2.6.3.2 - determine the root cause of a withdrawal or recall?

Hello,

Hoping someone can give me some advice. We've been working on implementing SQF for almost a year and are preparing for our certification audit. We had a pre-assessment audit and there were a few points where the auditor gave us a minor for not having documented things that hadn't occurred yet.

We have our actual desk audit in a couple of months and I'm wondering if we're going to need to show evidence for 2.6.3.2, investigation shall be undertaken to determine the root cause of a withdrawal or recall? We don't have (and hope to never have) a recall. Should I do a mock investigation with my mock recall in order to satisfy this? Any other advice?

Thanks!

Kelley P

sooo... you got a non conformance for never having had a recall?

i'll go out on a limb here but I think what your auditor means (I have a few ideas)

1) they found your recall procedure did not initiate a Corrective Action, which in turn would require a root cause analysis and a CAR is how you would document the evidence

2)or possibly they found your Corrective action procedure to be inadequate which would not allow you to provide evidence for the recall. do you state in your Corrective action procedure what form of root cause analysis you use I prefer 5why over fishbone type.

3) when you did your mock recall did you do a traceability exercise or did you create a scenario?

I had a similar NC during certification but he gave me a  NC on recall procedure for an inadequate CA procedure not on "not showing evidence" that never happened... that would be forging documents

You could do a mock investigation to show the auditor how you would react in such a case. However, I am curious what your withdrawal/recall SOP says about investigating the root cause. If there isn't a section that already addresses investigating, I would add one and assign responsibility. Also, you could create a form for investigating the cause of a recall that you keep stored. That way you can show the auditor what you would fill out if such an event occurred.

I run a mock recall and do a full investigation into the cause and document corrective actions.

Last year I ran a mock recall on peanut contamination in a non peanut contamination. I 'staged' a scenario where the decant team 'dropped' a bag of peanuts and a handful of peanuts found their way into another raw material container that was then used to manufacture a non peanut product. Allergen spillage proucedure was not complied with.

Of course none of this actually happened but in the course of my mock recall I stated the above as my findings from my investigaiton.

I then could document corrective actions - retraining of staff in allergen spillage procedures etc etc.

That was I could demonstrate how my system works in a 'made up' situation.

And you should not get an issue about falsifying records as long as oyu are clear that these are 'mock' records for a 'mock' scenario.

S

This is all terrific input! Yes my corrective action procedure was deficient in the method of determining root cause at the time of the pre-assessment (I've remedied that since.) I have a mock recall to do in the next week and will definitely use all of these suggestions.

Grateful to have this community!

I found this webinar that was extraordinarily rich with details : http://www.saiglobal...all-webinar.htm

Although the title uses the generic GFSI, the webinar actually uses the BRC code in its examples. It's a free, on-demand webinar, but you do have to fill out a form to gain access.

Regards