25 replies to this topic

[Belicia]

We had an auditor who basically said we have to maintain a register of all printed documents to ensure we know who has what and where. I foresee this as a nightmare. Is there a better way to manage this?

[Charles.C]

Dear Belicia,

 

So what are you doing at the moment ?

 

Rgds Charles.C

 

 

We had an auditor who basically said we have to maintain a register of all printed documents to ensure we know who has what and where. I foresee this as a nightmare. Is there a better way to manage this?

[kanyisa]

Hi Belicia

what I have is a document Issue every time I give some one a paper they sign

date ,document ,department

[cazyncymru]

Can't beat an old fashioned spread sheet

 

Document number / id

Document title

Version Number

Version Date

Copies in circulation

location of documents

Author of document

Authourisaton by

 

Make sure your register is controlled too!

 

Cazx

[Setanta]

What is your auditing system?  I don't have all the details that Cazx has laid out and get by with a book of all current documents and any sheet being used has an origin date ( to see that it is the most recent copy) and the word COPY stamped on it to show it is from the book. 

 

Anything else has been removed from circulation.

 

Best regards,

Setanta

[Marshenko]

My document control program states that all documents are only to be printed out by myself or a Designated Employee with access to my files, and that photocopies are not allowed for any recordkeeping documents.

Any QPM or QAM documents (any policy or procedural document) also have a footer with:  Date and Time Printed, and "This Document Expires after 24 hours"

All documents must contain the document number, revision number and revision date within the header (or footer if space is really limited on the document)

I keep an Excel spreadsheet register with Document Number, Document Name, SQF Element, Revision Number, Revision Date, and Amendment History

Auditor seems to like it well.  He checks dates to ensure that documents aren't being used past a new revision date, and he'll check random documents against the register to ensure that the doc #, revision #, and revision # all match.

 

I do like the idea of having a little binder with all current documents marked copy, thanks for that one :)

Edited by Marshenko, 02 August 2013 - 01:52 PM.

[TheDude]

Do daily recordkeeping documents also need to be stamped as "copy"? We currently have a binder that is considered the master and then a back-up on an external hard drive that is named "copy" and is password protected.

[Setanta]

Do daily recordkeeping documents also need to be stamped as "copy"? We currently have a binder that is considered the master and then a back-up on an external hard drive that is named "copy" and is password protected.

All of ours are...

Edited by Setanta, 02 August 2013 - 03:48 PM.

[Charles.C]

Dear All,

 

Interesting discussion, I had thought stamping was strictly a thing of he past (eg everything with a printed date is a copy, controlled ones being colour coded). Apparently not.

 

But regarding the OP, there seems to be a consensus that a register is necessary. It's certainly nice to have as long as you don't have to do it yourself.

 

Any comments, Belicia ? 

 

Rgds / Charles.C

[Setanta]

We do not have printers available for the production floor.    We still rely on copies. 

[mgourley]

Perhaps a watermark that says "This document, once printed out, is not controlled" or words to that effect.

 

The original document, preferably stored on a server that only authorized persons have access to, are the controlled documents.

 

Marshall

[TheDude]

Perhaps a watermark that says "This document, once printed out, is not controlled" or words to that effect.

 

The original document, preferably stored on a server that only authorized persons have access to, are the controlled documents.

 

Marshall

 

I think I may steal this and put it in the footer of our documents. Will an auditor be satisfied with this?

[MM1]

I have document registers for SOPs, Forms, WI etc. Each document has a header and footer with document title, number, version number, date of issue. Footer has wording 'Controlled Document'. Procedures and  work instructions also contain a small amendment log at the end of document which includes version number, reason for change, changed by and date of change.  Soft copies of these documents are kept on server which have restricted access only to quality team for editing and print.

 

MM

[Mr. Incognito]

No you need an actual register for all of your documentation you can't just say that a copy is not controlled.

 

I highly suggest you use an excel workbook like what was mentioned earlier.   Here are some of my excel sheet sections:

 

Form Tab:

 

 

Form # | Name of form | File Name | Policy form supports | Origination Date | Date of last revision

Revision Number

 

 

 

Policy Tab:

 

 

Policy # |Name of Policy | File Name / Location | Section Policy Supports | Origination Date | Date of last revision | Revision Number

 

DPS Tab:

 

 

DPS # | Name of DPS | File Name | Policy DPS supports | Origination Date | Date of last revision | Revision Number

 

I also have all of my forms serialized for sections by hundred numbers:

 

Admin - 100

Quality - 200

Processing - 300

Filling - 400

Packaging - 500

Warehouse - 600

 

So that they are easier to find by area of the plant so my full form number would be AF-F-100 (AF is the plant name abbreviated, F is for Form, 100 is the form number).  I have my policies the same way AF-P-001 (P for Policy obviously), DPS's are the same AF-D-001...

 

My file names also coincide with the rest for example a form file name such as: "AF-F-205 - 60 day exp non-leap".  It includes a short description (or title if available) of the document so if someone other than me is looking for it on the share drive they can find them easier.

 

As for control all of my forms and dps's have a password to modify them that only my manager and I know and the policies have electronic signatures so if there is any change all signatures are wiped.  My doc register is only on my computer and not on the share drive and nobody else has it (other than my 1 backup) so that nobody can change it but me.  There is a shorter one I have with just the form / policy number / name / file name with share drive location that is available.

 

The reason for the register is for organization etc.  Have to have one.  Plus make sure if you have a document control policy that you include updating the document register when there is a change.

 

Just my suggestion.

Edited by MerleW, 06 August 2013 - 01:33 PM.

[Chris @ Safefood 360°]

We had an auditor who basically said we have to maintain a register of all printed documents to ensure we know who has what and where. I foresee this as a nightmare. Is there a better way to manage this?

 

Hi Belicia,

 

Your auditor was correct - for adequate document control you should maintain a register of your controlled documents. This would include SOP's, Specifications, Logs, etc. etc. etc.. Depending on the type of certification you are trying to comply with, the word "should" becomes "shall".

 

BRC

3.2.1 - The company shall have a procedure to manage documents which form part of the food safety and quality system. This shall include:

• a list of all controlled document indicating the latest version number

SQF

2.2.1.1 - A register of current SQF  System documents and amendments to documents shall be maintained

 

As Charles C. pointed out, the register is "certainly nice to have as long as you don't have to do it yourself". Unfortunately, when the QA/Food Safety Manager or SQF practitioner informs upper management that they need to have a document register, this all to often becomes the function of the QA/Food Safety Manager or SQF practitioner. What this typically boils down to is a lot of time spent on data input, rather than proactively assuring the quality and food safety at your facility.

 

There have been quite a few really great contributions to this discussion.

 

mgourley: Perhaps a watermark that says "This document, once printed out, is not controlled"

This is a great idea and one that I've used (and have seen used at many facilities) to indicate that as soon as the document is printed it is no longer "controlled" and it is up to the user of the document to maintain control of it. Should the "official" electronic version be updated, it is the requirement of each individual to ensure they have the updated version. This effectively saves the documentarian from having to spend an entire day walking around the facility updating manuals, and now the onus is put on each individual to conform to the company policy of obtaining their records from the updated, correct electronic version rather than a depleted stack of outdated records from 10 years that they found in a desk drawer. 

 

MerleW: No you need an actual register for all of your documentation you can't just say that a copy is not controlled.

Exactly. First item of business is the document register. The watermark in conjunction with the register helps you meet the requirement to control your documents.

 

I might add that if you are going to utilize an excel spreadsheet to create (and maintain) what will amount to be another pain in the rear end database, make sure to include the document # (see MerleW's post for numbering suggestions),  Rev. date, name of document, document version, folder path, and status at a minimum. As all food safety professionals know, Murphy's Law is in full effect when the auditor comes to visit so if you forgot to update one cell, you can be sure that it is the document they look at during the audit.

 

Best of luck to you!

 

-Chris

[Cravin' Cajun?]

BRC auditor suggested we add the words, "Uncontrolled document, if printed" to the footer of all SOPs, Work Instructions, etc. and we haven't had any problems since!

[Charles.C]

Dear All,

 

It is undoubtedly true as indicated in this thread that where all interactions can be done direct to/from a dedicated computer(s), document control can be somewhat smoothed out.

 

Unfortunately, IMEX, there are many, many locations where such technology is a mere dream and the  situation as spelled out by Setanta is the norm. Mainly for the latter type of case, I  have listed below (A-E) a few of the more common disasters I hv encountered on both sides of the audit fence plus a few more options (1-3) not yet mentioned which I have personally found useful.

 

(A) Multiple photocopies are made of  all black/white “controlled” documents. Known as  the “squirrel effect”.

 

(B) Same error for non-black/white originals. It will occasionally happen despite the improbability. Often in overtime production.

 

(C) The near-irresistible dodge to use “printed > “uncontrolled” + transfer of  document responsibility to the recipient can rebound with severe consequences all round. Human error is ubiquitous and internal audits not failsafe.

 

(D) A QA-donated responsibility to maintain a Distribution Control scheme for “controlled documents” will be immediately de-prioritised.

 

(E) Stamping utensils, eg “Controlled” are capable of  mitosis.

 

 

(1) Include a  specified  period of usability with respect to the current date in the footer for key printed documents, particularly where procedures are under development/change. Can assist in self-control.

 

(2) When initiating a FSMS system, collect  all the (probably) non-compatible, pre-FSMS documents (usually in the hundreds) into one “lumped manual(s)”. Implement a  specific document control system on the manual which avoids selective  re-naming / re-dating of pages etc but still complies with the Register concept. Specify the existence of this exception within the general Document Control Procedure.

 

(3) Include an “exception” in the general Document Control Procedure for Emergency situations. It will happen.

 

Rgds / Charles.C

[bacon]

This is all very... *shakes head*... I gather that nobody is looking at 21 CFR Part 11 perchance?  It is 2013.... Sorry for bring it up here but it does seem relevant (and my previous posting on this has had many views but no response).

 

This has to do (on the US side) with US Federal Regulations concerning Digital Signatures and Electronic Records. Originally written in 1997 for the medical device industry (but still under food safety regulations), I see very few food manufactures venturing into this area this area.

 

I hear from auditors I know dealing with the excuses when the digital documents (not even commenting on the 21 CFR 11 legal requirements) not being available at the time of the audit.

*shakes head*

 

There are many systems (ERP, Production, Document Control, etc) that say that they are "technically complaint" with 21 CFR 11... but anybody using them? And happy?

 

PS - for you on the other side of the pond, EU DIRECTIVE 1999-93-EC would be in the same category of discussion.

 

FYI: anybody providing software that is 21 CFR Part 11 complaint have generally done their homework and can deal with all BRC, SQF, et al requirements.

 

Cheers,

-Baron

[TheDude]

I am still reading this code as it refers only to policies, procedures and selected recordkeeping forms. The only line in the guidance that refers to any recordkeeping documents reads "This includes forms which are the templates for records that are used to report test, inspection and audit results." We have so many daily papers that it would be a large task for 1 person to control all of the documents. We also run continuously. If the night shift runs out of a form, then what? Charles C recommends including an "emergency" acceptation in the policy.

 

To sum it up, I am still questioning if we have to include paperwork such as a batch sheet or a form used to document cases produced per batch.

[Tony-C]

I am still reading this code as it refers only to policies, procedures and selected recordkeeping forms. The only line in the guidance that refers to any recordkeeping documents reads "This includes forms which are the templates for records that are used to report test, inspection and audit results." We have so many daily papers that it would be a large task for 1 person to control all of the documents. We also run continuously. If the night shift runs out of a form, then what? Charles C recommends including an "emergency" acceptation in the policy.

 

To sum it up, I am still questioning if we have to include paperwork such as a batch sheet or a form used to document cases produced per batch.

 

Normally for records you will have master copy or maybe several master copies which are registered and controlled.

 

Being practical these master copies are photocopied as they could be used hundreds of times in a week. When a record is changed the old master copy is archived, the new master copy issued, any photocopies are destroyed, relevant staff are notified of a change and a new register is also issued. To facilitate control it is better if the photocopies are held in a fixed/known location before being issued for use.

 

Routine checks & auditing against a register of current records should pick up any issues with control of records and if your system is working or not.

 

Regards,

 

Tony

[Ruhama]

Dear all

 

Indeed this is interesting topic, I am using controlled stamp to stamp all print outs. Last when I was communicating the mock recall procedure to involved parties they wanted to have copies of that procedure. so I refused to give them, while reading wht Cazx is saying is that means I can give them the copies but they should sign for them?

 

Can't beat an old fashioned spread sheet

 

Document number / id

Document title

Version Number

Version Date

Copies in circulation

location of documents

Author of document

Authourisaton by

 

Make sure your register is controlled too!

 

Cazx

[Ruhama]

Dear all

 

Indeed this is interesting topic, I am using controlled stamp to stamp all print outs. Last when I was communicating the mock recall procedure to involved parties they wanted to have copies of that procedure. so I refused to give them, while reading wht Cazx is saying is that means I can give them the copies but they should sign for them?

 

Can't beat an old fashioned spread sheet

 

Document number / id

Document title

Version Number

Version Date

Copies in circulation

location of documents

Author of document

Authourisaton by

 

Make sure your register is controlled too!

 

Cazx

[Charles.C]

Dear Ruhama,

 

 

I don't understand the problem.

Why not give a copy without the stamp so just a "procedure"?

Or stamp "SAMPLE ONLY" on it.

 

Rgds / Charles.C

[GrumpyZA28]

Greetings all,

I am employed as a QA: Compliance Officer for a large retail manufacturer of RTE Meals (Chilled and Frozen).

Documents of our FSMS have a "standard" header which identities it as a System / Controlled Document. Consequently, only myself have the authority and responsibility to draft, approve, review, amend and control documents. NO hard copies are issued without an prefab (manufactured) "authorisation stamp"; something like this:

____________________________________

|        CONTROLLED             |

|        DOCUMENT                |

____________________________________

I add my signature and date of authorising this. All our printed documents issued are B & W; the stamp pad is GREEN to ensure no photocopies are passed off as authentic.

An unplanned plant walk-thru had, without fail, highlighted attempts to by-pass the system. Several dismissals were sanctioned to individuals brought up on disciplinary charges.

I trust this illustrate the severity of the statement: " FOOD SAFETY IS NOT NEGOTIABLE!"

 

I am a frequent 'visitor' to IFSQN; this is an invaluable "colleague" gauge for recommendations on tackling FS-challenges in our sector of industry.

 

Sincerest Thanks to ALL CONTRIBUTORS
 

[Tony-C]

Very good GrumpyZA28, I'm sure that other managers can review and amend etc. but you control the issue of the new document?

 

Don't forget to follow up and withdraw the old documents when you issue new ones.

 

What do you do regarding records?

 

Regards,

 

Tony