Validation Vs 100% inspection

Hedgecutter

I had an interview for an associate engineering role last week. The engineering manager asked me about the cost effectiveness of validation over 100% inspection.

I answered as best I could, I assumed that if your manufacturing med devices you'll have ISO quality management and FDA approval where needed, this requires validating your process (i think). 100% inspection need people or equipment to measure whats manufactured.

I not sure if my answer was right, I tried an educated guess. I have a second interview and would appreciate someone with experience in this clarifying which is more cost effective, validation Vs 100% inspection?

Thanks

CatFromHue

I'm no expert but assuming it's either one or the other, as in no regulatory rules apply, then I would have said validation is more cost effective.

If you rely on 100% inspection you've little controls over what is actually manufactured, you're only measuring the final product. Who know's how many will be within spec so there'll be a cost for rework/scrap, plus the cost of actually having each product inspected.

If you validate the process then you have controls over what's actually being manufactured and so your final product should be more within spec. This will cut down on rework/scrap and you won't need the same inspection staff.

The process will only have to be validated once, and then monitored, whereas you will continuously need a larger number of staff for 100% inspection.

That's just my opinion though.

If you got a second interview you've done something right 😁

Hedgecutter

Thanks. 100% is mad in my opinion but I suppose it depends on what the product is. If the product has a lot of in process checks, and a quick cycle time 100% would be tough going. A simple product with a couple of in process checks might work. Still have to pay someone to stand and measure.

Hijpo

Also, depending on how quality critical an inspection is, one person's fail may be another person's pass. Validation should ensure repeatability.

I guess in terms of the initial cost in time and money the validation would probably be more expensive but in the long run would prove to be more cost effective.

Hedgecutter

Ya good point. Have anyone of ye experience of a second interview? I'm meeting the engineering director and HR director Monday. Any advice would be appreciated

Hijpo

I guess the theme depends on the field of engineering, is it process engineering, automation, validation? Some will involve problem solving and debug, others might focus on testing methodology and metrics.

My experience with interviews is that it's like an aptitude test, you can't really prepare for it just answer the questions put to you as best you can, with examples if possible.

If you dont have examples try put yourself in the situation and step through what you would do. It will get across how you think about stuff and how your mind works which is just as important.

Hedgecutter

https://www.boards.ie/discussion/comment/119376339#Comment_119376339

Its an associate engineering role. I have 26 years experience in manufacturing, as a GO and process technician, but only qualified as an engineer in 2018. Due to the pandemic I haven't worked since 2019.

Hijpo

Isn't associate engineering a level though, rather than a particular area of engineering?

Hedgecutter

Ya it would be similar to graduate level i think

Hijpo

So is the role process or validation or automation etc etc

Hedgecutter

https://www.boards.ie/discussion/comment/119376430#Comment_119376430

This is what was sent on to me.

Key Responsibilities:

Key responsibilities will include (but are not limited) to the following:

 Actively participate in cross functional teams and value stream initiatives to meet company goals.

 Represents the company in customer interactions including customer visits in a professional, constructive and

commercially aware manner.

 Ensures that customer expectations are managed and met in all areas of business interaction.

 Works with Customer Services, Sales, value stream teams to facilitate professional and timely

delivery of information relating to quotes, orders, deliveries, complaints and other queries as they arise.

 Carries out day to day engineering functions including but not limited to:

o Process characterization

o DOE

o Production support

o Validations

o FMEA

o Problem solving

o Statistical analysis

o Tooling management and design

o Equipment purchase, commissioning and installation

 Upgrade of current, and the development of new equipment and processes including tooling, jigs and fixtures

 Project Manage, co-ordinate and execute customer development projects if assigned.

 Validation and development of manufacturing processes including materials and processing technology.

 Identify and implement improved processes which will eliminate waste and deliver a more efficient and

effective commercial result.

 Take responsibility for new equipment purchasing, installation and commissioning.

 Carry out validation work in accordance with the appropriate FDA and ISO regulatory requirements

 Work in project teams to develop new processes and deliver new products to the Manufacturing team.

 Where possible, provide technical support on new technology and process development across the plant with

an emphasis on supporting the development of robust manufacturing processes.

 Become proficient in the relevant manufacturing processes so that the incumbent has a strong understanding

of the factors which will have an effect on qualifying manufacturing processes.

 Ensure full compliance with regulatory requirements.

 Ensure Quality and EHS policies and procedures are adhered to at all times.

 Drive CIP project.

CatFromHue

No one gets an interview unless the company is interested in them, and no one gets a second interview unless the company is interested in them. So they're interested in you.

I'd go over your CV and just review what you know. So if you say you've studied statistics, which is on their job description, spend some time going over what you know already.

Hedgecutter

https://www.boards.ie/discussion/comment/119376526#Comment_119376526

True

CatFromHue

Probably too late now but you could ask the Engineering Manager what they thought.

It would show your interest at the least.