Design process goal for ISO 9001

[Austin]

OK the question now is...Did you require KPI's with goals and a review? If you did, then shame on you (self inflicted), if you didn't then shame on him (making crap up).

I did not require those, so I am relieved to say its shame on him. He has his mindset and preferences on certain subjects, I was just hoping this was another one where he was misspeaking about a goal for a process so I am able to converse this with him and can hopefully get both of us on the same page.

Thanks

 

[John Broomfield]

Not sure what you or your auditor mean by design goals but here a suggested objective for your design process:

1. To translate customer needs into specified requirements for our services and products.
2. Verified by customer approval of the design inputs (description of customer needs) and of the resulting specifications per the design plan.

Best to engage the design team in describing their actual objectives. They may want to add a time-based element.

 

[normzone]

This may be an entirely separate issue, so pardon if I go astray here, but this reminds me of a nonconformance I dealt with recently where the Quality Objectives had no stated target level, and some of the "Quality Objectives" did not pass the quantifiable test.

You can assign a target level to the former, but the latter means while it may be a good idea, it's ineligible to be a Quality Objective.

 

[Randy]

This may be an entirely separate issue, so pardon if I go astray here, but this reminds me of a nonconformance I dealt with recently where the Quality Objectives had no stated target level, and some of the "Quality Objectives" did not pass the quantifiable test.

You can assign a target level to the former, but the latter means while it may be a good idea, it's ineligible to be a Quality Objective.

Nothing says objectives have to be quantifiable, they only have to be "measurable", objectives may also be "qualifiable"

 

[normzone]

Thanks [Randy] ... that's a good point. I've always sought measurements I could quantify, but you are correct that it is not the requirement.

In the instance I referred to above, we had no clear method of measurement.

"Never" would be good, "some" or "lots" was bad, and "many" was worse though. But the nonconformance was for not meeting 9001:2015 - 6.2.1 & 6.2.2

 

[Randy]

Was it involving the word "relevant"? If so, it's your decision as to what's relevant for monitoring & measuring improvement (which is all that objectives do, define what you deem to be necessary to improve, provide a starting point and an end point and includes all the happy stuff in between the two).

I know there's more to it than this, but I struggle not to choke fellow auditors that make garbage up, don't really know what they are doing and continually complicate something that is intended for a mom & pop, 10 employee business with 2-3 customers to easily and effectively do.

(The whizzo-bango experts, pip pip proper people are gonna kill me with the next bit)

Oh yes, oh yes I know, big multi-thousand employee, multi billion $ companies are different.....Really? Large or small organizations have the same problems, needs, expectations, and everything else, just to varying degrees and they are....Managing cash flow while meeting expectations to a point that what comes in outweighs what goes out....It's all the same! Objectives are just goals or self defined expectations that YOU determine are necessary to improve areas that you've identified as either weak or identified as necessary to go to the next level (whatever that level is). In this case if you ain't got no problem in design (and the beans are coming out of the pot well cooked), your customers are happy campers, you're jumping thru every little hoop there is (and you're making $$$ to boot) what are supposed to improve upon?

Am I reading this whole thing wrong?

 

[AMIT BALLAL]

His words from the audit report, out of section 4.4.1c.
Evidence: "No KPI's with goals for review." I did have KPI's, but not enough to help with the goal review apparently.

Was the auditor referring to "Effectiveness" measures for the design process (to check whether required output of the process is achieved)?
Please specify the KPIs you had shown to the auditor.

 

[Austin]

Was it involving the word "relevant"? If so, it's your decision as to what's relevant for monitoring & measuring improvement (which is all that objectives do, define what you deem to be necessary to improve, provide a starting point and an end point and includes all the happy stuff in between the two).

I know there's more to it than this, but I struggle not to choke fellow auditors that make garbage up, don't really know what they are doing and continually complicate something that is intended for a mom & pop, 10 employee business with 2-3 customers to easily and effectively do.

(The whizzo-bango experts, pip pip proper people are gonna kill me with the next bit)

Oh yes, oh yes I know, big multi-thousand employee, multi billion $ companies are different.....Really? Large or small organizations have the same problems, needs, expectations, and everything else, just to varying degrees and they are....Managing cash flow while meeting expectations to a point that what comes in outweighs what goes out....It's all the same! Objectives are just goals or self defined expectations that YOU determine are necessary to improve areas that you've identified as either weak or identified as necessary to go to the next level (whatever that level is). In this case if you ain't got no problem in design (and the beans are coming out of the pot well cooked), your customers are happy campers, you're jumping thru every little hoop there is (and you're making $$$ to boot) what are supposed to improve upon?

Am I reading this whole thing wrong?

I agree with what youre saying. I think its safe to say we know what is relevant to our process that makes our customers happy and keep them coming back. Maybe it seems in his eyes we should be jumping through more hoops, but what he is too stubborn to see is we are meeting and exceeding our customers expectations with our design process. I agree with how do we improve on this thing thats working well, dont fix what aint broke.

 

[normzone]

You are not reading it wrong ... but you are perhaps a bit optimistic (I'll bet you don't hear THAT often ;-)

The challenge is that customers are sometimes less than fully satisfied. Evidence of this is in Management Review minutes, and efforts to address those challenges can be ... inconsistent.

 

[Julius123dash4]

I have started the ISO 9001 quality system for a metal fabrication job shop company and in our Stage 1 audit he pointed out we don't have a good goal set for design and measurables for that goal. We rarely do design, but its enough to not be exempt from it. Most of our design is recreating prints or models from customers to fit our system. Maybe 5-10 times a year do we actually start a design from scratch for a customer. So my question is how do I set a goal for something we rarely do? How can we measure something efficiently/easily that we rarely or barely do? Would there be an easy way to track our small design projects like I mentioned earlier by time or something, and if so how would we create a goal off of that?

Anything helps,

Thanks

Hi Austin, Demonstrate that you have control over the design process.
Something in place that ensures you deliver what the customer has agreed with you upon. Tell the auditor thats your goal and you measure it with forms.
The simplest way if your starting from scratch is to create three forms. The first a "customer specifications" form or whatever you want to call it. Use it to capture the dimensions or specifications the customer wants, it can be a questionnaire or anything you like. Its a place to capture all the customers requirements. The second form would be a tracking form, something that tracks how many times you have sent them a draft and the draft number. Making sure you name it something different each time you send a new revision or draft to the customer. The third form is the approval form. The customer references the draft they would like made for them. Thats your design control. It doesn't have to be complicated for it to be effective.
It facilitates the goal of ensuring you deliver what the customer expects and has agreed with you upon.
It negates risk of rework, costs, time and damaged customer perception.
You measure whether its effective based on returns/customer satisfaction and whether the three forms exist with every new draft made. The forms will become a system that serves you.
Just write a 1 page SOP titled Design Control to fomalise it all and thats the simpliest way I would do it.