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Quality Objectives - Where in the QMS Quality Objectives should be located

#1
How do these particular indicators add value to the QMS, Patrick?

Time to close Corrective/Preventive actions at less than 14 days is, in my experience, naive. A large, systemic issue may require significantly more time, money, people than can be allocated in 14 days (all while the organization continues to operate and meet customer requirements). In fact, my current organization, it can take up to 6 months to close these items, including verification period.

I also disagree with the "number of". It's a double-edged sword, this metric. Sure, no one LIKES to be on the receiving end of a Corrective/Preventive action, but its also important to identify and address them. Some companies put "near misses = 0" as a safety metric, but this ends up resulting in people being afraid of reporting them. The same mentality can occur with a "number of" indicator in quality.

Recurrence isn't too bad, however, you need to be very clear about what constitutes as recurrence. is it the same clause? Same root cause? Same description? Same process? What if Process A has a document control finding and fixes it...and then a few months later Process B has a document control finding? Is this a recurrence?

Your list of internal audit KPIs are more like check boxes - Did we do the audit? Did we do the right number of audits? Did we close all audit issues? How do these speak to the overal health and value of the internal audit system? You could consider "ontime completion of audits" if your set on having a completion metric. You could also have auditee experience results (similar to satisfaction). Rather than have a metric about resolving issues, find a way to capture if results were disputed (i.e., did auditees agree to and understand the value of the finding(s)?)

Management review - Does it really need a metric? In my experience, the majority of your metrics should be addressed and resolved and corrected (where needed) by process owners PRIOR to management review. I'm not saying that management review is a pointless exercise - it can, in fact, add a lot to an organization if done properly and in such a way that it presents a picture of the organization instead of flashing a bunch of charts and graphs and tables that no one quite understands.

Maintenance - These are more operational than traditional quality, but they do at least speak to what's going on down on the floor. I would offer that from a quality perspective, as an example, uptime (% or hours) does not drill down deep enough. it may be good for Maintenance but that's not the story we're interested in. While I applaud the positive slant to the indicator, I'd suggest we flip it over to downtime. The line could go down 30 times in a month for 2 minutes each and then 1 time for 60 minutes. They both equal 1 hour, giving us a total downtime of 2 hours. But so what? Is 2 hours good or bad? Which is more of a concern - the 30 hiccups of 2 minutes or the 1 full-hour session? In a previous life, we acknowledged that downtime was downtime, but we looked at our data and said that we'd focus on getting the larger downtime sessions under control (e.g., any unscheduled downtime > 1.5 hours required a corrective action). After a year of this, we re-analyzed our data and saw that our larger downtime sessions had decreased, so we decreased our trigger for a corrective action (e.g., any unscheduled downtime > 1 hour). We repeated this year over year, tightening our processes and gaining better control.

Calibation - A tracking sheet does not equate to a KPI. What would be more interesting would be the number of times a quality defect was identified and attributed to a piece of equipment being out of calibration.
Hi Roxane, I'm relatively new to Quality. Please can you advise wherein the QMS the Quality Objectives should be located?
 

RoxaneB

Super Moderator
Super Moderator
#2
Hi, Fat Larry.

There is no one "right" answer to this. It really depends on your organization and perhaps even the maturity of your QMS.

For some, they put their objectives in their Quality Manual - but this may not be ideal as (1) that means potentially revising your manual regularly and (2) there is no documented requirement to have a Quality Manual in ISO 9001 any more.

For others, it's a separate document.

And for some organizations, it's incorporated into their planning and strategy, as well as their KPI reporting structure.

Please note that I moved your question from other forum and post, to create this new post in the ISO 9001 group. If ISO 9001 is not the correct standard for you, please let me know which standard you are asking about, and I'll relocate this thread.
 
#3
Our objectives are "officially" contained in our business planning/management review materials. We also cross reference them on some process mapping docs. to ensure we have caught everything and for easy cross reference.
 
#4
Hi Roxane, Golfman25, Thanks for your feeback, they've been very helpful. I've just started at a UK based company which has ISO 13485:2016 certification and the QMS is still very young. The Quality Manual makes reference to the Quality Policy and Quality Objectives but does not refer to them specifically. We have Quality Objectives in the Management Review meeting minutes which the last QA Manager conducted but not all are measureable or stated anywhere else.
 

John Broomfield

Staff member
Super Moderator
#6
Your system/quality objectives should not be hidden away in a manual hardly anyone reads.

You could post them alongside your policy statements and on your company’s website.

Just as process teams need to know what they are trying to achieve they should also know how their process contributes to the fulfillment of the wider quality/system objectives.
 
#7
We have Quality Objectives in the Management Review meeting minutes which the last QA Manager conducted but not all are measureable or stated anywhere else.
Management Review Meetings is a great place to have them. It makes it clear all that 9.1.1 stuff.

Food for thought: a controlled management review meeting form (or agenda, etc.) can be a good method of control, and allows for continual improvement (10) and change control (6.3) should you enhance your process and associated documented information, including the objectives.

One last thing, it is a risk to have objectives in more than one place. They tend to get out of sync and become confusing or is a registrar non-conformance waiting to happen.

Best of luck!
 

RoxaneB

Super Moderator
Super Moderator
#8
I agree that Management Review is a great place to have them, but it is not the only place, especially if the organization wants people to be aware and understand why the organization takes certain initiatives or actions.

I would, however, prefer to have the objectives used in Management Review as a way to help keep the discussion on track and give much of the information presented some context or framing.

From my own experiences, an engaged and inspired workforce often occurs when people understand why things happen. There really shouldn't be much to hide in Quality objectives so why not have objectives and goals out in the open?

As part of our planning cycle, when objectives were determined along with their associated KPIs, we cascaded the metrics down to the team level so that each team could see how they contributed to the achievement (or not) of the objective. Beyond fostering some healthy competition, our team meetings also become an invaluable source of ideas and corrective actions if results were off-target.

I go back to my original response that this is no one "right" answer. It really does depend on the organization and how they wish to use their objectives.
 
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tony s

Information Seeker
Trusted
#9
Since the standard requires an organization to "establish quality objectives at relevant functions, levels and processes", It would be expected that departments maintain documented information of their quality objectives. Typically, quality objectives are established during the planning period of an organization. These objectives are then reviewed periodically (could be done during a management review) to determine whether the efforts/actions are successful or inadequate in ensuring that the objectives are fulfilled.
 
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