8 replies to this topic

[dairydairydairy]

I am being told by our corporate team that we need to have a specific ingredient risk analysis for incoming ingredients. Does anyone have an example of this? I am slightly confused because I thought ingredients were addressed via our food safety plans.. 

[SHQuality]

How do you know your food safety plans address your ingredients when you haven't done a risk analysis?

What kind of risks do these ingredients bring into the facility and how do your food safety plans manage them?

[Tony-C]

Hi dairydairydairy,

 

You should have already done this when you developed your food safety plans? Relevant info posted below.

 

Subpart G—Supply-Chain Program

§117.405   Requirement to establish and implement a supply-chain program. (a)

(1) Except as provided by paragraphs (a)(2) and (3) of this section, the receiving facility must establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which the receiving facility has identified a hazard requiring a supply-chain-applied control.

 

Guidance for Industry Chapter 2 (Hazard Analysis)

2.4 Conducting a Hazard Analysis

Examples of questions to be considered when identifying potential hazards

1. Ingredients

a. Does the food contain any ingredients that may present microbiological hazards, chemical hazards, or physical hazards?

b. Is all the water used at any point in the manufacturing process of the appropriate quality standard?

c. What are the sources of the ingredients (geographical regions, specific supplier details)?

2.4.2 Evaluate Potential Hazards to Determine Whether the Hazard Requires a Preventive Control (Hazard Evaluation)

See 21 CFR 117.130©.

• Under 21 CFR 117.130©(1)(i), you must assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls.

 

Kind regards,

 

Tony

[GMO]

Just a quick question, are you certain they mean for your food safety plan? Or could it be they're meaning it for food fraud? The latter I would always do as a separate ingredient risk assessment.

 

But for ingredients for HACCP or food safety plans, I'd include the specific ingredient risks as "present". The one thing with US legislation of course is there is a clause around preventive controls for supplier controls of specific hazards. So you might need to go into more detail on that than someone operating a HACCP plan would to identify which PCs are needed for which ingredients if there's something beyond the typical supplier controls or something you'd need to monitor on COAs. (These would all be prerequisites in non US HACCP plans.)

[dairydairydairy]

How do you know your food safety plans address your ingredients when you haven't done a risk analysis?

What kind of risks do these ingredients bring into the facility and how do your food safety plans manage them?

 

Hi - what do you mean? The hazard analysis is the risk analysis or no? In our HA we have the applicable ingredients listed out and their potential hazards, followed by controls we use. 

[dairydairydairy]

Hi dairydairydairy,

 

You should have already done this when you developed your food safety plans? Relevant info posted below.

 

Subpart G—Supply-Chain Program

§117.405   Requirement to establish and implement a supply-chain program. (a)

(1) Except as provided by paragraphs (a)(2) and (3) of this section, the receiving facility must establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which the receiving facility has identified a hazard requiring a supply-chain-applied control.

 

Guidance for Industry Chapter 2 (Hazard Analysis)

2.4 Conducting a Hazard Analysis

Examples of questions to be considered when identifying potential hazards

1. Ingredients

a. Does the food contain any ingredients that may present microbiological hazards, chemical hazards, or physical hazards?

b. Is all the water used at any point in the manufacturing process of the appropriate quality standard?

c. What are the sources of the ingredients (geographical regions, specific supplier details)?

2.4.2 Evaluate Potential Hazards to Determine Whether the Hazard Requires a Preventive Control (Hazard Evaluation)

See 21 CFR 117.130©.

• Under 21 CFR 117.130©(1)(i), you must assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls.

 

Kind regards,

 

Tony

 

Tony, yes that is my argument as well. We have the ingredients listed out in our HA section of the food safety plans. I have had an auditor call us out for not having a separate risk assessment for ingredients as well. So it's confusing. 

[dairydairydairy]

Just a quick question, are you certain they mean for your food safety plan? Or could it be they're meaning it for food fraud? The latter I would always do as a separate ingredient risk assessment.

 

But for ingredients for HACCP or food safety plans, I'd include the specific ingredient risks as "present". The one thing with US legislation of course is there is a clause around preventive controls for supplier controls of specific hazards. So you might need to go into more detail on that than someone operating a HACCP plan would to identify which PCs are needed for which ingredients if there's something beyond the typical supplier controls or something you'd need to monitor on COAs. (These would all be prerequisites in non US HACCP plans.)

 

We do already have Food Fraud Plans for our ingredients. Also ingredients are listed out on each of our food safety plan hazard analysis sections. 

[GMO]

We do already have Food Fraud Plans for our ingredients. Also ingredients are listed out on each of our food safety plan hazard analysis sections. 

 

Then I guess I'd go back to the corporate team. Share what you have and ask what they would like to be different and how changing it adds value?

[SHQuality]

Hi - what do you mean? The hazard analysis is the risk analysis or no? In our HA we have the applicable ingredients listed out and their potential hazards, followed by controls we use. 

Sorry, you didn't specify exactly what you had in your food safety plans, so based on the question I assumed they didn't cover the issue.

 

Technically, I would say a hazard analysis lists the hazards that can come up and the actions you take the control them.

The risk analysis would be the part where you score the risk of the hazard actually occurring based on severity and, likelihood of occurrence. But that is just semantics. As long as you have both of those covered and follow it up regularly, you still have the risks covered.

 

Are your food safety plans all in one file? That could make management and auditors touchy as it makes updating and change tracking a complete pain. Perhaps the questions is that they want multiple combined documents to be separated from each other. If that's not it, I agree with GMO. Ask them to clarify what they want.

Edited by SHQuality, 8 minutes ago.