Design Validation According to § 820.30 g

Hi Don and Marc,

According to § 820.30 g. The results of the design validation, including identification of design, method(s), the date and the individual(s) performing the validation shall be documented in the design history file.

Does the method(s) mean statistical techniques such as acceptance sampling plans, analysis of means, analysis of variance, capability studies, design of experiments, chart control etc.

Would it be sufficent to say that you have used the capabilty study as a method to validate a specific process. If not then I assume that one has to refer to an international/national standard regarding capability or write an SOP. How about making a refernce to an article on how to conduct a capability study or just telling an FDA inspector that the person is trained in that method an show him/her the persons training record.

[Don Winton]

Validation: confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled and establishing by objective evidence that device specifications conform with user needs and intended use(s).

Would it be sufficient to say that you have used the capability study as a method to validate a specific process.

The standard does not require a specific method fro validation, only validation and objective evidence. The answer is yes.

Usually, you would follow these guidelines for validation:

Establish that the designed equipment has the capability of operating within required parameters;

Demonstrate that controlling, monitoring, and/or measuring equipment and instrumentation are capable of operating within the parameters prescribed for the designed equipment;

Perform replicate cycles (runs) representing the required operational range of the equipment to demonstrate that the design has been operated within the prescribed parameters for the design and that the output or product consistently meets predetermined specifications for quality and function; and

Monitor the validated design during routine operation. As needed, re-qualify and re-certify the equipment.

How about making a reference to an article on how to conduct a capability study...

I would suggest that the objective evidence be on file for the validation results. From the Small Business Compliance Guide: In particular, personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions. You may want to see http://Elsmar.com/pdf_files/CPK.pdf for more info on capability studies.

Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

Regards,
Don

[Kevin Mader]

Monica,

Don or Marc are probably better sources on this, but I'll take a crack at it. Your Device History Record must contain the information as required by your Device Master Record. As I understand it, the DMR acts as your Control Plan. If you have qualified your method, or an operation, a record of this should be in the DHR file. I would be looking for a statistically proven qualification myself (i.e. the statistical tools you have listed). Saying so without the proof would not be acceptable to me.

Guys, am I close on this or have I muddied the water? Back to the group...

Don got to it one minute before my initial post.

[This message has been edited by Kevin Mader (edited 03-12-99).]

[Don Winton]

Saying so without the proof would not be acceptable to me.

I agree Kevin. I would be looking in the Design History File for objective evidence of validation.

Don got to it one minute before my initial post.

Yea, nothing like timing.

Regards,
Don

Product specs is design input; and procedures,test reports, drawings - design output.
Design verification or validation is the process that establish and document that design input corresponds to design output- at various stages of the design process, depending on what aspec of the product or manufacturing process is being verified. For example, safety and reliability testing must be done later in design process using prototype or finished product.
Once the pilot run have been verified, the manufacturing process can be validated and documented, and all the documentation that was initiated during the design output stage can be finalized.

I think that you need a clear division between design output and design input documents.

Validation plan might include:
1. Performance test plan.
2. Enviromental test plan.
3. Clinical test.
4. Reliability test.

[Kevin Mader]

Don,

I'll take second (LOL)! I'm good with that.

Mike,

Good points on the stages of design validation. As with any good design model, you need to verify and validate that the design output meets the design inputs periodically through the process. The same certainly exists in the automotive world.

Regards,

Kevin