Just a note on 1.1.3 (saw that coming), there is a handy FDA free download I played with last December:
FDA food defense plan builder (http://www.accessdat.../fdplanbuilder/) is quite interesting once you dig into a wee bit… “food defense” with “site security” sometimes called “Operational Risk Management” [Security of Property/Product/Personnel]. This is all GFSI anyway… but don’t know if FDA will push this on FSMA “exempt” industries like 21 CFR 123 (seafood), 113 (L-A canning), 120 (juice)…
If you upload it (not very big)
An interesting tool:
If you download the program:
1) 2nd tab "Broad Mitigation Strategies":
a) is exactly what I was thinking when tracking the GFSI Benchmarks.
i) Clause/Section # hierarchy
ii) Checklist
iii) Full Clause/Section Description
iv) Comments
2) 3rd tab “Vulnerability Assessment”:
a) A rather simple quantifiable risk assessment structure (by flow/process steps) and identify it as a “action” point.
3) 4th tab “Focused Mitigation Strategies”:
a) keys off of the flow/process steps of the previous tab, a check mark for all “actions” that apply (a good start to show the user the themes of control actions, and later able to input one’s own actions if there is some variation not listed, “Mitigation Strategies” not linked with “Action Steps” tab 6)
4) 6th tad “Action Plan”:
a) A summary (but “Action Steps” not refresh/linked to “Mitigation Strategies” on tab 4)
b) Additional comments able to be added at this point.
5) 7th tab “Food Defense Plan”:
a) A complete write up of all previous tab inputs:
i) Company info (tab 1)
ii) "Broad Mitigation Strategies"
(1) Section (tab 2)
(2) Plan Content (tab 2)
(3) Comments (tab 2)
6) 8th tab “Supporting Docs”
a) Able to upload documents
Food for thought… I thought it was pretty well done as far a architecture (apart from some small quirks) and worth poking around.
Cheers,
-B
