6 replies to this topic

[maria_esparza-]

Hello all,

 

I have my overall Master Document List where I list out every single document that is part of the SQF System, along with a written out schedule on when to make changes on documents.

 

I have completed my P-220 Document Control & Records, which states that all documents follow a specific template and coding system. 

 

Unfortunately, I took over a previous quality manager last October, who had neglected the SQF system (I don't know for how long), and I had to play catch-up, create new records, and now I am slowly making changes. I have an unannounced audit coming up, and not all of my documents have changed to reflect what is stated on P-220.

 

I wouldn't want to just change all documents to reflect the new template and their own coding system, and leave all the procedures as is, as they are quite incomplete.

 

Thinking of the upcoming unannounced audit, would it be better to simply make the template and coding system changes, and change the "meat" later on? Or am I able to show my schedule for when changes are scheduled and keep making good and complete changes as I have?

 

TIA:)

[SQFconsultant]

"Or am I able to show my schedule for when changes are scheduled and keep making good and complete changes as I have?"

 

You can do that, however you will need to have a very good explanation for the Auditor when asked.

[maria_esparza-]

Thank you for your reply!

[jfrey123]

I wouldn't want to just change all documents to reflect the new template and their own coding system, and leave all the procedures as is, as they are quite incomplete.

 

Thinking of the upcoming unannounced audit, would it be better to simply make the template and coding system changes, and change the "meat" later on? Or am I able to show my schedule for when changes are scheduled and keep making good and complete changes as I have?

 

TIA:)

 

Agree with SQFconsultant above, but you're opening the door for the auditor to dig deeper into your reasoning and you'll end up admitting your programs are weak to them.  "I haven't changed the template and numbering on all of the documents because they're wrong and I want to fix them all at once" is going to invite the auditor to really nitpick the programs and find the flaws you admitted to.

 

As the cliche goes: How do you eat an elephant?  One bite at a time.  In your shoes, I would revise the entire program into your new template/format.  That alone gets you out of a finding for not following your own document control procedure.  That's the one bite you can take right now while staring at the rest of the elephant you have to eat.

 

From there, take the assessment tool spreadsheet and audit your system.  Keep in mind 2.5.4.1 requires:  i. All applicable requirements of the SQF Food Safety Code: Food Manufacturing are audited per the SQF audit checklist or a similar tool; ii. Objective evidence is recorded to verify compliance and/or non-compliance;  So you have to show how exactly you comply (or don't comply) with each line item of SQF code.  You can use this tool to record these neglected programs, document your changes to them, and it helps to cover why there might be missing records or non-compliances from the year prior that weren't captured.  If you've found the problem yourself and can show a good CAPA that closed it, most of the time it'll avoid a finding in your actual audit.

 

Say you come up with 10 programs that need to be revised and validated during your assessment.  You might get through 7 of them before the unannounced audit, but if you can show an action plan was formed as part of the open CAPA you have for those, sometimes it is sufficient to get out of it being a finding for the auditor.  Not always, but sometimes.  Auditors hate to hear "well the last guy screwed up" when it comes to a problem, but they're human too and if you can demonstrate how you're bringing the program back into alignment, they're usually open to a discussion.

[maria_esparza-]

I hate to admit it, for what is ahead of me, but you have a great point. Thank you, jfrey123:) I never would have thought of opening a CAPA for this! 

[kingstudruler1]

Were / are there issues with the P-220 /"old" template and coding system?  If the template and coding system are not in violation of the SQFI standard, why change now?   

Or if possible, rewrite the procedure vague enough to cover both the old and new "template" and "coding".  Fix the rest after the audit - again this only applies if there is not currently a food safety issue or SQFI noncompliance with the "old" way.  While I am no fan of complacency, the program has in theory been auditied twice by SQFI.   

 

I too would do exaclty what JFREY stated in regards to auditing and entering a non conformance for those programs that are deficient.  The self assessment / internal audit form is a great place to do this.  

[maria_esparza-]

Were / are there issues with the P-220 /"old" template and coding system?  If the template and coding system are not in violation of the SQFI standard, why change now?   

Or if possible, rewrite the procedure vague enough to cover both the old and new "template" and "coding".  Fix the rest after the audit - again this only applies if there is not currently a food safety issue or SQFI noncompliance with the "old" way.  While I am no fan of complacency, the program has in theory been auditied twice by SQFI.   

 

I too would do exaclty what JFREY stated in regards to auditing and entering a non conformance for those programs that are deficient.  The self assessment / internal audit form is a great place to do this.  

 

In my personal opinion, it was too vague, and to top it off, it wasn't being followed! From my understanding 2.2 it is meant to be a detailed procedure on how we do things in the facility regarding document control.

 

All of the system codes were all over the place, and we had no real document/sheet/way to track said documents. Some of the documents had no control due to them simply being created and released without following the old procedure (before I got here). There was no way to track current from old. Even with revision numbers, there were multiple copies with different content. I believe I spent about 2 weeks going through the drive collecting documents to put all in one place. And to this day, I am still finding stragglers! 

 

It was easier for me to create P-220 first to get a grip on things, and to make the changes I wanted to following an actual system. I do get your point though. I would not have put myself in this conundrum, had it been fine, but I dare say it was rough!