6 replies to this topic

[it_rains_inside]

So I probably could have done a poll on this, but just thought I'd throw this out there....

 

Has anyone ever hit a big issue internally, and NOT generated a corrective action for it for whatever reason??

 

Maybe no mgmt backing to fix the problem, not enough resources, etc.. [ you know if wouldn't be taken care of properly]

Maybe it is an issue that you wouldn't want found out during a third party audit, etc... [ documenting it as part of the CAPA program means you have to admit failure in an area where it may cause more problems ]

Maybe some other third reason I cant think of because I am over-worked, sleep deprived and delirious...

 

Or maybe you've had a bigger issue and carried out a corrective action but kept it "off the books" so to speak so that it can only be tracked internally... under the radar.

 

So tell me.... does this happen?? What's your story??

 

 

 

[MWidra]

Ooh, this is a "touchy" subject.  And I don't mean touchy-feely either.

 

I have not seen this happen here...yet. I have made decisions that something did not rise to the level of a documentable corrective action and should be handled less formally, but I've always got records of the situation.  That's for CYA as well as continuous improvement.  If it's food safety, the HACCP Committee is kept in the loop.

 

At my last position, I saw that a state agency had not been properly notified of a situation.  In that case, there was a plausible scenario for the situation, which was legal, but it could not be verified.  The person in charge of that function just decided that the scenario was correct, and did not discuss it with the agency.  Likewise, it was not recorded anywhere.  I had no authority for that situation, but it did not make me comfortable.

 

It happens, but we hope not too much and not for anything that could cause damage to people.

 

Martha

[fgjuadi]

At the last job I was fired from

 

We treated our (infested) facility with dichlorovous (aka Vapona) - I had to get a special license to supervise our employees, and we got to do blood tests, and wear masks and release the building.

 

Well, if you have organic in your facility, which we did, you have to move it out, because dichlorovous isn't allowed for organic food (and frankly I'm amazed it hasn't been banned for people food, despite petitions almost annually)

 

So we would move the organic out to our trailers outside.  The lines took like 16 hours to clean, and that was all done -pre shut down.

 

Because we would be bringing organic product in first, it was easiest for clean out schedules etc to bring it back and run it (no pre-organic clean out, because the lines had been cleaned the weekend before fogging)

 

But we never cleaned the surfaces of the equipment after fogging.  Just ran.  And started with organic!      And the place was so gross after we fogged- you could feel the film on desks, chairs, everything.  

 

We had General Mills as a customer and they tested our product and when, came up with dichlorvous.  It's half life is very short, so we waited a week and sent them another sample from the same lot, which was magically negative.  

 

I wanted a pretty simple corrective action as the Sanitation Supervisor / Pest Control "Guy" - wash the lines before running.  The QA Manager & Plant Manager looked at the clean time and flat out said no, then got very, very angry at me for suggesting we test it, and refused to acknowledge that they were actively contaminating their IP foods with pesticide.

 

So I brought it up during our next audit.  

 

Then I got fired a couple days later (mostly for other things, but probably also for this).   In the mean time, they're gotten NOP certification as well, and maintain their organic cert, so .. either they went ahead and fixed or they're still doing it.  Either way, I don't use them as an ingredient vendor, and I never ate the stuff from there when I worked there.  

[it_rains_inside]

Thank you guys for sharing...

 

I know what you mean Martha... this can be touchy...

 

I bring up the question, because obviously this is something I have been asked to do. And it makes me feelers tingle when I think that this may be taboo.

 

Every quarter, we do a mock recall for a customer. They send us the form and give us a due date - on good faith we record our own start / stop times and pick ingredients and primary packaging. Then just report back  to them with what we did.

For the ingredient - we were WAY outside of our allowable variance. Like almost 18%. So they scrapped that result and picked another ingredient to trace. I told the food safety team we should do a corrective action on this. Plant mgr said if the CA points to spending money on a better inventory system or yada yada than we aren't doing it because it works 99% of the time.

 

We did a little investigating and changed some practices... mostly had to do with weighing procedure. However, the QA manager told me not to make this a formal CA. Keeps the records of when it happened and what we did. But in the event an auditor (like our BRC auditor, or customer, regulatory, etc) looked at CA book and saw we had an issue with traceability. That was a road he didn't want to go down. 

 

It just kinda feels dishonest... and counterproductive to continuous improvements to hide a failure... no matter how big or small. 

[fgjuadi]

Thank you guys for sharing...

 

I know what you mean Martha... this can be touchy...

 

I bring up the question, because obviously this is something I have been asked to do. And it makes me feelers tingle when I think that this may be taboo.

 

Every quarter, we do a mock recall for a customer. They send us the form and give us a due date - on good faith we record our own start / stop times and pick ingredients and primary packaging. Then just report back  to them with what we did.

For the ingredient - we were WAY outside of our allowable variance. Like almost 18%. So they scrapped that result and picked another ingredient to trace. I told the food safety team we should do a corrective action on this. Plant mgr said if the CA points to spending money on a better inventory system or yada yada than we aren't doing it because it works 99% of the time.

 

We did a little investigating and changed some practices... mostly had to do with weighing procedure. However, the QA manager told me not to make this a formal CA. Keeps the records of when it happened and what we did. But in the event an auditor (like our BRC auditor, or customer, regulatory, etc) looked at CA book and saw we had an issue with traceability. That was a road he didn't want to go down. 

 

It just kinda feels dishonest... and counterproductive to continuous improvements to hide a failure... no matter how big or small. 

Oh, that's a weird one.  It seems so minor and totally fixable (actually it sounds like you already fixed it!)

 

I understand that you don't want to raise any red flags, but it sounds like you followed through and did exactly what you were supposed to - stuff happens in a factory, and you document it, then correct it, then document that the problem is corrected.  

I think it's a bigger flag when you review records and all you have are 100% perfect, no corrective action ever results.  But it does seem strange and unnecessarily cagey

[MWidra]

Human beings have a predisposition to sweeping stuff under the rug and not owning up to problems.  I think it's in our genes.  It takes an effort for most people to make things totally transparent.

 

So having someone say, "Don't write a formal CA up, just fix it and move on" is understandable, but it makes some of us uncomfortable.  We wonder where the line will get drawn to move over into a CA, or if that person will never want a CA. 

 

The best way to show continuous improvement is to document that problems are fixed.  Maybe fostering that mind set can help people do more formal documentation of problems and solutions.  But, human nature is hard to fight, it's been in existence for thousands of years.  It's based on fear of failure or of being found out.

 

We can learn from Dune...

 

“I must not fear. Fear is the mind-killer. Fear is the little-death that brings total obliteration. I will face my fear. I will permit it to pass over me and through me. And when it has gone past I will turn the inner eye to see its path. Where the fear has gone there will be nothing. Only I will remain.”

 

When we bring problems into the light of day, and conquer/fix them, it feels so much better.

 

Martha

[SLadd]

It's all in how you word it. Rather than make a corrective action for having lost control of your ingredients, write one up for.. oh let's say... during an internal review it was determined that some of the weighing practices were not being performed accurately. Bam, documented corrective action and continuous improvement with no reference to the customer or the issue that management would rather not have on the books. When things get touchy, sometimes you have to start your corrective actions from the end rather than the beginning to make everyone happy or at least not angry.