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#1 EssentialFA

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Posted 15 March 2017 - 03:43 PM

Good morning everyone,

 

Compliance dates are coming fast and I feel like I am still quite confused about the shape and form that FSMA compliance has to take for our company. a few questions for you knowledgeable people:

 

- is acceptable to have the "team" writing the Food Safety plans to be composed of only me? the QA team in my company is composed of 2 people (I am the manager of the QA department), and the rest of the staff is currently overworked already because budget cut lead to reduced teams in the past year. I took the PCQI training a couple of months ago.

 

- is it normal to have customers request to have your food safety plan sent to them? is it something that we should be ready to share with whoever requests it? Should I start requesting it from our own suppliers? (until now we asked for various documents like 3rd party audits, allergens declaration, spec sheets, flowcharts, etc.)

 

- FSVP: we don't have too many foreign suppliers right now, but we do purchase a lot of products originating from outside the US from brokers/distributors located in the USA. My understanding is that we don't need a FSVP for these suppliers.However, should I ask them to send confirmation that their own suppliers from outside the US have a Food Safety plan?

 

I am a little bit at a loss here, if anyone can help I would greatly appreciate it.


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#2 sthompson75

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Posted 15 March 2017 - 08:17 PM

- is acceptable to have the "team" writing the Food Safety plans to be composed of only me? the QA team in my company is composed of 2 people (I am the manager of the QA department), and the rest of the staff is currently overworked already because budget cut lead to reduced teams in the past year. I took the PCQI training a couple of months ago.

Simple answer: yes, however all members on the TEAM should review and sign off on it. Especially senior management

 

- is it normal to have customers request to have your food safety plan sent to them? is it something that we should be ready to share with whoever requests it? Should I start requesting it from our own suppliers? (until now we asked for various documents like 3rd party audits, allergens declaration, spec sheets, flowcharts, etc.)

​This is pretty normal from my exp. Some folks do request it to see how you're validating your processes. It is not a necessity. We require an up to date 3rd party audit and cert. Letter of guarantee, and what you mentioned above. We now are also requesting that they include a letter stating that they are compliant with having a HARPC plan. (For domestic suppliers) 

 

- FSVP: we don't have too many foreign suppliers right now, but we do purchase a lot of products originating from outside the US from brokers/distributors located in the USA. My understanding is that we don't need a FSVP for these suppliers.However, should I ask them to send confirmation that their own suppliers from outside the US have a Food Safety plan?

We ask our brokers for copies of food safety records of their suppliers. They may be responsible as far as the rule goes but, ultimately the product we sell, we are responsible for. As well as COA testing for ALL lots of product. (Salmonella. E.coli, Listeria, yeast, mold and plate count.)

 

I am a little bit at a loss here, if anyone can help I would greatly appreciate it.


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#3 Ryan M.

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Posted 21 March 2017 - 09:57 PM

1.  NO.  People from other departments need to participate such as maintenance personnel, operations, supply chain / warehouse, and best if you can get the head honcho of the facility to participate.  If you meant only you writing everything, then YES, but a team should consist of people from multiple functional disciplines within the company.

 

2.  YES.  Typically, they will request a flow chart and your HACCP Summary.  The HACCP "Plan" is basically the summary of the CCP's, or for FSMA, your control programs in place for the FSMA controls required for your process.

 

3.  NO.  You are not required to make sure the foreign suppliers comply with FSVP.  However, you should get in writing from your brokers the suppliers they use comply with current FSMA regulations, including FSVP.  Reputable brokers will have this in place already.  Depending on how you handle the ingredients they may be higher risk and you might want to do what the person above posted for liability reasons.  However, if you have ingredients that undergo a kill step in your process then it isn't as much of a risk.


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#4 pablo coronel

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Posted 22 March 2017 - 02:13 PM

1.  It is better if you get feedback form the other members of the team, and it is especially important to have  the TOP MANAGER/CEO/COO in your team (the top banana).  Normally Food Safety fails because there is no management commitment, and you have to make sure they are in the team.

 

2. If the client is large enough, yes it is quite normal. 

 

3. Brokers should make sure this is in place, you should be able to ask for compliance documents/certificates.  

 

Good morning everyone,

 

Compliance dates are coming fast and I feel like I am still quite confused about the shape and form that FSMA compliance has to take for our company. a few questions for you knowledgeable people:

 

- is acceptable to have the "team" writing the Food Safety plans to be composed of only me? the QA team in my company is composed of 2 people (I am the manager of the QA department), and the rest of the staff is currently overworked already because budget cut lead to reduced teams in the past year. I took the PCQI training a couple of months ago.

 

- is it normal to have customers request to have your food safety plan sent to them? is it something that we should be ready to share with whoever requests it? Should I start requesting it from our own suppliers? (until now we asked for various documents like 3rd party audits, allergens declaration, spec sheets, flowcharts, etc.)

 

- FSVP: we don't have too many foreign suppliers right now, but we do purchase a lot of products originating from outside the US from brokers/distributors located in the USA. My understanding is that we don't need a FSVP for these suppliers.However, should I ask them to send confirmation that their own suppliers from outside the US have a Food Safety plan?

 

I am a little bit at a loss here, if anyone can help I would greatly appreciate it.


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#5 john.kukoly

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Posted 22 March 2017 - 08:24 PM

Good thing you separated those questions, the second one can be pretty daunting.

 

Since you put things under the heading FSMA, I will do my best to answer from that perspective.

 

1. The team question. In Preventative Controls, there is no mention of a food safety team the way BRC or other GFSI benchmarked programs describe it. FSMA talks about the "PCQI" or preventative controls qualified individual. You took the training, good start. There is nothing wrong with maintaining a "team" approach to developing your food safety plan (FSMA doesn't say it has to be only one person), and will that way satisfy both FSMA and other audit programs. What is important, is to focus on competency, not the numbers. Whoever is responsible for he food safety plan needs to have the ability and knowledge to design and maintain it across the facility. 

 

2. Sending out your food safety plan. The part in preventative controls covering supply chain approvals and monitoring give options that range from audits to system review. Look up 21 CFR 117.410 for all the fun details. Essentially the requirement is that a manufacturer (who falls under the FSMA rules) have a risk based system to approve suppliers. You need one for your suppliers, your customers need one for you. Obviously I have a bias for using GFSI benchmarked certifications as the basis, but there are some instances where simply reviewing a suppliers food safety plan, or parts of it, may be sufficient. The challenge would be in the assessment - if there is insufficient evidence in the audit report that the auditor reviewed the food safety plan, the audit doesn't give you enough.

 

Here is the way to assess what the best course is. The Agent in Charge (that's site senior management) and the PCQI (thinking that's you) are responsible and liable for the food safety plan. You both need to be confident that the risk based supplier approval mechanism is going to stand up to critique if things should go wrong in future, since it's you two who are held accountable. I would recommend erring on the side of robust, not simple.

 

There is also the time factor. You would need to have the time to chase, receive, and assess (don't forget to document your assessment) of each plan. From an effectiveness, and efficiency stand point, having every customer ask every supplier to provide their food safety plan documentation is not good. There is also the document security aspect to consider when shipping things off site - and that goes both ways - if you are holding a load of customer information you need to make sure it's secure. The one core weakness in trying to approve a supplier based on a paper program sent in - you have no idea if it's a valid representation of the supplier.

 

If a customer demands you send it, and are unwilling to accept a recognized third party audit, you may be stuck with it. For your suppliers, use a more effective method wherever possible.

 

3. The broker question can be a really long and complicated answer.

 

First look at the role of the importer of record. This would be the US based person or company that is legally importing food products - they have the responsibility for supplier approval according to FSVP. It may be the broker, it may not - good question to ask. Supplier approval is similar for foreign and domestic, you need to verify the food safety plans of both.

 

If you have a good broker, they can have their own supplier approval program that satisfies FSVP (BRC has a great guidance document for brokers and importers of record). You have to essentially verify their supplier approval program.

 

If your broker doesn't have supplier approval programs or information, you have to see through the broker to the manufacturer. Either way, you need to know someone has approved the supplier, and using what methods.

 

Good brokers should be able to provide all the information you need to ensure foreign suppliers meet your risk based approval program.

 

Ryan had the right advice above - talk to the broker and find out how their supplier approval works. The last thing you want is just before a production rush, finding out your broker can't source materials for you because they, or the supplier, weren't ready.

 

John


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#6 EssentialFA

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Posted 27 March 2017 - 07:34 PM

Thank you so much for your answers! It is helping me see a bit clearer in this issue, but also making me feel like I really don't know anything... not a good feeling.

 

Now what about suppliers who are not sharing documents? I fully expect some refusal to share food safety plans, or anything beyond a HACCP certificate or 3rd party audit.

 

And I might have used the term "broker" not correctly

What I mean is that we purchase bulk products (vegetable oils of various kinds) from suppliers and I know that they don't manufacture the oil themselves, and purchase a lot of it from outside the USA. The most they would do would be transfer from Tanks to drums or something like that. In the event that they JUST store it for resale, would they need to be registered with the FDA, and therefore have the FS plans and FSVP?

I hope so otherwise it is going to get hard to get any kind of info.

 

As a side note, how do you guys deal with "sneaky" suppliers? one of our suppliers told us they were 3rd party audited, but refused to tell us who inspected them or to send us a copy of their certificate unless we came for a visit in person... that is odd, right?


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#7 katjad

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Posted 03 April 2017 - 04:51 PM

Some suppliers will refuse documents, but to refuse a certificate for a third party audit sounds suspicious. I have had validation documents refused and this only accessible on site which i would accept but not a third party certificate or audit report.


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