6 replies to this topic

[JJF]

Hi Everyone -

 

I was wondering if anyone has a procedure for when FM is found in the production process, specifically for items that are not metal detectable. We are working on writing a procedure that our supervisors can follow should anything be found. This is stemming from a recent incident where a pair of safety glasses had been dropped into a machine which led to the plastic pieces being found in our product piping. 

[Dorothy87]

Hi  

 

a few thigs : 

 

- Staff should be fully aware to report such incidents to the management immediately 

- Staff / Production supervisor should stop the production immediately

- Ingredients / mix / machine must be placed on hold

- QA & Technical must be informed immediately to conduct investigation - all pieces shall be accounted for (if possible) 

- Cleaning / pipes flushing shall be supervised with QA/Technical and at least shall be done twice 

[MDaleDDF]

Ouch.   What's your product?   

 

This is exactly why my crew is no longer allowed safety glasses on the floor.....They're not needed, there's no danger of them suffering an eye injury due to the process itself.    If it were me, I'd ditch those if possible, or look at x ray?   What if a pair fell in and nobody noticed?   Is it possible?  

 

Again, this all depends on your product of course, I have no idea what you product or process is.   But here, no way.....

[GMO]

I think there should be something in your overarching non conforming product procedure which should cover this off.  I wouldn't necessarily write something different.  

 

So in that (and in your training) there should be a principle that if there is known contamination or found contamination that the line is stopped and someone in a position of authority and Quality is alerted.  The general principle then being:

 

The product or work in progress is held, risk assessed, rescoped if necessary and then if necessary, rejected and destroyed with records of destruction and appropriate communication.

 

It should include roles and responsibilities (particularly it's important to know who has authority to release if you do), how quarantined stock is made clear to staff (e.g. labelling or on electronic systems) and what to do with product which has been made with any impacted ingredients or work in progress.

 

After all of that your process should capture that RCA should be part of closing out any significant incident.

 

I think then it keeps it vague enough so that if it was, say, a chemical contamination incident tomorrow, the process still works.

 

Lastly and perhaps most importantly, from a cultural point of view, it's important to train your managers that if someone does step up and say "I've made a mistake" that it's treated in good faith that it's better to make the problem visible.  Issues like this lead to large rejections when people try to keep it quiet.  And it does sound a bit like that happened in your case by the way it was "found".

 

As for avoiding glasses getting in your machinery?  There are some options.  Did you know for a start that safety glasses are not great for chemical use normally?  The reason being they have gaps where a splash could still get in the eyes.  If you want chemical safety to be assured, goggles are much better and have a strap which keeps them attached to your head.

 

So if they're using the safety glasses kind it might be worth pointing out those aren't actually very good protection so either they're not needed or not effective...

 

Secondly, also I would agree that trying to design out the risk is a good idea.  If your machine is say a filler or a cooking vessel has a big opening, a simple mesh of, say 1-2cm on top is enough to capture most "whoops!" moments.

[JJF]

We are making a meat, rolled product. Safety glasses are required, so we can not eliminate them. We are sourcing metal detectable ones now as an additional safe guard. We have pumps and other pieces of equipment that any FM can get caught in. However sometimes determining where the entry point is, proves to be difficult or requires hours of camera work to find. 

[G M]

I would keep any written correction policy very simple, to help retain usefulness and applicability to a wide range of theoretical FM incidents.  If it gets too specific, your inspector can just claim you didn't follow your written procedure and slap a regulatory hold on it or give you an NR.

[GMO]

We are making a meat, rolled product. Safety glasses are required, so we can not eliminate them. We are sourcing metal detectable ones now as an additional safe guard. We have pumps and other pieces of equipment that any FM can get caught in. However sometimes determining where the entry point is, proves to be difficult or requires hours of camera work to find. 

 

I'm still not getting why this is a significant hazard and parts of those glasses will still by definition not be detectable.  However, the person knows when they've lost their glasses, especially if they're on their face, held on with an elastic strap.

 

• I would focus as I said earlier on three things, a good but generic procedure for non conforming product.
• Building psychological safety so that the team know that if they make a mistake they can put their hands up and admit it.
• Preventing accidentally falling in to start with by using physical barriers if possible or different glasses which are less likely to fall off.  Or if you found that they fell in because they were stored somewhere inappropriate when not in use, provide a sensible storage location which isn't as likely for them to fall into product.

I think there is a knee jerk reaction as Technical people that we have to go to "detectable" but much as in my, and others, previous posts on hierarchy of control, the best place to start is preventing the contamination to begin with or, if it does happen, limiting the scope of it.

 

I would focus personally on a good generic process and then really do some solid RCA with your team on why this happened and the potential preventive actions.  I bet you detectable glasses will not be high on the prioritised list of things you could do (often cheaply) to prevent this recurring.