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When should validation be carried out in the context of ISO 22000?


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definitions, haccp (hazard analysis & critical control points), iso 22000 - food safety management systems, validation testing, verification (general), validation of machines equipment processes design etc.
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  Post Number #1  
Old 27th January 2011, 11:04 AM
Ka Pilo

 
 
Total Posts: 610
Question When should validation be carried out in the context of ISO 22000?

When should validation be carried out? Please cite some examples of validation activities.

Perhaps it would be of help to differentiate monitoring, verification, and validation in the context of ISO 22000 first. i found these terms confusing.
Also, if anyone could share a monitoring form to address the principle 4 of HACCP would be very much appreciated.

Thanks a lot.

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  Post Number #2  
Old 27th January 2011, 11:20 AM
Marc's Avatar
Marc

 
 
Total Posts: 24,719
Re: When should validation be carried out in the context of ISO 22000?

First off - You should read about the basics and get the basic definitions. For example:

Verification Definition
Review of the design to ensure it meets the specifications. Verification always precedes Validation.

Validation Definition
Testing to ensure the design/product works.

I can not help with respect to HACCP / Food Safety. Hopefully one of those in that field can help you.
Thanks to Marc for your informative Post and/or Attachment!
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  Post Number #3  
Old 28th January 2011, 12:42 PM
tsmith7858's Avatar
tsmith7858

 
 
Total Posts: 129
Re: When should validation be carried out in the context of ISO 22000?

Quote:
In Reply to Parent Post by Ka Pilo View Post

When should validation be carried out? Please cite some examples of validation activities.

Perhaps it would be of help to differentiate monitoring, verification, and validation in the context of ISO 22000 first. i found these terms confusing.
Also, if anyone could share a monitoring form to address the principle 4 of HACCP would be very much appreciated.

Thanks a lot.
Validation needs to be first performed when you establish a CCP and critical limit. It is the proof that you are capable of meeting the critical limit that you set. You also need to do continuing validations at some suitable interval, like a year or two years (or whatever fits your risks)

Example:
Say you use roasting as a kill step for micro organisms (salmonella) in peanuts. You choose to roast nuts at 250 F for 15 minutes. Does this time and temperature actually kill enough salmonella to make the peanuts safe (below your Critical Limit)? You need to validate this in order to call your CCP of time and temperature correct.

Monitoring is after you validate your CCP and Critical limit. In the example above it is how you make sure the time and temperature are consistently met. It could be physical measurements at a certain interval or it could be through a data recorder that alarms if you go out of range.

Verification is simply making sure that the monitoring is happening. Someone other than the person responsible for monitoring (usually someone in a higher position) must verify that the monitoring occurs by review paperwork or data collected at the monitoring point.

So in my case, we roast peanuts. We have a critical limit set for salmonella. Theorectical data tells us we need to roast at 250 for 15 minutes to reduce risk of salmonella. To validate this theory, we did a challenge study to show that 250 for 15 minutes reduces the salmonella to accepted levels.

We monitor the time and temperature through chart recorders on the roaster. The operator puts on a chart each day and documents what product is being run. He observes it once an hour to make sure it is correct and there are alarms if the temperature drops.

He hands in the charts at the end of the day and it is reviewed by QA Supervisor. They verify all information is available and correct and that the data is within range and sign off that they verified.

Validation - Proof that time and temperature chosen can satisfy the critical limit (we validate this process every two years)
Monitoring - Chart recorder and operator real time data
Verification - QA Supervisor verifies monitoring was conducted
Thank You to tsmith7858 for your informative Post and/or Attachment!
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