3 replies to this topic

[salesmch]

Hello. I have a question for which I need feedback.   Our company is fairly small and we produce one item that is used in food packaging.  We have built a room within our plant just for the production of the one item and have begun having 3rd party audits for GMPs.  

 

Part of the audit covers our glass and brittle plastics program and we've scored quite well on this section. There are always 1-2 items that somehow don't make it to the list that are revealed during the audits. Meanwhile we are continuously adding items to the list from our self-audits. Most of the items are well outside the room that contains the food packaging items.  So we wonder why they even have to be listed.

 

Over the last few years, the list of items for inspection has grown to well over 100 items.   My question:  How can you effectively maintain such a list?  We try to have different people in our company do our safe, brittle plastic self-audit but just knowing all the names of the various machines makes it difficult.  For example, one item on the list might be a guage on a certain machine. To complete the self-audit, one would have to know what each machine in our plant is called and there is quite a large number of different machines, many of which are quite small and get moved around. So they aren't likely to be in the same spot the following month.  So basically, my question is how do you manage such a program?  We even thought of numbering items with stickers.  We thought of adding pictures of the various machines to our list.  Any thoughts and experience in dealing with this issue?   

 

Thanks in advance for your help.

[lmarquez]

Hello,

 

When in our company we have all equipment identified by asset number. This helps us for both preventive maintenance and identifying all equipment, so on our register we refer to the equipment description and our asset number, because we also relocate our equipment constantly. We are constantly also updating our register as well, i dont think there is a more efficient process, but it helps if you assign someone to do the task, this way they become familiar with all machinery and possible locations.

[Charles.C]

Dear salesmch,

 

Factories which have 50-100 spring balances, all with brittle plastic fronts / spread over various production sections have a similar problem.

 

One possibility is to use letters for areas and then start numbering but it can get tricky when someone cross-borrows a balance without informing QA.   Bit like easter eggs.

 

Another less approved solution is to remove the fronts of course. Or change the plastic.

 

Rgds / Charles.C

[jenmarshall]

I agree with Charles - make an effort to eliminate or validate through documentation that the plastic is lexan which is not considered "brittle".

We also limited the scope of where we inspect to the product zone only - so from our product to the next hard surface.  That limit in scope combined with a risk assessment of our product to say that glass contamination would be very difficult (we wind product into rolls) has passed muster in our audits.