5 replies to this topic

[camilaq]

Hi all,

I am wanting to develop a risk assessment as a way to set a standard to determine if a recall/withdrawal is necessary. The reasoning is that by going through this risk assessment (as questionnaire, or decision tree), a decision to recall or not can be made.

From what I have (not) found, this does not seem to exist. Any thoughts?

Thank you!

Edited by camilaq, 22 August 2023 - 04:52 PM.

[Scampi]

If you cannot reach a decision via a decision tree I don't know how you think a risk assessment would help

 

You're product either conforms (available for sale) or doesn't (recall OR rework) and this should be in your procedure already

 

What part of the process exactly are you having trouble with?

[G M]

Hi all,

I am wanting to develop a risk assessment as a way to set a standard to determine if a recall/withdrawal is necessary. The reasoning is that by going through this risk assessment (as questionnaire, or decision tree), a decision to recall or not can be made.

From what I have (not) found, this does not seem to exist. Any thoughts?

Thank you!

 

I'm not sure a risk assessment is really the right tool for determining if a recall is needed.  This is typically based on product safety, for which you presumably have CCP's or other pass/fail objective minimum or maximum parameters set before you even start production.

 

A simple checklist or decision tree to establish if safety obligations have been met should be all the review needed.  

 

A quality based withdrawal of product from the market might be a better use-case scenario for the application of a risk assessment.

[Tony-C]

Hi camilaq,

 

 

Welcome to the IFSQN forums.

 

I would tend to agree with the previous posts by Scampi and GM.

 

The need to recall is often dependent on where the product is and in particular if is is on sale publicly. Sometimes products can be withdrawn before they reach the market place.

 

If your product is unsafe or illegal then a recall is necessary if the product is in the market. If there is a quality issue then the need to recall is more subjective.

 

It might be a case that instead of a decision tree that you stipulate other condictions where the product should be withdrawn or recalled. For example: more than 1 serious complaint (such as glass contamination) of the same nature from a product batch.

 

Experience shows that whilst you can have some firm rules you need some fluidity and need to investigate serious complaints and when you receive a larger than normal number of complaints* of the same nature. Based on the seriousness and number of complaints you may then decide to recall or withdraw the product.

 

* Number of complaints should also consider the batch size so complaints per million units as an example.

 

Kind regards,

 

Tony

Edited by Tony-C, 23 August 2023 - 05:09 AM.

[camilaq]

Hi Thank you for your replies

I am talking in the context of for example, a Food Service, where the product has been produced at a facility, then transported to a distribution centre and then to the food service.

My hope is that specific "guidelines" or standards can be set. For example, a size limit for extraneous materials. Also microbiological limits. Also a set of questions that are asked for every incident could be helpful.

While I recognize every incident must be examine with critical thinking, and cannot fully rely on such standards, I do think these could be a helpful guide.

 

Does this make more sense? Thank you!

[Scampi]

A) zero is the acceptable limits on KNOWN extraneous material-----if you know about it---that is intentional adulteration

Health Canada has guidelines on the size of foreign material based on a choking hazard

 

B) micro will be wholly dependent on your finished good.     Are you really prepared to test everything???  how would you know without testing everything

 

 

To be blunt, I think you need to have a good look at your process and program before you worry about this piece as this should ALL have been addressed in your HACCP plan, specifically your hazard analysis 

Edited by Scampi, 23 August 2023 - 04:10 PM.