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Use Lean Concepts to Right-Size Your Documentation System

Reduce procedures by 50% via ISO 13485 and AS9100 upgrades

Mike Micklewright
Mon, 01/14/2013 - 11:54
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Body

Got your attention by what seems a bizarre claim? Yes, you can significantly reduce the number of procedures you maintain by converting your ISO 9001 quality management system (QMS) to one that is also certified to the medical device standard ISO 13485 and the aerospace standard AS9100.

ADVERTISEMENT

I am currently working with a small company of fewer than 100 employees on this very endeavor. Our achievable plan is to make the following conversion happen:

 

Current state

Future state

Number of procedures

39

26*

Number of flow charts

19

0

Number of quality manual pages

35

2

 …

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Comments

Submitted by thomas.iliadis on Mon, 01/21/2013 - 13:51

Flow Charts

Mike;

Great and timely article!!!

One comment I have is on the removal of flowcharts.  While I agree strongly they have gotten increasing complex and hence useless; top level flowcharts are helpful to organizations as part of problems solving/troubleshooting quests.  I personally use them extensively in root cause analysis in many of my efforts with clients (CAPA, 483's, WL).  But you're right they make them complex, and hence useless, and often times detrimentail toward my efforts.

They should be part of the procedures, at a top level to break down the process into unit operations.  But to the extent they add value to the procedures.

Just my thought on this topic of flowcharts. But the rest of the article is on target.... Great job for raising the awareness of this corporate paralysis.

 

Tom Iliadis

 

 

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Submitted by Michael McLean on Mon, 01/21/2013 - 15:00

Leaning ISO MS's

Nice and refreshing article Michael.

We find it interesting like yourself it seems how many companies persist with their Standard/Element/Clausal-based structures of their Management Systems. They say its what the 3rd Part Auditors want and they are certified so why bother!

We point to "Product Realization" requirement has the Flowchart Chevron symbols - well we explain its a 'Process' therefore we can use it to map our Mgt System and like the APQC Process Classification Framework provides, a Process hierarchy for then overlaying various ISO Stds and others into an Integrated MS.

The Recently launched ISO9004:2012 provides even more support for your article as it describes the Core, Management and Support Processes; the BEM's of Europe and USA Baldrige have "processes' as central (more the European of course) and so what is the problem in reengineering the Mgt System to be process-based. Even ASQ has a Process Based Auditing Book and the auto sector implore and use Process layered Audits.

We loved GE's "C.R.A.P." - Complacent Redundant Activities and Procedures from a few years ago to assist the 'leaning' too. One client simplified not made simplistic their Quality Manual and now Integrated MS, onto one A3 sheet and reduced the "CRAP" - they interviewed 3 certification bodies and their audit team leaders until they found one who 'got' process. Sad indictment.

A good test for folk trying to do Lean and the Standardization piece is when we ask what does ISO actually stand for - 95% miss it. For those doing AS9100 and ISO TS16949 - when we say Process, these Body of Knowledge for those industries require Process MS's - APQP, PPAP, PCP, SPC [Process Stability and Capability Studies], Process Improvement, , PFMEA etc.

Even BPR and Six Sigma (Reg Trade and Service Mark of Motorola's 'Program') people realise that their 'As-Is' process mapping or Lean's Value Stream Mapping, should have been described and drawn from the clients Process-based documented MS - that's a shock and provide credence and status for the Quality or Systems Manager to be relevant to the QCD debate.

Congratulations on this 44th US president inauguration today for Mr Barrack Hussein Obama. Uplifting speech, respectful ceremony, acknowledgment of Martin Luther King legacy, citizen walks, affirming pageantry and we hope a catalyst for his next 18 months.

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Submitted by umberto mario tunesi on Mon, 01/21/2013 - 21:45

Hot Freezing

I don't mean to cool down, let alone freeze, the Commenters' enthusiasm; I just intend to remind us all, and the Standards-makers, especially, that the Standards' focus, and not only that, unfortunately, is more and more put on "documentation", than on "facts". Documentation has been made a Fact itself. I'm consulting a small company, too, they deliver consultancy services oriented to make their customers complying with regulatory requirements. And what does this company obsessively ask for? Procedures and forms, to put records on. How performing the services they deliver are, is the last of their concerns, and of their customers, too. The long-established ISO 9000 saying according to which "when it is not documented, it doesn't exist", biases any effective lean approach to any process. We can daily hammer the rock, but if we really want to make our way beyond it, using an explosive charge will be more effective. Thank you. Post-Scriptum, a striking example: in Rob Reiner's "A Few Good Men" movie, 1992, during the trial, the defence attorney asks a key testifier to show to the jury where, in the Marines' manuals, the "red code" practice is documented. Nowhere, as expected. But the prosecutor asks the same testifier to show to the jury where the same manuals document where the Marines' canteen is and how to get there. Nowhere, as expected once more: but how and where could the Marines get their daily three meals?  

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Submitted by jandell on Tue, 01/22/2013 - 05:25

Right On!

I worked for a place that took its documentation system online well ahead of other companies (early 1990's). You'd think that was a good thing, right?

Only problem was, the document that listed the other documents (yes they had one) was 32 pages long!!!!

And when we had a process problem that required some root cause analysis, the GM ordered us not to mess with "that team s**t," but rather just to write another document. Yep. That'll fix things...

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