posted 02 February 2000 05:17 PM               

quote:

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Originally posted by Merrion:
Just wanted to let you know more about MQ1 by CEBOS.

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Has anyone actually used this software?? This is the second attribute post.

posted 09 February 2000 11:01 AM               

In other words, you type in PFD, and PFMEA, PCP appropriate field are filled in?

Is your enginnering on-site or remote?

posted 11 February 2000 07:25 PM              

We went from ISO to QS 9000 in March of 99. Cebos was a definite benefit.

We are a foundry with 3 sites and approximately 185 employees.

Cebos is a smallish company located in Detroit. There are not a lot of users yet (my guess is around 50). Their focus is on automotive manufacturing.

The founder of the company is a quality consultant who couldnāt find software to support QS, so he decide to create it. The thing I appreciate the most is their apparoach. Cebos stands for Continuously Improving Business Operating Software. It is a Business System which results in Quality, not a software package that prints tons of compliance paperwork (although it can do that too).

Support is excellent. Real people answer the phone and donāt hang up until the problem is fixed.

Since we bought it, there have been 2 major upgrades. A new client server version is
coming soon.

posted 15 February 2000 05:12 AM               

If you are working in an FDA regulated industry, any paperless system will have to be compliant with the title 21 of the CFR part 11 www.fda.gov/cdrh/devadvice/part011.html#top.

This is the FDA's section on electronic records and signatures. It has caused quite a lot of consternation among pharmaceutical and medical device companies with its requirements.

In my company (Johnson & Johnson Consumer Products), we have paper forms that are routed manually via a sign-off sheet when changes are requested. Managing all of the forms, their changes, and keeping current ones on the floor consume many resources (approximately 7 full time people to manage documentation for 500 workers). We are aggressively trying to achieve some level of paperless system for better compliance. Forms are used to record inspection data taken off the floor and for finished product release.

Part 11 is divided into roughly two parts: electronic records and electronic signatures. For electronic records, data integrity must be assured with restricted access and an audit trail if the original data is changed. Electronic signatures encompass electronic records but includes a requirement that the signature be 'authentic'.

In the current interpretation of part 11, standard email does not comply with electronic signatures since email can be forged. Most Word documents do not comply with records since MS Word does not generate an audit trail when the document is changed. Passwords many help assure data integrity meeting electronic record requirements, but does not guarentee author identification like a retina scan or thumbprint, called biometric identification.

Depending on your level of complexity and the size of your budget, part 11 compliance can be achieved. Penop Inc. (http://www.penop.com/) has developed a set of OLE objects that will permit you to embed a true electronic signature in a Word document or Adobe pdf file.

Probably the best system for right now is some kind of hybrid. If data is entered into a computer, say an SPC system or Access database, and an inspection form generated automatically, then this can be manually signed skirting the electronic signature ruling. You would still have to meet the electronic record requirements, however. This has been done for sterile water systems where a PLC dumps raw data on temperature for example into a file every minute or so and an inspection record is generated from a validated program at the end of the shift with the average, maximum, and minimum requirements.

posted 18 February 2000 11:32 AM               

quote:

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Originally posted by Laura M:
Are all the APQP doucments linked?

In other words, you type in PFD, and PFMEA, PCP appropriate field are filled in?

Is your enginnering on-site or remote?

Is their a job instruction feature?

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Sorry for the delay in responding. We have approximately 80 employees at one location. Our engineering is definitely on-site, it's in the middle of the shop.

Yes, PFD/PFMEA/PCP are all linked. For a given part (we do not have assemblies, but there is support for that as well, you would have to talk to Cebos) you enter a process flow with your own predefined processes. FMEA entries are related to processes and can be further specified as applying to all parts with that process, one part only, or all parts in product family. So work done on reducing RPNs can apply to a large number of individual FMEAs. You can then use this information to add characteristics, operator instructions, visual aids, and reaction plans to individual part control plans. For one of our home-grown modifications, I was able to use the Specifications field in the control plan to print on a packing list for outsourced processes.

I am looking forward to having SPC software (WinSPC) integrated into this package as they are planning now.

posted 23 March 2000 09:35 PM               

quote:

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Originally posted by Laura M:
I had looked at System9000 about 4 years back. Does anyone know if that survived? It didn't look that bad, but was too much $$$.

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Laura

I think I looked at this too. Try this link
http://www.systemcorp.com/Products/PC98/index.html

The company is Systemcorp in Montreal. They seem to have a new product called Process Components 98. It seems ISO based, with no QS 9000 add ons.

I recall a QS 9000 version about 4 years ago offered in association with ASQC. It seems to have vanished from their web site.

I also have had no luck with Powerway. Several years ago I took our IT guy to a trade show with the express purpose of buying the APQP module of Powerway.

It took 20 minutes to tear them away from the golf games, tee shirts, free draws, business card collection, and general sales fluffery.

It then turned out that no one really knew how to run the demo. They did find someone in the booth who would try. Two crashes later we walked away.

Now in all fairness, that was a while ago and the APQP product had just come out. It sure looks good on their web site...but as always, buyer beware.

Cheers

posted 26 March 2000 06:51 PM               

I use MS Outlook as a database for Documents (Archive Log, Controlled Doc Distribution, External Document Log, Internal Documents Log, Records Log), for Personel and Training records, for Corrective Action tracking (Non-Conformance reports and Process Improvement Notices (PIN's) which are my version of CAR's, and to maintain Supplier Records.
I also use Outlook public calendar to control the Internal Review schedule and assign tasks to my review team.

Because the company is on an MS Exchange messaging backbone I use the Public Folders to distribute this database, but it could work equally well for one person to control the database, you would just need to distrubute the information by email.
Outlook is a great freeform database. You simply create a new form based on one of the built-in forms. The new form then inherits the capabilities of the original. For example, I based the PIN system on the Outlook Task system. I created a new Public Folder containing task items. Then created a new form based on the task form. I used a few standard elements of the original form, the subject, created date, owner, priority, due date, status, % complete, completed date, and the message field. By draging the fields from the field chooser to a new page, rearranging and renaming them and then hiding the original page I had an instant new PIN database. The PIN system then tracks the progress of the PIN, and flags when it is over due. You can also assign the PIN to other people on the network for action and receive reports when it is completed (all properties of the original Task system.

Another other way of doing things is to create new fields that are specifically what you want, eg a distribution method for the Document Control system. This is much much simpler in Outlook than traditional databases and much easier to make changes later. For example, there are no limits for field sizes (single and double precision and all tha rubbish), the forms are automatically kept independant from the data.

A good book is (without wanting to fill Bill's pockets even more) "Building Applications with MS Outlook 98" from MS Press.

Now can anyone with more Outlook knowledge help me? I can't get outlook to start up in a Public Folder. I try to follow what it says in Help but I keep getting invalid switch errors. Any ideas?

posted 26 April 2000 01:41 PM               

Way back up there like George >>> Word w/Visio's flowcharting software. Works great, but it depends upon the size of your company. We are 200 at this facility. We recently opened up facilities in Ireland and China and they took the system which I designed and used them as a base for development in those facilities (much smaller in number - personnel).

Flowcharting is highly recommended by users and even auditors. Visio is the best I've used and their technical support, updates, information is great and easy to come by. Flowcharts are user friendly. Before discovering Visio, our entire system was text-based (MS Word) and people HATED it. (Not to mention excessively verbose.) Flowcharting forces you to be succinct (preventing audit traps) and it has worked for us since 1995.

posted 09 May 2000 09:40 AM               

I used it at a previous company about 1 year ago. From a QA end user stand point, I can tell you that I pretty much liked it.

But I can also tell you that it gave my IT/MIS guy fits. He was always having trouble with it and not having much luck with IT support.

If it was up and running - from my point it was very good. But down times were killers and probably took 10 years off my MIS's life.

posted 10 May 2000 07:33 AM               

I purchased the Gauge Management Module (gage to USA persons!)and wished I had not.

The support I received in the UK is non-existent. As an example, it will only print reports if you system is configured to the American date format. Not very good over here!

When I questioned this with PowerWay I was first told that there was no problem. When i persisted I was told there may be a problem and that they were looking into it.
Finally, I pinned them down and was advised that they had received several complaints and a fix was only two weeks away (this was January this year)
I still have had no fix despite trying, and the cheeky sods even tried to sell me the SPC module.