Hello...
Sorry for having so many questions, but now after our inspection I am confused regarding the interpretation of some requirements.
21 CFR Part 820(d) Design output states.... "Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented."
How do you realise the requirement written in bold, the one about essential design outputs?
Our actual procedure states, that essential design outputs are identified using risk management, and the procedure states that those outputs identified as risk control measures are essential design outputs.
The inspector told us, this is not appropriate.
Furthermore the inspector mentioned, that the DMR of out Device is the essential design out put. I do not understand that...because according to ?820.3 the total finished design output ist the device, its packaging and the DMR...so what is the difference to the esssential design output?
I am really confused...do you have some advices?
How do you identify and document essential design output according to your procedure?
Thank you very much in advance.
Best regards,
Aphel
Sorry for having so many questions, but now after our inspection I am confused regarding the interpretation of some requirements.
21 CFR Part 820(d) Design output states.... "Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented."
How do you realise the requirement written in bold, the one about essential design outputs?
Our actual procedure states, that essential design outputs are identified using risk management, and the procedure states that those outputs identified as risk control measures are essential design outputs.
The inspector told us, this is not appropriate.
Furthermore the inspector mentioned, that the DMR of out Device is the essential design out put. I do not understand that...because according to ?820.3 the total finished design output ist the device, its packaging and the DMR...so what is the difference to the esssential design output?
I am really confused...do you have some advices?
How do you identify and document essential design output according to your procedure?
Thank you very much in advance.
Best regards,
Aphel