MRP / ERP Software Systems - Small medical laser manufacturing company - ISO 13485

[janiswilson]

Hello All,

I'm a Document Control Supervisor for a small medical laser manufacturing company in CA. (I use the term manufacturing loosely since our CEO is an engineer and his focus is R&D. This makes compling with ISO13485 particularly difficult. "Design Control?? What's Design Control??? Let's build it first and then figure out the documentation later.") We upgraded our Max/MRP system in 2002 to Intuitive ERP. We're all finally getting used to it, however, the CEO feels it isn't "engineering friendly" and is threatening to buy a new ERP system. He came to this assumption because the engineering staff is unable to find part numbers of documentation they need by searching ERP. (Schematics, drawings, etc.) I was wondering what ERP systems you all are using and your feelings about them. Any input would be appreciated.

Thanks,
Janis

[ddunn]

Many MRP and ERP systems have a design control module as an add on or other source have design control systems that will interface with the MPR/ERP system.

If these are not available they Acseni by Active Sensing as a low cost solution. The problem is the interface to MRP/ERP is manual.

[Wes Bucey]

Originally Posted by janiswilson

Hello All,

I'm a Document Control Supervisor for a small medical laser manufacturing company in CA. (I use the term manufacturing loosely since our CEO is an engineer and his focus is R&D. This makes compling with ISO13485 particularly difficult. "Design Control?? What's Design Control??? Let's build it first and then figure out the documentation later.") We upgraded our Max/MRP system in 2002 to Intuitive ERP. We're all finally getting used to it, however, the CEO feels it isn't "engineering friendly" and is threatening to buy a new ERP system. He came to this assumption because the engineering staff is unable to find part numbers of documentation they need by searching ERP. (Schematics, drawings, etc.) I was wondering what ERP systems you all are using and your feelings about them. Any input would be appreciated.

Thanks,
Janis

Welcome to the Cove, Janis!
Maybe I'm the Luddite, here.

Luddite
Any of a group of British workers who between 1811 and 1816 rioted and destroyed laborsaving textile machinery in the belief that such machinery would diminish employment.
One who opposes technical or technological change.

[After Ned Ludd, an English laborer who was supposed to have destroyed weaving machinery around 1779.]

Normally, I love technology and electronic systems, but it seems to me there is a fundamental difference between an ERP or MRP (Enterprise or Manufacturing Resource Planning) being called to service in dealing with a design Document Management System and using a dedicated Document Management System to do the task.

ERP and MRP are essentially glorified accounting systems which help keep track of orders, work in process, inventory, employee hours, shipping, and some Customer Relationship Management (CRM) chores. Typically, the bulk of documents in an ERP are "records" which rarely, if ever, are modified.

Alternately, "design documents," by their very nature, are frequently modified and used as a reference in creating new designs of similar products.

The document management system consists of managing documents prior to approval and assuring only the most recent authorized version is available for manufacture once the approval process is complete. (configuration management.)

Intuitively, your boss may understand he needs TWO systems - ERP for his accounting and manufacturing tasks and an Electronic Document Management System for his design documents.

I've written extensively on the topic of document management elsewhere in the Cove. Here's an excerpt of one of the posts:

Background:
An organization wants to improve efficiency of document management by “grafting” a program over current legacy files and all newly-created files which will provide the following minimum benefits:

• Ease of Search & Retrieval (on different fields/characteristics)
• Ensure only the most recent revision is available on standard Search menu
• Automate the procedure of notifying pertinent parties a document is ready for redlining
• Maintain an audit trail for the status of documents (released or waiting for checking/approval [and by whom])
• Allow “full preview” of documents without opening native programs – i.e. AutoCAD documents can be viewed without latest revision of AutoCAD being resident on user’s computer.
• Permit “group printing” of documents, regardless of native file format.
• Maintain up to 30 security levels on any document, determining whether user has authority to create, modify, redline, view, print, copy, etc.

How do they work?
The primary feature of Document Control Software is a relational database which manipulates very small files called “metatags”, which relate to certain attributes of documents. Basic attributes are file name, revision level, author, topic, key words, type of file format, etc. which are used for field headings in the database.

By querying the database, a user retrieves a “menu” of documents which meet the search criteria. Self-contained viewing software permits a user to view and print documents, regardless of the native file format. The views can be scrolled, zoomed, and cropped (i.e. user can print an enlarged detail of a document.)

Users who have redline authority can markup documents without invoking the native file program (the redlines are saved as “overlays” in separate files without changing the original document.)

Users who have checking/approval/redline authority can be automatically notified via email when a document is ready for their review. The program will track when and whether the review is completed and maintain an audit trail for “real time” status reports on any or all documents in the review process.

By keying on the attribute “Revision level”, the program can ensure only the most recent, authorized revision is available to most users, reserving authority to view “superseded” documents to special categories of users.

An important consideration in grafting legacy documents into the new system is choosing fields pertinent to the organization. Many documents, like autocad and word documents have features which provide automatic tags (create date, author, department, etc.) [click on "properties" under File in a Word document to get an idea of already available fields.]

The problem is most users write documents which still show "valued customer" as the author because they have never explored the Properties feature.

An expense to consider is going back into each legacy document and adding the meta tags which allow for sorting and retrieval.

I hope this helps - there are many consultants like me who would come in and give your organization background on choosing the best brand for your organization. Caution is "Are they truly independent or do they have bias toward one brand?"

It seems to me simple enough to export bills of material from the EDM system to the ERP system once the final list is approved. Similarly, the final approved drawings, themselves, can be exported as jpg, gif, pdf files or document files to the ERP for coupling with manufacturing travelers that include purchase order, inspection criteria, work instructions, etc.

More questions? Just ask. Lots of experience here in the Cove to help you.

[janiswilson]

Thanks for the info Wes, it certainly gives me something to think about. I've been with this company since it's birth in 1994. I've suffered through ISO9001:1994 certification in '96 and ISO13485 certification in 2003, not to mention all the surveillence audits inbetween and a couple of FDA audits as well. Even though we managed to pass all of our audits with no serious issues, I still feel that Design Control is sorely lacking and Document Control is certainly not all it could be. Finances and a very thrifty (cheap) CEO keep us from making technological advancements in the area of quality. Is there an inexpensive solution to our dilemma? Maybe we could come up with something in-house? Thanks again for your input.

Janis

[ddunn]

Originally Posted by janiswilson

Is there an inexpensive solution to our dilemma? Maybe we could come up with something in-house? Thanks again for your input.

Janis

Try Acseni by Active Sensing. It is a low cost simple solution to Engineering Document Control. It's not the best system but it is effective and cheap.

[janiswilson]

Thanks... I'll take a trip to their website and check them out.

[Wes Bucey]

Originally Posted by janiswilson

Thanks... I'll take a trip to their website and check them out.

Just "on account of because" tell us how many design documents you have as legacies and annual production of new documents (including revisions of legacies.) How many designers? Lot of collaboration on documents with suppliers or customers or scattered sites?

Some folks get all excited about electronic document management when "shoeleather modem" is perfectly adequate.

For the first 30 years of my career, I got along fine without electronic document management. So did literally thousands of other organizations.

The difference is I used to have staff (secretaries and file clerks) performing the grunt work the computers and software do now. That means that small organizations shuffling few documents could get along with just a simple system similar to Outlook, coupled with a joint calendar, when security against unauthorized modification or access is not an issue.

The list of features I cited can easily be pared (trimmed), if necessary, from

• Ease of Search & Retrieval (on different fields/characteristics)
• Ensure only the most recent revision is available on standard Search menu
• Automate the procedure of notifying pertinent parties a document is ready for redlining
• Maintain an audit trail for the status of documents (released or waiting for checking/approval [and by whom])
• Allow “full preview” of documents without opening native programs – i.e. AutoCAD documents can be viewed without latest revision of AutoCAD being resident on user’s computer.
• Permit “group printing” of documents, regardless of native file format.
• Maintain up to 30 security levels on any document, determining whether user has authority to create, modify, redline, view, print, copy, etc.

to

• Ease of Search & Retrieval (on different fields/characteristics)
• Ensure only the most recent revision is available on standard Search menu
• Automate the procedure of notifying pertinent parties a document is ready for redlining

The other features are "nice to have" but not crucial or critical.