Design Verification & Design Outputs - FDA and 13485

T

tomnmiami

#1
As a first time poster, I've tried to do my homework and looked at many of the prior posts on this topic, but none really satisfied my questions, so here goes...

BACKGROUND:
We are a start-up medical device company (ortho implants, mainly 510k). We are creating a QMS which we hope will be both FDA and 13485 compliant, but at the same time will give enough detail to aid new employees (aka engineers fresh out of school or from other industries) in understanding the intent of the regs.

We know that Design Verification is providing obj. evidence that the Design Output meets Design Input.

We intend to use a "Design Characteristics Document" to capture the user requirements (generally subjective in nature) and translate this into a "Product Specification" to document the Design Input in engineering terms (with a measurable value, tolerance, and defined test method). This is a pretty simple concept for everyone to understand.

I am writing the Design Verification procedure and am trying to give explicit examples of verification activities. We intend to document the Design Output via a trace matrix that will tie the input (product specifications) to the output.

ASSUMPTION:
Engineering Prints are a design outputs.
Risk Analysis (FMEA in our case) is a design output.

QUESTIONS:
  1. What are other design outputs?
  2. Are engineering calculations used to justify part dimensions and tolerances, such as those typically documented in lab notebooks, considered verification activities? If so, how do you later tie them to the Desing Inputs?
  3. Is review and approval of an engineering print a Design Verification? (I am approving that dimensions, notes, etc., in the print are adequate to meet the product specification.)
  4. If I simply confirm that a part meets it's print (i.e. via First Article Inspection), can I claim that it's been verified?
  5. Are verification activities expected to be statistically significant? (I've heard of 1-3 samples being used for verification.)
  6. If I require verification protocols & reports as the sole means of performing verification activities am I being too prescriptive? (I envision a protocol calling for bench testing of a production ready part to the product specification)
  7. Does anyone have a practicle example of Design Verification in the orthopedic implant business (plates and screws)?
Many thanks to all readers,
T
 
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M

MIREGMGR

#2
Re: Design Verification & Output

1. What are other design outputs?
A useful definition of "design outputs" can be inferred from the definition of "Device Master Record" at 21 CFR 820.181. The DMR is the next logical link after Design; every element of the DMR must be created as a Design Output, by an engineer or other delegated product creator. It's up to you to define which departments contribute to product creation, but every component of the DMR must be accounted for.
 
T

tomnmiami

#3
Miremgr, thx for the quick reply. I reviewed the DMR reg per your suggestion. Are all elements of the DMR really output of the design process? For instance, I would have assumed that things like "Production process specifications..." aren't really a design output (although I do believe they need to be addressed in Design Transfer.

My rationale stems from the concept that Design Output needs to be verified against the Design Input. If my Design Input calls for something like the anodized color of a bone screw, what type of verification activity would I need to document to tie that input to the vendor's, probably proprietary, anodizing process?

Thx again,
T
 

yodon

Staff member
Super Moderator
#4
I'll give it a go...

QUESTIONS:
  1. What are other design outputs?


  1. Whatever you need them to be. I think what Miregmgr was trying to point out is that the DMR contains the list of typical artifacts. You draw the line between inputs and outputs. It's really just a matter of what you want since both inputs and outputs have to be reviewed.

    [*]Are engineering calculations used to justify part dimensions and tolerances, such as those typically documented in lab notebooks, considered verification activities? If so, how do you later tie them to the Desing Inputs?
    I would not consider them verification activities. You may want to use them as evidence of how you made the transition between design inputs and outputs.

    [*]Is review and approval of an engineering print a Design Verification? (I am approving that dimensions, notes, etc., in the print are adequate to meet the product specification.)
    I would say no, I would call that what it is - a design review. Remember that both design inputs and design outputs are expected to be reviewed and approved.

    [*]If I simply confirm that a part meets it's print (i.e. via First Article Inspection), can I claim that it's been verified?
    I would consider this to be more in the process validation / acceptance area. When I think of verification, I tend to think more along the lines of product verification; i.e., testing to confirm the requirements are met.

    [*]Are verification activities expected to be statistically significant? (I've heard of 1-3 samples being used for verification.)
    I think you're getting into manufacturing process validation again. For that, statistical significance is a consideration. From what I've seen, a de-facto standard is typically 3 lots.

    For product verification, hopefully through manufacturing process validation you've shown that production units are equivalent and so there should be no need to do product verification on multiple samples. That said, I expect that there would be some cases where it might make sense to execute on multiple units.

    [*]If I require verification protocols & reports as the sole means of performing verification activities am I being too prescriptive? (I envision a protocol calling for bench testing of a production ready part to the product specification)
    That sounds pretty reasonable to me. You will typically have a V&V Plan which gives an overview of how you plan to perform V&V activities. Certainly bench testing is a viable means. All that's required for a protocol is a controlled environment, defined expected results, recording of actual results, and analysis of whether the actual results meet the expected results.

    [*]Does anyone have a practicle example of Design Verification in the orthopedic implant business (plates and screws)?
    Can't help there. Hope some of the above is helpful.
 
M

MIREGMGR

#5
In our operations, which involve different types of medical devices from yours, we regard production processing as having a strong influence on the quality, clinical effectiveness and sometimes clinical safety of our products. Thus we control that processing by having it specified by our production process engineers. Often for us, the production process is as important as the material type, and much more important to quality than the physical design.

We do quite a bit of metalworking, both in-house and contractural. We always consider whether we should specify and control subcontractors' process techniques, because we don't want to be surprised by their use of a new or different process that meets the detailed product specifications we call out at a lower cost to them, but doesn't result in the clinical performance that our end-users expect and our regulators require.

Unfortunately I don't have enough specific experience in your field to recommend particular verification approaches.
 
R

rlbate

#6
Design verification and Design outputs are simply what you want them to be. By looking at your product what do you expect to need to manufacture the product: Prints, instructions, validation activities, verification activities, there maybe in even some procedures needed to perform the validation activity.

You had stated you didn't think the manufacturing instructions were considered as an output but as a design transfer. However, a design input might be a requirement for certain clarification instructions (in this case maybe it's how to align tooling in a certain way to ensure an error free process) then the output would be the manufacturing instruction.
 
P

Palt88

#7
A design output is something that concretely show you the input.

For example:

User need / Intended use: Device to be handling safe
Design input: all edges to be rounded
Target input: Edges to have a minimum radius of 0.05mm
Design output: Drawing xxxxxx (this is the document where you identify the point)

--------------

Another one:
User need / intended use: Device to be sterilizable
Design input:Sterilizable according ISO standards xxxx
Target input: Gamma sterilizable
Design output:Raw material spec xxxxx


You have to follow that in a table where you will state also what kind of verification and validation you have done against each user needs / intended use.

Relate to 21 CFR 820.20 "design controls"

--------------------------------------------------
Does anyone have a practicle example of Design Verification in the orthopedic implant business (plates and screws)?

Not done this type of device, but assume this is the same approach that for other device:
As you have define each user needs / intended use of the device, and now you have now some parts in your hand => you have to define tests where you verifiy each user needs / intended use. For example:
- handling
- force testing
- sterilization testing
- integrity
- raw material challenging
- etc...

THe goal is that you can at least say ok against the design points that were defined we are good and we can go further in the development.
If a problem came out then you are able to improve, modify, etc, at an earlier stage of the development. You can do again a new iteration loop for some points.

Also you can already mitigate some DFMEA critical points if they were sucessfully tested in the DV.
 
Last edited by a moderator:
A

alexfeile318 - 2010

#8
As a first time poster, I've tried to do my homework and looked at many of the prior posts on this topic, but none really satisfied my questions, so here goes...

BACKGROUND:
We are a start-up medical device company (ortho implants, mainly 510k). We are creating a QMS which we hope will be both FDA and 13485 compliant, but at the same time will give enough detail to aid new employees (aka engineers fresh out of school or from other industries) in understanding the intent of the regs.

We know that Design Verification is providing obj. evidence that the Design Output meets Design Input.

We intend to use a "Design Characteristics Document" to capture the user requirements (generally subjective in nature) and translate this into a "Product Specification" to document the Design Input in engineering terms (with a measurable value, tolerance, and defined test method). This is a pretty simple concept for everyone to understand.

I am writing the Design Verification procedure and am trying to give explicit examples of verification activities. We intend to document the Design Output via a trace matrix that will tie the input (product specifications) to the output.

ASSUMPTION:
Engineering Prints are a design outputs.
Risk Analysis (FMEA in our case) is a design output.


QUESTIONS:
  1. What are other design outputs?
  2. Are engineering calculations used to justify part dimensions and tolerances, such as those typically documented in lab notebooks, considered verification activities? If so, how do you later tie them to the Desing Inputs?
  3. Is review and approval of an engineering print a Design Verification? (I am approving that dimensions, notes, etc., in the print are adequate to meet the product specification.)
  4. If I simply confirm that a part meets it's print (i.e. via First Article Inspection), can I claim that it's been verified?
  5. Are verification activities expected to be statistically significant? (I've heard of 1-3 samples being used for verification.)
  6. If I require verification protocols & reports as the sole means of performing verification activities am I being too prescriptive? (I envision a protocol calling for bench testing of a production ready part to the product specification)
  7. Does anyone have a practicle example of Design Verification in the orthopedic implant business (plates and screws)?
Many thanks to all readers,
T
Let me try to answer your question.
Take surgical gloves as am example. your input for the product may be like this:
white, water-proof under certain presure, survive certan force and so on.
The above may be part of your design input.

I dont take drawings or prints as output. when the gloves or samples were produced, the outputs are characteristics beared in the products or samples.

So you have to verify whether your product or samples meet design input because up to now you dont know whether the gloves are water proof or whether they can survive certain force.

so you observe the color and compare it to specified color chart, you charge the gloves with air and put them into water to test whether they are water-proof under certain presure and you put it under certain force to test whether it can survive the tension. All this you do is the verification. You get satisfied results from these experiments or tests. It means the outputs meet inputs or the desing process is successfu.

ok, it is a long post but i hope it helps you understand.

Alex
 
R

rlbate

#9
There are many things to consider, however, starting out, I would encourage you to try and keep the initial process as simple as possible and grow into it. Letting the system develop as your organization learns.

1. What are other design outputs? Other examples would be work instructions, product specifications, user manuals, technical sheets, performance standards, risk analysis, etc.

2. Are engineering calculations used to justify part dimensions and tolerances, such as those typically documented in lab notebooks, considered verification activities? If so, how do you later tie them to the Desing Inputs?
Yes/no, these would/could be included in design verification activites and filed in your the verification section of your design files. It depends on what other check documentation you use. - Here is where I see some organizations try to get very particular in what they include where and end up going overboard and create a very cumbersome and complicated process to follow. In my organizations process, we have created a seperate section titled misc. to store this type of information and calculations. If a question is asked about justification of a dimension then we can easily pull this section and get out the specific calculations used. If overtime you find the data is pulled many times, then you can amend your process to include this information elosewhere as needed - But I would encourage you to keep it simple.

The "tie in" if needed would be created by cross referencing the dated or numbered test results in a tabulated spreadsheet.

Input (need) - out put are those records that support and verify the input.

3. Is review and approval of an engineering print a Design Verification? (I am approving that dimensions, notes, etc., in the print are adequate to meet the product specification.) No. Design verification is the product meeting the drawing and specification requirements. The documented evidence of verification would be inspection reports and other data that verifies you made what you intended to make.

4. If I simply confirm that a part meets it's print (i.e. via First Article Inspection), can I claim that it's been verified? Verification is performed at the intiation product development phase. It could be rationalized that one part would be acceptable for verificatiojn activities, however, any good auditor or investigator will ask what is the statistical significance of one piece? I would recommend using a statistically based sample to verify conformance to designs.

5. Are verification activities expected to be statistically significant? (I've heard of 1-3 samples being used for verification.) See the above response. You can use any number if you can rationalize that qty is enough to verify the device to the planned intent (inputs).

6. If I require verification protocols & reports as the sole means of performing verification activities am I being too prescriptive? (I envision a protocol calling for bench testing of a production ready part to the product specification). I would think that bench testing falls under validation activities and might not be enough to verify the device meets requirements.
I try and follow a simple rule:
Verification is used to determine if the device "looks" like the requirements.
Validation is used to determine if the device "acts" like the requirements.

There are some that will argue this point, however, if you have the information and your worst offense is that it is in the wrong file, you should do fine with anyone that asks. But I would add, that if if falls under the validation section, write up a protocol of what you expect the the test to do (what is it testing, what is the statistically valid sample, and what are the results you expect to see.)

7. Does anyone have a practicle example of Design Verification in the orthopedic implant business (plates and screws)? If you send me your e-mail address, I'll be more then happy to send you some examples and ideas.

rlbate
[email protected]
 

patmelad

Starting to get Involved
#10
I am trying to figure out what to do. We were written up for excluding design and development. We outsource all design function but we do own the product and also have all of the design records which we maintain. What is the best way to approach this. I cant seem to find anything that applies to our situation.

any help would be appreciated.
 
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