In a traditional haccp scheme, the basic haccp requirements would "simply" be to first define the potential BCPA hazards followed, including consideration of prerequisite programs, by a hazard analysis / risk assessment (ie due the process) to determine which of the potential hazards are significant. Followed/associated with CCPs/control measures and all the other familiar steps in the Codex/NACMCF scheme.
FSMA/HARPC has attempted to reorganise the preceding paragraph in various (sometimes mysterious) ways, notably via Preventive Controls. Not my locational area of expertise but, based on the (slightly old) FSVP link below, FDA seem to have a parallel semi-confusion scenario akin to the (still ongoing?) one in HARPC.
The inherent difficulty with all probability (eg "reasonably likely"/consequential) based decision rules is that some subjectivity (eg the middle area of risk matrices) is unavoidable due to (a) Interpretation, (b) Definition of Risk Criteria for Action/No actions. This characteristic is fundamental to HACCP Systems.
i am curious as to whether a similar uncertainty element is built into the decision mechanism for Class1, Class 2 etc Recall situations ?. I anticipate that it is. If so, I can understand yr quest for examples. But the usual problem for Authorities is that such examples are only definable at the end of the chain. Hence "Revisions".
afaik FDA are (supposed to be) in the process of formulating a list of "High Risk" foods which will presumably also be listed with the hazards which render them so. Such a list may assist yr decision queries.
My own area (seafood) went through analogous USFDA haccp convulsions in the 90's. FDA, eventually, and via 3-4 Revisions over 10 years, issued an amazingly ingenious (xy) matrix table which compiled all the (for FDA purposes) potential process hazards along the top(x) against all the typical final product presentations,, eg RTE, NRTE, chilled, frozen, down the left hand side(y). Appropriate pairings of Product/hazard which had to be considered for CCPs were then indicated in the relevant (xy) matrix cells. Basically, to assist the industry, FDA defined for internal/external processors what they had to do to comply with FDA's new Regulations. I imagine the later FDA Juice Regulations did something similar.
Hopefully the HARPC/FSVP will eventually offer a similar, detailed, programmed, assistance but the Product scope/Haccp complexity are in FSMA, presumably, substantially increased, even without the inclusion of FDA seafood/ USDA meat products.
PS - A few additional comments.
I did not see a single example harpc/FSVP plan in my browsing. = Good business for Consultants.
I noticed in my browsing this rather provocative comment in one Company's response to the proposed FSVP rules. May be of interest -
While FDA does provide some examples of SAHCODHA (for example, hazards leading to Class 1 recalls), there is still much in the way of subjectivity. This, then, leads to the question: why would an importer ever lean toward a SAHCODHA determination, especially in a close-call scenario? If the importer doesn’t classify it as SAHCODHA, it won’t have to comply with onsite audit requirements. The importer has a conflict of interest in this situation.
If onsite audits are not required, does the proposed Rule accomplish what FSMA intends to do, which is to ensure that imported foods are held to the same standards as foods produced in the U.S.? Additionally, if FDA can’t even decide whether Option 1 or Option 2 is better, should the decision be left to industry or the entity being regulated ?
I also noticed a few files/link which maybe of some assistance. Not sure if any of these recently posted here already. If so, apologies in advance.
Foreign Supplier Verification Manual,FSVP.pdf 18.76MB
FSVP 1 - Supplier programs for FSVP,2017.pdf 2.65MB
FSVP 2 - fsma-foreign-supplier-verification-program-outline,2016.pdf 524.81KB
FSVP 3 - FSMA - Impact on Dairy,2014.pdf 1.37MB
FSVP 4 - full text,2015.pdf 550.06KB
FSVP 5 - FSVP implementation,2016.ppt 1.21MB
Edited by Charles.C, 22 May 2017 - 06:42 AM.