HACCP plans

From: Schalk Alain (alain.schalk@cotecna.ch)
Date: Mon Nov 15 2004 - 06:39:15 PST

  • Next message: ranjith_edirisinghe@nara.ac.lk: "Chemical Checks for Canned fish"

     

    Dear all,

     

    ISO, HACCP, Compliance certification, traceability and other quality schemes
    all have the same logic always seen differently at producer and importer'
    sides....

     

    For importers/buyers, those quality programs are seen as regulatory schemes
    supposed to bring confidence in the quality of imports and they are
    considered as necessary investments to be made by producers at their own
    expenses.....but on the other side, in very often less developed countries,
    it is seen as another "crazy" obligation coming from rich and selective
    partners...

     

    So the sellers/producers would often try to do the minimum to please the
    importer or the state regulation (FDA, EU) and they would not consider this
    action as a "plus" for their own image/operation. Most of the time they
    would try to spend as little money as possible to reach minimum requirements
    for being eligible for imports in the said country and if to get there they
    have to copy plans or just adjust some old ones they would only do the
    minimum at lowest possible price.

     

    And this is really where the misunderstanding lies........it is just like
    giving pills to someone who cannot sleep because of having night
    worries......it would be much better to eliminate the source of worries and
    the guy would sleep without pills...

     

    What I mean is that the industry must understand that they are not asked to
    follow a book or guidelines to please someone but they must take their own
    personal measures in order to be able to increase business and sleep better
    by being confident in the quality they produce......Guidelines are good but
    I think common sense and professional approach are what lead the quality of
    such delicate products as fish and seafood...A plan is just a way of putting
    down a picture of the risks detected at a certain moment and start
    monitoring them ... so it is based on the field reality. To try to adapt any
    operation on basis a copied plan or just a standard basic guidelines book
    would just be inappropriate and risky...

     

    Who wants to have the supposed risk management program to become a risk
    generator itself ? A plan adapts itself to a structure and certainly not the
    contrary! So it is always unique to my point of view! And in this respect I
    do not see any need to treat them as confidential as long as they are good
    and not subject to any possible obvious criticism....transparency might
    expose some unprofessional or foolish players.

     

    As Hector said it is really up to management to do a first evaluation
    mission in order to define where their critical points could be (sanitary,
    temperature abuse, mixture of species reacting differently to histamine
    etc...) and they should address them internally or with the help of
    consultants in order to better manage their risk. The plans or the written
    procedures would just report on what they do to monitor and minimize their
    risks...and they would never fear any audit or final lab tests imposed by
    anybody ...

     

    Their safety actions become then documented to the benefit of the buyers
    and/or the importing countries...

     

    Alain Schalk

    Cotecna Inspection SA

     

       _____

    From: owner-seafood@ucdavis.edu [mailto:owner-seafood@ucdavis.edu] On Behalf
    Of Lupin, Hector (FIIU)
    Sent: 15 November 2004 13:39
    To: Francisco Blaha; CHARLES DAXBOECK; seafood@ucdavis.edu
    Subject: RE: HACCP plans

     

     

    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

     

    ________________________________________________________________
    This communication contains information that is confidential and is intended
    for the exclusive use of the addressee(s) only. The unauthorized reading,
    disclosure or copying of this email is strictly prohibited. If you are not
    the intended recipient(s), please note that any distribution, copying or use
    of this communication or the information contained in it is strictly
    prohibited. If you have received this communication in error, please notify
    the sender immediately and then destroy any copies of it. The content of
    this message does not reflect the opinion of the Cotecna Group or any of its
    affiliates except to the extent that it relates to their official business.

                    Cotecna Group strives to protect itself from computer
    viruses. However, as new viruses constantly appear, we do not accept
    responsibility for the effects of any virus which you may contract from us.
    We encourage our correspondents to implement anti-virus software, and to
    keep it up to date.

                    Please visit our website <http://www.cotecna.com>


    image001.jpg

    This archive was generated by hypermail 2b29 : Mon Nov 15 2004 - 06:42:00 PST