This is for the FDA who audits us and also for when we do our voluntary GMP audit.
Hi biddlecom,
Thks for response.
i apologize for my ignorance since I'm not in USA but is there any specific link as to the FDA's requirements ? If not, never mind. The point is that IMEX every Standard / regulatory body have some individual expectations of their own which may differ to all the others and dictate the associated HA, etc.
I don't use the US table format for haccp so other people are better equipped to comment on the details in this layout. Personally in my style i include items like glass breakage directly under the heading of "potential hazard" while the BCP text is under a "category" heading. But maybe just different style.
The usual order of preparing a FS system is to initially decide which PRPs are necessary (basically setting up a GMP system/SOPs/SSOPs). The PRPs may be pre-defined by the auditing body, eg FDA.
Next the usual procedure is to implement a haccp plan if required, in Europe this usually follows the various steps of Codex, in yr case presumably NACMCF as interpreted by FDA.
It is crucial to generate a workable flowchart since the hazard analysis must match this. This is IMEX the first thing any auditor usually checks by "walking the production walk."
I notice at the moment you have 2 separate flow paths for dry/refrigerated. IMO the HA should show this if both are required to be maintained.
I assume the "refrigerated" path relates to quality factors only so will not be involved in haccp safety evaluations..
i agree with most of comments of sussykraus in Post 3. Some typical (for me) examples of flow charts are in the links/sub-attachments of my post 11.
Basically this should be a very simple HA if no hazards other than those controlled by PRPs, ie no CCPs. Yr layout generally looks similar to that for equivalent hazards in the files I previously linked to and seems reasonable to me though maybe needs a little "elaboration"/expansion. It is important that it makes sense when compared to the Flowchart.
I anticipate that the only problem you consider of any operationally extent relates to broken glass which will presumably be detailed in the PRP-SOP. The only comment is that if there is an excessive number of reported incidents you might find an auditor will suggest it should be a CCP since the PRP not adquately controlling. Unless it's normal for the Industry.
All risk matrices are subjective. I don't quite understand the intended separation of grey/red cells in yr template. IMEX both would be handled by CCPs. Otherwise the text looks internally feasible to me although quite different to my own usage. Maybe this format is typical for brewing Industry.
Hope the above makes sense.
HA TEST.xlsx 14.83KB
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