Monitoring of Nonconformity products

Dear Saferpakers,

ISO 22000 requires you to establish procedures and documentations to handle nonconformity products derived from out-of-range or defective monitoring devices / equipment.

The international standard also requires you to do more than just that. It expects you to review and if necessary, hold, isolate and investigate all previous production batches (released later if justified) that were suspected to have been monitored under the "out-of-range or defective devices/equipment"

Handling of nonconformity product is a huge area of concenr under ISO 22K. Have you got this Covered?

Regards
Charles Chew

It expects you to review and if necessary, hold, isolate and investigate all previous production batches (released later if justified) that were suspected to have been monitored under the "out-of-range or defective devices/equipment"
Handling of nonconformity product is a huge area of concenr under ISO 22K. Have you got this Covered?

The risk is the device/equipment out of range ? We will monitor it and the monitoring frequency will be risk-based.

Nevertheless should it happen ? We will investigate: that's exactly why we keep lots of samples.

Do we really need ISO 22000 WG and a standard in order to understand that food safety is our primary goal ?

BTW is there any other way to ensure food safety ?

There is very little difference between EN ISO 9001:2000 - Quality Management Systems - Requirements 7.6 Control of Measuring and Monitoring Devices and ISO 22000:2005 8.2 Monitoring and measuring.

Like Franco says the monitoring and measurement equipment that needs to be controlled, how it will be verified and at what frequency should be determined by risk assessment.

In order to avoid time consuming and potential costly nonconformity reviews; where ‘out of control' monitoring and measurement equipment can affect food safety and / or quality you would expect verification to be tight enough for early detection; so that when an item is not measuring accurately it cannot be used on more than one batch of product. Depending on run size verification of monitoring and measurement equipment may be needed more frequently than say once at the start and end of the batch - perhaps even continual verification throughout the batch could be considered if justified.

Regards,
Simon

The risk is not just about the device being out of range (thats a calibration issue.... 8.3) - but rather the handling of potentially unsafe products (7.10.3)..... the result being derived from the use of a defective device i.e. the nonconforming products.

In most instances, only the current production batches are isolated but what about previous to the current batch (assuming that you only found out about the defect say a day later when in fact, the device was already defective 5 days ago.)

In a process line, funny things can happen but I would expect the auditor to raise this issue to satisfy this clause.

Charles Chew