Dear Forum
There are two definition of qualification date existed in my service.
Usually, the date of equipment qualification is defined on the approval date by QA.
However, in some case, someone said it is better to define the date at the end date by engineer. Because there is exist a duration before QA approval.
My question is how do you define qualification date ?
Only after approval from QA, qualification is valid . Hence you consider approval date of QA as qualification date
The end date of qualification excercise is more logical, if the end is successfull off course, the qualification report can be longtime in the hands of QA for reviewing even though the task have been fully completed
Hi nil_upadhyay
Thanks for your comment ! At the beginning, I think also approval date of QA as qualification date. Then, what if it’s been three weeks after QA approval. On this matter, I have the same thought with arturot. Because I am afraid of auditor may challenge my service exists two kind of definition right now. And if I choose approval date of QA as qualification date, auditor may think I am stealing the time between the end date of qualification exercise and approval date of QA. I would like to look forward for your opinion.
Hi arturot
Thanks for your judgment! In this situation, how could we release this equipment before QA approval?
Hi chia_yu_chiu.
In my opinion, qualification date represents the day from we are allowing equipment for regular use. QA clearly mentioned in its final conclusion that "the equipment has successfully completed the qualification according to procedure defined in the protocol and now onwards equipment release for regular intended use.
Every process has some critical process parameters and equipment has some critical operational parameters. It has direct or indirect impact on product quality or quantity. Capabilities of equipment is finally verifies on product during performance qualification. On successfully complition of PQ the equipment release by QA for regular production.
Such comments not available by engineers, they verify its technical capabilities, operational abilities but engineer could not conclude impact on product like performance qualification where the quality evaluation done.
I think we are performing equipment qualification to prove the ability of new equipment with its intended use. Only QA can finally conclude that new equipment is suitable or not with the product. Hence release date of QA is more important with respect to actual use of equipment as well with respect to documentation purpose.
Hi nil_upadhyay
It is really good opinion that I have ever heard. That is very constructive and inspiring. Thank you!!
Now, I create a SOP of qualification status to indicate the qualification date should be the approval date of QA. In order to avoid a longtime of QA reviewing, I set an dateline for QA conclude that equipment is suitable or not for production.But I am wondering maybe some expert have different experience who would like to indicate their opinion.
The qualification is not complete until it is approved by all required approvers. If the approvers reject it for some reason, (tests missed for example) the qualification is not valid, and you have been running on non-qualified equipment.