5 replies to this topic

[neilmac]

Good morning everyone, looking for some thoughts. We have an upcoming first BRC audit in my new place of employment. Our bottling hall and warehouse have an adjoining wall separating them, but no roller door for complete segregation from one area to another. I don't see a definite requirement in the standard but as good GMP and in previous employment there has always been one Does anyone think this could be picked up as a major issue or an area of improvement perhaps? (we have roller door at warehouse and it is kept closed when not in use). Thanks, Neil

 

 

[pHruit]

Is the entry point between them completely open?
I've seen this work with e.g. strip curtains rather than a full solid roller shutter.

[neilmac]

There is a door beside it for pedestrians safe entry into warehouse and a gap where the old roller door used to be.

The plan is put one in but I don't think it will de done in time before our audit.

I had thought about plastic curtains but there is quite a bit of traffic through from warehouse supplying the lines with glass, so from an H&S point point of view  we didn't think this was a good idea.

[SQFconsultant]

Cross contamination (potential.)

Not a major - but will be on the report.

[Duncan]

I would think you would need to distinguish between open-product-handling areas and the warehouse.

 

Clause 4.3.1 states:

"There shall be a map of the site. At a minimum, this map shall define:

• access points for personnel

• access points for raw materials (including packaging), semi-finished products and open products

• routes of movement for personnel

• routes of movement for raw materials (including packaging)

• routes for the removal of waste

• routes for the movement of rework

• location of any staff facilities, including changing rooms, toilets, canteens and smoking areas

• production process flows."

 

and clause 4.3.3 states:

"The movement of personnel, raw materials, packaging, rework and/or waste shall not compromise the safety of products. The process flow, together with the use of demonstrably effective procedures, shall be in place to minimise the risk of the contamination of raw materials, intermediate/semi-processed products, packaging and finished products."

 

Also, take into account clause 4.9.3.1:

"Glass or other brittle materials shall be excluded or protected against breakage in areas where open products are handled or there is a risk of product contamination."

 

 

I would think any demonstration of compliance or non-compliance with the standard would depend heavily on whether you could show a meaningful level of segregation between your open-product area and the warehouse. Especially where glass controls are concerned, the absence of any kind of physical barrier seems problematic, but in the same light if you have raw materials or packaging items in your warehouse and there is no physical segregation from your open-product area I would expect this to result in non-conformity at audit.

 

If it isn't possible to introduce physical segregation in time for your audit, my advice would be to have prepared a documented risk assessment on hand to demonstrate that these issues have been considered and that risks are being controlled. Section 4.9.4 is mainly focussed on the potential for glass or brittle containers to contaminate packaged product, but from your description I would anticipate concerns surrounding contamination from articles in your warehouse as well as glass contamination  into your warehouse from your bottling hall.

[neilmac]

 

I would think you would need to distinguish between open-product-handling areas and the warehouse.

 

Clause 4.3.1 states:

"There shall be a map of the site. At a minimum, this map shall define:

• access points for personnel

• access points for raw materials (including packaging), semi-finished products and open products

• routes of movement for personnel

• routes of movement for raw materials (including packaging)

• routes for the removal of waste

• routes for the movement of rework

• location of any staff facilities, including changing rooms, toilets, canteens and smoking areas

• production process flows."

 

and clause 4.3.3 states:

"The movement of personnel, raw materials, packaging, rework and/or waste shall not compromise the safety of products. The process flow, together with the use of demonstrably effective procedures, shall be in place to minimise the risk of the contamination of raw materials, intermediate/semi-processed products, packaging and finished products."

 

Also, take into account clause 4.9.3.1:

"Glass or other brittle materials shall be excluded or protected against breakage in areas where open products are handled or there is a risk of product contamination."

 

 

I would think any demonstration of compliance or non-compliance with the standard would depend heavily on whether you could show a meaningful level of segregation between your open-product area and the warehouse. Especially where glass controls are concerned, the absence of any kind of physical barrier seems problematic, but in the same light if you have raw materials or packaging items in your warehouse and there is no physical segregation from your open-product area I would expect this to result in non-conformity at audit.

 

If it isn't possible to introduce physical segregation in time for your audit, my advice would be to have prepared a documented risk assessment on hand to demonstrate that these issues have been considered and that risks are being controlled. Section 4.9.4 is mainly focussed on the potential for glass or brittle containers to contaminate packaged product, but from your description I would anticipate concerns surrounding contamination from articles in your warehouse as well as glass contamination  into your warehouse from your bottling hall.

 

Thanks Duncan, after consideration we are going to install PVC curtains as I am not happy to leave an open gap, never seen a warehouse/production facility without segregation and if I put my auditors hat on it would be noted as a concern.