To Erasmo: Hmmm, judging from your posts, its seems you are an expert practise, an auditor or consultant perhaps? BTW, now you mention it. Ive read the Draft of validation from Codex too, its already posted in this forum, but I dunno when and by who..:p May I know which part of example that you dont agreed, and why? And one more question that might be off topic: do we only need validation once in a lifetime (considering that monitoring & verification is enough), or do we need to re-validate it again? And for how long? Thanks.
Yes, I'm an auditor for this standard...
To your first question: The requirement states that you have to validate before the implementation and after a change... the need for re-validation is in th mentioned document:VII. NEED FOR RE-VALIDATION
There are many changes that could lead to a need to re-validate a control measure or combination of control measures. Examples include:
• System failure: If monitoring or verification identifies failures for which a process deviation cause cannot be identified, re-validation may be needed. Non-compliance with monitoring or verification criteria may indicate a need for a change in the parameters (i.e., the selection and specification of the control measures) on which the design of the food safety control system is based. A system failure may also result from an inadequate hazard analysis and may require re-validation.
• Process changes: The introduction in the food safety control system of a new control measure, technology or a piece of equipment that is likely to have a decisive impact on the control of the hazard may necessitate that the system or parts of it be re-validated. Similarly, changes made in product formulation or the application of current control measures (e.g. time/temperature changes) may result in the need for re-validation of control measures.
• New scientific or regulatory information: Re-validation may be needed if the hazard associated with a food or ingredient changes as a result of (i) higher concentrations of hazards than originally encountered and accounted for in the design, (ii) a change in response of a hazard to control (e.g. adaptation), emergence of a previously unidentified hazard, (iv) new information indicating that the hazard is not being controlled to the level specified (e.g. new epidemiological findings or new validated and internationally accepted analytical technologies ) or (v) a new food safety outcome.
To your second question: I'm not agreeing with the example of the labeling of table eggs... the reason is that I'm not agree with:
-The expected outcome (change in 25% of the understanding in the correct handling)
-In my understanding, this is part of the intended use.
It is totally obvious that if someone get sick for not follow the correct instruction it won’t be a food safety problem by definition: Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use
If I get a bag of berries and the label stated that you have to washed before consume, I'll do it!