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Poll: Are you ready for FSMA? (104 member(s) have cast votes)

Does FSMA affect your business?

  1. Yes (80 votes [76.92%])

    Percentage of vote: 76.92%

  2. No (13 votes [12.50%])

    Percentage of vote: 12.50%

  3. Unsure (11 votes [10.58%])

    Percentage of vote: 10.58%

What is your biggest challenge regarding FSMA compliance?

  1. Lack of understanding (51 votes [34.46%])

    Percentage of vote: 34.46%

  2. Management buy-in (15 votes [10.14%])

    Percentage of vote: 10.14%

  3. Supplier compliance (26 votes [17.57%])

    Percentage of vote: 17.57%

  4. Documentation (25 votes [16.89%])

    Percentage of vote: 16.89%

  5. Audit Management (16 votes [10.81%])

    Percentage of vote: 10.81%

  6. None (15 votes [10.14%])

    Percentage of vote: 10.14%

Have you mastered HARPC?

  1. Yes (7 votes [6.73%])

    Percentage of vote: 6.73%

  2. No (38 votes [36.54%])

    Percentage of vote: 36.54%

  3. Getting there (43 votes [41.35%])

    Percentage of vote: 41.35%

  4. What is HARPC? (16 votes [15.38%])

    Percentage of vote: 15.38%

Is your facility ready for an FSMA compliance audit?

  1. Yes (10 votes [9.62%])

    Percentage of vote: 9.62%

  2. No (50 votes [48.08%])

    Percentage of vote: 48.08%

  3. Almost (27 votes [25.96%])

    Percentage of vote: 25.96%

  4. Unsure (17 votes [16.35%])

    Percentage of vote: 16.35%

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#1 Simon

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Posted 12 May 2016 - 06:58 PM

There's no doubt FSMA has been the talking point in the food industry (esp. USA) for the last few year's and now it's almost reaching fever pitch.  As we are the leading discussion platform for all things food safety I thought I'd start a poll to canvass opinion and start some debate on the subject among members.

 

Please vote and share your opinions.

 

Regards,

Simon


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#2 Big Wally

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Posted 13 May 2016 - 06:35 PM

I attended the Food Safety Summit and was lucky enough to learn our company does not fall into the FSMA bandwagon. My audible sigh of relief echoed off the walls and caused a couple of chuckles.


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#3 Slab

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Posted 13 May 2016 - 06:45 PM

As a seafood processor we are regulated by Title 21 CFR, so compliance to FDA oversight was mandatory some time ago.  :shades:

 

I'm still going forward regardless with HARPC as a "forward thinking" program.  I just feel that parts 123 and 110 of the code are too vague and dated to rely on for compliance. From what I can gather, HARPC is a model that offers much more flexibility in mitigating risk in a process. 


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#4 Charles.C

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Posted 14 May 2016 - 05:05 AM

As a seafood processor we are regulated by Title 21 CFR, so compliance to FDA oversight was mandatory some time ago.  :shades:

 

I'm still going forward regardless with HARPC as a "forward thinking" program.  I just feel that parts 123 and 110 of the code are too vague and dated to rely on for compliance. From what I can gather, HARPC is a model that offers much more flexibility in mitigating risk in a process. 

 

Hi Slab,

 

Out of the Frying Pan .......?

 

HARPC should certainly give you more pseudo-CCPs to play with.


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#5 dshapos

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Posted 16 May 2016 - 05:06 PM


 

If you take care to look at your pre-requisite programs, you shouldn't have any more CCPs than with a fully integrated HACCP.  The "preventive controls" are an extension of the pre-requisite controls you would consider when formulating the HACCP.  As a Lead Instructor for the FSMA approved FSPCA Preventive Controls Course, I see this question a lot.  It can get confusing if you try to think of HARPC instead of thinking of it as an enhanced HACCP that reviews all your SOPs and SSOPs when evaluating a particular hazard.


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#6 Charles.C

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Posted 16 May 2016 - 05:48 PM

If you take care to look at your pre-requisite programs, you shouldn't have any more CCPs than with a fully integrated HACCP.  The "preventive controls" are an extension of the pre-requisite controls you would consider when formulating the HACCP.  As a Lead Instructor for the FSMA approved FSPCA Preventive Controls Course, I see this question a lot.  It can get confusing if you try to think of HARPC instead of thinking of it as an enhanced HACCP that reviews all your SOPs and SSOPs when evaluating a particular hazard.

 

Hi dshapos,

 

Sorry but i don't understand the first sentence. Why would you have CCPs in harpc ?

 

i thought PC (new) ~>= PRP(old) + CCP(old)

 

But I'm happy you make no mention of oprp.


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Charles.C


#7 dshapos

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Posted 16 May 2016 - 07:34 PM

You don't need to eliminate your HACCP to make is FSMA compliant.  Therefore, you will still have your CCPs. Many HACCP plans fail to identify the prerequisite programs that control a hazard, eliminating the need for the CCP.   What you are adding is the preventive controls to identified hazards, which are not necessarily a CCP.  What FSMA looks for is how are you controlling your potential food safety hazards.... they may be controlled at multiple steps in the process, from purchasing to shipping.  What we would refer to as a prerequisite program, FSMA is looking for a preventive control.  I've attached a sample of a preventive controls chart, it is very similar to a how you would do a HACCP hazard analysis.

 

 

 

 

 

(1) Ingredient/ Processing Step

(2)

Identify potential food safety hazards introduced, controlled or enhanced at this step

(3)

Do any potential food safety hazards require a preventive control?

(4)

Justify your decision for column 3

(5)

What preventive control measure(s) can be applied to significantly minimize or prevent the food safety hazard?

Process including CCPs, Allergen, Sanitation, Supply-chain, other preventive control

(6)

Is the preventive control applied at this step?

Yes

No

Yes

No

Receiving refrigerated ingredients – liquid pasteurized egg

B

Vegetative pathogens such as Salmonella

X

 

While pasteurization minimizes the likelihood of Salmonella USDA recommends the product be used in cooked foods. Experience has shown Salmonella occasionally occurs in this ingredient.

Process Control - subsequent cook step

 

X

C

Allergen – egg

X

 

Egg is an allergen that must be labeled to inform consumers. Cross-contact is not an issue – all products contain egg.

Allergen Control – allergen labeling at other steps

 

X

P

None

           

 

  • There are many types of food safety hazards
  • The hazard analysis process:
    • Identifies known and reasonably foreseeable hazards (potential hazards)
    • Evaluates the likelihood and severity of potential hazards to identify those requiring a preventive control
    • Identifies process, allergen, sanitation, supply-chain or other preventive controls for potential hazards
  • An effective hazard analysis reduces risk and focuses efforts
  • A written hazard analysis is required for all products

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#8 Charles.C

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Posted 16 May 2016 - 09:08 PM

Hi dshapos,

 

I'm sorry, you've lost me. Unfortunately the chart is rather unintelligible.

 

Perhaps you could upload an example of a harpc plan with some CCPs in it to illustrate yr understanding.

 

Or are you saying that FSMA will also accept a HACCP plan ?

 

Under the FSMA act, the FDA now has a legislative mandate to require comprehensive, science-based preventive controls across the food supply chain. This means that all food facilities that fall under the FSMA act must conduct Hazard Analysis and Risk-Based Preventive Controls (HARPC) and shall establish science-based preventive control measures to reduce the risk of food contamination

.https://dfaofca.com/...accp-and-harpc/


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Charles.C


#9 mgourley

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Posted 02 June 2016 - 10:19 PM

Charles,

 

The above post should have looked like the attached.

 

CCP's are now Process controls.

 

No, FSMA will not accept HACCP plans, because they do not have the required "Preventive Controls", such as Supplier Controls, Sanitation Controls, Allergen Controls, etc... which just re-opens your jar of dislike for OPRP's and such.

 

In the attached example, further down the process you would have Ingredient or Processing Step of, I don't know, "Cooking". The Preventive Control at that step would be something like "Process Control - CCP 1"

 

Marshall

 

 

 

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#10 mgourley

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Posted 02 June 2016 - 10:31 PM

Then you have to document the preventive control on a sheet like on the attached Blank Process Control Form

 

Marshall

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#11 Charles.C

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Posted 03 June 2016 - 01:31 PM

Hi Marshall,

 

Thanks for the effort,

 

It looks semi-identical to the example you previously posted. USDA seem to lack confidence in the regulatory control of the egg industry. Mea culpa.

 

i note the continuing absence of likelihood/severity data. Non-compliant with HARPC requirements according to previously posted references.

 

No doubt clarity will appear in the unforeseeable future.

 

The FSPCA manual looks more of a business opportunity to me inasmuch as it appears to avoid answering some seemingly obvious queries (maybe within the blocked content on website).

 

i am comparing this FDA project, admittedly at long range, with the FDA's previous introduction of the Final Seafood Rule. So far it's a "no-contest"  IMO. Different team presumably.

 

The high-risk list may be the Last Chance Saloon. Inasmuch as an analogous study/list has long been published for the Fresh Produce Industry, i am curious as to the delay. Producer pushback ?.   :smile:.


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#12 mgourley

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Posted 03 June 2016 - 03:40 PM

Charles,

 

Indeed, it is the same example.

 

I have modified mine to look like the attached.

 

Marshall

 

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#13 Charles.C

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Posted 03 June 2016 - 05:13 PM

Charles,

 

Indeed, it is the same example.

 

I have modified mine to look like the attached.

 

Marshall

Hi Marshall,

 

Thks above excel. Very nice format. No flowchart though. :smarty:

 

I missed yr paragraph in Post 9 ending "Process Control - CCP1"

 

Do you mean that the CCP1 text is literally entered on first sheet (column K) of the excel in post 12 ? That seems bizarre. Is the idea to make sure people who have normal haccp plans don't forget to move all their CCPs over to PCs ? :uhm:  Suggests very limited confidence in the memory banks of HARPC users. 


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#14 mgourley

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Posted 04 June 2016 - 12:50 AM

Charles,

 

Kindly stop being pedantic.

There was no flow chart because, as obvious, we were not talking about flow charts.

We were talking about a modified "official" "suggested" way of identifying the "suggested" way of doing FSMA required food safety plans.

I'm sure that if the FDA needed your input, they would have asked.

 

Since they apparently did not, you can either take that as a good thing or as a bad thing. We can spar forever on this. Fact is, FSMA is law in the US. If you are not affected by it's reach, why would you care what the content is?

Whether it is, in you opinion, right or wrong, in it's execution, is irrelevant.

 

Marshall


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#15 Charles.C

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Posted 04 June 2016 - 02:48 AM

Charles,

 

Kindly stop being pedantic.

There was no flow chart because, as obvious, we were not talking about flow charts.


Marshall

Marshall,

 

It was a joke.

Sorry you didn't get it.


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Charles.C


#16 jcruzborreros

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Posted 28 July 2016 - 02:51 AM

Dear All,

 

Could really use your inputs and help guys. I haven't really comprehensively read/studied the FSMA because of the hectic schedule and honestly right now I am still

 

confuse if our Facility is covered by the act. We are a Seafood processor producing Low Acid Canned Tuna here in Indonesia and we export our products to buyers

 

located on the EU and US. What I only understand so far is that, that we are exempted on the Foreign Supplier Verification Program-FSVP (correct me if I'm wrong). If

 

so, does it mean that we are only covered with the VQIP (Voluntary Qualified Importer Program) which in my understanding only if we decide or if our buyer require us to

 

comply that we will need to actually comply(again please correct me if I'm wrong)?Are we only exempted to only some parts?If so, what are those parts? If otherwise,

 

and need to really comply on the whole act, may I ask what process do we need to undergo and when are the deadlines for these? Forgive me for asking too many

 

questions. Many thanks ahead to your help and inputs!

 

Best Regards,

Joven 


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#17 Slab

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Posted 30 July 2016 - 12:25 AM

Dear All,

 

Could really use your inputs and help guys. I haven't really comprehensively read/studied the FSMA because of the hectic schedule and honestly right now I am still

 

confuse if our Facility is covered by the act. We are a Seafood processor producing Low Acid Canned Tuna here in Indonesia and we export our products to buyers

 

located on the EU and US. What I only understand so far is that, that we are exempted on the Foreign Supplier Verification Program-FSVP (correct me if I'm wrong). If

 

so, does it mean that we are only covered with the VQIP (Voluntary Qualified Importer Program) which in my understanding only if we decide or if our buyer require us to

 

comply that we will need to actually comply(again please correct me if I'm wrong)?Are we only exempted to only some parts?If so, what are those parts? If otherwise,

 

and need to really comply on the whole act, may I ask what process do we need to undergo and when are the deadlines for these? Forgive me for asking too many

 

questions. Many thanks ahead to your help and inputs!

 

Best Regards,

Joven 

 

Hi, Joven;

 

I would highly recommend that you consult with your legal consultants as to the full scope of your export operations, but from the information you have provided I can say that you are exempt from section 117 as you fall under Title 21 both sections 113 and 123. 


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#18 jcruzborreros

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Posted 01 August 2016 - 01:12 AM

Dear Slab,

 

Thank you for the advice and the inputs!Will do.

 

Many thanks and best regards,

 

Joven


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