Hi, I'm now working in a medical device company, and we had an electronic documentation system in terms approval. Uploading of documents to the system is being done by Document Controllers(one) and send to review/approval electronically. The issue we're encountering right now is that, customer documents came in like a marathon (like 70 a day, or maximum 200 a week) but the system we use is like a turtle(we could only upload 12-15 documents a day). Uploading process takes 15-18 minutes per document, final process (replacing the old revision) takes 30 minutes for small files, for bigger files 1hr minimum. We've been suggesting to have an alternative procedure to speed up the review process but the management prefers to use it because if we don't we will have a major compliance. Pls correct me if I'm wrong but, it is more critical issue if we have a new revision of document from the client and we still use the old revision because it is not available in the electronic system, just because the electronic system we had is really slow and they need to wait for document control to enter it to the system before they could review/see the new document. Sometimes the revision was overlapping, especially if the client sends two to three revisions in a week.

Any suggestion or comments, pls let me know. I don't know anymore how to make them realize that we need to improve the current electonic system we've got to meet the documentation requirements. Thanks.

Regards,
Geraldine

I have a hunch the large number of customer documents per day means one of two things:

Every customer document is NOT a product revision, but merely an order for existing versions of products you make and the revisions are increases or decreases in quantity or changes in delivery date
OR
They are actually custom orders for a specific NEW variation of one of your product lines.If the first alternate is correct, you can modify the approval process to eliminate choke points. (We can discuss this on or off-line if you supply more details.)

If the second alternate is correct and you are actually getting 70 custom revisions a day for product categories, you need to revamp your entire system to increase your capacity to do business or your business will implode from long delays, irritating customers and driving them to competitors.

So we can help you more, tell us about the character of these 70 documents per day.

Hi, I'm now working in a medical device company, and we had an electronic documentation system in terms approval. Uploading of documents to the system is being done by Document Controllers(one) and send to review/approval electronically. The issue we're encountering right now is that, customer documents came in like a marathon (like 70 a day, or maximum 200 a week) but the system we use is like a turtle(we could only upload 12-15 documents a day). Uploading process takes 15-18 minutes per document, final process (replacing the old revision) takes 30 minutes for small files, for bigger files 1hr minimum. We've been suggesting to have an alternative procedure to speed up the review process but the management prefers to use it because if we don't we will have a major compliance. Pls correct me if I'm wrong but, it is more critical issue if we have a new revision of document from the client and we still use the old revision because it is not available in the electronic system, just because the electronic system we had is really slow and they need to wait for document control to enter it to the system before they could review/see the new document. Sometimes the revision was overlapping, especially if the client sends two to three revisions in a week.

Any suggestion or comments, pls let me know. I don't know anymore how to make them realize that we need to improve the current electonic system we've got to meet the documentation requirements. Thanks.

Regards,
GeraldineHello

What are these documents? New orders, changed orders, or changes to specifications, etc.?

How can you even review 70 of these a day to decide what needs to be done to comply?

My first thought is to treat each new doc as a contract ammendment and requote the business at a higher cost and with a greatly delayed delivery time. Hit them in the pocketbook.. you'll quickly find out if these changes really matter.

I tend not to give realistic advice, they are the customer after all, but 70 changes a day? 2 or 3 revs a week? I hope you are getting well paid for all the customer induced chaos!

Ever had any home renovations done? Surprised at the "extras" bill? If its good business for the trades, its good business for you.

In automotive, often the only money to be made is as a result of customer changes.