6 replies to this topic

[ArnieTheTerminator]

We're scratching our heads in the lab regarding the HACCP decision tree process.

 

we have our process steps and hazards down, now we're trying to apply the decision tree to determine if it's a CCP or not.

 

We don't know how or why this would be a CCP?

 

Process Step: Material Offloading and Inspection from Delivery

 

Hazard: Contamination of Pallet Wood "PRP 10: Raw Materials (Supplier selection, Specification)", "PRP 10: Raw Materials (Supplier selection, Specification)"

 

Control Measure: Disinfection of Wood Pallets and Decanting of Materials from Wood Pallet onto Aluminium Pallets

 

Control Measure Justification: Disinfection of Wood Pallets and Decanting of Materials from Wood Pallet onto Aluminium Pallets

 

---

 

By disinfecting the wood pallets and decanting our product, the hazard would be eliminated, so would this mean that in Q3, that the hazard would be fully eliminated and hence not a CCP? Based on Q3 the identified hazard could not increase due to disinfection, however there is a control measure in place, so we seem to be stuck? 

If we have our PRP in place for disinfection with an SOP, then we don't need to run this hazard through a CCP decision tree correct?

Edited by ArnieTheTerminator, 06 May 2022 - 12:46 PM.

[Scampi]

You are correct

 

AND in the grand scheme of things the likelihood of the wood penetrating the shipping container is quite low

 

 

What made you determine you would sanitize the wood skids?  I'm curious to the thought process

 

Your incoming materials should be in some sort of packaging on the pallets, so sanitizing the wooden skids isn't really achieving anything

 

I've never in my 20+ years been in a facility where this step is controlled this way-----------are you really thinking micro hazard?  Generally speaking this is a physical hazard step only

[ArnieTheTerminator]

You are correct

 

AND in the grand scheme of things the likelihood of the wood penetrating the shipping container is quite low

 

 

What made you determine you would sanitize the wood skids?  I'm curious to the thought process

 

Your incoming materials should be in some sort of packaging on the pallets, so sanitizing the wooden skids isn't really achieving anything

 

I've never in my 20+ years been in a facility where this step is controlled this way-----------are you really thinking micro hazard?  Generally speaking this is a physical hazard step only

 

 

Thanks for the amazingly quickly answer.

Basically we don't have too many hazards which are troubling for us in the manufacturing of supplements outside of microbial testing and metal contamination, we wanted to potentially minimize or eliminate the risk of microbial hazards through transport arriving to our warehouse storage which is next to our lab (cleanroom). 

 

By potentially quickly spraying around the wooden pallet with a dedicated sprayer with isopropyl we thought it might minimize the transfer of bacteria/viruses from the bottom of the drums on the wooden pallets themselves. The powder in the drums are already packed into double sealed plastic bags. These drums would then get placed onto our shelving. 

 

Thinking about this more it does seem overkill, but that was the thought behind including it as a potential hazard in our material delivery step. 

Edited by ArnieTheTerminator, 06 May 2022 - 01:04 PM.

[olenazh]

Completely agree with Scampi, wooden pallets present potential physical hazard if not controlled. However, sanitizing seems unnecessary.

[Scampi]

Ah, now that I see what you're manufacturing, I get why you're concerned about micro

 

I would be inclined to put less emphasis on the wooden pallets and more on 

 

A) how the inner bags of the barrels are handled to prevent micro contamination from your employees

 

B) the forklift equipment (wheels and forks)

 

C) the barrels themselves---if you plan on relocating the barrels to clean/sanitized pallets (you can buy plastic FYI) than I would be more likely to spray isopropyl on the barrel surface and remove the pallets from the facility

 

As long as the pallets are visibly clean, in good condition and don't smell of anything other than wood, your risk is exceedingly low

 

 

From a overall perspective, I'd would put more emphasis on equipment cleaning, as the introduction of moisture to your facility is probably the single largest hazard (aside from batching issues/label compliance) you're likely to have

Edited by Scampi, 06 May 2022 - 01:17 PM.

[Charles.C]

Hi ATT,

 

Standard is unknown but these days the receiving stage controls are a near 100% guaranteed PRP status in haccp. (I am unfamiliar with  FSMA/HARPC).

 

Yr OP queries should be interpreted via an understanding of (a) the PRP concept as utilised within the HACCP Plan  and (b) the Scope of the HACCP Plan, its "backbone " Hazard Analysis and the Process to which the HACCP Plan relates.

 

In the original interpretations of HACCP, the factors/risk assessments discussed in yr previous Posts might well have led to a CCP but this "vision" of HACCP has changed with time and particularly according to the expanded usage of the Prerequisite concept which has concomitally decreased the total number of CCPs in a HACCP Plan..

 

Effectively, potential hazards associated with the first Receiving Stage are still determined/expressed  in the overall  HACCP Plan but any controls deemed necessary are considered to be handled via PRP Programs. The result is that significant hazards are not generated by the Hazard Analysis/Risk assessment at the Receiving Step. (The ongoing effectiveness of such PRP programs is typically demonstrated  via a Verification Routine).

 

The above conceptual aspects are well explained/detailed in the foundation texts of Codex (particularly regarding Scope) and  NACMCF (particularly regarding PRPs).

 

More recent Codex-type Decision Trees (eg Campden) simply include the above PRP factor as a precursor Step to the original Codex Tree.

Edited by Charles.C, 07 May 2022 - 07:23 AM.
expanded

[PQEdwards]

Agree with Charles C on this, the control can most likely be specified and managed as through a PRP