15 replies to this topic

[Plastic Ducky]

Hello all,

 

I am looking for some guidance here. 

 

SQF 8th ed

 

2. 4. 3. 17 Where food safety regulations in the country of production and destination (if known) prescribe a food safety control methodology other than the Codex Alimentarius Commission HACCP guidelines, the food safety team shall implement food safety plans that meet both Codex and food regulatory requirements. 

 

I though I had this addressed. But I don't.

 

I am being told that a "Food Safety Plan with risk assessment of all raw materials and process hazard is required.

 

What exactly is a "risk assessment of all raw materials and process hazards"

 

I thought that was the information I displayed by communicating the HACCP CCPs that exist after the application of all of my prerequisite programs including Vendor Approval program and a SOP for Testing raw materials?

 

 

Do I really have to demonstrate this for every individual raw material? We just blend and package dry blends like sugar substitutes (1 CCP). Could I just demonstrate the risk analysis by identifying all powders as having the same dangers? We have thousands of ingredients so I can't imagine going though them all.

 

This was a one point deduction so I want to make sure I don't misinterpret what is wanted here. It  appears to be a huge pile of work for one point so I need to make sure I am understanding this.

 

any and all feedback and guidance will be appreciated as always.

 

Thank you

[The Food Scientist]

I had this one too for a previous Audit. The auditor explained and said that we weren't really FSMA compliant.( for USA) ie, no evidence of FSMA implementation. They wanna see you have preventive controls in place that will reduce and/or eliminate any hazard associated with raw materials and process hazards. What I sent in for a CA was evidence of signing up for a PCQI course, and they accepted it. 

[Plastic Ducky]

I just finished my AIB PCQI course yesterday. Oh man, I sure hope that does it, I have a ton of work to do!

[Scampi]

PlasticDucky, how did you determine CCP's without a risk assessment or hazard analysis..........................and how do you know you've covered all the risks/hazards without it?

[Scampi]

Step#

Incoming materials/ process steps / hazards on schematic diagram

Category and identified hazard

Determine if fully controlled by prerequisite program.

* If yes = indicate "Prerequisite Program" and proceed to next identified hazard.
* If no = proceed to question 1 (Q1).

B

C

P

Q1. Could a control measure(s) be used by the operator at any process step? 

* If no = not CCP. Identify how this hazard will be controlled before and after the process. Then proceed to the next identified hazard.

* If yes = describe the measure and proceed to Q2.

Q2. Is it likely that contamination with the identified hazard could occur in excess of the acceptable level or could increase to an unacceptable level?

If no = not CCP. Proceed to the next identified hazard.

* If yes = proceed to Q3.

Q3. Is this process specifically designed to eliminate or reduce the likely occurrence of the identified hazard to an acceptable level?

If no = proceed to Q4.

* If yes = CCP. Enter its number in the last column.

Q4. Will a subsequent step eliminate the identified hazard or reduce its likely occurrence to an acceptable level?

If no = CCP. Enter its number in the last column.

* If yes = not a CCP. Identify subsequent (controlling) step and proceed to the next identified hazard.

 

This is the form I've always used

Edited by Scampi, 04 April 2019 - 03:53 PM.

[Scampi]

it won't hold the formatting for some reason, but the Questions go across the top and then you enter EACH process step, ingredient, allergen etc down the side and then proceed with PRP's.

 

Yes, it is time consuming and can be enormous...........but you never have to do it again PLUS you know you've adequately addressed everything you possibly can.

[The Food Scientist]

Congrats on the PCQI! In that case you can use your knowledge in creating a risk based food safety plan that complies with FSMA. You will be in compliance with regulations. Also from my understanding is that you already have a HACCP plan, which is how you already established your CCPs, correct? 

[Plastic Ducky]

Scampi,

 

Thank you for your response. 

 

The HACCP plan I wrote makes use of the same risk analysis steps from Receiving to Shipping, every process step and how hazards are contained at each step by the prerequisites. The ones not contained became my CCP. This HACCP plan even addresses product description, intended use, 

[Scampi]

Sooooooo silly

 

It is a risk assessment, just a different name!!!!!!!!!!!!  Hopefully like other posters all that your missing is the PCQI!  O

[Plastic Ducky]

Thank you again Scampi,

 

I felt exactly the same way! Good to hear i'm have not gone crazy yet. I stress the word "yet".

[Scampi]

Was this an auditor or an FDA inspector outta curiosity

[Plastic Ducky]

this was an NSF auditor for SQF.

 

We will see if she accepts the PCQI cert.

 

Meanwhile as a contingency plan, I am cranking through a free, FDA provided Food Safety Plan Builder.

 

Hopefully one of these answers will suffice.

[Charles.C]

Hi PD,

 

To answer the query in OP, Yes, if many ingredients can be validated as having the same significant hazards, they can be grouped, ie >  Ingredient X + a Table.

 

Presumably the Product Specification(s) would have to be grouped also unless you already have an Encyclopedia of them.

[Plastic Ducky]

Just as an update.

 

They did accept the PCQI cert after all. 

 

I am still going to fill out the rest of this FDA Plan generator just for good measure.

[majoy]

Just as an update.

 

They did accept the PCQI cert after all. 

 

I am still going to fill out the rest of this FDA Plan generator just for good measure.

 

So you got dinged because you didn't have didn't have pcqi certification? so this clause is being interpreted by some auditors as pcqi certification is required to conduct a proper hazard/risk analysis.

 

I thought attending a cert course is not required to be a pcqi? 

[The Food Scientist]

So you got dinged because you didn't have didn't have pcqi certification? so this clause is being interpreted by some auditors as pcqi certification is required to conduct a proper hazard/risk analysis.

 

I thought attending a cert course is not required to be a pcqi? 

 

Getting the PCQI cert is the first step towards FSMA/regulatory compliance, since we don't have much time to redo a risk based food safety plan to close out the corrective action. Therefore this one is accepted by auditors (some auditors maybe) as a start. It isnt a requirement to sit for the course however you do need some evidence to show them you are willing to comply. 

Edited by The Food Scientist, 05 April 2019 - 05:43 PM.