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 220.127.116.11.
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 18.104.22.168. Let’s firstly see what the standard requires before I get into how a food business can comply.
SQF Requirement 22.214.171.124
SQF Requirement 126.96.36.199 – 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 188.8.131.52
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 184.108.40.206 states that “Processing utensils and packaging shall not be stored in areas used to store hazardous chemicals and toxic substances”. To comply with this, you would not store processing utensils and packaging where hazardous chemicals and toxic chemicals are stored. This makes sense to prevent chemical contamination of those utensils and packaging.
Now maybe, by some bizarre logic, you believe you can better control this potential for chemical contamination via another method. Let’s say, your alternative control will be to clean all processing utensils and packaging prior to use. The thought process being – if by chance the utensils did become contaminated, it is all good, because we are going to clean it before use anyway.
Completing a risk analysis
You would then need to do a risk analysis which includes:
- The hazard
- The cause of the hazard
- The likelihood of that hazard occurring
- The consequence of that hazard occurring (pre and post control)
- The overall risk of the hazard (based on your chosen risk analysis tool)
You would also need to validate that your alternative method of control will actually work (to stop the potential for chemical contamination).
Evidence for implementation
As part of the implementation process for this control, your business would need to have documented procedures, verification checks (to support that the control has been implemented) and staff training. Records and documentation need to be available to support your implementation.
Wrap Up to Ask Me!
Alright, hopefully, my explanation has helped to demystify your compliance responsibilities for SQF Requirement 220.127.116.11. A big thank you to JoAnn for sending in the question and thank you for listening.
If you have a question to ask, just as JoAnn did, all you have to do is go to haccpmentor.com/askme and click the Submit Question button. You can leave your question there for me to review and who knows, your question could be in the spotlight in an upcoming episode of Ask Me!