that electronic does not need massive amounts of file boxes, but how many times do things just mysteriously disappear never to be found again when it is only electronic.  

I don't mind beneficial change and am open to electronic information, but there is something about a piece of paper that is comforting.

For those using electronic devices in production areas, what are you using? Laptops? Tablets? Desktop computers?

What type of protection from the elements?

 

One of our rooms is a dry room with flour dust. My concern is that the flour dust will cause issues with the electronic device. Anyone have any ideas/suggestions?

I used to work at a place that milled rice flour.

It was everywhere- it didn't mar the tablet or smart phones, but we had to blow out our desktops (in the enclosed supervisor room adjact to the mill room) with computer air cans often.

Ironcially, the dust did competely destroy one piece of electonic equipmet -

The printer.

Eff.  That. Printer. 

The dust would *always* get in the machine and trigger the jam sensors. It owuld not print.  There was no jam.  I knew the repair tech by name within two months.  If we needed a hard copy of somehting, a supervisor always had to stop and print it out, because we had keys to the office area.

Here's a link to a popular web comic regarding printers which reflects my feelings on them aftter working next to the mill room (it also has a helpful food safety tip about meat expiration) -

http://theoatmeal.com/comics/printers

Here's a link to a popular web comic regarding printers which reflects my feelings on them aftter working next to the mill room (it also has a helpful food safety tip about meat expiration) -

http://theoatmeal.com/comics/printers

So funny...! :roflmao:

and so true.

I didn't see this mentioned, but in the United States, if you go to electronic records, they must comply with 21 CFR part 11:

http://www.accessdat....cfm?CFRPart=11

Essentially this says that systems must be validated and robust, access must be restricted to authorized users, and there must be an audit trail.  It is definitely not a trivial matter.  Unfortunately Excel falls far, far short of meeting these requirements.

http://www.fda.gov/R...s/ucm125067.htm

By the way, FDA will check whether you have "establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures" according to the link above.  That means make sure people sign out of, or otherwise secure, their work stations and devices before leaving them unattended for long periods.

In short, there are many regulatory requirements for electronic systems, so paper records are really not so bad if they are the only way you can comply with the regs.

We have been doing a trial on excel since one month. Simultaneously, we are recording on papers. This is beacause many tests (during production) are done by operators. Before shifting to electronic database, we have to ensure that recording is being effective. Till date, we are not 100% satisfied with the electronic recording being done by factory operators. There ares still area for improvement.

Rudra

I didn't see this mentioned, but in the United States, if you go to electronic records, they must comply with 21 CFR part 11:

http://www.accessdat....cfm?CFRPart=11

 

Essentially this says that systems must be validated and robust, access must be restricted to authorized users, and there must be an audit trail.  It is definitely not a trivial matter.  Unfortunately Excel falls far, far short of meeting these requirements.

 

http://www.fda.gov/R...s/ucm125067.htm

 

By the way, FDA will check whether you have "establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures" according to the link above.  That means make sure people sign out of, or otherwise secure, their work stations and devices before leaving them unattended for long periods.

 

In short, there are many regulatory requirements for electronic systems, so paper records are really not so bad if they are the only way you can comply with the regs.

Thank you for mentioning this Matthewcc because I was scanning this post to warn the "Excel" users (on the US side) and depends how one uses the software. For navigation/mapping out ones FSMS, it can facilitate finding documents with great ease, however, Excel (for truly paperless records) does not have the adequate version control and version audit tracking for digital signatures required by FDA's 21 CFR Part 11 ERES regulations (Electronic Records Electronic Signatures).

I brought up this issue a wile back (along with EU DIRECTIVE 1999/93/EC) for your viewing pleasure:

http://www.ifsqn.com...tal-signatures/

Only 3 FDA warning letters went out to one pharmaceutical and two medical device manufactured in 2001 - 2002. I have yet to hear of a food processing company that has come under 21 CFR Part 11 scrutiny... but it will come. With the complexities with global souring and traceability alone; I spoke with the now retired 40 year FDA Seattle District Director Charles Breen on the matter; emphatically he agrees.

-Baron

we do both, mostly electronic though, all our computers are networked with shared areas so there is access from the office or production floor and then they are being constantly backed up by a service that keeps them offsite should anything occur

For those using electronic devices in production areas, what are you using? Laptops? Tablets? Desktop computers?

What type of protection from the elements?

 

One of our rooms is a dry room with flour dust. My concern is that the flour dust will cause issues with the electronic device. Anyone have any ideas/suggestions?

We use these for our production computers. They are used in our cookie and bread production rooms with no problem. They are expensive but they have flour dumped on them continously and can take water directly during washouts. Otherwise cheap enclosures work with micro pcs but you need to clean them out more as flour dust gets everywhere.

We use these for our production computers. They are used in our cookie and bread production rooms with no problem. They are expensive but they have flour dumped on them continously and can take water directly during washouts. Otherwise cheap enclosures work with micro pcs but you need to clean them out more as flour dust gets everywhere.

Whoa, that thing is cool !

Bet my mechanic could make one from an old key cabinet too!   :happydance:  Martha Qu-art Time!  We should have a monthly Martha Qu-art column appear next to dear Quabby.