6 replies to this topic

[hacksalot]

All,

 

In our current Foreign Material and Brittles Policy, we check glass and other brittle items through out facility, not just in production areas.  Our offices and labs are separated from production areas by a hallway.  Is it necessary to check brittles throughout the facility, or can we just limit to production and warehouse areas?  Was thinking of changing so we just need to check in production and warehouse.

 

TIA

[Charles.C]

All,

 

In our current Foreign Material and Brittles Policy, we check glass and other brittle items through out facility, not just in production areas.  Our offices and labs are separated from production areas by a hallway.  Is it necessary to check brittles throughout the facility, or can we just limit to production and warehouse areas?  Was thinking of changing so we just need to check in production and warehouse.

 

TIA

 

You need to think about risk assessment, if there is a significant risk that any external location may contaminate  the product (eg people) then "YES".

Hopefully office staff do not randomly walk around production areas.

[Mr. Wallace]

check other areas than the  production area! Just because a glass and brittle plastic incident happens away from the production floor does not mean the fragments wont make their way to that area. 

Consider adding maintenance shop,boiler room,sanitation area,electrical room,compactor rooms, QA lab and trash dock. The more in depth and efficient the better. Good luck!

[PQEdwards]

The approach I took was to risk assess and identify critical glass/hard plastic sources, i.e. those located above open process, those with direct product contact and those in high GMP processing areas.

 

These sources have a very specific audit program.

 

Other source of glass/hard plastic (e.g. lighting in none GMP areas) are inspected but a much lower frequency and less formally.

 

This means you resource and effort is used where most critical.

 

It has passed our animal feed, food and cosmetic ingredient auditors requirements (so far)

[Tony-C]

Hi hacksalot,

 

Your brittle plastics policy as per previous posts should be based on risk.

 

For low risk areas such as offices it may be that you can carry out an annual check and any breakages managed by a breakage policy and procedure.

 

For product areas, regular inspections of registered items are normal. For open product areas the first policy should be to exclude, secondly high risk items should be adequately protected from damage and if there a risk of a breakage causing brittle material to fall* into product then checks before starting and at the end of the production shift/day. Other brittle items in the area should also be checked at an appropriate frequency such as weekly/monthly based on the risk.

 

* In the case of these type of breakages strict controls should be in place to clean up, control of cleaning equipment, disposal of debris, quarantine product, supervision, training and authorization to recommence operations.

 

Kind regards,

 

Tony

[Jeffrey Ort]

Think of the risk and the possibility of bringing the containment into the processing area, in the case of a breakage.

What is the impact on the process -

Are you a closed system?

Do you have overhead walkways that can allow for the contaminant to enter exposed product from footwear?

 

Make sure that you program also identifies a breakage zone that would be required to be inspected,and include uniforms and foodwear!

[Scampi]

I would put the low risk areas on a reduced frequency monthly bi-monthly etc. The likelihood of offices contributing to production contamination should be very low and the risk of something breaking in the office even lower (perhaps only when lights are getting replaced) 

 

Agree with other posters---checking all of these on the same schedule as the production floor is not a good use of resources