Hello everyone!

Help me please with a food recall procedure, which is necessary to be in conformance with ISO 22000.

We manufacture candies and chewing gum. To what extent should we recall nonconforming product from the market? I mean, should we inform consumers and how? Or maybe this is enough just to inform distributors? I am confused.

If anybody has a sample recall procedure for this type of product, it would be helpful.

Thank you in advance.

I'll let the experts correct me.

Whether or not to inform consumers would depend upon the reason for, and the severity of, the recall.

Being Canadian, this topic hits a little close to home. Maple Leaf Foods (http://www.mapleleaf.ca/) has implemented a recall on many of their deli meats and other products due to an outbreak of the food-borne bacterium listeria monocytoenes. There have been around 12 deaths linked to this outbreak with many more illnesses waiting for confirmation (or denial).

If you visit cbc.ca (http://www.cbc.ca), there is link to the listeriosis outbreak, including the timeline from awareness to public communication. The timeline will show how Maple Leaf Foods contacted the distributor first and some time afterwards, the public. Whether or not this was the correct way to communicate will be up to the courts to decide - a class-action lawsuit is already in the making.

Hello everyone!

Help me please with a food recall procedure, which is necessary to be in conformance with ISO 22000.

We manufacture candies and chewing gum. To what extent should we recall nonconforming product from the market? I mean, should we inform consumers and how? Or maybe this is enough just to inform distributors? I am confused.

If anybody has a sample recall procedure for this type of product, it would be helpful.

Thank you in advance.A lot depends on the nonconformance. IF it involves, "life, health, or safety" you must inform everyone to prevent injury, harm, or death.

If it is a minor thing (product weight, blurred type on the package, etc.) which will not harm the user's body, then the decisions are essentially economic - will customers be alienated if they find out or will they not even care?

Got a scenario of the type of nonconformance to work through the reasoning?

I'll let the experts correct me.

Whether or not to inform consumers would depend upon the reason for, and the severity of, the recall.

On top of these, you need to work/liaise with the authorities. Ultimately, they may be making the final decision requiring you to take whatever appropriate action.

You will need a mock recall exercise or whatever other acceptable method to validate your recall & traceability procedure.

This is a link to a sample/guide from the Canadian Food Inspection Agency (http://www.inspection.gc.ca/english/fssa/recarapp/rap/rgguide.shtml).

By the way, welcome to the forum.

Aside from the ethical, marketing and civil-liability issues, is your possible recall only from countries that have no laws governing public health and safety regarding food-product adulteration? One condition for conformance with ISO 22000:2005 is conformance with statutory food safety regulations in the countries of manufacture and distribution. I would think that if such statutes exist in your market area, they would constrain your actions to a greater extent than ISO 22000 itself.

Thanks a lot to everybody. :thanx:
The problem is I don't know where distributors sell our product to. Distributors sell to retailers, then retailers sell to people. Should I know each retailer? How can I inform thousands of people?? Maybe TV, newspapers? Any opinions?

Thanks a lot to everybody. :thanx:
The problem is I don't know where distributors sell our product to. Distributors sell to retailers, then retailers sell to people. Should I know each retailer? How can I inform thousands of people?? Maybe TV, newspapers? Any opinions?

That's why you need to work with the authorities or rather, the authorities are interested in regulating this aspect. You will jointly (usually) assess the situation with them and if a recall is needed, they will help decide on the method to use. No problem between manufacturer and distributor (if traceability is there). Advertisements in paper and other media are made more effective if it comes from the authorities.

If the product is exported - such as XXX Chocolates, there is a mechanism for the authorities to spread the news to their counterparts in other countries.

The problem is almost always due to the manufacturer who suppress news hoping that it is just a 'scare' or the issue will blow over.

Thanks a lot to everybody. :thanx:
The problem is I don't know where distributors sell our product to. Distributors sell to retailers, then retailers sell to people. Should I know each retailer? How can I inform thousands of people?? Maybe TV, newspapers? Any opinions?Right! It requires effort and investigation on your part.

This is NOT a simple matter. One of the MOST important things you need to have in place for future events is a tight Lot control and traceability. With traceability (labeling of individual retail package), you can determine WHICH distributors received suspect goods and concentrate on their downstream supply chain.

If the issue is current and real, not hypothetical, contact me off line and I will help you go through all you need to do to assure the life, health, safety of your retail customers.

Right! It requires effort and investigation on your part.

This is NOT a simple matter. One of the MOST important things you need to have in place for future events is a tight Lot control and traceability. With traceability (labeling of individual retail package), you can determine WHICH distributors received suspect goods and concentrate on their downstream supply chain.

If the issue is current and real, not hypothetical, contact me off line and I will help you go through all you need to do to assure the life, health, safety of your retail customers.

Thank you very much for your proposal!
Fortunately the issue is hypothetical. I am developing a procedure and trying to get other people's opinions to do it better.
Now its clearer.
Thanks again.

In the US, each FDA District Office has a specific individual with the title and job responsibility of Recall Coordinator. Particularly in regard to food and similar products, blood/biological materials, or Class II/III medical/dental devices, that should be the first point of contact whenever the possibility of a Recall situation arises, and sometimes when the likely action will be a Correction or Removal. That means informal discussion before any of the legally required notifications are filed, so as to proactively demonstrate your commitment to doing the right thing and protecting the public.

I don't know specifically how other countries handle parallel situations. Ideally that information would be incorporated into a company's procedures, so that the appropriate response to a given situation can be implemented without having to do research under the gun, so to speak.

That's probably something that it would behoove us, as Regulatory Managers, to be aware of for each of the countries and regulatory jurisdictions where our products may reach end users.

Maybe a listing of summaries of that info would be a good subject for a sticky thread.

The problem is I don't know where distributors sell our product to. Distributors sell to retailers, then retailers sell to people. Should I know each retailer? How can I inform thousands of people?? Maybe TV, newspapers? Any opinions?
Taking the issue further, how extensive should the traceability procedures be with regards to product recovery that goes beyond the immediate distribution network.

I agree that media releases and other forms of effective communications would provide the necessary reach to warn / advice public on the affected product lots and the actions to be taken by the public.

To conform with clause 7.9, does this requirement covers out-sourced distributors after all they are part of the distribution chain. (i.e if it is necessary for the FSMS to have control on all out-sourced processors (clause 4.1), then it should have similar control requirements for out-sourced distributors)

I am aware that in certain countries, the food act places the responsibility onto the importer / distributor / agent which is clear and good for the public. What about others? Comments appreciated.

Taking the issue further, how extensive should the traceability procedures be with regards to product recovery that goes beyond the immediate distribution network.

I agree that media releases and other forms of effective communications would provide the necessary reach to warn / advice public on the affected product lots and the actions to be taken by the public.

To conform with clause 7.9, does this requirement covers out-sourced distributors after all they are part of the distribution chain. (i.e if it is necessary for the FSMS to have control on all out-sourced processors (clause 4.1), then it should have similar control requirements for out-sourced distributors)

I am aware that in certain countries, the food act places the responsibility onto the importer / distributor / agent which is clear and good for the public. What about others? Comments appreciated.This is a very insightful addition to the thread.

Traceability is a two-way street. Someone with a retail package of faulty product needs to be able to trace back to the source (that person or authorities working on that person's behalf or attempting to stave off wholesale injury, sickness, or death in the general population.)

When the manufacturer can trace faulty product to a specific batch or lot, he can have a leg up on discovering root cause and implementing corrective action. Most package labels say [paraphrased] "send the product back to us with the original packaging" BUT that statement would be so much more effective if EVERY producer added an explanation about traceability to reinforce the IMPORTANCE of keeping the original package, if possible, but a the very least, the known retail outlet will have remaining packages with the necessary data.

From an economic standpoint, being able to limit a recall to a single batch saves money AND embarrassment and, most importantly, TIME.

Someone with a retail package of faulty product needs to be able to trace back to the source (...)

In the US, at least for foods and similar consumables, this would not extend to consumers.

The standard direction to US consumers is to return the product to the store where you bought it. If that's not practical, you have the option of contacting the manufacturer for a refund, and/or contacting the FDA directly. Instructions for the latter are at http://www.fda.gov/opacom/backgrounders/problem.html#emerg.

For food and similar consumables in the US, normally there is no traceability below the point where master cartons/cases or pallets, as applicable, are broken down. That might be at individual superstores, at store-chain warehouses, or at the distributor level for smaller stores.

In the US, at least for foods and similar consumables, this would not extend to consumers.

The standard direction to US consumers is to return the product to the store where you bought it. If that's not practical, you have the option of contacting the manufacturer for a refund, and/or contacting the FDA directly. Instructions for the latter are at http://www.fda.gov/opacom/background...lem.html#emerg (http://www.fda.gov/opacom/backgrounders/problem.html#emerg).
Interesting feedback however, I have no issue with a mandatory recall with this regards. But what happens when a voluntary recall is invoked by a foreign Manufacturer that wishes to protect its brand image but found it difficult to do so "beyond their shores" when they realized (assumption in this case) that their distributor does not have a recall procedure in place.

I reckon this situation would have breached the requirements of clause 5.1 where food safety objectives are not supported by the business objectives of the organization.

Funny enough though, "clause 7.9" states that "the traceability system shall be able to identify incoming materials from the immediate suppliers and the initial distribution route of the end product"

Clearly clause 7.9 appears to be quite limited in terms of product tracking for recovery purposes however I believe the cross functional objectives of the standard goes beyond these mentioned clauses or is it?