Annual/Skip-Lot Product Testing

Hello All!

I am working to implement an annual audit testing program and have a few questions.  Certain chemical testing of products will be required annually, rather than every lot (justified based on a number of consecutive in-spec results).  

• Does anyone have a good, free system/method for implementing skip-lot testing to ensure that the testing is completed on time (aside from putting a not in a calendar and crossing your fingers that production will occur at the same time your calendar reminds you)?
• What does management of OOS results look like under this system?
  • If an annual test comes back OOS, the lot cannot be released without appropriate investigation and deviation (if appropriate)
  • As this method of testing is for trending, what is the best way to evaluate additional lots after an OOS is identified?
    • If we test previous lots in an attempt to identify a negative trend quickly, what is the implication if the older lots (already in the marketplace) are OOS also?  It seems logical to work to identify and resolve the potential issue as soon as possible by testing previous lots, but what action, if any, must be taken with the previously released lot once the OOS is identified?

NOTE - None of the testing is for any food safety.  This testing only captures analytes to support label claims.

Thanks in advance for any thoughts!

• Does anyone have a good, free system/method for implementing skip-lot testing to ensure that the testing is completed on time (aside from putting a not in a calendar and crossing your fingers that production will occur at the same time your calendar reminds you)?

   

   

I assume you have a reminder system in place already to do supplier review or raw material specification review? Include any necessary testing at the next available day post-review.

What does management of OOS results look like under this system?

 

Can't say without being able to know what you're testing and at what limits it becomes an issue for your product or it's label.

As this method of testing is for trending, what is the best way to evaluate additional lots after an OOS is identified?

 

Testing on an annual basis isn't really going to give you any meaningful trends...Again, best way to evaluate other lots will depend on what you're actually testing and how important it is to you.

If we test previous lots in an attempt to identify a negative trend quickly, what is the implication if the older lots (already in the marketplace) are OOS also?  It seems logical to work to identify and resolve the potential issue as soon as possible by testing previous lots, but what action, if any, must be taken with the previously released lot once the OOS is identified?

 

Again, it depends on what you're testing. But if results mean the product is adulterated or misbranded, you can't unlearn that information, this is the risk of skip lot testing. You have a risk management decision to make at that point.