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FSMA Hazard Analysis & Preventive Controls


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#1 Chris Domenico

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Posted 26 March 2013 - 02:50 PM

As long as I have a HACCP plan I’ll be ok, right??

http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0920-0001

The short answer is ALMOST, but there is still additional work needed on your part. This will impact the business in that this ultimately equals more work for all of us!

In your HACCP plan, you have already identified hazards, established controls, ongoing monitoring, corrective action to take when a control step exceeds tolerable limits, verification procedures, and ongoing record keeping. Your initial (HACCP) hazard analysis addressed the likelihood that a risk might occur along with the severity of that risk. (Keep in mind that in your traditional HACCP plan, you will have addressed biological, chemical, and physical hazards while FSMA Preventive Controls has added “radiological” to that risk group). With HACCP, this activity has been performed to identify which step should be a Critical Control Point (CCP) and which steps can be controlled with a prerequisite program (PRP), whereas FSMA’s proposal suggests that a hazard which is reasonably likely to occur needs a specifically selected preventive control (or controls) to address that hazard. For instance, consider that Clostridium Botulinum is an identified hazard in the canning process. Within the boundaries of a HACCP plan, identification of a “Thermal Process” might have been an acceptable control method. This remains similar under FSMA Preventive Controls, however the FDA will want you to define the control further:

-How (specifically) does the thermal process reduce or eliminate the hazard (C. Bot.)?
-How do you know that you are controlling that risk?

Think of a more arbitrary risk such as contamination. Under HACCP, you might have identified the control as “GMP’s”. FSMA will want you to define HOW you are controlling that risk (gloves, protective clothing, etc.), and there may not necessarily be control measures in place that you can point to and say, “contamination is controlled when X = Y”. So how do you know that you are controlling an identified risk when it may not be a measurable control? This is one of the areas where the “extra work” comes in.

Your HACCP plan is a great starting point and is (according to FDA) the framework from which to build your Preventive Controls on.

I’m interested to hear your input. What is your take on the proposed rule?

-Chris


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#2 mgourley

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Posted 26 March 2013 - 08:31 PM

I think it's premature to try to comply with something that is not even past the comment stage yet.

Granted, HACCP gives you a leg up and can be tweaked to fit whatever the final rule is, although everything I have read states that you would be well advised to keep your current HACCP system and whatever will be required by FDA separate.

This is basically the problem with anything that has to go through the "rule making process". Nobody actually knows anything until the final rule is approved. If you have time and resources to attend to the minutia of the process, you probably will be better situated when the final rule is approved.

If you don't, you keep abreast of the ongoing sausage making and then swing into action when you have to.

My 2 cents.

Marshall


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#3 Chris Domenico

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Posted 27 March 2013 - 01:41 PM

Great insight, Marshall! Thanks - you make a great point.


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