Understanding Quality Objectives, Metrics and KPI

[SGquality]

I am here again -

I know that Quality Objectives come from the Quality Policy but need help in understanding the terms Quality Objectives, Metrics and KPI.

Could someone give me an example clarifying the above terms ?

 

[prekajski2]

Re: Pls help me understand Quality Objective, Metric and KPI

Its not a big deal at all.

Metrics is just another word for mesaurable. Like in school: someone gets A someone an F. So the idea is the same: you have to find way to measure process. For example: how many reworks this week ? Is it more than last week ? Is it more than targeted ? Or less ?

KPI is key performance indicator: like when you drive a car you know speed, rpm, temperature of motor, oil and petrol level.
It is the same for company: how many goods sold, how many scrap, how many customer complaints...
According to these KPI you can "drive" your company. Are we good, are we bad, what is the problem,...

 

[SGquality]

Re: Pls help me understand Quality Objective, Metric and KPI

Its not a big deal at all.

Metrics is just another word for mesaurable. Like in school: someone gets A someone an F. So the idea is the same: you have to find way to measure process. For example: how many reworks this week ? Is it more than last week ? Is it more than targeted ? Or less ?

KPI is key performance indicator: like when you drive a car you know speed, rpm, temperature of motor, oil and petrol level.
It is the same for company: how many goods sold, how many scrap, how many customer complaints...
According to these KPI you can "drive" your company. Are we good, are we bad, what is the problem,...

Thanks for your practical explanation. If I have to align my objectives with metrics and KPI below, would this be right ?

Quality Objective - ensure 100 % compliance to Customer requirements

Metric - Critical Observation

KPI -

1. Perform Internal audits per scheduled
2. No critical observations in customer audits
3. No finding in ISO audits

 

[Big Jim]

Re: Pls help me understand Quality Objective, Metric and KPI

There are several parts of ISO 9001 that apply to objectives, metrics, and KPI.

Cutting to the chase, you missed 8.2.3 and 8.4.

8.2.3 says you need to monitor, and measure when applicable, your processes. This is a repeat from 4.1 where the process approach is introduced. The processes they are talking about are your business processes or core processes, and defined in your explanation of the interaction of processes (4.1 again, and 4.2.2 pointing out that this explanation needs to be part of your quality manual).

Every company is likely to have different names and different alignments, but some typical core processes are quoting, planning, purchasing, production, quality, shipping/receiving/inventory, and management.

You already know that the quality objectives need to be set at relevant levels and functions within the organization from 5.4 where quality objectives are introduced.

What are those relevant functions and levels? Your core processes. This is in keeping with 4.1 and 8.2.3.

So the last topic here is 8.4 which provides you with a big hint about what appropriate objectives can be. 8.4 says that you need to determine, collect, and analyze data that helps you determine the health of your quality management system and aid in determining how to improve it.

Now here is the most useful part. 8.4 lists four specific topics that need to be included in the analysis of data: 1) customer satisfaction 2) product quality 3) process performance (an excellent overall measure of which is on-time delivery) 4) supplier performance.

So do yourself a big favor and allow your quality objectives to serve multiple duty. Choose objectives that align with 8.4. Align them with your processes and they become KPI metrics to fulfill 8.2.3. So it could look something like this:

quoting - customer satisfaction
planning - on-time delivery
purchasing - supplier performance
production - product quality
quality - product quality
shipping/receiving/inventory - on-time delivery and/or supplier performance
management - customer satisfaction or perhaps all four topics

 

[SGquality]

Re: Pls help me understand Quality Objective, Metric and KPI

Thanks Big Jim.

My question was to have better understanding of these terms - my organization has come up with lots of statements so I am trying to figure out how to categorize those properly into Objectives vs Metrics vs KPI.

 

[prekajski2]

Re: Pls help me understand Quality Objective, Metric and KPI

Thanks for your practical explanation. If I have to align my objectives with metrics and KPI below, would this be right ?

Quality Objective - ensure 100 % compliance to Customer requirements

Metric - Critical Observation

KPI -

1. Perform Internal audits per scheduled
2. No critical observations in customer audits
3. No finding in ISO audits

Thats fine, but my opinion is that these targets are too high

 

[silentrunning]

Re: Please help me understand Quality Objective, Metric and KPI

I agree. Admirable, but probably not attainable.

 

[Ronen E]

Re: Pls help me understand Quality Objective, Metric and KPI

Thanks for your practical explanation. If I have to align my objectives with metrics and KPI below, would this be right ?

Quality Objective - ensure 100 % compliance to Customer requirements

Metric - Critical Observation

KPI -

1. Perform Internal audits per scheduled
2. No critical observations in customer audits
3. No finding in ISO audits

I agree that setting "zero"-type objectives (hypothetical example: "No customer complaints") is likely to be unrealistic, and is also less useful in translating the objectives into daily life practices. I prefer setting a realistic threshold and aiming to go below it. If you succeed, you can lower the threshold next year. You will look at your performance vs. objectives during management review.

In the medical devices industry, the relevant section would be ISO 13485:2003 s. 8. The terms "Metrics" and "KPI" do not appear in this standard. The relevant term is "Measurement" (in the context of processes and organization performance). Basically these are all different ways to say the same thing. Your policy would be usually very general and high-level. Your objectives would be more specific, but not necessarily quantifiable. Your measurements / metrics / KPI make sure that all this is usable and practical, i.e. they should be specific and measurable in practical terms.

Example:
Objective - High level of compliance with customer requirements
Measurement / Metric / KPI - number of noted findings in customer audit (this is just an example, you will probably need several metrics for the above objective)
Target - Average number of noted findings less than <X>

Cheers,
Ronen.

 

[shallowmike]

Re: Pls help me understand Quality Objective, Metric and KPI

Hi Ronen,

May I just intrude on this thread as I have a related question re objectives. I recently audited our Asian division and couldn't find anywhere in the quality manual regarding objective statement. They said that they have KPI's in place and these are the objectives.
I disagreed saying they are metrics to achieve objectives.
My question is should there be present in the quality manual objective statements?

 

[Ronen E]

Re: Pls help me understand Quality Objective, Metric and KPI

Hi Ronen,

May I just intrude on this thread as I have a related question re objectives. I recently audited our Asian division and couldn't find anywhere in the quality manual regarding objective statement. They said that they have KPI's in place and these are the objectives.
I disagreed saying they are metrics to achieve objectives.
My question is should there be present in the quality manual objective statements?

Hi Mike,

Did you audit them to ISO 13485:2003?

4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
...