Sample Risk Assessment for Microbiological Testing

I wonder if anyone can help, I am looking for a sample risk assessment for microbiological testing on product.  I want to reduce the testing carried out as there have been no issues and the frequency of testing is not required (in my opinion!) however I have to justify my opinion with a risk assessment.

Thanks!

I wonder if anyone can help, I am looking for a sample risk assessment for microbiological testing on product.  I want to reduce the testing carried out as there have been no issues and the frequency of testing is not required (in my opinion!) however I have to justify my opinion with a risk assessment.

 

Thanks

Dear Waferthin,

A risk assessment usually requires the ability to assess risk.

Perhaps you could briefly summarize (or reference) yr current procedure as used for (??) on products such as ( ??).

One problem may be that most microbiological measurements are relatively inaccurate, and so quite often is the sample itself. Hence they often need either large samples or frequent application. Or both. Especially if you are talking about low level possibilities for zero-tolerant pathogens.

Rgds / Charles.C

Thank you for your response Charles.  

Yes I have carried out a number of risk assessments in the past just not one using this scenario.  I was looking at using a scoring method as other risk assessments but it was not 'falling into place' for me so I may shelf that idea! I shall justify my request on our results history. Yes unfortunately we are doing large samples and frequent testing for a low output of product which as you can imagine is rather costly!

Thanks again!

Dear Waferthin,

Frankly, it all depends on what you mean by "large" samples and "frequent" testing. And possibly on the number of products involved.

HACCP agrees with you that routine micro.analysis of the end product should be minimised. This essentially comes within the verification program.

IMEX, the worst case scenario is that some customers simply demand detailed micro.data on every lot/sublot. Most companies tend to cave in to this request for business reasons.

If you do have freedom of choice, it becomes a question of where to set the verification "balance"  between adequate "self-protection" and a waste of time and money. Unfortunately the temptation is to bias the sampling to the former for obvious reasons.

The statistical aspect IMO can be relatively undemanding if a minimalist approach is followed, eg as per EC micro. acceptance standards.

Rgds / Charles.C

Dear waferthin,

in my opinion 'process' is more important than 'result',

so if your process stable and match with your standard i think you can reduce your sampling number

if reduce your sampling number, sure you must do risk assesment,

and make sure will be okay for your whole product

Thanks DAW

Thank you for your replies.  

At the minute we are doing 4 tests per batch for one Customer on one product at the Customer's request of course.  So we would be quite happy to still conduct one test per batch.  Although we would reduce further if permitted :)  

We conduct tests for other Customers on the same recipe when we produce for them so results will still be available for monitoring. Heres hoping................:)