Design and Process Validation - Different?

W

Woodray

#1
Cant differentiate the two. Anyone knows if they are different and why?

Also a standard copy of design validation SOP would be helpful. Although validation sop is device specific, I am trying to make a general validation SOP and then a WI for a specific device. Appreciate any advice and examples

Thanks
 
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yodon

Staff member
Super Moderator
#2
Different as night and day, for the most part.

Design validation falls under 7.3.7 and the goal is to demonstrate that the "product is capable of meeting the requirements for the specified application or intended use." In other words, does the product meet the user needs. (Typically a product has defined user needs which are validated - versus system requirements which are derived from the user needs and are verified).

Process validation falls under 7.5.6. The focus is on manufacturing, applicable to "processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered." The goal is to demonstrate "the ability of these processes to achieve planned results consistently." So, can you build the product consistently to meet specifications.
 
W

Woodray

#3
Thanks for clarifying. Would you happen to have a standard set of procedures for design validation.
 

John Broomfield

Staff member
Super Moderator
#4
Cant differentiate the two. Anyone knows if they are different and why?

Also a standard copy of design validation SOP would be helpful. Although validation sop is device specific, I am trying to make a general validation SOP and then a WI for a specific device. Appreciate any advice and examples

Thanks
Woodray,

First we verify that prototype process, product, service conforms to the design information (spec/dwg).

Then we know what we are validating.

We validate the prototypes by testing them to see which of them fulfills the needs of the customer (product or service) or results in a repeatable, reproducible, effective process with affordable operators (competences).

Several iterations may be necessary but always verify before validating.

The customer or their reps (at a representative level of competence) are usually involved in the validation of their products and services and of course services involve the customer in the service delivery processes. Selecting customers who are too smart or dexterous may invalidate the testing so make sure the selection criteria are a design output.

Mistake-proofing use of the product or operation of the process may also be included to improve safety and to reduce the cost of poor quality.

You may find that your colleagues already do this and it would be better to capture their procedures as they are instead of imposing something you’ve built from the internet.

Sorry, all my examples belong to my clients but you may find this site useful.

John
 
W

Woodray

#5
Thanks John. I am a start up and building my QMS from scratch, examples can help to save a ton of time. Cant afford to buy them. I only need the procedure part for the methodology. Cheers
 
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