11 replies to this topic

[MStud]

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!

[DBF]

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.

[RMAV]

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

 

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

[FurFarmandFork]

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

 

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

[Charles.C]

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 -

 

 FSMA Food Plan Example.pdf   841.65KB   855 downloads

[usmanashraf]

I was looking for the the same. Thanks

[MsFS]

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

[mgourley]

Yep.

 

Marshall

[Charles.C]

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) ?

[MsFS]

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]

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 ?

[MsFS]

Thks.

 

But where are the specific process examples ?

 

I see your point. 

 

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