Dear Charles
I guess different countries have different methods, but an underlaying line
should be confidentiality in regards commercially sensitive information...
If your compliance systems are allowing you market access, and there was a
cost associated to their development (doesn't matter who paid for them, in
my opinion). Then that is commercially sensitive information.
During the early days of the application of HACCP, I found copies of plans I
developed for a company appearing at another one, and the vector was a
verification officer (who was later reprimanded).
In the countries I have worked since them, I make sure that the
³confidentiality issue², becomes a component of the CA code of practice,
particularly when the CA request copies of the plans and or compliance
programmes.
In NZ, the verification officer has open access to all systems while on
site, but it would face scrutiny if he request copies of it to take away. In
the case of Risk Management Programmes, an outline of it is lodged with the
top regulatory group, but not the whole document.
Have faced the situation you are presenting in some Pacific Islands
countries, East Africa and the Caucasus, however the advantage was that
neither industry or CA werenıt big.... Therefore the situations could be
arranged after a few talks and phone calls
As far as the US FDA system, I do remember that the ³positive steps²
included sending copies of your systems to your importer... Again I have
seen a compliance system popping in a in another Pacific Island country, and
the vector was the importer.
I guess there is no complete security around it, except creating the
appropriated conditions for it not to happen, by promoting and maintaining
access to training, an open CA-Industry relationship, and rewarding
ownership of systems and good compliance, with schemes such as Performance
Based Verification (or Auditing).
This is an interesting and recurring topic, hope my contribution helped
Francisco
On 13/11/04 10:28 am, "CHARLES DAXBOECK" <biodax@mail.pf> wrote:
>
>
> Dear Group :
>
> Thanks to those who responded to my last set of queries.
>
> I now have another more "legal" sort of question. Under the USFDA seafood
> HACCP regulation, the agency does not "validate" plans. FDA must nonetheless
> have access to existing plans for inspections and can make comments and
> recommendations as their appropriateness for controlling identified CCPs. FDA
> may also recommend additional control measures should there be missing food
> safety hazards for the particular commodity, that may not not been identified
> or considered in the particular plan. As far as I know, FDA does not keep
> individual plans on file, since again as far as I know these plans remain in
> the domain of private, individual property which may contain trade
> secrets/proprietary information. The situation is a bit different in other
> countries, and especially in the EU, where plans MUST BE submitted for
> validation and verification before an "export permit" can be issued. In
> addition, at least for EU, the facility in which the export commodity is
> produced must also pass inspection. Only when BOTH PLAN and FACILITY pass
> muster can the company export. Now the question remains, under the latter
> situation, would it then be "legal" for the "competent authority" to keep a
> photocopy of each "validated" plan despite the fact that the plans have been
> elaborated by the private sector, at private sector expense (or sometimes
> subsidised by public funds/assistance) ? Don't these plans still remain
> private property, but as such must still be available for official review and
> inspection upon request in the facility of commodity production ? The
> potential for unauthorized "sharing" of plans among persons outside of the
> "official circle" to me seems to be a fairly serious issue. The obvious way
> around this is the USFDA system whereby the plans stay in place and are
> available for consultation in place upon request and therefore there is less
> of an "unauthorized sharing" problem. Would anyone on the list care to
> enlighten me on this issue, either in group or off-line ?
>
> Thanks again all in advance.
>
> Dr. Charles Daxboeck
> Tahiti, French Polynesia
> biodax@mail.pf
>
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