Control of documented information
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? 
9 Replies
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
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
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.
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.
I have a different kind of issue with document management. The organization I'm working with maintain the original issue date on documents rather than updating the date when a new revision has been issued. (i.e. The original issue of a procedure for Identification and Traceability was 1/29/03. The last revision D was issued 4/30/18 to align the document with the requirements of ISO 9001:2015. 

The team here has told me that a consultant told them they didn't need to issue a new issue which is a conflict with the way my teams have managed documents in the past and the way all document control software systems behave. Please share you thoughts.
Brian, the way our documents are set up, they have the original issue date in the document header, then the revision date in the revisions section.
I would advise having the revision date somewhere in the document, along with the changes made.

Carol Wrisley-Williams
ASQ CQE
Kelly Gau
7 Posts
Mingzhi - there is a lot of different practices around Document Control. I have managed both paper-based and eQMS based systems. They are really managed the same way; one is just a physical hand-off for review/approval and signatures, while the other is electronic. I have found the system works best when there is a "Document Coordinator" to keep documents moving. If you do not have a lot of documents, or a lot of revisions, you may not need a dedicated employee for this role.This person manages the back and forth of ensuring writers/reviewers/approvers are keeping the document moving as needed, and then once it is approved, issues the document for training. He/she may also manage the tracking of training.  

As another poster mentioned, if there is a network folder or shared drive with limited access, the control mechanism it not posting until it is approved and trained. If using an eQMS system, the system can manage the availability of the documents for you.
Grace Duffy
67 Posts
This is a very valuable thread. I am pleased to see the recommendations of the contributors. I am a strong fan of document control. Not only for the reasons already stated, but because it is critical for auditing. Formal and informal. We know audits check to make sure SOPs and other documents are current and maintained. Informally, when I work with a client, I want to see how often they review their SOPs, standards, procedures, etc. as an indicator of their culture around process improvement. If the document originated 20 years ago and it hasn't been updated in the last 15, then I have to wonder what the process owner values. Key processes, at least, should be reviewed at least every two or three years. Simple CAPA activities will indicate need to validate processes affected. If there is not a good review/revision trail in the table at the end of the document, I wonder just how well that process is being followed and measured. Any process that supports a Key Performance Indicator had better be looked at on a pretty regular basis. If there is a major process redesign or a new KPI, the update log should comment that a previous process document was archived when the new process document was generated. 
With huge amount of documents we control, we allocated a dedicated team to receive, process and publish approved documents within our organisation. All these transactions are facilitated via Q-pulse software. When new/amended procedure are introduced, our document controllers ensure process owner,  stakeholders (impacted by the procedure) and approving authority are identified. After a Change Request has been raised, the new/amended procedure will be sent to stakeholders for review  and acceptance. If anyone reject/disagree on the procedure, it will go back to process owner for re-submission until everyone accepted it. Amendment history and feedbacks are retained within q-pulse. A broadcast will then be sent to release the approved documents to users. Document standard format also include title, revision number/date and associated references.

Im also a big fan of document control and i always remind our team that document control is not just simply allocating numbers.