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Dear Francisco and other colleagues:
I think there are a number of misunderstandings dragging on HACCP (and
Hygiene) plans since the beginning of the introduction of regulatory HACCP:
(i) The HACCP, and Hygiene (as a plan or just as monitoring) are the sole
responsibility of the plant (company). In the case of the EU there is a
"validation" step based on the rationale of the assignment of a code (number)
to each establishment and subsequent inspection/ audit. That is taking in
some regulations further (e.g. with export purposes) which de facto seems
transfer part of the liability to the "competent authorities" (does it
really?).
(ii) At the beginning of the HACCP saga when we (FAO) toured the world trying
to teach how to draft HACCP (& Hygiene) plans; one of our mottos was "One
plant, one case". We found many cases where the same product (in different
plants) required different HACCP & Hygiene plans, simply because of
unavoidable time delays, type of technology utilized, environmental
conditions, different specie (even if the generic/ commercial name was the
same); etc.etc. At that time we had to face a number of problems, for
instance the existence of generic HACCP plans (that many people never
understood were only indicative). The eagerness of fish importers and
exporters to continue "business as usual"; etc. But the plans are not the
most important thing ....
(iii) The plants are liable not for the HACCP & Hygiene plans in themselves,
but for what they are actually doing, at ant time. In this sense the approach
of FDA HACCP Inspection (Audit) seems to me very appropriate, because FDA
inspectors enter the facility and look for what the plant is producing at
that specific time (e.g. in terms of hazards and hygiene monitoring). They do
not ask initially for the HACCP plan (at least in the training film). If the
plant/ product are in agreement with the basic HACCP scheme (e.g. the one
derived from the FDA Fish and Fisheries Products and Hazards and Control
Guidance) then it would be all right (could be differences but I will not
discuss them here, the process in such a case is clear from the FDA site).
(iv) The only way for management of given plant to know if they are doing
what it is supposed they have to do is "verification" and "internal HACCP
audit" (the last one "review" in terms of the EU and "reassessment" in terms
of the FDA regulations). "Verification" is independent of "monitoring at CCP
points". In the other hand "Review/ reassessment" of the HACCP (& Hygiene or
SSOP plans) should be in turn independent of who drafted, approved,
validated, implemented and run the plans. And this is currently a serious
problem for the regulatory HACCP system worldwide, because "verification" and
"review/ reassessment" are the weakest part of all the HACCP system as result
that very often are the same persons to audit themselves.
The "misunderstandings" were/ are of different type:
1. HACCP plans can be copied from other similar plants (even more an
"approved/ validated" plan could be much better than an appropriate plan!).
2. HACCP plans (and related documents) are just papers to make inspectors
happy.
3. "Who say I should have a Hygiene plan too (or monitor as if I had a SSOP
plan)?" I insist with Hygiene plans because this is one of the main problems
found in practice, people tend to forget that HACCP regulations ask also for
Hygiene plans (or in the case of FDA regulations to monitor as if you had a
SSOP - written SSOPs not mandatory in FDA regulation for the fishery
industry-).
4. "If I pay for the consultant/ veterinarian, etc. doing the HACCP plan,
then this is his/her responsibility."
5. Regulatory HACCP audit replaces internal HACCP audit ("review/
reassessment"). It does not.
6. Who made the monitoring can perform the verification. It is not a good
practice and safe procedure.
7. Who drafted, approved, validated, implemented and run the HACCP plans, can
audit ("review/ reassess") it. This is a very bad practice and only
perpetuate mistakes, starting with the first one. There is a very clear
conflict of interest at this level.
The need for trained people for dealing with HACCP added some additional
complications because it was seen as a way to expand work markets for
consultants or for specific professions (e.g. veterinarians). Well, things
have to be done by somebody, but reading careful the justification to
regulations this was not the initial idea. The initial idea was that people
that were already doing the things (from managers and professionals/
employees in the plant to fish inspectors - from any profession-) become
conversant with HACCP to apply it properly. There could not be a
"responsible" for HACCP (regulatory or not), because regulations are very
clear that the responsible is the producer, and this can not be delegated
(because there is not provision in the regulations for such a delegation).
In this sense nice "HACCP certificates" hanging from the wall, or
consultants/ veterinarians hired "because" of implementing HACCP are equally
worthless in terms of liability for the firm. Unfortunately some companies
have already discovered that, the hard way.
This "work syndrome" in HACCP has created in my opinion a large distortion in
actual HACCP implementation. Because, among other things, if you seek to be
paid for something that should be justified in some way. Mystification is one
of the results. The more pages in the HACCP (and Hygiene) plans you prepared
the more you can ask for. But to copy a plan that has been approved is fine
because inspectors (in principle) can not say you "no". In turn inspectors
will (in general) refrain to reject a HACCP plan similar to other that has
been already approved ....
HACCP (& Hygiene) plans are not "rocket science" (despite the stories about
astronauts) and by now there is a lot of practical experience. By now HACCP
and Hygiene plans in each fish processing plant should be tailored to the
specific plant/ product; more or less like a pair of shoes designed and
constructed at measure, and utilized in practice. To copy them for use in
other plant may not have any true reason, but ignorance and/ or insecurity in
the "expert" side. Following with this analogy a pair of supermarket shoes
will make suspicious any true HACCP Auditor; somebody else shoes even worst.
No indication of changes along the years it is usually an indication that the
concept of HACCP was never ever grasped.
HACCP (& Hygiene or SSOP plans) should be increasingly seen as a "risk
management tool". Not because it is fashionable, but because they are just a
risk management option. In practice there are a number of other "risk
management options" to be taken both by "competent authorities" and industry.
They should provide safe food to consumers.
To copy somebody else HACCP plan (particularly if "approved/ validated")
could be seen by the plant owner/ manager as a right "risk management tool"
to solve his/her problems (you never know what the industry or others will do
to meet regulatory requirements, and assumptions are only that, assumptions).
But in this particular case the copy is not good "risk management" practice,
and industry people (and competent authorities) should know that. This is
one of the reasons why HACCP and HACCP (& Hygiene) plans are not enough, and
there is the need to move to the next step. Risk management.
Risk management, when adopted, should clarify roles and actions and
personally I hope that the term "management" makes clear who are the
responsibles. But history moves slowly and in most places it would take some
time to arrive there.
Kind regards.
Hector M. Lupin
Senior Fishery Industry Officer (Quality Assurance)
Fish Utilization and Marketing Service
Fishery Industries Division / FAO of the UN
Viale delle Terme de Caracalla 00100 Rome Italy
Tel.: +39 06 570 56459 Fax: + 39 06 570 55188
E-mail: hector.lupin@fao.org
Please visit our website: http://www.fao.org <http://www.fao.org/>
-----Original Message-----
From: owner-seafood@ucdavis.edu [mailto:owner-seafood@ucdavis.edu] On Behalf
Of Francisco Blaha
Sent: 13 November 2004 04:28
To: CHARLES DAXBOECK; seafood@ucdavis.edu
Subject: Re: HACCP plans
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
"confidentiality issue", 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 weren't 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 "positive steps" 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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