For compliance managers in any industry, it’s imperative to provide tools and practices for a company-wide commitment to quality. Whether the industry is construction, government, education, healthcare or manufacturing, there are usually plenty of different compliance regulations to meet.

In that kind of a corporate climate, being as efficient as possible at ensuring compliance can be a significant time-saver. Not only that, but efficiency at implementing some of the necessary compliance solutions can ensure that human error has been reduced to a minimum. And in today’s environment of technological advancement, efficiency is often the synonym for automation.

Automating compliance processes is something any company can benefit from, regardless of the industry. Still, automation is beneficial for those organizations that need to comply with ISO and FDA quality standards. Let’s have a look at three compliance issues that can be solved by automation:

Staying on Track with Quality Objectives

Automation of quality management doesn’t only mean that it will be easier to complete compliance and quality management processes in the technical sense. It also helps everyone in the organization be aware of the organization-wide quality objectives. Losing sight of them makes for inconsistent employee performance, and the organization might fail at building a culture around compliance and quality.

Since quality standards and goals are visible to everyone in an automated system, it makes it easier for the employees to meet them. And, in the case of collaboration with external teams, it ensures that the same quality standards will apply to them.

Corrective And Preventive Actions (CAPA)

CAPA is an integral part of any automated QMS, and it’s crucial to staying within compliance standards. In case of any undesirable events, the CAPA can help identify its cause. After that, it’s only a matter of prevention and coming up with a plan that won’t let it happen again. A procedure that helps set everything back on track is necessary. By having an automated solution that handles it, everyone in the organization will be aware of how best to handle any unwanted situation and resolve it quickly.

Document Control

An automated system creates a centralized hub for all organization-related activity. And when it comes to daily functions of an organization, document control is one of the most critical processes. Without a well-organized document control system, you’re inviting chaos into your organization (and most likely inspection as well.) Since FDA-regulated and ISO-certified companies are required to have a document control system, it’s clear to see how problems in this area can affect the whole company. Keeping up with audits and making sure that all necessary documents are created, stored and shared according to the company’s quality standards helps maintain a team that’s more accountable and informed. Therefore, automating document control can significantly improve an organization, not only with compliance but with the day-to-day operation as well.

Today’s business revolves around complex rules and regulations. To ignore any of them is a fatal mistake, but to comply most efficiently, you need a staunch ally. An automated compliance solution that can meet your company’s unique needs could be the difference between success and failure.

With Intellect’s QMS solution, you don’t have to develop your workflow unless you want to customize the existing ones. It works out of the box and makes sure you have an easy time automating your organization’s quality management and compliance processes.

Rapidly changing technologies primarily drive Digital Transformation, but its adoption is dependent on a carefully planned out strategy. Big companies and organizations that adopt digital transformation have their goals and digitalization objectives predefined. It helps the process of digital conversion to be fully integrated into the business process rather than optimizing ad-hoc functionalities.

In short, real benefits of digital transformation do not lie in optimizing individual technologies used rather than the overall integration and dependencies of the whole system.

Quality dramatically impacts all aspects of business such as profitability, brand equity and overall operational efficiency and business performance. Thus, an enterprise quality management system is placed at the core of the value chain of each business, and most medium-to-high level enterprises implement it as a backbone of their business operations.

So let’s lay out a few steps to creating a digital transformation strategy for your eQMS integration.

Assess Your Quality Capabilities - Needs, Strengths, and Weaknesses

As mentioned above, you need to lay out a structure and define what quality management aspects you need improving. Surely there are weak points in your workflow that need addressing both in technical and cultural aspects of your business operations. Digital transformation doesn’t happen overnight, and as with any automation or new technology adoption, your business operational efficiency will be impacted. It will happen either because of new technology integration and it’s compliance with existing architecture, or training and education needed for it to be adopted by employees.

Understand Different Approaches That Can Be Taken

Enterprises try to integrate eQMS as an ad-hoc solution to solving specific pain points of the system such is CAPA and doc control. Again, quality management system should be at the core of a value chain as it affects multiple modules such as CRM, MOM, PLM, and SCM. If ERP orchestrates the business processes, the eQMS plays a role in quality management throughout the whole process chain. If you are looking for a digital transformation of a specific aspect of a business, you should look into different approaches to achieve this. However, in long-term, a well-designed strategy around streamlined architecture backed with an eQMS is hugely beneficial.

Determine the Gaps in Functionalities and Invest in IT Architecture

We’ve already mentioned some of the main obstacles when adopting new technologies and making integration to existing business operations and workflow. The effect of this can be dampened by reevaluating the whole business operation processes and pointing out gaps in architecture and operational efficiency that could be improved. Investing in IT architecture of one medium-to-large enterprise can present a considerable expense; however, if planned out correctly it gives a proportional ROI.

Your Next Step

Regardless of industry or organizational complexity a great eQMS is defined by five essential elements - process integration, flexibility and extensibility of the system, centralized monitoring and management, compliance enablement, and culture and quality compliance. Most organizations today build their own QMS solutions or push ERP to their limits because they fear their business operational efficiency will be negatively hit throughout the transition period of digital transformation.

And this is where Intellect eQMS comes into play. We’ve built an out of the box eQMS that is compliant with most industries or business verticals. A solution that can be highly customized to adapt to your business processes and enable a smooth transition to digital transformation of your Quality Management without damaging your workflow.

For businesses to keep up with the competition and respond to the change in consumer demand, they need to let go of outdated interfaces and practices. But before a company can make the digital transformation, it needs to decide how ready they are.

Beyond adapting to new IT systems and equipment, business culture will also be transformed. Not only will leadership need to establish a digital transformation strategy in relation to systems, process, and technology, but it needs to manage any resistance from employees who may worry about being replaced by new technology.

As you prepare for your digital transformation, alleviate the fears of your employees by empowering them with knowledge through updates and training. Your compliance team should also be involved in the early stages of your digital transformation to ensure alignment and keep all departments on the same digital page with regards to conducting business in full compliance with all laws and regulations.

In preparation for the transition, establish where your company is currently and what your goals are. You also have to determine if your organization has the resources and expertise to get you there. There are three main categories that your company is probably currently in:

Legacy system -  A legacy system refers to old method technology or an outdated computer system. These systems do not integrate with IoT. And without the ability to connect via IoT, a company with a legacy system will be out of sync with real-time operations. These systems will not be fit to meet the demands of today’s digital environment.

Web-enabled – While not ideal for digital transformations that are data-intensive, web-enabled platforms provide some data interaction. They also have a more user-friendly interface.

Digital ready – Your digital transformation will be hindered if your company doesn’t have a digital-ready culture. Digital-ready cultures are those that are highly innovative and whose decision-making is data-driven. If digital ideas and solution are your default option, then your organization has a digital-first mindset and are, therefore, digital ready.

In preparation for a digital transformation, your company must have a digital-ready culture and systems. One of the crucial first steps towards your digital transformation is deciding the right type of cloud that meets your company’s specific needs. Choosing between public, private, or hybrid will depend on your budget, scalability, and how much control you want to maintain.

You will also have some decisions to make on services within the cloud itself such as Software as a service (SaaS), Platform as a Service (PaaS) and Infrastructure as a Service (IaaS). Each comes with their own pros and cons.

The next step is data migration. It’s a chance for you to eliminate the unnecessary data that will only clutter your new systems, slowing down the migration process. Think of data migration as an opportunity to start fresh with only the relevant data you need. Remember that as you migrate to a completely new system, you need to rethink best practices. What worked in the past won’t be as effective.

Remember that adapting to your new system will not happen overnight and means developing a plan that will keep your business running as changes take place. As your company embraces digital transformation, leadership must champion the change to help align employees.

In my previous post, “Workflow Automation Can Be Scary!”, I outlined how workflow automation can be scary to many employees, as it creates uncertainty, introduces transparency and takes away control.  In this post, I will explain three well established strategies that will help address each of these concerns. 

1. Listening is key to managing the fear of uncertainty

Management has to invest the time to listen to everyone’s concerns.  Often times, the concerned employees just want to be heard, understood and feel like their concerns were taken seriously.  This can also provide key information that will be helpful in the design and implementation of the process.  It may be that adding a certain report or business rule is all it takes to alleviate some of the concerns, and it may also improve the workflow process when automated.  In addition, by listening, management can uncover and address some of the hidden concerns which may be less about the automation itself, and more about the reasons for it, i.e. will they lose their jobs. It is amazing how many problems can be avoided by simply listening.

2. Communicating the benefits is key to addressing the concerns around transparency

Transparency can stir fears in employees that they are distrusted and will be monitored by management after the automation.  It’s very important to address this by highlighting the many major benefits that transparency and visibility  provide to all employees in the process, not just to the organization. Some of these major benefits include: 

Saving time: Rather than employees spending their time chasing people and paper forms or searching through emails to get status information, a well implemented workflow automation project will provide key dashboards and reports that let everyone know the status of each process.

Providing peace of mind: A typical workflow system will send alerts and reminders to each person when their part is due.  This streamlines the workflow and increases peace of mind when running these processes.  The employee is no longer concerned that they may have forgotten to complete a task as the workflow platform keeps them alerted throughout.

Reducing frustration: Often times, the processes that are being automated are causing a lot of frustrations to many people.  Automation will improve their work life quality, and eliminate wasted time and rework due to mistakes.

Increasing productivity:  The goal for automation is to free up employees’ time to focus on higher value work rather than shuffling paper or manual processes that don’t add value.  They are able to be more innovative and produce more with less manual effort.

By communicating often and clearly the benefits of transparency and visibility from workflow automation, fear and distrust can be turned into anticipation and excitement.

3. Turn process owners into change agents to address fears around loss of control

Process owners can provide a lot of critical insight into the culture, uniqueness of the processes and skillset of the employees who will need to change.  Their resistance to change can be reduced greatly by listening to them, valuing their input and experience, and leaning on them early on in the implementation and even in the platform selection process.  They can provide valuable information that can influence the selection of the workflow solution as well as the design and architecture of the implementation.  By involving the process owners in the design process, their fear and uncertainty turns to pride and security, as they become the thought leaders, owners of the new automated process and designers of the system.  They will then turn into champions and change agents in the organization, helping with training and adoption of the system.

In conclusion, cultural resistance is one of the biggest obstacles to a successful workflow automation project.  Organizations who address this obstacle early on and directly with the strategies listed in this article will improve greatly their chances of project success. A well implemented and adopted workflow automation project will quickly become a success story given all the benefits and time savings it provides for everyone.  Within a few weeks of launch, most people will find it hard to imagine, or even remember, that they were running the process any other way.

If you’d like to learn more and create a Proof of Concept app with Intellect, click here for a free trial. http://www.intellect.com/free-trial

Many companies are using business process management platforms to automate internal workflows that streamline their processes, increase regulatory compliance and digitize forms. From a business perspective, automation saves money and time, reduces training costs and lead times, and ensures a consistent experience for customers and employees.  This should be common sense for everyone in the organization, however, for many employees, workflow automation means change, and change can be very scary. 

Companies develop their culture and processes over many years and they become ingrained in people, policies and habits.  Thus, changing culture and processes is one of the most difficult challenges to overcome, especially when transitioning from manual processes to automated ones.  Most employees are afraid of change for three main reasons: Workflow automation brings uncertainty, creates transparency, and takes away control.

Workflow automation creates uncertainty:

Change always creates uncertainty in companies, and especially when the change is due to automation.  Is the automation intended to replace jobs with the software?  Or perhaps the automation is intended to cut costs and therefore it’s an indication that the company may be facing financial difficulties.  Could that mean layoffs are next?  This real concern causes employees to feel uncertain about their jobs and livelihood.  As it is often said, people are creatures of habit, and the status quo always feels safer, easier and better.

Workflow automation introduces transparency:

Most of the time, manual processes run slowly, not due to the process steps, but due to the friction involved in the workflow steps passing from person to person or from entering data multiple times in different systems.  That creates delays.  Some delays are unintentional (i.e. “the email went to my spam”, or “the file was under a pile of papers on my desk”, or “I had to rekey the data 3 times”), while others can be intentional (i.e. “I am going to wait on processing this so that I don’t get assigned too many”).  In any case, transparency eliminates all of the delays.  When a workflow is automated, everyone can see where the process is at, how long it has been with someone and when they were notified. In addition, real time reports can compare how long steps take to complete based on role or function. These benefits eliminate the ability for someone to hide behind excuses for not completing their job.  In addition, there is no need to re-enter data in different systems as the workflow can be integrated and send the data automatically which eliminates human error.  Transparency can make some employees nervous as they can no longer hide behind and blame the inefficiencies of a manual process.  Everything is visible and transparent.

Workflow automation takes away control:

Many long term employees at companies develop institutional knowledge over time, and when a process is manual, their input and knowledge is critical to ensuring the successful completion of the workflow.  Some people feel a sense of entitlement, power and security, if they are the only ones who understand the process and can ensure it is executed correctly.  As such, they feel they are in control over situations or can exert control when needed, given they are the experts and no one can challenge them and everyone needs their help.  When automation is introduced however, the goal is to codify the institutional knowledge into the system process rules, templates and workflow.  Those who felt safe in their positions due to the knowledge that only they possessed, now face the reality that they will no longer be needed to run the process.   Automation takes control away from an individual as the process becomes institutionalized in the platform and it guides everyone on how to complete it successfully.

In a follow up post, we will discuss and share best practices and strategies that will help overcome these fears and increase substantially the adoption of workflow automation. If you’d like to learn more and create a Proof of Concept app with Intellect, click here for a free trial. http://www.intellect.com/free-trial