Design Procedure and Safety Issues

[Chickenlips]

We recently set up our Design Procedure which includes a Project Checklist for the designer to use to ensure that all items are addressed during the design process (inputs, outputs, validation, etc.).

Up until now, we have designed and manufactured electronic items that had no impact on safety for the end user. We are now entering into Contract Design and Manufacturing, and we are finding that some of these things have impact on the end user safety. So the question was raised, do we want to add a "Safety Review" bullet on the project checklist, so our Designer can check off that it is required, or not applicable? Our worry is that if we sign this "N/A" and an end user gets hurt, will we be liable, or is the company that we were contracted by responsible for verifying that the product was safe? Can we have the company that we are doing the design work for sign a liability waiver of some kind?

Any help would be greatly appreciated!

Thank you! Becky

[db]

Wow Becky! Talk about a can of worms. Here is my take. The question you are asking has two answers. One is practical in nature, the other is political. It makes sense to include the bullet from a practical standpoint because you want the engineers to be alerted when a potential safety issue is involved. The political aspect is you don’t want to open yourselves up to a lawsuit later.

Your legal department may have the final say on this, but my recommendation would be to include the bullet. If we look deep enough, we will find that anything can be blamed for some sort of injury. I think the risk of not identifying a safety issue has far more potential implications than the opposite.

[Angela-2007]

I believe one of the rules in business is "protect thyself" Use the bullets and ask the companies to sign waivers. When it comes to lawsuits there is never too much coverage.

Angela

[David Mullins]

Instead of a safety bullet (unless I'm not fully understanding your definition) couldn't you have a standard risk assessment section in you project plan that covers items like safety, as well as numerous other risk categories like political, timing, scope, related projects, resources, financial, industrial relations, cultural, etc, etc.

Generally project managers aren't safety experts and really need some clear "tick and flick" guidelines to lead them through the minefield.

A risk management matrix could also be used to grade the record assessments of likelihood and impact, as well as mitigation measures / treatments and monitoring and control methods, as well as documenting who will be responsible during the project.

If I had an insight into what industry, process types, etc., I could give a more meaningful answer/examples.

[M Greenaway]

FMEA in other words ?

[Chickenlips]

I have brought up using a FMEA as a tool to do risk assessments, but this company has never used a FMEA before, and the response I got was less than positive, because they don't understand the use of FMEA's.

This area gets kind of tricky for us, because we were contracted by a company to design and manufacture a component of a larger assembly. We can only test the design in-house, not when it's fully assembled. Does this mean that the customer is responsible for the risk assessment of the component in it's final assembly?

We are in the agriculture industry, and we are designing and manufacturing controllers for ag equipment, such as mixers, balers, etc. We design the electronics portion of it, as well as the housings, power cords, etc. Up until now, all of our products were additions to mixers grain carts, but had nothing to do with the control of the farm equipment, but some of our new business does. So this is a completely new area for us. I want to make sure that our designers are paying attention to these things.

I am thinking that we will add the Safety assessment to our Product Design Checklists, and it may also be wise for us to have some kind of liability waiver, holding the customer responsible for performing the final risk assessment on the completed assembly?

Thank you for all of your help!

Becky

[db]

IMO, the FMEA is one of the most powerful tools available. Unfortunately, it is also one of the most misunderstood and abused tools. With this in mind, two potential stategies.

1) contact your local manufacturing assistance center (nearby college, known training company, etc) and have them provide a training class on the FMEA. This should take some of the apprehension away.

2) talk with your customer. In many cases, they are even more aware of the safety implications of your product, and will often provide someone to assist you in developing your FMEA. They do this because it also shows "due diligence" on their part and can become valuable should the product cause injury.