Let’s face it. There are very few people who truly enjoy using elaborate paper based QMS. Truth be told, filling in and filing compliance paperwork is complete drudgery. It consumes so much time and gives so little back. Depending upon the complexity of the system, filing errors can be extremely difficult to detect. Non-conformance handling requires manual orchestration and often consumes significant management time. And if you want to see a general overview of your compliance status or to identify trends, well strap yourself in for the proverbial ten day camel ride as you strive to compile and collate that data from your paper records. And the most painful part of the journey has to be the ever-stressful preparation for the accreditation audits.
So why on earth do we keep doing it? Why don’t we switch en-masse to electronic QMS systems that are 100% paperless? Is it cost? Is it fear of the unknown? Although compliance is stressful, it is business critical, and maybe you just like to feel the quality in those paper filing folders?
Most often it’s that you cannot make a convincing business case to make the switch. The bottom line matters in most organizations, and a proposition to spend more money that doesn’t have a revenue generating or cost saving upside will often flounder. If time savings don’t result in headcount reduction then the organization is not making a financial gain from the investment.
And yet, some organizations do invest in a paperless system. It’s enlightening to talk to them after they have been operating paperlessly for some time. None of them would countenance the thought of going back to paper. In general, they are gushingly positive about operating with a 100% paperless system. Here’s their top-ranked feedback:
- It’s fully paperless. There are no more folders. All filing is totally automated. Everything is in one place so we can seamlessly review all phases of audit, non-conformance and CAPA.
- It’s so fast and simple to do everything. Everything you do is automatically documented and filed. Related items and activities are automatically linked together without any user intervention.
- It enforces our processes and eliminates all of our documentation and filing errors. It’s impossible to avoid responsibilities or to leave something unfinished. The system keeps track of everything and repeatedly reminds you. It also highlights open and overdue issues for key management so nothing slips through the cracks.
- We used to spend lots of time orchestrating the handling of non-conformances through all phases, including CAPA. That’s completely automated now and really saves us a lot of time.
- We’re always ready for an accreditation audit. We can see from our dashboards that we are in good shape so it’s a lot less stressful than it used to be. We use the dashboards to walk through every issue raised by the auditors.
We notice other changes too. They tend to exhibit a greater interest and focus on improving the effectiveness of their quality processes. This is particularly interesting because it addresses risk to the organization and it’s community of connected parties. Risk is intangible until an adverse event happens. Then it has a disproportionate impact.
It can often be easier for very small organizations to make an effective business case based upon efficiency alone because frequently their quality management team borrows production personnel to carry out aspects of their compliance operations. By minimizing that impact on production personnel you can often demonstrate meaningful savings that can be offset against the investment.
So, what should the ingredients of the business case be? Cost is important. Paperless compliance platforms are much more affordable than they used to be, particularly since the arrival of Software-as-a-Service cloud platforms. Being better at quality and risk management is really important. Your brand reputation and the future prospects for your organization may depend upon it. For some industries, the lives and personal safety of your employees or customers may even depend on it. Going paperless creates the opportunity to be better by eliminating all of the drudgery that consumes so much time and giving you a lot more time to plan and operate strategically. Having up-to-the-second trend data at your fingertips creates the opportunity to be better. Enforced processes that cannot be avoided creates the opportunity to be better.
Paperless is better.