20 replies to this topic

[EmmaDamas95]

Can anyone clarify the reason behind why we perform a direct observation and is it only referring to a CCP check or is it CCP and CP's included?

[Charles.C]

Can anyone clarify the reason behind why we perform a direct observation and is it only referring to a CCP check or is it CCP and CP's included?

 

Hi Emma,

 

Can you supply a little context to yr rather vague query ? eg Source, relevance, etc

[EmmaDamas95]

Hi Charles,

 

I'm in the process of reviewing our company's HACCP plan, and currently we only have 1 CCP but the substantiation behind one of our CP's no longer holds so it has to become a CCP. In this process its come to my attention that the CP action required a direct observation as did the CCP. So I want to better understand what is the criteria behind perform a Direct observation as the research I've done behind it has confused me.

[Slab]

Hi, Emma;

 

What is the process step and hazard? An observation may be appropriate eg. "vigorous boil" "metal detector present".  A CP is considerably different from CCP in a regulatory matter.

[Charles.C]

Hi Charles,

 

I'm in the process of reviewing our company's HACCP plan, and currently we only have 1 CCP but the substantiation behind one of our CP's no longer holds so it has to become a CCP. In this process its come to my attention that the CP action required a direct observation as did the CCP. So I want to better understand what is the criteria behind perform a Direct observation as the research I've done behind it has confused me.

 

Hi Emma,

 

Need more info.

 

Additionally to previous Post - 

Standard  = ?

Product = ?

 

I am not familiar with the terminology "direct observation" ?  = measurable ?

 

"CP" has a variety of interpretations depending on the Standard/context.

 

afaik, SQF/IFS are the only GFSI Standards which, respectively implicitly/explicitly, require CPs. FSMA no idea.

 

Maybe unrelated(?) but CCP's Critical Limit in Codex-based Standards can be an observable or measurable criterion but only a measurable datum in some others.

[EmmaDamas95]

So the product is a mixed nut or dried fruit product.

 

The CP is metal detection and the CCP is label inspection.

 

Our checks are in regards to both of these is to verify that the metal detector cards were actually detected by the metal detector properly. The label inspection action is to verify that the allergens are accurately verified per the product in the bag and the bag its placed in.

[Charles.C]

So the product is a mixed nut or dried fruit product.

 

The CP is metal detection and the CCP is label inspection.

 

Our checks are in regards to both of these is to verify that the metal detector cards were actually detected by the metal detector properly. The label inspection action is to verify that the allergens are accurately verified per the product in the bag and the bag its placed in.

 

Hi Emma,

 

It might depend on the Standard involved and the specific hazard analysis/haccp Plan but, typically, "metal detection" is a CCP and "Allergen Labelling" is a PRP.

[EmmaDamas95]

Ah okay. and we're under SQF 

[Charles.C]

Ah okay. and we're under SQF 

 

Hi Emma,

 

I'm not a SQF user but I know that SQF is a bit weird regarding "CPs" . Afaik the only mention of CPs is in the Glossary, ie -

 

As described in the SQF Food Safety Code. The plan shall be prepared based on the CODEX  HACCP  method,  include  process  controls  at  control  points  in  production  to monitor  product  safety,  identify  deviations  from  control  parameters  and  define corrections necessary to keep the process under control.

("CP" is an SQF "specialty" since neither Codex HACCP nor SQF Guidance make mention of such control points. Furthermore there is no definition of a CP in the SQF Code).

 

afaik  "allergen control" is usually an "inclusive"  PRP Program within SQF however it is conceivable that a CP might exist depending on the detail of steps presented in yr Process flowchart. The latter then defines the detailed hazard analysis.

 

Other SQF users may have more knowledge about SQF's expectations of "artificial"  "CP elements".

 

PS - There is a lot of history attached to "Control Point" /  "CP", eg -

 

https://www.ifsqn.co...cps/#entry15805

 

https://www.ifsqn.co...ccp/#entry76114

[Slab]

 

 

afaik  "allergen control" is usually an "inclusive"  PRP Program within SQF however it is conceivable that a CP might exist depending on the detail of steps presented in yr Process flowchart. The latter then defines the detailed hazard analysis.

 

 

 

Under USFDA HACCP labeling for storage temp (C. bot.) and allergens is a CCP. Under USDA it is both a PRP and CCP...

[Charles.C]

(a) Under USFDA HACCP labeling for storage temp (C. bot.) and allergens is a CCP. (b) Under USDA it is both a PRP and CCP...

 

Hi Slab,

 

Thanks input.

 

(a) Applies for allergen labelling of all FDA jurisdiction Products  ?.

(b) Choice depending on ?

 

Presumably, in USA, (a,b) supercede any existing SQF recommendations ?

 

What about CPs ?

[Slab]

Hi Slab,

 

Thanks input.

 

(a) Applies for allergen labelling of all FDA jurisdiction Products  ?. 

(b) Choice depending on ?

 

Presumably, in USA, (a,b) supercede any existing SQF recommendations ?

 

What about CPs ?

 

Hi, Charles;

 

You have to meet all regulatory requirements for SQF, however code may exceed jurisdictional requirements as long as it does not undermine the intent of enforcement. 

 

As far as allergens and C. bot. control measures, I believe that CFR Title 9 (USDA), 50 (USDC), and 21 (USFDA) all expect a vigorous labeling program as a CCP to control these hazards. Control points generally are not given much scrutiny as these are seen as quality measures, or internal controls with arbitrary values which for the most part is not regulated unless it is a voluntary program such as CFR Title 50 USDC (eg. the much vaunted bureaucratic Seafood Inspection Program for export).

 

For the OP, it would seem that the CCP metal detection "direct observation" is borrowed from the USFDA seafood hazards guidance in Ch. 20 

 

 Metal Inclusion-Chapter-20.pdf   1.95MB   9 downloads

 

I would say that the OP methodology is erroneous per regulation, unless they can justify decision with other validated methods. 

[Charles.C]

Hi, Charles;

 

You have to meet all regulatory requirements for SQF, however code may exceed jurisdictional requirements as long as it does not undermine the intent of enforcement. 

 

As far as allergens and C. bot. control measures, I believe that CFR Title 9 (USDA), 50 (USDC), and 21 (USFDA) all expect a vigorous labeling program as a CCP to control these hazards. Control points generally are not given much scrutiny as these are seen as quality measures, or internal controls with arbitrary values which for the most part is not regulated unless it is a voluntary program such as CFR Title 50 USDC (eg. the much vaunted bureaucratic Seafood Inspection Program for export).

 

For the OP, it would seem that the CCP metal detection "direct observation" is borrowed from the USFDA seafood hazards guidance in Ch. 20 

 

Metal Inclusion-Chapter-20.pdf

 

I would say that the OP methodology is erroneous per regulation, unless they can justify decision with other validated methods. 

 

Hi Slab,

 

Again, thanks for the above.

 

I now recall that the US seafood PRP vs CCP debate has a long, long forum history , eg -

 

https://www.ifsqn.co...ol-to-be-a-ccp/

 

The 2020 fishery hazards guide well demonstrates that for FDA/seafood, labelling control is an allergen-related CCP. I assume as per Post 12 that the Scope of seafood's interpretation extends to all other FDA regulated products.

(I suppose FSMA implicitly agrees with FDA since allergen control is included within the "PC Group" [albeit Seafood excluded from FSMA]).

 

For  USDA I haven't yet seen any specific, detailed, FDA-like elaborations regarding the former's allergen viewpoint or Scope. So as yet (for me), choice of PRP/CCP for USDA-regulated product  is un-defined.(to be "continued").

 

As an extension of above Fishery text, I anticipate metal detector will also be a CCP if FDA-regulated and assuming a significant hazard exists.

 

Conclusion is that SQF requires to implement a CCP for labelling control if a FDA-regulated item.

 

I anticipate that Product involved is FDA-regulated.(?).

 

So likely to be 2 CCPs.

 

Re - "direct", Yes, I note this is emphasised regarding critical limit (Fishery-pg33/501) however the reason for SQF's fascination with expecting enhancement of  "CPs"  in their flowcharts has always eluded me.

 

PS - I wonder whether a FSMA control option (Regulatorially-wise) trumps FDA/USDA if a discrepancy occurs.

[Scampi]

Ok now even I'm confused from the banter above

 

CCP require onsite verification to ensure the CCP is being applied as written as you have determined that step CANNOT BE REDUCED OR CONTROLLED to an acceptable level in the process.  A CP means that there are simply other controls available 

 

If the OP question is why onsite monitoring of CCP vs CPs i believe I have answered

 

However-I am wondering why labelling accuracy is a CCP??????????  Has there been multiple failures in final packaging?

[KTD]

Emma -

 

Going back to your original question. I am not sure about FSMA, but the idea may be a carryover from USDA FSIS. 9 CFR 417.4 which talks about verification and validation. Direct observation of CCP monitoring is required under (a)(2)(ii).

 

Keith

[Charles.C]

Ok now even I'm confused from the banter above

 

CCP require onsite verification to ensure the CCP is being applied as written as you have determined that step CANNOT BE REDUCED OR CONTROLLED to an acceptable level in the process.  A CP means that there are simply other controls available 

 

If the OP question is why onsite monitoring of CCP vs CPs i believe I have answered

 

However-I am wondering why labelling accuracy is a CCP??????????  Has there been multiple failures in final packaging?

 

Hi Scampi,

 

Did you miss the mention of "allergens" ?

[Scampi]

No, I didn't miss allergens. But a process would have to be VERY broken for allergen packaging to be a CCP!!!!!!!!!

 

There are lots of checks/balances that could be incorporated into a process to ensure the correct packaging is used on the correct product WIHTOUT calling a CCP

 

In this case it tells me the entire process is out of control-so slap a CCP on it because you can't fix the root cause

 

To be clear-I've worked in multiple facilities, running multiple allergens that look very similar and this is not the route I would EVER take

[Charles.C]

No, I didn't miss allergens. But a process would have to be VERY broken for allergen packaging to be a CCP!!!!!!!!!

 

There are lots of checks/balances that could be incorporated into a process to ensure the correct packaging is used on the correct product WIHTOUT calling a CCP

 

In this case it tells me the entire process is out of control-so slap a CCP on it because you can't fix the root cause

 

To be clear-I've worked in multiple facilities, running multiple allergens that look very similar and this is not the route I would EVER take

 

Perhaps USA does not always follow Canada.

 

You need to study the USFDA's Manual. This is a common CCP for Them.
 

If the finished product is known to contain an allergenic ingredient or a food intolerance substance you should identify the product labeling step as a CCP.

 

The point is that, afaik, for most everybody else (maybe not USDA?), it's covered within the PRP - Allergen Control Program.

Can take it up with FDA.

 

 FDA allergen control.pdf   132.48KB   17 downloads

 FDA allergen CCP.pdf   137.86KB   22 downloads

[Scampi]

Example 2 is fine Charles-that is for receiving labels and verifying that the ingredient deck is correct-totally makes sense

 

Poster was talking about the CCP being FINAL PRODUCT IN FINAL PACKAGE

 

Example 2 is referring to cross contamination

[zanorias]

Interesting discussion. Hopefully the OP's question is answered and pardon me for veering into the CCP/CP debate..

 

I have a friend who works for a competitor manufacturing the same product, they are pretty well established and have some major customers and BRC. Interestingly they have designated labelling of finished product as a CCP, I have not. On discussion it basically came down to the decision tree, we both used Campden however where I answered yes to Q1 (managed by PRP) they answered no, proceeding to yes at Q3 and hence CCP for labelling. Not something I agree with personally but obviously they deem appropriate and can justify so to auditors

[Charles.C]

Example 2 is fine Charles-that is for receiving labels and verifying that the ingredient deck is correct-totally makes sense

 

(a) Poster was talking about the CCP being FINAL PRODUCT IN FINAL PACKAGE

 

(b) Example 2 is referring to cross contamination

 

Hi Scampi,

 

These were "examples".

 

(a) Included in the full text.

(b) Negative.