Instead of getting COAs...what are the alternatives?
Hello,
I am in a small company so we dont order by the truck loads but we do order by the pallet (sometimes thats still a lot) so to fill up a pallet we will order a couple cases of different products that we need from the supplier. Most of the suppliers charge over $100 for COAs and for a case of something the owner doesnt want to pay that amount for COAs.
What other options are there? Anything we can do internally? Any advice or recommendations are welcomed :)
COAs are not mandatory unless you state it in your FSMS. Letter of Guarantee, GFSI and specs (including nutr, allerg, storage, etc.) could help plus you could either do in-house testing or send ingredient samples to external lab as ingredient validation.
COAs are not mandatory unless you state it in your FSMS. Letter of Guarantee, GFSI and specs (including nutr, allerg, storage, etc.) could help plus you could either do in-house testing or send ingredient samples to external lab as ingredient validation.
See I thought that too in regards to the guarantee and all the documents but my auditor still said that it wasnt valid. That there is no proof of tests being done, and how are in house testing done? I am trying to do that but not sure on the how part. We do in house sal and lis testing for contact surfaces using swabs and in an incubator for those swabs but I was told by the company that the swabs only work on surfaces.
You can do Petrifilm tests for TC & E. Coli in house, same incubation idea, just get Petrifilms
My little incubator only uses swabs. The incubator is from hygenia
Afternoon larrissa. Your question seems weird to me, because most of those one off boxes of product could be tied to a lot analysis/CoA.
Can you expound a little more about "my auditor still said that it wasnt valid," namely:
- Did your auditor cite your own FSP's requirement for a CoA
- Did the auditor tell you what type of things require a CoA (example, ingredients vs flow aid)
- What auditing scheme is being used
As olenazh mentioned, spec accompanied by CLOG might be an option. Another option to look into might be a CoC (Certificate of Conformance).
This was a GMP audit, and trust me its weird for me too. He stated that product guarantees or COCs arent good enough because they do not state that they test for E. coli, Salmonella, or Listeria I have product guarantees for every supplier we have and list all the things are to be compliance with their signatures, some companies provided their own guarantees or COCs however again because it does not state that the company sends to the lab for testing that my papers or the suppliers papers arent good enough and that we should get a COA or do in house testing. My supplier program states COAs or the guarantees from suppliers.
He even said that my COCs from the supplier was weird and he never seen them before.
And we do receive some COAs from some of our suppliers but many of them charge a large amount that we cant justify for 1 case of a product
OK, so just a standard GMP audit, not even a GFSI recognized auditing scheme?
I know AIB's GMP standard mentions CoA's as a 'can include' for monitoring supplier performance, however there is no mention that product MUST be accompanied by CoA's.
My suggestion to you would be to have the auditor provide you the code they feel you are out of compliance with.
I know as an AIB audited facility, we have some processing aids which I keep a CoC on hand for in their supplier approval, as the couple pallets of it we purchase a year doesn't give us a leg to stand on to push for CoA's. However, our actual 3 ingredients are all accompanied by a CoA that's reviewed prior to unloading. We also purchase thousands of gallons a month of those, so we're in a better position to require one.
Some additional context might help.
So whose GMP audit was it and what does the relevant Standard's text specifically state ?
The basic requirement is often for "Supplier Approval" for which you can define your requirements unless items like CoA are spelled out in the Standard (or perhaps the Guidance which could be another source of contention).
It was siliker and the section states "When a hazard is identified that requires supply-chain-applied controls, verification activities are implemented. These programs must include one or more of the following (based upon risk) and must be conducted before using the raw material and periodically thereafter: (i) On-site audits (by customer or 3rd party); (ii) Sampling and testing of inbound materials; (iii) Review of supplier’s relevant food safety records; (iv) Review of COAs to ensure that the identified hazards are effectively controlled, product was sampled at the appropriate size and applicable test methods were used; (v) Other appropriate verification activities based on supplier performance and risk."
The companies send audit certificates as part of the supplier approval, I have records of HACCP and other documents if they are ok with us having them and I also get product guarantees and/or COCs
It was siliker and the section states "When a hazard is identified that requires supply-chain-applied controls, verification activities are implemented. These programs must include one or more of the following (based upon risk) and must be conducted before using the raw material and periodically thereafter: (i) On-site audits (by customer or 3rd party); (ii) Sampling and testing of inbound materials; (iii) Review of supplier’s relevant food safety records; (iv) Review of COAs to ensure that the identified hazards are effectively controlled, product was sampled at the appropriate size and applicable test methods were used; (v) Other appropriate verification activities based on supplier performance and risk."
The companies send audit certificates as part of the supplier approval, I have records of HACCP and other documents if they are ok with us having them and I also get product guarantees and/or COCs
Hi larissaj,
Thks the details.
It appears the requirements are minimally only one of (i, ii, iii, v).
Hopefully for product X you can do one of above (the quotes in Post 3 seem nonsensical to me.)
Perhaps you should refer the Standard's text to the auditor.
When I showed the auditor what I had he said its not good enough. Trust me, I showed him and argued and he still gave me a NC for it. Along with a few others that are just too ridiculous
Hey larissaj, you can always complain to CB to object auditor's professionalism, you have a right as your company's paying for the quality audit. The question is: would your Management go for that or not:)
Hey larissaj, you can always complain to CB to object auditor's professionalism, you have a right as your company's paying for the quality audit. The question is: would your Management go for that or not:)
I dont know if thats what we are going to do, I do own up to some of the NCs but he almost got me for not separating my tree nuts with other tree nuts. I have NEVER heard of that and would have argued then because I have never separated my tree nuts to be like only almonds here and only cashews here. It is listed separated on the allergen section for tree nuts (every tree nut gets listed) but while roasting he said we couldnt have them near each other! He had to make a few calls to confirm I was doing the allergens correctly.
Doesn't look like your auditor has much experience and knowledge... Then, following his logic, duck eggs should be stored separately from hen's, cow milk from goat's, basa fish from cod, etc? Even a word "near" demonstrate lack of auditor's knowledge as allergens can be stored near each other, not ABOVE/BELOW.
Well this was in regards to tree nuts, we roast them and when it comes to putting them on the table we have the nuts on their own table and he said well when you have a salted cashew what do you do if you go to an almond? Like he wanted an allergen change over along with storing them in their own zones, and roasting at their own zones.
We do all of that when it comes to tree nuts to seeds or to peanuts and all that fun stuff but we do not have an almond away from cashews or walnuts and so on with the tree nuts
It was siliker and the section states "When a hazard is identified that requires supply-chain-applied controls, verification activities are implemented. These programs must include one or more of the following (based upon risk) and must be conducted before using the raw material and periodically thereafter: (i) On-site audits (by customer or 3rd party); (ii) Sampling and testing of inbound materials; (iii) Review of supplier’s relevant food safety records; (iv) Review of COAs to ensure that the identified hazards are effectively controlled, product was sampled at the appropriate size and applicable test methods were used; (v) Other appropriate verification activities based on supplier performance and risk."
The companies send audit certificates as part of the supplier approval, I have records of HACCP and other documents if they are ok with us having them and I also get product guarantees and/or COCs
Instead of CoAs - do iii - review of the supplier's relevant food safety records.
Their supply chain control is basically taken from FSMA. So if you haven't done so yet - do a hazard analysis on your ingredients (use appendix 1 from FSMA). Then if the hazard is controlled by your supplier - have them provide you information on how they control the hazards. If all the hazards are controlled by your facility - you can prove this with your hazard analysis.
These then will need to be verified yearly.
If your system says nothing about COAs, and your suppliers are GFSI certified, can't you use your Supplier Approval Program in a risk assessment that determines the risk level being low (or lower) as a result of their gaining a GFSI certification? I would immediately appeal the decision statin gthe information you provided him at the audit and let their tech dept make a call on it. I can't believe they would uphold the auditor's decision. Sounds like the guy fell on the wrong side of the grey area.