Our company is large enough to have a stand alone Lean Department who have never been audited by an external body or internally. We included them in our Internal schedule this year and I drew the short straw. They have no work instructions or Policy documents to review and they do not apply the tools of the quality Management System. (The audit scope is compliance to ISO 9001:2000, ISO 13485:2003, 21 CFR 820, CMDCAS and rPAL.)
Any suggestions what to consider looking at?:confused:

Our company is large enough to have a stand alone Lean Department who have never been audited by an external body or internally. We included them in our Internal schedule this year and I drew the short straw. They have no work instructions or Policy documents to review and they do not apply the tools of the quality Management System. (The audit scope is compliance to ISO 9001:2000, ISO 13485:2003, 21 CFR 820, CMDCAS and rPAL.)
Any suggestions what to consider looking at?:confused:

Hello Harmony and welcome to The Cove!

You can begin with the identification of the expectations of the Lean Process.
What does the organization expect to happen as a result of the Lean Process? In some audit models we call that "Input."
Next, what are the indicators of the effectiveness of the Lean Process? In other words, what tells you that the Lean Process is doing what it is supposed to do? ("Output"). Compare expectations with the results. If not, you'll keep digging deeper. There are some audit models here at The Cove that could help you. Even a simple process model would help you to further investigate the process.

I hope this helps to get started. Other Covers will chime in soon!

Stijloor.

Good advice thanks Stijloor - At least I feel I have a starting point now! Where a process for audit doesn't sit obviously against a particular requirement of the associated standards it can sometimes be tricky to see where to begin...
Harmony

Since 'Lean' is a set of tools, I'm not sure you can audit them as a process, more that you can audit a process, on which lean tools have been applied. It would be like looking at a toolbox, without understanding which work was going to be done - plumbing? carpentry?

Lean can be audited, but it relies on your knowledge and understanding of the tools and what management's implementation strategy has been in deploying them.
:2cents:
Andy

Well explained Andy - I like the analogy and think this was partly why I was wrestling with the approach to take. This has made me think that looking at the Lean Strategy assigned by the Management Team and reviewing the progress / impact they have made against this will be worthwhile.
I guess the Department's compliance with the associated systems of change control, validation management etc can be audited for any given Lean project, (more obvious audit territory). I can see an audit plan starting to take shape now, thanks...Harmony

Good advice above.
Maybe these attachments will help as well:
http://elsmar.com/Forums/attachment.php?attachmentid=6520&d=1172804310
and you can download one from here:
http://www.strategosinc.com/assessment.htm

Let me know if you need more literature.
Good luck
György

I had a feeling of rejection to the idea and then discarded it.

While there is a group of people "doing" lean, much as some people will focus on Six Sigma projects, you can audit how the Lean process works.

How opportunities are identified.
How plans are made.
How players are made ready to competently perform their duties.
How the organization accomodates these potentially disrupting activities.
How change is managed.
How the activities are controlled against becoming ad-hoc in nature.
How it is assessed for results.
Who is told about the results and what they are doing about it.
How the lessons learned are applied to the next opportunity.
Recordkeeping and requirements for documents.

An audit like this might involve people outside the Lean department.

I hope this helps!

Lean, six sigma, 5s, kaizen, and other improvement activities are all PROCESSES with clearly defined expectations and measurable outcomes, thus auditable like any other process. I have audited a number of these processes. I had the cooperation of the great folks utilizing these processes and they provided me with all the information to conduct an effective audit. As long as the process is reasonably well defined, an audit can be conducted.

Stijloor.

Tons of great advice here folks - thanks a lot! Much happier with tackling this now...:D

Our company is large enough to have a stand alone Lean Department who have never been audited by an external body or internally. We included them in our Internal schedule this year and I drew the short straw. They have no work instructions or Policy documents to review and they do not apply the tools of the quality Management System. (The audit scope is compliance to ISO 9001:2000, ISO 13485:2003, 21 CFR 820, CMDCAS and rPAL.)
Any suggestions what to consider looking at?:confused:

We have started using simple process models, we have found this effective for area with little to no documentation.
The idea is that you work through the Inputs, Controls, Resources and Outputs asking for objective evidence along the way, then walk the process to see if it all fits together.

Have attached a simple (very simple) aid that we would use (knocked up just now) that you could expand and use as an aid (or not) hope this helps.