GMP Audit
We have done a hazard analysis on the need for some form of foreign object detection system and have come to the conclusion that it is needed. We are a very small company at this point and don't have the budget for it at this time. How much would this count against us on the gmp audit? Anybody have any information on a possible solution to this problem?
If you've identified a hazard in your process but don't address it then yes this may be brought up during a review of your HACCP plan. An xray/metal detector isn't the only method for foreign material control, however. Have you considered filters/screens? Depending on the specific type of foreign material hazard, there may be other options available to you.
We make smoked meat products, so filters would not do much. The hazard that we encounter is broken grinder blades. So I think metal detector or x-ray is our only option. If there is another option that would be great. As it is now, if we encounter a broken blade, then we have to put on hold all products that were affected and go through them one by one and visually look for any metal. Or, we find all the broken parts and piece them together until they are complete.
Would it be a fail if this is not addressed is what I am wondering or is it just points against the total?
Is this an SQF audit? You've posted in the SQF subforum so I'll assume so for now. I don't run an SQF facility so I wouldn't be able to say whether this constitutes an instant fail. It likely has to do with how significant of a risk you've identified. A good food safety program really shouldn't leave significant risks unanswered.
Could you not implement a routine grinder blade inspection along with a hardy blade PM program? If your batches are small, do frequent inspections of the grinder blade for breakage (after each run, or even at time-intervals within a run). This reduces the amount of product that would need to be held for foreign material examination. Grinder blades also wear away over time, so a PM program will stay on top of getting the blade replaced as needed.
I'd be more concerned for when the FDA shows up. If you have determined it is needed, then you need to control it, otherwise you are knowingly putting a potential hazard out there.
Depending on what you are making there may be other options as suggested above.
Unfortunately I can speak directly on SQF, however for my Primus GFSI guidelines It doesn't look like it is an automatic fail, however it would be a loss of 10 points, which is a decent amount. But if it is a hazard you have identified it should be a top priority to try to figure out a preventive control for the safety of your customers and to keep the trust in the quality of your product high.
Focusing on staying "compliant" to auditors standards instead of making sure that you have the safest and best quality food possible. If you focus on QA and Food Safety itself it is difficult not to be complaint, as long as you keep up on your paperwork.
We make smoked meat products, so filters would not do much. The hazard that we encounter is broken grinder blades. So I think metal detector or x-ray is our only option. If there is another option that would be great. As it is now, if we encounter a broken blade, then we have to put on hold all products that were affected and go through them one by one and visually look for any metal. Or, we find all the broken parts and piece them together until they are complete.
You have a control, and if the inspection of blade condition is a requirement for a positive release system, it could be adequate. If you scale up a metal detector seems like a good addition. As was previously mentioned you could increase the frequency of checking the condition of the at-risk metal parts, this would reduce batch size for your positive release system.
Are you currently USDA inspected, or under a state equivalency program? What system or type of customer is the GMP audit for?
Yes we are a USDA inspected site. Very well could be one of the most highly inspected plants around. We check the blades after every batch for any damage and do a pre-op inspection, mid-op inspection, and pre-ship as well.