Hi every one
its my third week in my new job, Quality Assurance Engineer,i am 25 years old, worked in QA for about 7 months only, graduated from Industrial Engineering in Alexandria University Egypt, had some studies and project in Q.A in my School days,

my new job requires me to be the coordinator with the consultant that will come help me in getting the company certified, it food industry any way, so in th elast three weeks i was reviewing the MESS :frust: i found from the IGNORED QMS since a long time, we were certified ISO9001:1994 BUT no body follows now, nothing at all...i had long time with papers on my desk trying to figure out whats going on , i had some problems to be solved with IT dept :argue: . and communication probelm with the organization so i tended to work on correcting MY DEPARTMENT's procedures till its solved,
now its time for me to fit in , i need to get ready for the consultant, getting in with the processes in all the factory is the first step i am starting tomorrow, but i need help on the Gap Analysis step, i am good reader and i spend much time studying when i need to, i am sure iw ill find much help here to keep me guided , since my manager is the GM and not a QA manager, i am the only QA person, its very challenging job for me, a step forward for the factory will be ten for me! any information to guid me will be highly appreciated.. thank you so much
Best Regards
Tanahy

Sounds like you are well on your way to a successful position in quality. My advice to you is don't try to re-invent the wheel. Use the QMS you have in place and work on bringing people back to it while making the adjustments with your consultant to bring it in line with the new standard. If the company was certified under the old QMS, it should be structurally sound even though it has to be re-implemented. Chances are that most employees there are already working in line with the old system although it may not be closely followed and/or documented. If you work within a framework they are already familiar with it may be easier than trying to change everything at once.

Good luck on your new job. Feel free to ask any specific questions as issues come up.

Dave

Thank you so much Dave,Starting from tomorrow,i will melt into the process and THEN get back to my desk when i am finished with that and the pain in my back gets away :) and yeah i will always ask when i need help..

Best Regards

I think you are asking the right questions and are showing a good attitude. You can do this, though it will be difficult and a long process. :whip:

If the QMS is not being followed in any way, I would ask if it is a system that the people are not happy with and why. People sometimes resent a QMS as a burden and resist it. This is not a good working atmosphere.

For a gap analysis, you can make an audit plan that asks the question "Is this being done?" for each element of your QMS. The audit plan should include enough blank space to write down your observations as you examine the QMS elements. The audit will include both a review of documents and interviewing people working in the processes. You can compare the activities and their documents against the QMS and take notes of what is being done per the QMS, and what is being done differently.

You can make a list of each element not being followed and a brief description of the "gap", and discuss the findings with the plant GM. I would include a series of blocks that can be used to show progress in correcting the gaps. I envision this looking somewhat like a matrix.

For each element that is not being followed, a Corrective Action must be proposed, approved, performed, assessed and then closed--or not, if the element is not "fixed" the Corrective Action process will be continued or even repeated until a followup of the process shows that practices match the QMS.

In industries like food processing we certainly can't be re-inventing processes as we go along, but I would do a round of audits that include asking the "whys" to go along with what is not being done per the QMS. If the people are not following the QMS, there may be good reasons. If they have a better way, you can recognize it. If not, they must be convinced to follow thew QMS or the problem will repeat itself.

This will require a close examination of the standard to which the food is being processed--not the QMS, the higher standard that the QMS has been made to follow--I presume there is such a standard.

If there are elements of the system that can be changed to match the new practice because the standard permits them, you can change the documents at this point. There will be followup audits to see if the changed process is being followed, but corrective actions need follow up checks too. So you would be revisiting these elements in either case.

I hope this helps!

Thanks Jennifer,
ofcourse that helps, I already prepared the checklist, and well, people were somehow used to work with the QMS, but they "LIKE MANY" didnt like the restrictions and the feeling of being audited and so on "resistance to change and too much rules", but teh great thing is that i have the complete management support, your reply is VERY useful for me and actually, i prepared MY audit procdure and forms are almost done, so i am about ready to go
thank you so much
Tanahy

Oh good, I'm glad to be helpful.

Lots of people don't like restrictions on how they work, but they may soften up if their suggestions for possible changes are seriously considered. Quality systems that do not absorb the workers' expertise can be difficult to follow when the workers believe their expertise is not recognized as valuable. Auditing is a pain for these people, who view auditors as policemenn and can be defensive, or even hide inappropriate practices.

Changing behavior is a slow process but it can be done. Winning the people's trust is an important part of that process. I think you can do it!

...my new job requires me to be the coordinator with the consultant that will come help me in getting the company certified, it food industry any way, so in th elast three weeks i was reviewing the MESS :frust: i found from the IGNORED QMS since a long time, we were certified ISO9001:1994 BUT no body follows now, nothing at all...i had long time with papers on my desk trying to figure out whats going on ...
Tanahy

Hi Tanahy.

I am also a quality engineer but I am with my fourth company now, and it is the third one I am helping develop a QMS in accordance with ISO9000. I've helped the first one register to the 1994 version, and the second one was registered to the 2000 version. My current company wants their system developed around the 2000 version, but they are not interested in the official registration at this time. I've learned a lot of helpful tips along the way and I'll try to pass a few of them along to you here.

1) A list of key business metrics is important.As you are asking questions during the gap analysis, also try to find out what measurement is MOST important to each department. Try not to have more than two metrics for each department, and not more than 15 for the company (or plant location). Compile your list, and try to also help everyone understand that one of the purposes of the QMS is to help drive improvement in those metrics. You want everyone to know that the QMS is their to help the company, and not just there to document who is not doing what.

2) Avoid attempts to "flowchart" the whole business.
I speak from experience here. This will embark you on a long journey of many wasted months, with an end product that will not match the current processes because they will change before you are done. Instead, allow flexibility in each department for them to document their own processes. If flowcharts make sense to them, great, if words make sense, that's fine too. The important thing is that they are THEIR processes, and they need to own them. Try to keep the procedures at a high level. By a high level I mean have them only document what they do at a level similar to what they would describe to a relative, or someone outside the company. There's no need to document every "nook and crany" of activity. Also remember not to spend too much time on procedure/work instruction writing, they don't have to be perfect and they will change anyway. Keep the focus on the metrics.

3) Audit around Plan-Do-Check-Act.
Develop you internal audit checklists and Gap questions around PDCA. Plan - do they have a plan? (procedures, work instructions, key metric), Do - are they following what is written? (and is the metric improving?), Check - do they have a key metric? how do they know what they are doing is good for the company?, Act - do they take corrective actions when the metric shows a negative trend? or when repeated/significant nonconformances occur?

I've found asking the questions this way helped me better organize the QMS. The consultant should also be helpful to you.
Good luck.
Andy 7/7/04

Despite the title of your thread, do not consider yourself "alone" or try to implement the QMS "alone" or you will fail for sure. No one can do it alone and have the QMS mean anything. It has to be supported by management at all levels, especially at the very top level, and you must get help and cooperation from everyone in the company. Some of that help can come from here, but much/most of it must come from within your company. Good luck!

Good luck with your newest "project"! It will be a big one, but you have the right attitude. I noted that you were looking for a gap analysis. There are a number of good ones out there -- already printed out in a spreadsheet program. If you do an internet search, you will find one. These gap analysis tools list the many requirements in ISO 9001:2000, arranged by element in the standard. They typically phrase the requirement as a question. If you then use that gap analysis and the guidance in ISO 9004:2000 and ISO 9000:2000, you can do a very thorough gap analysis and have a report created at the same time.

I also agree with the person who posted regarding the lack of use of the previous QMS. You might also want to consider a "satisfaction survey". :bigwave: The customers of the previous QMS may have some excellent suggestions for making the system more user-friendly. That has been my experience with a QMS that has fallen out of use -- it was too hard for people to use. That's why I only recommend the gap analysis in a pre-written format. Otherwise, you just have to work hard to incorporate the ISO standard into the way your company does business. Don't fall for one of those packaged ISO-in-6-months deals.

--Jodi

Thank you every one, this is all very helpful for me and i will sure let every one know when we the system is running and when we get certified
Best of luck for all
Tanahy

To go with the others,

look at what is already down and see if it is workable to go towards the 2000 standard. The most important step I'd recommend is to get on the shop floor with the supervisors AND the employees who are doing the work. Compare what the old QMS has to what is being done now to conduct business. Then wrap that into the 2000 requirements. But you have to get out there and get a good sense of what is going on. Get the heads of the departments in your business to help you write out what they do in each department, even if it means they tell you, and you then write it out yourself.

It isn't all that bad an idea to use flow charts, either. You can at least use them to give yourself an idea of how your business' processes flow while you write the QMS. You may not end up using any charts, but they do have their uses, and can be used for the process map in your QMS to show how everything in the business flows. They can also be used for how each department flows.

Good luck,

Joe

Tanahy,

If the previously documented QMS has not been maintained/updated since its implementation/development, I would NOT expect it to reflect the current methodologies. You have to keep in mind that a QMS is a "living" organism. The company's methods SHOULD change as process and product improvements are developed (this is a good thing). So don't be discouraged if it appears that they are NOT compliant with the documents on hand, just ensure that what is currently happening meets the intent of the companies policies, external regulations, and the ISO 9001 requirements.

Also be open to "interpretations" of the ISO requirements. It is NOT a prescriptive set of standards, but is a guideline that should be viewed with a jaundiced eye towards what's best for your company, their customers, and your community.

Thank you ddhartma
Being on the shopfloor is my first step and its working so well now, workers and supervisors are showing very nice attitude especially when they are convinced that we are doing that FOR IMPROVING THE SYSTEM, which will reflect on thier working conditions for sure, some other people are showing a very strange reactions, probably because i am the youngest engineer in the factory, and they have like double my age of experience, :) but oh well, one way or another there must be a way to fit all into the system
thanks for help regards
Tanahy

Youth has the advantage of not inherently getting caught in the "We've always done it this way" mind set.

It certainly sounds like you are on the right track, and that your coworkers on the floor have given you their support. This is the most important thing.

Good lighting, and safety practices like lifting equipment and clean floors can do wonders for working conditions. I encourage you to look at the workers' comfort as one important means to raising morale and lowering defect rates. It is okay to do this while reviewing the QMS as "Man" is among the most basic factorsa within the Cause-and-Effect analysis for improvement.

Be well!

... some other people are showing a very strange reactions, probably because i am the youngest engineer in the factory, and they have like double my age of experience, :) ...

Tanahy,

I can relate! I just started work this past October (graduated from uni last April) and my first major deliverable was to transition the company from QS 9000 to ISO 9001:2000. I was 23 when I started (turned 24 a couple of months ago). Age has been thrown at me on many occasions - not just at this job, but at co-op placements as a student.

The best advice I can give you is LISTEN. When half of the people at your company have been working there longer than you've been alive, you can bet they have some pretty good ideas about how to make things more efficient. I know a lot of engineers - some, my classmates! - who headed into the workforce with a totally cocky attitude, thinking they were going to change the face of the industry - and while initiative is good, there's a way to present it. Contrary to what many of us youngsters think, things *don't* always work out the way the textbook says they will - real life is a completely different playing field than the assume-vacuum-pressure-and-perfect-insulation situations that we experienced as students.

So, my advice - don't get overwhelmed - pick things apart into small chunks that are more chewable and don't choke you - and get feedback from those around you. It's a neat position to be in, getting into a project from the start and having the ability to mould your system into something better - but make sure that you take into consideration the wealth of *real-life* experience around you. They've been doing this job for years - they've got to have tons to tell you!

Just my :2cents: - take it with a grain of salt (preferably on the rim of a margarita!).
Cheers,
-R.

Tanahy,

The advice so far has been very good.


Stay Positive- While it is sometimes frustrating, it isn't rocket science. You can do it.

Take it section by section and ask yourself "what do I have to show that supports this requirement?" If you have evidence that you are doing it, don't dwell on it and move on.

Keep it as simple as possible, if you do not need it to meet the standard, don't include it. You can (and will) expand in the future to benefit the business.

Relax- As long as you pay the bill from the registrar, you are going to pass.

Regards,

Carl-

Tanahy,

I believe you are facing the problems most of Management Representatives face. The top management appoints the MR, and the MR has to do all the work. It is hard should there be no commitment / cooperation from the team. I have seen many of these cases.

My advise is to do things a step at a time. And always try to get involvement of the top management in decion making and pushing the system and people to work. U cant work alone.

Regards.