Will these Quality Objectives cover the Product Requirements?

[jzengj]

Hi,
I'm currently working together with the management of my company to better define our quality objectives. One of the ISO 13485/9001 requirements for the objectives set is that they should cover product requirements. The objectives we have are:

1) Meet customer or regulatory requirement(s) and customer's satisfaction
2) To improve project schedule adherance and ensure project completion within budget

Will these likely be sufficient to cover the product requirement?

 

[Big Jim]

You really have four or more objectives here. The first part of #1 is the main one that deals with product quality.

It helps greatly to keep from having complex objectives. Have a few more and keep them separate, instead of making them compound.

How are you going to measure meeting customer and regulatory requirements? Some typical measures are warranty returns (pretty much a big no-no in medical devices), first pass yield (how many items make it through final inspection the first time without re-work), scrap rate, rework rate, both as a result of final inspection and as a result of problems found at any other inspection point.

Some overall guidance on coming up with objectives are that the data is easy to gather and the results are useful. Element 8.4 provides some guidance on what to measure as well, where it tells you to determine, gather, and analyze data that tells you the health of your quality management system and aids you in making improvements. It then goes on to say that there are four topics to cover 1) customer satisfaction (not a topic for medical devices, but a topic for ISO 9001) 2) product quality 3) process performance (often measured by on-time delivery), and 4) supplier performance.

 

[Tara Monson]

Those are a great start!

I agree with BIG JIM. You really want something you can measure so progress can be tracked.

EXAMPLE:

Your objective, "Meet Customer Satisfaction."
Restated, "Obtain 75% customer satisfaction on Customer Satisfaction survey."

On-time delivery..."Meet an OTD rate of 90%."


Those are just some examples. You want to have a goal that is measurable.

Good luck!

 

[Mallya]

I believe u have put forward draft proposal, apart from being complex, they are not SMART, Importantly make sure they are measurable, time frame, realistic and achievable depending with u situation on ground. Check Tara's examples on previous post.

Regards

Benny

 

[Hodgepodge]

You can track the scrap rate of manufactured product (how many parts manufactured meet product requirements?). This is something that can be measured objectively.

 

[jzengj]

Thank you all for the replies! So can I say only this objective "Meet customer or regulatory requirement(s)" is the one that deals with product requirements?

What i also gather so far is that the objectives have got to be measurable. We do have measurable targets for each year, but our practice is have targets written into a separate document, while we define the objectives within the QM. However, the one issue we are facing is finding the right data to measure, as our product usually stops at the design transfer stage and they are varied being of research nature.

 

[drgnrider]

... One of the ISO 13485/9001 requirements for the objectives set is that they should cover product requirements. The objectives we have are:

1) Meet customer or regulatory requirement(s) and customer's satisfaction
2) To improve project schedule adherance and ensure project completion within budget

Will these likely be sufficient to cover the product requirement?

Thank you all for the replies! So can I say only this objective "Meet customer or regulatory requirement(s)" is the one that deals with product requirements?

What i also gather so far is that the objectives have got to be measurable. We do have measurable targets for each year, but our practice is have targets written into a separate document, while we define the objectives within the QM. However, the one issue we are facing is finding the right data to measure, as our product usually stops at the design transfer stage and they are varied being of research nature.

It looks like what you are creating here are the high-level business goals and then creating more targeted objectives to reinforce those goals, and that your "product" is a design.

Both of your goals can be product-related and have some of the same targets. An 'on time delivery' objective covers both 'Adhering to design schedule' and 'customer satisfaction'; as stated earlier, just need to quantify the target.

 

[jzengj]

Thanks drgnrider! It seems like what I need to do is to quantify the targets better in this case.