Completing a risk assessment for a compliance exemption

I regularly receive ‘how-to’ questions from people working in the food industry so the HACCP Mentor Ask Me! Series is all about providing answers to your food safety, quality and business compliance questions. To kick off episode 1, I am going to cover how to complete a risk assessment related to obtaining a compliance exemption. This is a requirement of SQF Requirement 2.4.2.1.

JoAnn, who is located in Chesterfield, Michigan is about to

start her company’s annual assessments. The bakery business is certified to SQF

and JoAnn has asked for input into complying with SQF requirement 2.4.2.1.

Let’s firstly see what the standard requires before I get into how a food

business can comply.

SQF Requirement 2.4.2.1

SQF Requirement 2.4.2.1 – The site shall ensure the Good Manufacturing Practices described in modules 3, 4, 9, 10 or 11 (as applicable) of this Food Safety Code are applied, or exempted according to a written risk analysis outlining the justification for exemption or evidence of the effectiveness of alternative control measures to ensure that food safety is not compromised.

What does it actually mean?

The way the SQF code has

been written for these sections is that the clauses are based on an industry

sector. However, not all manufacturing sites in a particular industry

sector will undertake all of the stated GMP processes.

For example, a business

might not have cold storage, so, therefore, they would not have to comply with

the requirements for cold storage.

Unfortunately, the SQF reference to “applied, or exempted according to a written risk analysis” is not aligned to what we know as being a “risk analysis” as per ISO 31000. Because of this, the action to take may be confusing. In brief, all it is asking you to do is show due cause and document what is relevant to your business and what is not.

How to comply with 2.4.2.1

To satisfy compliance

with this clause:

* List all of the clauses in a table  * Determine what GMPs are applicable to your food business (based on the requirements for your SQF Code Category). A simple Yes / No will suffice.* If you answer ‘No’ to any of these, provide the reason or justification why the clause does not apply.* If you answer ‘Yes’ to any of these, and your food business wants to implement an alternative control (from the one listed in the clause) you will need to state what that control is (keeping in mind the identification of the hazard that is trying to be controlled). 

The designation of an alternative control is where it starts to get tricky and triggers the need for a true risk analysis to be undertaken.

Implementing alternative

controls

To give you an example, Clause 3.6.5.2 states that “Processing utensils and packaging shall not be stored in areas used to

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