5.4.1 Quality Objectives - Nonconformity: The process was not fully effective

[John Broomfield]

1. Are SMART Objectives compulsory?

2. Can an auditor raise NCR for not having SMART Objectives?

3. If SMART Objectives are compulsory then what is the reference?

Syed,

Your organizational management system may require SMART objectives.

But ISO 9001 does not specify SMART objectives.

Just make sure the people concerned know what the objective is, how they know if it's being achieved and how to recognize when it has been achieved.

Normally, organizations monitoring their processes (see 8.2.3) responsible for the fulfillment of their objectives or by review of the system; depending on the nature of the objective.

An effective system or processes is a system or process that fulfills its objectives. So, certain objectives may show the process or system is not yet effective but is bring improved.

John

 

[ksanders]

In 5.4.1, it states that "Top Management shall ensure that quality objectives, ..., are established at relevant functions and levels within the organization. What methods do you use to determine 'relevant functions' within your organizations? Are these directly off your process map? Has anyone ever ran into disagreement with auditors regarding what is considered 'relevant'?

 

[John Broomfield]

In 5.4.1, it states that "Top Management shall ensure that quality objectives, ..., are established at relevant functions and levels within the organization. What methods do you use to determine 'relevant functions' within your organizations? Are these directly off your process map? Has anyone ever ran into disagreement with auditors regarding what is considered 'relevant'?

ksanders,

Functions or departments serve processes.

On review of your quality objectives you can shortlist the processes from your process-based management system that are primarily responsible for their fulfillment.

You can then see if the objectives for these processes (see 4.1c) contribute to the fulfillment of the quality objectives.

Of course, when you audit the planning, operation and monitoring of the responsible processes you have the opportunity also to evaluate employee awareness of the quality objectives at relevant functions and levels.

Of course, departmental objectives that direct effort away from process objectives are causing system weakness and should be investigated.

John

 

[AndyN]

1. Are SMART Objectives compulsory?

2. Can an auditor raise NCR for not having SMART Objectives?

3. If SMART Objectives are compulsory then what is the reference?

1. No

2. They can write whatever they feel compelled to report as an NCR, but that doesn't mean they are correct - have you had an NCR for this?

3. There isn't one, because they aren't compulsory. But having clear, measurable objectives established, is...

 

[Kronos147]

1. Are SMART Objectives compulsory?

2. Can an auditor raise NCR for not having SMART Objectives?

3. If SMART Objectives are compulsory then what is the reference?

A registrar can work with an organization to help point out where it could (maybe should) be more effective.

The organization needs to be aware of the text in ISO 9001:2008 0.1

If the organization is just looking for a certificate to wave in a clients face, then they address this nonconformity with questions such as those quoted above, IME.

There is a clear trace to objectives and KPI's when one bothers to read 0.2

 

[Fishmanszmit]

"The auditor then went on dictating what relevant objectives we should have.".... this is NOT the auditors job and he or she should NOT be dictating anything to the company other than what is nonconforming. What you "should or should not do" is NOT in the auditor's scope or best interest. None the less.... improvement is te best medicine and you will improve due to the finding, right or wrong.Look up Quality Objectives on Google and you can find hundreds of examples that apply to a wide variety of industries. Good luck

 

[LUV-d-4UM]

During a previous surveillance audit, the auditor wrote a Minor CA for us not having relevant objectives. The Auditor wrote:

Nonconformity: The process was not fully effective in that objectives weren’t at relevant functions and levels.
Evidence: There were quality objectives, however they weren’t at relevant functions and levels within the organization (only three top level objectives).

Our objectives were, Percentage RMA's per month, Sales per month, Tardies percentage per month (we have a tardiness problem).

The auditor then went on dictating what relevant objectives we should have. I feel that this should have been an observation, versus a CA. Is anyone in agreement? Disagreement?

100% disagreed with you auditor.