Continuous improvement and Management review process links

[Helmut Jilling]

Hello,

Could you please advice how to describe Continuous improvement process and Management review process? It is obvious that they are linked: Management review is part of Cont. improvement.
What would you say for following description:

Continuous improvement:
1) Collect inputs (Survey results, Customer complaints, Internal/external audit results, Business results)
2) Indentify root causes
3) Define Preventive / Corrective actions
4) Follow-up implementation
5) Management Review

Management review:
1) Review process performance and product conformance and define adequate actions
2) Review customer feedback and define adequate actions
3) Review and Tracking of preventive and corrective actions
4) Review audit-results and implement recommendations appropriately
5) Review Follow up actions from former Management reviews

Also what bothers me is that both descriptions are quite similar. They both cover the cycle P-D-C-A.

What would you say

Maybe it would be useful to create a form to help direct a Continual improvement Project. or one to recommend an improvement suggestion. There could be enough guidance on the form to guide the person through a beneficial project. For example:

Project Objective
Project Leader
Costs or other Constraints
Affected Departments
Expected Savings or Improvements
Expected Completion date
Management Sponsor or Support
Actual Completion date and Actual savings or results.

Just like a CAR form, it would help the team work toward a succeful completion, as well as make a record of the project.

 

[Patricia Ravanello]

:mg:I can't believe some of the comments I'm reading in this thread...

"CI is not something that is easily documented...in fact, I think the only time my site put it down on paper was in our Business Management System Manual"

"'CI' is not normally something that one puts into a written procedure." ​

Continual Improvement is one of the 3 tools available to management to steer their ship....

1) Corrective Action,
2) Preventive Action and
3) Continual Improvement.​

It is, beyond the shadow of a doubt, one of the KEY processes of the MANAGEMENT System (the upper level documents that map out the entire system), and if it isn't documented, it should be. It's Management's Work Instruction...Collectively CA/PA/ and CI are the ship's rudder and throttle...which give Sr. Management control to make the ship move faster, slower, backwards, forwards, stop and go, etc..

It's the "ACT" in the PDCA cycle. If it's not documented, it's probably not being implemented in a disciplined, standardized and/or predictable manner. The fact that it's difficult to document doesn't justify it's non-existence...and in fact, is exactly why it needs to be documented.

Brutas, you need to work on the sequence of activities for your Continual Improvement process...as Jane said, it looks more like a Corr Act process - there should be no need for root cause analysis in a Continual Improvement.

Helmut's suggestion of using a form to help guide the process is a good one. It would help to standardize things.

See attachments for examples and further clarification.

Patricia Ravanello

 

[RoxaneB]

I can't believe some of the comments I'm reading in this thread...

Patricia, with all due respect, both Jane and I essentially said that CI is not a stand-alone process and that it is a culmination of various inputs. In fact, your own attachments supported that (i.e., your organization references audits, ca/pa records, data from other sources).

I applaud the idea of a process map showing how your organization uses these tools in the pursuit of Continual Improvement. The path you chose was different than mine (i.e., citing the tools in our BMS Manual), but the overall objective is the same.

We, too, have procedures on planning, data analysis, internal audits, etc. We even have some pretty process flows showing how we use these tools not for improvement but also for the establishment and standardization of our routines.

It is not, however, a required procedure. Those which are required do play a role within our improvement process.

It's the "ACT" in the PDCA cycle. If it's not documented, it's probably not being implemented in a disciplined, standardized and/or predictable manner. The fact that it's difficult to document doesn't justify it's non-existence...and in fact, is exactly why it needs to be documented.

The fact that it is not documented as its own specific document has not impacted our ability to improve in the least. In fact, over the course of 3 years, our external auditor remarked on how much we improved...not just our product or our processes, but also within our tools (i.e., their application, their undertanding,). In fact, we were noted as a "Best in Class" in her audit notes which is not something that she hands out easily and has remarked how pleasant it is to visit a site that applies the concepts of CI to heart, instead of cluttering it up with paperwork and red tape.

I would also argue that Continual Improvement is the entire PDCA cycle; all 4 "steps" are needed if any improvement is to occur. "Act" is the lessons learned where you either go back to the drawing board (when planned results are not achieved) or you aim even higher (when planned results are achieved).

 

[JaneB]

Excellent post, Roxanne.

I would also argue that Continual Improvement is the entire PDCA cycle; all 4 "steps" are needed if any improvement is to occur. "Act" is the lessons learned where you either go back to the drawing board (when planned results are not achieved) or you aim even higher (when planned results are achieved).

Me too - I disagree that it's restricted to 'Act' only - all four steps are involved (unless one doesn't bother doing any 'Planning' or 'Implementing' or 'Check/Review' while improving!).

Process? yes. Document the Approach? Can be useful. Have a documented model to follow for improvement? Ditto. But a procedure? Only in some cases and in some contexts.

Yes, Helmut's suggestions IS a good one - where a project team is available etc. But recall that 9001 is for all types of organisations of many different sizes. CI needs to be appropriate.

I repeat my question: if you have a written 'procedure', who uses it? When? And if someone doesn't follow it exactly (but implements improvement) - would you consider that "nonconformity"? Require 'corrective action'?? Because I sure as hell know what most of my client personnel would respond if I argued that one.

 

[brutas]

Thank you for your active involvement in this topic.

Jane, call it process description, not procedure.
Here some more clarification:
We have a process description called "Continuous improvement" which we have to revise.

We don't have documented procedures for Corrective actions and Preventive actions.
The standard says:

8.5.2 Corrective action
A documented procedure shall be established to define requirements for...
........
8.5.3 Preventive action
A documented procedure shall be established to define requirements for...

Question: Is this a gap? Should we have such procedures?

8.5.1 Continual improvement
The organization shall continually improve
the effectiveness of the quality management
system through the use of the quality policy,
quality objectives, audit results, analysis of
data, corrective and preventive actions and
management review.

Question: Should I include (would be enough) all those activities in my CI process description?

Currently our CI process description includes six sigma (green belt / black belt) methodology to improve our key business processes but we want to uncude all the activities.

There is very interesting Guidance on this place: http://isotc.iso.org/livelink/liveli...nodeid=3554880
which says:

5.5. Corrective action and improvement of the process
Whenever corrective actions are needed, the method for implementing them should be defined. This should include the identification and elimination of the root causes of the problems (e.g. errors, defects, lack of adequate process controls). The effectiveness of the actions taken should be reviewed. Implement the corrective actions and verify their effectiveness according to plan.

When planned process outcomes are being achieved and requirements fulfilled, the organization should focus its efforts on actions to improve process performance to higher levels, on a continual basis.

So, for my understanding, all actions related to taking process under control monitoring process metrics is Corrective action and everything beyond (exceeding current process requirements) should be considered as Continuous improvement. Is that correct?

 

[Ajit Basrur]

.............The standard says:

8.5.2 Corrective action
A documented procedure shall be established to define requirements for...
........
8.5.3 Preventive action
A documented procedure shall be established to define requirements for...

Question: Is this a gap? Should we have such procedures?

8.5.1 Continual improvement
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

Question: Should I include (would be enough) all those activities in my CI process description?

Currently our CI process description includes six sigma (green belt / black belt) methodology to improve our key business processes but we want to uncude all the activities.

There is very interesting Guidance on this place: http://isotc.iso.org/livelink/liveli...nodeid=3554880
which says:

5.5. Corrective action and improvement of the process
Whenever corrective actions are needed, the method for implementing them should be defined. This should include the identification and elimination of the root causes of the problems (e.g. errors, defects, lack of adequate process controls). The effectiveness of the actions taken should be reviewed. Implement the corrective actions and verify their effectiveness according to plan.

When planned process outcomes are being achieved and requirements fulfilled, the organization should focus its efforts on actions to improve process performance to higher levels, on a continual basis.

So, for my understanding, all actions related to taking process under control monitoring process metrics is Corrective action and everything beyond (exceeding current process requirements) should be considered as Continuous improvement. Is that correct?

ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:

4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action

and these documented procedures have to be controlled in accordance with the requirements of clause 4.2.3 - so the answer to your question is YES its a GAP

For your second question, there are several areas of the quality system where you could demonstrate commitment to continual improvement. Some of the areas are -

a. quality policy
b. quality objectives
c. audit results
d. data analysis
e. Corrective Actions
f. Preventive actions
g. management review

Over and above these if your organization have, its good and can be demonstrated.

 

[trainerbob]

If you are planning on a rewrite of your "Continuous" improvement and insist on having one, than you should call it what it is - and that is "Continual" improvement. "Continual" improvement, which is a requirement, not a required procedure, implies a stable process to begin with so that we have metrics to measure against and therefore can show results.

 

[Patricia Ravanello]

It is not, however, a required procedure. Those which are required do play a role within our improvement process.

This is not about what's mandatory...it's about what makes sense. The ISO organization and the ISO standard don't have a monopoly on logic. ISO doesn't have to justify why you do or don't need a documented procedure...each organization has to come to that realization on their own.​

I would also argue that Continual Improvement is the entire PDCA cycle; all 4 "steps" are needed if any improvement is to occur. "Act" is the lessons learned where you either go back to the drawing board (when planned results are not achieved) or you aim even higher (when planned results are achieved).

,,,Can't agree with this statement. Corrective, preventive and Continual Improvement activities are the "ACT" in the PDCA cycle. I think that's clear from the second attachment in my previous post.

I think we are agreeing in the need for a defined methodology and implementation of the Continual Improvement process, where we diverge is in our individual perceptions of how the Management System is structured, and the placement and prominence of the CA/PA/CI process in that model. I don't think it further serves the purpose of this discussion to belabor that point.​

Brutas, back to your question,

"So, for my understanding, all actions related to taking process under control monitoring process metrics is Corrective action and everything beyond (exceeding current process requirements) should be considered as Continuous improvement. Is that correct? "

It's up to you, where you draw the dividing line between processes. The attached segment of a "Monitoring, Measurement and Analysis" procedure shows that, once the performance status of the respective process/activity is determined, the appropriate action is simply linked to the next process which interfaces with it, which in this case is SOP-0005 Corr/Prev Action and CI.
How you cut it up and dish it out is up to you. The above discussion might be somewhat confusing, but that is, in part, due to the way our individual systems are mapped out, and how the sequences and interfaces are defined. I don't repeat the CA/PA/CI process in my other processes, I just link to it, as demonstrated in the attachment. There's no need to repeat it over and over again in each process.

I think you've demonstrated that you understand the concept...how you map it out and interlink the whole system, is up to you.

Patricia

 

[Jim Wynne]

Continual Improvement is one of the 3 tools available to management to steer their ship....

1) Corrective Action,
2) Preventive Action and
3) Continual Improvement.
​

It is, beyond the shadow of a doubt, one of the KEY processes of the MANAGEMENT System (the upper level documents that map out the entire system), and if it isn't documented, it should be. It's Management's Work Instruction...Collectively CA/PA/ and CI are the ship's rudder and throttle...which give Sr. Management control to make the ship move faster, slower, backwards, forwards, stop and go, etc..

It's the "ACT" in the PDCA cycle. If it's not documented, it's probably not being implemented in a disciplined, standardized and/or predictable manner. The fact that it's difficult to document doesn't justify it's non-existence...and in fact, is exactly why it needs to be documented.

I think things are getting overcomplicated here. We measure things. The measurement result should be used to determine if the thing measured is:

• The same as before
• Worse than before
• Better than before

The third case represents improvement, assuming that the gain is sustained. It doesn't matter which letter in "PDCA" is represented. If it's worth measuring, and it gets better over time, continualous improvement has taken place. We can point to the measurement results as evidence of continualous improvement.

 

[JaneB]

We don't have documented procedures for Corrective actions and Preventive actions....

Question: Is this a gap? Should we have such procedures?

Yes, it is and yes, you should have one (or more) procedure/s that cover the requirements of those clauses. Nonconformity otherwise.

You don't have to do it in 2 separate procedures and you don't have to call them CA and PA - call 'em anything you like. For example, you could include them in your CI process/procedure if it makes sense to you. As Patricia has said, it's your choice how you do it.

8.5.1 Continual improvement
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

Question: Should I include (would be enough) all those activities in my CI process description?

Currently our CI process description includes six sigma (green belt / black belt) methodology to improve our key business processes but we want to uncude all the activities.

Can't give a definite yes/no answer here, because I don't know your system, its doco or how you're structuring and using your CI process (which I assume is including or perhaps is solely DMAIC or something similar ) Maybe yes, maybe no, or maybe 'depends' . eg, I don't know what you mean by 'would be enough' - 'enough' for what?

It's less important (in my view) that it's 'in the process description' than that you can demonstrate that your CI does include considering/taking all those various things into account - but when & where relevant. (One reason I resist having a procedure and including a list such as that is that sometimes people then may think they have to do each and every step in a 'lockstep fashion) - eg, sit down and go through every single one of them and decide whether each is included before they ever start any kind of improvement planning - and that's one reason IMO why people start saying 'quality is too much paperwork)

But I also can see Patricia's strongly put view that if it isn't in a formal process (and I assume you're in a med-largish organisation) it won't/may not happen. Certainly if we're talking 'formal change projects' I agree there's a need for process.

In your case, you may wish to include them in your process description as some possible inputs/triggers, or you could simply reference them.

It does sound as though you've read up on the guidance and have good reasoning behind what you're proposing. Your suggestion that

["everything beyond (exceeding current process requirements) should be considered as Continuous improvement.

appears a good one to me.