14 replies to this topic

[tsmith7858]

We are working on a new ERP system with a goal of going paperless in as many areas as possible. Today we were discussing quality and food safety records and CCP records were being discussed at length. Our QA manger likes paper because she has it in front of her and she can easily show signatures. I think paperless will work and electronic signatures will serve the same purpose.

My first question: Is anyone using a totally paperless CCP program.

In other words, if you have metal detection as a CCP the operator would run the tests and input an accept or reject when testing the metal detector. If rejected, an automated Corrective Action would be generated. The system would also allow for entry of metal hits throughout the shift (pictures could be attached to show the metal findings). All of this data would be entered and you could easily track by line or product to trend issues.

My second question: How are you handling verification?

We are thinking that a work flow would send the information to the person doing the verification at the end of each shift or production run (QA Manager or Supervisor) and then they would "sign off" with an electronic signature.

My third question: It all sounds good but are auditors, customer and regulatory bodies accepting electronic records?

Thanks in advance for any feedback!

[KTD]

Dear TSmith7858:
FSIS accepts electronic records, so long as appropriate controls can be demonstrated. I am not familar with FDA, but believe they are the same. There is a BRC clause discussing electronic document control, which would imply that e-records are acceptable. I am aware of several commercial packages for electronic HACCP documentation.
On your second question: Not sure if you are FSIS or FDA regulated, but how will you handle the direct observation of monitoring activities of 9 CFR 417.4(a)(2)(ii)?

Personally, I can feel for your QAM. I'm old enough that I find it disconcerting to read a book electronically, much less put my HACCP program on the line electronically.

[Scotty]

Attached file may be of interest. Aimed at thermal processing but provides guidance of how these paperless sytems should be implemented and managed.

Regards  Electronic Chart Recorders.pdf   187.6KB   257 downloads

[Charles.C]

Attached file may be of interest. Aimed at thermal processing but provides guidance of how these paperless sytems should be implemented and managed.

Regards  Electronic Chart Recorders.pdf   187.6KB   257 downloads

Dear Scotty,

Impressive but rather daunting document. Sort of reminiscent of the "IT Crowd".

Not yet forgotten the first time I was confronted with a documentation system maintained entirely on a PC. Man vs Machine. Sadly i am a very poor chess player.

It would be nice to see some actual output to generate some belief in the concept.

Slightly OT but so far i hv not encountered an electronic haccp program which works for me. Not exactly a criticism, more a feeling that the (general) range / nuances of QA options are maybe not infinite but certainly can be far from small.

Rgds / Charles.C

[ladytygrr]

Hey guys,

 

I'm revisiting this with a couple of questions. Firstly, I'm wondering how the OP, TSmith, made out on their program. Did you get all the kinks worked out so you could move forward entirely paperless?

 

Secondly, I'm curious as to how TSmith (or anyone) has set up their electronic signatures. Are you having them "sign" with their finger/stylus on a tablet or table-like device? Input a numeric code unique to them like a PIN?

 

Thank you in advance for your input!

 

~Emily~

[Mr. Incognito]

I am completely against a paperless system and am constantly fighting the idea locally.

 

The reason why I'm against it is that there are too many problems that can happen with computers.  You can have a computer go out, hard drive crash, loss of internet/intranet connectivity, etc.

 

Even if you have multiple computers you can lose the database, have corrupt files, etc.

 

I would only trust it if it was locally and externally backed up but still you could have serious problems.

 

I like having paper, as a Quality Manager, because I can always pull out the paper and show it to the auditor.  Yes you could have a fire, flood, etc that destroys the records but if that happens you probably lost you computers as well.

[ladytygrr]

I am completely against a paperless system and am constantly fighting the idea locally.

 

The reason why I'm against it is that there are too many problems that can happen with computers.  You can have a computer go out, hard drive crash, loss of internet/intranet connectivity, etc.

 

Even if you have multiple computers you can lose the database, have corrupt files, etc.

 

I would only trust it if it was locally and externally backed up but still you could have serious problems.

 

I like having paper, as a Quality Manager, because I can always pull out the paper and show it to the auditor.  Yes you could have a fire, flood, etc that destroys the records but if that happens you probably lost you computers as well.

Mr. I:

 

Thank you, as always, for your post.

We are a company which is striving to be as environmentally sound with as small of an environmental-impact footprint as possible and we are very nearly at a point where all documentation generated on the production/packaging floor is paperless.

 

I'm from Southern California and moved to the midwest 9 years ago...this is the first place I've worked since moving here where I'm not the only tree-hugging hippie around and it's so nice to not be alone!    

 

Back on topic, generating MORE paper is basically a zero proposition as ALL of management/ownership is on board with less paper generation. We currently have things set up so our operators performing our SSOPs, etc. are signing with their finger on a tablet. I'm thinking that since it's the same signature they'd put on a piece of paper, we should be good to go but would like to know if anyone else is doing this.

 

We have already experienced the pitfalls of being computer only. Our router died and those of us in the offices couldn't do ANY work at all. Luckily, the tablets used on the floor store completed forms and then automatically upload them to the web once an internet connection is re-established. (I actually stopped writing this post to absolutely confirm this by conducting a test - thank you for the prompt!)

 

I appreciate, however, the ease of pulling out a binder full of records and simply turning to the correct section over having to navigate through layers of digital folders (especially in the event of an audit which is guaranteed to make you at least a little nervous and therefore more likely to forget where even basic stuff is located). 

 

I guess I'll just have to see how things progress on this end; if anyone knows of a reason why digital signatures WON'T work (we're headed for SQF L2 certification in the slightly near future), I would like to hear about it.

 

Thank you!

 

~Emily~

[Mr. Incognito]

Good luck Emily!

 

I would be terrified to not be able to pull down the data when the auditor comes but I get where you are coming from.

 

I didn't even think of the upload failure possibility.  

 

I also argued against tablets because they can break, glass/brittle plastic, etc.

[Madam A. D-tor]

As an auditor I like a good paperless system.

However it tricks me to audit other things, like the license system and the way documents can and con not be changed.

I do like databases, because I can check trends and results from a longer period in a simple mouse click.

[Sim Fallible]

I am so for paperless systems, have pushed and pushed in all the businesses I have worked in for the last 10 years and am now in a business that believes in it and in the opening stages of buying into and developing it, of course I want to be at the forefront, and as the Quality Manager have a great opportunity, so this is all very interesting.

In my last place I got some simple hand held units that used menu input methods, select the menu, select the check and enter a set response, or measure the temperature kind of thing, great for basic things such as despatch temperature selected by depot, or by sign off checks such as hygiene. The users signed in using PIN numbers and everything was logged by person to the second and was accessible online anywhere when logged in so no loss of data, and gave totally traceable data.

BRC were more than happy with the records, security and sign off and the best thing was they asked for a check record on date x for procedure A and I was able to pull it up and present it instantly, worked very well. Sure there is the fear with the intranet/internet going down, but this is technological age and there is more acceptance of these possibilities, as well as there being less chance of it happening. As a back up, it being stored on line, a mobile phone connection would have been enough to pull up the data.

Overall I see this as the way forward, but also respect that concern over the sudden loss of data, but in the current age I see there being more backup of electronic data than the one copy of paper.

[FoodSafety_101]

Hi,

 

Through conducting third-party food audits I run into a lot of people/products within the industry. I recently was introduced to a company with an amazing food safety software which is fully compliant with GFSI, HACCP and FSEP ( for Federal Canadian facilities).  This deals strictly with food safety and does not have other applications such as ERP or CRM (They are partnered with another major company to provide these types of services as well). Once I was given a tutorial of the software I was blown away, this software has everything a facility needs to run an effective food safety system, and the cost is exceptionally low then other market competitors (from what I hear through the grape vine). If anyone is interested in a "true" software dedicated to food safety with tons of features that gear towards facilities big or small shot me a message and I can provide you with more details...

[Philip @ Safefood 360°]

Hi,

 

Through conducting third-party food audits I run into a lot of people/products within the industry. I recently was introduced to a company with an amazing food safety software which is fully compliant with GFSI, HACCP and FSEP ( for Federal Canadian facilities).  This deals strictly with food safety and does not have other applications such as ERP or CRM (They are partnered with another major company to provide these types of services as well). Once I was given a tutorial of the software I was blown away, this software has everything a facility needs to run an effective food safety system, and the cost is exceptionally low then other market competitors (from what I hear through the grape vine). If anyone is interested in a "true" software dedicated to food safety with tons of features that gear towards facilities big or small shot me a message and I can provide you with more details...

 

Hi FoodSafety_101,

 

That sounds fabulous, similar to the feedback you have given in other threads.  Please enlighten us; we’re a friendly bunch so there is no need to be shy and keep this super all-compliant software a secret any longer.

 

Ifs it’s as good as you say it is, then it can only be service to our members to know about it.

 

Thanks,

Philip.

[123Herewego]

I have gone through this process too and eventually figured out that it's not a great idea as its mentioned by one of our expert up in the comments. I did considered partially electronic records as this wa more feasible on our end..

Good luck!

[dandy0215]

Hi,

 

Through conducting third-party food audits I run into a lot of people/products within the industry. I recently was introduced to a company with an amazing food safety software which is fully compliant with GFSI, HACCP and FSEP ( for Federal Canadian facilities).  This deals strictly with food safety and does not have other applications such as ERP or CRM (They are partnered with another major company to provide these types of services as well). Once I was given a tutorial of the software I was blown away, this software has everything a facility needs to run an effective food safety system, and the cost is exceptionally low then other market competitors (from what I hear through the grape vine). If anyone is interested in a "true" software dedicated to food safety with tons of features that gear towards facilities big or small shot me a message and I can provide you with more details...

I tried sending you a message but was given an error message stating that you're unable to use the message services on here.  I'd like information that you have for FS electronic records, please.  Thanks

[FoodSafety_101]

I tried sending you a message but was given an error message stating that you're unable to use the message services on here.  I'd like information that you have for FS electronic records, please.  Thanks

Dandy contact me at mark@jlconsultantsinc.com