To Evaluate Effectiveness in All Improvements? (ISO 9001:2015)

qualprod

Trusted Information Resource
#1
Hello everyone
Pleasure give insights in this issue.
In 6.1.2.1, the standard requires to evaluate effectiveness in risk and opportunities (which are improvements), but in clause 10, doesn't specifically
Ask to evaluate effectiveness of improvement, it mentions to have effectiveness but for all the management.

The issue is, that when I implement opportunities as improvements, I always evaluate effectiveness and wonder if I have to evaluate it in all improvements I implement in my system? See clauses below.
I apply minor improvements by modifying procedures, format s, kpi, etc., however big improvement are managed/controlled in a special format, where is evaluated the effectiveness.
Thanks

6.1.2 The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management system processes (see 4.4);
2) evaluate the effectiveness of these actions.
******
10 Improvement
10.1 General
The organization shall determine and select opportunities for improvement and implement any
necessary actions to meet customer requirements and enhance customer satisfaction.
These shall include:
a) improving products and services to meet requirements as well as to address future needs and
expectations;
b) correcting, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the quality management system.
 
Elsmar Forum Sponsor
#2
Hello everyone
Pleasure give insights in this issue.
In 6.1.2.1, the standard requires to evaluate effectiveness in risk and opportunities (which are improvements), but in clause 10, doesn't specifically
Ask to evaluate effectiveness of improvement, it mentions to have effectiveness but for all the management.

The issue is, that when I implement opportunities as improvements, I always evaluate effectiveness and wonder if I have to evaluate it in all improvements I implement in my system? See clauses below.
I apply minor improvements by modifying procedures, format s, kpi, etc., however big improvement are managed/controlled in a special format, where is evaluated the effectiveness.
Thanks

6.1.2 The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management system processes (see 4.4);
2) evaluate the effectiveness of these actions.
******
10 Improvement
10.1 General
The organization shall determine and select opportunities for improvement and implement any
necessary actions to meet customer requirements and enhance customer satisfaction.
These shall include:
a) improving products and services to meet requirements as well as to address future needs and
expectations;
b) correcting, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the quality management system.
I always worry when someone says "I make improvements". Are you sure you aren't simply changing something? If you make a change to a procedure, what was the improvement?

I think you are, again, over complicating this thought. If you (and I mean management) arrive at the end of their management review of the QMS, taking the various inputs into consideration, comparing performance to objectives and so on, it'll be pretty darned clear what needs improvement...
 
Last edited:

qualprod

Trusted Information Resource
#3
From the clause 10 at the end.
NOTE Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.

That is what I meant, I did corrections,CA´s, for that, I changed procedures,documents, kpi´s, etc.

Maybe no is clear my comment.
thanks
 
#4
Hello everyone
Pleasure give insights in this issue.
In 6.1.2.1, the standard requires to evaluate effectiveness in risk and opportunities (which are improvements),
You are reading more into this than is there. Your addition of "which are improvements" is not a sound assumption.

You need to plan actions to address the risk and opportunities. For example if you have a request for quote for a job that requires using a supplier that you have had problems with in the past, you would need to determine how to handle them for this job. That might include allowing more lead time. It might include inspecting what you are buying from them at their place of business before they ship it to you. It may include notifying your potential customer that this is a problematic supplier and suggesting another.

After you have taken the actions you need to evaluate how effective they were.
 

AMIT BALLAL

Super Moderator
#5
6.1.2 asks to evaluate effectiveness of actions taken against risk and opportunities.

And this effectiveness evaluation will be input to management review (9.3.2.e), and necessary actions shall be decided if required.
 

AMIT BALLAL

Super Moderator
#6
Agree with Jim, you are over reading the clauses than required. Documentation is supportive to QMS. What required is actual (bottomline) benefits. Try to simplify things, if you are stuck in too much documentation / difficult to understand system (documentation), then people will not follow it and ultimately the system will be ineffective.
 
H

Hieupm

#7
Hello everyone
Pleasure give insights in this issue.
In 6.1.2.1, the standard requires to evaluate effectiveness in risk and opportunities (which are improvements), but in clause 10, doesn't specifically
Ask to evaluate effectiveness of improvement, it mentions to have effectiveness but for all the management.

The issue is, that when I implement opportunities as improvements, I always evaluate effectiveness and wonder if I have to evaluate it in all improvements I implement in my system? See clauses below.
I apply minor improvements by modifying procedures, format s, kpi, etc., however big improvement are managed/controlled in a special format, where is evaluated the effectiveness.
Thanks

6.1.2 The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management system processes (see 4.4);
2) evaluate the effectiveness of these actions.
******
10 Improvement
10.1 General
The organization shall determine and select opportunities for improvement and implement any
necessary actions to meet customer requirements and enhance customer satisfaction.
These shall include:
a) improving products and services to meet requirements as well as to address future needs and
expectations;
b) correcting, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the quality management system.
I aware that if we recognize something whatever thay are risks, opportunities, noncomformities, improvements,...at anywhere in the qms, we implement the pdca on it.
In yours case, evaluation in 6.1.2 is for the actions in risks and opportunities field, but evaluation in 10 is for whole system, it's also included evaluation in 6.1.2
 
#8
I aware that if we recognize something whatever thay are risks, opportunities, noncomformities, improvements,...at anywhere in the qms, we implement the pdca on it.
In yours case, evaluation in 6.1.2 is for the actions in risks and opportunities field, but evaluation in 10 is for whole system, it's also included evaluation in 6.1.2
No. PDCA is NOT a requirement of the standard. It is presented before the shalls start in the standard.
 
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