New job, what did I get into? Just love it……….
Need to update to ISO 9001-2000, current registered to ISO 9002
Time is limited (need Quality Manual & Procedures to external auditor by 10/1).
No money for outside education, unless absolutely required.
Small job shop – 10 employees
Because of lack of business, Quality position has been limited. So I am having a rough time of finding OE.

Last job was bigger company. Someone else was responsible for Quality Manual and main procedures. I was responsible for the Prototype department procedures and other documentation. I’m trained in QS9000 and have done QS9000 internal auditing. Is it required that I have additional training to do internal auditing or is a way I can show OE, that I have the requirements to audit to ISO?

Need to revise Quality Manual & Procedures, which currently is very lengthy and set up by numerically to ISO 9002. Importance of maintaining registration for future business is mandatory, so we are looking for a way to get through this first audit, and then making additional improvements. Hopefully then, outside training will also be available.

How many months of OE will I need to show the auditors in December?
Trying to get a feel for process approach?

I know that most of this information is out here somewhere, but I’m starting to panic…… :frust:
So short and sweet, would be great.
Thanks!!!

Not a good situation.

1) Take the QS blinkers off :)
2) Research what a process is, how to map it & how to audit them.
3) Draw a visual representation of your business to include in your QAM
4) Make sure you have the 6 required procedures (Maybe maps, up to you)
5) Try & map as many processes if possible - Not strictly required (Unless your training is pants) but it does help looking at systems that way.
6) Pray your interpretation matches your assessor.

Here are some test docs, many, many other good examples here.

V,

Aside from the above good advice, for $25 I think you can become a member here with download access and download lots of great examples of q manuals, process map examples, procedures, etc. submitted by others. Sounds like it would be a good investment for your company. And, of course, advice is free for any specific questions from lots of experts on the Cove!

I know that most of this information is out here somewhere, but I’m starting to panic…… :frust:
So short and sweet, would be great.
Thanks!!!

First of all: Welcome to the Cove. :bigwave:

Next: You will not be the only one in this situation. Unfortunately, many have postponed (procrastinated?) the upgrade to the last moment. At the moment I'm about 10 minutes away from going on a vacation trip (I'm actually on vacation now), but I'm quite certain the other Cove dwellers will aid you in your quest.

And hey: Don't panic... and good luck. :agree:

/Claes

New job, what did I get into? Just love it……….
Need to update to ISO 9001-2000, current registered to ISO 9002
Time is limited (need Quality Manual & Procedures to external auditor by 10/1).


Hello and welcome :bigwave:

The grand idea is Not To Panic, but to sit back enoy your coffe and take your time scaning this site. Im sure you will find ample support here. enough to take some of stress from your mind anyway.

I should know since I am in the very same position as you are, BUT WHY I AM STILL PANICKING? then again it might just be my personality.

I recomend you use the search function diligently as well as the related links function at the bottom of the current thread you have open. Exellent items both!

Now Im sure regular contributors will be most generous with tips and good counsel but be warned they have a tendency to add clever remarks such as: "This problem was ventilated sometime last century - go look fore that thread". Please accept them as they are. Wisdom and expericnce, especially with ISO, comes with age. These guys are very ... experienced.

Cheers!

Hello and welcome.

First thing, as already stated, don't panic (easier said than done). Don't be afraid to take a step back and take a breath throughout the transition.

I would agree that getting access to attachments would be very beneficial. There are a number of quality manuals, process maps, and other procedures posted all over.

Have you performed a gap analysis yet? There are several checklists that you can use and this would be helpful in determining what you need to do. You may be surprised that you don't have to do as much as you think. Since you are 9002 certified you already have a good groundwork for everything.

Make sure you have the support of everyone and that your coworkers are willing to assist you as needed.

Start at a high level and get an overall picture to determine what absolutely needs to be done and then break it up into chunks that are easier to get done.

There are plenty of people here who have gone throught the same thing that are more than willing to help. Don't be afraid to ask any question. No matter how silly you may think it is, someone here has probably asked it before. :)

I would suggest that sit down and simplify the entire system. Spending money on training can be kept to a minimum if you phone the government agencies or local business to find out the cost of a one day course for auditing. Most times you can join another company to keep costs lower.

As for your manual and procedures, I have found the best way to do this is to keep it simply and write exactly what is being done in the plant. You can always add to the system later.

It seems to me like you have lots of time, there is an article in Quality Progress Magainze on the change over in less than a year. Very good helpful hints.

Kim

A better place for $25?

Link removed as it appears to be an advertisement for a book.
Marc

A better place for $25?

But it's kind of difficult to ask a book questions and get good answers:vfunny:

Kim is right. You do have plenty of time, even though it may not seem like it. We actually made the transition in less than 3 months.

Keeping things simple is also good advice. There's no need to put in extra detail if it doesn't serve any purpose.

And always remember to relax. It's just a job :D

My advise would be to get your auditor to come in and do a pre-transition assessment. That way you will know what your gaps are in the auditors eyes. (then close them)

Don't worry about not understanding the process approach, most auditors don't understand it yet either.

Also don't worry about changing the numbering of your old documentation, that doesn't matter. Just provide a cross reference table somewhere to show where the elements in the old documentation meet the new standard.

Like the others said you probably already have 99% of what is required from your 9002 stuff. Most likely a little look at the process interactions, what goes in - what comes out - what is required to make the input into the output - and what are the next process' that use the output of this process as their input.

Another area that 'we' needed to address was customer satisfaction monitoring. I think it was more our specific area that was causing the problem, but you might want to look at this.

BTW, you mentioned that your bosses say it is essential that certification is maintained - but you can't have any extra money for training! This to me is not showing much of a commitment to the system (5.1 Top management shall provide evidence of it's commitment to...the quality management system...). You cite a lack of business as the reason for the shortfall in funds, but then what happens if you lost the certification because there was no money for training (doubtfull I know). You said yourself that certification was necessary for new business. Where is the money going to come from now? I think you need to talk with your senior management about their priorities, if certification is so important, then training to maintain certification is even more important. (you gotta spend a little to get a little)

Reading through the GAP analysis our Assessor did for us in 2001, these are the points they said we had to cover as a minimum to become compliant to ISO9000:2000 from ISO9002:1994

1) Determine the sequence & interaction of our processes.
2) Communicate to people about meeting customer, Ststutory & Regulatory requirements.
3) Establish Quality Objectives consistent with the Quality Policy
4) Include Opportunities for Improvement & need for changes to the QMS during Management Review (MR)
5) Include Customer Feedback in the MR
6) Include Follow Up actions from the previous MR in the MR
7) Include competancy needs on Job Descriptions.
8) Evaluate effectiveness of Training.
9) Control Customer Intellectual property.
10) Monitor Customer satisfaction.
11) Use the Quality policy & Objectives to facilitate continual improvement.

Not much in there from 2001 about processess, as already mentioned a lot of assessors just dont understand them.

But since then, I have become a firm believer & supporter of process mapping, as our customers are also pushing us towards TS16949.

You cannot simply pretend your QS procedures are textual processess for TS, they wont accept it. I dont know whether this will extend to ISO9000 registrars, I guess its going to be the luck of the draw whether you get a competent assessor or not.

My advise would be to get your auditor to come in and do a pre-transition assessment. That way you will know what your gaps are in the auditors eyes. (then close them)

Don't worry about not understanding the process approach, most auditors don't understand it yet either.

Also don't worry about changing the numbering of your old documentation, that doesn't matter. Just provide a cross reference table somewhere to show where the elements in the old documentation meet the new standard.

Like the others said you probably already have 99% of what is required from your 9002 stuff. Most likely a little look at the process interactions, what goes in - what comes out - what is required to make the input into the output - and what are the next process' that use the output of this process as their input.

Another area that 'we' needed to address was customer satisfaction monitoring. I think it was more our specific area that was causing the problem, but you might want to look at this.

Right On!

I completely rewrote our Policy Manual, but I have not yet converted text procedures to process maps. I did not change our document numbering either, and the last page of the manual is a list of Level II procedures. My plan after the upgrade registration is to review these procedures during Internal Audits throughout next year to determine where process maps will supplement or replace text.

I'm attaching my rough draft policy manual. You will note two areas that are incomplete. Our Auditor is performing our Desk Audit on site for us next Tuesday, the 22nd. I have rough hand sketches that I will run past him before I put all the work into creating these two pages. The measurable objectives and management review were the two biggest implementation challenges for us.

Do not worry, if the system in place is good most is in place. As far as numbering, keep what you have but cross reference it. Lots of info here. Contact your registrar, many have info packets and suggestions to make a smooth transition.
The QM will need to be adjusted, less is best, remember it is generally an introduction to your company's QMS.
The SP's, I would just add to them if they fall short. Since time is limited and you more than likely wear more than one hat. You can reduce and improve them for the surveillance

Thanks everyone for your suggestions and support. I just need to step back, relax and take one day at a time. All the information is here, its just that there is so much of it. Like 75 forms for 10 employees, they wouldn't have time to do anything put paperwork. :eek: No wonder most of them don't see the advantage of ISO. But they give me a lot of support, so we will get there, and then they will see the added benefits.

Again Thanks for the support.
Vickie :bigwave:

Thanks everyone for your suggestions and support. I just need to step back, relax and take one day at a time. All the information is here, its just that there is so much of it. Like 75 forms for 10 employees, they wouldn't have time to do anything put paperwork. :eek: No wonder most of them don't see the advantage of ISO. But they give me a lot of support, so we will get there, and then they will see the added benefits.

Again Thanks for the support.
Vickie :bigwave:

Vickie:

Here is my take. The biggest difference is in the process ID. Begin with that. Once you do identify your processes, then begin to go through your Level I documents and see which still apply, which you can dump, and which new ones you need to create. Do the same for your Level II. More than likely, your Level III and Level IV will not change in substance. You may want to renumber them, but it is not required.

For each document/form, ask yourself two questions:
1) Is this document/form necessary?
2) Why is it here?

Keep your paperwork to a minimum. With 10 employees, your total documetation should be less than 1 inch thick.

Hope that helps

Vickie:

Here is my take. The biggest difference is in the process ID. Begin with that. Once you do identify your processes, then begin to go through your Level I documents and see which still apply, which you can dump, and which new ones you need to create. Do the same for your Level II. More than likely, your Level III and Level IV will not change in substance. You may want to renumber them, but it is not required.

For each document/form, ask yourself two questions:
1) Is this document/form necessary?
2) Why is it here?

Keep your paperwork to a minimum. With 10 employees, your total documetation should be less than 1 inch thick.

Hope that helps

DB- I agree with almost everything you said, the only part I disagree with is your last statement. I don't undersatnd how you can say that, do you even know what VP's company does, do you know what the Regulatory requirments are, to make a blanket statement that with 10 people documentation should be less that 1 inch thick IMO is bad advice. They may need lots of documetation based on what they are doing, maybe they only have 10 people but they have 50 different processes they perform. Like I said JMO.

DB- I agree with almost everything you said, the only part I disagree with is your last statement. I don't undersatnd how you can say that, do you even know what VP's company does, do you know what the Regulatory requirments are, to make a blanket statement that with 10 people documentation should be less that 1 inch thick IMO is bad advice. They may need lots of documetation based on what they are doing, maybe they only have 10 people but they have 50 different processes they perform. Like I said JMO.

You are right in your caution that size of the organization does not necessarily equate to complexity. However, my experience is that most organizations have way more documentation than they need. Even though they may have 50 processes, having a goal of 1” thick documentation is not bad advice (IMO). Perhaps my statement was stronger than it should have been, but then again, I’ve worked with many job shops (some were QS) that had far less than 1” of paperwork. Here is a sample breakdown:

QM: 10 pages, including company profile, org chart and master process map.
Procedures: 25 pages (figuring about 15 procedures and some being multi-page)
Forms: Only have masters in the QMS, keeping to the minimum you might have 12?
Work instructions: Once again, only masters, and only those that are “fixed”. Most of the work instructions will be routers, prints, control plans, and things like that, which might not be in the QMS (examples maybe). Once again, perhaps 12.

So now we are up to less than 60 total pages. Note, I have not included documents of external origin or records. But other than that, you’re well below 1”.

You are right in your caution that size of the organization does not necessarily equate to complexity. However, my experience is that most organizations have way more documentation than they need. Even though they may have 50 processes, having a goal of 1” thick documentation is not bad advice (IMO). Perhaps my statement was stronger than it should have been, but then again, I’ve worked with many job shops (some were QS) that had far less than 1” of paperwork. Here is a sample breakdown:

QM: 10 pages, including company profile, org chart and master process map.
Procedures: 25 pages (figuring about 15 procedures and some being multi-page)
Forms: Only have masters in the QMS, keeping to the minimum you might have 12?
Work instructions: Once again, only masters, and only those that are “fixed”. Most of the work instructions will be routers, prints, control plans, and things like that, which might not be in the QMS (examples maybe). Once again, perhaps 12.

So now we are up to less than 60 total pages. Note, I have not included documents of external origin or records. But other than that, you’re well below 1”.

DB- I agree most companies do have too much documentation, there are also quite a few that do not have nearly enough documentation. I guess it all depends on what industry you are in and how heavily it is regulated. :truce:

Vickie,

I agree with db, start with the process. If you are new to the business of your new company, get with the order entry folks, the shop floor folks, shipping, and management. Find out how your company decides what to make, how to make it, etc. With the small company size, it should not be too hard to get in touch with the process. Look at your current manuals and review them with the people who are doing the stuff documented in them. Condense, flow chart, and/or toss things, as you see the need to fulfill the new standard's requirments.

Sounds like your fellow employees are behind you, and should be able to help you map out exactly what they do and how they interact on a daily basis.

Good luck,

Joe

New job, what did I get into? Just love it……….
Need to update to ISO 9001-2000, current registered to ISO 9002
Time is limited (need Quality Manual & Procedures to external auditor by 10/1).

How's it going Vickie?

Some of the new biggies of ISO92K are Quality Objectives - Define a few upper or corporate level objectives and they don't have to be just "quality" related. Then have some supportive dept level objectives. Example: On time delivery is corporate level objective and maintenance downtime for a production supports it. After all if the line is not running then you can not get the customer the product.

Next biggie is customer satisfaction and how to measure it. Our registrar has openly admitted this is the first thing they will look at every time. If our customers are happy they are likely to be more lenient. How do you measure customer satisfaction effectively and not be a huge pain? Usually you just ask them. How? Many companies are going the survey route which is ok but quite often only the slightly ticked off customers fill these out. If they are happy they may not bother and if they are thoroughly ticked they will just pitch it and not use you. Maybe I will start a new thread and ask How to measure customer satisfaction? Great hope that helps and this forum is a great resource. I am personally likely to join soon as I see many benefits for the $25 I just wish I could get my company to pay for it. :(

How do you measure customer satisfaction effectively and not be a huge pain? Usually you just ask them. How? Many companies are going the survey route which is ok but quite often only the slightly ticked off customers fill these out. If they are happy they may not bother and if they are thoroughly ticked they will just pitch it and not use you.(

Everywhere I've worked they had the survey thing going on, faxed or mailed. You're absolutely right - I generally only received about a 30% response. I am the purchasing agent at my current job, and I have to admit - they become the bottom of my low priority tray.

Our Sales Manager and I have decided to try a different route. We are working on a short survey and a rating system. We plan to have each sales rep. survey the customer during routine sales calls. They call on the customers regularly anyway - this will take up about 10 minutes once or twice a year (we haven't decided yet). This way we avoid only getting responses from the "slightly ticked off customers". We also avoid wasting time (and trees) faxing or mailing only to get no response.
This will also ensure that the survey ends up getting to the right person.

This annual or 6mo survey, in conjuction with customer complaints and our hit/miss ratio for quotes submitted, is how we intend to gage customer satisfaction. We'll see how it goes!

Cari,

That is pretty much the system I have set up in my company. Our sales guys administer surveys (Chosen random from the system based on their sales panners). These are geared toward an aministrative level (the people actually in control of awarding the business or taking it away). We also have a second survey with different questions that our Managers administer, geared more toward operations. Gives us a pretty good overview.

:bigwave:

C - Nice!
I didn't think about the "geared toward operation" side. Who does the Manager contact? The buyer as well?

Well, my business in tranportation. So the Managers are contacting the people working in the Shipping and/or receiving areas of different businesses. This allows me to record perception based on local terminal facilities (drivers, local customer service reps etc.).

The same customer could end up with two surveys, but we usually are not talking to the same people based on the questions. It is really neat to see if the perception at both levels match up!

Thank you - you've given me some food for thought. I'm going to bring this up to the team and see what they think.

More than welcome, I guess thats what the formum is all about! Believe me, I have received more food from thought from the Cove than I have contributed thus far! :)

Wow... lots of good advice here. I'll chip in my 2 cents and hope it helps. I agree that if you can get your registrar in to complete a pre-assessment, you may be able to focus your efforts where you need to. I do however recommend that you at least have a QM and the required procedures in place before you do that.

As I see in some of the replies above, I also believe in the keep it simple approach. I have found it easier to work on the requirements using a top down approach... Start with the Goals and Objectives of your organization (start with basic goals of your organization = xxxx units per month, reduce scrap/discard by 10% over last year's average, 100% on-time delivery, 0 lost time accidents, etc). When a parent company is involved, some of these goals come straight from the head office. Those may help you understand what is important to your organization and what details you may need to put into your Quality Manual.

The Quality Manual can be as simple or complex as you wish to make it. One of the transition courses I attended led the class to believe that our QM could be 2 pages long. In reality, we ended up cutting about 15 pages from our former QM, but our manual is still about 45 pages. Our choice to keep it this long. I believe that we probably could have gotten our manual down to about 5 pages if we really wanted. You may wish to start with a "canned" QM and tweak it. That may help to get you less worried about your deadline?

Once you have a QM, make sure you have the minimum required procedures. I recommend that you use flowcharts liberally, a picture is sometimes worth more than 1,000 words. Two things I use to help reduce the volume of our procedures is to (1) include a flowchart of the process and (2) define the roles and responsibilities of those involved in that process. Keep it as simple as you want, as long as you can show that what you have documented meets the requirements of the standard, represents what goes on in your organization, and is effective.

Those highly documented - detailed work instructions can be left alone as long as they support what your higher level documents are saying and represent the current process? Why reinvent the wheel? Can you simplify them with flowcharts? probably, but you may not need to...

From my experience, the two biggest changes we needed to address with the new standard were competence and customer satisfaction. Our old system did not directly address either of these issues, so we had a big learning curve with these two. In fact, we are still in the process of addressing competence issues.

Customer Satisfaction on the other hand is something we have basically pooled all of the various pieces of information which may represent whether or not a Customer is satisfied (survey's being just one small piece of that overall picture). We have basically flowcharted the various pieces of information (market share, surveys, customer visits, customer requests, customer complaints, customer report cards, etc.); these represent an input into our Management Review. Our Management Review then makes a determination if any actions are needed to improve what we are seeing? we also continue to monitor the various pieces and look for improvements over time... A flowchart and some roles and responsibilities and we call it a procedure. :smokin:

Not sure if any of this helps, or if you would want to duplicate some of our efforts? but keep it simple where you can and good luck. E

How's it going Vickie?
Things are going well, I have put to use many of the great suggestions and ideas that I have received. Qualilty Manual started out canned and is now almost treaked to our company. Working on leaning the procedures that were previously wrote like novels, with doors leading everywhere. Would be an auditing nightmare for our company. No really value in them, except maybe they meet the standard.
so......I'm off and running.
Thanks again :bigwave: