Must every Process have a Quality Objective?

Y

yoosuf

#1
Dear Covers,

Clause# 5.4.1 of ISO 9001:2008 requires that Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

Does this mean that each and every process ( core and support processes) should have quality objective(s) ?

Thanks

Yoosuf
 
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somashekar

Staff member
Super Moderator
#2
Re: Quality Objectives

Hi Yoosuf.
The standard sets directions, and does not dictate what has to be done.
So it is necessary that the organization determines and decides which are those core / support process, where a quality objective when set and measured and found meeting the objective, helps the organization to progress towards meeting the quality policy.

In simple terms if you have to be into office at or before 9am per the company policy, then your objective may be to start from your home at 8am, while the objective of your colleague could be to start around 8:45am. These objectives are dependent upon your distance, traffic and mode of transport.
 

John Broomfield

Staff member
Super Moderator
#3
Re: Quality Objectives

Yoosuf,

No. Think more in terms of what top management requires from their management system in context with their quality policy.

Then help TM to explain their objectives to the employees and those who are responsible for resourcing, monitoring, reporting and invoking the necessary preventive action to ensure the quality objectives are achieved.

Clause 8.4 lists useful topics for quality objectives.

As to process objectives take a look at clause 4.1c.

John
 

Big Jim

Super Moderator
#4
The short answer is no, but there is more to it.

You are correct in recognizing that relevant functions and levels are specified in 5.4.1. Just what those levels and functions are isn't defined so for the most part the organization gets to make that determination.

There is an additional term that is becoming more and more prevalent in the ISO 9001 world, even though it isn't specifically in the standard. That term is Key Performance Indicators (KPI). Although the term is not there, the spirit of it strongly is. Strongly enough that KPI is part of what auditors are being trained to look for when auditing. AS9100 auditors are driven to looking for KPI (and/or other things) when filling out the PEAR (Process Effectiveness assessment Report). Some Certification Bodies Workbooks for ISO 9001 have a KPI chart that covers similar ground for auditors to complete.

The basis for KPI being tied to ISO 9001 is from several places in the standard. In 4.1, organizations need to determine what their processes are, how they function, how they relate to each other, the criteria and methods to make sure they are effective, and how to monitor (and where applicable, measure) them.

You are already familiar with 5.4.1 about the relevant functions and levels. There seems to be an attitude that this would be applied to your core business processes.

8.2.3 gets very specific in that it tells you to monitor (and where applicable, measure) your processes.

There also seems to be an attitude that monitoring only without measuring is a rare exception.

Then as an earlier poster noted, 8.4 provides some insight to the types of things to measure. There are four topics that must be addressed. How and if you apply them to your core processes isn't specified. It is not uncommon to create quality objectives that also double as KPI and also fulfill the requirements for 8.4.

Cutting to the chase, what auditors are trained to look for then is some sort of performance data that tells you the health of each of your core business processes.

There is nothing that prevents you from using the same indicator for more than one process. If you have four quality objectives that are based on the required topics for 8.4, you could determine which ones of the four apply to each of your core business processes.

For example, a quality objective/KPI for purchasing might be 8.4 d supplier performance. A quality objective/KPI for manufacturing might be 8.4 b product quality and 8.4 c which is often tracked as on-time delivery. I think you can get the picture.

I realize that this response may raise the eyebrows of some here, but I'm only reporting on what I see.

So the long answer might be more like the Jacques Cousteau universal response of yes/no.
 
J

JaneB

#5
No. Choose the ones that make sense in your organisation.

Avoid the mistake of attempting to set them for processes that are already concerened with measurement/improvement (eg, there's little point in setting metrics /KPIs for the internal audit process for example).
 
K

kgott

#6
Dear Covers,

Clause# 5.4.1 of ISO 9001:2008 requires that Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

Does this mean that each and every process ( core and support processes) should have quality objective(s) ?

Thanks

Yoosuf
Think of it this way Yoosuf. One could argue that the purpose of document control is to ensure that the most up to date information is in the right place at the right time.

You could write that into your 'objectives at lower levels .. ' i.e. into your document control procedure.

The next step is ask what data and from where do we get it, do we need to collect to measure the effectiveness of our document control process.
 

rickpaul01

Involved in HankyPanky
#7
Big Jim is spot on. But some auditors will disagree with this statment. "There is nothing that prevents you from using the same indicator for more than one process."
They would argue that each process will have its own KPI.
 
J

JaneB

#8
One could argue that the purpose of document control is to ensure that the most up to date information is in the right place at the right time.

You could write that into your 'objectives at lower levels .. ' i.e. into your document control procedure.

The next step is ask what data and from where do we get it, do we need to collect to measure the effectiveness of our document control process.
You could. But is it really going to be valuable to do this for document control? I very much doubt it.
 

x-files

Involved In Discussions
#9
Should every procedure have a KPI? What if the auditor asks "How do you measure your process?" or "What are your KPIs for the process?" or "Where are the objective evidences that you measured the process performances (black on white)?"

What KPIs from the procedure are to be shaped and promoted to Objectives?

I saw many sample procedures which mandatory table of contents structure provides "Process monitoring and measurement methods".

We have "Document control" procedure (and many others) in which we measure nothing.

For example (DCP is just example) we can measure number of requests per month, and time from receipt and closing a DC request form.

Further there are two problems in this particular (imaginary about DCP) scenario:
1. We do not have any problems with Document Control process, that's why we are not measuring it, ie recording times diffs etc

2. We'll mix apples and oranges when forming a KPI, if we try to summarize number of requests. We'd rather want to find out what department is lazy to improve it's process by periodically revising the procedures. When I join all numbers into one number, than I haven't got a real KPI, I just got something to satisfy the auditor. On the other hand, not all months in a year are the same, so sometimes we could collect fake information about laziness. In fact vacation was the cause of absence of requests. With all that said, we must provide pretty complex analysis and methodology to calculate KPI.

My question is where is that methodology (event if the methodology is complex as A/B) supposed to be documented? I assume it's 8.4 point of ISO 9001:
a) in the procedure itself, in the appropriate section
b) in a separate procedure, which is a placeholder for all potential methodologies
c) something other

Other question related to this /process monitoring section from a procedure found on internet/:
Process Objective(s): Control QMS documents in an efficient and effective manner that meets ISO requirements
Information or Data Collected: Number of document changes requested per month and average processing time
Review/Report Cycle: QMS Audits; Management Review

Should the process owner of DCP have a special intermediate document where he made a calculation about "Number of document changes requested per month", before he embeds that information into Management Review report?


Best Regards,
Vladimir Stefanovic
 

Mikishots

Trusted Information Resource
#10
Dear Covers,

Clause# 5.4.1 of ISO 9001:2008 requires that Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

Does this mean that each and every process ( core and support processes) should have quality objective(s) ?

Thanks

Yoosuf
No, it simply means that a decision needs to be made as to which processes need objectives set. If they are set, they need to align with the policy and business objectives of the organization as well.
 
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