3 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.)