8 replies to this topic

[guardiansofthequality]

I've recently joined a company that has had some bad luck with their last 3 practitioners. It's clear to me that these practitioners lacked the attention to detail to maintain a food safety management system properly. Many documents are completely missing, most documents don't match one another in terms of the numbering system, many include contradictions in procedure and policy, in-text citations of external documents are inconsistent, and revision dates and change logs are incomplete. Some SOPs/forms I have found several files for and it isn't clear to me what the most recent validated document was. 

 

I've begun the process of basically rewriting their entire program from scratch for SQF modules 2&11, but the lack of continuity has me concerned about the best way to document the transition from the previous system (or lack thereof) and the one I'm designing. 

 

For example - I found two files for a Corrective Action Register. It's not clear to me which one is the most current, and to be honest they both kind of suck. So I'm designing a new one. But neither of the old ones had a revision number or a creation date, and there isn't even a reference to this document on the Doc Revision Register, so I don't even have an amendment history on it to refer to. Almost every document has some sort of issue like this. 

 

As long as I archive the old system, my question is can I treat my new SOPs, forms, WI's, etc. as "Revision A" and do a complete system reset? Or do I need to try to maintain a through-line from old, incomplete, or non-existent records? 

[saraclemens]

Hello!

   

To answer your specific question (25 years of document control multi-industry), yes. I reference the old document # and rev in my revision history and start over at 01. In cases similar to yours, I also make a disclaimer statement in my procedure that covers the documents in process of rewrite and nomenclature change.

Having created and recreated multiple systems over the years, I think the biggest challenge you may face in this is the management part of your system - more specifically - the "management" personnel. In my experience, it is not the prior SQF practitioners to blame, they probably worked within the constraints given. 

 

The most common denominator in coming into companies that require overhauls was lack of support from the management team. I think you will see what I mean. 

 

Good luck! Enjoy your creation and experience gained from this process. It's been one of my personal favorites, in spite of having to redefine what constrains me. 

 

Thanks

Sara

[nwilson]

I had to do the same with a company I started with over a year ago (SQF as well), they have been in business for over 26 years and had several QA touching and modifying the FS&QMS.  I just rewrote the whole program and archived the older one and added into my change control log the reasoning stating: "SQF/FS&QMS rewrite to align to SQF Code and Regulatory Requirements".  Went though and unannounced last cycle and an FDA inspection this year no issues auditor/inspector wise.  Just make sure you can speak to the reasoning, which in my case (similar to yours) is that is became convoluted and couldn't be adequately maintained or updated, nor working for the process and need a refresh.  

 

Best of luck.  

[jfrey123]

My start in QA was being hired by a company to rewrite their existing, crappy SOP's into a new format prior to their first SQF audit.  At the time, we were adapting old programs into a new format with sometimes a different title and always a new policy control number.  On the revision history for each new document, we put the published date and stated "New Document:  Formerly "blah blah program" document xxxx.  Updated to fit new program template.  Updated [any actual information that got updated]."  It provided us a chance to completely restart the revision history for the whole FSQMS, and referencing the old document gave us the continuity to show any auditor who asked to see prior document history.  None of the SQF auditors who ran through that facility in my time had an issue with that.  When they would ask about it, we were upfront:  our old documents sucked, lacked information, and we did a huge cleanup of the FSQMS to improve our system.  They liked it.

 

That said, I do not envy the spot your in.  I wish you copious amounts of coffee and hope you have a comfortable keyboard.

[lillabec]

Ugh i feel you, I'm in the same positon...luckily I have corporate policies to refer to, but our facility-specific policies that elaborate on the corporate requirements were a total mess. I've been re-writing them all as addendums to the corporate policies, they used to be carbon copies of old versions of the corporate policies with facility specific policies and procedures randomly thrown it. I've been working on it for yeeeears now, separating out procedures and aligning to the corporate policies. It's like a really un-fun scavenger hunt at times. I wish you luck in your endeavors. 

[SQFconsultant]

Pull the old tire off (entire doc system plus all supporting docs) and stick that in a file.

 

Write you entirely new system + go thru all the group exercises as if you were just preparing to get audited the first time.

 

Stick a statement page at the front of the binder fir module 2 indicating that the entire SQF system was re-done (this for the benefit of the auditor) and do the same for your module 11 binder.

 

Your Auditor will fully understand and appreciate what you did.

 

As a Consultant we write entire doc systems and sometimes do patch work on old tires but frankly and most times when I am told that all I really need to do is update We most times find it easier and better for the client to pull the old tire off and replace it with a brand new one.

 

You'll just need to reference back to the old system that you have it but that your new one replaced it.

 

You may need to go over the facilitya with a fine tooth comb to ensure there are no un-controlled docs related to the old system as this can wreak havoc during an audit when the auditor finds 3 different metal detector procedures and the line operator does not know which is which.

 

So its a real top down and bottom up change out to undertake, but much better than patching the tire.

[G M]

...Many documents are completely missing, most documents don't match one another in terms of the numbering system, many include contradictions in procedure and policy, in-text citations of external documents are inconsistent, and revision dates and change logs are incomplete. Some SOPs/forms I have found several files for and it isn't clear to me what the most recent validated document was. 

...

As long as I archive the old system, my question is can I treat my new SOPs, forms, WI's, etc. as "Revision A" and do a complete system reset? Or do I need to try to maintain a through-line from old, incomplete, or non-existent records? 

 

I inherited a patchwork of documents and rewrote the safety and quality systems entirely.  In most cases what will matter is the current procedure, and old forms, policies, etc. will just need to be kept around as reference for the next few audits if there is a major difference or the auditor asks to review older material (most aren't going to bother to look back past the last audit).  

 

Document numbers and versions format can change entirely, and the first generation I wrote had a mix of "New" and one or more references for the "Supersedes" field to keep track of what it replaced.

[AltonBrownFanClub]

I feel for you too. This has been an ongoing task at my current job.

 

I found it much easier to start over and establish my own revision/ version format.

I add a footer to each document that has 3 sections.

 

Left: Company Name 

Middle: Document Name & Version (ex: Glass & Brittle Plastic Policy v4)

Right: Date of Last Revision (ex: 9.05.2024)

 

Details of each revision can be recorded in an Excel spreadsheet.

My columns are:

Date, Document Name, New Document Name, Summary of Changes

9/05/2024, Glass & Brittle Plastic Policy v3, Glass & Brittle Plastic Policy v4, Updated locations, added new clock to register...

[Tony-C]

Hi guardiansofthequality,

 

 

Welcome to the IFSQN forums

 

I would start again as others have posted. You can always extract anything useful from the old system and put it in your new system as a new document or record as appropriate.

 

Clearly the changeover needs to be carefully managed so preparation and planning from old to new is required.

 

Good luck, some will say it is a nightmare but I would it regard it as an opportunity, ‘new broom sweeps clean’ sort of thing.

 

Kind regards,

 

Tony