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Mike Micklewright

Lean

Use Lean Concepts to Right-Size Your Documentation System

Reduce procedures by 50% via ISO 13485 and AS9100 upgrades

Published: Monday, January 14, 2013 - 12:54

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.

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

*Includes the addition of three new procedures. Also, the 26 remaining procedures will be shorter, not longer, than their current state counterparts.

When you add up the number of procedures plus flowcharts and compare the current state to the future state, you can calculate that the overall reduction of these documents is from 58 to 26, or a 55-percent decrease. That’s our plan, and it is achievable. I’ve helped many other companies achieve the same type of reductions by showing them how to see the waste in the documents they have produced and maintained over the years. I’ve written about how to do this in my book, Lean ISO 9001 (ASQ Quality Press, 2010), which should probably have been named Lean Quality Management Systems because the concepts apply to any QMS based on any standard.

The general perception

There is a general perception that as companies “upgrade” their ISO 9001 QMS to ISO 13485, AS9100, or both, that they will experience a significant increase in the number of documents. Therefore this endeavor is viewed as a negative situation to avoid if possible. ISO 13485 has at least 18 additional procedures and six additional requirements that must be documented; however, some of these may not be applicable to certain companies (e.g., sterilization). Many procedures may already be in place, and updating existing documents to validate that the new procedures are also in compliance to ISO 13485 could suffice. AS9100 contains a significant amount of additional requirements beyond ISO 9001, but unlike ISO 13485, it has few additional documentation requirements.

Instead of looking at this situation negatively, I prefer to see it as an opportunity to review the quality manual, and as we do in the lean world when applying 5S, “sort” out the documents and sections of documents that are wasteful and do not add value. “Sort” is the first S in a 5S system and should always be applied to a document and record management system within a QMS, especially during some type of conversion such as the one mentioned here.

Within the medical device industry, there seems to be even greater apprehension and anxiety about reducing the number of documents in place, especially when the FDA is involved with auditing the system. There is this perception that you must document the hell out of everything, and once you have a document in place, you must never remove it because “they” will ask questions, regardless of whether the document adds value to the system. Over the years, a QMS grows and grows, in response to corrective actions and document-happy auditors. There’s never any effort to remove documents that have no value out of fear of the auditor. The QMS develops into a system the auditor prefers or the perception of what the auditor wants, and not the useful tool it can be, to help employees produce consistent products or services.

Obviously that’s just not right, and most good auditors would tell you that as well. Any good auditor, within the FDA or elsewhere, wants to see a healthy, robust system that is useful to and used by the employees—for which you do not want to document the hell out of everything.

Converting your ISO 9001 system to one that is certifiable to ISO 13485 or AS 9100 offers an opportunity to see the waste, once you learn how to see it, and eliminate documents and parts of documents that do not add value. The process also allows you to see the vast amounts of redundant statements, paragraphs, sections, and topics made between the same types of documents (e.g., procedures), within the same documents, and between different levels of documents.

An example of the redundancy between different levels of documents exists at the small client referenced in this article and explains why we will be removing 19 flowcharts. The flowcharts are, without exception, redundant with many of the procedures, and are therefore wasteful and unnecessary. Even though flowcharts are supposed to be easier to understand and train people to, often they are not because they end up looking like spider’s webs with the multitude of junctions and different paths. They often omit information that is extremely important, such as who is supposed to carry out each task. Regardless of the format, a procedure, whether it is in flowchart or paragraph format, is supposed to define who does what, when, and where. Also, a procedure, in whatever format, should be easy to understand and written in a process fashion in which the output of one step is the input into the next step.

Years ago, the managers at my client’s business thought they had to have flowcharts, in addition to the procedures, because they assumed ISO 9001 required them, and the registrar auditor strongly suggested it. They were mistaken about the ISO 9001 requirement, and they were led astray by the registrar auditor for whatever reason. Both diversions seem to happen frequently in many companies and lead to an increase in unnecessary documentation and a user-unfriendly QMS. Additionally, over the years, the existing flowcharts mutate into complex webs that are difficult to follow, thus defeating a flowchart’s purpose. For the small company referenced in this article, the flowcharts have been reviewed, and existing information or steps that are not currently in the procedure format (there are very few of these) will be incorporated into the existing procedures. The flowcharts will then be deleted from the system.

Integrating standards into one system

When integrating new or additional document elements as required by ISO 13485 or AS 9100 into an ISO 9001-based QMS, the goal should be to integrate the requirements into existing documents, whenever and wherever it makes sense from a process-flow standpoint. There should not be separate, standalone documents for “normal” products, medical devices, and aerospace products because that would mean the system is standards-oriented rather than process-oriented—which is exactly what you don’t want. The same is true when integrating a QMS such as ISO 9001 with an environmental management system such as ISO 14001 and a health-and-safety standard such as OSHAS 18001. One should integrate all the requirements into process-oriented documents so they are user-friendly to internal customers.

With the client in this example, we used a spreadsheet with the following columns (some project management-type columns were omitted from the example below). The first two columns represent the current state of documents. The third column represents the results of a 5S sorting, in which such words “keep,” “remove,” “combine,” “split,” “shorten,” or “modify to form or work instruction” would be indicated. Normally, there would be a lot of “remove,” “shorten,” and “combine” AS9100’s additional requirements. We also added a column for references to new or existing work instructions, ensuring that all documents are linked to each other.


Document
Title

Document
Number

New Document
 Title

Document
Reduction/ Modification

ISO 13485
Modification

Work
Instruction Ref.

AS9100
Modifications

We will later address the other three S’s of the 5S application—sweep, standardize, and sustain—to the documentation system. By going through this process, we will be able to achieve the documentation reduction results stated at the outset of this article, and we now have a road map for how to get there.

Other opportunities to decrease documentation

Expanding a QMS to include sector-specific product lines offers an excellent opportunity to review and thin out documents in an organization’s cumbersome and over-lengthy QMS. Here are some other opportunities to use lean concepts to “right size” your documentation system as I have used in the past:
• Adding ISO 14001 and/or OSHAS 18001 to your organization
• Standardizing processes across different facilities
• Purchasing and deploying document control or record control software (you don’t want to add all the existing waste to a new system)
• Purchasing and deploying a new MRP system
• Instituting training within industry (TWI) job instructions throughout the company

With a lean mindset, it is therefore possible and desirable to reduce your documentation significantly, even when converting to ISO 13485 or AS 9100.

Discuss

About The Author

Mike Micklewright’s picture

Mike Micklewright

Mike Micklewright has been teaching and facilitating quality and lean principles worldwide for more than 25 years. He specializes in creating lean and continuous improvement cultures, and has implemented continuous improvement systems and facilitated kaizen/Six Sigma events in hundreds of organizations in the aerospace, automotive, entertainment, manufacturing, food, healthcare, and warehousing industries. Micklewright is the U.S. director and senior consultant for Kaizen Institute. He has an engineering degree from the University of Illinois, and he is ASQ-certified as a Six Sigma Black Belt, quality auditor, quality engineer, manager of quality/operational excellence, and supply chain analyst.

Micklewright hosts a video training series by Kaizen Institute on integrating lean and quality management systems in order to reduce waste.

Comments

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...

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?  

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.

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