Essential Design Output - Still a problem

Aphel

Involved In Discussions
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
 

somashekar

Leader
Admin
Re: Still a problem: essential design output

There are two very critical design output groups. Safety and Effectiveness. Everything else can be absorbed within these, like usability and stuff
Your procedure perhaps is directing the essential design outputs mostly from the safety angle, coming out of the risk management.
Where are the design outputs about medical device effectiveness.
Taking a clue from the ISO13485, the essential design outputs must provide appropriate information for purchasing, production and for service provision.
Now you have to broaden your procedure.
 

Ronen E

Problem Solver
Moderator
Hi,

Design Output in general is as defined by 21 CFR 820.3(g). This definition tells us nothing about Essential Design Outputs and is therefore less relevant to your question.

Relating to 21 CFR 820.30(d) --

Design output procedures shall... ensure that those design outputs that are essential for the proper functioning of the device are identified.

"Proper functioning" = functioning according to all relevant requirements in the Design Input. Those outputs that don't relate to any functional requirement in the Design Input (either directly or indirectly) are not essential. E.g. if the device's colour is of no functional (i.e. performance, safety etc.) significance, it should be specified in the Design Output but it's not an essential design output.

You could conveniently identify the essential Design Outputs in a side-by-side matrix, listing the relevant Design Inputs, Design Outputs and references to the outputs (drawings, BOMs etc.).

Cheers,
Ronen.

PS IMO the DMR can reflect non-essential design outputs as well. However, all the essential Design Outputs must be reflected in the DMR. I tend to think that the inspector's concern was that your procedure only seems to identify as essential those Design Outputs that relate to risks in your risk management file.
 
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M

MIREGMGR

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.

I agree with Ronen...maybe the inspector's concern had to do with whether the best way to identify essential design outputs is via risk management as you have implemented it. Perhaps in the inspector's view, risk management would not adequately identify everything that needs to be an essential design output.
 
Last edited by a moderator:

Aphel

Involved In Discussions
Hello all,

Sorry to come up with this topic again...I am still dealing with "how to make it"...

Thats why I just want to ask you...can someone explain the way you are doing / realising this QSR requirement...what kind of records do you have as evidence for this task - "identifying and documenting essential design output" ???

Thank you very much for your responses!

Best regards,
Aphel
 
C

cff920

EDO (Essential Design Outputs) is closely related to risk management. FDA did provided very limited guidance on it, for example, in QSIT, FDA said:

Outputs must be comprehensive enough to characterize the device design to allow for verification and validation. Also, design outputs which are essential for the proper functioning of the device must be identified. Typically a risk analysis tool such as FTA or FMEA is used to determine essential outputs. For the selected project, verify that essential outputs have been identified. In addition, review the firm's process for determining how the essential outputs were identified and determine if it was done in accordance with their design output procedures.

In a guidance to PMA submission, FDA said:

You should provide a copy of the procedure(s) used to define and document design output in terms that allow an adequate and measurable evaluation of conformance to design input requirements for the device under review. Provide a list of the design outputs you consider essential for the proper functioning of the device for the device under review.
Your procedure(s) should contain or refer to design output acceptance criteria.
Your procedure(s) should explain the mechanism used to ensure that you identify those design outputs that are essential for the proper functioning of the device.
Your identification of essential design outputs will help us determine the adequacy of your design verification and design validation.

Best regards,
CG, China
 
R

rjhill

Aphel, "How" could be tracing the design output (performance or safety) down to the part features and manufacturing process parameters that influence that output the most. Annotate these features and processes in the design documents (drawings and procedures) with a symbol. Keep a tracing document so you can easily produce the list of what you are monitoring to ensure essential output.

My company is trying to come up with a comprehensive way to do this, the above are my thoughts on the topic.
 

TWA - not the airline

Trusted Information Resource
Search FDA's website for the following documents: ucm377644 and ucm070642 or the key words "design control". The design process that converts/links design input to design output can use tools like the house of quality (quality function deployment) and cause-effect matrix as well as risk management tools like fault tree analysis and failure mode and effect analysis. The decision about essential or not can be a cut-off based on whether safety and effectiveness are affected or by some kind of grading like the risk priority number in an FMEA.
 
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