Is a Corrective Action Expected if a Quality Objective is not in compliance?
- Thread starter qualprod
- Start date
That's called Management by Clowns.
What happened to all the things that should have been determined in 6.2.2 a) through e)? A quality objective still has to follow the PDCA cycle. Assuming the objective was relevant and the organization is serious, one must determine WHY we haven't reached it.
If you just allow management to take the easy way out and simply "forget that" you are supporting the lack of accountability by upper management.
First of all, not every nonconformance needs a corrective action. This was made clear with ISO 9001:2015. Element 10.2.1a requires that you react to the nonconformity and as applicable, take action to control and correct it and deal with the consequences. Element 10.2.1b requires that you evaluate the need for action to eliminate the cause or causes of the nonconformity.
In clear terms, the organization gets to determine if a corrective action is needed or not.
So, no, it is not a requirement to perform a corrective action unless your own procedures require it.
In other words, it is up to top management to determine if they need to go further.
Keep in mind, it is their objective. Objectives can and should be altered as needed so that they accomplish their most important goal of helping "steer the ship". When first selecting an objective often it cannot be told how realistic it is until some data is gathered. If it is unrealistic, it should be adjusted or determined if it should be used at all. This stuff is simply Business 101. It isn't rocket science. It isn't ISO speak.
Really? Management by clowns?
6.2.2a-f was a very controversial element when ISO 9001:2015 was introduced as it could be considered to be prescriptive, which was something that ISO 9001 strictly avoided in the past. Now with that said, how do you get the PDCA cycle as a requirement for quality objectives? Sure, it could be a tool to help you accomplish 6.2.2a-f, but it isn't there. It isn't a shall or set of shall anywhere. Don't overreach and make a requirement that doesn't exist. Just don't.
AMIT BALLAL
Super Moderator
6.2.2 asks to determine how quality objectives will be achieved.
9.1.1 asks to define what to monitor and measure. Let's consider that we defined KPI in line with these Quality objectives and we'll measure performance against same in order to monitor effectiveness of QMS.
9.1.2 asks to evaluate and analyse performance of what we defined to monitor and measure. Hence we would need to do analysis of what went wrong and what actions needs to be taken in order to achieve quality objective.
9.1.1 asks to define what to monitor and measure. Let's consider that we defined KPI in line with these Quality objectives and we'll measure performance against same in order to monitor effectiveness of QMS.
9.1.2 asks to evaluate and analyse performance of what we defined to monitor and measure. Hence we would need to do analysis of what went wrong and what actions needs to be taken in order to achieve quality objective.
Randy
Super Moderator
What's happened to management just saying we need to do something more important, something else of value, or less adversarial? All this MS dribble should never neuter an organizations leadership from changing direction if it deems it appropriate, or should an organization keep on with it's version of a Yugo or New Coke because it has a MS?
I would make several points:
OF COURSE management can redirect the organization to other more important things. Change happens all of the time. This doesn't make them clowns. Prioritization is a fluid thing and responsible knowledgeable management understands this. A change in prioritization is not a sign of professionalism or incompetence; the motivation behind it is the sign.
Goals should be set according to the needs of the business. They should not be arbitrary or even "what we think we can 'reasonably' get". They should not be set to 'satisfy' a clause in ISO either. THEN there must be assigned resources with an effective method for achieving the goal and regular reviews of the progress. AND THEN there must be logical thinking applied to progress - many times when we apply effective methods we get even more improvement than we needed simply because the causal system had such a great control over the results. Sometimes we find that there either many causes that can't all be controlled in the stipulated time frame OR the solution will take longer than the stipulated times frame. this DATA informs us that the goal - while well intended simply can't be attained in the time frame OR will inform us that we need to double down on our investment if the goal is absolutely essential to meet in the stipulated time frame.
Slapping management with a CA won't solve anything.
OF COURSE management can redirect the organization to other more important things. Change happens all of the time. This doesn't make them clowns. Prioritization is a fluid thing and responsible knowledgeable management understands this. A change in prioritization is not a sign of professionalism or incompetence; the motivation behind it is the sign.
Goals should be set according to the needs of the business. They should not be arbitrary or even "what we think we can 'reasonably' get". They should not be set to 'satisfy' a clause in ISO either. THEN there must be assigned resources with an effective method for achieving the goal and regular reviews of the progress. AND THEN there must be logical thinking applied to progress - many times when we apply effective methods we get even more improvement than we needed simply because the causal system had such a great control over the results. Sometimes we find that there either many causes that can't all be controlled in the stipulated time frame OR the solution will take longer than the stipulated times frame. this DATA informs us that the goal - while well intended simply can't be attained in the time frame OR will inform us that we need to double down on our investment if the goal is absolutely essential to meet in the stipulated time frame.
Slapping management with a CA won't solve anything.
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:
Management will do what management always does, but SERIOUS management, one that is also committed to Quality should take the aspect of selecting quality objectives seriously and follow through.
Your previously post implied the scenario where, after not reaching a pre-determined objective, management could simply say: "We didn't get it. Let's drop it". That is NOT what should happen. If the objective was well thought out to start with, if it was relevant, the organization should react adequately to it's lack of success and not simply shrugging their shoulders and saying: "forget that one, let's do something easier".
Randy
Super Moderator
Serious management will be committed to profitability and quality is just one of the tools available. 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.
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