Food Recall procedure - Should we inform consumers? ISO 22000 Conformance

[MIREGMGR]

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.

 

[Soon Loy]

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.

 

[Wes Bucey]

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.

 

[MIREGMGR]

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.

 

[Soon Loy]

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.

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?