“The real world is where the monsters are.
―
The journey from paper-based to a digital QMS could be challenging and full of monsters, regardless of where you are in that journey, being able to identify these monsters will help you arrive to the wanted destination. Focusing on Small and Medium businesses, in this article I will shed some light on journey stages that you will go through, trying to indirectly describe the shape and color of each monster you will face, or have already faced, depending on where you are in your Journey.
Stage 1 – Need Identification:
The need to have a QMS in place usually pops up to surface when the company is starting up, in many cases the goal is far away from achieving better quality in delivered products and services. Instead, the goal is to bootstrap and be able to sell products in certain markets or to certain industries that require compliance with either standards or regulations, like ISO 9001, ISO 13485, 21 CFR – Part 820 or many others.
Some companies mistakenly conclude that they do not need to build a Quality function. “Let’s get an external part time consultant to tell us what needs to be done, after all and at this stage, QMS is a checkbox”. Everyone is happy – “We killed the first monster that prevents us from bootstrapping”!!
Stage 2 – Building a Paper-based / Manual System:
Your part time QMS consultant is now onboard, everyone is getting excited about the first presentation that will unveil the QMS strategy. The meeting starts and the consultant starts to explain how QMS will be built as a manual system.
“Don’t we need a digital system to manage all of these processes”, a clever person in the room asks.
Unfortunately, this question is kind of expected, and there is a ready-made slide for it, with 10 “difficult to argue” reasons on why a digital system is not for your company (at this stage).
End result slide in the presentation is about a folder on a shared drive that contains files:
1. SOPs
2. Form Templates
The goal is simple and clear, SOPs need to be revised each time the process is changed, and Forms need to be printed, filled, signed and scanned multiple times on each record creation and approval (e.g., CAPA or Complaint).
“Why not filled electronically?”, same clever person asks.
“Compliance reasons, wet signatures are required!”, simple and direct answer.
Stage 3 – Struggling:
Survival audit is in the coming weeks, what you currently do is totally NOT in-line with SOPs that were established long time ago, most quality events were not recorded in file forms (team was too busy to print and scan). The team is very dissatisfied with the amount of work they need to do to maintain these records. Moreover, work cannot be done remotely.
“We need to get our ducks in a row”, An executive says. Action Items:
– Establish a Quality Function to be responsible for QMS (Who is the lucky quality manager to inherit this mess?)
– IT to provide better digital means than the shared drive (Browser Based Document Library?)
Stage 4 – Growth and realization:
Business is expanding, product is becoming popular and your company now serves different markets, conclusions are now made that Quality is not just a checkbox, Quality is an essential part of the business, and without it, the reputation of the company brand will be on the line.
The manual QMS you have is not up to this challenge, and simple questions like “What is the trend of customer complaints” cannot be answered.
The following needs are very clear now:
– Digital forms and workflows to govern the process we have and to ensure consistency.
– Moving from content (files) to data that can be understood and analyzed.
– Accessibility to remote employees is key.
– And much more.
It is now clear to everyone that a move to a digital system is due.
Stage 5 – Digital QMS Selection:
Now that you are ready to select your digital QMS, be prepared for some dangerous monsters.
The selection needs to be done very carefully. After all, the digital system is supposed to make your life easier, not the other way around, and last thing you want, is to end up with a system with one of these characteristics:
– Was built using old technologies from the 90’s and cannot evolve to address requirements of 2021+.
– Difficult to upgrade (especially after you configure and customize).
– Limited when it comes to configurability (you will need to adjust your process based on the software not the other way around).
– Requires coding to configure (Implementation consultants visit for weeks and months leaving you with thousands of lines of code and scripts that you can never maintain).
– Moving your configuration to a production system requires repeating a lot of manual work.
– If it exists: Analytics function is not built in and requires moving data to external lakes.
– Cannot scale and causes lots of performance issues for your users.
– Bad user interface and usability.
– Bugs are countless.
– Compliance & Validation is a challenge.
– Integrating with external parties like suppliers is a rocket science and costly.
– Cost is ridiculously massive (especially after adding implementation, hosting, upgrade, support, and customization fees).
Stage 6 – Digital QMS Implementation:
The size of monsters you will face in this stage really depends on how correctly you made the selection in the previous stage. In all cases, the biggest monster is the decision on how to go about moving from the manual system that evolved over years to a digital system. The options are:
1. Scrap the old manual system (or big parts of it), sticking to the out of the box solution provided in the digital system you are moving to. This would be your only option if the system you are moving to is not configurable, or if implementation services are not affordable.
Advantage: Adopt best practice in a ready-made solution (could be better than what you have in place).
Disadvantage: You must rework your processes and SOPs to match the digital system (not the other way around)
2. Configure processes in the new digital system, to match your existing process and established SOPs.
Advantage: Your processes and SOPs will not be impacted by digitalization.
Disadvantage: You are possibly inheriting wrong implementations instead of moving towards a solution that is driven by an out of the box best practice.
Disadvantage: Implementation could turn out to be very costly, but could still be justified compared to the cost of changing the process itself if you include all the related organizational knowledge.
Selecting one of the options above really depends on the maturity level of the current manual system you have in place, and in some cases, you might end-up adopting a hybrid approach where you implement some out of the box processes as is (or with minor changes), and configure some other processes to match what you already have.
Stage 7 – Going live with a digital QMS and evolving it:
The most dangerous monsters are in this last stage (not only true in video games), if mistakes were made in previous stages, then monsters here will be really damaging, especially if the digital system is not working as you expected.
Finding out that the digital QMS system you selected is not working as you expected, is the biggest monster that you could face in this whole journey, because after all the investments and efforts that were made, and after your data has been moved to the new digital system, going back in time to a previous stage is not something that will be entertained.
On the other hand, if you ended up with having the right system in place, and it is helping you to manage Quality of your products and services properly, then congratulations, you have killed all monsters successfully, and you can enjoy the fruitful benefits of digitalizing QMS, these benefits are countless and will make a huge difference compared to a manual/paper-based system.
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