3 replies to this topic

[jannel]

Hi,

 

Could somebody help me find a link for the guidelines when to have a product recall or withdrawal?

 

Currently, we are into BRC accreditation and clause 3.11.2 at a minimum requires for it.

 

In advance, Thank you for those who will reply to this topic.

[Tony-C]

Hi Jannel,

BRC Interpretation Guideline 3.11.2:
The site must have a documented recall and withdrawal procedure. As a minimum, it must include:
• Details of the recall management team members, their roles, responsibilities and contact details. In larger businesses the recall team will involve head office personnel and may be run from head office. This is clearly acceptable, but links between the production-site management and the recall team need to be clear.
• Guidelines for deciding whether a product needs to be recalled or withdrawn and the records to be maintained. Although causes for recall are often unpredictable, defined responses to known risks (e.g. identification of pathogens in routine product sampling) could be documented.

 

So the guidelines in your organization may be based on finding a serious non-conformity (say affecting product legality or safety or conformity to customer requirements) subsequent to product dispatch.  It may also be due to a quality defect that may cause numerous complaints or it may be based on the receipt of a certain complaint level say > 100 complaints per million units.

 

Kind regards,

 

Tony

 

 

[QAGB]

Hi,

 

Could somebody help me find a link for the guidelines when to have a product recall or withdrawal?

 

Currently, we are into BRC accreditation and clause 3.11.2 at a minimum requires for it.

 

In advance, Thank you for those who will reply to this topic.

 

 

Hi Jannel,

 

The FDA has specific definitions of market withdrawal and recall. If you export to the US, you may be under FDA jurisdiction; however, I'm not sure if the guidelines globally are different.

 

A recall (there are three classes) would be the removal or correction of a product in commerce that the FDA considers being in violation of its laws.

 

• Class 1 Recall: Reasonable probability that the use or exposure to product will cause serious health consequences or death.
• Class 2 Recall: Use or exposure to product may cause temporary or medically reversible health consequences or probability of serious adverse health consequences is remote.
• Class 3 Recall: Use or exposure to product is not likely to cause health consequences.

 

A market withdrawal is the removal or correction of a product in distribution, which involves only a minor violation, which would not be subject to FDA action. An example of this would be the removal of old stock from distribution channels.

 

 

Basically, if the affected product has some likelihood to cause health consequences (be it physical, biological, chemical, radiological), it would be considered a recall. The definitions can be found on the link below.

 

http://www.fda.gov/S...s/ucm165546.htm

 

QAGB

[jannel]

Thanks we need the guidelines for our programs. Though it still so broad at some point we now know where to start.