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Dear Charles,
The EU regulation also includes HACCP "Audit" as part of the EU Council
Decision 94/356/EC, Art. 6,2,(a); 20 May 1994. Specifically it says in HACCP
Principle No 6 that the "own checks" (HACCP) should establish: "- procedures
for verification and review" (Italics are mine).
The EU regulation (like the US FDA regulation) does not call it "HACCP
audit", but "review" (in the same way the US FDA regulation calls it
"reassessment"). In the other hand "HACCP audit" does not appear specifically
nominated in Codex Alimentarius, even if extra-official interpretations argue
that it is included in the "verification" (No 6) principle.
The EU regulation does not establish a mandatory period for "review", but in
turn (and as in the case of the US FDA regulations establish a number of
reasons for "review", that are rather similar in both regulations). A
comparative list of possible EU & US FDA "HACCP Audits", regulatory and
recommended is as follows:
Possible partial internal
HACCP (complete or partial) audits
Type of audit
Purpose
Procedure
Responsible to decide
Frequency
Consumer complaints (USA)(1)
To decide on the need to modify HACCP and/or hygiene (SSOP) plans
Partial audit according to the type of complaint. Complaint research
Main Management/ Owner
Immediately after receipt of the complaint
Change(s) in condition(s) (1) (2)
To decide on the need to modify HACCP and/or hygiene plans
Desk audit on current and necessary HACCP and hygiene plans
Main Management/ Owner
Before changes are introduced and production started
Surveys on actual conditions during storage, distribution and sale (3)
To decide on the suitability of HACCP, hygiene plans and preventive measures
Product audit
Main Management/ Owner
As necessary
Surveys on actual use of the product (3)
To decide on the suitability of HACCP, hygiene plans and preventive measures
Product audit
Main Manager/
Owner
As necessary
Validation of Critical Limits (CL) (3)
Accomplishment of process control
Process (or operation) audit.
Challenge studies.
Main Management/ Owner
As necessary
Hazard analysis (3) (1)
To decide on the need to modify the HACCP plan
Hazard analysis. Risk assessment.
Main Management/
Owner
As necessary (EU)/at least once per year (US) (4)
Suppliers (5)
Accomplishment of raw material condition control
Product audit
Main Management/
Owner
As necessary
Notes:
(1) Mandatory in US regulations
(2) Mandatory in EU regulations
(3) Suggested as possible procedure in the EU regulations
(4) It is mandatory once per year even in the cases where initially it has
been found that no HACCP plan was needed (this is a possibility only within
US HACCP-based fishery regulations)
(5) Not mentioned in regulations but essential for those relying heavily on
the safety of raw materials (e.g. industries dealing with aquaculture fish or
shrimp)
Of particular importance is the need to perform a review/reassessment when
there are changes in conditions. According to regulations, this is mandatory
when there are changes in any of the following:
(i) Raw materials (EU and USA) or source of raw materials (USA)
(ii) Product formulation (USA) (EU)
(iii) Processing methods or systems (USA) or conditions (factory
layout and environment, process equipment, cleaning and disinfecting
programme) (EU)
(iv) Finished product distribution system (USA) (EU) or packaging
and storage conditions (EU)
(v) Intended use, or consumers of the finished product (USA)
(EU).
(vi) Receipt of any information on a new hazard associated with
the product (EU).
If you analyze the two previous tables it is clear that in a normal fish
processing plant, there would be enough reasons, once per year (or perhaps
with a higher frequency) to perform partial (or complete) HACCP audits.
Unfortunately, in practice there are a number of misunderstandings with HACCP
Audit in the fish industry. The most common are:
(i) To confuse "verification" with "audit" (in turn "verification" is
sometimes confused with "monitoring").
(ii) To confuse internal HACCP audit with regulatory HACCP audit. Both exist,
however, the "audit" (review/ reassessment) that basically appears in
regulations is internal audit (responsibility of processors). They are not
equivalent.
As a result probably the weakest part of HACCP implementation, all around the
world, is HACCP audit.
I did not finish to analyze the new EU regulations package yet, as you well
say it will enter in force on January 2006 (and there are a lot of other
subjects with more urgency like traceability), but from my first lectures I
do not think things will change too much in respect of HACCP audit.
In any case and based on my own experience regulations, I always suggest to
read them carefully, several times. In particular EU regulations (and till
certain extent US FDA and USDA regulations too) for a specific implementation
are a cluster of related regulations with some of them acting as kernel
regulations and other as periphery regulations. This is important for HACCP
Audit, because some of the specific aspects to audit could be not only in
horizontal or vertical regulations, but in some periphery regulations (e.g.
water regulation, method of analysis). HACCP Audit is not ISO (or Quality)
Audit, because you are not auditing against standards, but against
regulations, that not always are clear (or coordinated) as oneself would
like.
Finally could exist a number of interpretations of existing regulations (even
within fish inspectors of the same country). There could be EU fish
inspectors that do not ask for "review" evidence, but some do (in the same
way that FDA inspectors could or could not ask for "reassessment" proof).
In my personal opinion "review" and "reassessment" may start to appear more
clear in the whole picture once other problems with HACCP implementation be
completely fixed. However, and as we inform developing countries (exporting
to the EU and the USA), "HACCP audit" is in the regulations, and proof of
compliance could be asked at any time by foreign fish inspectors (even if
they may be not asking too loudly for it at home, yet).
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 CHARLES DAXBOECK
Sent: 11 September 2004 04:20
To: seafood@ucdavis.edu
Subject: HACCP plan audits and European regs
Dear Group :
As we all are aware, for USFDA Seafood HACCP compliance (and for that matter
nearly all other countries' HACCP requirements), there is need for at a
minimum, an annual audit of each operational plan (with written report to
that effect), under the plan verification practices, Section 123.8 of Title
21 CFR Part 123. In the older versions of the European Union's "self-checks"
seafood HACCP regulations 91/493/CE of July 22, 1991 and 94/356/CE of May 20,
1994 (with or without their subsequent modifications), I don't seem to able
to explicitly find any direct mention of requirements for at a minimum an
annual review of the effectiveness of the HACCP plan. If this is true then,
once you have your plan for the EU, you don't need to do anything anymore -
except the occasional critical limit "verification", and of course keep the
ever-present veterinary inspectors happy with test after test after test of
your end product ? If not please could someone clarify the real situation. I
do realize that as of January 2006, the new, better, revised EU "Food Hygiene
Package - 2004/C 48 E/ 01 through 04" will come into effect. Therein are
provisions for "official audits" of HACCP plans by an official vet, approved
vet or official auxiliary designated by the "competent authority", at what
frequency is not specified. One could interpret that to mean only for initial
approval of not only the facility but also of the HACCP plan, then if ever a
"question" about a real or imagined public food safety issue. Now under the
EU "own-checks Haccp", unlike the USFDA which is clear, there again is
absolutely no mention or provision (unless I completely missed it) for any
review or audit of the plan at any minimum frequency whatsoever. I do
understand that, after initial approval (provisional or permanent) EU
sanitary inspection approvals for operating permits (EU agreement #'s) are up
for renewal every 4 years. At that time of competent authority inspection, a
valid HACCP plan must also be presented. It would therefore seem all too
logical that in order to prove that your plan has been effective over the
last 4 years, that you have all records available and that at a logical
minimum also, you have your plan audited and verified annually by a competent
team (either internal or external of your seafood operation) that does not
have to be a priori approved by the competent authority. If those who put
into place and costruct the HACCP plan then one should assume that they are
competent enough to underastand the underlying principles of HACCP and
therefore will insist in their plan that a reasonable frequency of internal
review, validation and audit is a mandatory part of THEIR plan, even if not
specified under EU regs. Is this correct or am I missing something ?????
Please, could someone help me understand ?
Thanks all in advance.
Dr. Charles Daxboeck
Tahiti, French Polynesia
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