Again, assuming you do not presently use a Laundry, you can, by risk assessment, demonstrate the validity of your current choice versus, say, using a Laundry.
I suggest a logical approach is to construct a simple 3x3 matrix based on the probability (P) of the laundering procedure failing (and thereby generating a hazard of micro. contamination) versus the consequence (severity)(S) of such an event. The two together giving a Risk = (P x S).
I suggest that the probability could be Medium (to be based on micro. evaluation after laundering).
This probability would then be associated with the severity at the various stages in yr process.
As an example, I suggest that the outcome severity in a Post-baking handling stage might be High so that the combination of (P x S) would yield a significant risk.
Such a result would invalidate yr choice not to use a laundry if the latter’s probability of failing were (validatably) Low thereby yielding a non-significant risk.
Alternatively, if you are determined to not use a laundry, it will be necessary to demonstrate that a suitable improvement (ie reducing the probability of failure) can be implemented and validated.
If necessary, a scale of frequencies of subsequent micro. testing could be associated with a specific L/M/H risk result.
Of course any actual result will depend on your (validatable) choice of Probability/Severity.
I recommend you watch the webinar on Oct 14th on the topic of risk assessment which I anticipate will discuss risk assessment techniques such as above for some GMP-type activities.
PS - you can see a generalised matrix presentation of the above in the attachment in post below although some of the details got a bit confused -
Edited by Charles.C, 07 October 2016 - 09:03 AM.
edited webinar date !