Non-conformance regarding Lean Process - Lean Process is not defined

[Big Jim]

Re: Non-conformance regarding Lean Process

Ooooh Sandy I agree with Andy and Stijl on this one. This auditor is out of gas. What irritates me about this is, rather than give you kudos for implementing such great tools, he/she dings you because you don't have a documented process? Cmon. The auditor is creating both mudi and muri - tell him that and see if he has a clue what you're talking about.

I vote for a push-back to registrar management. Cheers - Pen

I was about to note that the auditor is more likely full of gas rather than out of gas, but others have show the same sentiment in a better manner.

The only way I can think of this as being a legit finding would be if Lean was called out as a process on the interaction of processes chart, much like some companies call out Quality as a process. Like the rest of you, I doubt that is the case. The auditor is full of something.

 

[Paul Simpson]

We recently went through a surveillance audit (ISO 9001:2000) and received a minor non-conformance: "The Lean Process is not defined within the QMS; application and interaction with other processes is not identified."

I agree with the non-conformance as we have no documented process, but am not sure where/how to connect the Lean activities within our QMS. Is continual improvement (8.5.1) the appropriate tie-in?

IMHO 'Lean' is not a process in itself. The various tools and techniques are part of a whole range of other processes like fulfilling customer orders, improvement, internal communications etc.

It's a bit like IT - part of a whole load of other processes!

 

[Sandyd]

Thanks for all of the input, but maybe I need to clarify. Lean is a large part of the organization and tends to "bump up against" many of the QMS processes without any definition. The auditor is referencing 4.1 a) and b) -- processes be defined and that the sequence and interraction of these processes be articulated within the QMS.

Although Lean plays a big part in the organization, it has not been measured or reported during data analysis and does not have "documented" ties to any of our management or quality objectives -- which we report and monitor monthly.

So... somehow I need to make the connection.

Thoughts?

 

[Paul Simpson]

Thanks for all of the input, but maybe I need to clarify. Lean is a large part of the organization and tends to "bump up against" many of the QMS processes without any definition.

Hi, Sandy. I tried to cover it quickly but obviously failed dismally to get the process across.

Lean is not a process - it is a philosophy underpinned by a range of tools and techniques that end up being absorbed into the organization's DNA until they are "The way we do things round here."

The auditor is referencing 4.1 a) and b) -- processes be defined and that the sequence and interraction of these processes be articulated within the QMS.

If you accept my argument that lean is not a process then

• a) it cannot be determined (using 9k08 terms), and
• b) it does not precede or follow any other process, nor does it interact with any process

What you should find is that aspects of lean are fully integrated in a range of other processes and the tools of lean are used throughout the organizations processes. Here are a couple of examples:

• All the self directed work teams are part of your internal communications processes (5.5.3) and continual improvement (8.1)
• You may have a support process for manufacturing that requires maintenance of production equipment (6.4). All the R & M work you do in terms of maintaining uptime by monitoring mean time between failures (MTBF) and mean time to repair (MTTR) is part of that maintenance of the work environment
• Value stream mapping is part of process design (7.1)
• Say you have a process called "Fulfilling customer orders" and part of that process is you receive orders from clients. Order quantities and delivery dates are received. This information is used in production planning and defines the takt time required (part of 7.1)
• First time through (FTT), right first time (RFT) and build to sequence (BTS) are process measures (8.2.3)
• Process and machinery FMEA are part of preventive action (8.5.3)

I could go on but you get the picture ...

Although Lean plays a big part in the organization, it has not been measured or reported during data analysis and does not have "documented" ties to any of our management or quality objectives -- which we report and monitor monthly.

So... somehow I need to make the connection.

Thoughts?

As mentioned above lean kicks out a whole load of measures of processes you already operate (again please excuse the electronic shouting). The Value added / non value addded ratio, RFT, FTT, MTBF, MTTR etc. measures should already be visible within your organization
and its management system. They should support your quality objectives. If not there is a significant alignment problem between your 'real' management system and the documented one.

 

[AndyN]

Thank you, Paul for that elucidation!

Clearly the CB auditor has gotten half a story about Lean! Hence the remarks! While apparently 'magical' to some folks (and they do give good results) I agree that 'Lean' is a toolbox, not a process. These tools are applied to existing processes to drive out waste. The performance is seen in the process to which the tools are applied, not to 'Lean' in and of itself. It doesn't need to be described in the QMS as a process etc.

Sandy, when you say there's no 'definition', surely somebody champions or leads your Lean initiatives? People who are in such positions can usually give forth about 7 wastes reduction, 5 "S" etc. Isn't that definition? Can the folks involved in the Kaizen events etc. talk to the improvements? Isn't that definition? Don't try to create documentation to serve the CB auditor! You'll undo years of trying to create effective systems, without bureaucracy.

 

[Sandyd]

The Value added / non value addded ratio, RFT, FTT, MTBF, MTTR etc. measures should already be visible within your organization
and its management system. They should support your quality objectives. If not there is a significant alignment problem between your 'real' management system and the documented one.

There you have it -- it's the "alignment" that is the problem. It seems that we have evolved into having two separate systems: Lean / QMS. Lean measures are visible within the organization, but NOT in QMS system and do not clearly support the quality objectives. The non-conformance is actually assisting my attempts for mgmt to view Lean as a tool that should be "supporting" the management system, not running seperately on the side.

Whew! this is a hard one to explain.

 

[AndyN]

It's difficult to get there, from what the CB auditor reported! This is one of the reasons why management see little benefit from CB audits! Happily Sandy, you know what the issue is, but without your interpretation, I rather doubt that anyone else would have drawn the same conclusions!

Score? 10 to you, 0 for the Auditor's report!

 

[Sandyd]

It's difficult to get there, from what the CB auditor reported! This is one of the reasons why management see little benefit from CB audits! Happily Sandy, you know what the issue is, but without your interpretation, I rather doubt that anyone else would have drawn the same conclusions!

Score? 10 to you, 0 for the Auditor's report!

Thanks Andy, but I really have no problem with our auditor. There is definitely a disconnect that needs to be addressed. I'm thinking of putting Lean into our process matrix with continual improvements and "assigning" a measurable objective that links to our QMS objectives that, in turn, support/link to our "corporate" objectives. It's a maze, but I'll find my way...

 

[Paul Simpson]

Thanks Andy, but I really have no problem with our auditor. There is definitely a disconnect that needs to be addressed. I'm thinking of putting Lean into our process matrix with continual improvements and "assigning" a measurable objective that links to our QMS objectives that, in turn, support/link to our "corporate" objectives. It's a maze, but I'll find my way...

Sandy, it sounds like you've got a decent auditor (although his / her nonconformity writing could be improved)

The disconnect is there and it should be incorporated as a lot of the lean tools and techniques relate to areas of 9k08 where documented procedures are required - nonconforming control, corrective action preventive action.

FWIW you could just document the 'lean system' - there should be enough there to satisfy all 9k08 requirements.

 

[Desara01]

Sandy - please, just make sure that whatever you do is actually adding value to your organization and is not just a response to this N/C that you will then have to maintain in addition to the other things that are actually adding value. I am not a fan of doing anything just to satisfy and auditor who is overstepping. from Penny.