November 7, 2018

Medical Device Document Control: 4 Common Issues to Avoid

Medical Device Document Control: 4 Common Issues to Avoid

Poor or outdated systems for managing documents can pose unnecessarily large risks for medical device companies dealing with an already staggering (and increasingly daunting) number of documents each day.

According to a report from McKinsey & Company, employees spend almost 20 percent of their time searching for and gathering internal information. In addition to the risks to safety and compliance, poor document control is a massive productivity killer.

We've shed light on four of the most common and damaging problems plaguing device companies today, as well as general strategies for remediation and improvement.

1. Mismanaged SOP Changes

Making changes to SOPs, and validating them, is anything but fast. It involves multiple people and stretches across multiple functions. Relying on manual or paper-based processes in this context often invites serious communication lapses, such as verbal hand-offs or quick paper-based notes that get lost and untracked.

This problem is common within companies using outdated management systems. Investing in a dedicated document control tool can mitigate these issues with features such as notifications when SOP changes are made that alter testing parameters, reports that show who has and hasn't completed training on updated SOPs, and more.

2. Over-Versioning

Many companies struggle with a large number of outdated “rogue” copies of outdated documents waiting to be found and used by accident. When versioning gets out of control, orders from suppliers can be bungled, production schedules can be disrupted, and unexpected downtime due to errors that lead to equipment problems can kill operational efficiency.

Automated management systems, implemented by a skilled outside systems expert, provides a single source of truth where people can collaborate, share, and review mission-critical documents in a controlled environment.

3. Deprecated Emergency Procedures

Emergency plans used in the laboratory absolutely need to stay current at all times. Too often though, these are filled with lists of outdated emergency contacts, directions, and references to equipment that may or may not be in the lab anymore. Worse still, hazardous materials may not be accounted for if the emergency plan is outdated.

Newer, more capable document control systems link change management initiatives to emergency procedure updates to account for changes, trigger new employee training requirements, and keep supervisors in the loop to current statuses.

4. Revision-Heavy Reports

Final reports produced by multiple, cross-functional groups can be unwieldy and frustrating. Varying goals between groups can lead to endless editing, making these working documents tough to finalize. Poor document control only throws another wrench into the system when different groups work from different versions of the same document, leading to total confusion and dangerous errors.

Effective document control software, when implemented correctly by an experienced third party expert, can enable important routing and review functions customized to your company's specific workflow. Combine this with a reporting process established by an experienced expert, and these problems can be largely eliminated.

Contact us today to learn how we can pair you with the perfect expert for implementing document control software, improving document control processes, and training your staff through hands-on instruction designed for maximum efficiency and effectiveness within your QMS.

Topics: Quality Systems