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FSMA- Preventive Controls- Practical example of hazard analysis?

FSMA Preventive Controls Hazard analysis

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#1 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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#2 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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#3 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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#4 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/


QA Manager and food safety blogger in Oregon, USA.

 

Interested in more information on food safety and science? Check out Furfarmandfork.com for more insights!

Subscribe to have one post per week delivered straight to your inbox.

 


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#5 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   331 downloads


Kind Regards,

 

Charles.C


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#6 usmanashraf

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Posted 09 September 2017 - 06:22 AM

I was looking for the the same. Thanks



#7 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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#8 mgourley

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Posted 06 June 2018 - 10:24 PM

Yep.

 

Marshall



#9 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


#10 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!



#11 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


#12 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.  







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