BRC 2.2: Hazard and Risk Analysis Template

We are transitioning from SQF Packaging Manufacturing Food Safety Code to BRC Global Standard Packaging and Packaging Materials, Issue 5. 

With SQF, we followed AIB's HACCP template (using Bio, Chemical and Physical contaminates) and had great success with the program and rave reviews from auditors, however BRC'S 2.2 Hazard and Risk Analysis clause states we must also consider the following hazards for each raw material and process step:

Biological

Chemical

Foreign Material

Recycled Materials

Legality

Defects Critical to Consumer Safety

Functionality/Integrity and Performance

Unintentional migration

Malicious Intervention 

If anyone has a template or an example to share, or any advice in creating the template, it would be greatly appreciated!

Thank You.

This template was given to us by a consultant.  I have since made some adjustments and use a calculation based template that I got from a colleague when I was working on Risk Assessment Rankings for ISO 28000. 

Types of Hazards Considered

Hazard Types

Examples

Physical

Glass, Brittle-Plastics, Ceramics, Wood, Soil, Pests, Insects, Jewelry, Food Stuffs, Blades, Hair

Chemical

Oils, Grease, Inks, Solvents, Pesticides, Herbicides

Biological

Yeasts, Molds, E Coli, Listeria, Salmonella, Staphylococcus aureus, Enterobacteriaceae, others

Likelihood X Severity = Risk

Likelihood

of

Occurrence = L

Severity

of

Outcome = S

Risk Score = L x S

Risk Category / Action

1 = Low

1 = Low

1 – 3 =

Low = (Establish control measures where appropriate)

2 = Medium

2 = Medium

4 – 6 =

Medium =  (Establish control measures)

3 = High

3 = High

7 – 9 =

High  = (Critical Control Point)

Hazard Analysis

Raw Materials

Type

Hazard

L

S

R

CC?

Control Measures

Documentation

Resins (PET, PP, PVC, HDPE)

Physical

Metal Shavings, water, cross contaminated resin, dust/ debris, corrugated debris (tote)

1

3

3

No

Screen at silo, Magnets at hoppers

Visual inspections

Dedicated rail cars

• Certificate of Conformance/Assurance
• Magnets inspections & strength verification
• Cleaning procedures

Chemical

Grease, LTL contaminants (pesticides, herbicides,

heavy metals)

1

3

3

No

Receiving inspection

• Certificate of Conformance/Assurance
• GMPs, Cleaning procedures

Biological

Bacteria, Pathogens

1

1

1

No

Receiving inspection

• Certificate of Conformance/Assurance
• GMPs, Cleaning procedures, FG testing

And it didn't transfer right.  Sorry about that. :(  It's in a table.  

Hi,

BRC packaging doesn't clearly determine what methods you use to make HARA. You can use either HACCP or "Likelihood - Severity" as tabikkat22 said, or others. IMO, it's easier for you to develop your current HACCP system to match BRC requirements. It would save time and workload.

Regards.

Hi tabikkat,

thks for the input.

JFI you can upload files by clicking on "more reply options" at bottom right-hand side  and following instructions on the new page.

Thanks for the great details, however I'm still not clear on the following listed below.

Determining Bio, Chemical and Physical Hazards are clear, however how would you incorporate the items below into a HACCP Program?

Would they be listed in the same column as the BIO, Chemical and Physical in the hazard analysis, as shown in my attachment, or would they be considered the "Identified hazard" (since Unintentional Migration could listed as a Chemical hazard)?

BRC'S 2.2 Hazard and Risk Analysis clause states we must also consider the following hazards for each raw material and process step:

• Legality
• Defects Critical to Consumer Safety
• Functionality/Integrity and Performance
• Unintentional migration
• Malicious Intervention 

Thanks again!!

Thanks for the great details, however I'm still not clear on the following listed below.

 

Determining Bio, Chemical and Physical Hazards are clear, however how would you incorporate the items below into a HACCP Program?

Would they be listed in the same column as the BIO, Chemical and Physical in the hazard analysis, as shown in my attachment, or would they be considered the "Identified hazard" (since Unintentional Migration could listed as a Chemical hazard)?

 

BRC'S 2.2 Hazard and Risk Analysis clause states we must also consider the following hazards for each raw material and process step:

• Legality
• Defects Critical to Consumer Safety
• Functionality/Integrity and Performance
• Unintentional migration
• Malicious Intervention 

 

 

Thanks again!!

For traditional haccp context, can try -

https://www.iopp.org...cfm?pageid=2267

There are one or two sample BRC Packaging haccp plans here if you are willing to search back a little. IIRC one poster handled the extra queries via a condensed tabular format.

It's true as you say that BRC  do have some specific oddities. Unfortunately this is usually the case for every Safety Standard.

PS - from a quick look, yr haccp plan seems a little "simplistic"

Would they be listed in the same column as the BIO, Chemical and Physical in the hazard analysis, as shown in my attachment, or would they be considered the "Identified hazard" (since Unintentional Migration could listed as a Chemical hazard)?

Yes they would when you can clarify how you categorise them.

In addition, the 2.2 is sequential and clear. The 2.2.3 says you need to list up all you products, materials and 2.2.4 asks you to draw a flow diagram how you fabricate stuffs (I think you have already had in your HACCP). Then analysis making is in 2.2.5.

Example:

Input 1 [Materials] >> Process 1 [Controlling,Method] >> Output 1 and/or Input 2 [WIPs/materials] >> Process 2 [Controlling,Method] >> Output 2 >> so on.

Let see here

- Inherent risks in materials / WIPs / products: Bio, Chem, Phys, (In/Output 1, In/Output 2, etc.) to food quality & safety such as odour/poisoning if you use organic solvents.

- Risks in methods, controlling: human, working environment, manipulation, etc. which cause Defects Critical to Consumer, Functionality/Integrity and Performance, Cross Contamination, Unintentional migration (also Bio, Chem, Phys), Malicious Intervention. You can link these to your GMP.

- Legal risks in your GMP, materials and products (prohibited substances, REACH, RoHS, etc.) at manufacturer's and customer's countries.

P/S: You also need to look on food security and fraud since they have to be included in your hazard analysis as here.

P/S 2: In my company, some risks in operation methods are categorised as "technical" alongside with Bio, Chem, Phys.

P/S 3: Unless you use recycled materials, you don't have to mention them in every process step of your hazard analysis with "None". Recycled material can also be exempted in certification audits.

Hope you can picture the idea.

Yes they would when you can clarify how you categorise them.

In addition, the 2.2 is sequential and clear. The 2.2.3 says you need to list up all you products, materials and 2.2.4 asks you to draw a flow diagram how you fabricate stuffs (I think you have already had in your HACCP). Then analysis making is in 2.2.5.

Example:

Input 1 [Materials] >> Process 1 [Controlling,Method] >> Output 1 and/or Input 2 [WIPs/materials] >> Process 2 [Controlling,Method] >> Output 2 >> so on.

Let see here

- Inherent risks in materials / WIPs / products: Bio, Chem, Phys, (In/Output 1, In/Output 2, etc.) to food quality & safety such as odour/poisoning if you use organic solvents.

- Risks in methods, controlling: human, working environment, manipulation, etc. which cause Defects Critical to Consumer, Functionality/Integrity and Performance, Cross Contamination, Unintentional migration (also Bio, Chem, Phys), Malicious Intervention. You can link these to your GMP.

- Legal risks in your GMP, materials and products (prohibited substances, REACH, RoHS, etc.) at manufacturer's and customer's countries.

 

P/S: You also need to look on food security and fraud since they have to be included in your hazard analysis as here.

P/S 2: In my company, some risks in operation methods are categorised as "technical" alongside with Bio, Chem, Phys.

P/S 3: Unless you use recycled materials, you don't have to mention them in every process step of your hazard analysis with "None". Recycled material can also be exempted in certification audits.

Hope you can picture the idea.

Thank you. Your explanation was very clear on how to incorporate BRC'S requirements for "quality, legality, food security, etc..." into an existing (B,C,P) HACCP Plan. MUCH APPRECIATED!

Hi beautiophile,

Thks for input.

I noted this fraud-related comment in yr link -

There is currently no overt mention of packaging materials within the FSMA legislation, but it’s not unlikely that packaging will be deemed a

raw material and will need to be assessed in the same way as any other raw material.

I have both BRC and SQF sites using the same HACCP template for their risk assessments for ingredients and process flow.  The auditors have really liked this template to start the audit.  The BRC sites however have a few extra risk assessments on specific topics such as building security, protective clothing, utilities, gloves, inline testing equipment and many more using a template similar to the one I have attached.

I have both BRC and SQF sites using the same HACCP template for their risk assessments for ingredients and process flow.  The auditors have really liked this template to start the audit.  The BRC sites however have a few extra risk assessments on specific topics such as building security, protective clothing, utilities, gloves, inline testing equipment and many more using a template similar to the one I have attached.

Hi Peak,

Thks for Yr template.

Basically this is a 3x3 risk matrix in a useful format presentation. IIRC  first published by Safefood360 for food GMP risk assessments.

However, as you note, it needs a lot more elaboration to approach BRC's voracious thirst for their "kitchen-sink"  hazard analysis.. Frankly, IMO, BRC Standards are a pest in this respect.

Thanks I'll have to look up Safefood360.  This template was shared with me by an SQF Auditor will all the customer information removed from it.