Dan, please correct me if I am wrong, is the point it depends what requirement you are aiming to verify. The simple example you highlighted can be verified by review. However, a couple of examples that probably can’t
WRT ISO 13485 the current version does not go into that level of detail. However it is believed that ISO 13485 3rd edition due to be published early 2016 will provide more detail regarding design verification
Original Message:
Sent: 08-20-2015 19:42
From: Dan O'Leary
Subject: Use of prototypes for Design Verification and Design Validation
I usually start any discussion of design verification with Warning – Heresy Alert!! My recommendations are not in line with current thinking, and, I expect, is the genesis of your question.
You say that you go by the “rule that Design Verification testing needs to be conducted on final design equivalent devices”. I disagree that this is the appropriate rule. First you don’t, necessarily, need to do conduct design verification testing, nor is there any requirement that when you choose testing it must be from initial product units. Recall the question answered by design verification; does the design output meet the design input requirements. There are many ways to do this including document review, comparison with previous designs, and alternate calculations.
Here is a simple example of “document review” that involves neither testing nor initial product units. The design input is “The color of the molded plastic case must match the corporate branding document for color, i.e., Pantone xxxxx. The design output is a drawing that defines the molded plastic case, and, in particular, specifies the color of the case as Pantone xxxxx.
In design verification I read the input and locate it in the associated output. If they align, the design verification is successful. If not, there is a nonconformance that must be resolved. Notice that, in this simple case, I never had to produce a molded plastic case. The results would state how I plan to perform the design verification, the identification number of the design input, the identity of the drawing (number and revision), and the location of the color information (e.g., Note 3, feature in Zone D5, etc.).
The recent trend confuses manufacturability with design verification. This leads them to make “production” units, invoke elaborate formulas for sample size, etc. In many cases, this is not necessary, ergo my heresy.
To continue the example, assume production of the molded plastic case is an outsourced process. The drawing (design output) moves to purchasing, is approved as a document under 820.40 and becomes purchasing data under 820.50(b). Supplier management identifies and selects a suitable supplier under 820.50(a).
Supplier management issues a purchase order for the molded plastic case. The supplier produces and ships them.
In parallel, the responsible person sets up the receiving acceptance activities under 820.80(b). In this case, the receiving inspection document requires product verification for the case, defines the verification method, and the number to verify (100% of all units received, a sampling plan, certificate of conformance, etc.)
In the end we know a few very important things:
a) The design is correct, based on the design verification in 820.30(f)
b) The supplier requirements (purchasing data) are correct based on the purchasing data approval in 820.40
c) The material received from the supplier and put into stock is correct based on the incoming acceptance activities in 820.80(b).
I’ll address Design Validation in a separate post.
------------------------------
Dan O'Leary
Swanzey NH
United States
------------------------------
Original Message:
Sent: 08-20-2015 16:40
From: Andrew Rodenhouse
Subject: Use of prototypes for Design Verification and Design Validation
Fellow RAPS members,
I would like your opinion on how "final" devices need to be for Design Verification testing and Design Validation testing. I have always gone by the rule that Design Verification testing needs to be conducted on final design equivalent devices and that Design Validation testing needs to be conducted on final design and process equivalent devices, and any differences in the design or manufacturing process between the final marketed device and the devices that were tested will need to be documented and need a justification why the difference don't impact the testing.
In 21 CFR 820.30(g) it requires the use of initial production devices or their equivalents for design validation.
Does IQ/OQ/PQ of equipment need to be completed before building Design Validation units?
Is there any similar regulation for Design Verification units?
What is the expectation of a manufacturer when justifying equivalence?
Are there any requirements in ISO 13485 regarding this issue?
Thank you for your help,
------------------------------
Andrew Rodenhouse
------------------------------