Risks of Design

Awe. the wonderful adjustment in :2015,

This standard is so loaded with BS. it is mind boggling that it was ever put through in the first place.

I understand the useless concept of RBT, but come on ! why add it ?

I like bridging the gap of APQP & PFMEA to production, but DFMEA to Quality Planning???

Simple enough if your Quality go with your production Failure mode for this.,

If your design being asked by quality go with your production Failure mode lol...

Just my suggestion.

Me sir me sir!
Paper cuts!
Everyone knows there's nothing worse than a paper cut.
Del

Oooh, I'm going to throw that one in just to see if anyone notices.

Eye strain? Carpal tunnel syndrome hazard?

Cutting yourself while carving your balsawood prototype? 3D printer running amok, and spraying everyone's cubicle with liquid metal?

Shall I continue?

• Local, State and Federal Equipment Standards being met.
• Project being killed
• Design Performance (Produced but doesn't Perform)
• Customer Cancels Project.
• Customer going Bankrupt
• Customer Changes Scope
• Ball of string rolls through room and del chases after it

Perhaps I should include shiny objects & cakes.

Its a shame you can't list as a risk having everyone so obsessed with risk management that not enough stamina is left over for project management or design.

I might try to slip that in as well, (can you tell I don't fully subscribe to the system).

risk of copying other design

Last time I got involved with a 9001 assessment the building near collapsed under the weight of the paperwork.

I hope for your sake the information/evidence system has changed.

This (effort) must be being imposed directly, or indirectly, by bureaucrats headquartered in Belgium...

I don't think it's changed, just become more electronic than paper based.

Time for a Code-exit?...

Past failure recovery successes don't necessarily guarantee future failure recovery time scales as a point of measurement for prognostication, therefore we can promise you anything but guarantee nothing...

And ya'll thought I was a wise guy...,

Well not really a recommendation, haha, more of a "if only" everything could be stated as a standard disclosure...

Also consider these "risks" also vary according to the tipe of product you are designing and it´s intended use.

A simple screwdriver can be a good example: if designed for industrial use, certain risks must be considered.

If the same screwdriver has been designed for surgical use, you have to consider all the previous risks, but also those specific to the intended use (just to mention some) the handle must withstand contact with blood, cleaning soaps, washing machines, ultrasound, sterilization by heat, gas and steam, must provide a good grip being wet, must not react with latex or any material the gloves are made of ... etc etc...

Should you provide more info about your product, we probably may be of more help!

...and what happens when it slips off the screw! Ouch!!!

If it slips off, it is what we can an OOOOPS!

This is not about the product, more about the design process & what could interfere with it.

...and No. 1 on the list: an angry wife at home (or at her job) calling you on the phone constantly.

Associated human frailties...

Our small company is also going through the same issues...Our opinion is that this new update is aimed at large corporations. Small business already having this accreditation will get swallowed up in the bureaucracy or drop the accreditation.

Gladly looking into this thread to see where it leads.

I had contracted with a same 80 employee company that was ASME and was also ISO certified.

They dropped it, just due it did not justify the overhead administrative costs.

We don't have much choice with this, some of our bigger customers will only deal with ISO approved companies.

That's fine,... if your established. just saying,... its tough to have ISO to draw in business.

The processes you have in place don't have to work, or be efficient, as long as everyone can be shown to follow them for the approval process.

That's true, the audits are paperwork exercises, they never actually look at the products.

We had this question raised at a board meeting several years ago. The most startling point made was "did we know that everybody in the design and production department was in a syndicate for the national lottery and how many would retire if their numbers came up?"

That's a good one, we have a similar syndicate here.

Calling in rich is always a preferred settlement over a pension that might not provide beans, and where the pensioner still has to wait another ten or fifteen years to see if he/she lives long enough to collect on it.

You are probably doing a lot more risk analysis right now that you think. Any successful business does risk analysis', the only difference is that you are now being asked to document it. Take a good look at what your current practices are and see if you have any supporting documentation. that will likely be what you need to create, the documentation only.

I thought the upgrade to 2015 would be more difficult, but it appears it is not as difficult as I first thought.

There is an easy way of getting by this "RISK BASED THINKING"

create a " context of the organization chart, preferably in excel.

with Parties involved, potential issues, a risk register and an opportunity register.

If you are part of a small business like I am, proof of thought is all that is required. Auditors cannot audit your way of thinking ! they can only verify that you thought about risk. hence compliance. If you are part of a larger organization, live it.. use it... it will be helpful.and actual risk of designs your initial question asks, think of all that has the potential to go wrong( risk) , and document it. also think of all that will go right ( opportunity ) and document it...

The risk register is basically what he's asking for. what you stated would be detailed enough...

an opportunity register,... I must have been sick that day that was covered....

so,... would you be assigning risk responsibility to the organizational chart?.

This is the best way I can answer that question. ! Make sure you read the last line !

ISO 9001 specifies requirements for the organization to understand its context and

determine risks as a basis for planning. Risk based thinking considers both risks and

opportunities.

The Introduction and Annex A of ISO 9001:2015 provide an explanation on risk based

thinking, including clarification on risk and opportunity concepts. More comprehensive

information can be found in Risk based thinking paper at www.iso.org/tc176/sc02/public.

An audit of risk-based thinking in an organization cannot be performed as a stand-alone activity. It should be implicit during the entire audit of a QMS, including when interviewing top management. An auditor should act in accordance with the following steps and collect objective evidence as follows:

• What inputs are used by the organization for risk and opportunity determination?

These inputs should include the following:

� analysis of external and internal issues

� the strategic direction of the organization.

� interested parties, related to its QMS, and their requirements, also

related to the QMS.

� the scope of QMS of the organization.

� the processes of the organization.

• The auditor should note that the organization has to determine the extent of

documented information needed to provide objective evidence of the application

of risk based thinking. There is no specific requirement in ISO 9001:2015 on how

to document the results of determinations of risks and opportunities.

Very useful comments & an interesting paper, thanks.

Risk of Design has always been legal requirement in the UK. This is why so many companies farm out the design to avoid risk. (Passing the buck to another).

If your design team is external to your company, (contracted in), the design team will have a risk register and mitigations. If it is internal to your company as it may seem, you will need to sit down with the designers and agree all risks in the design and final design use and mitigate for idiots using/installing or utilising your design and product in a final finished product.

You main risk is obtaining all certifications for the designers and all, or any, calculations which may be applicable to the item/proccess/product/part of finished item. It is an arse covering exercise if you want the insurance to be valid.

Start at the design(er) risks, the rest will flow

In-house is correct & this exercise is the arse-covering that you describe.

I once saw a procedure to provide countermeasures for a loss of gravity accident.

Anchor chair to floor.

Add seat belts.

Double sided tape under the keyboard, CPU, monitors and mousepad.

Plastic film covers over the coffee cups

Pen and pencil lanyards.

Zero G backup toilet.

The list goes on.

Don't forget, "What we have here, gentlemen, is a failure to communicate."

No wonder government coffee pots on the vomit comet cost over $1000.

Sheesh...

the procedure in question was generated in response to the NRC requirement to develop procedures for nuclear plants for credible accidents. The procedure was written by engineers as a joke and was never intended to be used.

However, when the time came for procedures to be submitted, a secretary found a copy and inadvertently shoved it into a stack for signature by the plant manager at Rancho Seco. He dutifully signed everything in the stack and submitted them to NRC.

NRC was not amused and was inspired to mightily fine the utility for "not taking the requirement seriously".

At the time, I worked at Trojan Nuclear Plant in Oregon and one procedure we submitted for that exercise was operation and recovery from a train car derailing across the Columbia River in Washington and releasing a large plume of chlorine gas, which would drift across the river and gas the plant. A couple of years later, we ended up using the procedure when a train derailed on the Washington side of the river and released a large plume of chlorine gas which drifted across the river and gassed the plant. Who'da thunk?

Now THAT is what I call realistic. The best one I ever came up with was a simultaneous release on I-27 of several 1 ton cylinders of chlorine with a giant hole appearing in our liquid ammonia tank at our combined cycle plant. Any ugly green cloud with abnormally high toxicity is expected in such an event, and we even predicted a plume that snaked around some streets downtown.

My silliest that actually led to a change was related to emergency breathing apparatus. I noticed that the oxygen bottle on the EAB was mounted valve down. We had just changed to 4000psi aluminum/composite tanks and the failure went like this:

Emergency declared and the teams go into containment in EABs. One slips on a banana peel and sits down hard, snapping off the valve stem. The question is, how high will he jump?

Impulse thruster calcs said he could clear the top of the 550' tall cooling tower, although in actual fact he would go into a high speed somersault fast enough to centrifugally fail all four limbs and make a mess out of the new paint job.

There actually was a change to the EABs. They added a valve guard made out of 1/4" plate steel to protect the valve.

For a while I envisioned test firing emergency crews out over the Columbia River to see how far they would go. Shooting off oxygen bottles by sledgehammering the valves is fun.

Were those Scott air packs? I have trained on them in class A Hazmat suit. The idea of losing all four limbs to a spin out is frightening, to say the least. Being catapulted out of the plant over a river (and landing on dead tree branches, or jagged boulders) does not really sound like fun and games either.

Biggest danger in the design process is people changing the spec'.

Del

It's not called changing the spec, it's called not knowing what you want to start with¡¿♫♫☻

....but...."you cain't always git what you wa-ant"..."you cain't always git wat yu wa-ant".

Then there are the rest of the lyrics:..."you might get just what you need!"

Knowing what you want and what you need are usually two separate things.

https://www.youtube.com/watch?v=j7leQB_Oe_k

One of my favourites so here it is for you.

scope creep

The whole purpose of the ISO 9000 series is to make you aware of everything you do, and to adapt as things change.

You will never cover all the risks, so rather than try to cover then all, put down the ones you know about, come across and those that have had an impact thus far. The Auditor will then assess your QMS, and either ask for you to change something or accept it.

What you must remember is that you can change anything in your QMS at anytime, all you need is a Management Meeting, write out the agenda, if there is a NCR regarding this issue then you deal with it in the meeting. You record the decision made in the meeting, amend the relevant QMS section, issue the amendments and your QMS is now current.

so try not to overthink it, and remember it's your QMS, not theirs, so you put in it what is applicable to you.