5 replies to this topic

[Larsson89]

Hi, everyone

 

I have a finding from an audit that I am struggling with the root cause. The auditor reviewed our and mock recalls and found that we have not done a mock recall with a product that has been reworked. 

 

I argued that the requirement says that it should be considered - which it is in the procedure and does not state that a mock recall should be conducted with reworked product, but the auditor insisted that there should be a mock recall with reworked product. 

 

We also have a rework procedure which addresses the requirements in iso 22002-1. 

 

Any guidance will be appreciated.  

[GMO]

Personally it depends on the audit on whether I'd raise that.  It's not a specific non conformance in most standards I've read (which standard was the audit against?)  But is it good practice?  Not really.  If you routinely rework product and then chose the one production run that you didn't have rework in that's called "cheating".  

 

Ok I'm being a bit cheeky in that but it's not really testing your system is it?  

 

So should it be a non con?  Against the letter of most standards, it probably would not but would I raise it as an observation if your trace for the last year didn't have rework and it's something you do most of the time?  Yes.  If you've never tested your traceability with rework, but that's your routine production method, then I think that is a valid non conformance whether it's explicit in the standard or not.  Then you're definitely cheating.  If you do rework for about 20 minutes once a month but had never completed a trace with rework, then I wouldn't raise a non conformance.  I'd raise an observation that it would be good practice for your next traceability test to include rework but that your existing traceability covered the vast majority of your production, I wouldn't see it as a non con.

 

I think it comes down to intent.  If you routinely do rework but your traces miraculously avoid those runs, then you are, in all likelihood, deliberately selecting those runs because you doubt your system is robust.  If you don't routinely do rework, it's once in a blue moon, then if you'd not tested a run with rework it's just as likely to have been by chance for the products you chose.  The former situation would set me on edge as an auditor and make me suspicious.  The latter would make me think "ok, but you could challenge yourselves more."

Edited by GMO, 15 April 2025 - 04:13 PM.

[Scampi]

I think your auditor is overstepping saying you MUST

 

However, best practice dictates that you should include reworked product to ensure your PROCEDURE and PROCESS are working as intended

[jfrey123]

Agree with above that it's a stretch to say rework must be included in a mock recall.  I'm most proficient in SQF and I'd say at best it's a gray area.

 

Nothing in 2.6.2 Produce Trace or 2.6.3 Product Withdrawal and Recall specifically calls out rework.  Though in 2.6.3.2 I'll admit there's gray:

 

2.6.3.2  The product withdrawal and recall system shall be reviewed, tested, and verified 

as effective at least annually. Testing shall include incoming materials (minimum 

traceability one step back) and finished product (minimum traceability one step 

forward).

Testing shall be carried out on products from different shifts and for materials 

(including bulk materials) that are used across a range of products and/or products 

that are shipped to a wide range of customers.

 

Auditor might argue that if rework is used across a "range of products", then including a reworked material in the mandatory trace could be valuable (borrowing from GMO's opinion above).

 

 

2.4.6 Product Rework

2.4.6.1 The responsibility and methods outlining how ingredients, packaging, or products are 

reworked shall be documented and implemented. The methods applied shall ensure:

 

ii. Reworked product is clearly identified and traceable;

 

iv. Each batch of reworked product is inspected or analyzed as required before release;

 

If an auditor's point was to say that you need to prove you can trace your rework, I'd argue that your analysis/inspection step done at the time of the rework can be reviewed and deemed sufficient to prove you maintained traceability of the rework.

 

 

SQFI | Code Document

Guidance website for mock recalls states:  "These records [mock recall records] may include production records, raw materials receiving records, rework records, product holds, and product storage and distribution records.

 

"MAY INCLUDE" is not a mandatory "MUST INCLUDE" and absolutely provides recourse for an auditor to make a casual observation, but I don't feel it's worthy of a finding alone.

 

Just my opinion based on my SQF reading, not sure what other codes specifically say about it.

[Larsson89]

Thank you everyone for your responses. It really helps. 

 

I do agree that the auditor was overstepping, although some of them tend to have a reputation to uphold and are known to have a finding that is questionable. 

 

We do not rework on a regular basis, but sometimes it does happen more often than we prefer. 

 

We are audited against the FSSC 22000 V6 standard, which comprises of ISO 22000:2018, ISO 22002-1:2009, and FSSC Additional requirements. 

[GMO]

I always find FSSC a bit woolly.  So I agree that if you believe it's not a risk, then you probably shouldn't have had a non con against it.  BUT, I would probably just take it on the chin because even if it's not really a non con, and even if I was a bit cheeky in my response earlier, I really think if you're in the situation where rework happens "more often than we prefer" that you would be testing your FSQMS better if you included runs in your traces with rework.  

 

There are loads of Quality Managers out there who think their jobs are to pass audits.  It's not.  it's to help sites make safe and decent quality food.  You'd do that better by making sure all your internal verification processes are really challenging.