Glass and Brittle Plastic Checklist
Hello Everyone,
I have a question regarding the items that should be included in the Glass and Brittle plastic checklist.
We have a mechanical room that is Physically separated from the Processing area by a wall. There are many gauges and display screens as part of equipment such as compressor and Boiler.
The existing checklist includes these items that are part of mechanical room. it also includes items from Lunch room and washrooms.
however, As per my risk assessment, these items can be removed from the checklist as they are not part of processing areas. and when a breakage of these items occur, the chance of contamination of product is none.
Please provide any feedback on this assessment.
Regards
Bhargav
Hi Bhargav,
You could also decrease the frequency of checking that area.
Any risk that broken glass could be tracked from that area into the production areas on people's feet?
-Josh Heinrichs
Hello Everyone,
I have a question regarding the items that should be included in the Glass and Brittle plastic checklist.
We have a mechanical room that is Physically separated from the Processing area by a wall. There are many gauges and display screens as part of equipment such as compressor and Boiler.
The existing checklist includes these items that are part of mechanical room. it also includes items from Lunch room and washrooms.
however, As per my risk assessment, these items can be removed from the checklist as they are not part of processing areas. and when a breakage of these items occur, the chance of contamination of product is none.
Please provide any feedback on this assessment.
Regards
Bhargav
Curious on this topic as well.
We currently only include items (brittle plastic, glass, ceramic and rubber) on our checklist that are found in GMP compliant zones. We have also included items in immediate entry areas to GMP compliant zones as we felt there could be a risk of contamination. Service areas outside of the building and other non-GMP compliant areas we have left off the checklist for the time being as these form part of general maintenance building work orders as the risk of direct contamination is none and indirect contamination would be extremely low.
Trying not to over complicate the already complicated and extensive checks and balances we all must have in place to safeguard products.
We include everything in the operations portion of the facility. We leave out the front office accountant's, sales and so on from the register. So far no problems with auditors.
This is one of those areas that over auditing may have done a disservice to the original intent. If you think about it, the checklist idea for brittle materials is a classic closing of the barn door after the horse ran away. Best in class systems think a little differently about it - prevention first. Continually chasing NC's to add more and more is far less effective than removing the risk managing it, and staff awareness.
Having a thought process like this:
1. identify brittle materials that post a risk to the product
2. remove wherever possible, protect where not
3. put practices and training in place to mitigate potential risk by damage or use
If the inspection ever turns up damage or breakage - the impulse to write a work order and replace the materials should be replace with a re-assessment of steps 2 and 3.
The boiler room example above is a good one: if the amount of time between checks is extended - what happens when you find something - assume everything since the last check is at risk? Potentially better to restrict traffic from boiler room to processing, and get staff in the boiler room upskilled to continually monitor for signs of damage, and she inspection, as they are in a glass area prior to going to common or open product areas.
I remember a sign off audit at a facility whose glass register had gone over 30 pages - and took one employee 3 days a month to complete. Everything including coffee pots in the front office made it onto the list. Hard to imagine how this activity, and staff investment made the product much safer.
By all means create the check list - move some onto pre-operational checklists to get them done frequently where necessary, and by the operators themselves. Glass checklists should be managed - one of those things where too much is not better than too little, in my opinion.
John
I do not include areas that are not part of warehousing or production. I do identify every knob, guage and items that can randomly break as part of a daily preoperational check. bathrooms, break rooms and offices I have identified as very low risk for glass breakage because we have never had a breakage in these area. I used the history of the plant to validate my claim.
I have never had an auditor question my glass and brittle plastics program in regards to our maintenence shop. If it is segragated from the production area is is not a major concern... whith that said, the auditor looks for cleanliness in all our non production areas and looks for documents that out line how we control contaminates when items such as tools and parts go from the shop out into the production areas.
Hello Everyone,
I have a question regarding the items that should be included in the Glass and Brittle plastic checklist.
We have a mechanical room that is Physically separated from the Processing area by a wall. There are many gauges and display screens as part of equipment such as compressor and Boiler.
The existing checklist includes these items that are part of mechanical room. it also includes items from Lunch room and washrooms.
however, As per my risk assessment, these items can be removed from the checklist as they are not part of processing areas. and when a breakage of these items occur, the chance of contamination of product is none.
Please provide any feedback on this assessment.
Regards
Bhargav
It comes down to risk assessment.
Risk = likelihood x Severity
If you are really, really, confident that L = 0 then "Risk" = 0 >> remove from list. And perhaps be prepare to be challenged by Auditor.
Thank you everyone for your feedback.
I followed your suggestion of adjusting the frequency based on the risk.