SBS - The best value in QMS software

Quality Objectives - Is this an audit nonconformity?

Is there an audit nonconformity in the situation described?


  • Total voters
    40
  • Poll closed .
B

Bill Pflanz

#41
Bill,

Thanks for giving it a go. Nice work.

The operative word in your requirement is 'documented.' So, you would expect the finding to include something about the objectives not being documented, but that's not exactly the way you wrote it. It seems that the requirement and finding don't match.

By the way, the objectives for this company are documented, with revision status, approval, and all the other hallmarks of document control.

Craig
One of the reasons that I did not use documented in the requirement is that there are objectives documented, the issue is whether those objectives are specifically the quality objectives.

I agree with Randy about the post being a good exercise. The lead auditor does face these type of decisions when reviewing the other auditors findings. The closing meeting will need to be used to clarify what the finding is so that the organization can decide the appropriate corrective action. It could be as simple as re-labeling the objectives but that should be decided by the company not the auditor.

Bill Pflanz
 
Elsmar Forum Sponsor
O

Old Quality Gal

#42
Observations aren't taken seriously. I stand by my choice for a nonconformity. I see it's "thin" grounds but it is for the better in the long run. I don't see that the standard is adequately addressed with the information presented so far.
Crusader I disagree with your opinion concerning observations. As an auditor if I have raised an Observation previously it carries real weight with me if I come back and find it was not addressed or there was no apparent discussion of what was raised.
If they blow it off and it is still an issue I make sure I get their attention the next time, unfortunately for them. I find most folks do deal with observations especially if the expectation is set and it has been thoroughly explained.
As Management Rep I take them very seriously. We just had our 10 year assessment and before the auditors left the building the CEO had scheduled a meeting the next day to discuss the single observation raised during the audit. At the meeting the next day we acted on the intent of the observation. The auditor had given us good advice ( which we pay them for) and we acted on it.
The emtire company attends the opening and closing meeting so every employee understood what was suggested.
I see your point though. Like my Grandpa said half of working with mules was getting their attention!
Regards,
Mary
 
#43
The auditor had given us good advice ( which we pay them for) and we acted on it.
The emtire company attends the opening and closing meeting so every employee understood what was suggested.

Mary
What? Is this true? Not hi-jacking this thread, but HuH??????:mg:

I sincerely hope that you are not talking of a third party auditor!:caution:

They are not 'paid for their advice', that is a conflict of interest, they should not offer 'suggestions', that the whole company (or anyone else) should hear:nope:

Can you make it clear that this isn't an independent 3rd party auditor you're speaking of..........

Andy
 

Crusader

Trusted Information Resource
#44
As an auditor if I have raised an Observation previously it carries real weight with me if I come back and find it was not addressed or there was no apparent discussion of what was raised.
If they blow it off and it is still an issue I make sure I get their attention the next time, unfortunately for them. I find most folks do deal with observations especially if the expectation is set and it has been thoroughly explained.
Maybe you missed my point? To clarify... The organization may not take the observation serious regardless of how it is explained to them. Unless there is a nonconformity identified (with good reason), the organization has the option to do absolutely nothing. As an auditor, it is also my duty to promote their continuous improvement/effectiveness of their QMS. 5 objectives and only 1 is related to the ISO 9001 Std requirements. To me, that is insufficient evidence. :whip:
 

Randy

Super Moderator
#45
The emtire company attends the opening and closing meeting so every employee understood what was suggested.
That's a pretty bold statement. The entire company attends? I'm at a place right now where there are over 5,000 employees on site alone. It would probably be a bit crowded:lol:
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#46
Not having read every response I'm sure I'll repeat someone...

I would not write a nonconformance because they seem to have defined and communicated their objectives. This is to the letter of the standard.

I suppose I might look at the last managment review minutes and records of customer freedback and determine if I would give an observation.
If they had significant returns, negative feedback, or other customer issues I would expect these to be in the next round of objectives.

If it still wasn't addressed in the next surveillance I might upgrade to a finding.
 

SteelMaiden

Super Moderator
Super Moderator
#47
OK, just a thought....or maybe a question....

How can anyone judge whether or not Improve sales by 40%, 2. Improve profit by 20%, Reduce energy consumption by $1 million, Reduce loss time accidents to 0 and Reduce product rework to 0.2% of total production will improve customer satisfaction without finding out a little about the organization?

A lot of posts have stated that there is nothing in these objectives that show commitment to customer satisfaction and/or product quality. I say that in some instances these can very well be the best opportunities this particular organization could take? Without some background, i.e. I'm not there to see what they are doing, how they are doing it, why they are doing it, I cannot say that there is a nonconformance. Now, if I ever ran across something like this, I would base my answer on the rest of the evidence I had gathered throughout the audit.:2cents:
 
J

JaneB

#48
OK, just a thought....or maybe a question....

How can anyone judge whether or not Improve sales by 40%, 2. Improve profit by 20%, Reduce energy consumption by $1 million, Reduce loss time accidents to 0 and Reduce product rework to 0.2% of total production will improve customer satisfaction without finding out a little about the organization? :
Agree strongly.

Without some background, i.e. I'm not there to see what they are doing, how they are doing it, why they are doing it, I cannot say that there is a nonconformance.
Me neither. It's an interesting discussion, but as has already been pointed out, sometimes hypotheticals don't always make for good test cases. Too many unknowns, too much room for assumption and that worst of all things for good auditing: no evidence, a few very basic facts, and not many of those. Given that, I didn't vote.

Now, if I ever ran across something like this, I would base my answer on the rest of the evidence I had gathered throughout the audit.:2cents:
Yup, me too.
 
J

JaneB

#49
The organization may not take the observation serious regardless of how it is explained to them. Unless there is a nonconformity identified (with good reason), the organization has the option to do absolutely nothing. As an auditor, it is also my duty to promote their continuous improvement/effectiveness of their QMS. 5 objectives and only 1 is related to the ISO 9001 Std requirements. To me, that is insufficient evidence. :whip:
Seems a rather harsh approach to me to make something an NCF just because you believe an organisation may not take something seriously otherwise!. (If of course you have specific experience that this one doesn't, then fine).

Perhaps it depends on your view of the purpose of audit, & whether you use a 'softly softly catchee monkee' or 'hit 'em hard & make 'em conform' approach.

Me, I'd go for an observation first (naturally, depending on the issue, the evidence & the seriousness of the case) which I'd discuss. I'd perhaps need to upgrade to nonconformance next audit if I then found there'd been no improvement and/or deterioration.

In my experience, people respond better to that approach. They also respect & appreciate an auditor who behaves in a reasonable fashion infinitely more than the auditors who adopt a rigidly 'right/wrong' approach. Also, my experience with many companies is that they look at whatever's said in the report carefully, including observations / recommendations as well as an actions/nonconformances (or whatever the particular certifier calls them.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#50
Observations aren't taken seriously. I stand by my choice for a nonconformity. I see it's "thin" grounds but it is for the better in the long run. I don't see that the standard is adequately addressed with the information presented so far.
That really depends on the mind set of the Company (emphasis added). The company I work for takes observations serious just as if the were an NC. Most of the time the observations could lead to an NC, in my opinion.
 
Thread starter Similar threads Forum Replies Date
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
A Quality Objectives 5.4.1 - KPI SOP - ISO 13485 Audit Observations EU Medical Device Regulations 6
E Audit of Exclusions et.al. - Quality Policy, Planning (including objectives), Etc. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Audit Findings: The quality objectives have not been quantified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Quality Objectives and resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
U Examples of Quality Objectives for a Medtech start up ISO 13485:2016 - Medical Device Quality Management Systems 4
V Quality Objectives - ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
I Quality Policy and Objectives examples Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 5
M Specific Values of Quality Objectives Benchmarking 7
Q Quality Objectives Not Met - Resources promised by investors ISO 13485:2016 - Medical Device Quality Management Systems 4
V What plans have been put in place to achieve quality objectives? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Objectives in Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
K ISO 13485 section 5.3 Quality Policy - No framework for establishing and reviewing quality objectives ISO 13485:2016 - Medical Device Quality Management Systems 2
S QUALITY OBJECTIVEs for third party garments factory inspection ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R ISO 13485 Software validation procedure and Quality Objectives Monitoring wanted Document Control Systems, Procedures, Forms and Templates 1
F Quality Objectives - Where in the QMS Quality Objectives should be located ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Farley.0 QMS Sales Goals & Quality Objectives Manufacturing and Related Processes 22
qualprod Annual SWOT for 4.1? I plan to revise quality objectives and strategic route ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Setting Quality Objectives (for the first time) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
V Discussion of ISO 9001:2015 - "Quality Objectives" term ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
S Quality Department Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
K Where in the quality manual do I put our Quality Objectives and our Quality Policy Quality Management System (QMS) Manuals 19
R ISO 13485:2016 - Quality Objectives Regulatory Requirement Examples ISO 13485:2016 - Medical Device Quality Management Systems 1
Q Additional KPI to Top Management beside Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R Examples of Quality Objectives related to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Setting Quality Objectives with a Timeframe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Identifying Objectives & Targets for Quality Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R 5.4.1 Quality Objectives - Nonconformity: The process was not fully effective ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
dubrizo If Quality Objectives are not known to employees, is it a Nonconformance? General Auditing Discussions 7
M Quality Objectives and Monitoring & Measurement of Processes - Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T Corrective Action for Quality Objectives which are not Measureable Nonconformance and Corrective Action 7
T Best place in QMS to manage Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Quality Objectives for Quality Control and Quality Assurance functions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
T Setting Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K Are Quality Objectives applicable on HSE Department? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J Will these Quality Objectives cover the Product Requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Presentation for tracking Quality Objectives across sites Preventive Action and Continuous Improvement 3
M Quality Objectives - Acceptable Levels and Functions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
H ISO 9001 Quality Objectives Scorecard or Matrix template to share ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Setting Quality Objectives for Service, Repair and Sales ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Understanding Quality Objectives, Metrics and KPI ISO 13485:2016 - Medical Device Quality Management Systems 15
L Changing Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
G Differences between Quality Objectives and Business KPI's ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A Where to document Quality Objectives ISO 13485:2016 - Medical Device Quality Management Systems 6
J Quality Objectives for Engineering Department and R&D Quality Manager and Management Related Issues 5
A Are Explicit Quality Objectives Required? Quality Management System (QMS) Manuals 8
G Defining Quality Objectives for Product Realization and Design and Development AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Quality Objectives - Telephone Calls ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Quality Objectives for Aerospace Chemical Conversion & other Surface Treatment Plant AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Determining Quality Objectives for the Finance Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16

Similar threads

Top Bottom