Design process goal for ISO 9001

[Tagin]

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.

Step back and look at 4.4.1c:

determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes

So, ask yourself: how do you ensure effective operation and control of the engineering process? You're probably doing things now that you're just not taking credit for.

It can help to think of it also in terms of your customers: e.g., "we promise our customers an X week turnaround on design", "we work with the customer to ensure the design meets their cost targets", "we want our design to be better than our competitors", etc. Whatever those criteria are that you want to achieve, that is the Purpose of your engineering process and you can then monitor suitable KPI(s) to make sure Engineering is living up to that purpose. Doesn't have to be complicated, just congruent with want you want to actually achieve.

 

[normzone]

"So, ask yourself: how do you ensure effective operation and control of the engineering process? You're probably doing things now that you're just not taking credit for. "

This is a common issue with organizations just getting into dealing with the requirements of a standard - the interpretation of the 'standard-speak' is not well developed yet.

 

[hoda ali]

i think iso 9001 Certification in details

1. Quality Management system
2. Management Responsibility
3. Resource Management
4. Product realization
5. Measurement, analysis, and improvement

 

[Jen Kirley]

Lots of good discussion here.

We have often debated whether goals are needed. The 9001:2015 standard says "...at all relevant functions, levels and processes in the organization." So, ask who in your organization is not relevant? Raise your hand and see what happens.

Still we argue the point. I can only say that while doing 3rd party audits I was forced to require a goal for each process. Our reports were developed in a way that these were required fields. I can guess the CB believed, or was in fact told by ANAB that this was a requirement of 9001:2015.

So the question came down to what was a good goal. I have had this discussions many, many times with clients and my associates here. Since the point of the standard is supposed to be of providing organizations with framework with which to make a robust quality management system, it still comes down to what is best for your organization and the customer. We know that the standard says goals shall be measurable, so the vague "Improve the design process" won't work because how will you know when you have done so? To make useful goals, I suggest 3 considerations:

1) What is the customer/interested party interested in? This could include regulators as well as paying customers. This is your #1 consideration because we need happy customers to thrive, and we need to stay out of costly trouble.
2) What would help you know if you are successfully doing what the customer is interested in? This is where we ask ourselves "What does winning look like?" or, if that seems too obscure, maybe you can ask "What does failure look like?" This is how management keeps aware of the process's effectiveness. That is why these goals, and performance against them, are supposed to be included in management review.
3) What would the people working in the process understand? Process members need to be able to tell if they are succeeding, we call that awareness.

Keep in mind that process goals don't need to always be the same. It can reflect the changing customer interests, challenges in the organization, and new organizational aspirations.

I hope this helps!