Is a Corrective Action Expected if a Quality Objective is not in compliance?

[Sidney Vianna]

Business history is rife with decisions to change course & direction with the justification many times that of "it just isn't the time to do this" or "the net gain in keeping on is out weighed by the net loss in frustration and trouble this course is presenting".

The organization (management/leadership) owns the process and as owner it's theirs to change as a result of whatever their reasoning process is.

Now, you apparently say they need to justify their change of heart.

Of course the leadership of an organization might rethink the business priorities and change objectives. These are not dogmas, cast in stone requirements. But the change in course should be the result of an analysis, an educated decision. Not simply the result of the fact they were not able to achieve the objective. They should reason and justify the change; not simply state "drop this one". Contrary to what you stated earlier, if I were auditing this scenario, I would expect the organization's management to justify their decision. Words matter. Intent matters.

Let management make a decision to eliminate the objective, they don't even have to justify it...."Nope, we ain't gonna do that this year." is all they have to say

 

[qualprod]

Thanks to all of you, great discussions,leading the issue to other level, from different angles and criteria, very helpful, thanks for your time, I'm getting other perception in this issue.

 

[Golfman25]

Now, you apparently say they need to justify their change of heart.

Of course the leadership of an organization might rethink the business priorities and change objectives. These are not dogmas, cast in stone requirements. But the change in course should be the result of an analysis, an educated decision. Not simply the result of the fact they were not able to achieve the objective. They should reason and justify the change; not simply state "drop this one". Contrary to what you stated earlier, if I were auditing this scenario, I would expect the organization's management to justify their decision. Words matter. Intent matters.

Who are you to require management to "justify" their decisions? If management's/ownership's house is on the line, I'm certain you'll get some serious push back if you didn't accept "because I said so."

 

[Marc]

This thread has been reported. Please - Let's keep discussions from getting personal.

Thanks.

 

[Golfman25]

This thread has been reported. Please - Let's keep discussions from getting personal.

Thanks.

Not sure where the personal comes in. "Who are you" is a figure of speech, not a direct reference to the person.

 

[Big Jim]

In my copy of ISO 9001:2015, I don't see a bullet f) under 6.2.2. But when I read 6.2.2 it has the PDC of PDCA. And, of course, there is a shall. Let me help you seeing it:

I stand corrected on bullet f. Perhaps you can help me see the PDC. a) shows plan. I don't see a direct do. e) shows check.

My real point is PDCA is NOT required by 6.2.2. A good practice for certain, but NOT required.

 

[Jen Kirley]

We need realistic objectives, especially given the number and types of influencing factors. I will never fit into a size 8 dress. Forget it.

It is not enough to set an objective without an improvement plan, as I can reduce defectives to zero by not making anything.

I agree with the PDCA approach. If the objective is to reduce defectives, a numerical objective is arbitrary without a well-constructed plan to improve. After considering all the factors and making process adjustments, a realistic objective can be set.

Missing a target can happen for many reasons. Some of the reasons may not be in an organization's management's control, while others are. Managers should review progress of the plans, and take action based on the results of the review and decisions that support the business.

What managers should not do is to make objectives and then ignore them. As a 3rd party auditor I might issue a nonconformity for this, but only after thoroughly exploring the matter. An internal auditor, likely having limited information to base a decision on, should report it to the audit program/quality manager.

I hope this helps.

 

[Randy]

Now, you apparently say they need to justify their change of heart.

Of course the leadership of an organization might rethink the business priorities and change objectives. These are not dogmas, cast in stone requirements. But the change in course should be the result of an analysis, an educated decision. Not simply the result of the fact they were not able to achieve the objective. They should reason and justify the change; not simply state "drop this one". Contrary to what you stated earlier, if I were auditing this scenario, I would expect the organization's management to justify their decision. Words matter. Intent matters.

Sorry, but sometimes it just takes a gut decision based on nothing more than instinct. Kinda like when Fred Smith went to Vegas and gambled every last dime he had to raise operating capital.

 

[Marc]

Sorry, but sometimes it just takes a gut decision based on nothing more than instinct. Kinda like when Fred Smith went to Vegas and gambled every last dime he had to raise operating capital.

To say "...it sometimes takes a gut decision..." is Fred Smith was a fool. That type of behavior is totally stupid and totally unacceptable. That may be a "gut decision", but it's just plain stupid when so many people depend upon the decisions of upper management, CEOs, etc.

As I read Sidney, he is simply saying there are responsible ways for upper management to act. Gambling at a casino isn't "responsible" in any way, shape or form. Business wise, a good example is the Big Boys in the Big Banks who "gambled" and produced the 2007 to 2009 financial catastrophe. They didn't go to a casino, but they did high stakes gambling none the less. Talk about a total lack of Risk Assessment... But then again, they were the Big Boys which you, me and millions of other US citizens paid to bail out. Were those responsible decisions? "Gut" decisions? Putting so may people at risk on a "gut decision" without consideration of risk, especially considering that most of them are rich enough that thy will be quite well off financially even when their "gut decision" is wrong... I'll never forget the picture of the US$18K (or there abouts) antique commode that one of the big bailed out bankers had in his office.

Anyway - @Golfman25 - Sidney is only stating his opinion.

Who are you to require management to "justify" their decisions? If management's/ownership's house is on the line, I'm certain you'll get some serious push back if you didn't accept "because I said so."

Sidney is stating an opinion. "Who are you to require management to "justify" their decisions?" is a bit much as it is Sidney's opinion of what should be. Sidney isn't "requiring" anyone to do anything.

Now I would really like to get the thread back to the original question: "Is a Corrective Action Expected if a Quality Objective is not in compliance?"

 

[Big Jim]

Now I would really like to get the thread back to the original question: "Is a Corrective Action Expected if a Quality Objective is not in compliance?"

I don't see anywhere in the standard that requires compliance to a quality objective. I do see some related topics though.

• 6.2.1e requires that the objectives be monitored.
• 6.2.2e requires that the results will be evaluated.
• 6.2.1g requires that quality objectives be updated as appropriate.

Certainly corrective action could be applied if a goal is not met, but you can't get to it being a requirement from anywhere in 6.2. Nothing in 6.2 defines a missed goal as a nonconformity.

Another area to look at would be 4.4.1 which deals with processes of the organization.

• 4.4.1c requires determining and apply criteria and methods (including monitoring and measuring and related performance indicators) needed to ensure the effective operation and control of the processes.
• 4.4.1g requires evaluation of the processes and implementation of any changes needed to ensure that the processes achieve their intended results.

If an organization chooses to use their quality objectives as process indicators (a common practice but not a requirement) then in light of 4.4.1g corrective action might be how they are ensuring the processes meet their intended results.

Still another area to look at would be 9.1.3 which deals with analysis and evaluation of data arising from monitoring and measuring. Process indicators and quality objectives may be used in the evaluation. There are four topics here that are often used as quality objectives.

• 9.1.3a requires analysis and evaluation of conformity of products and services.
• 9.1.3b requires analysis and evaluation of the degree of customer satisfaction.
• 9.1.3c requires analysis and evaluation of the performance and effectiveness of the quality management system (often by tracking on-time delivery).
• 9.1.3f requires analysis and evaluation of the performance of suppliers.

There doesn't seem to be anything in 9.1.3 that requires corrective action, just analysis and evaluation. It cans be reasonably assumed that corrective action could be appropriate when one of these topics are found to be outside of expectations.

Management style plays a big role here too. A topic that the standard only lightly addresses. An example is shown in Note 3 of 4.1 where understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

Randy's comments suggest that we should consider a company culture that is very loosely run, and we should. Not all are run in a tight button-down manner suggesting the company is run by a Harvard MBA. What a dull world it would be if all were.

So I don't see where missing a goal would automatically be a something that would require corrective action. It would likely be desirable, and it may be a requirement under their own procedures or culture, but not a requirement of the standard.