Keeping track of documents is essential for maintaining an audit-ready quality management system (QMS). Document control software has existed in some form since the late 1980s, but has evolved over the past decade to mesh with higher-tech, business-boosting trends like automation and real-time data exchange on smart factory floors.
For more insight into modern document control, Quality asked Dave Hunter, director of product management and user experience at MasterControl, and Jennifer Sillars, product marketing manager at Ideagen, to share their top trends and tips that manufacturers should know.
Trend 1: Real-Time Collaboration
According to both Sillars and Hunter, the most ntable trend is Cloud-based collaboration. The use of tablets and smartphones to automate the entire lifecycle of documents in a virtual collaboration workspace is growing, too, and all of this is bringing new challenges to the fore.
“You think of Google Docs, real-time collaboration, and the challenge there is to marry that to a regulated space—making sure the content there is approved and distributed appropriately,” Hunter says. “That means creating a Google Docs-like experience in the creation and the revision process; and then downstream of that, making sure the documents are controlled and released appropriately to the right people, and making sure those people are trained to the new revisions.”
Sillars characterizes 2017 as “the year of collaboration by any means necessary.” Social collaboration platforms widened the sphere of influence in document review, she says, giving more people a voice. But there was a catch: As more voices were allowed front and center in the social stream promoted by various collaboration platforms, frustrations grew—especially for manufacturing companies.
“Chat only gets you so far towards a decision point,” Sillars explains. “Buyers need document-centric collaboration because they strive for excellence in business-critical documents.”
Thus, Sillars contends that 2018 will be “the year of document-centric collaboration.” As proof, she points to three concurrent trends:
Collaboration fatigue: The abundance of collaboration tools in the market has created a collaboration paradox: the more tools available to us, the more fragmented our interaction becomes. Users are tired of endlessly shouting into the abyss and will retreat from tools that aren’t focused.
The document management module within Ideagen’s Q-Pulse software allows the user to manage documentation, regulatory or otherwise, from creation right through to approval, publication, and distribution. Source: Ideagen
SaaS Supremacy: Geographical barriers and time zone differences are common barriers to document-centric collaboration. Whether due to the rise of working from home or the reality that decision makers are often on the road, buyers are looking for software as a service (SaaS) solutions to overcome these barriers. The majority of new spend in 2018 will be on SaaS solutions.
Collaboration beyond the Firewall: While 2017 saw great strides made in internal collaboration, document-centric collaboration with third parties failed to develop beyond traditional email chains. Now we will see efforts made to improve collaboration with suppliers, customers, partners, and industry groups using the same tools they are using internally. In response, vendors focus more on access control and security.
Trend 2: Configurable Workflows
The old standby with keeping documents up to date is a review policy. What’s changed with modern document control software is being able to distribute some of that workload, Hunter says, so that the person reviewing a particular document is the content expert.
“You want to make sure that the tool is flexible enough to be sending out the right alerts to the right people, relative to the right document, because one person getting inundated with documents doesn’t work very well,” Hunter says. “Having a robust review process is key in quality, but another piece to that is being able to track changes to the next revision easily, and having software that can facilitate that.”
Sillars says that the document creation phase also has witnessed an evolution in recent years, particularly in the area of co-authoring and redaction. Ideagen’s PleaseReview product, for example, allows many complex pieces of documentation to be reviewed by multiple stakeholders at the same time—tying in with the top trend of collaboration.
Additionally, manufacturers are being asked to produce more regulated documents than ever before, Sillars says, but without sacrificing time and labor that could be funneled elsewhere. For instance, a first article inspection process can be time-consuming and labor-intensive when being completed manually. “If an airline engine has 30,000 parts, then manufacturers are required to sign off every single measurement on a part and ensure that they are correct,” Sillars says. “That’s a huge task, and also time spent doing paperwork and away from actual production of a product.”
By automating the process with document control software, Sillars says manufacturers “can improve the productivity, efficiency, and reliability of their quality inspection work.” At the same time, a module dedicated to a specific process—like Ideagen’s Q-Pulse FAIR solution for first article inspections—can help manufacturers validate that a product has been manufactured to the correct specification.
Trend 3: Tighter Control
A large number of manufacturing companies still rely on “read and understand” training with their documents, Hunter says, as in: “Here’s the new revision, mark that you’ve read and understood it.”
“I think that’s a constant challenge for quality folks,” Hunter continues. “You write the procedures and send them out, but are people reading them and actually using them? And how do you really know that they’ve read it, without testing the competency?”
MasterControl’s software offers a concise quiz at the end of each document to verify that the user has read and understood it, “which helps with adoption and the understanding of the procedure,” Hunter says.
Another important aspect of document control for manufacturers is the distribution of controlled copies to manufacturing lines, suppliers, and other locations. MasterControl streamlines this process by allowing users to create customizable watermarks, sequential numbers, and location tracking. The software also tracks new revisions with automatic histories—including reasons for every change, when it was approved, who approved it, and the approver’s signature—and cuts off access to the previous version, thus preventing the accidental use of obsolete or unapproved documents.
“The tracking of controlled copies is still an issue for some customers, though it’s less of a problem now that you have tablets on the manufacturing floor,” Hunter says. “We recommend being able to track those controlled copies electronically, and to have all of your suppliers in that same system.”
A diagram of MasterControl’s document control and change control process. Source: MasterControl
Top Tips for Manufacturers
Be open to change in the first place.
Sillars: The first piece of advice we provide clients rolling out our software for document management is to think of it not just as a tick-the-box exercise but as a process which is going to be absolutely critical for their organization—which it is. Once you standardize and automate the document control process, the burden is being taken from you and your quality team. This lays a foundation for regulatory compliance and develops a framework for operational excellence.
An organizational shift is needed from managing documents as a difficult exercise and bureaucratic necessity to managing documents in order to strengthen the foundation of your business, and this is where a lot of organizations fall down. It is a culture change, from simply ticking a box to making document control work for you across the business.
Keep it simple.
Hunter: One caution from a best practices standpoint is that simpler is generally better. Usually we encourage clients to simplify their processes before they implement the system, because it’s a good opportunity to streamline. You don’t necessarily need 50 different approvals. Who really is approving it?
Focus on productivity.
Sillars: The biggest thing I see within the manufacturing industry today is a reluctance to accept technology and software that will reduce time wasted and enhance productivity. There are still a lot of manufacturers that aren’t investing in technology in regard to quality in general, but specifically in document management and internal document collaboration. They are creating documentation manually; and although they might have a system for distributing, what is the point in distributing something if it’s not a great document or has mistakes throughout it?
Ensure that metrics are clearly defined.
Hunter: Be careful with metrics: You will get what you’re measuring. If the goal in measuring a document approval process is a shorter cycle time, you may get it, but is that really what you want? People may take shortcuts along the way that aren’t desirable to get that cycle time down.
A lot of times, you’ll want to pair metrics together with other metrics. For example, if you have a shorter cycle time metric, you might want to have a quality metric along with it to balance it out. Overall, you want to be careful with what you define as success and how you measure it, and analytics—being able to pull that data out, and having the flexibility to track and measure trends—is a key part of that. Q