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FSMA- Preventive Controls- Practical example of hazard analysis?

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MStud

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Posted 07 September 2017 - 11:18 AM

Dear all,

 

I am struggeling with the creation of the hazard analysis in compliance with FSMA /PCHF rule. Is there anyone, who can provide practical examples (PCQI Training)? I am aware with the basic required structures of the hazard analysis, but this would help to understand the implementation process much better!

 

​Thanks!



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DBF

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Posted 07 September 2017 - 02:44 PM

Hello,

This isn't any training or example but what we did was create a column in our hazard analysis titled "Is Preventative control applied at this point" between "What control measures can be applied to prevent the significant hazards" and "Is this step a critical control point (ccp)".  Not sure if this helps you but as I said, it's what we did.



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RMAV

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Posted 07 September 2017 - 07:18 PM

Starting around page 440 is an example hazard analysis straight from the standardized PCQI training.

 

https://www.ifsh.iit...2_Watermark.pdf



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FurFarmandFork

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Posted 08 September 2017 - 06:55 PM

FDA also has a food safety plan builder you can use to create something compliant.

 

https://www.accessda...etyPlanBuilder/


Austin Bouck
Owner/Consultant at Fur, Farm, and Fork.
Consulting for companies needing effective, lean food safety systems and solutions.

Subscribe to the blog at furfarmandfork.com for food safety research, insights, and analysis.

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Charles.C

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Posted 09 September 2017 - 05:24 AM

Dear all,

 

I am struggeling with the creation of the hazard analysis in compliance with FSMA /PCHF rule. Is there anyone, who can provide practical examples (PCQI Training)? I am aware with the basic required structures of the hazard analysis, but this would help to understand the implementation process much better!

 

​Thanks!

 

Hi Mstud,

 

Here is an introductory example generously posted here ca 2 years ago by mgourley -

 

Attached File  FSMA Food Plan Example.pdf   841.65KB   907 downloads


Kind Regards,

 

Charles.C


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usmanashraf

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Posted 09 September 2017 - 06:22 AM

I was looking for the the same. Thanks



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MsFS

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Posted 06 June 2018 - 08:43 PM

After having our FDA PC Inspection, I highly suggest thoroughly using this as a reference:

 

https://www.fda.gov/...n/ucm517412.htm

 

The expectation of our Inspector was that every applicable PC listed in Appendix 1 for each raw material is covered in your HARPC plan.

 

https://www.fda.gov/...A/UCM517402.pdf



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mgourley

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Posted 06 June 2018 - 10:24 PM

Yep.

 

Marshall



Charles.C

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Posted 06 June 2018 - 10:55 PM

After having our FDA PC Inspection, I highly suggest thoroughly using this as a reference:

 

https://www.fda.gov/...n/ucm517412.htm

 

The expectation of our Inspector was that every applicable PC listed in Appendix 1 for each raw material is covered in your HARPC plan.

 

https://www.fda.gov/...A/UCM517402.pdf

 

Hi MsFS,

 

I cannot see any worked out examples of a Process hazard analysis in 1st Link/1st download (306 Pgs) ?


Kind Regards,

 

Charles.C


MsFS

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Posted 08 June 2018 - 12:32 PM

Hi MsFS,

 

I cannot see any worked out examples of a Process hazard analysis in 1st Link/1st download (306 Pgs) ?

 

The FDA website has a drop down entitled "download the draft guidance".  Once you select the down arrow next to it, a list of the entire guidance is available for download.  Chapters 7-14, 16 and Appendix 4 are still "coming soon".

 

https://www.fda.gov/...n/UCM517610.pdf

 

Hope this helps!



Charles.C

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Posted 08 June 2018 - 05:07 PM

The FDA website has a drop down entitled "download the draft guidance".  Once you select the down arrow next to it, a list of the entire guidance is available for download.  Chapters 7-14, 16 and Appendix 4 are still "coming soon".

 

https://www.fda.gov/...n/UCM517610.pdf

 

Hope this helps!

 

Thks.

 

But where are the specific process examples ?


Kind Regards,

 

Charles.C


MsFS

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Posted 08 June 2018 - 06:47 PM

Thks.

 

But where are the specific process examples ?

 

I see your point.  :smile:

 

Among all those pages......there are none.  



jithu_fj

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Posted 03 October 2023 - 05:32 AM

I was looking for the the same. Thanks

do you have any sample FSVP plan with you that you can share? If so that will be super helpful for me as I am completely new to this



kingstudruler1

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Posted 03 October 2023 - 06:19 AM

do you have any sample FSVP plan with you that you can share? If so that will be super helpful for me as I am completely new to this

 

 

Have you taken the FSVP course?   Like preventive controls, FSVP requires a qualified individual.  

 

I used https://www.afius.org/   they have a zoom course in a couple of weeks. 


Edited by kingstudruler1, 03 October 2023 - 06:19 AM.

eb2fee_785dceddab034fa1a30dd80c7e21f1d7~

    Twofishfs@gmail.com

 


jithu_fj

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Posted 03 October 2023 - 06:24 AM

I attended FSVP zoom course and got training certificate however I was wondering if you had any sample FSVP plan document for any product. I have work aid A, G, etc with me though.





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