8 replies to this topic

[Linfield]

Hi everyone!

 

I do see this has been a topic brought up here, however wanted to ensure I am on the right track specific to my company.

 

My company is a beverage manufacturer of agglomerated flavored powders that we receive from various flavorhouses and agglomerators, that we then fill into bulk filler to fill our capsules.

 

I'm currently working on updating our documentation, put have been a bit confused as to whether we even need a HACCP plan. We are not currently GFSI certified, so I believe a FSMA compliant FSP would suffice.

 

Any help would be appreciated!

[Charles.C]

Hi everyone!

 

I do see this has been a topic brought up here, however wanted to ensure I am on the right track specific to my company.

 

My company is a beverage manufacturer of agglomerated flavored powders that we receive from various flavorhouses and agglomerators, that we then fill into bulk filler to fill our capsules.

 

I'm currently working on updating our documentation, put have been a bit confused as to whether we even need a HACCP plan. We are not currently GFSI certified, so I believe a FSMA compliant FSP would suffice.

 

Any help would be appreciated!

 

Hi Linfield,

 

I am not an expert on FSMA but afaik, the "FSP" you refer to is (sort of) FDA's version/interpretation/vision of  Codex/NACMCF's "HACCP", and was (at least originally) entitled HARPC.

 

Again, afaik, FSMA is a FDA-inspired Regulatory Act  whose compliance necessity depends on, perhaps[?] inter alia, the specific Organisation which has legal jurisdiction over yr Manufacturing Activity (eg FDA/USDA).

 

You perhaps need to look at the details of "FSP" to appreciate the differences between HACCP and HARPC, eg with respect to FSMA's notion of "Preventive Controls".

 

To put it more succintly, HARPC = FSMA(HACCP)

 

In comparison, GFSI is not a Regulatory "function", eg -

 

GFSI is a business-driven initiative for the development of food safety management systems to ensure food facilities are processing safe food for consumers.

 

 

Whether you need  to have "GFSI-recognition" often depends on your customers' requirements or perhaps your own desire to have your FSMS System "recognised" as being equivalent to one of the GFSI "approved" (recognised) Standards such as BRC, SQF, FSSC22000 etc

[The Food Scientist]

Food manufacturer? OF COURSE YOU NEED A HACCP PLAN.

[mgourley]

If you are a FDA regulated facility, then you need to comply with the requirements in the Food Safety Modernization Act.

Long story short, a HACCP Plan is not a Food Safety Plan, as proscribed by FDA. And to make it more confusing, if you are regulated by FDA, you also have to have a plan that meets the requirements of their Intentional Adulteration rule.

Marshall

[MsMars]

To be on the safe side in the past, I've always just molded an existing HACCP plan into a HACCP/FSP plan with both CCPs and PCs on the same hazard analysis.  Depending on your third-party certifications and regulatory oversight, this may not be necessary. 

 

See more: 

https://www.ifsqn.co...p/#entry135265 

[Linfield]

Thank you everyone! That was the part I was confused about (and seems I'm not the only one)- CCP's versus PC's.

 

In reviewing the current FSP Flow Chart, the CP's listed include sifting through a mesh screen to break down any clumps (screen set at 6mm- anything larger cannot pass through), Auger Filler Magnet pass, and the X-ray Machine.

 

We're not currently GFSI certified, and only have one production line, but I have been confused between the 2 (if we really need both), and what documentation I'll need for just a FSP- will I need PRP's, etc?

[MsMars]

Thank you everyone! That was the part I was confused about (and seems I'm not the only one)- CCP's versus PC's.

 

In reviewing the current FSP Flow Chart, the CP's listed include sifting through a mesh screen to break down any clumps (screen set at 6mm- anything larger cannot pass through), Auger Filler Magnet pass, and the X-ray Machine.

 

We're not currently GFSI certified, and only have one production line, but I have been confused between the 2 (if we really need both), and what documentation I'll need for just a FSP- will I need PRP's, etc?

 

Have you per chance been through the PCQI course? If not, I highly recommend, especially if you do not have another PCQI on-site (it is required). The course manual is very helpful for questions like these as it walks you through creation of a new plan.  I've used the FSP Builder software in the past too (can someone chime in if this still exists?).  In a nutshell, yes, you will need pre-requisite programs for your FSP. 

[Linfield]

Yes,I have completed the course. I'm currently split between product development and quality at my company (smaller start up, however expanding quickly into different markets and locations). While I have had experience in QA and reviewing documentation, this is my first time having to review and recreate/rework a FSP, so it has been a lot to figure out exactly what documentation is needed, in addition to being the only person creating and reviewing QA work

[Charles.C]

Thank you everyone! That was the part I was confused about (and seems I'm not the only one)- CCP's versus PC's.

 

In reviewing the current FSP Flow Chart, the CP's listed include sifting through a mesh screen to break down any clumps (screen set at 6mm- anything larger cannot pass through), Auger Filler Magnet pass, and the X-ray Machine.

 

We're not currently GFSI certified, and only have one production line, but I have been confused between the 2 (if we really need both), and what documentation I'll need for just a FSP- will I need PRP's, etc?

 

Hi Linfield,

 

Yr example is a good example of various  "Matter of Opinion(s)" . eg -

 

(1) Does this activity remove a significant safety hazard ? (As stated, probably not).

(2) Is the 7mm FDA pseudo-Critical limit justifiable ? (As stated, probably not)

(3) Is a magnet a CCP when followed by X-Ray (or MD).(Most often not but exceptions exist)

 

PRPs sometimes look the easy way out.

 

Happy head-scratching !