FSMA- Preventive Controls- Practical example of hazard analysis?
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!
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.
Starting around page 440 is an example hazard analysis straight from the standardized PCQI training.
FDA also has a food safety plan builder you can use to create something compliant.
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 898 downloads
I was looking for the the same. Thanks
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.
Yep.
Marshall
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.
Hi MsFS,
I cannot see any worked out examples of a Process hazard analysis in 1st Link/1st download (306 Pgs) ?
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The FDA website has a drop down entitled "download the draft guidance".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!
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 ?
Thks.
But where are the specific process examples ?
I see your point. :smile:
Among all those pages......there are none.
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
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.