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Estimated cost of a FSMA Gap Assessment (21CFR117)

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oacosta60

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Posted 08 November 2022 - 07:04 PM

Hi friends

Could someone help me? What is the estimate cost of a FSMA Compliance Gap Assessment for Human Food (21 CFR 117)? It would be for an airline catering business.


 



Kara S.

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Posted 08 November 2022 - 09:50 PM

Just did this! Went to 7 facilities. It was about $20,000 + T&E for all 7. 

 

Plan for 2 days on site and 1 day for writing the report. They also fall under 21 CFR Part 1250 and need to autoclave their waste. 


Kind regards, 

 

Kara Scherer 

Food & Beverage Industry Consultant

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Charles.C

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Posted 10 November 2022 - 05:31 AM

Just did this! Went to 7 facilities. It was about $20,000 + T&E for all 7. 

 

Plan for 2 days on site and 1 day for writing the report. They also fall under 21 CFR Part 1250 and need to autoclave their waste. 

Hi Kara,

 

T&E = ? (Treats and Elevenses ?)

Only $20,000 ?

Then again, I guess Airlines can afford it. :smile:


Kind Regards,

 

Charles.C


Kara S.

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Posted 10 November 2022 - 01:39 PM

Hi Kara,

 

T&E = ? (Treats and Elevenses ?)

Only $20,000 ?

Then again, I guess Airlines can afford it. :smile:

 

T&E = travel and expense hahaha

 

That's less than $3000 per site. I guess I am too expensive  :dunno: What would you charge Charles? 


Kind regards, 

 

Kara Scherer 

Food & Beverage Industry Consultant

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oacosta60

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Posted 10 November 2022 - 02:01 PM

Thank you very much. In my case there will be one big facility that offers service to different airlines. How much do you think I must charge?

 

Two days and one for the report is really what I thought.

 

$4,800 is OK or is too low or too high

 
Oscar

 



Kara S.

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Posted 10 November 2022 - 02:07 PM

 

Thank you very much. In my case there will be one big facility that offers service to different airlines. How much do you think I must charge?

 

Two days and one for the report is really what I thought.

 

$4,800 is OK or is too low or too high

 
Oscar

 

 

Mine was only for GMPs not the full regulation. If you are taking a deeper dive into their programs, policies, and food safety plans - maybe give yourself an extra day?


Kind regards, 

 

Kara Scherer 

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oacosta60

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Posted 10 November 2022 - 03:07 PM

In my case will be all the regulation. I have been noticed that people in this industry (airline catering) keep using HACCP instead to move to HARPC according to FSMA. Do you know why?

 

Do you think that $4,800 is too low?

 

Oscar



Kara S.

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Posted 10 November 2022 - 08:11 PM

I ran into the same thing but I think its because their headquarters is outside the US. 

 

They can use their HACCP plan to comply to the FSMA but they will likely need to treat many of their PRPs as Preventive Controls. 


Kind regards, 

 

Kara Scherer 

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oacosta60

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Posted 10 November 2022 - 08:44 PM

Hi

 

Which regulation cover the use of an autoclave for waste. 

 

Oscar



Charles.C

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Posted 11 November 2022 - 02:02 PM

T&E = travel and expense hahaha

 

That's less than $3000 per site. I guess I am too expensive  :dunno: What would you charge Charles? 

Hi Kara,

 

Frankly, I'm not familiar with the relevant Scope involved but i was more responding to the absolute cost mentioned. 

Just as a comparison, how does the suggested  figure compare to that for a BRC, RTE, Food audit ?.


Kind Regards,

 

Charles.C


oacosta60

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Posted 12 November 2022 - 12:13 PM

Hi

 

I will be performing a gap analysis for an air catering service company.  Any charge recommendation. This is the first project for this type of industry. I am planning to perform this activity in 3 (three) day. I am thinking of charging $6,000 USA dollars. Is this too much or too low?

 

The following areas and systems will be observed during the assessment (gap analysis) if applicable:

 

  • HACCP/HARPC
  • Quality Management System (Audits/Inspections)
  • Risk Management
  • Training
  • Document Control
  • Change Control
  • Corrective and Preventive Action (CAPA)
  • Complaints
  • Product Disposition
  • Reprocess/Rework
  • Process Validation & Equipment Validation
  • Facilities & Equipment Design
  • Facilities Cleaning & Sanitation
  • Environmental Monitoring Program for Bacteria (Example; Listeria Monocytogenes, Salmonella, E. coli., etc.)
  • Environmental Monitoring Program for allergens
  • Equipment Maintenance
  • Calibration
  • Good Manufacturing Practices.
  • Sanitation Standard Operating procedures (SSOP)
  • Standard Operating  Procedures(SOP)
  • Waste Management plan.
  • Pest control program.
  • Traceability (mock) and recall plan.
  • ​Manufacturing
  • Design Control
  • Process Monitoring
  • Gowning Monitoring
  • In Process Controls
  • Managing Contractors
  • Specification Development
  • Supplier Quality Management
  • Receiving, Warehouse, and Storage
  • Inventory Management
  • Transport
  • Return/Salvage
  • Label and Labeling Controls & Approvals
  • Packaging
  • Food Defense Program
  • Previous Audit Findings / Follow Up

 

References:

 

  • 21 CFR part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk- Based Preventive Controls for Human Foods (CGMP & PC Regulation).
  • 21 CFR 1, subpart L, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (the FSVP Regulation).
  • 21 CFR part 121, Mitigation Strategies To Protect Food Against Intentional Adulteration (the IA Regulation).
  • 21 CFR 1, subpart O, Sanitary Transportation of Human and Animal Food (the ST Regulation)
  • 21CFR 1250 - INTERSTATE CONVEYANCE SANITATION
  • Food Code 2017
  • IFSA World Food Safety Guidelines 2016 Version 4
  • FDA Observations and Warning Letters
  • Food Safety and Inspection Service (USDA)


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Posted 12 November 2022 - 02:31 PM

If you are just talking about the fee itself and not $ for trabel time, travel and related expenses then I think 6 - 7.5 is about right.

Charge by the project and not number of days as you may run longer or shorter.

I have done on-site air catering audits that involved the trucks and spot inspects on the flights east coast us to west coast.

Lots of varibles on these projects, do not short change yourself.


Kind regards,
Glenn Oster

GOC GROUP | SQF & EESystem Operations Consultant

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Posted 12 November 2022 - 02:39 PM

Hi Kara,

T&E = ? (Treats and Elevenses ?)
Only $20,000 ?


Then again, I guess Airlines can afford it. :smile:


Ahhh - $20,000 for all 7 - wow, those airlines must love you because most will gladly pay 5,000 - $7000 each on multi's.

Kind regards,
Glenn Oster

GOC GROUP | SQF & EESystem Operations Consultant

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Kara S.

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Posted 12 November 2022 - 02:50 PM

Ahhh - $20,000 for all 7 - wow, those airlines must love you because most will gladly pay 5,000 - $7000 each on multi's.


Hahaha That project was unique. Can't go into detail on it. It was not as in depth as what's being proposed. I always do these by the hour and not a flat rate. Provide an estimate +/- 20% so the client knows that it may come in slightly over the estimate.

Kind regards, 

 

Kara Scherer 

Food & Beverage Industry Consultant

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oacosta60

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Posted 12 November 2022 - 03:18 PM

Thank you very much. Yes, it was for the fee, I live very close to the place. Did I miss any regulation related with air catering service business.

 

Oscar



oacosta60

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Posted 12 November 2022 - 03:32 PM

Thank Glenn and Kara both have great experience in food. Most of my experience is in the pharmaceutical industry though I also work with food. I am a chemist with a PH. D in Physical and Inorganic chemistry.



Kara S.

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Posted 14 November 2022 - 01:26 PM

Thank Glenn and Kara both have great experience in food. Most of my experience is in the pharmaceutical industry though I also work with food. I am a chemist with a PH. D in Physical and Inorganic chemistry.

 

wow! My 2 least favorite classes in college! I just have a Bachelors in Microbiology but have been considering master & PhD in regulatory affairs/food safety/ food law - still researching.

 

I don't believe you missed anything related to food safety. There was a lot of security protocols that I learned while there. Unique industry. Reach out if you run into issues while there. We'll all do our best to help you out!


Kind regards, 

 

Kara Scherer 

Food & Beverage Industry Consultant

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oacosta60

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Posted 14 November 2022 - 05:52 PM

Jajajaja Not many people like it, including chemists. Regulatory Affairs is an excellent one, keep going. I really appreciate all your help.

 

 

 

Oscar





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