10 replies to this topic

[lavalienteQA]

hi all,

 

Currently reviewing our allergen program. Our HACCP of course contains Preventive Controls ( Process, Allergen, Sanitation, Supplier, etc. analysis and our hazard analysis.

I'm getting lost in the risk assessment. Do those references support the risks  identified or separate assessment for each process and a certain hazard rating?

 

See doc attached that I feel my facility may be missing. 

 

 

[lavalienteQA]

here's file 

Attached Files

•  rssl (semi-quantitative) allergen risk assessment (1).pdf   987.3KB   460 downloads

[Charles.C]

hi all,

 

Currently reviewing our allergen program. Our HACCP of course contains Preventive Controls ( Process, Allergen, Sanitation, Supplier, etc. analysis and our hazard analysis.

I'm getting lost in the risk assessment. Do those references support the risks  identified or separate assessment for each process and a certain hazard rating?

 

See doc attached that I feel my facility may be missing. 

BRC8 Standard ??

 

Clause ??

[lavalienteQA]

I think @Charles.C that the standard is not BRC or SQF? BUT 

our facility is SQF- So I'm trying to assess if what we have already will suffice for section 2.8.

 

 

The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented. The allergen management program shall include:

i. A risk analysis of those raw materials, ingredients, and processing aids, including food grade lubricants, that contain food allergens;

ii. An assessment of workplace-related food allergens that may originate from locker rooms, vending machines, lunchrooms, and visitors;

iii. A list of allergens that is applicable in the country of manufacture and the country(ies) of destination, if known;

iv. A list of allergens that is accessible to relevant staff;

v. The control of hazards associated with allergens and incorporated into the food safety plan, and

vi. Management plans for control of the identified allergens.

I feel.. I may be overthinking.

We definitely do not have an assessment regarding those particular areas, but our allergen programs calls those areas out and what programs we have in place to eliminate risk within our Allergen Program SOP.

In which case, I suppose I am asking then what TYPE of assessment to conduct to satisfy that part?

 

 

We are a dressing facility.

Our hazard analysis discusses the manual handling and potential contamination with control by cGMPs. 

I want to add color code for employees who are handling allergens and wonder if necessary then to change anything there or leave plan as is. 

[Tony-C]

Hi lavalienteQA,

Is your question just related to:

ii. An assessment of workplace-related food allergens that may originate from locker rooms, vending machines, lunchrooms, and visitors?

This can be done by looking at policies and activities:

Are people prohibited from taking food/drink into product areas?

Are people allowed to bring in their own food? if so where is it stored?

Are people allowed to eat in their protective clothing?

Is there segregation of items brought in and workwear?

Etc.

Based on this you can conduct an assessment and decide if there is any significant risk.

With regards to color coding when handling allergens I have previously used disposable color coded aprons to identify staff working on those lines.

Kind regards,

Tony

[Charles.C]

I think @Charles.C that the standard is not BRC or SQF? BUT 

our facility is SQF- So I'm trying to assess if what we have already will suffice for section 2.8.

 

 

I feel.. I may be overthinking.

We definitely do not have an assessment regarding those particular areas, but our allergen programs calls those areas out and what programs we have in place to eliminate risk within our Allergen Program SOP.

In which case, I suppose I am asking then what TYPE of assessment to conduct to satisfy that part?

 

 

We are a dressing facility.

Our hazard analysis discusses the manual handling and potential contamination with control by cGMPs. 

I want to add color code for employees who are handling allergens and wonder if necessary then to change anything there or leave plan as is. 

Hi Lavaliente,

 

I'm more familiar with BRC but assuming your process is already SQF certified (is it ?) your current SOP was presumably found satisfactory ?.

 

Apologies for my ignorance but I'm not sure precisely what "dressing " actually means ? The process is obviously critical in respect to risk relevant allergens (if any).

 

The SQF expected response in ver. 9 looks similar to ver 8.1 for which a detailed Guidance is available. IMEX risk assessment typically requires (eg from process mapping) an evaluation of the likelihood of intrinsic allergenic items but any others deriving from potential contamination (eg cross-contamination other materials/environment).

 

This post/thread is fairly typical of a generic scenario -

https://www.ifsqn.co...nt/#entry144185

 

Offhand, colour code separation sounds rather ambitious to me but the value maybe depends on the specific process.

[Lino]

Hello everyone,
very interesting and current topic. Does anyone use this risk assessment approach? What are your thoughts on it?

Attached Files

•  esa-allergen-risk-assessment-model-calculator.xlsx   14.5KB   211 downloads

Edited by Lino, 23 February 2023 - 04:00 PM.

[Charles.C]

Hello everyone,
very interesting and current topic. Does anyone use this risk assessment approach? What are your thoughts on it?

Hi Lino,

 

This (I anticipate) is VITAL based/oriented. The latter is only legally relevant afaik in a handful of Countries.

Edited by Charles.C, 23 February 2023 - 04:35 PM.
edited

[Lino]

Hi Charles,
correct, this is the template in xls of VITAL 2.0, now updated to version 3.0.
Regarding the scientific consultations organized by FAO and WHO (2021. See footnote 4) and the practical allergen risk management guidelines published in June 2022 by ILSI, they converge in confirming the validity of the approach taken by Allergen Bureau in the Vital system.
Do you know the FDA's position on this issue?

[Charles.C]

Hi Charles,
correct, this is the template in xls of VITAL 2.0, now updated to version 3.0.
Regarding the scientific consultations organized by FAO and WHO (2021. See footnote 4) and the practical allergen risk management guidelines published in June 2022 by ILSI, they converge in confirming the validity of the approach taken by Allergen Bureau in the Vital system.
Do you know the FDA's position on this issue?

Hi Lino,

 

It appears that FDA are (indirectly) looking at certain aspects of VITAL type related data in this 2022 originated Draft Guidance which is available here -

 

https://www.fda.gov/...allergens-other

 

(eg search for refs 38, 39)

[Lino]

Hi Charles,

Thanks so much for sharing!