Must every Process have a Quality Objective?

[JJC1979]

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

Vladimir~

Every process does not need to have a KPI. Only use KPIs to truly measure something that you want to measure (Customer Complaint Closure, for example). Something that is tied back to the product that you supply, is what I normally use as a rule of thumb. First Pass Yield percentage, CAPA closure, etc...those all tie back to the product/service or the service of the product/service.

Also don't make up KPIs that tell you nothing. If the thought is, "so what", the odds are, it is not the most ideal KPI and it will mean nothing to the Management team.

Those are my two cents

JJC1979

 

[db]

I say that every process will have objectives. Not because they are mandated by any standard, but because they are mandated by necessity. The question is: "How does the process owner the process is working?" Each process will have some sort of goal or objective, even if it is informal. And tracking them may very well be informal as well. If I can't seem to find the right employee, then perhaps my hiring process is not working properly. The same holds true for late shipments or quality issues. Quality goals and late shipments may be formal and we may keep pretty good records of those, but the hiring goals... not so much. We may not even be able to agree on what we will be measuring for hiring goals.

If an organization has pain, one of their processes are not working right. We base "working right" on our objectives. Not meeting the objectives results in pain.

Now, let's throw the standard back into the mix. Now, we have a different type of pain. 4.2.1a requires objectives to be documented. So much for those informal goals. What we document, we really need to track. Now, how formal does that have to be? So what do we do? Those important goals, we document and track. Those informal goals are still there, but now they are kept and monitored in secret. So we formally track on-time shipping and quality metrics, but nothing is kept on percent of new hires who successfully make completely through the process and become regular employees.

 

[LUV-d-4UM]

Thank you Big Jim. I found it difficult to audit the effectiveness because most of the processes do not have key performance indicators. Do I give the process a nonconformance against 8.1.1 or 5.4 ?

 

[Big Jim]

Thank you Big Jim. I found it difficult to audit the effectiveness because most of the processes do not have key performance indicators. Do I give the process a nonconformance against 8.1.1 or 5.4 ?

8.2.3 would be the most likely fit, monitoring and measurement of processes.

 

[LUV-d-4UM]

Thank you! I think I was in the identification of what statistic to measure the process.

 

[JaneB]

Yes, of course every process has at least one objective - what it intends to achieve. (Otherwise, why do it?). But not every process requires measurement.
You measure processes where it's valuable to do so and where the results of that measuring will be useful. I'd certainly be measuring whether services to clients (for example) are being delivered on time, whether they met the requirements and whether clients were satisfied with them. All of those are going to yield useful data.
But I would not measure, say, the process for controlling documents or the internal audit process, because measurements there aren't useful. Monitor, yes. Measure, no.

 

[x-files]

[...] Monitor, yes. Measure, no.

Sorry for this very basic question. What is the core difference between monitoring and measurement, in context of process?

Is monitoring the informal way to track/watch something?
Is measurement formalized/shaped monitoring?


Reading the (8.2.3.), monitoring includes the word "suitable methods". If the auditor asks "How do you monitor Document control process?", what should I say or show? (employees never complained about the process, internal audits never detected nonconformance...)



Best regards,
Vladimir Stefanovic

 

[LUV-d-4UM]

THank you Jane.

 

[JaneB]

Sorry for this very basic question.

Nothing to apologise for. Ask away - someone will answer.

Measuring implies something that involves gathering "hard" or specific data, such as temperature, variation, dollars, time to mention a few. For example, if onetime delivery was important for a particular process or system, then you'd expect to measure your deliveries, whether they're on time, and if not, how much they're outside acceptable time, etc.
Whereas monitoring, as you suggested, is less formal, and includes activities such as observing, watching, 'walking around', "keeping an eye on things", etc. it might also involve noting the absence of indicators of problems or failures.
So with document control ( for example), I'd be more inclined to monitor it rather than measure it. Keep an eye out for indicators, such as a lot of references to problems with it from sources such as audits, user feedback, etc. Unless it's a critical element in a system - electronic drawings produced in an architectural practice for example.

In the Standard, you'll notice that it refers to both activities, but they are not interchangeable (although some people refer to them as though they were). Measurement is usually more time-consuming and expensive to do than monitoring.

 

[Mikishots]

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

I don't see why not. Every process has a reason for existing, and every process would have an expected outcome (otherwise, why even bother with it?).