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1. TIME-CONSUMING COLLABORATION 2. PARALYZING DELAYS 3. GHOST OF REVISIONS PAST 4. TRAINING FALLS THROUGH THE CRACKS 5. DOCUMENT REVIEW CAN BE NEGLECTED 6. NOT HAVING THE RIGHT PEOPLE IN EVERY CHANGE 7. RELIANCE ON TRIBAL KNOWLEDGE 8. TIME-CONSUMING SEARCH FOR DOCUMENTS TO AVOID DURING THE DOCUMENT CONTROL PROCESS Gathering all stakeholders in a room to collaborate is impractical. Sending emails back and forth is inefficient. Those who use a paper-based or hybrid system are at the mercy of these methods. Switch to an electronic system that provides a virtual collaboration space. In a manual process, paper documents can be misplaced or they might sit in someone’s inbox for days and weeks. An electronic system will automate routing, follow-up, escalation, review, and approval. When a document revision becomes effective, access to the prior revision should be cut off. In a manual system, the ghost of revisions past continue to haunt users because it’s harder to control documents. Most regulated companies are required to train affected personnel on important quality documents. When the document is changed or updated, it might require re-training. In a paper system, document control and training control are separate, so training tasks related to document changes might fall through the cracks. Integrate your processes to ensure timely training on crucial documents. A review is meant to ensure that a document is still applicable and accurate. Many times, processes evolve without the documentation being updated to reflect the change. An effective document control system should ensure that the actual process and the documented process are in sync. Sometimes a change that makes perfect sense to engineering, regulatory, and quality may be next to impossible from the point of view of manufacturing without significant changes. Your change control process should involve the right people in every change. It takes a long time to develop a medicine, medical device or other regulated products, so it’s likely that by the time the product is launched, some of the people in the original team have moved on. In a manual process, this means relying mostly on the knowledge of other employees to understand the product’s history. Your system should be able to document the history of a product so there is no need to rely on tribal knowledge. Finding a document shouldn’t be like looking for a needle in a haystack. You want users to be able to search for a document and find it easily because documents that are created and approved, but never referenced are of little use. 9. INEFFECTIVE DOCUMENT RETENTION A document retention policy sounds like a process to keep documents around for as long as possible. In fact, it’s about determining when documents can be safely deleted. Your document control process should support your retention policy and not clutter your systems. © 2016 MasterControl Inc. All rights reserved. For more information visit mastercontrol.com. Learn more about this topic with a whitepaper and Slideshare presentation.
