Control of documented information

Control of documented information

Posted by Mingzhi Deng on May 23, 2019 12:04 pm

Would anyone like to share with us your good practices on control of documented information? for instance, do you have special person taking care of it? What software applications are used for? How do you improve the access to the documents and how can you make sure documents to be reviewed and approved before releasing to users? 
Major Deng, Mingzhi (ASQ CMQ/OE)

Re: Control of documented information

Posted by Timothy Whetten on May 23, 2019 4:54 pm

We have a small group of people who have write access to an otherwise protected shared drive. They place new versions of approved documents there.

Generally, users access the documents through a web interface.

Over time, the people who maintain the document folder now also have technical document writing responsibilities. In addition to maintaining the document folder, they author new documents, along with subject matter experts (SMEs), and manage major document revisions.

Tim Whetten, CQE

Re: Control of documented information

Posted by Elinaldo De Araujo on May 24, 2019 9:01 am

Hello Deng,
Regarding product and process development documents we use the Windchill PLM  software from PTC Inc.

Regarding documented procedures, manuals, etc; we use the document management system (DMS) inside SAP.
We do not have one single person in charge of the whole document control of the company. The licenses and technical support for these systems are managed by IT area. Each department of the company has at least one trained key use, familiar with the workflow of document approvals and release, in order to support other users of the company In case they need.
I hope that helps your research.
All the best.
Elinaldo Araujo

Re: Control of documented information

Posted by Paul Dionne on May 24, 2019 9:02 am

We use the same software that we sell to our clients. It includes automatic routing for collaboration on files, automatic routing for approvals, creates a PDF version for distribution and integrates with training management. You can find out more by googling Intellect QMS

The cost of QMS software needs to be justified with a business case showing how you will reduce staff effort and reduce costs associated with errors. If you need help building the cost-justification case, please contact me. I have a few resources we can go over together.

Re: Control of documented information

Posted by Jeremiah Genest on May 24, 2019 9:11 pm

The critical thing in document management is to decide what type of documents you have and how to manage each of the three: functional, records and reports. Based on what these documents are, and what the risks inherent in using them, an appropriately robust document management systems can be developed.

A lot of my thoughts on this have been written on my blog, a good place to start is here: https://investigationsquality.com/2018/09/14/document-management/

I think its pretty critical to understand how document and knowledge management shade together when developing or improving upon this system.