Hi, I'm new here and to ISO 13485 and ISO 11135 so go easy on me.
I am new to the company and have been tasked with continuing the work that the company has done with the notified body to resolve the audit findings from the last audit.
One finding has been plaguing them/us...
Product "B" was added to a validated product process and was deemed equivalent to or a lesser challenge than the currently validated product. The protocol used for adoption stated that the candidate part was shorter and wider and did not have a plastic sheath around it before it was put into the heat sealed pouch (sterile barrier). Therefore, the predicate part is still the greater challenge to sterilization. However, the candidate part has a larger shipper container. Therefore, a larger load size was validated using 3 half cycles and 1 full cycle alongside the already validated load size for comparison.
The finding started out that there was no rationale provided that the PCD remains valid for the new maximum load size and has now evolved into the larger product size was not assessed in the rationale for how it was adopted.
The notified body has been given the protocol used for both the original validation that included the fractional cycle to validate the PCD and the new maximum load validation. Both documents state which is the greater challenge to sterility and the second document states why the fractional cycle was not performed for the new maximum load.
I know this is cryptic but this has frustrated the company for way too long and I want to get this resolved. Any assistance would be helpful.
Thank you in advance!
I am new to the company and have been tasked with continuing the work that the company has done with the notified body to resolve the audit findings from the last audit.
One finding has been plaguing them/us...
Product "B" was added to a validated product process and was deemed equivalent to or a lesser challenge than the currently validated product. The protocol used for adoption stated that the candidate part was shorter and wider and did not have a plastic sheath around it before it was put into the heat sealed pouch (sterile barrier). Therefore, the predicate part is still the greater challenge to sterilization. However, the candidate part has a larger shipper container. Therefore, a larger load size was validated using 3 half cycles and 1 full cycle alongside the already validated load size for comparison.
The finding started out that there was no rationale provided that the PCD remains valid for the new maximum load size and has now evolved into the larger product size was not assessed in the rationale for how it was adopted.
The notified body has been given the protocol used for both the original validation that included the fractional cycle to validate the PCD and the new maximum load validation. Both documents state which is the greater challenge to sterility and the second document states why the fractional cycle was not performed for the new maximum load.
I know this is cryptic but this has frustrated the company for way too long and I want to get this resolved. Any assistance would be helpful.
Thank you in advance!