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ISO 9001 - QS-9000 (Now TS 16949) Information Exchange

Before you criticize, remember this is only one implementation strategy and it is a general one. I am not here saying "If you want to know about..... See my book, Chapter 12, Section 3." The info is free. If you have comments, I appreciate your sharing them with me!

The intent here is to give some pointers and direction from my experience and that of others. My only authority in writing this are my several successful experiences.

I do not want to imply that this is the only strategy nor that this precise strategy will work for you. It has worked, in variation, for me several times, however. In addition, the steps are steps but are not dependencies - it is not always the case that starting one depends upon fully completing the other. Many steps overlap and some can be done concurrently. Common sense must be used here. Don't let your effort get bogged down in frivolous details - especially at this point. Just remember that every company, large and small, is different and different mixes of methodologies will be necessary for each company and each sub-division of larger companies. TAILORING is the Key Word.

I also want to point out the MOST IMPORTANT PART of a successful effort at the start. You will hear me many times talk about a Resident Expert or a Knowledge base. Folks, I'm not kidding when I saw someone within the company must really know and understand ISO 9000 (or QS 9000, as the case may be). If you do nothing else, dedicate someone to this end.

No matter how you look at it, everyone, starting with management, has to learn ISO (or QS) 9000.

Get together and define an Implementation Team and a Team leader. The larger your company, the more important this is. If you have more than 50 or 100 people you should make very sure the team is cross-functional. Also define a Steering Committee if you're more than 100 souls. The Steering Committee should include all major players (upper management) but should also have hourly representative(s). The broader the spectrum of activities represented the better.

Steering Committee meetings (if you are that big) and Implementation Team meetings should be formal and weekly. Don't stretch out the meetings to every other week. Make sure there are meeting minutes and, just like in management review meetings (which you will have if you don't already), make sure each old business item is discussed so it can be marked as addressed or as still a problem (shades of a non-conformance/corrective action system).

So - You're going to implement in-house. Here's some help. And some advice. One major piece - if you are going to 'do this in-house', you will need a resident expert. Someone in your company will have to do some studying up on ISO or QS. I highly recommend you have someone in-house who is at least somewhat knowledgeable in the document you plan to comply with BEFORE you proceed. Or consider a consultant to get you started. Your toughest problem will to get adequate guidance for interpretation.

Let's assume this is a customer mandate. Before you do ANYTHING - Are you SURE of what your requirement is? Have you discussed in detail with your customer their specific requirements to ascertain whether you have to be registered to QS 9000? ISO 9001? ISO 9002? Or do you simply have to have a 'PLAN' to reach compliance? Or do you have to just be compliant to one document?

The FIRST major step in the process is to DEFINE THE SCOPE OF YOUR BUSINESS. You will be discussing this with the registrar during negotiations. And they WILL negotiate - or at least some will. Entela is an excellent registrar and is known to bargain. Don't blindly accept any single registrar's price! But back to the point - Define the Scope FIRST!

The SECOND step in starting a program is to dedicate a person as the company ISO knowledge source. Depending upon the size of the company, this may be a person whose entire time is dedicated to the project (and it IS a project!) or it may be a person who is dedicated a day a week to the project. Either way, every company needs to have an internal "ISO Expert". This expert will become the company knowledge source.

You must now define who has Authority over the Quality System. This may be the same person who is in charge of the ISO implementation project. If your company is large enough to have one, it may be the Quality Assurance Manager. The standard requires that someone be charged with the task of ensuring (by the way, NEVER use the work insure unless you are sure that is what you really mean - verbiage can be everything) that the system is maintained and that it is effective.

At the stage where you are defining 'authority' it is time to begin your company Organizational Chart(s). Each 'job classification' must be listed. In smaller companies, each person may be listed. Always list positions or job classifications. You may add peoples names to the boxes or use a cross-reference list. A small company may have one chart. Larger companies, as logic tells us should happen, have more. Sometimes many, many more. Think of GE or GM. Lots of org charts.

Companies which hire consultants screw up 90% of the time by failing to provide a dedicated person for the consultant to 'Download' Information and Understanding to. The perception is "We will go out and find someone who can set this up for us and we'll be back to business!" It grieves me more when I come in and I'm introduced to Ms. or Mr. X who is to assist me and work with the project only to find they have provided a temporary employee. Folks, in the long run I guess I don't care a whole lot. BUT - You are undermining your effort and you are providing an expensive education to a temporary employee which would be much better spent educating a full-time employee.

The awful truth is, just as is OSHA compliance, this is a new business process. Period. And it will come at a cost despite the standard "You'll save in the long run" rhetoric. Not every company will find savings. Most will, in the long run, but there are many which will find it is an expense, like complying with OSHA regulations, with little or no return on investment. Real money it will cost your company. AND - SOMEONE has to run it! Every company needs to have a resident 'ISO Expert'. It is a system and someone needs to know how to understand it as a system.

A word to the wise: Companies have a tendency to 'take pride' in their quality systems manual and their documentation in general. Things like the Quality Policy are often debated at distant locations for a long time in larger companies. When a company spends too much time in the effort it becomes a noose. Make speedy decisions. Debate is good, but get it done. One company I did some work for promised corporate tier 2 procedures by a certain date. Upper management held numerous meetings all over their territory. The met at each facility. They met at corporate. Must have spent $100K or more on all the meetings when you consider real costs. Six months late with their procedures, they are STILL not finished. They did 'finish' them all three months late, but 80% were totally void of significance (they were really corporate work instructions - tier 3s) and addressed ISO 9000 only obliquely. They are still trash as they have no one who understands how to do tier 2's and documentation in general. They have too much 'ownership' in them to readily accept advice, guidance and criticism.

In the case I am thinking of, Corporate DOES expect facility tier 3s and facility specific tier 2s to be completed on schedule, though. Well, it's hard to have all your sub-documents when the documents which define them are not finished. Sorta like asking someone to gas up a car which hasn't yet been built to get ready for a trip next year. The point of this is, someone has to have authority and knowledge of the spec to help get things done and done correctly. After a while corporate and everyone else is spinning their wheels.

Advice: get good advice early on and get the documentation done!

You would have a difficult time, at best, building a car or a house without a frame (backbone). Systems are no different. At this time the quality systems should be defined in consonance with current systems. From this systems backbone the Quality Systems Manual can be written in coordination with the company policy and the documentation coordination (numbering) scheme. I cannot stress how important the definition of the systems backbone is at this point in the project. In order to get your systems backbone defined, start flow charting jobs and systems which exist. Ask everyone to write down what they do.

Now is the time to think FLOW CHARTS. Have your consultant or internal 'ISO Guru' give a short course on flow charting. Folks, it will make your life 100% easier if people flow chart what they do rather than write text descriptions. When Apple made the Macintosh, they ripped off ideas from Xerox - it is now what we call a GUI (Graphical User Interface). Mac has had it for years and Microsoft is still struggling to 'get it right' with Windows 95 and Windows NT (same situation as Plug-and-Play - introduced in the Macintosh in 1985 - Microsoft isn't anywhere close, except in their advertising...). The point is, the whole world is going to pictures (icons). They are easier to understand than plain text. As one plant manager said to me, "WOW! This (how their systems work together) is really making sense to me now!" Believe me - it's worth it. A client of mine from several years ago went thru registration with tier 2 documents which, other than the face page, were entirely flow charts. If you do anything, reduce your documentation while you make it understandable using flow charts. Flow charts are Pictures of Systems.

As you begin getting your flow charts together, put a call out for copies of all forms and tags. Where a form or tag exists, a system exists which (probably will have to be documented - flow charted). Flow chart the system. Put the flow chart and the form or tag in your new (see below) Procedures Master History Binder. With this preliminary look at your systems, you should be able to start looking at Defining Your Documentation Systems.

This person should by now have set up several binders for project tracking and historical purposes.

• The Project Master Binder should be made up of copies of just about everything. Notes, correspondence with registrar(s), etc. I cannot give you a definitive index or sections because each program is different.
• The Procedures Master History Binder should be filled with all systems documentation. Tab the binder and keep EVERYTHING. If you finish and sign off a procedure, the entire development history should be there. You might want to separate 'versions' with a sheet of coloured paper to make it easy to distinguish between versions.

Again - everything from the first draft flow chart to the signed off draft should be in this binder. It will amaze you as you watch while the systems develop. You will see an increased understanding.

When you talk to the registrar, there will be discussion about a Pre-Audit (Gap Analysis) is what it is. An audit to 'find out where you are' in respect to the spec. One thing you might do is think about cheaper alternatives. Your consultant can do it or he/she can find and arrange for someone. But - also call your local ASQC chapter. May have a local group who does audits for FREE (yuppers, I said FREE). Some have restrictions. Some groups will audit just about anyone. I think the Cincinnati OH chapter limits audits to 'committee members' companies. But do check it out. They're really good and again,, generally they are FREE! Well, then again, you really ought to buy the lunches. Cheap price to pay. Also check with local colleges, universities and community colleges. Many have courses and/or lists of people who can help you. I know one gal who has a regular job but takes a day off here and there or vacation time when she does audits and such. She also teaches a course at a local community college in ISO 9000 Implementation and Internal Auditing.

	The. Deming PDCA Cycle	QMS Implementation	FMEA Information	APQP Information
Auditing Information	8-D Problem Solving	Statistics	Error Proofing (Poka Yoke)	Brainstorming
Identifying Waste	Pull Systems	Lead Time Reduction	Planned Maintenance	Quick Setup
Discovering Change	Process Capability - Cp vs. Cpk	Histogram. Animation	Process Loop Animation	Taguchi Loss Function
		Fishbone / Cause and Effects Animation

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This page last reviewed or edited: Friday, August 17, 2012 7:20 AM (Coordinated Universal Time [ZULU] -5 hours)