5 replies to this topic

[CheeseQueen]

Hello,

This message board has proved invaluable to me throughout my years in a QA position.  I've never posted before but have spent a great deal of time wrestling with this situation so I've finally decided to ask for advice.

 

We produce a cheese product which incorporates several different imported herbs and herb blends.  The instructions on the herb and herb blend packaging state they must be boiled prior to use for sterility.  The packaging lists all ingredients, allergens, producer location, lot code, exp., etc.

 

We must use these imported herbs so I have been tasked with making this feasible. The problem is documentation.  I have two expired audit certificates and several 3 yr old spec sheets for this supplier.  That's it and all attempts to obtain anything else have been met with futility.  The spec sheets state the herbs are not irradiated.  We are the importer of record.

 

I have added the boil step to our HACCP and we do pathogen testing for finished product.  I am looking for a lab to do validation testing on the boiled herbs based on the FDA risk analysis index for these herbs.

 

My question is, we boil them which should control some hazards but don't we need some documentation as to pesticides, heavy metals, etc.? Boiling them doesn't negate the need for some documentation of their origin, (other than what's on the package label), does it?

 

In a perfect situation I would be able to obtain audits and certs, spec sheets, LOGs, and HACCP plans from this supplier.  I cannot, so please help me with what I need to do to make this work.

Thank you

 

[Evans X.]

Greetings,

 

The obvious answer is change your supplier! I believe you can easily find another who will meet your standards.

The next thing you can do is "threaten" them with termination of the collaboration if they fail to comply with your request within a time limit (this is a bit of a double-edged sword though, you may win or you may lose them, so use it at your discretion!).

If you really really do want to keep them, then you will have to perform said tests (pesticides, heavy metals etc) yourselves, including the costs of it and according to a sampling plan. You can set aside your worries for the spec sheets at least for a couple more years, since this kind of raw material doesn't really change that much (you will just get the same sheet with an updated date). If you worry about irradiation, you can also send a couple of samples to a laboratory for radioactivity analysis, just to verify the claim. As for the expired certificates you can't do much, with the exception of you being willing to perform an internal audit on the site of your supplier (yet another cost) or find and send an independent auditor for a second party audit (from my experience you charge this cost to them).

 

All-in-all it will come down to wether you can accept the additional time/cost for getting what you need or -as said before- change the supplier!!!

 

Regards.

[CheeseQueen]

Good morning,

Thank you for your reply.  I agree switching suppliers is the best route but unfortunately, management is insistent on using this supplier. 

It may be possible for myself to travel overseas and audit this company.  Do you think if we preform our own pathogen, heavy metal, and pesticide testing along with myself auditing them, that would be enough to fulfill FSVP requirements?

I really appreciate the advice.

[Evans X.]

Yes it can be enough. What is better, if you perform the on-site audit yourself, is that it's a great opportunity to ask the documentation you are missing (certificates, maybe updated spec sheets but don't worry so much about it, possible recent analyses, origin documentation through traceability etc). Ask for a copy or to take a picture of them and you will also be able to check for the possibility of irradiation process during site tour, if it may have been implemented without you being notified (it is not something you can easily dismantle in the far-fetched case they have it and want to hide it).

You write up a detailed report then and store it in your files for whatever use it may be needed. It's an acceptable and good practice to audit your suppliers!

[Charles.C]

Hello,

This message board has proved invaluable to me throughout my years in a QA position.  I've never posted before but have spent a great deal of time wrestling with this situation so I've finally decided to ask for advice.

 

We produce a cheese product which incorporates several different imported herbs and herb blends.  The instructions on the herb and herb blend packaging state they must be boiled prior to use for sterility.  The packaging lists all ingredients, allergens, producer location, lot code, exp., etc.

 

We must use these imported herbs so I have been tasked with making this feasible. The problem is documentation.  I have two expired audit certificates and several 3 yr old spec sheets for this supplier.  That's it and all attempts to obtain anything else have been met with futility.  The spec sheets state the herbs are not irradiated.  We are the importer of record.

 

I have added the boil step to our HACCP and we do pathogen testing for finished product.  I am looking for a lab to do validation testing on the boiled herbs based on the FDA risk analysis index for these herbs.

 

My question is, we boil them which should control some hazards but don't we need some documentation as to pesticides, heavy metals, etc.? Boiling them doesn't negate the need for some documentation of their origin, (other than what's on the package label), does it?

 

In a perfect situation I would be able to obtain audits and certs, spec sheets, LOGs, and HACCP plans from this supplier.  I cannot, so please help me with what I need to do to make this work.

Thank you

Hi CheeseQueen,

 

I only have GFSI-related experience  but I I suggest you simply create your own detailed specification sheets.  Herbs not my area but that's what I did for many of my received materials plus  required the supplier to provide documented agreement to the result. If the latter step is not possible and neither is a change in Supplier then could either use the trick of stating lack of response implies agreement and/or have some samples validated as per yr own specification. Obviously not ideal but offers one path to generate Approved Suppliers when all else fails.

This assumes of course that you have sufficient technical capabilities to generate appropriate specifications or "borrow" from sources like ASTA..

 

PS - I thought that steaming was a more rigorous  process than boiling albeit less simple ?. Effectiveness may also relate to time. .

[Sayed M Naim Khalid]

Hello CheeseQueen, 

 

After reading you post, here is my recommendation: 

 

1. Old spec: Review the document, update it, even if you have minimal information. Documents have to be reviewed annually. It is your (your business) responsibility to provide specification for the supplier. 

 

2. Supplier mischief: FDA and GFSI standards MANDATED businesses to get food from APPROVED/REPUTABLE suppliers. In order to verify if your supplier is verified you have three options. 1) ask for their government inspection report, certifications, GFSI certification and their lab test results for your products. 2) Ask a third party auditor to go and audit the company for you. However, the 2nd option, need to stipulate in an agreement or contract. You cannot just go there and audit someone. 3) Lastly, you should annually review the performance of your supplier. If they do not comply with your requirements, you should not buy from them.

 

3. Added boiling step to HACCP: It is a good preventive step provided you can justify that whatever bacteria/mold you are looking for is reduced to acceptable level. However, this does not find the heavy metals, mycotoxins, foreign matters and pesticides residue. Instead of adding a step to my HACCP/ or in addition to this step, I would mandatorily ask my supplier of herbs to provide a certificate of analysis (COA) from a certified lab. This way, you can transfer the risk to the lab.

 

4. HACCP plan updating: If you are having cheese product/cheese production. It means you have HACCP in place. I recommend that you check your Hazard Analysis, mainly for the herbs. Herbs can have all three hazard i.e., physical, biological and chemical. It might be one of your CCPs mainly during receiving phase. As soon as you update your Hazard Analysis and HACCP plan. You have new documents.

 

5. Documents: By implementing your updated HACCP plan, you generate the following that you can use as your justification for records: 

Your company spec for Herbs
Your company procedure for import of herbs from a food safety perspective

Your procedure for controlling specification for your suppliers (e.g., annual review, audits, COA)

Your HACCP plan. 

Your CCP records

Your Receiving records

Lab test results for herbs 

Corrective actions

etc

 

For more information, please read the FSVP regulation required documents list. Link is from FDA: https://www.fda.gov/...131229/download

 

__________________________
Sayed M Naim Khalid

FSQA Professional