This is what they are asking for:
"Do the validation reports appear to support a conclusion for effectiveness of the control measure? (e.g. control, reduce, or eliminate the hazard to the specified Critical Limit; for a consistently safe product; as determined through scientifically designed experimental validation studies which are objectively measured and formally reported with conclusions, evidence from professional bodies, trade associations, scientific literature, regulations, and legislation).
Is a Validation Report attached in the Process Controls section for EACH of the identified Process Preventive Controls and CCP's?"
I sent them our annual validation record, which is proof that the metal detector works on each of our products which was not the information they were looking for. They said I must conduct a study to ensure the effectiveness of the control measure.
I reached out the the manufacturer of our metal detector and they did not understand what I was looking for.
These are the audit criteria the customer referred me to:
"Does validation/scientific justification documentation exist to support adequacy of critical limits or parameters for controlling the significant hazard at each CCP? Is there annual verification performed and documented? Where scientific justification of critical limits or parameters relies upon published, referee journal research publication, regulatory guidance, etc., are the processing critical parameters and prudent matrix adequately represented?"
I'm afraid I am with our metal detector manufacturer and really don't understand what they are looking for. I have read some of the other metal detection threads here and felt like the didn't completely address what I needed. Can anyone help, explain, or point me in the right direction?
Thanks in advance!