2.4.8 Product Release/2.5.6 Product Sampling

We make low risk RTE confectionery products with a shelf life of 2 years or more. Currently, when a product is released we retain a sample from each lot for the duration of the products shelf life. I was always told that we retain the samples because it is an FDA requirement, I am in the process of implementing SQF level 2 and I was trying to update our procedures but I can not find any FDA or SQF requirement regarding sample retention. 

The retain samples are separate from our inspection and analyses samples that we collect when approving a product for release. Some customers require us to retain samples for future testing and quality comparisons, so for some products we collect 100 grams to test, 100 grams to retest, 100 grams to retain per customer specs and then 100 grams to retain per FDA regulation. This is according to our existing procedure but I don't know where the author came up with the information.

When releasing finished product, is it a mandatory requirement for us to retain a sample from every lot/batch of product?

If so, then would someone be so kind as to provide me with a link or code to reference.

If you look at 2.5.6. ii,  level 2, it says -

On the FDA side of things - they require drug manufacturers to retain samples, but nothing I could find on food.   

The real reason you keep them is because they come in handy for a lot of things - shelf life examinations, comparing sensory attributes back to back, customer complaints, etc. 

Samples are very useful to retain and we refer to them regularly, but we currently retain a lot of product and we often run out of room. I want to make sure we are retaining the correct amount of product with out retaining more than we need. If we are not required by any regulatory authority to retain samples then I can reduce the number to the minimum amount needed for future quality comparisons. 

Hi Cody13,

For auditors purpose, it was ok for BRC and SQF at least for me, to just group my products/processes and do one shelf life evaluation. So if I do fish I have to make sure I do a shelf life evaluation for every species I have but not every production run. I have one shelf life evaluation for product sold whole fish and another fillet. I have shelf life evaluation on product sold in MAP. Shelf life will include microbiological results and organoleptic results.

However, as M_M mentioned "they come in handy for a lot of things - shelf life examinations, comparing sensory attributes back to back, customer complaints, etc."

However it will become pricy to lose so much inventory & with limited space.

Dear Cody,

Not in USA but I didn't realise anyone routinely retained samples of  all  shipped lots for shelf lives >= 2 years. Must be a logistical nightmare unless you only ship one or two containers / month with a uniform lot number.

I believe (TTBOMK), in respect to yr OP - FDA / SQF that for shipped lots, the previous posts are to be interpreted as a NO.

Rgds / Charles.C

Dear Cody,

 

Not in USA but I didn't realise anyone routinely retained samples of  all  shipped lots for shelf lives >= 2 years.

With the amount of ambulance chasing lawyers it also seen as some liability protection. 

Dear Cody,

 

 Must be a logistical nightmare unless you only ship one or two containers / month with a uniform lot number.

It is.   

well that helps, I guess I can let people know we don't have to retain everything that we currently do, or at least for as long as we do. 

We DO rwetain first and last item from each SKU run during a day.

BUT our shelf life is 6 months. It IS a bit of a pain, but when you can send the specific item that a customer claims to have become ill from, test it and bring the results back to the insurance company and their lawyers...it is worth it.

The majority of GFSI standards require end of shelf life testing to be undertaken with records maintained of this testing. Maintaining retention samples helps to achieve compliance with these requirements.

For example:

• BRC - 5.5.1.3 - talks about records and results from shelf life tests and also that there is a system of on-going shelf-life assessment is in place
• SQF - 2.5.6 Product Sampling, Inspection and Analysis - talks about Inspections and analyses to be completed at regular intervals as required and to agreed specification and legal requirements. This would mean retention samples need to be kept to be able to verify end of product shelf life. 
• If you are in Australia and supply to Woolworths, Section 15.4 requires retention samples for entirety of the shelf life.

To find out more, I wrote an article a while ago on Retention Samples. Find it at http://www.haccpment...ention-samples/

Dear HACCP Mentor,

Nice to hear from you.

The Woolworth's ref i can well believe, they are an Enigma.

But the BRC/SQF interpretations look a bit of a generalized stretch.

Rgds / Charles.C