What exactly does a Validation Engineer do? 1

[vonsteimel]

Greetings,
I was wondering if someone could enlighten me on what exactly it is that a Validation Engineer does?
I get the whole IQ, OQ, PQ concept but how does one actually go about it?

How would you Testing Operator and/or manufacturer documentation for conformity?

Or how would you validate a set of injection molds for their ability to create parts in adherence with the tolerances?

Are they essentially for supervising the implementation of change whether revising a production line or installing a new piece of machinery?

Can anyone shed a little light here?
Thanks,

VS

 

[desertfox]

Hi

Try this link

http://education-portal.com/article..._Job_Description_Duties_and_Requirements.html

 

[tbuelna]

In almost every industry, there is heavy emphasis on using controlled manufacturing and quality assurance processes to ensure a high quality end product. Every step in the process of designing and manufacturing a product is performed and validated using a controlled and defined approach. And if this system is followed it works very well.

With your example of validating a set of injection molds, there are many steps along the way to validate that the deliverable product conforms to the customers requirements. First, the engineers who design the tooling should have an established procedure for verifying the documentation released to manufacturing conforms to the customer's requirements. Manufacturing should have an established process to verify that the tooling they produced conforms to the engineering requirements. Your job as a validation engineer is to verify that a first article inspection meets both the engineering and customer requirements. Things like injection molds are often qualified by checking a certain number of parts made from the mold. And the mold itself is not inspected. Initially, a larger percentage of parts made from the mold are checked, but over time the percentage of parts checked gets smaller. As long as the occasional sample part checks out, the mold is assumed to be in good shape.

Of course, with QA processes like ISO 9000 one important function of a validation engineer is to compile statistical data of product quality, and then use that data to provide feedback to engineering on ways they can reduce costs or improve quality.

I'm a design engineer, but I'd be the first to tell you that a good manufacturing, process or validation engineer is worth their weight in gold. Consider what it can cost a company to recall and replace tens of millions of products simply because there was a tool or process that produced non-conforming parts. The work of QA engineers is greatly under appreciated.

 

[SomptingGuy]

One activity that you might get involved in is Statistical Process Control, described quite well by

http://en.wikipedia.org/wiki/Statistical_process_control

I was working as an intern for a manufacturer of electric machines once and got involved in introducing SPC to the process of machining the bearings. The metric was bearing diameter and it didn't take much analysis to find out that the process was not under control - the variance was not normal/common. It transpired that the design tolerance had been "relaxed" (ignored) over time, otherwise the motors would jam. There was quite a stand-off between the two camps when this came to light (change the tolerance vs redesign the fixture). I suspect these things are common in this line of work and the guy who points out the problem isn't necessarily everyone's favourite person.

The actual validation part requires an appreciation of statistical variation and will involve measuring parts hot off the line, often getting hands dirty to expore the process producing the variation.

(Note: An unfamiliar person that looks like management, wandering around a shop floor with a clip-board, interfering with parts, can be mistaken for a bringer of bad news.)

- Steve